linjc16/ctgov huggingface dataset:
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Detailed Description
-----------------
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Official Title
-----------------
A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
ADHD, ADD

Intervention / Treatment
-----------------
* Drug: Dexmethylphenidate HCl extended-release capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term Exclusion Criteria: Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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: Dexmethylphenidate HCl extended-release capsules|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the symptoms by the patient's teacher after 5 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the symptoms by the patient's parent after five weeks of treatment. |  |  | 
| Change in severity of the illness assessed by the physician after 5 weeks of treatment |  |  | 
| Improvement of the illness assessed by the physician after 5 weeks of treatment |  |  | 
| Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
A Device for Rapid, Painless, Bedside Muscle Evaluation of Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.

Official Title
-----------------
A Device for Rapid, Painless, Bedside Muscle Evaluation of Children

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Duchenne Muscular Dystrophy: Inclusion Criteria: 1. Age 0-18 2. Male 3. Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member. Exclusion Criteria: 1. Age over 18 2. Female 3. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Subjects<br>Healthy subjects aged 0-18 years old. Subjects cannot have a presence or past history of a neurological disorder or other disease that would be expected to substantially impact health. | |
| Duchenne Muscular Dystrophy Subjects<br>Male subjects aged 0-18 years old with genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member. Additionally, subjects cannot have the presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical Impedance Myography Measurements | Up to 11 muscles will be measured using EIM technology. These muscles include: Right Lateral Deltoid, Right Biceps, Right Triceps, Right Wrist Flexors, Right Wrist Extensors, Right Vastus Lateralis, Right Tibialis Anterior, Right Gastrocnemius, Right Gluteus Medius, Right Biceps Femoris, and Right Thoracic Parapinal. | Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMD, Duchenne Muscular Dystrophy, EIM
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Study Overview
=================
Brief Summary
-----------------
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.

Official Title
-----------------
Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: Fasudil eye drops (concentration 0.5 percent)
* Drug: receive artificial tears drop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2 Exclusion Criteria: Serious systemic problems Other ocular problems Except ROP

Ages Eligible for Study
-----------------
Maximum Age: 45 Weeks

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fasudil eye drops (concentration 0.5 percent)<br>twice daily | Drug: Fasudil eye drops (concentration 0.5 percent)<br>* receive Fasudil eye drops (concentration 0.5 percent) twice daily<br>|
| Placebo Comparator: receive artificial tears drop with the same frequency<br> | Drug: receive artificial tears drop<br>* receive artificial tears drop with the same frequency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulation of normal retinal vascularization and disease progression inhibition | Fundoscopy and examiner judgment which will be documented by retinal camera | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any adverse event | Neonatologist and ophthalmologist examination | 3 months |
Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

Study Overview
=================
Brief Summary
-----------------
This study is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of Investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.

Official Title
-----------------
Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy

Conditions
-----------------
Epilepsy, Pyridoxine, Behavior Problem

Intervention / Treatment
-----------------
* Drug: Pyridoxine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years Patients with epilepsy Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month Complaint of behavioral problem Patient's consent for participation Exclusion Criteria: History of known psychiatric disease Pregnancy Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt Treatment with psychiatric medications Alcohol or drug abuse Mental retardation to the degree that intervenes comprehension and response to questionnaire

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pyridoxine<br> | Drug: Pyridoxine<br>* Pyridoxine tablet 40mg once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablet once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral side effects | Behavioral side effects are measured by SCL-90-R questionnaire | 3 weeks |
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Official Title
-----------------
A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: KLH-2109
* Drug: KLH-2109


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with endometriosis Exclusion Criteria: Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: KLH-2109, lower dose<br> | Drug: KLH-2109<br> <br> |
| Experimental: KLH-2109, higher dose<br> | Drug: KLH-2109<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity score of the pelvic pain |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gonadotropin-Releasing Hormone (GnRH) antagonist
Cognitive and Memory Function in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests. Their results will be compared to those with active RA associated with pain and with a normal control group.

Official Title
-----------------
Cognitive and Memory Function in Patients With Fibromyalgia and Their Influence on Disability

Conditions
-----------------
Fibromyalgia, Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from fibromyalgia patients suffering from active RA Exclusion Criteria: Patients with depressive disorders Patients treated with SSRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| patients with fibromyalgia<br> | |
| patients with active RA<br> | |

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
-----------------
memory disturbances
Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

Study Overview
=================
Brief Summary
-----------------
The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.

Official Title
-----------------
Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

Conditions
-----------------
Cytoreductive Surgery

Intervention / Treatment
-----------------
* Drug: tranexamic Acid infusion
* Drug: saline infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery. Age above 18 years & less than 65 years. Exclusion criteria: Thrombophilia or any bleeding disorder. Previous or active thromboembolic disease. Family history of thromboembolism. Known Allergy to TA. Liver dysfunction. Preexisting renal dysfunction (serum creatinine >1.2 mg/dL). Coronary stent insertion within a year prior to operation. Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), Lifelong warfarin therapy for thromboembolism prophylaxis.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid group<br> | Drug: tranexamic Acid infusion<br>* The tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision.<br>|
| Placebo Comparator: placebo group<br> | Drug: saline infusion<br>* In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood loss | Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery). | 1st 24 hours. |
Tübinger Diabetes Mellitus Database (TUEDID)

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is a widespread disease with increasing prevalence worldwide. Patients with diabetes can develop multiple late complications such as neuropathy, retinopathy, nephropathy and cardiovascular comorbidities. So far, there are no reliable predictive tools or markers to estimate if, when and to what extent a patient with diabetes develops late complications. For the patients quality of life and for health economic reasons an improved risk assessment would be desirable. The prospective TUEDID study will characterize diabetic patients to look out for parameters the predict progression of diabetes and its complications.

Official Title
-----------------
Tübinger Diabetes Mellitus Database (TUEDID)

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years Exclusion Criteria: no written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| TUEDID cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control (blood glucose) | Assessed as fasting blood glucose and HbA1C | At enrolment | 
| Glycemic control (HbA1C) | Assessed as fasting HbA1C | At enrolment |
Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.

Official Title
-----------------
Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

Conditions
-----------------
Coronary Artery Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Device: zotarolimus-eluting stent (ENDEAVOR®)
* Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
* Device: everolimus-eluting stents (PROMUS®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) Patients with stable or acute coronary syndrome considered for coronary revascularization Reference vessel diameter of 2.5 to 3.5 mm by operator assessment Exclusion Criteria: Contraindication to anti-platelet agents Ostial lesion within 5 mm from ostium Different DES in other vessel simultaneously Creatinine level 2.5 mg/dL Left main stenosis more than 50%. vein graft lesion Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries Life expectancy 1 year Reference vessel < 2.5 mm or > 4.0 mm diameter by visual Long lesion that require more than three stents

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

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: zotarolimus-eluting stents (ENDEAVOR®)<br> | Device: zotarolimus-eluting stent (ENDEAVOR®)<br>* zotarolimus-eluting stent<br>|
| Active Comparator: sirolimus-eluting stents (CYPHER SELECT® PLUS)<br> | Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)<br>* sirolimus-eluting stents<br>|
| Active Comparator: everolimus-eluting stents (PROMUS®)<br> | Device: everolimus-eluting stents (PROMUS®)<br>* everolimus-eluting stents<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare coronary endothelial function after primary angioplasty. |  | 6 months and 12 months | 
| To compare the presence of neointimal stent strut coverage via optical coherence tomography. |  | 6 months and 12 months | 
| To compare the serum biomarker levels measured in coronary artery blood. |  | 6 months and 12 months |