linjc16/ctgov huggingface dataset:
Measurements of Facial Dimensions in Infants and Toddlers 0-4 Years of Age

Study Overview
=================
Brief Summary
-----------------
Anthropometric data of infants' face will be obtained using special 3D scanners and software.

Detailed Description
-----------------
A digital camera will be used to take a 3D picture the face of each infant. Off line measurements of landmarks on the face will be marked and dimensions will be calculated using a special analysis software.

Official Title
-----------------
Facial Dimensions in Infants and Toddlers

Conditions
-----------------
Infant Development

Intervention / Treatment
-----------------
* Procedure: Digital camera picture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants, 0-4 years of age Exclusion Criteria: Facial anomalies

Ages Eligible for Study
-----------------
Maximum Age: 4 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 |
| --- | --- |
| Infants<br>Healthy 0-4 years of age both boys and girls | Procedure: Digital camera picture<br>* A digital camera will be used to take a 3D picture the face of each infant. Off line measurements of landmarks on the face will be marked and dimensions will be calculated using a special analysis software.<br>* Other names: none applicable;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Dimensions | Landmarks that are relevant to face mask application such as the distance from the chin to the bridge of the nose will be marked and measured. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infants, morphometry, face, 3D
Myasthenia Gravis and Psyche

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients. Additionally the researchers want to find out in what way certain aspects of the disease have an influence on the quality of life, and whether different concepts of coping with the disease have different effects on the quality of life for patients with myasthenia gravis. During the study, close relatives of patients will also be asked to provide input about their current stress situation in the context of supporting their relative. Based on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.

Official Title
-----------------
Myasthenia Gravis and Psyche

Conditions
-----------------
Myasthenia Gravis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Myasthenia Gravis Age ≥18 years Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Questionnaire Survey (Patient) | Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information on diagnosis of mental illness and psychotherapeutic care Hospital Anxiety and Depression Scale (HADS - questionnaire for self-completion by patients to determine the levels of anxiety and depression) Breslau scale PTBS-7 (questionnaire for self-completion by patients to determine the levels of Probability of posttraumatic stress disorder (PTSD)) Mya Quality of Life 15 (Mya QoL15 - questionnaire for self-completion by patients for use as a measure of health outcome) Freiburg questionnaire for coping (FKV - questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior) | directly after inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Häusliche Pflegeskala (HPS) | questionnaire is used to assess social work Intervention and couple's counselling | directly after inclusion in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myasthenia Gravis, Psyche, Depression, Anxiety Disorder, Posttraumatic Stress Disorder, Disease Processing
Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Official Title
-----------------
Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)

Conditions
-----------------
B-cell Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: FCCam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: B-CLL in need of treatment One or two prior prior therapies WHO performance status 0-2 Exclusion Criteria: Serum creatinine > 1.5 ULN Major organ dysfunctions Pregnant or nursing

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCCam<br>After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles | Drug: FCCam<br>* After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles<br>* Other names: Fludarabine, Cyclophosphamide, Alemtuzumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete and partial response rate) | Response Evaluation has to be done according the the NCI guidelines | 28 days after the end of the last cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 28 days following the last dose of FCCam | 
| MRD response rate |  | 28 days after the end of the last cycle | 
| Response rate in biological defined risk groups |  | 28 days after the end of the last cycle | 
| Duration of response |  | up to 36 months after the end of treatment | 
| Treatment administration (dose intensity) |  | up to the last day of the last given cycle (day 28 of the 6th cycle) | 
| Overall survival |  | up to 36 months after the end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, Immunochemotherapy
(+)-Alpha-Dihydrotetrabenazine Phase I

Study Overview
=================
Brief Summary
-----------------
This research study is intended to determine the initial safety and tolerability of single oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ, the drug to be studied in this research, is the active ingredient in TBZ. The present study will confirm safety and tolerability of HTBZ and will investigate its expected effects on brain sites that are the target of TBZ therapy.

Official Title
-----------------
(+)-Alpha-Dihydrotetrabenazine Phase I

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: HTBZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to provide informed consent Exclusion Criteria: pregnant or lactating female subjects Subjects taking medications that interfere with VMAT2 (ex amphetamine) History of significant neurologic or psychiatric conditions Significant active medical conditions Alcohol or illicit substance use or dependence

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose escalation<br>Single dose administration of (+)-alpha-Dihydrotetrabenazine (HTBZ), escalating dosage amounts 7.5 - 30 mg orally | Drug: HTBZ<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning |  | 60 minutes post-administration of HTBZ |
Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

Study Overview
=================
Brief Summary
-----------------
The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.

Official Title
-----------------
Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's disease who do not receive L-Dopa supplementation Exclusion Criteria: Patients should have been treated according to the Japanese insert slip
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 |
| --- | --- | --- |
| Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years. | during 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement | Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). | after 36 months treatment | 
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement. | Baseline and at 36 months (or at the time of discontinuation) | 
| Change From Baseline in Modified Hoehn & Yahr Rating Scale | A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst). | Baseline and at 36 months (or at the time of discontinuation) |
Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

Study Overview
=================
Brief Summary
-----------------
Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

Official Title
-----------------
Cardiovascular Complications in Patients With COVID-19

Conditions
-----------------
COVID, Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All consecutive patients with COVID-19 infection admitted to the ICU or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included Exclusion Criteria: - Patients under 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 |
| --- | --- |
| Patients with cardiovascular complications<br>Patients presenting with cardiomyopathies or venous thromboembolism | |
| Patients without cardiovascular complications<br>Patients without cardiomyopathies or venous thromboembolism | |
| Intensive Care Unit patients<br>Patients admitted in intensive care unit | |
| Hospital Ward patients<br>Patients admitted in hospital ward | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of cardiomyopathies and venous thromboembolism | Incidence of cardiomyopathies and/or venous thromboembolism at day 28 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence of mortality at day 28 | 28 days | 
| Duration of mechanical ventilation | Number of day of using mechanical ventilation for each patients | hospitalisation duration | 
| Shock | Incidence of shock during hospitalisation | hospitalisation duration | 
| length of stay | Number of day at hospital | hospitalisation duration | 
| Mechanical ventilation | Setting up or not of mechanical ventilation | hospitalisation duration | 
| Renal replacement therapy | Administration or not of renal replacement therapy | hospitalisation duration |
Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

Study Overview
=================
Brief Summary
-----------------
The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.

Official Title
-----------------
Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

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

Intervention / Treatment
-----------------
* Drug: Glucose potassium insulin solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes mellitus patients (as defined by WHO) Diet, oral hypoglycaemic or insulin therapy Undergoing elective and urgent coronary artery bypass surgery Exclusion Criteria: Non-diabetics Emergency and redo CABG < 18 years Pregnancy Dialysis-dependence History of CVA/TIA < 6 months Heart valve disease requiring surgery STEMI < 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L | Drug: Glucose potassium insulin solution<br>* Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution<br>|
| No Intervention: 2<br>Normal departmental practice using dextrose insulin infusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study |  | 3 months post CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control will be assessed 2 hours pre-operatively and 72 hours post-operatively. Measurement timings will be standardized allowing comparison of glycaemic control during different time-periods. |  | 72 hours post CABG |
Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.

Conditions
-----------------
Work Stress, Work Ability, Work Performance

Intervention / Treatment
-----------------
* Drug: Acetyl-L-carnitine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overt hepatic encephalopathy (HE) or a history of overt HE Exclusion Criteria: history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Ages Eligible for Study
-----------------
Minimum Age: 33 Years
Maximum Age: 68 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: acetyl-L-carnitine<br>2 g acetyl-L carnitine twice a day for 90 days | Drug: Acetyl-L-carnitine<br> <br> |
| Placebo Comparator: sugar pill<br>Placebo twice a day for 90 days | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| work stress |  | 90 days |
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Epirisone 50mg or placebo TID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing 20≤ age ≤60 A patient has symptom of acute low back pain 4≤ VAS Exclusion Criteria: Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial Chronic rheumatoid arthritis patients Patients having a medical history of hypersensitivity to Eperisone Hydrochloride Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption Participation in other studies before 60 days of first dosing Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial Inadequate subject for the clinical trial by the investigator's decision

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Eperisone 50mg BID<br>Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days | Drug: Epirisone 50mg or placebo TID<br>* 3 times a day after meals for 1 week<br>|
| Experimental: Epirisone 50mg TID<br> | Drug: Epirisone 50mg or placebo TID<br>* 3 times a day after meals for 1 week<br>|
| Placebo Comparator: Placebo comparator<br> | Drug: Epirisone 50mg or placebo TID<br>* 3 times a day after meals for 1 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS improvement of pain at rest, on movement and at night |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Modified Schober test |  | 7 days | 
| Change of Lateral Body Bending test |  | 7 days | 
| Change of EuroQol by patients |  | 7 days | 
| Change of Oswestry Disability Index |  | 7 days | 
| Overall pain improvement by investigator |  | at last visit (D7+2) |