linjc16/ctgov huggingface dataset:
FemBloc® Permanent Contraception - Early Pivotal Trial

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.

Official Title
-----------------
BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: FemBloc
* Procedure: Laparoscopic bilateral tubal sterilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 21 - 45 years of age desiring permanent birth control Sexually active with male partner For FemBloc Arm: Regular menstrual cycle for last 3 months or on hormonal contraceptives For Control Arm: Undergoing planned laparoscopic bilateral tubal sterilization Exclusion Criteria: Uncertainty about the desire to end fertility Known or suspected pregnancy Prior tubal surgery, including sterilization attempt Prior endometrial ablation Presence, suspicion, or previous history of gynecologic malignancy Abnormal uterine bleeding requiring evaluation or treatment Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemBloc<br>Investigational device and procedure | Device: FemBloc<br>* Treatment with FemBloc for women who desire permanent birth control (female sterilization)<br>|
| Active Comparator: Control<br>Laparoscopic bilateral tubal sterilization | Procedure: Laparoscopic bilateral tubal sterilization<br>* Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of short-term and long-term adverse events in each arm | Safety: Incidence of short-term and long-term adverse events in each arm | 1-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Permanent contraception, Birth control
A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets

Study Overview
=================
Brief Summary
-----------------
comparison of effectiveness of ultrasound guided genicular nerve blockades and radio frequency stimulation

Official Title
-----------------
A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets in Chronic Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial

Conditions
-----------------
Knee Pain Chronic

Intervention / Treatment
-----------------
* Procedure: Current Targets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Coagulation disorders Rheumatoid disorders Infections

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 nerve<br>3 genicular nerve blockade and radio frequency ablation | Procedure: Current Targets<br>* blockade and radio frequency stimulation of genicular nerves<br>* Other names: Revised Targets;|
| Active Comparator: 5 nerve<br>3 genicular nerve blockade and radio frequency ablation 2 genicular nerve blockade and pulse radio frequency | Procedure: Current Targets<br>* blockade and radio frequency stimulation of genicular nerves<br>* Other names: Revised Targets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Pain will be evaluated with a Numerical Rating Scale (NRS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Post injection sixth month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Radiofrequency, Ultrasound, Anatomical landmarks
An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness

Study Overview
=================
Brief Summary
-----------------
The study tries to reveal if aminobisphosphonates influence aside the bone density also the vascular status in the typical elderly patient population

Detailed Description
-----------------
The subjects - starting bisphosphonate treatment due to medical reasons - will be additionally investigated as outpatients (arterial stiffness, applanation tonometry), for each subject 3 individual dates with a duration of approx. 30 min each are scheduled, prior to therapy with bisphosphonate, after 3 and 6 month of treatment

Official Title
-----------------
An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness (Changes of the Aortal Elasticity Due to a Newly Established Aminobiphosphinate Therapy for the Treatment of Osteoporosis)

Conditions
-----------------
Arteriosclerosis, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided Exclusion Criteria: patients with major cardiovascular disease patients participating in another clinical trial 1month prior to inclusion in this study patients unable or unwilling to give informed consent

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 |
| --- | --- |
| 1<br>Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation.

Official Title
-----------------
The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness

Conditions
-----------------
a Myocardial Infarction, Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement

Intervention / Treatment
-----------------
* Behavioral: Dean Ornish Heart Disease Reversing Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be accepted into the study if they demonstrate one or more of the following within the previous 12 months: a myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty, stent placement, or rotoblator procedures. Patients will also accepted if they have stable angina as determined by the Rose Questionnaire or pacemaker associated with one or more of the previously mentioned diagnoses. For the purposes of this study, myocardial infarction is defined as the presence of at least two of the following three criteria: continuous chest pain lasting at least 30 minutes; electrocardiogram changes expressing an evolving myocardial infarction (ST segment elevation or depression, evolving Q waves, or symmetric inversion of T waves); or elevated cardiac enzyme levels (at least twice the I levels). Exclusion Criteria: -

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Dean Ornish Heart Disease Reversing Program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

Official Title
-----------------
Betaferon Treatment and Exercise Data Gathering IN Early MS

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple sclerosis diagnosed within the last 12 months Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment

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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Intravenous therapy according to product information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity and Fatigue |  | At baseline and at Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life |  | At baseline and at Month 24 | 
| Depression |  | At baseline and at Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Fatigue, RRMS, CIS
Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study will investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic or recurrent breast cancer.

Detailed Description
-----------------
The objective of this study is to investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic/recurrent breast cancer.

Official Title
-----------------
Psychosocial Treatment Effects on Cancer Survival

Conditions
-----------------
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Supportive-Expressive Group Therapy plus education
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women were eligible for the study if they had documented metastatic or recurrent breast cancer, were proficient enough in English to be able to complete questionnaires and participate in a support group, were living in the Greater San Francisco Bay Area, and had a Karnofsky score of at least 70%.19 Exclusion Criteria: Women were excluded if they had any of the following risk factors: positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis; active non-breast cancers within the past 10 years; or other concurrent medical conditions likely to influence short-term survival. Basal cell or squamous cell carcinomas of the skin, in situ cancer of the cervix, or melanoma with a Breslow depth less than 0.76 mm were allowed.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supportive-Expressive Group Therapy plus education|nan|
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Patient Reported Outcomes in Living Donor Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

Detailed Description
-----------------
In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Official Title
-----------------
Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation

Conditions
-----------------
Lung Transplantation

Intervention / Treatment
-----------------
* Procedure: Living donor lung transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New donors for living donor lung transplantation Exclusion Criteria: Inability to obtain informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Living donor lung transplantation<br>Living lung transplantation donors | Procedure: Living donor lung transplantation<br>* Living donor lung transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health status |  | At entry and every year for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea |  | At entry and every year for 5 years | 
| Change in psychological status |  | At entry and every year for 5 years | 
| Change in sleep quality |  | At entry and every year for 5 years | 
| Prognosis |  | At entry and every year for 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Living donor lung transplantation, Health-related quality of life, Prognosis, Patient reported outcome
Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

Study Overview
=================
Brief Summary
-----------------
Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.

Detailed Description
-----------------
Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system. Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.

Official Title
-----------------
Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: Validated questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep endometriosis Surgical treatment Single surgeon Exclusion Criteria: Lost to follow-up unwillingness to answer the interview

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| NERVE SPARING<br>Patients who underwent surgery for deep endometriosis were submitted to surgical procedures aiming at sparing the pelvic ortho- and parasympathetic nerves. The subjects were then followed with interviews using validated questionnaires, to assess the possible changes in post-operative urinary sexual and fecal function. | Other: Validated questionnaires<br>* Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic function | Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, pelvic function
Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Detailed Description
-----------------
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

Official Title
-----------------
Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: None - Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the diagnosis of HCC who are on the wait list for liver transplantation Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours. Age Range: 18 to 75 years old Exclusion Criteria: Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation. Patients older than 75 years old and younger than 18 years old. Patients who are unable to consent. Pregnant patients.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular Carcinoma with Cirrhosis<br>Subjects with hepatocellular carcinoma and cirrhosis. | Other: None - Standard of Care<br> <br> |
| Cirrhosis without Hepatocellular Carcinoma<br>Subjects with only cirrhosis. | Other: None - Standard of Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, Liver Cancer