linjc16/ctgov huggingface dataset:
Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

Detailed Description
-----------------
This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.

Official Title
-----------------
A Randomized Controlled Trial to Evaluate the Efficacy of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Other: Whole Body Vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing maintenance hemodialysis three times a week . Exclusion Criteria: Having difficulty in walking by oneself. Having difficulty in receiving whole body vibration training because of cognitive impairment. History of fracture of lower limb within 1 year. History of total hip arthroplasty. Unsuitable for participant in the trial by an attending physician.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Whole Body Vibration<br> | Other: Whole Body Vibration<br>* Receiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the timed up and go test |  | 12 weeks after starting intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the one-leg standing test |  | 12 weeks after starting intervention | 
| Change in the 30-second chair-stand test |  | 12 weeks after starting intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whole body vibration, hemodialysis, gait function
Osteoporosis in Children and Adults Following Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
This pilot project aims to 1) estimate the prevalence of osteoporosis in adults having undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis in this group. We aim to study 40 individuals.

Detailed Description
-----------------
Background: Osteoporosis is defined as an absolute decrease in the amount of bone (volume and/or density). Chronic liver disease is associated with osteoporosis in both adults and children. Bone density is also decreased in the months immediately after liver transplantation, but improves to pretransplant values after 1 to 2 years. Immunosuppressive agents, most notably steroids, are a cause of osteoporosis. However, studies on adults have shown that bone densities afer transplantation continue to improve within the normal range for healthy adults. In the case of children, bone accretion is necessary for growth. Chronic liver disease and transplantation in childhood will have an adverse effect on bone metabolism and the outcome in terms of bone density after the growth period cannot be predicted on individuals transplanted as adults or other transplant groups.

Official Title
-----------------
Osteoporosis in Children and Adults Following Liver Transplantation

Conditions
-----------------
Osteoporosis, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Liver transplantation in childhood or young adulthood

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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 |
| --- | --- | --- |
What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?

Study Overview
=================
Brief Summary
-----------------
The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.

Official Title
-----------------
Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos

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

Intervention / Treatment
-----------------
* Drug: human menopausal gonadotrophins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. Women with a regular cycle (between 21 and 35 days). Embryos with 50% intact blastomeres after thawing. Embryo and endometrium are synchronized. Exclusion Criteria: Embryo storage time not longer than 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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: 1<br>Daily injections with a small dose of gonadotrophins from day 2 of the cycle | Drug: human menopausal gonadotrophins<br>* Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation<br>* Other names: Menopur;|
| No Intervention: 2<br>No daily injections with hormones | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate per embryo |  | 15 days after the embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of the endometrium |  | 0-2 days before the human chorionic gonadotropin (hCG) injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subfertility, endometrium thickness, implantation rate, embryo cryopreservation, embryo transfer
Rosuvastatin and Ischemia Reperfusion

Study Overview
=================
Brief Summary
-----------------
Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent atherosclerotic disease. Recent preclinical evidence suggests that statins also increase tissue tolerance to ischemia-reperfusion injury. This is a randomized, double blind, parallel designed study comparing the effect of 1 week treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours after injection. Annexin A5 targeting is calculated as the percentage difference in activity (counts/pixel) between the thenar muscles of both hands.

Official Title
-----------------
Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (18-50 years of age) Exclusion Criteria: Hypercholesterolemia Hypertension

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

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annexin A5 targeting to ischemically exercised hand |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipid levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia-reperfusion, Annexin A5
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration

Study Overview
=================
Brief Summary
-----------------
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months). The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

Official Title
-----------------
Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO

Conditions
-----------------
HIV Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infection maraviroc-naives patients CD4 less than 350 cells/mm3 viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months Exclusion Criteria: HIV-2 infection X4 tropism at inclusion pregnancy and breast feeding interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy hypersensibility of peanut or soya

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: maraviroc|maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load |  | immunologic benefit at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36. |  | immuno-virologic evolution between week 0 and week 36 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maraviroc, immune restoration, treatment intensification
New, Easy and Efficient Ways to CLassify AcetabulaR Fractures

Study Overview
=================
Brief Summary
-----------------
Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one. Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult. So the the aim of this study is: Evaluate the efficacy of four special 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel. Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures. Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.

Detailed Description
-----------------
12 reviewers will be given the different imaging of each case and will be divided in 4 groups: novice (junior ER and ortho residents), intermediate (non-experimented orthopedic surgeons), intermediate with a formation on classifying acetabular fractures and finally experts (acetabular fracture expert surgeons) . For each patient, representative CT scans are provided for each assessment. The study will be divided into 3 phases separated by 4-6 weeks of time. In the first phase, for each patient, representative CT scans are provided for each assessment with 2D and multiplanar reconstruction (MPR) without 3D views. In the second phase, 3D views are added. In the third phase, the cases are evaluated using the Acetabular Diagnosis Tool To note, the evaluation of the cases is done twice in each phase separated by 4-6 weeks and the order of the cases is changed, both in order to minimize recall bias

Official Title
-----------------
New, Easy and Efficient Ways to CLassify AcetabulaR Fractures

Conditions
-----------------
Acetabular Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acetabular fracture Exclusion Criteria: no criteria

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 |
| --- | --- | --- |
| 3D reconstruction of pelvis CT scan |  | 6 months |
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Study Overview
=================
Brief Summary
-----------------
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

Detailed Description
-----------------
The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Official Title
-----------------
Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Intravenous Diclofenac (DIC075V)
* Drug: Intravenous Ketorolac
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery Moderate to severe pain within 6 hours following completion of the required surgery. Exclusion Criteria: Surgical procedure involves a subcostal incision. Chronic disease or recent cardiovascular events. Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study. Additional Inclusion/Exclusion Criteria May Apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>intravenous diclofenac dosage level 1 | Drug: Intravenous Diclofenac (DIC075V)<br>* Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels<br>|
| Experimental: B<br>intravenous diclofenac dosage level 2 | Drug: Intravenous Diclofenac (DIC075V)<br>* Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels<br>|
| Active Comparator: C<br>intravenous ketorolac | Drug: Intravenous Ketorolac<br>* Intravenous Ketorolac<br>|
| Placebo Comparator: D<br>placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of the pain intensity differences (SPID) over the 0-48 hour time interval. |  | 0-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID over the 0-24 hour interval |  | 0-24 hours | 
| Other measures of pain relief |  | Multiple |
Risk Factors of Stroke or Systemic Embolism After Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.

Detailed Description
-----------------
Since catheter ablation for AF reduces the burden of AF effectively, several studies have demonstrated that catheter ablation not only improves the quality of life but also reduces the risk of stroke and all cause mortality. However, until now the guideline has recommended the continuation of oral anticoagulation (OAC) therapy in patients who are at risk of stroke or systemic embolism (SE) based on the CHA2DS2-VASc score, even though they have sinus rhythm following catheter ablation. The aims of this retrospective study is to assess the rate of stroke/SE during follow-up period after AF ablation and identify the independent risk factors for stroke/SE in patients who underwent catheter ablation for AF.

Official Title
-----------------
The Characteristics of Patients Experiencing Stroke or Systemic Embolism During Follow up Period After Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent catheter ablation for AF Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke group<br>Patients who experienced stroke or systemic embolic event following catheter ablation for AF. | |
| Control group<br>Patients who did not experienced stroke or systemic embolic event following catheter ablation for AF. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke or systemic embolism after AF ablation | Risk factors for stroke or systemic embolism after AF ablation | From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years) |
Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy

Study Overview
=================
Brief Summary
-----------------
Patients needing lipid lowering therapy will be recruited before initiation of the treatment. For each patient, total and LDL cholesterol levels before start of therapy will be measured. One, three and six months after his/her first visit, when steady-state will be reached, for each included patient, the cholesterol levels will be re-assessed in order to evaluate the response to statin therapy calculated as the amplitude of cholesterol reduction. The aim is to assess the association between patient's genotype and the response to statin therapy.

Official Title
-----------------
Lipid-lowering Therapy Individualization

Conditions
-----------------
Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy

Intervention / Treatment
-----------------
* Other: Genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient known to be compliant Age [25-80] treated with Atorvastatin, simvastatin, fluvastatin. Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Statin users<br> | Other: Genotyping<br>* DNA extraction from blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol levels-side effects |  | 1 to 6 months |