linjc16/ctgov huggingface dataset:
Patient Experience With OMS Procedures Regarding Anesthesia

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to know more about the experience/satisfaction of patients undergoing oral and maxillofacial surgery (OMS). Depending on the type of procedure, the patient will receive a sedation or a general anesthesia. At the first day post-operatively, patients will be contacted to complete a questionnaire. The questionnaire will be subdivided into anaesthesia-related discomfort and anaesthesia care in general.

Official Title
-----------------
Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: OMS procedure signed informed consent Age above 12 years Exclusion Criteria: need for post-operative hospitalization mental disorder with no capability of filling in questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OMS procedure under general anesthesia or sedation<br>Questionnaire | Other: Questionnaire<br>* Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bauer questionnaire at post-operative day 1 | The Bauer questionnaire contains a set of questions on anaesthesia-related discomfort and another set on satisfaction with anaesthesia care in general. The questions on discomfort will be assessed on a 3-point scale, and those on patient satisfaction on a 4-point scale. | post-operative day 1 | 
| Brice questionnaire at post-operative day 1 | The questionnaire attempts to identify patients who may have had memories of their operation i.e. accidental awareness under anesthesia. These are open questions. | post-operative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General anesthesia, Sedation
Different Endoscopic Gastric Cancer Risk Assessments

Study Overview
=================
Brief Summary
-----------------
The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.

Official Title
-----------------
Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer

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

Intervention / Treatment
-----------------
* Procedure: Kimura-Takemoto classification
* Procedure: EGGIM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 40-80 years undergoing gastroscopy Patients intend to undergo ESD treatment Exclusion Criteria: patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy Patients with previous surgical procedures on the stomach patients with contraindications to biopsy Patients who refuse to sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kimura-Takemoto classification<br> | Procedure: Kimura-Takemoto classification<br>* All patients were given two risk scores, the order of which was randomly determined.<br>|
| Active Comparator: EGGIM<br> | Procedure: EGGIM<br>* All patients were given two risk scores, the order of which was randomly determined.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early gastric cancer detection rate | The detection rate of early gastric cancer | 36 months |
NSAID Treatment of Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.

Official Title
-----------------
BEVAR: Patientspecifik Behandling Ved Artrose - Et Proof-of-concept- Kvalitetssikringsstudie

Conditions
-----------------
Osteoarthritis,Knee

Intervention / Treatment
-----------------
* Drug: NSAID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed Knee Ostoarthritis Exclusion Criteria: Current ulcer diagnosed by endoscope Asthma or other allergic reaction to NSIADs Kidney disease Myocardial infarction within the last six months Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg) Severe thrombocytopenia (thrombocyst count <50x10^9/l) Insufficience lever or kidney function

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAID treatment<br>8 weeks of NSAID treatment | Drug: NSAID<br>* NSAIDs are among the most common pain treatments for patients with osteoarthritis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured on a 10cm visual analog scale | Patients will be asked to rate the pain intensity 8 weeks after treatment on a 10cm visual analog scale (0 indicating no pain, 10 indicating worst imaginable pain | 8 weeks after treatment |
Registry of Patients With Hypophosphatasia

Study Overview
=================
Brief Summary
-----------------
In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.

Detailed Description
-----------------
The HPP Registry is an observational, prospective, long-term registry designed to collect data on HPP epidemiology, disease history, clinical course, symptoms and burden of disease from patients of all ages who have a diagnosis of HPP. Evaluation of safety and effectiveness data in patients with HPP who have/are receiving treatment with Asfotase alfa

Official Title
-----------------
An Observational, Longitudinal, Prospective, Long-Term Registry Of Patients With Hypophosphatasia (HPP)

Conditions
-----------------
Hypophosphatasia (HPP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants, of any age, with a confirmed diagnosis of HPP. Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation. Participant or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language. Signed informed consent and medical records release by the patient or legal representative. Patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations. Exclusion Criteria: Currently participating in an Alexion-sponsored clinical trial. Enrollment in the Registry will not exclude a patient from enrolling in a future clinical trial.
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 |
| --- | --- | --- |
| Natural History Information | To collect information on the natural history of HPP from patients of all ages, including pediatric patients and adults with HPP, regardless of age at onset. | 1 Year | 
| Burden of Disease/Patient-reported Outcomes | Age-appropriate PRO data will be collected using instruments to asses below: Pain, Motor Capacity, Functional Status/Disability, including Activities of Daily Living (ADL), Quality of Life (QoL) | 1 year | 
| Characterize the epidemiology of the HPP population. | To characterize the epidemiology of the HPP population. Inclusion of all classifications of HPP is planned: pediatric-onset (perinatal-, infantile-, and juvenile-onset), adult-onset, benign perinatal, and odontohypophosphatasia. | 1 year | 
| Long-Term Safety and Effectiveness of Asfotase Alfa | To collect and evaluate long-term safety and effectiveness data in HPP patients who have/are receiving treatment with asfotase alfa. | 1 year |
Intravenous Immunoglobulins for Post-Polio Syndrome

Study Overview
=================
Brief Summary
-----------------
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.

Conditions
-----------------
Post-polio Syndrome

Intervention / Treatment
-----------------
* Biological: intravenous immunoglobulins
* Biological: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a history of acute poliomyelitis increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi Exclusion Criteria: clinically relevant systemic disease malignancy hypothyroidism diabetes mellitus not fully controlled by medical therapy medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome conditions associated with prolonged coagulation time serum IgA deficiency previous allergic reaction to IVIG body-mass index greater than 30 immune-modulating treatments other than IVIG within the preceding 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline solution<br> | Biological: Saline solution<br>* Placebo<br>|
| Experimental: intravenous immunoglobulins<br> | Biological: intravenous immunoglobulins<br>* One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 physical component |  | Baseline; 2 and 4 months after treatment |
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.

Official Title
-----------------
Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients

Conditions
-----------------
Esophagus Cancer

Intervention / Treatment
-----------------
* Biological: adenovirus-transfected autologous DC vaccine plus CIK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed diagnosis of esophagus cancer Age >18 years at time of consent Received standardized treatment of Small-Cell Lung Cancer Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks KPS (Karnofsky performance scale) >60 Patient's written informed consent No severe viral or bacterial infections Predicted survival >3 months Exclusion Criteria: Serious dysfunction of vital organs(heart, liver or kidney) History of autoimmune diseases Pregnant and breast-feeding patient Active or chronic infectious diseases History of allergy or hypersensitivity to study product excipients Currently participating in another clinical trial Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks Clinically relevant diseases or infections (HBV, HCV, HIV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: adenovirus-transfected autologous DC vaccine plus CIK cells<br> | Biological: adenovirus-transfected autologous DC vaccine plus CIK cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective rate response (CR+PR) as measured by RECIST criteria |  | Time Frame: 4 weeks after DC/CIK treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events |  | Time Frame: 3 days within DC/CIK treatment |
Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.

Conditions
-----------------
Total Hip Replacement

Intervention / Treatment
-----------------
* Device: standard polyethylene acetabular irradiated at 3 Mrad
* Other: radio stereometric analysis (RSA) of the acetabular
* Device: acetabular polyethylene vitamys®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged men and women 18 to 75 years with a primary or secondary osteoarthritis or osteonecrosis having a functional disorder requiring the installation of a total hip prosthesis of primary Exclusion Criteria: patients aged 76 years or more pregnant or desiring to be for the duration of the study minors or adults protected repeated hip replacement cephalic prosthesis recovery or intermediate repeated cupules primary or secondary malignant tumor of the hip

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acetabular polyethylene vitamys®<br>acetabular polyethylene vitamys® | Other: radio stereometric analysis (RSA) of the acetabular<br> <br> Device: acetabular polyethylene vitamys®<br> <br> |
| Active Comparator: standard polyethylene acetabular irradiated at 3 Mrad<br>standard polyethylene acetabular irradiated at 3 Mrad | Device: standard polyethylene acetabular irradiated at 3 Mrad<br> <br> Other: radio stereometric analysis (RSA) of the acetabular<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| penetration of the metal femoral head in acetabular | head penetration in milimeters | 2 years |
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

Study Overview
=================
Brief Summary
-----------------
Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.

Detailed Description
-----------------
In this study, the investigators aim to compare the effect of Nifedipine and MgSO4 therapies on Doppler parameters of the uterine, umbilical, middle cerebral arteries, and ductus venous in the first 48 hours of therapy in pregnancies with preterm labor threat and also compare perinatal outcomes after delivery between the groups.

Official Title
-----------------
Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor

Conditions
-----------------
Preterm Labor Without Delivery, Pregnancy Preterm

Intervention / Treatment
-----------------
* Drug: Nifedipine
* Drug: Magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancies with preterm labor threat between 28-34 weeks gestational ages Exclusion Criteria: Cervical dilatation at > 4 cm and/or cervical effacement >80%, Multiple pregnancies, Pregnancy complications including preeclampsia, ablatio placenta, intrauterine growth restriction, placenta previa, gestational diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulfate treatment<br>A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate. | Drug: Magnesium sulfate<br>* A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.<br>|
| Active Comparator: Nifedipine treatment<br>A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine. | Drug: Nifedipine<br>* A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.<br>|
| No Intervention: Healthy pregnant women<br>A total of 30 pregnancies without preterm labor threat will be included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler parameters | Pulsality index of middle cerebral artery. | Gestational age at delivery (weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal outcomes | NICU admission | Gestational age at delivery (weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nifedipine, Magnesium sulfate, pregnancy, preterm labor threat