linjc16/ctgov huggingface dataset:
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

Study Overview
=================
Brief Summary
-----------------
The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.

Official Title
-----------------
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

Conditions
-----------------
Hematopoiesis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening. For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening. Exclusion Criteria: Age superior to 65 years old, Active cancer

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Previous proximal unprovoked pulmonary embolism<br> | Biological: blood sample<br>* Blood sample withdrawal in order to perform DNA sequencing<br>|
| Active Comparator: Previous proximal provoked pulmonary embolism<br> | Biological: blood sample<br>* Blood sample withdrawal in order to perform DNA sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of CHIP markers between patients groups | Variation of CHIP markers (clonal hematopoiesis of indetermined prognosis ) between patients groups. CHIP concept have been defined as a mutation of preleukemic genes at an allelic variation inferior to 2% associated with normal complete blood count. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, hematopoiesis, genetic sequencing, endothelial dysfunction
Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever

Study Overview
=================
Brief Summary
-----------------
to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF).

Detailed Description
-----------------
Familial Mediterranean fever (FMF) is also known recurrent polyserositis the most common hereditary recurrent febrile disorder. It is characterized by paroxysmal episodes of the high fever and signs of serositis-peritonitis, pleuritis, synovitis. Between these attacks, patients are usually asymptomatic. FMF mainly affects populations of the Mediterranean region such as Turks. The diagnosis of FMF may be extremely difficult to establish in the presence of atypical signs, and absence of family history . Colchicine is effective in most of the patients with FMF. The one the most important complications of FMF is the development of renal amyloidosis. It potentially progress sequentially through preclinical, proteinuric, nephrotic, azotemic and uremic stages to end stage renal disease if not treated properly with colchicine. Previous studies suggests that colchicine does not appear to be a major human teratogen, and, probably, has no cytogenetic effect. FMF affects females mainly in their childbearing years. FMF is associated with higher rates of recurrent abortion, premature rupture of membranes (PROM) and preterm birth. Despite of adverse outcomes have been reported in pregnants with FMF the outcome of pregnancies in FMF appear favorable with the healthy population since the usingof the colchicine. Although the effect of pregnancy on the course of FMF related amyloidosis is controversial, it is generally accepted that renal function may disrupt during pregnancy. Few studies have investigated the effect of FMF complications (amyloidosis and nephrotic syndrome) on pregnancy course. The aim of this study is to investigate the effect of basal proteinuria on pregnancy outcome of patients with Familial Mediterranean fever (FMF).

Conditions
-----------------
Basal Proteinuria in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant patients with FMF Exclusion Criteria: multiple pregnancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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 |
| --- | --- | --- |
| change in proteinuria correlation to the adverse outcomes of pregnancy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
basal proteinuria, FMF, pregnancy
Effects of Acute Dietary Changes on Estimates of Body Composition

Study Overview
=================
Brief Summary
-----------------
The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.

Official Title
-----------------
Effects of Acute Dietary Changes on Estimates of Body Composition

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Other: High-carbohydrate diet
* Other: Low-carbohydrate diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Recreationally active (>150 min/week of moderate or vigorous physical activity) Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only) Exclusion Criteria: Failure to meet inclusion criteria Commencement or cessation of taking the dietary supplement creatine within the past month Pregnant or may become pregnant during the study Known or suspected food allergy to any items used in study Presence of medical condition that could reasonably be negatively affected by participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-carbohydrate diet<br>Single day of 9 g/kg body weight consumption of carbohydrate. Isocaloric to very low-carbohydrate condition. | Other: High-carbohydrate diet<br> <br> |
| Experimental: Very low-carbohydrate diet<br>Single day of 1 - 1.5 g/kg body weight consumption of carbohydrate. Isocaloric to high-carbohydrate condition. | Other: Low-carbohydrate diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual-energy X-ray Absorptiometry Output | Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry. | 2 days | 
| Bioelectrical Impedance Analysis Output | Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Composition
Intestinal Microbiota in Stem Cell Transplant Transplant Admission

Study Overview
=================
Brief Summary
-----------------
In this prospective study, the primary objective will be to investigate the association between the use of antibiotics administered during the admission period of Stem cell transplant (SCT) and the rate of overall change in microbiota composition across adjacent samples in time.

Detailed Description
-----------------
Early preclinical studies suggested that intestinal microflora contribute to aGVHD and may be relapse. There is increasing evidence that use of antibiotics may have a detrimental impact on intestinal microbiota composition and, consequently, the outcome of SCT.However, effect on different antibiotic prophylaxis regimens and broad-spectrum antibiotics used during transplant and the intestinal microbiota composition and hence adverse outcomes are not known. Stool samples will be collected from patients who are undergoing SCT at: preconditioning at day 0 (stem cell infusion) once in the period of day + 7-10 post SCT once first day or second day of BMT OPD clinic visit once if they develop >=grade I GVHD once at time of recovery from GVHD

Official Title
-----------------
Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission

Conditions
-----------------
Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Diagnostic Test: intestinal microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 years patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: intestinal microbiota|Stoll samples will be tested for different bacteria|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome |  | Up to 6 months post stem cell transplant |
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.

Official Title
-----------------
Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery

Conditions
-----------------
Hallux Valgus, Hallux Rigidus

Intervention / Treatment
-----------------
* Procedure: surgery, bioabsorbable screw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment Exclusion Criteria: Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bioabsorbable screw<br> | Procedure: surgery, bioabsorbable screw<br>* In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery<br>|
| Active Comparator: titanium screw<br> | Procedure: surgery, bioabsorbable screw<br>* In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS score | score | 2 years |
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

Official Title
-----------------
A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Conditions
-----------------
Atrial Flutter, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: RSD1235
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days Exclusion Criteria: Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RSD1235<br>* IV<br>* Other names: Kynapid;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm |  | Infusion plus 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the time taken from exposure to first treatment to first conversion to sinus rhythm |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Flutters, Atrial Fibrillations, RSD1235
Physical Characteristics of Retrieved Massive Allografts

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.

Detailed Description
-----------------
Allograft bone is the primary source of graft material for large skeletal defects resulting from trauma, disease, oncological resection, or reconstruction of failed total joint arthroplasties. The physical characteristics of such grafts after various intervals of remodeling and incorporation in vivo have never been studied. The purpose of this study is to obtain tissue from allografts retrieved at autopsy, at amputation for oncological complications and from patients undergoing revision procedures for failed allograft transplantation. We will evaluate the mechanical properties, histomorphometric indices and presence of microfractures. Our hypotheses are: histomorphometric parameters of porosity and microfracture density will predict allograft strength, microfracture density will be correlated with time in vivo and allograft strength, the rate of host-allograft nonunion and fracture will correlate with radiation therapy and chemotherapy. The retrieved tissue will be processed using standard undecalcified histology and quantitatively assessed for degree of incorporation, allograft porosity, and microfracture density. The biomechanical characteristics of the bulk allograft and allograft-host junction will be quantified and compared to allograft bone prior to transplantation.

Official Title
-----------------
Physical Characteristics of Retrieved Massive Allografts

Conditions
-----------------
Bone Cancer

Intervention / Treatment
-----------------
* Procedure: retrieve massive allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: failed allograft bone removal of allograft due to oncological complications amputation due to oncological complications Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: retrieve massive allograft|Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy). Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.

Official Title
-----------------
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant recipients Age range: 18-70 Patients taking MMF Able to understand and sign an informed consent Exclusion Criteria: Active myelodepression Systemic infections or other that may affect MMF absorption Pregnancy/breastfeeding (History of) cancer Drug abuse, psychiatric conditions Already enrolled in other clinical trials or participation ended less than one month earlier Known sensitivity to polysorbate 80 or MMF

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| 1<br>MMF+cyclosporine | |
| 2<br>MMF+tacrolimus | |
| 3<br>MMF+sirolimus | |

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
-----------------
kidney, transplant, Mycophenolic acid, Inosine monophosphate dehydrogenase
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.

Official Title
-----------------
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

Conditions
-----------------
Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds

Intervention / Treatment
-----------------
* Device: SNaP® Wound Care System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease). Wound present for >30 days. Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings. Patient is able to comply with study protocol requirements. Patient is able to understand and provide written consent. Exclusion Criteria: Patient has evidence of wound infection in the opinion of the physician. Patient has a thick eschar that persists after wound debridement. Patient has an HbA1C >12%. Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis. Patient has untreated osteomyelitis. Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study. Patient is allergic to the wound care device or occlusive dressing. Patient has exposed blood vessels. Patient is pregnant or pregnancy is suspected. Patient is actively participating in other clinical trials that may interfere with their participation in this study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SNaP® Wound Care System<br> | Device: SNaP® Wound Care System<br>* Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure |  | 12 weeks |