linjc16/ctgov huggingface dataset:
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.

Official Title
-----------------
A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: MK-0431/ONO-5435
* Drug: MK-0431/ONO-5435


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy Exclusion Criteria: Patients with Type 1 Diabetes Mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: E<br> | Drug: MK-0431/ONO-5435<br>* Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD<br>|
| Placebo Comparator: P<br> | Drug: MK-0431/ONO-5435<br>* Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 16 weeks | 
| Safety and Tolerability |  | 16 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 hour post-meal glucose |  | 16 weeks | 
| Fasting plasma glucose |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MK-0431/ONO-5435, Type 2 diabetes mellitus
The Impact of Sleep Disorders on Motor Vehicle Accidents

Study Overview
=================
Brief Summary
-----------------
Patients who have sleep disorders may be involved in accidents more frequently than those without. In addition patients who have sleep disorders may have more serious accidents and have increased length of stay.We aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.

Official Title
-----------------
The Impact of Sleep Disorders on Motor Vehicle Accidents

Conditions
-----------------
Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Drivers admitted as result of motor vehicle accidents - Exclusion Criteria:Drivers aged < 18 years -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Motor vehicle accident<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of treating opioid-dependent individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.

Official Title
-----------------
Buprenorphine Maintenance Dose Schedule and Treatment Setting

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  |  | 
| Withdrawal symptoms |  |  | 
| Opioid and cocaine use |  |  | 
| Social and psychological functioning |  |  | 
| AIDS risk behavior |  |  | 
| Opiate withdrawal symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid-Related Disorders
Innovation in Endobronchial Sampling

Study Overview
=================
Brief Summary
-----------------
Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.

Detailed Description
-----------------
The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.

Official Title
-----------------
Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis

Conditions
-----------------
Diffuse Interstitial Lung Disease

Intervention / Treatment
-----------------
* Procedure: Advanced endoscopic imaging modalities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation. Informed consent available Age > 18 FVC > 50%pred DLCO > 35%pred PaO2 > 55 mmHg, pCO2 < 45 mmHg (ambient air) No exclusion criteria Exclusion Criteria: Age > 75 Systolic arterial pressure in the pulmonary artery : PAPS >40mmHg Platelet count <100000/µl INR > 1.4 BMI >30 Diffuse bullous lung disease Active anti-platelet or anticoagulant treatment Active heart failure or unstable coronary heart disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung transplant recipients<br>Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities | Procedure: Advanced endoscopic imaging modalities<br>* Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT<br>|
| Diffuse intersitial lung disease<br>Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities | Procedure: Advanced endoscopic imaging modalities<br>* Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield |  | postprocedural |
Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

Study Overview
=================
Brief Summary
-----------------
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).

Official Title
-----------------
Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ACP-001 (TransCon PEG hGH)
* Drug: ACP-001 (TransCon PEG hGH)
* Drug: ACP-001 (TransCon PEG hGH)
* Drug: ACP-001 (TransCon PEG hGH)
* Drug: Placebo
* Drug: Human Growth Hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects 20 to 45 years old Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2 Others Exclusion Criteria: Known history of hypersensitivity to human growth hormone (hGH) Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies Others

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP-001, dose-level 1<br> | Drug: ACP-001 (TransCon PEG hGH)<br>* ACP-001, dose-level 1, s.c., single-dose<br>Drug: Placebo<br>* Placebo, s.c., single-dose<br>Drug: Human Growth Hormone<br>* Human Growth Hormone, s.c., daily for 7 days<br>|
| Experimental: ACP-001, dose-level 2<br> | Drug: ACP-001 (TransCon PEG hGH)<br>* ACP-001, dose-level 2, s.c., single-dose<br>Drug: Placebo<br>* Placebo, s.c., single-dose<br>Drug: Human Growth Hormone<br>* Human Growth Hormone, s.c., daily for 7 days<br>|
| Experimental: ACP-001, dose-level 3<br> | Drug: ACP-001 (TransCon PEG hGH)<br>* ACP-001, dose-level 3, s.c., single-dose<br>Drug: Placebo<br>* Placebo, s.c., single-dose<br>Drug: Human Growth Hormone<br>* Human Growth Hormone, s.c., daily for 7 days<br>|
| Experimental: ACP-001, dose-level 4<br> | Drug: ACP-001 (TransCon PEG hGH)<br>* ACP-001, dose-level 4, s.c., single-dose<br>Drug: Placebo<br>* Placebo, s.c., single-dose<br>Drug: Human Growth Hormone<br>* Human Growth Hormone, s.c., daily for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (adverse events, local reactions, immunogenicity) |  | 0-42 days | 
| Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP |  | 0-28 days |
Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy

Study Overview
=================
Brief Summary
-----------------
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.

Conditions
-----------------
Common Melanocytic Nevi

Intervention / Treatment
-----------------
* Device: RCM imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination. Exclusion Criteria: Patients who are unwilling or medically unable to lie down for 30 minutes. Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 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 participants<br>patients 18 or older presenting to the Sheba Medical Center pigmented lesion clinic for skin cancer surveillance. Patients routinely undergo total skin examination that includes clinical and dermoscopic evaluation of skin lesions. Patients also routinely undergo annual total body digital photography that allows identification of new or changing lesions. | Device: RCM imaging<br>* RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images). |  | 3 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of rates of retention and change in RCM pattern of nevi during follow-up |  | 3 YEARS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
banal-appearing nevi, NEVUS
Psychological and Physiological Status of Former Prisoners of War

Study Overview
=================
Brief Summary
-----------------
Assessing the psychological and physiological status of Israeli former prisoners of war (POW).

Conditions
-----------------
PTSD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Former POW Exclusion Criteria: Was not defined
Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Study Overview
=================
Brief Summary
-----------------
Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.

Official Title
-----------------
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Nefopam 20 MG/ML
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schedule to video-assisted thoracoscopic surgery : VATs lobectomy Can operate a patient-controlled analgesia (PCA) device No contraindication for nefopam Exclusion Criteria: Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma Creatinine clearance < 60 ml/min Liver disease: child-pugh score B or C Allergy to nefopam Chronic opioid use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nefopam group[<br> | Drug: Nefopam 20 MG/ML<br>* Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative<br>|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption in first 24 hours post-operative | morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric pain score | numeric pain score in 1, 2, 12, 24 hours after surgery | 24 hours | 
| side effect of nefopam | side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation | 24 hours |
Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.

Detailed Description
-----------------
Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation. The major goal of treatment for T1G3 BC should be bladder preservation whenever possible. Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.

Official Title
-----------------
Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Combination Product: chemoradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy Exclusion Criteria: Any patients with distant metastasis or positive LN on CT or MRI. Patients unfit for chemoradiation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemoradiotherapy<br>Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr | Combination Product: chemoradiation<br>* chemoradiation in case of T1G3 BC after BCG failure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of chemoradiation for recurrentT1G3 BC after BCG failure | treatment of 20 patients with recurrent T1G3 BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival. | followup within two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemoradiation for, T1G3 BC
Study of Early Infant Diet on Growth and Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.

Official Title
-----------------
Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Infants Birth weight = 6 to 9 lbs Mostly fed breast milk, milk-based formula, soy-based formula Mother over 18 years of age Exclusion Criteria: Unhealthy pregnancy Illness during pregnancy or for the child that could interfere with the study parameters

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Months

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 |
| --- | --- |
| no grouping<br>IDE used for outcome measurement not for an intervention. | Device: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth and development |  | yearly, 1-6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant Nutrition, Soy Phytochemicals, Infant Body Composition, Brain Function, Cognition and Development, Healthy Infants