linjc16/ctgov huggingface dataset:
Pulmonary Hypertension: Assessment of Cell Therapy

Study Overview
=================
Brief Summary
-----------------
The primary objective is to establish the safety of autologous progenitor cell-based gene therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to conventional treatment.

Detailed Description
-----------------
This is a two centre, phase I clinical trial. A total of 18 patients will be studied using an open-label, dose escaling protocol; three patients will be entered into each of the five dosing panels. An additional three patients will be entered into the final dose panel to establish safety at the maximum tolerated dose.

Official Title
-----------------
Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional Treatment

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Biological: eNOS transfected EPCs will be delivered via a PA line


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of idiopathic Pulmonary Arterial Hypertension Familial PAH or anorexigen induced PAH Specified 6-minute walk distance Exclusion Criteria: Intra or extra cardiac communication between the right and left sided circulations Hemodynamic instability Left ventricular ejection fraction < 40% Thromboembolic event or recent hospitalization for worsening right sided heart failure in past 3 months CVP>20mmHg at time of research heart catheterization Pregnancy Concurrent hepatitis or HIV

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eNOS transfected EPCs<br>eNOS transfected EPCs will be delivered by injection via a PA line, incremental doses over three days | Biological: eNOS transfected EPCs will be delivered via a PA line<br>* incremental dosing over 3 days<br>* Other names: eNOS transfect EPCs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints will be related to the tolerability and safety of injection of genetically engineered progenitor cells in patients with severe PAH. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential efficacy of this approach will be assessed by changes in hemodynamic pressures, patient perceived quality of life and exercise capacity |  | 3 month post cell delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Arterial Hypertension (PAH)
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.

Official Title
-----------------
A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

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

Intervention / Treatment
-----------------
* Device: Remogen
* Device: Cationorm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With at least a 3-month documented history of bilateral dry eye With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale With at least one objective sign of tear deficiency With Ocular Surface Disease Index (OSDI) score of ≥ 18 Exclusion Criteria: Refractive surgery within 12 months prior to selection Any other ocular surgery or ocular trauma within 6 months prior to selection Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

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 |
| --- | --- |
| Experimental: Remogen<br> | Device: Remogen<br>* instil 1 drop of the product in each eye, 4 times per day<br>|
| Active Comparator: Cationorm<br> | Device: Cationorm<br>* instil 1 drop of the product in each eye, 4 times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSSF | Ocular surface staining with fluorescein (OSSF) | Day 28 |
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Study Overview
=================
Brief Summary
-----------------
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.

Official Title
-----------------
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A 6-month history of constipation defined as <3 complete spontaneous bowel movements per week and >1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining Exclusion Criteria: Patients with cancer, inflammatory bowel disease or other structural bowel disease Past or current diagnosis of irritable bowel syndrome were excluded. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm. |  |  | 
| Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use. |  |  | 
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male patients, chronic constipation, tegaserod
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment

Conditions
-----------------
Acute Upper Respiratory Track Infection

Intervention / Treatment
-----------------
* Drug: Guaifenesin
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days Exclusion Criteria: patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mucinex D<br>Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days | Drug: Guaifenesin<br>* 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days<br>* Other names: Pseudoephedrine;|
| Placebo Comparator: Placebo<br>Placebo given bid with a full glass of water for 7 days | Device: Placebo<br>* Placebo bid for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Sparing | Number of patients who received an antibiotic | Day 7 | 
| Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). | WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147. | Baseline and 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Upper Respiratory Track Infection Who Seek Treatment
Register of Therapeutical Patients Over 60 Years

Study Overview
=================
Brief Summary
-----------------
Register for the study of the prevalence and burden of diseases, risk factors and outcomes of hospitalizations in older age groups in the countries of Eurasia.

Detailed Description
-----------------
An open, multicenter registry to track all major noncommunicable diseases and risk factors in older age groups, prescribed drugs, and disease outcomes.

Official Title
-----------------
Register on the Study of Prevalence and Incidence, Risk Factors and Outcomes of Hospitalizations in Older Age Groups in Eurasia.

Conditions
-----------------
Men, Age Problem, Therapeutic Alliance

Intervention / Treatment
-----------------
* Other: Non-intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 60 years Appointment to a doctor of a therapeutic profile Exclusion Criteria: Reluctance of the Patient to participate in the Register; Age under 60 at the time of inclusion in the Register.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-intervention|Non-intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | Incidence of non-infectious diseases | 12 months | 
| Non-infectious diseases | Age-related non-infectious diseases dynamics of the development of the main after 60 years | 12 months | 
| Age groups | The prevalence of various non-infectious diseases in different age groups | 12 months | 
| Therapy | Names, doses and duration of prescribed therapy | 12 months | 
| Drugs | Analysis of prescribed therapy and calculation of losses from improper treatment due to repeated hospitalizations, disability and complications | 12 months | 
| Measure criteria | 12000 patients | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
register, therapy
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Study Overview
=================
Brief Summary
-----------------
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Official Title
-----------------
Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Device: Stellarex DCB
* Device: PTA Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford Clinical Category 4-5 Life expectancy > 1 year Significant stenosis ≥70% Patent inflow artery Target vessel(s) diameter between 2 and 4 mm Target vessel(s) reconstitute(s) at the ankle Exclusion Criteria: Pregnant or planning to become pregnant History of stroke within 3 months Planned major amputation eGFR <30 Acute limb ischemia Prior stent placement in target lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellarex DCB<br>Spectranetics Stellarex Drug Coated Balloon | Device: Stellarex DCB<br>* Intervention with the Stellarex DCB<br>|
| Active Comparator: PTA Catheter<br>Standard Uncoated Balloon Angioplasty Catheter | Device: PTA Catheter<br>* Intervention with an uncoated Standard PTA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Major Adverse Limb Event (MALE) | Composite of major amputation or major reintervention on a per patient basis | 30 days | 
| Freedom from Perioperative Death (POD) | Death on a per patient basis | 30 days | 
| Patency | Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis | 6 months | 
| Limb Salvage | Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically-driven target lesion revascularization | Rate of clinically-driven target lesion revascularization | 6 months | 
| Major adverse event rates | Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention | 6 months | 
| Patency rate | Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention | 6 months |
Acupuncture for Women's Health Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

Detailed Description
-----------------
This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Official Title
-----------------
New England School of Acupuncture (NESA) Acupuncture Research Collaborative

Conditions
-----------------
Ovarian Neoplasms, Endometriosis, Pelvic Pain, Uterine Neoplasms

Intervention / Treatment
-----------------
* Procedure: Chinese Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Study 1: Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube Currently undergoing chemotherapy Meet certain laboratory test requirements Inclusion Criteria for Study 2: Currently closed to recruitment Diagnosed with endometriosis or unspecified pelvic pain Exclusion Criteria for Studies 1 and 2: Use of white blood cell boosters Prior radiotherapy with the exception of whole-breast irradiation for breast cancer Prior myelotoxic chemotherapy History of symptomatic cardiac or psychiatric disorder Use of a pacemaker Use of herbs or herbal supplements Prior use of acupuncture Enrollment in other research studies

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chinese Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Medicine, Chinese Traditional
Changes of Oral and Intestinal Microbiota After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Purpose The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation. Materials and methods This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2. Analysis and endpoints Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB

Official Title
-----------------
Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent to participate in the study meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB). Exclusion Criteria: treatment with antibiotics within 30 days prior to gathering microbiological material gastrointestinal infections inflammatory bowel disease thyroid diseases cancer (especially the digestive tract) immunodeficiency.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG<br>Patients undergoing laparoscopic sleeve gastrectomy. | Procedure: Bariatric surgery<br>* Surgical treatment of morbid obesity.<br>|
| LRYGB<br>Patients undergoing laparoscopic Roux-en-Y gastric bypass. | Procedure: Bariatric surgery<br>* Surgical treatment of morbid obesity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of microbiota in oral cavity |  | 6 months | 
| Change of microbiota in large intestine |  | 6 months |