linjc16/ctgov huggingface dataset:
Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.

Official Title
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Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia, Adult

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years primary diagnosis of acute myeloid leukemia diagnosis results available written informed consent ability to understand the nature of the study and the study related procedures and to comply with them Exclusion Criteria: age < 18 years lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with AML<br>Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation | |
| Healthy controls<br>Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMTM6 expression (FC) | CMTM6 expression on blasts/monocytes will be measured by flow cytometry | At primary diagnosis | 
| T cell activation (FC) | T cell activation and cytokine production will be measured by flow cytometry | At primary diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMTM6 expression (WB) | CMTM6 expression on blasts/monocytes will be measured by Western blot | At primary diagnosis |
TENS and Orthognathic Surgery

Study Overview
=================
Brief Summary
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All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks

Official Title
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The Effect of Transcutaneous Stimulation (TENS) on the Recovery of Muscle Function After Orthognathic Surgery

Conditions
-----------------
Orthognathic Surgery

Intervention / Treatment
-----------------
* Behavioral: TENS
* Behavioral: sham TENS


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Class II facial deformity absence of temporomandibular joint pain and preoperative opening mouth limitation normal cranial form presence of dentition Fit to GA Exclusion Criteria: temporomandibular joint pain and preoperative opening mouth limitation; craniofacial anomalies and abnormal cranial form absence of facial trauma, mandibular condylar fracture

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS arm<br> | Behavioral: TENS<br>* apply TENS after orthognathic surgery<br>|
| Active Comparator: non TENS arm<br> | Behavioral: sham TENS<br>* apply non active TENS after orthognathic surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum mouth opening | will be measured by caliber between the incisal edges of upper and lower centrals | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale | will be measured by VAS scale at the same time points of mouth opening(0_10) 0 represent no pain,10represent high pain | 6months | 
| muscle activity | measured by EMG at the same time points | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthognathic, TENS, EMG
Imfinzi/Imjudo NSCLC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Study Overview
=================
Brief Summary
-----------------
To collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer who receive combination therapy of IMJUDO, IMFINZI and other platinum-based anti-cancer agents under actual use in the postmarketing setting.

Detailed Description
-----------------
This investigation will be conducted to collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who receive combination therapy of IMJUDO Intravenous Infusion 25mg, IMFINZI Intravenous Infusion 120mg, 500mg and other platinum-based anti-cancer agents under actual use in the postmarketing setting. The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Postmarketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Among the safety specifications defined in the Japan Risk Management Plan of IMJUDO and IMFINZI, the following items are set as the safety specifications for this study. Interstitial lung disease, Colitis/Severe diarrhoea/Gastrointestinal perforation, Hepatic function disorder/Hepatitis/Cholangitis sclerosing, Endocrine disorders (Dysfunction thyroid, Adrenal dysfunction, Pituitary dysfunction), Type 1 diabetes mellitus, Renal disorder (interstitial nephritis, etc.), Myositis, Myocarditis, Myasthenia gravis, Immune thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including guillain-barre syndrome), Infusion reaction, Pancreatitis, Rhabdomyolysis, Meningitis, Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal toxicity, Use in patients with a history of organ transplant (including haematopoietic stem cell transplant)

Official Title
-----------------
Specific Use-results Study of IMJUDO Intravenous Infusion 25mg / IMFINZI Intravenous Infusion 120mg,500mg All Patient Investigation in Patients With Unresectable Advanced or Recurrent Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All patients who receive IMJUDO, IMFINZI and other platinum-based anti-cancer agents for their unresectable advanced or recurrent NSCLC Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ADRs |  | 52 weeks |
Microbiota and Metabolomics of Intestinal Type of Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Compare with the gastric cavity without cancerous transformation in atrophic gastritis, analyze the microbiota and metabolomics changes in intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Detailed Description
-----------------
This study adopts a prospective cohort study. The expected recruitment time for all participants is 6 months, and all cases are cases who would receive magnifying endoscopy examination. The extent of atrophy and the presence of early gastric cancer are determined under magnifying endoscopy. Cases are chose into the gastric cancer group and atrophic gastritis group in a 1:1 ratio. There are 16 cases of intestinal type of gastric cancer under the background of atrophic gastritis, and 16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy, totaling 32 cases. Analyze the characteristics of early gastric cancer under endoscopy, investigate the changes in microbiota and metabolomics of intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Official Title
-----------------
Microbiota and Metabolomics of Intestinal Type of Gastric Cancer in the Context of Atrophic Gastritis

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: •Intestinal type of gastric cancer or atrophic gastritis Underwent Endoscopic submucosal dissection（ESD） Exclusion Criteria: • have simultaneously other cancer have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the gastric cancer group<br>16 cases of intestinal type of gastric cancer under the background of atrophic gastritis | |
| the atrophic gastritis group<br>16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics results of lesions and atrophic gastritis. | liquid chromatograph mass spectrometer metabolic profling | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiomics of lesions and atrophic gastritis. | 16SrRNA analysis | 1 year |
Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to investigate methodological if ultrasound is comparable to chest X-ray in verification of intensive care patients enteral feeding tube positioning. The main question to answer is: Is ultrasound a comparable method to chest X-ray in verification of intensive care patients enteral feeding tube positioning.

Detailed Description
-----------------
In Norway, around 4000 patients are yearly in need of ventilator, and many of them will need enteral nutrition through a feeding tube. 40 % of all intensive care patients have signs of malnutrition. If ultrasound is a comparable method to chest X-ray in verification of intensive care patients enteral feeding tube positioning, then enteral nutrition in many cases can be started several hours earlier than using chest X-ray verification. The ultrasound examination will be performed in a research based in a 4-step approach. In this project 20-30 intensive care patients prescribed by a medical physician to have an enteral feeding tube will be included in the project due to written informed consent by 1) Awake intensive care patient or by 2) Patients informal caregiver if the patient is not competent to consent.

Official Title
-----------------
Investigate if Ultrasound is Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning in an Observational Study

Conditions
-----------------
Intensive Care Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive care patient prescribed by a medical physician to have an enteral feeding tube Exclusion Criteria: <18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring enteral tube position both by standard chest X-ray and ultrasound | Ultrasound measure by a research based 4-step approach | maximum five minutes for each method | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive care patient, Enteral feeding tube
Systane® Complete Preservative Free Lubricant Eye Drops

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) Lubricant Eye Drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by DED groups.

Detailed Description
-----------------
Subjects will participate in the study for approximately 30 days, with a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete a patient questionnaire on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB].

Official Title
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Systane® Complete Preservative Free Lubricant Eye Drops

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Propylene glycol solution/drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be able to understand and sign an informed consent form Subject with mild to moderate dry eye Other protocol-defined inclusion criteria may apply Exclusion Criteria: Has suffered any ocular injury to either eye in the past 3 months prior to screening. Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study. Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Complete Preservative-Free<br>1-2 drops in each eye four times a day for 30 days | Other: Propylene glycol solution/drops<br>* commercially available eye drops<br>* Other names: Systane Complete Preservative-Free;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean overall IDEEL-Symptom Bother(SB) score | The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint. | Visit 3 (Day 30) |
Association Between Uric Acid and Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to acess the association between admission serum uric acid level and in_hospital outcomes in patients with acute coronary syndromes

Detailed Description
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Prospective study To acess patients with acute coronary syndrome including one of (typical Chest pain _ECGchanges _elevated cardic enzyme) the complication occur in patients with hyperurecemia and those with normal uric acid

Official Title
-----------------
The Association Between Serum Uric Acid Level and Acute Coronary Syndrome in_hospital Outcomes

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Uric acid level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with acute coronary syndrome with one of the Following Typical Chest pain ECG changes Elevated cardiac enzyme Exclusion Criteria: patients aged less than 18 years patients with gout patients with treated with diuretics Patient with CKD Patient with chronic haemolytic anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with normal uric acid levels<br>Patient with uric acid level (2.5_6)for femal and (3_7)for males | Diagnostic Test: Uric acid level<br>* Uric acid will be measured for all Patients with acute coronary syndrome and result will be analysed<br>|
| Patients with elevated uric acid level (hyperurecemia)<br>Uric acid level more than 7 for males and more than 6 for female | Diagnostic Test: Uric acid level<br>* Uric acid will be measured for all Patients with acute coronary syndrome and result will be analysed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between serum uric acid level and acute coronary syndrome in hospital outcomes | Comparision between Patient with hyperurecemia and those with normal uric acid level | From the day of admission and 30 days post discharge |
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

Official Title
-----------------
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: FAB122


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who completed the full study period in the main ADORE study (FAB122-CT-2001); whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view; a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria: female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating. female subject who is not of reproductive potential is eligible without requiring the use of contraception a male patient must: agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential Exclusion Criteria: Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Drug: FAB122 Daily dose 100 mg | Drug: FAB122<br>* FAB122 Daily dose 100 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nature, frequency and severity of Treatment Emergent Adverse Events. |  | 3 years |
Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy

Study Overview
=================
Brief Summary
-----------------
Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data. The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.

Official Title
-----------------
Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy. Exclusion Criteria: < 18 years patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT with coline in patients previously treated with radical prostatectomy. | Retrospective observational study with 302 patients with prostate cancer were considered. | 1 year |