linjc16/ctgov huggingface dataset:
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Patients with congestive heart failure will be assessed for safety and clinical effects of Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.

Official Title
-----------------
Multi-Center, Double-Blind Study to Compare the Effects of 30mg Qd Versus 15 Mg Bid of Tolvaptan in Congestive Heart Failure Patients

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Tolvaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
History of CHF

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolvaptan|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
-----------------
CHF
Effects of Storage on Lactate in Blood Samples

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years. Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test lactate levels.

Detailed Description
-----------------
Lactic acidosis syndrome is a complication of therapy with nucleoside reverse transcriptase inhibitor (NRTI) drugs. Measurement of lactate levels is important in clinical trials of antiretroviral treatments. The preferred collection method for determining plasma lactate is with NaF/KOx tubes, while a number of ACTG studies have stored blood in ethylenediaminetetraacetic acid (EDTA) tubes. This study will analyze lactate in samples collected and stored in NaF/KOx and EDTA tubes to investigate the reliability of lactate concentrations over time. Pre- and post-exercise blood samples are drawn from participants into NaF/KOx and EDTA tubes and a portion is tested for lactate levels immediately. The remaining portions are frozen and tested at 1, 3, 6, 12, 18, 24, and 36 months.

Official Title
-----------------
Effects of Storage on Plasma Lactate Determinations

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Participants may be eligible for this study if they: Are at least 18 years old. Have sufficient forearm veins. Exclusion Criteria Participants will not be eligible for this study if they: Have a physical disability that prevents forearm exercise. Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.

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?
-----------------
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
-----------------
Specimen Handling, Blood, Cryopreservation, Lactic Acid, Sodium Fluoride, Oxalates
TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: TLK286


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer Recurrent ovarian cancer or persistent disease following primary treatment At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one) At least 18 years of age Exclusion Criteria Pregnant or lactating women History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years Known leptomeningeal metastases or carcinomatous meningitis Having received whole pelvis radiation therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TLK286|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments. Another objective of the trial is to assess and compare the safety of each treatment.

Detailed Description
-----------------
Further study details as provided by Centre Oscar Lambret.

Official Title
-----------------
Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: XELODA
* Drug: TEGAFUR URACIL - FOLINIC ACID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced or metastatic colo-rectal cancer Age > or = 18 years old PS-WHO < or = 2 Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3 Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN Effective contraception Written informed consent signed Exclusion Criteria: Concomitant radiotherapy Contraindication to fluoropyrimidines Treatment with sorivudine and its chemical analogs such as brivudine Severe hepatic insufficiency Severe renal insufficiency Pregnant or lactating woman Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: XELODA<br> | Drug: XELODA<br>* XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days. Cycle treatment duration : 21 days<br>|
| Other: UFT<br> | Drug: TEGAFUR URACIL - FOLINIC ACID<br>* Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients preference after randomization and cross-over |  | after 2 cycles of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of each treatment |  | at day 56 (after two cycles of treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects

Detailed Description
-----------------
This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.

Official Title
-----------------
Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Tenofovir exalidex (TXL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-55 Capable of giving written informed consent Capable of completing study requirements Exclusion Criteria: History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Interventional Model Description: Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regimen A<br>Immediate release tablet Tenofovir exalidex (TXL) | Drug: Tenofovir exalidex (TXL)<br>* Oral formulations<br>* Other names: Lipid conjugate YTFV;|
| Experimental: Regimen B<br>New Formulation 1 Tenofovir exalidex (TXL) | Drug: Tenofovir exalidex (TXL)<br>* Oral formulations<br>* Other names: Lipid conjugate YTFV;|
| Experimental: Regimen C<br>New formulation 2 Tenofovir exalidex (TXL) | Drug: Tenofovir exalidex (TXL)<br>* Oral formulations<br>* Other names: Lipid conjugate YTFV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state | Measuring Cmax, the peak plasma concentration | up to four days post dose |
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

Study Overview
=================
Brief Summary
-----------------
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

Detailed Description
-----------------
The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices. The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required. Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.

Official Title
-----------------
A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)

Conditions
-----------------
Mitral Valve Regurgitation, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: MitraClip NTR/XTR System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who give consent for their participation Subjects scheduled to receive the MitraClip per the current approved indications for use Subjects with Symptomatic MR (≥3+) Exclusion Criteria: 1. Subjects participating in another clinical study that may impact the follow-up or results of this 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 |
| --- | --- |
| MitraClip NTR/XTR System<br>Percutaneous mitral valve repair using the MitraClip NTR and XTR system | Device: MitraClip NTR/XTR System<br>* Percutaneous mitral valve repair using the MitraClip NTR/XTR system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measure: Number of Participants With Major Adverse Events (MAE) | MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated). | At 30 Days | 
| Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ | The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits. | At 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MitraClip, MitraClip NTR, MitraClip XTR, Mitral Regurgitation
Esophageal Manometry in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure. In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.

Detailed Description
-----------------
Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure. In this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.

Official Title
-----------------
Esophageal Manometry in Mechanically Ventilated Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery Exclusion Criteria: Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.

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 |
| --- | --- |
| Critical care patients<br>Mechanically ventilated patients in the critical care unit | |
| OR-patients<br>Mechanically ventilated patients in the operating room | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pressure measurements in mechanically ventilated patients | Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room. | Within one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal pressure, chest wall elastance, lung elastance, transpulmonary pressure
Transcranial Doppler Ultrasonography and Brain Death

Study Overview
=================
Brief Summary
-----------------
In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.

Official Title
-----------------
Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis

Conditions
-----------------
Brain Dead

Intervention / Treatment
-----------------
* Other: Transcranial doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brain death patients Exclusion Criteria: craniectomy post anoxia encephalopathy no TCD performed before the clinical diagnosis of brain death transtemporal approach impossible

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 |
| --- | --- |
| Usual<br>CT angiography is performed 6 hours after the clinical diagnosis of brain death. | |
| TCD<br>When the diagnosis of brain death is made, TCD is performed and then every 2 hours until the flow patterns compatible with brain death are found. Then a CT angiography is performed. | Other: Transcranial doppler<br>* A TCD is performed on all cerebral arteries (mean cerebral arteries, anterior cerebral arteries, basilar trunk, vertebral arteries and carotid arteries) until a flow pattern compatible with brain death is found<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between clinical diagnosis of brain death and realization of CT angiography |  | the outcome is assessed when the CT angiography is performed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CT angiography required for the diagnosis of brain death |  | the outcome is measured until the diagnosis of brain death is confirmed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain death, CT angiography, Ultrasonography, doppler, transcranial
Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study

Study Overview
=================
Brief Summary
-----------------
To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.

Official Title
-----------------
Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Age above 18 Subjects with typical GERD symptoms: predominant heartburn/regurgitation Naive patients or off PPI treatment in the last 2 months Exclusion Criteria: Inability to read and understand PRO instructions Patient not suitable to be treated following the AEG guidelines Concomitant treatment with NSAID, antiplatelet drugs Previous PPI failure

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| GERD patients<br>Patients with typical GERD symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic outcome of GERD management following new guideline |  | End of study visit 4-8w | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome |  | End of study 4-8w | 
| To evaluate the impact of GERD symptoms in HRQoL |  | End of study 4-8w | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, CLINICAL GUIDELINE, Symptoms, clinical outcome