linjc16/ctgov huggingface dataset:
ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Ischemic cardiomyopathy undergoing coronary artery bypass surgery

Official Title
-----------------
Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Conditions
-----------------
D017202

Intervention / Treatment
-----------------
* Biological: ADR-002K administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent Others Exclusion Criteria: Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator Others

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of subjects undergoing cell transplantation<br> | Biological: ADR-002K administration<br>* ADR-002K administration<br>|
| Sham Comparator: Group of subjects undergoing sham operation<br> | Biological: ADR-002K administration<br>* ADR-002K administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse event | Safety assessment related to adverse events and this product | 26 weeks | 
| Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery | Efficacy (Exploratory) | 26 weeks | 
| Number of complication associated with drug administration method | Feasibility of drug administration method | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Study Overview
=================
Brief Summary
-----------------
We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.

Official Title
-----------------
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Inhaled Furosemide vs Placebo (Normal Saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 0-12 months. Infants who are otherwise healthy Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately. Parents signed a written informed consent. Exclusion Criteria: • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

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: Inhaled Furosemide vs Placebo (Normal Saline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical respiratory effects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The duration of hospitalization |  |  | 
| 2. Time weaned off oxygen |  |  | 
| 3. Time to full enteral feeding |  |  |
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment of different forms of chorea, including Huntington's disease (HD).

Official Title
-----------------
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease

Conditions
-----------------
Huntington's Disease

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36) Moderate stage of the disease (UHDRS motor>= 30) Predominant movement disorder Compliance of the patient, stable cognition during a 6 months phase prior to inclusion (Mattis Dementia Rating Scales（MDS）>/= 120) Signed informed consent. Exclusion Criteria: Patients with hearing impairment; Failures of important organs and in severe conditions; Be reluctant or disabled to receive neuropsychological assessments; Participate in other clinical trial; Has a life expectancy of < 1 year. The investigator and/or enrollment review committee, would preclude participation in the study.

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: Deep Brain Stimulation<br>Stimulation is on. | Device: Deep Brain Stimulation<br> <br> * Other names: Rechargeable Neurostimulator;|
| Sham Comparator: Placebo<br>Stimulation is off. | Device: Deep Brain Stimulation<br> <br> * Other names: Rechargeable Neurostimulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Huntington's Disease Rating Scale(UHDRS) |  | 12 month |
Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Official Title
-----------------
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism

Conditions
-----------------
Bruxism

Intervention / Treatment
-----------------
* Device: Grindcare (Active)
* Device: Grindcare (Placebo - the device is not activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated ICF 18 years or older Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b) Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period Exclusion Criteria: Contraindication of concommitant diseases for the study judged by investigator Daily use of pain medication, e.g. prophylaxis against migraine or headache. Patients who are using occlusal splints in the treatment period.

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 |
| --- | --- |
| Experimental: 1<br>24 patients receiving active treatment | Device: Grindcare (Active)<br>* Active treatment<br>|
| Placebo Comparator: 2<br>Placebo treatment | Device: Grindcare (Placebo - the device is not activated)<br>* Placebo treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is to reduce the EMG activity per hour per night |  | 10 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome is to evaluate long-term effect of FES om EMG activity |  | after end of treatment with FES | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bruxism, EMG, Biofeedback
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

Official Title
-----------------
An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the previous protocol and wish to continue to receive pregabalin. Diagnosis of epilepsy with partial seizures Exclusion Criteria: Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: pregabalin<br>* pregabalin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Frequency |  | Baseline up to Week 28 | 
| Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to Week 28 | 
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. | Baseline up to Week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-label, extension study, pregabalin, partial epilepsy
Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assess the effect of intraoperative oxygen (O2), which was applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Oxidative Stress Index (OSI).

Official Title
-----------------
The Effects of Intraoperative Oxygen Used at Different Concentrations on Oxidatıve Stress Markers

Conditions
-----------------
Stress, Hyperoxia

Intervention / Treatment
-----------------
* Procedure: taking arterial blood sample through the injector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged between 18-60 years, ASA I-II risk class with a minimum operative time of 1.5 hour(s) for whom septoplasty operation under elective conditions Exclusion Criteria: metabolic, endocrine, hepatic, cardiac, or renal diseases, malignancies and who used a drug with antioxidant properties such as vitamin E-C acetylcysteine in the last 48 hours, patients requiring intraoperative 100% O2 inhalation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group I<br>50%Fio2 | Procedure: taking arterial blood sample through the injector<br>* taking blood samples from patients applied with different oxygen concentrations<br>|
| Active Comparator: group II<br>30%Fio2 | Procedure: taking arterial blood sample through the injector<br>* taking blood samples from patients applied with different oxygen concentrations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS | TAS and TOS values occurring at different oxygen concentrations | end of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxidative stress markers, general anesthesia
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.

Detailed Description
-----------------
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Official Title
-----------------
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro

Conditions
-----------------
Subjects Presenting With Normal Eyes

Intervention / Treatment
-----------------
* Device: 3D OCT-1 Maestro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Participants must be at least 18 years of age They must be able to complete all testing (all OCT scans) They must volunteer to be in the study and sign the consent form Exclusion Criteria Subject with history of ocular disease or ocular pathology TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.

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 |
| --- | --- |
| Subjects Presenting With Normal Eyes<br>Subjects with no known ocular diseases will be scanned on the Maestro device | Device: 3D OCT-1 Maestro<br>* OCT Machine used for diagnostic purposes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TopQ Cut Off | To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
no known ocular pathology
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Study Overview
=================
Brief Summary
-----------------
Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.

Official Title
-----------------
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Conditions
-----------------
Ventricular Tachycardia

Intervention / Treatment
-----------------
* Drug: Stellate Ganglion Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned catheter based VT ablation Age at least 18 years Exclusion Criteria: Pregnancy Contraindication to SGB or VT ablation Hypersensitivity of local anesthetic of amide type Hemodynamic instability during the procedure prior to the study protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate ganglion block<br>All subjects will undergo stellate ganglion block during their VT ablation procedure | Drug: Stellate Ganglion Block<br>* Left sided percutaneous stellate ganglion block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Effective Refractory Period | Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds) | 30 minutes following stellate ganglion block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Arrhythmia Inducibility | Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation | 30 minutes following stellate ganglion block | 
| Neuropeptide Y | Change in level of neuropeptide Y from baseline (measured in pg/mL) | 30 minutes following stellate ganglion block |
The Glycaemic Index of Manuka Honey

Study Overview
=================
Brief Summary
-----------------
Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different geographical locales around the North Island of New Zealand and tested for glycaemic index (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed honey containing 25g of available carbohydrate in 200 ml water and the blood glucose responses measured (area under the curve; AUC) and compared to that of 25 g of available carbohydrate from glucose.

Official Title
-----------------
The Glycaemic Index of Manuka Honey

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

Intervention / Treatment
-----------------
* Dietary Supplement: Manuka Honey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy (Body mass index (BMI) 20-25) non-smoking aged between 18-45 years absence of diabetes or chronic illness not taking any medications. Exclusion Criteria: currently dieting suffering from illness or chronic disease currently taking medication smokers (including recreational) outside healthy BMI range

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: honey<br>Manuka honey | Dietary Supplement: Manuka Honey<br>* honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water<br>* Other names: Manuka Health New Zealand Manuka honey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Glycaemic index of Manuka honey | 10 healthy individuals consumed honey (25g of available carbohydrate in 200 ml of water) in a fasted state. Blood glucose levels were recorded at 0, 15, 30, 45, 60, 90 and 120 mins and the area under the blood glucose curve was calculated. All 10 participants took five different honeys and a glucose standard on six different days (with randomised allocation of samples). | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manuka honey, glycaemic index, blood glucose control, individuals, current disease, medication use
Tumour Registry Lung Cancer (TLK)

Study Overview
=================
Brief Summary
-----------------
Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.

Detailed Description
-----------------
The TLK is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with NSCLC and SCLC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Official Title
-----------------
Clinical Registry Describing Treatment Reality and Therapy Modalities of Patients With Lung Cancer (NSCLC, SCLC and Neuroendocrine Tumors) Requiring Therapy.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed Small Cell Lung Cancer (SCLC), Non Small Lung Cancer (NSCLC) or neuroendocrine tumors receiving therapy written informed consent start of neoadjuvant, adjuvant or first-line therapy no longer than 4 weeks before informed consent Exclusion Criteria: patients not receiving any systemic therapy

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 |
| --- | --- |
| Patients with lung cancer<br>Patients with lung cancer requiring therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of actually used therapy forms in bronchial carcinoma requiring treatment |  | 3 years per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial carcinoma, registry, real life treatment, cohort study, NSCLC, SCLC, Germany