linjc16/ctgov huggingface dataset:
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either Responders or Non-Responders in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be Responders in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA 102A). The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were Non-Responders in Study #D203 - FDA 102A; 2) To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in Responders from Study #D03 - FDA 102A.

Official Title
-----------------
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either Responders or Non-Responders in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

Conditions
-----------------
Diarrhea, HIV Infections

Intervention / Treatment
-----------------
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study. Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Octreotide|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
-----------------
Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Assessment of Validity of Depth by PocketCPR as Sites of Smartphone on Arm

Study Overview
=================
Brief Summary
-----------------
For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most important teaching point. However, the tool to feedback depth of chest compression like Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to be used widely. In these days, smartphone free application can measure depth of chest compression in real-time. This study assess the validity of depth of chest compression by smartphone application, PocketCPR, as three sites of smartphone on arm or hand. 1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band To analyze the difference between Skill Reporter manikin and PocketCPR application, the investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.

Official Title
-----------------
Assessment of Validity of Depth by PocketCPR as Sites of Smartphone on Arm

Conditions
-----------------
Chest Compression With Smartphone

Intervention / Treatment
-----------------
* Device: Site of smartphone on chest compressor' arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest compressor with Basic Life Support certification Physician, Nurse, Emergency medical technician with more than 3 years clinical experience Exclusion Criteria: Person who cannot practice normal chest compression with any reason

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smartphone positioning during Chest compression<br> | Device: Site of smartphone on chest compressor' arm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of chest compression | Depth of chest compression by reporting manikin and application of i-phone. Scale : millimeter | up to 1 month |
A Micro/Nano Device for Exhaled Breath Analysis

Study Overview
=================
Brief Summary
-----------------
Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.

Detailed Description
-----------------
Will use Fourier Transform Mass Spectrometry (FT-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) to analyze concentrated VOCs. The purpose of this study is to search for disease-related markers in the breath in subjects with known or suspected lung or other cancer, or pulmonary disease.

Official Title
-----------------
A Micro/Nano Device for Exhaled Breath Analysis

Conditions
-----------------
Lung Cancer, Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For controlled (healthy) subjects - we are seeking persons who do not have a known history of cancer or pulmonary disease. Both smokers and nonsmokers are invited to participate as control subjects. For experimental subjects, we are seeking persons with pulmonary disease but no known history of cancer, as identified by the investigators during routine clinic or office visits. Additionally for experimental subjects, we are seeking persons with known or suspected lung or other cancers, as identified by the investigators during routine clinic or office visits. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental<br>patients with pulmonary disease; and, patients with known or suspected lung or other cancers | |
| Control<br>healthy subjects (for example, family members of the patient or graduate students | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of disease related markers (biomarkers) from concentrated volatile organic compounds in breath samples | The concentrated volatile organic compounds in exhaled breath samples will be analyzed by statistical software for search for disease related markers (biomarkers). | 1 day (After sample collection) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, pulmonary disease
The Effect of the Nutraceutical Hemofix on the Coagulation System

Study Overview
=================
Brief Summary
-----------------
Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.

Official Title
-----------------
Phase 1 Study of the Nutraceutical Hemofix Safety and Effect on the Coagulation System

Conditions
-----------------
Von Willebrand Disease, Menorrhagia

Intervention / Treatment
-----------------
* Dietary Supplement: HEMOFIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers and volunteers with a mild bleeding disorder Exclusion Criteria: people with thrombophilic and cardiovascular complications, people who are treated with anti-coagulants, women taking birth control pills people with a history hypercoagulability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEMOFIX<br>3 grams a day | Dietary Supplement: HEMOFIX<br>* unique complex herbal mixture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding and blood test results |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild bleeding disorder
To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Ramipril 10 mg Capsule (Sandoz)
* Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ramipril 10 mg Capsule (Sandoz) | Drug: Ramipril 10 mg Capsule (Sandoz)<br> <br> |
| Active Comparator: 2<br>Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical) | Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 30 days |
Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

Study Overview
=================
Brief Summary
-----------------
To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

Detailed Description
-----------------
Diabetic foot ulcer is a major world health problem with a very high recurrence rate, 50% at two years. The main causes of diabetic foot ulcer recurrence are inadequate footwear, lack of podology care and lack of self-care. International recommendations call for regular podological monitoring to prevent recurrence of diabetic foot ulcer. The remission foot consultation assesses recommended items and is offered to any healed patient at the rate of two annual visit. A retrospective study on multidisciplinary specific follow-up may show a real efficacity on recurrence rate.

Official Title
-----------------
Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

Conditions
-----------------
Diabetic Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with type 1 ou type 2 diabetes followed-up in Centre Hospitalier Sud Francilien, Discharge from hospital for diabetic foot ulcer between 2017 and 2019 and post-healing follow-up for two years, 18 years of âge or older, Person not deprived of liberty, person who was informed of and did not object to the study. Exclusion Criteria: - Person refusing the study.

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 |
| --- | --- |
| Experimental group<br>Patients who have honored two consultations per year for two years. | |
| Control group<br>Patients who have not honored two consultations per year for two years. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of wound | Diabetic foot ulcer recurrence | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation | Days of hospitalisation for diabetic foot ulcer | At 2 years | 
| Number of visits to the pedicure | Podology follow-up | At 2 years | 
| Adequate footwear | Wearing of adequate shoes | At 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot ulcer, Recurrence, Prevention, Remission, Follow-up, Multidisciplinary team
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics. The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.

Official Title
-----------------
Remote Implant Support

Conditions
-----------------
Bradycardia, Sudden Cardiac Arrest

Intervention / Treatment
-----------------
* Other: Remote Implant Support Capability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned IPG implant or planned ICD (without CRT) implant Signed informed consent Exclusion Criteria: Pacing dependency Defibrillation threshold testing planned Basal ventricular rate >110 beats per minute Younger than 18 years Pregnant Currently involved in another IPG or ICD related clinical trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Implant Support<br>Implant supported through remote implant support capability | Other: Remote Implant Support Capability<br>* Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Integrity | Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support. | At implant | 
| Successful Support | Percentage of implant attempts with successful support. If the local support person does not participate in any part of the surgery, other than observing, then the remote support will be called a success. | At implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Defibrillator, Remote Consultation
Effectiveness of Aspirin in Compare With Heparin Plus Aspirin in Recurrent Pregnancy Loss Treatment

Study Overview
=================
Brief Summary
-----------------
This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin.

Conditions
-----------------
Recurrent Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unexplained recurrent miscarriage, women had previous venous or arterial thromboembolism or who were heterozygous or homozygous for mutations for FV Leiden G1691A, prothrombin gene G20210A (FII G20210A), and methyltetrahydrofolate reductase C677T (MTHFR C677T) Exclusion Criteria: abnormal karyotypes of both partners, uterine and cervical anatomical disorders on pelvic ultrasonography or hysteroscopy, abnormal ovaries and abnormal endocrine tests.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recurrent pregnancy loss<br> | |
| thrombophilia, aspirin<br> | |
| heparin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Official Title
-----------------
A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently participating in study VX17-659-105 (NCT03447262) Exclusion Criteria: History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator Current participation in an investigational drug trial (other than study VX17-659-105) Other protocol defined Inclusion/Exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELX/TEZ/IVA<br>Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks. | Drug: ELX/TEZ/IVA<br>* Fixed-dose combination (FDC) tablet for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* Tablet for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |  | From Baseline through Week 100 |
Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

Study Overview
=================
Brief Summary
-----------------
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery

Detailed Description
-----------------
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients

Official Title
-----------------
a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

Conditions
-----------------
Laparoscopic Surgery

Intervention / Treatment
-----------------
* Procedure: new laparoscopic access technique for group a
* Procedure: Hasson's technique for laparoscopic access in group b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery. underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022. Exclusion Criteria: Patients with distended abdomen due to bowel obstruction. Patients with uncorrected coagulopathy.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new laparoscopic access technique<br>in which we used our new laparoscopic access | Procedure: new laparoscopic access technique for group a<br>* new laparoscopic access technique through the epigastric region<br>* Other names: new laparoscopic access technique;|
| Experimental: Hasson's technique<br>in which we used the well-known Hasson's technique for primary laparoscopic access | Procedure: Hasson's technique for laparoscopic access in group b<br>* Hasson's technique for laparoscopic access in group b<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time needed to access the peritoneal cavity | time needed to access the peritoneal cavity | the first 15 minutes of operation | 
| numbers of trials till the good peritoneal access achieved | numbers of trials till the good peritoneal access achieved | the first 15 minutes of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complications | rate of complications | the first 15 minutes of operation |