linjc16/ctgov huggingface dataset:
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.

Detailed Description
-----------------
Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.

Official Title
-----------------
Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder, Antidepressant Treatment Response

Intervention / Treatment
-----------------
* Drug: Pindolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a depressive episode HDRS score > 18 Written informed consent Exclusion Criteria: suicidal risk > 3 severe organic illness other psychotropic drugs

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Citalopram + placebo<br>Citalopram 20 mg/day t.i.d | Drug: Pindolol<br>* Pill orally administered. 15 mg/day t.i.d.<br>|
| Experimental: Citalopram + pindolol<br>Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d. | Drug: Pindolol<br>* Pill orally administered. 15 mg/day t.i.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on Hamilton Depression Rating Scale |  | 8 time points through 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder, citalopram, pindolol, HDRS
Brilinta DaYu Study

Study Overview
=================
Brief Summary
-----------------
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome

Official Title
-----------------
A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Incidence of Major Cardiovascular Events of Ticagrelor in Chinese Patients With Acute Coronary Syndrome(ACS)

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Ticagrelor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese Exclusion Criteria: 1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticargrelor<br>90 mg/tablet, 1 tablet bid | Drug: Ticagrelor<br>* 90mg/tablet, 1 tablet bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Events | PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal | 12 months | 
| Serious Adverse Events Other Than Bleeding | SAEs except the blending events which have aleady been reported as SAEs. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major CV Events | Combination of CV death, MI, and stroke | 12 months |
The Circadian Rhythm of Potassium and Cystatin C

Study Overview
=================
Brief Summary
-----------------
The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In patients with renal failure, the potassium value is not stable and tends to raise. Until now there are no data available if the potassium value has a circadian rhythm and if there are individual changes from day to day.

Detailed Description
-----------------
Potassium and cystatin c is measured every 2 hours during 24 hours, twice. There are two groups of patients: Patients with eGFR < 60 ml/min and patients with eGFR > 60 ml/min

Official Title
-----------------
The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability

Conditions
-----------------
Cardiac Arrhythmias, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Procedure: Blood withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old normal renal function and impaired renal function (GFR < 60 ml/min) respectively Exclusion Criteria: pregnancy anaemia (Hb<10 mg/dl)

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 |
| --- | --- |
| Healthy group<br>15 persons with normal renal function | Procedure: Blood withdrawal<br>* blood withdrawal every 2 hours during 24 hours<br>|
| Renal failure<br>15 persons with renal failure (GFR < 60 ml/min) | Procedure: Blood withdrawal<br>* blood withdrawal every 2 hours during 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium rhythm | 15 persons with normal renal function are hospitalized for 24 hours. Blood samples are taken every 2 hours in order to investigate the potassium value. It is repeated with 5 persons after 2 days, with 5 persons after 4 and with 5 persons after 6 days. | twice in 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium value in renal failure | 15 persons with renal failure (GFR < 60 ml/min) are hospitalized for 24 hours. Blood samples are taken every 2 hours in order to investigate the potassium value It is repeated with 5 persons after 2 days, with 5 persons after 4 and with 5 persons after 6 days. | twice in 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
change of potassium amount, circadian and day-to-day variability
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.

Official Title
-----------------
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients

Conditions
-----------------
Patients With Type 1 or 2 Diabetes, Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot

Intervention / Treatment
-----------------
* Other: biological examination at consultations at 3 and 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have provided oral consent Patients older than 18 Patients with type 1 or 2 diabetes Patients who can be followed-up in the context of consultations for diabetic foot at the endocrinology, diabetology and metabolic diseases unit of Dijon CHU. Lesion situated on a toe or on the plantar or dorsal side of the foot Lesion that has evolved for 1 to 24 months Exclusion Criteria: Adult under guardianship Patient without national health insurance Pregnant or breast-feeding women Patients with progressive cancer Patients with terminal renal insufficiency on dialysis Patient with severe respiratory insufficiency Patients with terminal heart failure Patients with severe liver failure Patients with immunodepriession (treatement with immunosuppressants, long-term corticotherapy, diseases leading to immunodepression) Patients with nephrotic syndrome (hypoalbuminemia) Patientswith a chronic inflammatory syndrome Alcohol consumption greater than 4 glasses per day Systemic infection uncontrolled by antibiotics Infected lesion with systemic repercussions Charcot foot Patients taking part or who have planned to take part in another clinical trial Severe disease affecting survival in the short term Lesion on an amputation Lesion of the ankle or leg

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 |
| --- | --- |
| Diabetic patients with a lesion on the foot<br> | Other: biological examination at consultations at 3 and 6 months<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of healed lesions |  | After 24 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of malnourished patients according to HAS 2003 and 2007 criteria |  | At inclusion |
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions

Study Overview
=================
Brief Summary
-----------------
This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.

Official Title
-----------------
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Give their signed written informed consent to participate Current symptoms COPD, as diagnosed by a physician Age 40 - 75 years Able to read and understand English Exclusion Criteria: • Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome) | The primary measures to demonstrate equivalency of electronic to paper PRO instruments are Usability and Cognitive Debriefing. Usability data is gathered using systematic observation under controlled conditions to determine how well the device may be used by subjects. Qualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for subject understanding of the instructions on the device used to deliver the PRO instrument. | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD PRO Instraments equivalency
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

Study Overview
=================
Brief Summary
-----------------
Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Official Title
-----------------
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: tenofovir + abacavir + lopinavir/ritonavir
* Drug: tenofovir + abacavir + efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection Antiretroviral-naive CD4 cell count below 100 cells/mm3 Exclusion Criteria: Pregnancy Current opportunistic infection requiring parenteral therapy Current malignancies requiring parenteral chemotherapy Any contraindication to the study drugs

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tenofovir + abacavir + lopinavir/ritonavir|nan|
|Drug: tenofovir + abacavir + efavirenz|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree and kinetics of recovery of the immune system. |  |  | 
| New CDC C events |  |  | 
| Mortality |  |  |
Individualized Deliberate Practice on a Virtual Reality Simulator

Study Overview
=================
Brief Summary
-----------------
Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate to the operating room. This randomized controlled trial effectively demonstrates that deliberate practice on a virtual reality simulator results in an improvement in technical skills in a real clinical situation. This enhances the feasibility of implementing simulation-based curricula into residency training programs, and consequently has the potential to improve patient safety.

Official Title
-----------------
Individualized Deliberate Practice on a Virtual Reality Simulator Improves Technical Performance of Surgical Novices in the Operating Room: A Randomized Controlled Trial

Conditions
-----------------
Education, General Surgery

Intervention / Treatment
-----------------
* Other: Deliberate Practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post graduate year 1 and 2 surgical residents performed less than 10 laparoscopic cholecystectomies as the primary surgeon Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deliberate Practice<br>Residents in the deliberate practice group received individualized feedback at the end of the initial assessment case. The staff surgeon supervising the case completed 3 previously validated technical skills assessment forms. | Other: Deliberate Practice<br> <br> |
| No Intervention: Conventional Feedback<br>Residents in the control group received informal feedback as they performed the initial laparoscopic cholecystectomy in the operating room. This was left up to the discretion of the staff surgeon supervising the operation. This corresponds to the routine teaching and feedback practices that occur during conventional surgical residency training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical skills | Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS) | 6 months |
Fungal Infection on a Joint Prosthesis

Study Overview
=================
Brief Summary
-----------------
It is generally accepted that the fungal infection on a joint prosthesis is to be treated in two surgical time: implant removal and prosthetic reconstruction. The service took the option for over 10 years to treat bacterial infections in joint replacement by a change in time. In four recent cases the diagnosis initially suspected of bacterial infection has been restated on intraoperative bacteriological examinations fungal infection. It is therefore a potentially harmful side effect of the chosen treatment option, but 4 patients in question were all cured of their fungal infection after a postoperative antifungal therapy. The objective of this study is to report these cases for discussion on the therapeutic choices in fungal infections on joint replacement.

Official Title
-----------------
Change in Joint Prosthesis in One Step Due to Fungal Infection

Conditions
-----------------
Fongal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patient having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014. Exclusion Criteria: Patients under 18 years

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 |
| --- | --- | --- |
| Fungal infection |  | for the duration of hospital stay, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fongal infection, joint prosthesis, prosthetic reconstruction
Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

Study Overview
=================
Brief Summary
-----------------
A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax. There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.

Detailed Description
-----------------
Primary outcome: - Tube site pain Pain medication requirement Secondary outcome: failure rate insertion-related complication

Official Title
-----------------
A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate

Conditions
-----------------
Traumatic Pneumothorax

Intervention / Treatment
-----------------
* Device: Pigtail catheter insertion (Cook)
* Device: chest tube (28-French)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and above Suffer traumatic pneumothorax that requires chest tube insertion Exclusion Criteria: Emergency chest tube insertion patient refuses patient is unable to provide or rate pain assessment prisoner pregnancy patient with GCS less than 13

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pigtail catheter<br> | Device: Pigtail catheter insertion (Cook)<br>* insertion of pigtail catheter to decompress pneumothorax<br>* Other names: Cook Critical Care, Cook Incorporated, Bloomington, IN);|
| Active Comparator: Traditional chest tube<br>28-French chest tube | Device: chest tube (28-French)<br>* inserting chest tube to decompress pneumothorax<br>* Other names: 28-French chest tube;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tube-site pain, pain medication requirement |  | day 0, 1, 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate |  | patients will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Insertion-related complication |  | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Pneumothorax