linjc16/ctgov huggingface dataset:
Comparison Between Two Strategies for the Diagnosis of TB

Study Overview
=================
Brief Summary
-----------------
Tuberculosis (TB) is a major cause of death among the communicable diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of contagious pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Detailed Description
-----------------
Tuberculosis (TB) is a major cause of death among the communicable diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission by starting earlier treatment. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Official Title
-----------------
Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis

Conditions
-----------------
Pulmonary TB

Intervention / Treatment
-----------------
* Procedure: sputum collection for acid fast bacilli


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients suspected of pulmonary TB (symptoms: lost weight, hemoptysis, chronic cough or fever, or a Chest-X-Ray (CXR) evocative of pulmonary TB) Exclusion Criteria: Patients who refused or were unable to give written 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One open-label arm<br>Patients suspected of pulmonary TB will have sputum collection for acid fast bacilli by the classical strategy (Day 1, Day 2 and Day 3) and the intervention sputum collection for acid fast bacilli by the same day strategy (Hour 1, 2 and 3) | Procedure: sputum collection for acid fast bacilli<br>* spontaneous or post fiberoptic bronchoscopy sputa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain | Ziehl Neelsen | one year |
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

Detailed Description
-----------------
This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high frequency TMS protocol is efficient in the treatment of the Negative Symptoms of schizophrenia. Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex (LDLPFC) was associated with negative symptoms. The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).

Official Title
-----------------
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Procedure: active iTBS
* Procedure: sham iTBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia according to DSM-IV Negative symptoms for at least 6 weeks Medication resistance according to Kane et al., 1988 Age between 18 and 50 years old Informed consent Exclusion Criteria: Contraindication to TMS Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active iTBS<br>iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day | Procedure: active iTBS<br>* Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day<br>* Other names: iTBS;|
| Placebo Comparator: sham iTBS<br>iTBS placebo (placebo coil)with same parameters than active | Procedure: sham iTBS<br>* iTBS placebo (placebo coil)<br>* Other names: placebo rTMS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the Assessment of Negative Symptoms (SANS) |  | before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI |  | 3 times, before treatment, immediatly after treatment and a last evaluation 3 months after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iTBS, Negative Symptoms
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Quantify how much PD-0332334 is removed from the blood with hemodialysis Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Detailed Description
-----------------
Assess the elimination of PD-0332334 from the blood with hemodialysis

Official Title
-----------------
A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis

Conditions
-----------------
Renal Dialysis, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: PD-0332334


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving regular hemodialysis Male or female patients 18 to 65 years Exclusion Criteria: Severe heart failure Renal transplant or renal allograft Illicit drug use (with the exception of prescribed sedatives)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-0332334<br> | Drug: PD-0332334<br>* A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject<br>* Other names: imagabalin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis |  | 0 to 8 days | 
| Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis |  | 0 to 8 days | 
| Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast). |  | 0 to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs. |  | 0 to 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, PD-0332334, hemodialysis, renal dialysis
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.

Official Title
-----------------
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: RAD001, Letrozole 2.5mg
* Drug: Letrozole 2.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-confirmed diagnosis of invasive breast cancer, previously untreated Patients must be postmenopausal Candidates for mastectomy or breast-conserving surgery Primary tumor of above 2 cm diameter, measured by imaging Clinical Stage M0 WHO performance status ≤1 Adequate bone marrow, liver, and renal function Exclusion Criteria: Multicentric invasive tumors Bilateral or inflammatory breast cancer Receiving concomitant anti-cancer treatments such as chemotherapy Patients with an uncontrolled infection Patients with other concurrent severe and/or uncontrolled medical disease Additional protocol-defined inclusion/exclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD001 + letrozole 2.5mg<br> | Drug: RAD001, Letrozole 2.5mg<br> <br> |
| Active Comparator: Letrozole 2.5mg<br> | Drug: Letrozole 2.5mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the four month treatment as being predictive of clinical tumor response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Cancer of the Breast, Neo-adjuvant, Primary breast cancer, postmenopausal, pre-operative
Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.

Official Title
-----------------
A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study Patient must give written informed consent before any study related procedure Exclusion Criteria: Patients with medical histories lacking data required to evaluate the study objectives

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

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

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 |
| --- | --- | --- |
| Prior treatment before progression to advanced or metastatic disease. | Number of participants with each category of treatment. | Baseline | 
| Treatment of advanced or metastatic disease. | Number of participants with each category of treatment. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice. | Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients. | Baseline | 
| Number of CRPC patients with signs and symptoms of metastatic disease. |  | Baseline | 
| Time to castration resistant state after beginning of hormonotherapy. |  | Baseline | 
| Demographic data. |  | Baseline |
Digital Ulceration

Study Overview
=================
Brief Summary
-----------------
The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

Official Title
-----------------
A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

Conditions
-----------------
Systemic Sclerosis, Digital Ulcers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all patients: Signed informed consent prior to enrollment Male or female, ≥ 18 years of age Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria For patients with no history of digital ulcers (DU) and no DU at enrollment only: - Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature Exclusion Criteria: SSc sine scleroderma (without any skin involvement) Patients who underwent stem cell transplantation Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)

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 |
| --- | --- |
| SSc DU-history subgroup<br>Systemic sclerosis patients with history of digital ulcers | |
| SSc with No-DU-history subgroup<br>Systemic sclerosis patients with no history of digital ulcers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of first new digital ulcer (DU) | Occurrence of the first new digital ulcer (DU) within 6 months | 6 months |
Survey of Buprenorphine Use Among Out of Care Population in France (P04933)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month. Subjects were surveyed at various locations (streets, railway stations, etc.) with a few simple questions in order to describe the use of buprenorphine in this out of care population.

Detailed Description
-----------------
Participants were found from various places and using a snow ball technique.

Official Title
-----------------
Out of Care Patient Survey

Conditions
-----------------
Drug Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy. Exclusion Criteria: Patients who have obtained buprenorphine only from the pharmacy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wave 1<br> | |
| Wave 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this survey is to describe quantitatively and qualitatively, the use of buprenorphine in the population who obtain buprenorphine only on black market or both on black market and in pharmacy. |  | Not Applicable, cross-sectional description. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This survey will provide data on patients in regards to their own experience in drug addiction. |  | Not Applicable, cross-sectional description. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heroin, Buprenorphine use
A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II 20 percent or Liposyn III 2 percent.

Official Title
-----------------
Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations

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

Intervention / Treatment
-----------------
* Drug: Fat Emulsion 2%
* Drug: Fat Emulsion 20%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: All drugs used for the standard treatment of Pneumocystis carinii pneumonia (PCP). Other drugs for treatment of other AIDS conditions if they have been started more than 3 months prior to study entry. Patients must have: Diagnosis of AIDS. Weight loss > 10 percent of premorbid body weight. First or second episode of acute Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Do Not Resuscitate (DNR) status. Biliary stasis. Patients with the following are excluded: Do Not Resuscitate (DNR) status. Biliary stasis. Prior Medication: Excluded within 3 months of study entry: Immunomodulators. Antiviral new DT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fat Emulsion 2%|nan|
|Drug: Fat Emulsion 20%|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
-----------------
Weight Loss, Pneumonia, Pneumocystis carinii, Parenteral Nutrition, Liposyn, Acquired Immunodeficiency Syndrome
Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with biomarkers improves the diagnostic accuracy. Hypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to solely stress testing for the workup of patients with suspected CAD or progress of already known CAD.

Detailed Description
-----------------
The COMBAT-CAD Study is an observational study with the aim to improve the diagnostic accuracy by a combination of stress testing with sensitive and specific biomarkers in detecting coronary artery disease or its progress. The main subjects are all patients with CAD or suspicion of CAD sent to the University Heart Center Hamburg. In these patients, ECG, laboratory examination, symptoms or transthoracic echocardiography in rest could not rule out CAD or progress of known CAD. The hypothesis of the study is that detection of CAD can be improved by adding biomarkers to stress testing for the diagnostic workup of patients with suspected CAD or progress of already known CAD.

Official Title
-----------------
Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Every patient referred to coronary angiography, or diagnostic work-up with suspicion of CAD or progress of CAD (in case of CABG patients or already treated with PCI) Exclusion Criteria: Insufficient knowledge of the German language (able to understand and write the German language) Physical or psychological incapability to take part in the investigation Persons with no sufficient language ability in German to understand the provided study information material.

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 |
| --- | --- | --- |
| Diagnosis of coronary artery disease | The diagnosis of coronary artery disease through stress testing alone and combined with cardiac biomarkers. | Within the initial diagnostic evaluation process (maximum within 30 days) |