linjc16/ctgov huggingface dataset:
In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic responses to infliximab antibody and can be used for personalized medicine in ulcerative colitis.

Official Title
-----------------
In Vivo Molecular Imaging With Infliximab Antibody With FITC Predicts Therapeutic Response in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with active ulcerative colitis will receive infliximab antibody therapy. Exclusion Criteria: Patients with impaired blood clotting. Patients with short bowel syndrome. Patients during the pregnancy and lactation period. Patients received enema therapy within 1 month before inclusion in the study, or had anti-TNF therapy within the last 12 months. Patients participated in another clinical trial or administrated other investigational drugs within 4 months prior to the screening visit. Patients with moderate to severe heart failure, active tuberculosis or acute infections.

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 |
| --- | --- |
| Molecular Imaging With IFX-FITC<br>Endoscopic examination with the fluorescent antibody (IFX-FITC) was performed in patients with active ulcerative colitis before infliximab therapy was initiated. Labeled infliximab was applied topically via a standard spray catheter onto the most inflamed region of the bowel during colonoscopy, followed by CLE. In vivo imaging of inflamed areas of the intestinal mucosa showed a specific fluorescence signal of mTNF+ cells after topical application of labeled adalimumab. These specific fluorescence signals were recorded. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of specific fluorescence signal of mTNF+ cells in patients with UC |  | 30 months |
3 Year Retrospective Analysis of IVF in Comparison With INVOcell

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

Detailed Description
-----------------
The following aspects of data will be collected to support the analysis of the two methods Procedure details for including oil overlay and incubation time frame Characteristics of embryo quality and phase of development and transfer rates Clinical pregnancy rate Live birth rate Secondary: Data regarding safety Adverse events noted by the women that received IVF and INVOcell IVC Adverse events noted for the offspring

Official Title
-----------------
A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: INVOcell IVC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection. Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INVOcell IVC<br>IVF using intravaginal incubation with INVOcell device for embryo development. | Device: INVOcell IVC<br>* Embryo development in intravaginal incubation<br>|
| Traditional IVF (tIVF)<br>Traditional IVF using laboratory equipment and incubators for embryo development | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo development | Characteristics of embryo quality and phase of development and transfer rates | 5 days | 
| Clinical pregnancy rate | Clinical pregnancy rate | 5 days | 
| Live birth rate | Live birth rate | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Adverse Events | Adverse events noted by the women that received IVF and INVOcell IVC | 5 days | 
| Offspring adverse events | Adverse events noted for the offspring | 5 days |
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries

Study Overview
=================
Brief Summary
-----------------
Single dose 600 mg gabapentin will be given preoperatively in anal surgeries

Detailed Description
-----------------
Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively

Official Title
-----------------
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II Aged from 18 to 65 years Scheduled for anal surgeries at Minya University Hospital Exclusion Criteria: Presence of contraindications to neuraxial anesthesia Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse. The use of neuropathic analgesic or antiepileptic drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups are included in the study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: postoperative pain<br>Measuring postoperative pain using the visual analogue scale | |
| Other: total analgesic consumption<br>Recording the total amount of analgesia consumed by the patients | Drug: Gabapentin<br>* single preoperative dose of 600 mg gabapentin<br>* Other names: Gaptin 600 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain | first 12 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gabapentin,, anal surgery,, postoperative pain
Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients

Official Title
-----------------
Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy

Conditions
-----------------
Mucositis Oral

Intervention / Treatment
-----------------
* Dietary Supplement: Hydrogen tablets
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor, Planning to receive daily fractionated radiotherapy for over 4 weeks' duration Karnofsky Performance Score (KPS) of at least 70 Able to describe pain Able to swallow food and water Able to sign consent Exclusion Criteria: -

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Dietary Supplement: Control<br>* Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that does not release any molecular hydrogen, for the duration of the radiation therapy<br>|
| Experimental: Active<br> | Dietary Supplement: Hydrogen tablets<br>* Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that releases molecular hydrogen, for the duration of the radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who develop grade 3 oropharyngeal mucositis |  | 3 months after completing radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck cancer, radiation therapy, supportive care
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors

Official Title
-----------------
Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Progevera
* Drug: Orgalutran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oocyte donors included in the oocyte donation program of Clinica EUGIN. 1st oocyte donation cycle at Clínica EUGIN. Exclusion Criteria: Polycistic Ovarian syndrome (PCOs). Estradiol levels on day 2 of menstrual cycle >70 pg/ml. Hormone treatments up to 3 months before the oocyte donation cycle. Medical contraindication to the treatments used in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progevera<br>Progevera 10 mg | Drug: Progevera<br> <br> |
| Active Comparator: Orgalutran<br>Orgalutran 0.25 mg | Drug: Orgalutran<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| donor ovarian response |  | 1 month |
Music and Perceived Rate of Exertion

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients.

Official Title
-----------------
Influence of a Distractive Auditory Stimulus on the Rate of Exertion During Pulmonary Rehabilitation Sessions

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participate in the program for at least one month after the initial medical investigation, be free of exacerbations for 1 month and have maintained exactly the same program session for both evaluated sessions Exclusion Criteria: participate to only session of one condition

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With music<br>Pulmonary rehabilitation with music in the room | Behavioral: Music<br> <br> |
| No Intervention: Without music<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of exertion |  | After 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Using a visual analogue scale | After 1 hour | 
| Hospital Anxiety Depression Scale | The score of anxiety and depression will be measured | After 1 hour |
Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division

Study Overview
=================
Brief Summary
-----------------
EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of lung cancer enlarged mediastinal or hilar lymph nodes (>10 mm) Exclusion Criteria: -

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 |
| --- | --- | --- |
| Sensitivity and Specificity of lung cancer diagnosis | We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful performed molecular RNA based analysis | We will analyse the second half of the sample regarding molecular analysis. RNA concentration and RNA integrity score will be assessed before a new RNA based test will be evaluated. | 3 month |
Retrospective Study of the Survival of Patients Suffering From Hiv-related Progressive Multifocal Leukoencephalopathy

Study Overview
=================
Brief Summary
-----------------
Retrospective medical chart review of HIV-infected patients diagnosed with progressive multifocal leukoencephalopathy

Conditions
-----------------
Progressive Multifocal Leukoencephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients Diagnosed with progressive multifocal leukoencephalopathy Minimal follow-up of one year OR patient deceased less than one year after diagnosis Exclusion Criteria: Loss of follow-up within 12 months after diagnosis

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 |
| --- | --- | --- |
| Rankin score |  | 12 months after diagnosis of leukoencephalopathy |
Phase I Pharmacokinetic Study (SALBLOCK)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the extent to which the charcoal prevents the absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).

Official Title
-----------------
Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: salmeterol / fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females aged 18-60 Normal weight at least 50 kg Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study. Known hypersensitivity to the active substance(s) or to the excipients of the drug. Pregnant or lactating females.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Salmeterol/fluticasone propionate with concomitant charcoal | Drug: salmeterol / fluticasone propionate<br>* 100/1000 μg oral capsule<br>|
| Experimental: Treatment B<br>Salmeterol/fluticasone propionate without concomitant charcoal | Drug: salmeterol / fluticasone propionate<br>* 100/1000 μg oral capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameter Area Under Curve (AUC) time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose. | The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic variables Cmax and tmax time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose. |  | 24 hours |
Special Survey for Patients With Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.

Official Title
-----------------
Special Survey for Type 1 or Type 2 Diabetic Patients

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with no treatment history of insulin aspart (NovoRapid®)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin aspart users<br> | Drug: insulin aspart<br>* Prescribed by the physicians as a result of normal clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of severe hypoglycaemic symptoms |  | Year 1 | 
| Occurrence of severe hypoglycaemic symptoms |  | Year 2 for patients who had an antibody titre test performed | 
| Antibody titre findings |  | Year 1 | 
| Antibody titre findings |  | Year 2 for patients who had an antibody titre test performed | 
| Adverse events |  | Year 1 | 
| Adverse events |  | Year 2 for patients who had an antibody titre test performed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control |  | Year 1 | 
| Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control |  | Year 2 for patients who had an antibody titre test performed | 
| HbA1c (glycosylated haemoglobin) |  | Year 1 | 
| HbA1c (glycosylated haemoglobin) |  | Year 2 for patients who had an antibody titre test performed | 
| Total dose of insulin infused subcutaneously |  | Year 1 | 
| Total dose of insulin infused subcutaneously |  | Year 2 for patients who had an antibody titre test performed |