linjc16/ctgov huggingface dataset:
Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients

Study Overview
=================
Brief Summary
-----------------
Preeclamptic pregnancy is associated with alterations in the left ventricular structure and function and elevation of cardiovascular biomarkers. The alterations are still persistent several months after delivery and are more clearly observed in early-onset and severe Pre-eclampsia

Official Title
-----------------
Prognostic Value of Ambulatory Blood Pressure Monitoring Pattern in Post-Partum Pre-Eclamptic Patients

Conditions
-----------------
Decrease Maternal Morbidity

Intervention / Treatment
-----------------
* Device: Ambulatory blood pressure monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All previously healthy women who were diagnosed as preeclampsia.( defined as gestational hypertension ( systolic BP of at least 140 mm Hg and/or a diastolic BP of at least 90 mm Hg on at least two occasions at least 6 hours apart after the 20th week of gestation in women known to be normotensive before pregnancy and before 20 weeks' gestation ) plus proteinuria (300 mg or more per 24-hour period) Exclusion Criteria: Current pregnancy Chronic hypertension or any condition requiring the use of antihypertensive medication Chronic kidney disease Any disease requiring the use of anti-inflammatory medication, diabetes or any other endocrine disease such as hyperthyroidism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ambulatory blood pressure monitor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of women with persistent hypertension |  | 6 months |
Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance.

Detailed Description
-----------------
Hypotension during cesarean section with spinal anesthesia is common. We compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.

Official Title
-----------------
Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

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

Intervention / Treatment
-----------------
* Drug: Phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women for elective cesarean section Exclusion Criteria Shorter than 160 or taller than 180 cm Pre-pregnant body mass index (BMI) over 32

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in cardiac output |  |  | 
| Blood pressure |  |  | 
| Systemic vascular resistance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea |  |  | 
| Fatigue |  |  | 
| Cardiovascular instability due to overdosing spinal anesthesia for cesarean section (CS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal, Hemodynamic, Hypotension, Anesthesia, Healthy pregnant women for elective cesarean section
Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia

Study Overview
=================
Brief Summary
-----------------
MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA) testing for the purpose of detecting active ischemia in patients with known or suspected coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular tachyarrhythmias and sudden cardiac arrest (SCA).

Detailed Description
-----------------
Ischemia, a common trigger for arrhythmias, is a well-documented cause of repolarization alternans. Human studies have shown that active ischemia can be associated with visible as well as microvolt-level T-wave alternans. While MTWA testing is traditionally used to evaluate arrhythmic risk, this known association with ischemia may allow MTWA testing to be used as a diagnostic tool to detect underlying CAD. The MTWA-CAD study will assess the feasibility of this concept by measuring MTWA during routine nuclear stress testing or stress echocardiography with treadmill exercise. This is a feasibility study designed to verify preliminary observations under controlled environments and to generate hypotheses, endpoints, and sample sizes for future investigations.

Official Title
-----------------
Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients With Known or Suspected Coronary Artery Disease: A Feasibility Study

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent Willing and capable of undergoing a SPECT MPI exercise test (or stress echo) at an approved clinical investigational center In normal sinus rhythm at the time of the exercise test A life expectancy of more than 6 months Exclusion Criteria: In atrial fibrillation at the time of the exercise test Left bundle branch block (precludes ST segment measurement) Pacemaker-dependent Life expectancy of less than 6 months Pregnancy

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 being evaluated for active ischemia<br>Subjects with known or suspected CAD who are scheduled to undergo routine exercise MPI or stress echocardiography for the detection of active ischemia are eligible for enrollment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Study Overview
=================
Brief Summary
-----------------
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Detailed Description
-----------------
Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

Official Title
-----------------
Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

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

Intervention / Treatment
-----------------
* Device: Electrical Stimulation
* Other: Dry Needling Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's Disease H&Y Stage >= 2 Existing bradykinesia symptoms Existence of one of the symptoms below Resting Tremor Rigidity Walking disorder Exclusion Criteria: Cardiac Pacemaker Psychiatric diagnosis Irregular heart/respiration rate Pregnancy Alcohol consumption Cardiovascular disease history Wearing an electro-active prosthesis Brain surgery history Ongoing TENS/PENS 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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Stimulation<br>Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes. | Device: Electrical Stimulation<br>* Percutaneous electrical nerve stimulation<br>|
| Other: Dry Needling<br>Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given | Other: Dry Needling Stimulation<br>* Percutaneous nerve stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI - Activation level comparison of the motor and supplementary cortex |  | Baseline and PostStim (right after the stimulation is terminated) | 
| fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN) |  | Baseline and PostStim (right after the stimulation is terminated) | 
| fMRI - STN, PPN and cortical connectivity alterations |  | Baseline and PostStim (right after the stimulation is terminated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurostimulator
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years

Study Overview
=================
Brief Summary
-----------------
Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.

Official Title
-----------------
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale

Conditions
-----------------
Fear

Intervention / Treatment
-----------------
* Other: Placing a scale self-assessment of fear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 4 to 12 years. Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6). Authorization of at least one person having parental authority for the child to participate in the study. Children affiliates or benefiting from a social security Exclusion Criteria: Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions. Children in vital emergency

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Placing a scale self-assessment of fear|Children spend a self-assessment scale of fear|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children who validate the 6 faces expressing fear. | Percentage of children who validate the 6 faces expressing fear. The test will be validated if we get a result at least 60%. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children who properly fit the faces expressing fear in ascending and descending order. |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scary scale
An Exploratory Investigation of Dietary Supplementation and Its Effect

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.

Detailed Description
-----------------
This will be a 2-arm randomized, double-blinded, placebo-controlled study.

Official Title
-----------------
An Exploratory Investigation of Dietary Supplementation and Its Effect

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Dietary Supplement: HUM supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study Must be in good health (don't report any medical conditions asked in the screening questionnaire) Willing and able to provide written informed consent Exclusion Criteria: Allergies to any test product ingredients Any other severe chronic disease Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding Participating in an investigational health product research study

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a 2-arm randomized, double-blinded, placebo-controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>HUM supplement - 1 capsule per day | Dietary Supplement: HUM supplement<br>* HUM supplement - 1 capsule per day<br>|
| Placebo Comparator: Placebo group<br>Placebo supplement - 1 capsule per day | Dietary Supplement: Placebo<br>* Placebo supplement - 1 capsule per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life improvements [Time Frame: Baseline to 8 weeks) | Survey-based assessment (0-5 scale) with higher scores representing an improved outcome | 8 week |
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Rising Dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Type I Diabetes Mellitus Patients

Conditions
-----------------
Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: INGAP-Peptide
* Drug: INGAP-Peptide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18-65 fasting C-peptide <0.3 ng/ml. HbA1c <10% history of onset of type 1 DM at or before 20 years of age. Otherwise healthy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: placebo<br>1.5 mL SC injection | Drug: placebo<br>* 1.5 mL, once daily, self-administered SC injection for 90 days<br>|
| Experimental: 300 mg INGAP Peptide<br>1.5 mL SC injection, once daily for 90 days | Drug: INGAP-Peptide<br>* 1.5 mL, once daily, self-administered SC injection for 90 days<br>|
| Experimental: 600 mg INGAP Peptide<br>1.5 mL SC injection, once daily for 90 days | Drug: INGAP-Peptide<br>* 1.5 mL, once daily, self-administered SC injection for 90 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes
Mobile Phone Messaging to Improve Women's and Children's Health (Mobile WACh) in Kenya

Study Overview
=================
Brief Summary
-----------------
With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes

Official Title
-----------------
Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial

Conditions
-----------------
Maternal Health, Neonatal Health, Family Planning

Intervention / Treatment
-----------------
* Behavioral: Two-way SMS Dialogue
* Behavioral: One-way SMS Messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Access to a mobile phone Able to read SMS messages Willing to receive SMS messages Exclusion Criteria: Unwilling or unable to meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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 |
| --- | --- |
| Experimental: Two-way SMS dialogue<br>Women will receive SMS messages with prompts to reply. They will have the ability to text back to the system and both respond to and initiate SMS dialogue | Behavioral: Two-way SMS Dialogue<br> <br> |
| Experimental: One-way SMS Messaging<br>Women will receive scheduled one-way SMS messages | Behavioral: One-way SMS Messaging<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive uptake |  | 10 weeks postpartum; 24 weeks postpartum | 
| Facility Delivery |  | Postpartum | 
| Exclusive Breastfeeding |  | 24 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANC attendance |  | Postpartum | 
| Infant Immunizations |  | Six months postpartum | 
| Maternal mortality |  | 6 months postpartum | 
| Infant mortality |  | Six months postpartum |
Study of Male Osteoporosis and Aging

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify potential risk factors for fragility fractures in men.

Detailed Description
-----------------
Osteoporosis is a disease characterized by decreased bone mass and pathological changes in the microarchitecture of the bones. The clinical significance of osteoporosis is the association with fragility fractures and, consequently, increases in both morbidity and mortality. In men, genetical and life-style factors are known to affect the risk of fractures, however, data relating these factors with measures of bone mineral density and fracture risk are limited. 30.000 men aged 60-70 were randomly selected from the Central Office of Civil Registration in Denmark. Each receive a questionnaire addressing demographics, potential risk factors of osteoporosis, past medical history and medication by mail. In case of consent, the participants will complete a full medical examination including DXA and sampling of DNA if they have a fragility fracture. At the same time, 2 participants from the study population will be selected as control. The study period is 10 years.

Official Title
-----------------
Study on Male Osteoporosis and Aging

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 60-70 being able to consent in writing

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
osteoporosis, male, fracture risk, genetical epidemiology