linjc16/ctgov huggingface dataset:
Independent Walking Onset of Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.

Official Title
-----------------
Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Diagnostic Test: gait analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maximum age of 3 years old Independent walking experience of maximum 6 months Ability to walk 5 m without falling or needing a technical assistance A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years Exclusion Criteria: History of lower limb musculoskeletal trauma in the last 6 months A known skin allergy to any adhesive product History of lower limb musculoskeletal surgery History of BTX injections into the lower limbs muscles in the last 3 months

Ages Eligible for Study
-----------------
Maximum Age: 36 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 |
| --- | --- |
| cerebral palsy infants<br>gait analysis | Diagnostic Test: gait analysis<br>* gait analysis using an optoelectronic system and a surface EMG<br>|
| typically developed infants<br>gait analysis | Diagnostic Test: gait analysis<br>* gait analysis using an optoelectronic system and a surface EMG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lower limbs Global Profile Score during gait | Data will be collected from gait analysis of unilateral CP children and the Global Profile Score, characterizing the overall kinematics of the pelvis and lower limbs, during gait, will be compared those of a typical developed children group matched in walking experience. Mann Whitney U test will be used for this comparison. | All the data collection and analysis wil be done within 2 months from the start point of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toddlers, gait
Cesarean Niche Examination by Transvaginal us

Study Overview
=================
Brief Summary
-----------------
The developed uterine scar developing due to cesarean section is usually clinically evaluated and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel installation sonography (GIS)

Detailed Description
-----------------
In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal

Official Title
-----------------
Cesarean Niche Examination by us to Assess Its Integrity and Dehescence

Conditions
-----------------
Cesarean Section; Dehiscence

Intervention / Treatment
-----------------
* Diagnostic Test: transvaginal us with 2D and 3D SHG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - women with secondary infertility Exclusion Criteria: obstructed labor, pregnant women having chronic diseases;

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transvaginal us with 2D and 3D SHG|transvaginal us is made to all women with SHG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will have dehesent scar | transvaginal us showing lower segment with assessing scar | within a week |
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.

Conditions
-----------------
Cardiovascular Risk

Intervention / Treatment
-----------------
* Dietary Supplement: Energy Drink, Taurine, Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent healthy (no acute or chronic desease) BMI 20,0 - 25,9 kg/m2 moderate and non-regular consumption of alcohol, EDs and coffee Exclusion Criteria: pregnancy regular medication (oral contraceptives permitted) hypertension and other deseases of the cardiovascular system liver-deseases psychiatric deseases epilepsy other relevant deseases (former) alcoholics non-compliance to the study-protocol simultaneous participation in another clinical trial retraction of the written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exposure under sleep deprivation<br>Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation. | Dietary Supplement: Energy Drink, Taurine, Caffeine<br> <br> |
| Experimental: Exercise after consumption<br>Examination of the effects of EDs in combination with alcohol consumption and exercise. | Dietary Supplement: Energy Drink, Taurine, Caffeine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart-rate-variability (HRV) |  | during 24 hours |
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

Official Title
-----------------
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Conditions
-----------------
Iron Deficiency, Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Ferinject (ferric carboxymaltose)
* Drug: Placebo (saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF Reduced left ventricular ejection fraction Capable of completing 6 minute walk test At least 18 years of age and with written informed consent prior to any study specific procedures Exclusion Criteria: Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months Chronic liver disease and/or elevated liver enzymes Vitamin B12 and/or serum folate deficiency Subject is not using adequate contraceptive precautions during the study Body weight ≤ 35 kg No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject (ferric carboxymaltose)<br> | Drug: Ferinject (ferric carboxymaltose)<br>* Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0<br>|
| Placebo Comparator: Placebo (saline)<br> | Drug: Placebo (saline)<br>* Subjects will receive Placebo (saline) intravenously on Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in six minute walk test from baseline to week 24 |  | 24 weeks |
Sleep Infra-slow Oscillations III

Study Overview
=================
Brief Summary
-----------------
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.

Official Title
-----------------
Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep

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

Intervention / Treatment
-----------------
* Other: Sensory stimulation during sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to participate and written informed consent Aged 20 to 40 years at the time of screening Body mass index (BMI) ≤ 30 Exclusion Criteria: Pregnancy or breast feeding at the time of screening Sleep related breathing disorders Any other sleep related breathing disorder according to AASM criteria Current history of psychiatric disorders according to DSM-V Current chronic treatment that may affect sleep Any significant neurological disorder or other medical disease that may affect sleep Any unstable medical condition Any clinically significant sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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

| Intervention/Treatment |
| --- |
|Other: Sensory stimulation during sleep|Sensory stimulation during sleep|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arousal probability | Number stimuli that are followed by an EEG arousal divided by the total number of stimuli | 8 hours |
Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

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

Intervention / Treatment
-----------------
* Drug: KLH-2109
* Drug: Placebo
* Drug: Leuprorelin acetate


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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KLH-2109, lowest dose<br> | Drug: KLH-2109<br> <br> Drug: Placebo<br> <br> |
| Experimental: KLH-2109, low dose<br> | Drug: KLH-2109<br> <br> Drug: Placebo<br> <br> |
| Experimental: KLH-2109, medium dose<br> | Drug: KLH-2109<br> <br> Drug: Placebo<br> <br> |
| Experimental: KLH-2109, high dose<br> | Drug: KLH-2109<br> <br> |
| Placebo Comparator: Placebo<br>First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels | Drug: Placebo<br> <br> |
| Other: Leuprorelin acetate<br>Active reference | Drug: Leuprorelin acetate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of average Numerical Rating Scale (NRS) score of pelvic pain |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse events |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis
Study in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical diagnosis of COPD Current or prior history of cigarette smoking Exclusion Criteria: Medical diagnosis of asthma Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD Significant condition or disease other than COPD

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: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, as well as vital signs |  |  | 
| Physical Exam results, Adverse Event reporting, etc |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD, formoterol, formoterol fumarate
E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.

Study Overview
=================
Brief Summary
-----------------
To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.

Conditions
-----------------
Hospital-acquired Pneumonia

Intervention / Treatment
-----------------
* Other: E test method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with suspected HAP undergoing BAL will be eligible Exclusion Criteria: contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E test method<br> | Other: E test method<br>* E test strips directly applied to BAL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major error defined as the MIC(s) classified as R or I by E test method and S by referent method |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E test, Hospital-acquired pneumonia, Antibiogram, Bronchoalveolar lavage
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Study Overview
=================
Brief Summary
-----------------
A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).

Detailed Description
-----------------
The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients. Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.

Official Title
-----------------
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Conditions
-----------------
Primary Immunodeficiency Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Immunodeficiency Disease (PID) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Immunodeficiency Disease<br>Patients with primary Immunodeficiency disease (PID) | |

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
-----------------
Primary Immunodeficiency Disease
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Donepezil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time. Exclusion criteria: Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E2020<br> | Drug: Donepezil Hydrochloride<br>* Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.<br>* Other names: Aricept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score |  | Baseline, Month 3, Month 6, and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigations on adverse events and adverse drug reactions |  | Baseline and Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, donepezil hydrochloride