linjc16/ctgov huggingface dataset:
Gastrointestinal Symptom Questionnaire Validation

Study Overview
=================
Brief Summary
-----------------
Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

Detailed Description
-----------------
210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.

Official Title
-----------------
Gastrointestinal Symptom Questionnaire Validation

Conditions
-----------------
Those With and Without Gastrointestinal Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: As above Either healthy or GI disease or non-GI disease Exclusion Criteria: Unable to provide informed consent

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 |
| --- | --- |
| Healthy<br>Volunteers over 18 years | Other: Questionnaire<br>* Form filling only<br>|
| Gastrointestinal disorders<br>Over 18 and with any gastrointestinal or liver disorder | Other: Questionnaire<br>* Form filling only<br>|
| Non-gastrointestinal disorders<br>Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease | Other: Questionnaire<br>* Form filling only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Construct validity measured by Validation of new score | Validation of new score | 18 months |
Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Detailed Description
-----------------
This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Official Title
-----------------
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

Conditions
-----------------
Pregnancy, Neonates

Intervention / Treatment
-----------------
* Drug: Org 36286
* Drug: recFSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and Able and willing to give written informed consent. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group 1<br>all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg) | Drug: Org 36286<br>* single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)<br>* Other names: Corifollitropin alfa;|
| Experimental Group 2<br>150 IU recFSH | Drug: recFSH<br>* 150 IU recFSH daily (reference group administered under protocol 38826)<br>* Other names: Follitropin Beta, Puregon®, Follistim®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy status at 20 weeks of gestation |  | one pregnancy period | 
| Take-home baby rate |  | one pregnancy period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy follow-up |  | one pregnancy period | 
| Delivery follow-up |  | one pregnancy period | 
| Neonatal outcome |  | one pregnancy period | 
| Infant follow-up |  | one pregnancy period | 
| Congenital malformations and chromosomal abnormalities |  | one pregnancy period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal outcome, Congenital malformations, In-Vitro Fertilization, Controlled ovarian stimulation, Follow-up
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.

Official Title
-----------------
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study)

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Amlodipine/Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are above target LDL-C and BP who are eligible for treatment Exclusion Criteria: High liver enzymes

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine/Atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the number of patients who reach target blood pressure (BP) and |  |  | 
| LDL-C targets as defined by their governing guidelines. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes from baseline to end of treatment for the following efficacy |  |  | 
| parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein |  |  | 
| cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure |  |  | 
| (SBP) and Diastolic Blood Pressue (DBP). |  |  |
Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.

Study Overview
=================
Brief Summary
-----------------
The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items assessing motor functional abilities in a person with neuromuscular disease. By exploring the potential of digital technologies applied to MFM, for each item completion we want to create digital animations containing different playful and informative scenarios. This digital evolution aims to standardize assessment on the therapist's side, but also to improve acceptance of scale and patient participation. Despite the modification of the MFM completion by digital animation, the study hypothesis is that the metrological qualities of the scale are retained. Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale before carrying out a validation study of the total MFM-Play.

Official Title
-----------------
Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.

Conditions
-----------------
Neuromuscular Diseases

Intervention / Treatment
-----------------
* Other: MFM-Play


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Girls and boys with a neuromuscular disease Aged 6 to 11 years old With parental assent Exclusion Criteria: Patients participating to a therapeutic trial Patients without compartmental capacities to participate normally to the MFM.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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 |
| --- | --- |
| MFM completion<br> | Other: MFM-Play<br>* Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MFM scores item 18 to 22 | Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular Diseases
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

Official Title
-----------------
A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis

Conditions
-----------------
Behcet's Disease Uveitis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline Effective contraceptive measures Exclusion Criteria: Infectious uveitis and masquerade syndromes End stage ocular disease History of allergic or anaphylactic reactions to monoclonal antibodies Active tuberculosis disease History of recurrent infection or predisposition to infection; active ocular infection Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for subcutaneous injection<br>|
| Experimental: Gevokizumab<br> | Drug: Gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first ocular exacerbation | Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation. | Randomization through Day 280 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behcet's Disease Uveitis, Uveitis, Behcet's Disease
Bioequivalency Study of Torsemide Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fasting Conditions

Conditions
-----------------
Edema

Intervention / Treatment
-----------------
* Drug: Torsemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Torsemide or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Torsemide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Metabolomics of Children With SMA

Study Overview
=================
Brief Summary
-----------------
The aim of the proposed project is to evaluate whether the metabolome of patients with spinal muscular atrophy (SMA) before the initiation of treatment with nusinersen differs from the metabolome of healthy individuals and whether it changes 14 months after treatment with nusinersen.

Detailed Description
-----------------
Spinal muscular atrophy (SMA) is a severe, debilitating disease and is an important source of morbidity and mortality of children. Novel disease modifying therapies can alter the natural course of the disease. However, many aspects of their action remain unknown. Metabolomics is the large-scale study of metabolites, within cells, biofluids, tissues or organisms. Collectively, these small molecules and their interactions within a biological system are known as the metabolome. The aim of this study is to evaluate whether the metabolome of patients with SMA before the initiation of disease modifying therapy with nusinersen differs from the metabolome of healthy individuals. Next, we would like to asses whether tretament with nusinersen alters the metabolome of patients with SMA. Utilizing metabolomics, we would like to assess whether we can identify parameters reflecting the state of the disease in a particular patient, and parameters with diagnostic and/or prognostic value. Using metabolomics, we will aim to identify SMA patients that will positively respond to gene therapy.

Official Title
-----------------
Metabolome of Children With Spinal Muscular Atrophy Treated With Nusinersen

Conditions
-----------------
Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Drug: Nusinersen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed SMA Age up to 21 years Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Children with SMA<br>All children with SMA are eligible for the study | Drug: Nusinersen<br>* Treatment with nusinersen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic difference from healthy children | Metabolomic difference between children with SMA and healthy children | Beginning of study | 
| Metabolomic change before and after treatment | Metabolomic change in children with SMA before and after treatment with nusinersen | At least 14 months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy, nusinersen, metabolome
Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.

Detailed Description
-----------------
This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.

Official Title
-----------------
The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Chlorthalidone 12.5 mg
* Drug: Hydrochlorothiazide 25 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 or older Diagnosis of hypertension Current blood pressure > 120/80 mm Hg Exclusion Criteria: Use of a thiazide-type diuretic within the last 1 month Known allergy to any study medications History of gout or hyperuricemia SCr >/= 1.8 mg/dl or CrCl < 25 ml/min Pregnancy or breastfeeding or planning to become pregnant during study period Dementia or cognitive impairment Hypokalemia Acute coronary syndrome or stroke within 6 months Current use of sildenafil, tadalafil, or vardenafil

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. | Drug: Placebo<br> <br> |
| Experimental: Chlorthalidone 12.5 mg<br>Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. | Drug: Chlorthalidone 12.5 mg<br> <br> |
| Active Comparator: Hydrochlorothiazide 25 mg<br>Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. | Drug: Hydrochlorothiazide 25 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated vasodilatation | Flow mediated vasodilatation will be measured after one month on each drug and placebo | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Endothelial dysfunction
Chronic Constipation in Children Among School Children is Assuit University Children Hospital

Study Overview
=================
Brief Summary
-----------------
Aim of the work to show rate of constipation among school age children in Assuit University Children Hospital

Detailed Description
-----------------
Childhood constipation is a frequently overlooked global health problem, which is developing in a public health issue in many parts of the world.(1) Constipation is one of the commonest digestive complaints in children(2) Constipation has long been considered a symptom, rather than a disease(3) It is often perceived as infrequent motions or passage of hard stools. Some defined constipation as less than 3 bowel motions per week)4( or as difficulty in passing stools (5) Approximately 0.5% of school children have defecation frequency less than 3 per week and 0.3% have fecal incontinence(6) Furthermore, 20% of children also have at least 1 clinical feature of constipation.7 Therefore, it is important to use diagnostic criteria based on multiple symptoms to define constipation

Official Title
-----------------
A Study on Chronic Constipation Etiology and Risk Factors Among School Age Children in Assuit University Children Hospital

Conditions
-----------------
Chronic Constipation in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:school age children 4:18 years old - Exclusion Criteria: neonates and younger than 4years children -

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A.study on chronic Constipation Etiology and risk factors among school age children in Assuit University Children Hospital | Constipation, risk factors ,management and outcomes | Baseline |