linjc16/ctgov huggingface dataset:
Evaluation of Patients With Vena Cava Inferior Thrombosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.

Detailed Description
-----------------
All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.

Official Title
-----------------
Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis

Conditions
-----------------
Inferior Vena Cava Thrombosis, Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-90 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 with vena cava inferior thrombosis | |
| 2<br>Patients with isolated lower-extremity DVT matched for gender and age | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent venous thromboembolism |  | 6, 12, 24 and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 6, 12, 24 and 60 months | 
| Post-thrombotic syndrome |  | 24 and 60 months |
Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Official Title
-----------------
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Men With Diabetes Mellitus Type 1 and Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, Diabetes type 1 Stable sexual relationship for > 6 month. Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy

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

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

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: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5mg, 10mg or 20mg taken 1h before sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 2 |  | 12 weeks | 
| Sexual Encounter Profile Question 3 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function - Erectile Function Domain |  | 12 weeks | 
| Safety and Tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction, Diabetes mellitus type 1, Vardenafil
COPD Prognosis in Covid Patients

Study Overview
=================
Brief Summary
-----------------
In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate.

Official Title
-----------------
Chronic Obstructive Pulmonary Disease Prognosis in Sars-covid 2 Infection

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: intubation and mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: more than 20 years old. Both Males and females will be included. COPD patients. Recent confirmed the diagnosis with SARS-COV-2. Exclusion Criteria: Pregnancy. Malignancy. Immunodeficiency disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| copd patients with covid infection<br> | Procedure: intubation and mechanical ventilation<br>* patients who were in need were intubated and mechanically ventilated<br>|
| non-copd patients with covid infection<br> | Procedure: intubation and mechanical ventilation<br>* patients who were in need were intubated and mechanically ventilated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA score measurement in both groups | monitoring of SOFA items along two weeks | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis of the disease | hospital stay, nedd for mechanical ventilation | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
copd, prognosis, covid
Volumetric Impedance to Guide Stroke Response

Study Overview
=================
Brief Summary
-----------------
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry

Official Title
-----------------
Volumetric Impedance to Guide Stroke Response

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Device: Visor System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being evaluated as a suspected stroke Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Visor System|Subjects are monitored one time with the Visor System.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemispheric bioimpedance asymmetry sensitivity and specificity | Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke | At the time of device monitoring - day 0 |
Electrical Control of Bladder in Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R&D, PVA and a commercial stimulator company.

Official Title
-----------------
Electrical Control of Bladder in Spinal Cord Injury Patients

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Bladder & Bowel Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury with bowel & bladder problems Exclusion Criteria:

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Device: Bladder & Bowel Control<br> <br> |

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
-----------------
defecation, electrical stimulation, penile erection, Spinal cord injury, urology
Prospective Observational Lymphoedema Intensive Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study was to describe usual practices in lymphedema management in France. It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.

Detailed Description
-----------------
Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase. These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.

Conditions
-----------------
Lymphoedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology indication for intensive decongestive therapy (IDT) Exclusion Criteria: bilateral lymphedema, lymphedema of both upper and lower limbs, intensive decongestive therapy in the previous 6 months, cancer recurrence, systolic pressure index < 0.5

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 |
| --- | --- | --- |
| Change from baseline in affected limb volume | According to the site, the first phase can lasts 1, 2 or 3 weeks. | At the end of 1st phase of Complex Decongestive Therapy and 6 months later |
Diagnosing and Treating Low Blood Sugar Levels

Study Overview
=================
Brief Summary
-----------------
Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia. Patients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed.

Detailed Description
-----------------
Study Description: The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of patients with fasting hypoglycemia due to diverse etiologies, such as insulinomas. Study subjects will be evaluated and treated for their particular condition according to standard care. Objectives: To understand the pathophysiology and various causes of hypoglycemia (e.g., insulinomas, MEN1, MEN2). To identify new circulating biomarkers of insulinomas. To create a repository of clinical data and samples for future research of insulinomas. Endpoints: None

Official Title
-----------------
Fasting Hypoglycemia: Diagnosis and Treatment

Conditions
-----------------
Hypoglycemia, Insulinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Male, females ages >= 18. Patients with documented fasting blood glucose below 55 mg/dl. 4. Patients with biochemical evidence for insulinoma or other pancreatic neuroendocrine tumors. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Patients with significant cardiac disease will be excluded. Subjects who are pregnant per self-report. Medically unstable per the assessment of the PI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 with hypoglycemia<br>Patients with hypoglycemia due to diverse etiologies. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcomes | resolution of hypoglycemia | every 1-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoglycemia, Insulinoma, Natural History
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.

Official Title
-----------------
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

Conditions
-----------------
Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Aquamantys Device
* Other: Standard of care treatment for hemostasis during a total knee arthroplasty.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient indicated for total knee arthroplasty Exclusion Criteria: Patients undergoing revision total knee arthroplasty Patients with blood disorders Patients on chronic anti-thrombotic medication such as Coumadin Patients with a history of deep vein thrombosis Patients with a history of pulmonary embolism

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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKA with the Aquamantys for hemostasis<br>This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. | Device: Aquamantys Device<br>* The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.<br>|
| Active Comparator: TKA without the Aquamantys for hemostasis<br>This group will receive total knee arthroplasty using the standard treatment for hemostasis. | Other: Standard of care treatment for hemostasis during a total knee arthroplasty.<br>* The active comparator arm will receive the standard-of-care for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain Output. | This is a measure of the average drain output collected in the first 24 hours following surgery. | First 24 hours following surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Official Title
-----------------
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: FTY 720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female Between 18 to 65 years old Exclusion Criteria: Patients in need of multiple organ transplants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: FTY 720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability based on adverse event reporting. |  |  | 
| BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation. |  |  | 
| Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, immunosuppression, transplant, rejection
Effect of Diltiazem on Pharmacokinetics of BMS-914392

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.

Detailed Description
-----------------
Protocol designed to evaluate the potential for a drug-drug interaction

Official Title
-----------------
Effect of Diltiazem on the Pharmacokinetics of BMS-914392 and on Heart Rate After Single-dose Administration of BMS-914392 in Healthy Subjects

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: BMS-914832
* Drug: Diltiazem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy Exclusion Criteria: Current or recent (within 3 months of study drug administration) gastrointestinal disease Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A (BMS-914832)<br> | Drug: BMS-914832<br>* Tablets, Oral, 30 mg, once, 1 day<br>|
| Experimental: Treatment B (BMS-914832 + diltiazem)<br> | Drug: BMS-914832<br>* Tablets, Oral, 30 mg, once, 1 day<br>Drug: Diltiazem<br>* Tablets, Oral, 360 mg, once daily, 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations |  | Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs) |  | Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing of BMS-914392 alone or in combination with diltiazem | 
| Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 |  | Daily |
Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

Study Overview
=================
Brief Summary
-----------------
the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.

Official Title
-----------------
Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

Conditions
-----------------
Acquired Haemophilia, Register

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Factor VIIIc < 30% and Factor VIII inhibitor > 1 u Bethesda Exclusion Criteria: absence and signed consent, haemophilia A

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acquired haemophilia