linjc16/ctgov huggingface dataset:
Effects of Phototherapy by Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical and Biomechanical of Muscle Performance in Athletes

Study Overview
=================
Brief Summary
-----------------
Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in experimental models and human researches. Now, the investigators used LEDT to increase muscle performance of professional athletes with high performance.

Detailed Description
-----------------
The study assessed muscle performance by vertical jump (height of jump and muscle power); creatine kinase; lactate; metabolism by resonance nuclear magnetic in urine; oxygen uptake (VO2) and its onset kinetic response.

Official Title
-----------------
Effects of Phototherapy by Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical and Biomechanical of Muscle Performance in Athletes

Conditions
-----------------
Athlete

Intervention / Treatment
-----------------
* Device: Light-emitting diode therapy
* Device: Placebo light-emitting diode therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: professional athletes aged between 14 and 16 years; professional athletes aged between 18 and 28 years Exclusion Criteria: previous injury to the femoral quadriceps or hamstring muscles, osseous or articular disorder in the lower limbs, cardiovascular system disorders, systemic disease.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 28 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effective Light-emitting diode therapy<br>Effects of light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes | Device: Light-emitting diode therapy<br> <br> * Other names: LED therapy;|
| Placebo Comparator: Placebo light-emitting diode therapy<br>Effect of placebo light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes | Device: Placebo light-emitting diode therapy<br> <br> * Other names: LED therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance | Muscle performance in vertical jump and running | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical analysis | Blood lactate and creatine kinase assessments | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Light-emitting diode therapy, Muscle performance, Aerobic performance, Lactate, Creatine kinase
An Open Study to Assess the Robustness of the CRC749 Inhaler

Study Overview
=================
Brief Summary
-----------------
To confirm the robustness of the CRC749 inhaler.

Official Title
-----------------
An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered Via Oral Inhalation in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Asthma, COPD

Intervention / Treatment
-----------------
* Drug: MGR001
* Device: CRC749 inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females at least 12 years of age. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio <0.7 for COPD subjects. Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects. Ability to use the CRC749 inhaler. Exclusion Criteria: Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening. History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds. Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction. Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGR001<br>MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) | Drug: MGR001<br>* Fluticasone Propionate / Salmeterol administered using CRC749 inhaler<br>Device: CRC749 inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro Measurement of Emitted Dose | CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product. | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 3 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhaler, Adolescent
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

Study Overview
=================
Brief Summary
-----------------
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

Detailed Description
-----------------
Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of difficulty in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).

Official Title
-----------------
Difficulty Scoring System in Robotic Pancreatoduodenectomy

Conditions
-----------------
Pancreatic Neoplasm

Intervention / Treatment
-----------------
* Other: Difficulty score system for robotic pancreatoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathology of the head of pancreas requiring surgery Exclusion Criteria: pathology of the head of pancreas not requiring surgery
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: patients undergoing robotic pancreatoduodenectomy<br>patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy | Other: Difficulty score system for robotic pancreatoduodenectomy<br>* calculate the score for patient in you cohort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation to post-operative complication | the score increase as complications increase | 6 months |
Follicular Activation by Fragmentation of Ovarian Tissue

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the chances of increasing the number of antral follicles in ovarian tissue of patients with diminished ovarian reserve by activation of primordial follicles through ovarian cortex fragmentation. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

Official Title
-----------------
Follicular Activation by Fragmentation of Ovarian Tissue

Conditions
-----------------
Diminished Ovarian Reserve

Intervention / Treatment
-----------------
* Procedure: Ovarian tissue fragmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous ≥ 2 poor ovarian responds (≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients >35 i <40 years previous cycle with ≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients >35 i <40 years with antral follicle count (AFC) ≤ 5 i/ili antiM¸ulelrian hormone (AMH) ≤ 6.5pmol/L premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years undetectable AMH serum levels and follitropin (FSH) >35 IU/ml in two serum samples separated by at least 4 weeks Exclusion Criteria: clinical/ultrasonographical signs of endometriosis previous ovarian/pelvic surgery previous gonadotoxic treatment genito-urinary tract malformations extreme male infertility ( <10 000 progressively motile sperms in the semen sample) inform consent unsigned -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants who opt not to go ahead with ovarian fragmentation. | |
| Experimental: Study group<br>Participants who opt for ovarian fragmentation. | Procedure: Ovarian tissue fragmentation<br>* Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral follicle count |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of oocytes retrieved |  | 1 year | 
| Clinical pregnancy rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Ovarian Failure, Infertility, Female, Ovarian tissue fragmentation
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Detailed Description
-----------------
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

Official Title
-----------------
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Glaucoma Surgery
* Procedure: cataract surgery only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications. All subjects must need cataract surgery. Exclusion Criteria: Angle closure glaucoma Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Fellow eye already enrolled

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: Glaucoma Surgery<br>* Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.<br>* Other names: two Glaukos iStent Trabecular Bypass Microstents;|
| Placebo Comparator: 2<br> | Procedure: cataract surgery only<br>* Subjects will undergo routine cataract surgery only (no stent implant).<br>* Other names: Phacoemulsification;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, Surgery, Cataract
Monitoring of Systemic or Organ Perfusion for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.

Detailed Description
-----------------
Hemodynamic observational comparisons will be performed in 6 episodes below on each patient. first 24 hours after birth during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours suspicion of sepsis: from the suspicion point for 48 hours oligouria (< 1 mL/kg/hour of urine): for 48 hours hypotension (mean blood pressure < 30 mmHg): for 48 hours

Official Title
-----------------
Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants

Conditions
-----------------
Hypotension, Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Oliguria

Intervention / Treatment
-----------------
* Device: NIRS (near Infra-red spectroscopy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight Exclusion Criteria: infants without the consent of their guardians

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premature infant<br>premature infants with 32 weeks or less gestational age or 1,500 g or less birth weight, who born in the Inha university hospital and admit to the neonatal intensive care unit of the Inha university hospital | Device: NIRS (near Infra-red spectroscopy)<br>* NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA) Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA) Echocardiography (Phillips HD 15 Ultrasound system, CA, USA)<br>* Other names: Echocardiography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of each index on hypotension | Positive predictive value of each index which are recorded through the monitoring machines | first 24 hours after birth |
The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Detailed Description
-----------------
Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Official Title
-----------------
Prospective Exploratory Study Evaluating Sleep Quality and Sleep-Wake Patterns in Parents of Children With Type 1 Diabetes Before and Several Weeks After Initiating Using RT-CGM of Their Children.

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children up to 16 years old with type 1 diabetes Exclusion Criteria: Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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 |
| --- | --- |
| Parents of children with Type 1 diabetes<br>before and several weeks after initiating using RT-CGM of their children. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality | Actigraphy: Sleep Diary:During the weeks participants will wear the actigraph, they will be asked to rate their previous nights' sleep using a very short questionnaire. Pittsburgh Sleep Quality Index (PSQI): | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | HbA1c level Mean blood glucose level: Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parents, Type 1 diabetes, Sleep quality
Feasibility and Safety of Acupuncture for Systemic Lupus

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.

Official Title
-----------------
Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent. Exclusion Criteria: known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets < 100,000, previous course of acupuncture treatment.

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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-post treatment effect size estimates for self-reported pain and fatigue |  | 6 weeks |