linjc16/ctgov huggingface dataset:
Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home. Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.

Official Title
-----------------
Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor

Conditions
-----------------
Labour Onset

Intervention / Treatment
-----------------
* Device: Bloomlife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Gestational age between 20 weeks and 0 days and 30 weeks and 0 days Willingness to participate in the study Exclusion Criteria: Implanted pacemaker or any other implanted electrical device History of allergies to silicone-based adhesives Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bloomlife<br> | Device: Bloomlife<br>* Women use the Bloomlife sensor to collect data throughout their pregnancy. The collected data is stored locally in the device, but it is not used to provide any feedback to the patients or to the clinical team. Therefore the use of the device doesn't have an impact on clinical decision making and patients' care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labour probability | Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor | At delivery |
Risk Reduction in Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death

Official Title
-----------------
Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: smoking cessation
* Drug: betablocker, diuretics, ACEI, ARB,
* Drug: statins, ezetimibe
* Behavioral: training
* Biological: influenza vaccine
* Drug: metformin, glimepiride, insulin
* Behavioral: weight reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction, CABG or PCI Exclusion Criteria: Age < 18 and age > 80 pregnant critical illness drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multifactorial intervention<br>Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin | Behavioral: smoking cessation<br>* NRT and varenicline<br>Drug: betablocker, diuretics, ACEI, ARB,<br>* blood pressure control according to ESC guidelines<br>Drug: statins, ezetimibe<br>* Cholesterol reduction according to ESC guidelines<br>Behavioral: training<br>* daily walking<br>Biological: influenza vaccine<br>* vaccine (FLuarix, Influvac etc)<br>Drug: metformin, glimepiride, insulin<br>* s.glucose control according to ESC guidelines<br>Behavioral: weight reduction<br>* diet tips<br>|
| No Intervention: Control<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New cardiovascular events (MACE) |  | 3 years |
Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Whether the mesenchymal injection on ALS patients is effective or not?

Detailed Description
-----------------
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.

Official Title
-----------------
Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Biological: mesenchymal stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sporadic ALS according to escorial criteria onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount normal polysomnography Signed consent form Exclusion Criteria: pregnancy or lactation, vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease Hospitalization due to serious illness in the last two months survival time less than two years Hypersensitivity to any component used in the cell culture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cell<br>intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline | Biological: mesenchymal stem cell<br>* intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS |  | every 6 months up 2 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALS-FRS(functional rating scale) score and EMG scale |  | before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation | 
| FVC (forced vital capacity)and DWSE±QoL score |  | before transplantation and every 6 months up 2 years after transplantation |
Long-term Remote Ischemic Preconditioning Improve Long-term Prognosis of Acute Myocardial Infarction Patients Without Emergency Reperfusion Therapy

Study Overview
=================
Brief Summary
-----------------
Patients with acute myocardial infarction (AMI) are in critical condition especially without emergency reperfusion therapy. For example, heart failure, heart rupture, malignant arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether long-term RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients without emergency reperfusion therapy. 220 AMI patients without emergency reperfusion therapy were randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year) or control group (routine treatment). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1), echocardiography and magnetic resonance（MR）were detected in hospital, 1 month and 1 year after discharge. Patients will be followed up by telephone at the end of one year. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: reported remote ischemic preconditioning (RIPC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-80 years; Acute myocardial infarction (STEMI); Without emergency reperfusion therapy. Exclusion Criteria: Age more than 80 or less than 18 years; Renal failure with creatinine >2 mg/dl; Reject taking part in the study.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: long-term RIPC group<br>routine treatment + once RIPC/day for a year. Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg. | Other: reported remote ischemic preconditioning (RIPC)<br>* Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.<br>|
| No Intervention: control group<br>routine treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke. |  | one year |
Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.

Official Title
-----------------
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety and Tolerability of AFQ056 in Reducing Chorea

Conditions
-----------------
Huntington's Disease, Chorea

Intervention / Treatment
-----------------
* Drug: AFQ056
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10 patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception Exclusion Criteria: patients with marked cognitive impairment (MMSE less than 18), with presence of psychosis and/or confusional states patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: AFQ056A<br> | Drug: AFQ056<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score. |  | Baseline to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. |  | Day 1 to day 46 | 
| Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients |  | Day 1 to day 46 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huntington's disease, Chorea, Dyskinesia
Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients

Study Overview
=================
Brief Summary
-----------------
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.

Official Title
-----------------
Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Clevudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBV DNA > 2,000 copies/mL at screening Patients who have compensated liver disease (Child-Pugh score =<6) Patients without LMV resistant mutation by RFMP assay Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy Patients who can submit the written consent and comply with the claims postulated of this clinical trial Exclusion Criteria: Currently receiving antiviral except LMV or corticosteroid therapy Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period Patients who is co-infected with HCV, HDV or HIV Serious concurrent medical conditions Prior organ transplantation Patient has creatinine clearance less than 60mL/min as estimated by the following formula: [(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dL])[Note: multiply estimates by 0.85 for women]

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>switching treatment from lamivudine to clevudine | Drug: Clevudine<br>* clevudine 30 mg qd for 24 seeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis

Study Overview
=================
Brief Summary
-----------------
The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.

Official Title
-----------------
The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis

Conditions
-----------------
Infertility, Autoimmune Thyroiditis

Intervention / Treatment
-----------------
* Drug: Immunomodulatory
* Drug: Thyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU. Exclusion Criteria: All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease. Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ….)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins) | Drug: Immunomodulatory<br>* Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle. Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle: Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin. Immunoglobulins will be used in cases not responding to treatment.<br>|
| Active Comparator: Control group<br>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D. | Drug: Thyroxine<br>* Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle. Patients will not receive immunomodulatory drugs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Achieved clinical Pregnancy |  | 6 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Achieved Ongoing Pregnancy |  | 18 weeks after embryo transfer |
Use of the Atkins Diet for Adults With Intractable Epilepsy

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

Detailed Description
-----------------
Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar. This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Official Title
-----------------
Use of the Atkins Diet for Adults With Intractable Epilepsy

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

Intervention / Treatment
-----------------
* Behavioral: Atkins diet (15 grams/day carbohydrates)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 and over Weekly seizures or 4 times per month Use of at least 2 anticonvulsant drugs Exclusion Criteria: Prior use of the Atkins diet for > 1 week Prior use of the ketogenic diet within the past year Kidney, heart disease, renal disease Hypercholesterolemia Pseudoseizures Pregnancy Body mass index (BMI) below 18.5 Status epilepticus within the past 6 months 2 week seizure-free period within the past 6 months

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

| Intervention/Treatment |
| --- |
|Behavioral: Atkins diet (15 grams/day carbohydrates)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketosis |  |  | 
| tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intractable, ketogenic, ketosis, Atkins