linjc16/ctgov huggingface dataset:
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

Official Title
-----------------
A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization Written informed consent obtained Exclusion Criteria: Subject has history of deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent Subject has an acute bacterial endocarditis Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke Subject is receiving anticoagulants/antiplatelet agents Subject has a body weight less than 40 kg Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 group<br> | Drug: YM150<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite assessment of VTE events and all cause death |  | Until day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding events |  | Until day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism
COVID-19 Patients Admitted to the ICU

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded. Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support). Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications. A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.

Official Title
-----------------
Prognostic Factors and Predictors of Mortality in COVID-19 Patients Admitted to the ICU. An Aid for Triage, Counseling, and Resource Allocation

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: no intervention will be administered, this is a retrospective observational study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Positive PCR test for COVID-19 Require admission to ICU Exclusion Criteria: Pediatric patients\ Any patient not requiring admission to ICU

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: Admitted to ICU and died during the hospital stay.<br> | Other: no intervention will be administered, this is a retrospective observational study.<br>* no intervention will be administered, this is a retrospective observational study.<br>|
| Group 2: Admitted to ICU was were discharged.<br> | Other: no intervention will be administered, this is a retrospective observational study.<br>* no intervention will be administered, this is a retrospective observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death Vs No Death | 30 day mortality | 
| Duration of ICU stay | Duration of ICU stay | 30 days | 
| Duration of mechanical ventilation | The duration the patient required support from a mechanical ventilator | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital complications | Wether patients developed in hospital complications. | 30 days |
Delphi Study on Rehabilitation Following Lumbar Arthrodesis

Study Overview
=================
Brief Summary
-----------------
Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.

Detailed Description
-----------------
The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.

Official Title
-----------------
Delphi Study on Rehabilitation Following Lumbar Arthrodesis in UZ Leuven (Belgium)

Conditions
-----------------
Surgery, Lumbar Spine Degeneration, Physical Disability

Intervention / Treatment
-----------------
* Other: Delphi study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis. Exclusion Criteria: N/A

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Care providers involved in lumbar arthrodesis<br>surgeons, physiotherapists, behavioral therapists, researchers, occupational therapists | Other: Delphi study<br>* Delphi study on the optimal rehabilitation pathway following lumbar arthrodesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of perioperative rehabilitation following lumbar arthrodesis | duration defined in amount of weeks | January - December 2018 | 
| Physiotherapeutic content following lumbar arthrodesis | describing the physiotherapeutic modalities defined as manual therapy, exercise therapy, or cognitive behavioural therapy | January - December 2018 | 
| Frequency of physiotherapeutic intervention following lumbar arthrodesis | frequency defined as amount of physiotherapeutic visits per week | January - December 2018 | 
| Multidisciplinary character of perioperative rehabilitation following lumbar arthrodesis | amount and type of involved health care providers, as well as the interaction between | January - December 2018 |
Renal Mass Registry

Study Overview
=================
Brief Summary
-----------------
Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and harness the latest technology to organize and analyze data.

Detailed Description
-----------------
RCC is a cancer that is poorly understood. The increase in both incidence and mortality rates for RCC, coupled with the lack of effective therapies for RCC beyond surgical excision, underscore the need for a better understanding of RCC tumor biology, immunology, and epidemiology. Such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. Recently, the National Cancer Institute's Kidney Cancer Progress Review Group identified as top priorities for future research the need to better understand the mechanisms underlying known risk factors for kidney cancer; and examine tumor tissue to identify predictors of patient outcome and targets for therapy. In addition, the review group stressed that the leaders in renal cancer research over the next decade would be those institutions that could enroll large numbers of patients, collect valuable risk factor and quality of life data from these patients and harness the latest technology to organize and analyze data.

Official Title
-----------------
Renal Mass Registry

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients with a renal mass or a suspected metastatic lesion from a renal primary who have been treated or are going to be studied and or treated surgically at Mayo Clinic Arizona Patients must be 18 years of age or older Patients must be capable of and willing to sign an informed consent Exclusion: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open<br> | Other: questionnaire<br>* questionnaires given to all patients to assess risk factors and quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Renal Mass Risk Factors as determined by patient questionnaire post surgery |  | 5 years |
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

Study Overview
=================
Brief Summary
-----------------
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.

Official Title
-----------------
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: dapivirine (TMC120) vaginal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-negative Willing to participate and sign and informed consent form. Willing to be tested for HIV and to use an experimental vaginal gel. Willing to use a reliable form of contraception during the study. Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study. Normal cervical assessment. Willing to abstain from using any vaginal product (other than the study product). Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10. Exclusion Criteria: Currently pregnant or breast-feeding. Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix. Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test. Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment. Current use of injection drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dapivirine (TMC120) vaginal gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, HIV Seronegativity
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

Study Overview
=================
Brief Summary
-----------------
Non-invasive monitoring to measure changes in blood volume.

Official Title
-----------------
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Device: CM 1500


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Between 18-35 years of age Weight between 130-200 pounds Exclusion Criteria: Known cardiac disease Recent caffeine intake Tobacco use in the (4) hours prior to screening Infection Pregnancy Hemoglobin <13.5 g/dl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: no blood draw<br>CM 1500 with no blood draw | Device: CM 1500<br> <br> |
| Active Comparator: blood draw<br>CM 1500 with blood draw | Device: CM 1500<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw | At study completion (completion of blood draw) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood loss
Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study

Study Overview
=================
Brief Summary
-----------------
In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.

Official Title
-----------------
Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders

Conditions
-----------------
Temporomandibular Joint Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Dual echo MRI sequence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pain related to temporomandibular joint. Patients with limited mouth opening. Exclusion Criteria: Patients with pain related to temporomandibular joint for less than one month duration. Patients with limited mouth opening for less than one month duration. Patients with history of TMJ surgical intervention. Patients with history of TMJ arthrocentesis.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Dual echo MRI sequence|new MRI sequences for imaging of joints|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of temporomandibular joint effusion. | Binary outcome measure | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delineation of temporomandibular joint disc position. | Descriptive measure: 10 - 12 - 2 o'clock position | through study completion, an average of 1 year |
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Official Title
-----------------
Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

Conditions
-----------------
Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
-----------------
* Drug: Pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Written informed consent Outpatients of at least 18 years (21 years in Argentina) Patient considered to have GERD symptoms Main Exclusion Criteria: Acute peptic ulcer and/or ulcer complications Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day) Intake of proton pump inhibitors during the last 10 days before study start Female patients of childbearing potential not using adequate means of birth control Pregnant or breast-feeding females

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pantoprazole|Pantoprazole 40 mg o.d.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ |  | 4 and 8 weeks | 
| Investigator assessment |  | 4 and 8 weeks | 
| Safety and efficacy |  | 4 and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal Reflux Disease, GERD, Pantoprazole, ReQuestTM
The ARCAN Database is Used for Retrospective Non-interventional Research Projects. The Database Collects Clinical and Laboratory Data From Patients With Lymphoid Malignancies. The Database Doesn't Require Biological Sample of Patients, it Records Only Information Based on the Patients' Medical File.

Study Overview
=================
Brief Summary
-----------------
To identify the diagnostic and therapeutic approach (efficacy and toxicity) of patients with lymphoid malignant hemopathy who are managed in the hematology department.

Official Title
-----------------
The ARCAN Database is Used for Retrospective Non-interventional Research Projects. The Database Collects Clinical and Laboratory Data From Patients With Lymphoid Malignancies. The Database Doesn't Require Biological Sample of Patients, it Records Only Information Based on the Patients' Medical File.

Conditions
-----------------
Hematologic Diseases

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients followed for hematological diseases in Lyon Sud Hospital Exclusion Criteria: - Patients who doesn't have hematological diseases

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Hematological diseases<br>Cohort of patients followed for lymphoid malignant hemopathy in Lyon Sud Hospital | Other: Data collection<br>* Data collection for biostatistical analysis about hematological diseases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Period between the end of the first treatment and the first confirmed relapse of lymphoma of patients who have received treatment to treat their lymphoma. | 730 days |