linjc16/ctgov huggingface dataset:
Association Between Plasma Melatonin and No-reflow

Study Overview
=================
Brief Summary
-----------------
ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death. A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin is associated with myocardial infarction and heart failure. However, no study has evaluated whether melatonin is associated with adverse clinical outcomes in STEMI patients.

Official Title
-----------------
Association Between Plasma Melatonin and No-reflow

Conditions
-----------------
ST-segment Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of STEMI and needed PCI Exclusion Criteria: patients with cancer patients who used melatonin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Quartile 1 of plasma melatonin<br>Quartile 1 of plasma melatonin | |
| Quartile 2 of plasma melatonin<br>Quartile 2 of plasma melatonin | |
| Quartile 3 of plasma melatonin<br>Quartile 3 of plasma melatonin | |
| Quartile 4 of plasma melatonin<br>Quartile 4 of plasma melatonin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in the prevalence of no-reflow | Thrombolysis in myocardial infarction (TIMI) flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow | mediately after percutaneous coronary intervention (PCI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital complications | defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia | up to 2 weeks after PCI | 
| in-hospital major adverse cardiac or cerebrovascular events | the composite of death, nonfatal MI, or stroke | up to 2 weeks after PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, STEMI, No-reflow
Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders

Study Overview
=================
Brief Summary
-----------------
We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.

Official Title
-----------------
Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Fostimon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval. Exclusion Criteria: High responder patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UrFSH<br> | Drug: Fostimon<br>* 450 IU for 4 days then adjusted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate per embryo transfer |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved |  | per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ART, poor responder, GnRH antagonist, Gonadotropins
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.

Official Title
-----------------
A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials

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

Intervention / Treatment
-----------------
* Drug: No Investigational Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial Ability and willingness to provide informed consent Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing. Exclusion Criteria: Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARV-Treated Participants<br>Those participants who received dapivirine during HIV seroconversion | Drug: No Investigational Product<br>* This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants<br>|
| ARV-Naive Participants<br>Those participants who received placebo during HIV seroconversion | Drug: No Investigational Product<br>* This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo. | The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infections, Anti-HIV Agents, HIV-1
Non-small Cell Lung Cancer Study US75 (Z-PACT)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.

Conditions
-----------------
Non Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: zoledronic acid
* Drug: Taxotere
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients at least of 18 years old Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery Women must not be pregnant or attempting to become pregnant Able and willing to sign informed consent Exclusion Criteria: Patients with cancer that has spread to the bone Patients with cancer that has spread to the brain who are receiving treatment Patients with kidney disease Patients treated with other investigational 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zometa®<br>4mg monthly for 12 months from date of first chemotherapy dose | Drug: zoledronic acid<br> <br> Drug: Taxotere<br> <br> Drug: Carboplatin<br> <br> |
| No Intervention: no further treatment<br>Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose | |

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
-----------------
lung cancer, ZPACT, US75, Bone Metastases
Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation

Study Overview
=================
Brief Summary
-----------------
Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone after ablation is needed.

Detailed Description
-----------------
Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone, are given prevent ventricular arrhythmias and ICD interventions that may not be curative. Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well elucidated. In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD interventions despite medical treatment. VT ablation is performed and patients divided into two groups; group one continues having amiodarone after ablation, group two does not have amiodarone after ablation. Both groups will be compared in terms of recurrence and death.

Official Title
-----------------
Effect of Amiodarone After Ischemic Ventricular Tachycardia Ablation

Conditions
-----------------
Ischemic Cardiomyopathy, Ventricular Tachycardia, ICD Shock

Intervention / Treatment
-----------------
* Procedure: Ventricular tachycardia ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic cardiomyopathy patients applied with frequent ICD interventionor electrical storms and having ejection fraction below 50%. Frequent ICD defined as more than 1 ICD intervention within month. Electrical storm defined as more than 2 ICD intervention within one day. Exclusion Criteria: Patients with cardiomyopathies other than ischemic etiology

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<br>Patients underwent ablation and continued having amiodarone after the procedure | Procedure: Ventricular tachycardia ablation<br>* Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously<br>|
| Group 2<br>Patients underwent ablation and not having amiodarone after the procedure | Procedure: Ventricular tachycardia ablation<br>* Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | Death, ICD intervetion | six months |
Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.

Official Title
-----------------
Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values

Conditions
-----------------
Primary Graft Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplant recipient Age > 18 years Signed informed consent Social security affiliation Exclusion Criteria: Age<18 Pregnancy or lactation Contraindication to femoral arterial catheterization Patient refusal

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 and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI). |  | H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion |  | H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplantation, Primary Graft Dysfunction, Extravascular Lung Water, Receptor for Advanced Glycation Endproducts (RAGE), Intercellular Adhesion Molecule-1 (ICAM-1)
Psoriasis and the Risk of Cardiovascular Disease. A Prospective Study

Study Overview
=================
Brief Summary
-----------------
There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. The main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.

Official Title
-----------------
Psoriasis and the Risk of Cardiovascular Disease. A Prospective Observational Study to Detect Cardiovascular Risk Factors

Conditions
-----------------
Psoriasis, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (PASI >10 or systemic treatment) Exclusion Criteria: familiar hypercholesterolemia, ongoing infections and cancer disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
FGF-23 Suppressibility by Calcitonin

Study Overview
=================
Brief Summary
-----------------
Introduction: Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans. Aim: In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men. Study Design: placebo-controlled, cross-over study Method: All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein. Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes Mealtimes: Calcium and Phosphate intake standardized on both occasions All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23 Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD Endpoint: A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

Official Title
-----------------
Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study

Conditions
-----------------
Hypophosphatemia

Intervention / Treatment
-----------------
* Drug: Calcitonin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2. Exclusion Criteria: Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min. Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels. Any medication.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Calcitonin<br>* Calcitonin 200 IU/ml, single subcutaneous injection, experimental group<br>|
| Placebo Comparator: 2<br>NaCl 0,9% 2 ml, single subcutaneous injection | Drug: Placebo<br>* NaCl 0,9 % 1ml, single subcutaneous injection, placebo group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU. |  | eight hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroblast growth factor - 23, Calcitonin
Low-fidelity Simulation to Teach Anesthetists' Non-technical Skills in Rwanda

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Human factors, such as communication, planning, and team working are considered nontechnical skills which contribute greatly to patient safety in complex hazardous systems such as aviation, nuclear power industry, and operating rooms. Simulation began in the aviation industry to train pilots in human factors. In the past two decades simulation has been valued in medical education as it allows the learner to rehearse skills in an environment that is similar to the workplace but without the threat of harm to patients. High Fidelity simulators involve computer driven interactive mannequins that recreate an authentic environment. This has been used successfully to teach anesthetists' non-technical skills (ANTS) such as: decision making, team working, task management, and situation awareness. Anesthetists' non-technical skills are particularly important in developing countries where the shortage of supplies, equipment, and qualified personnel can lead to a perilous working environment making team work and communication vital for patient safety. The costs of high fidelity simulation are prohibitive for many developing countries. This study seeks to examine whether low fidelity instructor driven simulation can provide an effective intervention to teach anesthetists' non-technical skills in Rwanda. If found to be effective, this method of training could be applied to other developing countries to improve non-technical skills for anesthesia providers with the goal of making surgery safer.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: low-fidelity instructor driven simulation training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthesia providers (resident or technician) that provides anesthesia for caesarean section Exclusion Criteria: anesthesia providers that do not provide anesthesia for caesarean section

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-fidelty instructor driven simulation training<br>participants receive simulation training | Other: low-fidelity instructor driven simulation training<br> <br> |
| No Intervention: No simulation training<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall ANTS score after simulation training |  | two weeks after training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Training Program