linjc16/ctgov huggingface dataset:
A Study to Evaluate the Bioavailability of BMS-986205

Study Overview
=================
Brief Summary
-----------------
Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.

Official Title
-----------------
A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: BMS-986205


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula Women must not be of childbearing potential (cannot become pregnant) Exclusion Criteria: Women who are of childbearing potential or breastfeeding Any significant acute or chronic medical illness Active tuberculosis (TB) requiring treatment or documented latent TB at screening Other protocol defined inclusion / exclusion criteria could apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986205<br>Single oral dose of BMS-986205 tablet on the morning of Day 1 followed by a 15-minute infusion of [13C]BMS-986205 solution for intravenous administration starting 01:45 hours after the oral dose administration | Drug: BMS-986205<br>* Specified Dose on Specified Days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute oral bioavailability (F) | Measured by plasma concentration | Up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 15 days | 
| Occurrence of serious adverse events (SAEs) | Safety and tolerability as measured by incidence of SAEs | Up to 15 days | 
| Occurrence of adverse events (AEs) leading to discontinuation | Safety and tolerability as measured by incidence of AEs leading to discontinuation | Up to 15 days | 
| Number of participants with vital sign measurement abnormalities |  | Up to 15 days | 
| Number of participants with electrocardiogram abnormalities |  | Up to 15 days | 
| Number of participants with physical examination abnormalities |  | Up to 15 days | 
| Number of participants with clinical laboratory test abnormalities |  | Up to 15 days |
Real-world Daptomycin Use in Chinese ICUs

Study Overview
=================
Brief Summary
-----------------
Analyze the effectiveness and safety of Daptomycin(Jiangsu Hengrui Medicine Co., Ltd) in Gram-positive infections in Chinese Intensive Care Units by using the real-world data platform, https://rws.scccmqc.com. Patients who received at least one dose of Daptomycin between 2016 to 2021 are eligible.

Official Title
-----------------
Real-world Effectiveness and Safety on Daptomycin in Gram-Positive Infections in Chinese Intensive Care Units

Conditions
-----------------
Daptomycin, Real-world Study, Intensive Care Unit

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received at least one dose of daptomycin Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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 |
| --- | --- |
| Study population<br>Patient who receive at least one dose of daptomycin | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death | 30 days | 
| Cure Rate | clinical and microbiological effectiveness | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | organ dysfunction，allergy，creatine kinase levels，eosinophilic pneumonia，etc. | 30 days |
Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

Study Overview
=================
Brief Summary
-----------------
The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Vitamin D3, 100 000 IU weekly, 4 times
* Biological: 25 OH vitamin D serum concentration measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women ≥ 50 years Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture having signed an informed consent Exclusion Criteria: Taking a loading dose of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study). Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance * *) Treatment with thiazide diuretic Known malabsorption (celiac disease) Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism. Persistent or nephrolithiasis occurred in the previous 5 years known sarcoidosis Persons under guardianship or trusteeship Hypercalcemia and hypercalciuria 25OH vitamin D levels> 50ng / ml

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3, 100 000 IU weekly, 4 times<br> | Drug: Vitamin D3, 100 000 IU weekly, 4 times<br> <br> Biological: 25 OH vitamin D serum concentration measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25 OH vitamin D concentration |  | 4 weeks |
Dynamic Internal Fixation of Femoral Neck Fractures

Study Overview
=================
Brief Summary
-----------------
Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.

Detailed Description
-----------------
Two implant systems are mainly used for internal fixation: canulated screws and plate-screw-systems. Regarding the latter, the dynamic hip screw systems (DHS)represent the most frequently used devices. Targon FN (Aesculap) is a new plate-screw system and available on the market since 2007. In contrast to the DHS, which uses only one telescrew, the Targon FN provides up to four telescrews. With this registry, we want to evaluate the results of Targon FN compared with DHS systems.

Official Title
-----------------
Dynamic Internal Fixation of Femoral Neck Fractures

Conditions
-----------------
Femoral Neck Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men >= 60 years, women >= 55 years femoral neck fractures needing surgical therapy femoral head preserving indication Living in a 100 km Radius from Hospital Exclusion Criteria: Patient not able to walk Previous fracture or surgery on ipsilateral hip pathological fracture open fracture

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Targon FN<br> | |
| DHS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Complication Rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral Neck Fracture, Internal Fixation, Dynamic Hip Screw
Metabolic Screening in Patients With Donnai-Barrow Syndrome

Study Overview
=================
Brief Summary
-----------------
This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).

Detailed Description
-----------------
The purpose of this study is to better understand the role of certain nutrients and vitamins in promoting the healthy development of individuals with Donnai-Barrow Syndrome. The investigators hope that the information gained by studying the metabolism of children with Donnai-Barrow Syndrome and their family members will lead to significant advances in the treatment of this disease.

Official Title
-----------------
Metabolic Screening in Patients With Donnai-Barrow Syndrome

Conditions
-----------------
Donnai-Barrow Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals affected with Donnai-Barrow Syndrome
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Donnai-Barrow Syndrome (DBS)<br>Individuals affected with Donnai-Barrow Syndrome (DBS) | |
| Unaffected<br>Healthy family members of individuals affected with Donnai-Barrow Syndrome (DBS) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of blood sugar, cholesterol, vitamins A and D, and other compounds |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donnai-Barrow Syndrome (DBS), metabolic testing, genes, genetic
Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.

Official Title
-----------------
ESWT Treatment of Diabetic Foot VS. Standard Care Trial

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Device: shock wave therapy
* Device: dermagold shockwave
* Procedure: standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent. Diagnosed with Diabetes. An Active Diabetic Ulcer larger than 5 cm2 Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5 Exclusion Criteria: Pregnancy. The patient is under another research protocol. One of the following: A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date. Sufficient Noncompliant. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: shock wave therapy, shortened wound healing time<br> | Device: shock wave therapy<br>* shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.<br>Device: dermagold shockwave<br>* shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.<br>|
| Other: normal wound care<br>standard of care intervention | Procedure: standard of care<br>* regular care including debridement and bandaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healed ulcer |  | 6 months |
Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

Study Overview
=================
Brief Summary
-----------------
The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Detailed Description
-----------------
Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.

Official Title
-----------------
Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

Conditions
-----------------
Obstructive Sleep Apnea Hypopnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 2 and 12 years child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome Exclusion criteria: - over 12 years old

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Overall signal quality of the respiratory polygraph | retrospective data collection : Overall signal quality of RP (Respiratory polygraphy) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric obstructive sleep apnea hypopnea syndrome, pediatric respiratory polygraphy, device acceptance, signal quality, automatic detection of respiratory events
Posterior Assisted Levitation of Dropped Nucleus

Study Overview
=================
Brief Summary
-----------------
Dropping of nucleus is a common complication during cataract extraction by phacoemulsification. The investigators describe a new technique to retrieve the dropped nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).

Detailed Description
-----------------
Upon recognition of posterior capsular rupture and dropping of nucleus phaco prob will be withdrawn, status of the nucleus will be visualized by posterior segment non contact lens and if the nucleus found floating, pars plana levitator will be introduced through temporal pars plana, its prongs will be opened and nucleus will be grasped between prongs. Nucleus will be lifted up till the anterior chamber where phacoemulsification will be performed in a usual manner and a posterior chamber intraocular lens will be implanted if possible in the remaining bag.

Official Title
-----------------
Posterior Assisted Levitation by Pars-Plana Levitator

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients during cataract surgery whose nucleus will be dropped during phacoemulsification Exclusion Criteria: Completely dropped nucleus touching the posterior pole

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posterior assisted levitation, Pars Plana, Dropped nucleus, cataract, complication of, surgery
Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Official Title
-----------------
A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Atrasentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate adenocarcinoma, radical prostatectomy, PSA between 0.4 and 5 ng/mL, PSADT < 1 year Exclusion Criteria: previous hormonal therapy, salvage therapy to the pelvis within 3 months prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA. |  |  |
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women

Study Overview
=================
Brief Summary
-----------------
The general hypothesis of the research is that stress decreases fertility and that Cognitive Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize that stress has a detrimental effect on DNA integrity and that stress reduction will reduce DNA damage in the cell.

Official Title
-----------------
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women Undergoing IVF Treatment.

Conditions
-----------------
Infertility, Stress

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between the ages of 18-35 without children undergoing IVF treatment Exclusion Criteria: undergoing treatment for a DSM-IV axis I psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COGNITIVE BEHAVIORAL INTERVENTIONS<br>PSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES | Behavioral: Cognitive Behavioral Therapy<br>* The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA damage/ γH2AX |  | with in IVF cycle (2 months) | 
| decreased stress |  | two months |