linjc16/ctgov huggingface dataset:
Role of Coenzyme Q in ADHD in Children

Study Overview
=================
Brief Summary
-----------------
Role of Coenzyme Q in ADHD in Children

Detailed Description
-----------------
Role of Coenzyme Q in ADHD in Children: will it add a benefit?

Official Title
-----------------
Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: Coenzyme Q


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ADHD Exclusion Criteria: Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atomoxetine and Coenzyme Q<br>Atomoxetine and Coenzyme Q | Drug: Atomoxetine<br>* Atomoxetine once daily<br>* Other names: atomox;Drug: Coenzyme Q<br>* Coenzyme Q once daily<br>|
| Placebo Comparator: Placebo and Atomoxetine<br>Placebo and Coenzyme Q | Drug: Coenzyme Q<br>* Coenzyme Q once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved CONNERS scale | The number of patients with improved CONNERS scale | 6 months |
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: REGN1033 (SAR391786)
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values. Low activity lifestyle Diet and exercise adherence Exclusion Criteria: Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease. Participation in any clinical trial within 6 months prior to screening. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period. Limb amputation (except for toes) and/or any fracture within 6 months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>placebo | Other: placebo<br> <br> |
| Experimental: Group 2<br>REGN1033 (SAR391786) | Drug: REGN1033 (SAR391786)<br> <br> |
| Placebo Comparator: Group 3<br>placebo + exercise regimen | Other: placebo<br> <br> |
| Experimental: Group 4<br>REGN1033 (SAR391786) + exercise regimen | Drug: REGN1033 (SAR391786)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in total lean mass | The primary endpoint is percent change in total lean mass at week 12 (day 85) | At week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of TEAEs | Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study) | day 1 to day 141 | 
| Appendicular lean mass by DXA | Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12 | At week 12 |
Gene Therapy for Chronic Granulomatous Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.

Official Title
-----------------
Phase I/II Gene Therapy Study for X-Linked Chronic Granulomatous Disease

Conditions
-----------------
Granulomatous Disease, Chronic

Intervention / Treatment
-----------------
* Drug: retroviral SF71-gp91phox transduced CD34+ cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: x-linked Chronic Granulomatous Disease history of life-threatening severe infections no HLA-matched related or non-related donor therapy resistent life threatening infections/organ dysfunction no other treatment options e.g. BMT Exclusion Criteria: < 18 years of age HIV infection life expectancy > 2 years infections treatable by conventional therapy (antibiotics, allogeneic granulocytes)

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: retroviral SF71-gp91phox transduced CD34+ cells|autologous ex-vivo retroviral transduced (SF71-gp91phox) CD34+ cells|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, toxicity and feasibility |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment of gene corrected stem cells, functional reconstitution of respiratory burst, clinical benefit |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CGD
Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Study Overview
=================
Brief Summary
-----------------
To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol

Official Title
-----------------
Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Prevention Strategy Including Clopidogrel

Conditions
-----------------
Intermittent Claudication

Intervention / Treatment
-----------------
* Drug: SL650472, Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months); 2. ICD of 30 to 200 m at screening constant workload treadmill test 3. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7. Exclusion Criteria: 1. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years; 2. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome); 3. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene. 4. Patients with a history of malignant or proliferate breast disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: SL650472, Clopidogrel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline |  |  | 
| Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline, |  |  | 
| Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires, |  |  | 
| Hemodynamic measurement post treadmill test (ABI/TB). |  |  |
Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

Detailed Description
-----------------
Fortyfive children with supracondylar humeral fractures were randomly divided into two groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins. The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost to follow up. Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. All surgeries were performed by the same surgeon. Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.

Official Title
-----------------
The Comparison of Cross Pin Configurations in the Treatment of Gartland Type III Supracondylar Humerus Fractures: 2 Pins Versus 3 Pins

Conditions
-----------------
Supracondylar Humerus Fracture

Intervention / Treatment
-----------------
* Procedure: crossed pin configuration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria was children with closed extension Type III of supracondylar fracture of humerus. Exclusion Criteria: Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: comparison of two cross pin fixation methods<br>Fixation of supracondylar humerus fractures with 2 crossed pins and 3 crossed pins are compared in terms of Flynn's criteria | Procedure: crossed pin configuration<br>* comparison of two crossed pin fixation methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome of two fixation techniques | comparison of Flynn's criteria | 5 years |
Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research proposal is to establish a mechanism to develop tools that will allow the investigators to measure the impact of magnetic resonance (MR) acquisition correction sequences for attenuation correction on positron emission tomography (PET) quantitation accuracy.

Official Title
-----------------
Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

Conditions
-----------------
PET/CT

Intervention / Treatment
-----------------
* Device: Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be ≥ 18 years of age Participant can be a male or a non-pregnant female. Successful completion of MRI screening form Participant must have undergone a PET/CT examination with injection of a standard dose of 18F-fluorodeoxyglucose (FDG) or other PET tracer with a half-life greater than one hour either for clinical or research purposes within 3 hrs of the proposed PET-MRI examination. Participant will be fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions Exclusion Criteria: Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants) Women who are pregnant. Subjects who require sedation to participate will be excluded. Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| PET/MR<br>Participants will be scanned on a PET-MRI scanner which is FDA-approved and will operate within FDA-approved guidelines. Participants will be asked to lie still within the scanner for up to 90 minutes | Device: Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)<br>* FDA approved scanner<br>* Other names: PET/MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the impact of MR acquisition correction sequences for attenuation correction on PET quantitation accuracy | -PET images from PET/MRI with the MR derived attenuation correction will be compared to images generated with the CT attenuation correction from the standard of care PET/CT scan. | At the time of the MRI scan |
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

Study Overview
=================
Brief Summary
-----------------
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.

Official Title
-----------------
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial

Conditions
-----------------
Uterovaginal and Vaginal Vault Prolapse

Intervention / Treatment
-----------------
* Procedure: Sacrospinous-Sacrotuberous fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 40 to 60 years. POP Q stage III & IV Uterovaginal prolapse. Vaginal vault prolapse. BMI >35. Exclusion Criteria: Age > 40 years or < 60 years. POP Q stage I or II. BMI < 35. Previous repair of uterovaginal or vaginal vault prolapse. Comorbidity with Stress Urinary Incontinence. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified technique for Sacrospinous-Sacrotuberous Fixation<br>Modified technique for Sacrospinous-Sacrotuberous Fixation | Procedure: Sacrospinous-Sacrotuberous fixation<br>* Sacrospinous-Sacrotuberous fixation<br>|
| Active Comparator: Conventional technique for Sacrospinous-Sacrotuberous Fixation<br>Modified technique for Sacrospinous-Sacrotuberous Fixation | Procedure: Sacrospinous-Sacrotuberous fixation<br>* Sacrospinous-Sacrotuberous fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrence of uterovaginal and vaginal vault prolapse |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | intraoperative | 
| Injury to surrounding structures | Number of participants that experience injury of important surrounding structure intraoperative | intraoperative | 
| operative time |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment
Greek Registry - Familial Hypercholesterolaemia

Study Overview
=================
Brief Summary
-----------------
Familial hypercholesterolemia (FH) [heterozygous (heFH) or homozygous FH (hoFH)] is a common genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and extensor tendons, rapidly progressing vascular disease, and aortic valve disease.

Detailed Description
-----------------
In contrast, timely recognition and effective treatment of FH can result in a significant improvement in clinical outcomes. The problem is that that majority of individuals with FH are unaware of their disease, particularly that the disease remains silent for many years. In most countries around the world <5% of individuals with FH are identified . Until lately the prevalence of heFH was traditionally considered to be   1:500 individuals , although clinical and genetic studies suggest that heFH affects   1:200-250 individuals . Thus, the aim of the Hellenic College of Treatment of Atherosclerosis (HCAT) is to 1). Evaluate the prevalence of FH in Greece (FHG-Registry) and 2). To inform population of FH disease.

Official Title
-----------------
Hellenic Registry for Familial Hypercholesterolemia

Conditions
-----------------
Familial Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both genders >18 years, <80 years door to door enrolment eligible to sign informed consent Exclusion Criteria: <18 years, >80 years deny to sign informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of Familiar Hypercholesterolaemia in Greece | patients with FH will be screened and include in Registry | 1 month |
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent

Study Overview
=================
Brief Summary
-----------------
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.

Conditions
-----------------
Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term newborns with blood cultures taken from them the first 48 hrs Exclusion Criteria: Preterm newborns Septic/ill appearing newborns Newborns requiring admission to NICU

Ages Eligible for Study
-----------------
Maximum Age: 48 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic newborns that had sepsis workup<br>Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymptomatic newborns that underwent sepsis workup | The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive blood cultures out of total cultures | Percentage of positive blood cultures out of the total cultures that were taken. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early onset GBS sepsis, Prevention, Maternal risk factors