linjc16/ctgov huggingface dataset:
An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

Detailed Description
-----------------
All patients who received one of the two combinations will be included in the study and followed-up until the patient is discharged from the hospital. They will be seen daily during the period of their active clinical follow-up at the hospital. At each visit, the medical history since the last visit (including treatments taken), signs and symptoms in progress if any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and then on day 21 if he is still positive in order to assess the evolution of the viral load. However if until the end of the follow-up on D21 the test is still positive, the sampling will be continued until the patient become negative as recommended by the national standard of care for the Covid patients management in Burkina Faso. In terms of safety, an ECG will be performed on day 0 prior to the treatment administration and this will be repeated on day 7 and day 14 and every week until it normalizes or the patient will be recommended to see a cardiologist to check the normalization of his ECG after discharge from hospital. Adverse events will be recorded including biological parameters (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory parameters.

Official Title
-----------------
An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso

Conditions
-----------------
Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient over 18 years treated according to the standard of care Willing to participate in the study by giving an informed consent Exclusion Criteria: Patients under 18 years of age Not willing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Clearance of viral load | The impact of the treatment on virological clearance (viral load) post-treatment | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment | This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters | 14 days |
Comparing the Effects of Exercise on the Structure and Function of Fat Tissue

Study Overview
=================
Brief Summary
-----------------
Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.

Official Title
-----------------
Effects of Exercise Training on the Structure and Metabolic Function of Fat Tissue

Conditions
-----------------
Adiposity

Intervention / Treatment
-----------------
* Diagnostic Test: Oral Glucose Tolerance Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-40 years old Body Mass Index: 23-35 kg/m2 Women must have regularly occurring menses and must be premenopausal Exclusion Criteria: Evidence/history of cardiovascular or metabolic disease Medications known to affect lipid or glucose metabolism, or inflammation Weight instability ≥ ± 6 pounds in the last 6 months Tobacco or e-cigarette users Women must not be pregnant or actively lactating Blood pressure > 140/90 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Glucose Tolerance Test<br>Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level | mg/dL | 2 hours at Experimental Trial | 
| Adipose tissue fibrosis | Pico-sirius Red stain (percent stained) | baseline |
LUPKYNIS US Registry Trial

Study Overview
=================
Brief Summary
-----------------
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).

Official Title
-----------------
A Prospective Observational Registry of Patients Treated With LUPKYNIS™ (Voclosporin) in the US

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: LUPKYNIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lupus nephritis (LN) confirmed by biopsy Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI) Written informed consent Exclusion Criteria: - Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)

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 |
| --- | --- |
| Lupkynis Treatment Group<br> | Drug: LUPKYNIS<br>* LUPKYNIS treatment per the approved US Prescribing Information<br>* Other names: voclosporin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LUPKYNIS utilization patterns | The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) >0.5 mg within 6 months of initiating LUPKYNIS. | 36 months | 
| Effectiveness of LUPKYNIS | The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) <=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment. | 36 months |
Aging and Cancer Effects (ACE) Study

Study Overview
=================
Brief Summary
-----------------
Hypotheses: Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains. Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer. Some aspect of baseline patient characteristic will be predictive of cancer-related outcomes.

Official Title
-----------------
Aging and Cancer: The Effects of Comorbidities on Cancer and it's Treatment

Conditions
-----------------
Breast Cancer, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to do memory testing Willing to participate in activities of daily living assessment Can use a cane or walker Willing to complete a balance performance assessment, if able. Exclusion Criteria: Currently receiving treatment for cancer. Has a previous history of brain cancer Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.

Detailed Description
-----------------
PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant. This study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. There will be no additional study visits.

Official Title
-----------------
Genetics of Primary Graft Dysfunction

Conditions
-----------------
Primary Graft Dysfunction, Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing lung transplant surgery Exclusion Criteria: - Individuals undergoing multi-organ transplantation except heart/lung transplants

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Primary graft dysfunction | ISHLT standard definition and grading system will be used | First 72 hours post lung transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PGD
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Menopause, Hot Flashes, Sleep Disorders

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, postmenopausal women who seek treatment for hot flushes Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening Body Mass Index (BMI) less than or equal to 40 kg/m2 Other inclusions apply. Exclusion Criteria: Hypersensitivity to Venlafaxine History of seizure disorder History of myocardial infarction or unstable angina within 6 months Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 0 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep, mood |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause
DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection

Study Overview
=================
Brief Summary
-----------------
Lung transplantation (LTx) , DNA-based testing. Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing. Experimental intervention: DNA-based testing of BAL fluid.

Detailed Description
-----------------
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.

Official Title
-----------------
DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection

Conditions
-----------------
Lower Respiratory Tract and Lung Infections

Intervention / Treatment
-----------------
* Other: Experimental Intervention: DNA-based testing of BAL fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after lung transplantation (single, double or combined) suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of new onset of malaise new or progressive pulmonary infiltrate hypoxemia (SpO2/SaO2 <92% or need for oxygen) temperature of 38 o C or above within 7 days purulent (yellow or greenish) sputum CRP of 30 mg/l or above PCT of 0,5 µg/l or above Exclusion Criteria: no informed 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Experimental Intervention: DNA-based testing of BAL fluid|DNA based testing needs 4.5 hours lab time in addition to standard testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection | Cohen's kappa measures the agreement between methods and the final clinical diagnosis. Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen. A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling. Cohen's kappa will be compared between the two methods. | 6 month |
Furcation Treatment With L-PRF and aPDT

Study Overview
=================
Brief Summary
-----------------
To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.

Detailed Description
-----------------
randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four patients with Grade II furcation involvement were recruited in this study. Control group only received L-PRF, while study group used a combination of L-PRF and aPDT Attachment level, pocket depth, horizontal component and gingival recession, also radiographic Bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

Official Title
-----------------
Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study

Conditions
-----------------
Furcation Defects

Intervention / Treatment
-----------------
* Procedure: L-PRF with aPDT
* Procedure: L-PRF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade II furcation involvement age range 18- 50 years 3 mm or more vertical probing depth Exclusion Criteria: systemic disease abnormal clotting and bleeding smokers, root caries or restoration Grade II mobility periapical lesions

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 48 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-PRF<br>Leukocyte platelet rich fibrin as a sole graft material in class II furcation | Procedure: L-PRF<br>* surgical open flap debridement followed by L-PRF alone<br>|
| Active Comparator: L-PRF with aPDT<br>Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation | Procedure: L-PRF with aPDT<br>* surgical open flap debridement followed by L-PRF with aPDT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of Vertical clinical attachment level VCAL | using periodontal probe in mm | 6 months | 
| clinical evaluation of vertical pocket depth VPD | using periodontal probe in mm | 6 months | 
| clinical evaluation of furcation horizontal component FHC | using periodontal probe in mm | 6 months | 
| clinical evaluation of gingival recession REC | using periodontal probe in mm | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet rich fibrin, photodynamic therapy
Testosterone and Weight Loss

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.

Official Title
-----------------
Effect of Testosterone and Diet on Weight

Conditions
-----------------
Obesity in Men

Intervention / Treatment
-----------------
* Drug: Testosterone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 Exclusion Criteria: contraindications to testosterone therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- |
| Active Comparator: testosterone<br>against placebo | Drug: Testosterone<br>* TU im<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo im<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 12 months |
Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

Study Overview
=================
Brief Summary
-----------------
To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.

Official Title
-----------------
Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Pelvic reconstruction surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery Women who had undergone pelvic reconstruction surgeries in our hospital Exclusion Criteria: Pregnant woman.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pelvic reconstruction surgery|Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the women's bladder function questionnaire of UDI-6 | Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome. | 10 years | 
| the women's bladder function questionnaire of IIQ-7 | Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome. | 10 years | 
| Change of psychosomatic score | Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome. | 1 year | 
| Change of Overactive Bladder Symptom Score | Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome. | 1 year | 
| Change of FSFI score | Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome. | 1 year |