linjc16/ctgov huggingface dataset:
Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

Study Overview
=================
Brief Summary
-----------------
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine or Risperidone + Aripiprazole
* Drug: Quetiapine or Risperidone + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder Stable symptoms and dose of Quetiapine or Risperidone Exclusion Criteria: First diagnosis in the past year Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quetiapine or Risperidone + Aripiprazole<br> | Drug: Quetiapine or Risperidone + Aripiprazole<br>* Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: Quetiapine or Risperidone + placebo<br> | Drug: Quetiapine or Risperidone + placebo<br>* Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint |  | (Week 16) or at time of discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S) |  | at endpoint (Week 16) |
Resistant Starch, Antioxidant Status and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.

Official Title
-----------------
The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Hi-maize resistant starch
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight and obese adults Age: 20-50 years Exclusion Criteria: weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month pregnancy, lactation or menopause History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease Gastrointestinal disease of which ingredients found in the study products have adverse effects on that Use of antihypertensive, lipid lowering or glucose lowering medications Taking antioxidant, vitamin, and/or mineral supplements smoking

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hi-maize resistant starch<br>13.5 g/day | Dietary Supplement: Hi-maize resistant starch<br>* 13.5 g/day<br>|
| Placebo Comparator: Maltodextrin<br>13.5 g/day | Dietary Supplement: Maltodextrin<br>* 13.5 g/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant status | Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR) | 4 weeks | 
| Lipid profile | Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol | 4 weeks | 
| Blood pressure |  | 4 weeks | 
| Anthropometric parameters | Height, Weight, Body Mass Index (BMI), Waist circumference | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant Starch, Antioxidant Status, Insulin Resistance, Overweight, Obesity
The Effect of Diabetes on the Newborn

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test and compare biochemical, hematological, and inflammatory factors in diabetic and healthy pregnant mothers and in their newborns.

Official Title
-----------------
Biochemical, Hematologic, and Inflammatory Effects of Diabetes on the Newborn

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Macrosomial, GD<br> | |
| Macrosomial, control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress | New borns of diabetic mother may have oxidative stress | Immediately after delivery by cesarean section |
Reproductive Health in Men and Women With Vasculitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

Detailed Description
-----------------
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.

Official Title
-----------------
Reproductive Health in Men and Women With Vasculitis

Conditions
-----------------
Behcet's Disease, Giant Cell Arteritis, Takayasu's Arteritis, Polyarteritis Nodosa, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Kawasaki Disease, Henoch-schoenlein Purpura, Vasculitis, Central Nervous System, Drug-induced Necrotizing Vasculitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in VCRC Contact Registry Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis 18 years of age or older English speaking Exclusion Criteria: Inability to provide informed consent and complete survey

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 |
| --- | --- | --- |
| The rate of infertility with and without prior cyc. |  | 1 year after the study is closed to enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis. |  | 1 year after the study is closed to enrollment |
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT

Study Overview
=================
Brief Summary
-----------------
A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)

Detailed Description
-----------------
The primary objective of this study is to capture high quality patient safety and effectiveness data on CDT for acute PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for PE patients undergoing CDT. Secondary study objectives include the following: - To assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide) These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of CDT for PE and to facilitate the design of randomized clinical trials

Official Title
-----------------
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Procedure: Catheter directed debulking of Pulmonary Embolus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be Age greater than or equal to 18 Obtain informed written consent. Diagnosed with acute pulmonary embolism (PE) (< 14 days) Catheter-directed therapy (CDT) was performed to treat acute PE

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients undergoing Pulmonary Embolectomy<br> | Procedure: Catheter directed debulking of Pulmonary Embolus<br>* A catheter will be used to break up the pulmonary embolism<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of hypoxia |  | Post-procedure and 3 months | 
| Survival from acute PE |  | Post-procedure and 3 months | 
| Stabilization of hemodynamics |  | Post-procedure and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical practice patterns across centers |  | 5yrs |
Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.

Official Title
-----------------
Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: ldalopirdine 120 mg
* Drug: Idalopirdine 360 mg
* Drug: Moxifloxacin 400 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2 Good general health ascertained by a detailed medical history, laboratory tests and physical examination Use of contraception. Exclusion Criteria: The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.). Other protocol defined inclusion and exclusion criteria do apply

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsules, orally, single dose<br>|
| Experimental: Idalopirdine 120 mg<br>Therapeutic dosages | Drug: ldalopirdine 120 mg<br>* Two 60 mg encapsulated film-coated tablets, orally, single dose<br>|
| Experimental: Idalopirdine 360 mg<br>Supra-therapeutic dosages | Drug: Idalopirdine 360 mg<br>* Four 90 mg encapsulated film-coated tablets, orally, single dose<br>|
| Active Comparator: Moxifloxacin 400 mg<br>Positive Control | Drug: Moxifloxacin 400 mg<br>* Encapsulated tablets, orally, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period | The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF) | For 24 hours in each dosing period |
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
This randomised controlled trial aims to compare the effect of microwave diathermy (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain patients. Every patient will also be treated by exercise and transcutaneous electrical neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves is justified in terms of pain relief or reduction of disability in this patients.

Official Title
-----------------
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Radiation: Continuous microwave
* Radiation: Pulsed microwaves
* Procedure: Sham microwaves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be between 18 and 65 years old to be diagnosed with chronic nonspecific neck pain (i.e. during more than 3 months in the absence of red flags (unexplained weight loss, fever, neurological signs, history of cancer, history of inflammatory conditions...) Exclusion Criteria: pregnancy sick leave litigation claims because the neck pain.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Microwave<br> | Radiation: Continuous microwave<br>* Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks<br>|
| Experimental: Pulsed Microwaves<br> | Radiation: Pulsed microwaves<br>* Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks<br>|
| Sham Comparator: sham microwaves<br> | Procedure: Sham microwaves<br>* Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain at six months | Pain as measured by visual analogic scale | Baseline. At three weeks. At six months | 
| Change from baseline in neck disability at six months | Neck disability as measured by Neck Disability Index and Northwick Park Neck Pain Questionnaire | Baseline. At three weeks. At six months | 
| Change from baseline in quality of life at six months | Quality of life as measured by SF-36 questionnaire | Baseline. At three weeks. At six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diathermy, Neck Pain
Ocular Hypertension Treatment Study (OHTS)

Study Overview
=================
Brief Summary
-----------------
The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the National Eye Institute, designed to determine the efficacy and safety of topically administered eye lowering medication

Official Title
-----------------
Ocular Hypertension Treatment Study

Conditions
-----------------
Ocular Hypertension, Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart. Normal and reliable 30-2 Humphrey Visual Fields in both eyes. Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center. Exclusion Criteria: Visual acuity worse than 20/40 in either eye on qualifying exam. Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population

Official Title
-----------------
A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intraesophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg od in Patients With Non-erosive Reflux Disease (NERD).

Conditions
-----------------
Non-erosive Reflux Disease

Intervention / Treatment
-----------------
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Written informed consent, ability to comply with study instructions Exclusion Criteria: Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety |  |  |