linjc16/ctgov huggingface dataset:
Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.

Detailed Description
-----------------
Patients included in this study will have chosen to breastfeed. The investigators will identify patients that are planning to breastfeed from their intake questionnaire that all patients receive upon admission to labor and delivery. They will also identify breastfeeding patients while performing our postpartum rounding. The investigators will perform a chart review to determine their co-morbidities and current medications. Specifically, the patient information recorded will be age, parity, gestational age, delivery route, vital signs, medications, race, whether they are breastfeeding. Of note, all of the individuals listed to participate in this study have routine access to the patient's charts since they will be working with the patients regardless of their participation in the study. Only hypertensive women will be included. Hypertension is defined as persistent Systolic blood pressure > 140 and or persistent diastolic blood pressure > 90. Once it has been determined that they have met the inclusion criteria for the study the investigators will ask the patient's attending physician if we can approach the patient and explain the study and obtain consent. Once consent is obtained, the investigators will inform the nurse. The patient will have her blood pressure taken prior to breastfeeding, during breastfeeding, and 1-2 hours after breastfeeding. This will occur 3 times in the postpartum period.

Official Title
-----------------
Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

Conditions
-----------------
Breastfeeding, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria include hypertensive women in the first 72 hours postpartum. The gestational age at delivery must be greater or equal to 34wk and the patient must be breastfeeding and/or pumping milk. The study will include patient's on anti-hypertensive. The study will also include patients receiving postpartum IV magnesium but they will have their blood pressure taken two times while on magnesium and two times after the magnesium has been discontinued. Exclusion Criteria: The study will exclude patient's on dopamine agonist medications or HIV positive.
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in blood pressure after breastfeeding | A decrease of 15mmHg systolic, 10mmHg diastolic, or a decrease of 10% from baseline will be considered significant. | Up to 16 months |
Registry of Hypogonadism in Men

Study Overview
=================
Brief Summary
-----------------
The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.

Official Title
-----------------
Registry of Hypogonadism in Men

Conditions
-----------------
Male Hypogonadism, Androgen Deficiency, Testosterone Deficiency

Intervention / Treatment
-----------------
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 18 years and older. Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have been diagnosed at any point in their lives. Documentation of the diagnosis of HG (including symptomatology and laboratory values including testosterone levels confirmed on two separate occasions) is required. Written informed consent. Exclusion Criteria: Any previous treatment with testosterone therapy. History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia. Prior radical prostatectomy. Life expectancy shorter than 24 months as judged by the Clinical Site investigator. Current major psychiatric disorders or drug or alcohol abuse, which will likely affect participation or compliance in the Registry, in the opinion of the Clinical Site Investigator. Gender dysphoria or sexual reassignment (e.g., transexualism). Patients actively enrolled in any interventional clinical trial. Planned relocation outside Clinical Site region within 24 months.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Hypogonadal males treated by standard of care, with or without testosterone replacement therapy | Other: Standard of Care<br>* Standard of care may or may not include use of testosterone replacement therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Cancer |  | 2-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA, IPSS, and Other Urologic Outcomes |  | 3-years | 
| Sexual Function and Hypogonadism Symptoms |  | 3-years | 
| Physical Health and Cardiovascular Outcome Measures |  | 3-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
registry, natural history
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization

Study Overview
=================
Brief Summary
-----------------
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.

Official Title
-----------------
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.

Conditions
-----------------
Chronic Critical Ischemia

Intervention / Treatment
-----------------
* Procedure: The Edge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemia Chronic critical lower limb revascularization procedure requiring fast. Written consent informed patient age greater than or equal to 18 Exclusion Criteria: Presence of an inflammatory or infectious (erysipelas) in the ischemic member. Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007) presence of sensory neuropathy, and / or foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or history of foot ulceration, and / or antecedent of one of these factors (ie antécedant diabetic foot). Necrosis of the toes. Participation in another clinical research protocol. Presence of peripheral arterial disease in the bilateral upper limbs. Patient in shock whatever the cause. Presence of hepatic failure. Too impaired general condition (bedridden, dementia, ...) Refusal of the patient to participate in the study Protected patients

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: lactate group<br> | Procedure: The Edge<br>* measuring blood lactate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) | Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if> 2). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease in the ratio LCO/LCD | The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization | 48 hours |
T-cell Minimal Residual Disease (MRD) Evaluation Using Flow Cytometric Analysis

Study Overview
=================
Brief Summary
-----------------
To determine if MRD (minimal residual disease) can be found in the blood (only) as opposed to bone marrow in children with ALL (acute lymphoblastic leukemia).

Official Title
-----------------
T-cell MRD Evaluation Using Flow Cytometric Analysis

Conditions
-----------------
Leukemia, Lymphocytic, Acute

Intervention / Treatment
-----------------
* Procedure: bone marrow aspiration
* Procedure: peripheral blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with newly diagnosed T-cell ALL

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bone marrow aspiration|nan|
|Procedure: peripheral blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance

Study Overview
=================
Brief Summary
-----------------
Pulsed electromagnetic field therapy (PEMFT) is a reparative technique most commonly used in the field of orthopedics for the treatment of non-union fractures. The aim is to test the effect of the magnetic induction on brute force of treated muscle in oncological patients. Oncology patients were chosen as we assume that the ipmrovement will be more noticable in oncology patients than in a non-oncology, healthy subjects.

Official Title
-----------------
The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance

Conditions
-----------------
Medical Oncology

Intervention / Treatment
-----------------
* Device: pulsed electromagnetic field therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patiant from the oncology clinic Exclusion Criteria: Known bone disease Pregnancy Birth defects or acquired uper extremity Neurology disease Medical history in the forehand Pacemaker neural modulation pacer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Other: 10 minutes of pulsed electromagnetic field therapy<br>10 minutes of pulsed electromagnetic field therapy | Device: pulsed electromagnetic field therapy<br> <br> |
| Other: 20 minutes of pulsed electromagnetic field therapy<br>20 minutes of pulsed electromagnetic field therapy | Device: pulsed electromagnetic field therapy<br> <br> |
| Other: 30 minutes of pulsed electromagnetic field therapy<br>30 minutes of pulsed electromagnetic field therapy | Device: pulsed electromagnetic field therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brute force |  | 2 weeks |
Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway

Study Overview
=================
Brief Summary
-----------------
The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation.

Detailed Description
-----------------
This study compares the insertion success rate and insertion time among the proceal laryngeal mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult laryngoscopy scenarios.

Official Title
-----------------
Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.

Conditions
-----------------
Airway Obstruction

Intervention / Treatment
-----------------
* Device: proceal laryngeal mask airway
* Device: tracheal tube
* Device: i-gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical student nurse no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway Exclusion Criteria: experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: i-gel<br>Each novice performs i-gel insertion in difficult laryngoscopy scenario. | Device: i-gel<br>* In i-gel group, i-gel is inserted by novices.<br>|
| Active Comparator: proceal laryngeal mask airway<br>Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario. | Device: proceal laryngeal mask airway<br>* In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.<br>* Other names: LMA proceal;|
| Active Comparator: tracheal tube<br>Each novice performs tracheal intubation in difficult laryngoscopy scenario. | Device: tracheal tube<br>* In tracheal tube group, tracheal tube is intubated by novices.<br>* Other names: TaperGuard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt | A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt. | intraoperative |
Oral Ghrelin Agonist in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing activity after intravenous administration.It is an analogue of the natural compound ghrelin. Since an oral delivery system would be preferable in many of the possible therapeutic indications, the pharmacological profile and the GH-releasing activity of increasing single, oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the pharmacokinetics and pharmacological effects of EP01572 will be investigated after intraduodenal administration.

Detailed Description
-----------------
EP01572 willbe given orally to 36 male subjects; the treatment will consist of one oral dose of either EP01572 or placebo (0.005, 0.05 and 0.5 mg/kg body weight). Subjects will receive one dose of EP01572 and placebo. Six subjects will receive two additional oral doses of EP01572: 0.125 and 0.25 mg/kg body weight. In another part, 6 subjects will receive the following treatments in a randomized order: 1) administration of a bolus of saline (placebo) to the small intestine; 2) intraduodenal (ID) administration of a bolus of EP01572 at 0.2 mg/kg body weight; 3) ID perfusion of a bolus of EP01572 at 0.35 mg/kg body weight; 4) ID perfusion of a bolus of EP01572 at 0.5 mg/kg body weight.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamic Effects of an Oral Ghrelin Agonist in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: EP1572 (ghrelin agonist) oral and duodenal application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Exclusion Criteria: Females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EP1572 (ghrelin agonist) oral and duodenal application|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone release |  |  | 
| Pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, GH release, Pharmacokinetics
The Vanderbilt Atrial Fibrillation Ablation Registry

Study Overview
=================
Brief Summary
-----------------
The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.

Detailed Description
-----------------
The study population consists of patients at least 18 years of age who are scheduled for AF ablation at Vanderbilt University. Data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac MRI or CT). At the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of DNA, and details of the ablation procedure are recorded. Post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ECG's are performed at each follow-up visit along with placement of an ambulatory ECG-monitor. At 6-months post-ablation, cardiac imaging with a repeat cardiac MRI or CT is performed.

Official Title
-----------------
The Vanderbilt Atrial Fibrillation Ablation Registry

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age >18 years Able to give written, informed consent Scheduled for an ablation procedure to treat atrial fibrillation Exclusion criteria: 1. None

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrence |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheter ablation, genomics
Phenotypic and Genetic Factors in Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

Detailed Description
-----------------
Participation in this research study involves two research visits, at least one of which is at Children's Hospital Boston. The first visit lasts about 4-6 hours. On this visit, the child will work with a research assistant on a few different cognitive assessments while one or both parents answer interview questionnaires about the child's development, along with other family history information. The second visit at the hospital lasts about 2 and a half hours and involves medical history and family history questionnaires, as well as height, weight, and head circumference measurements and a blood draw from each family member. In addition, digital photographs will be taken of each family member and a 3-D picture of the child's face will be taken. Shortly after the visits, participants will receive a research report of our observations. These results include cognitive, behavioral, developmental, and social findings. The total time commitment for the study is 6 to 8 hours.

Official Title
-----------------
Phenotypic and Genetic Factors in Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray) Age ≥ 18 months Exclusion Criteria: Presence of a metabolic disorder Acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype-phenotype correlation |  | enrollment and sample analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorder, Autism, Asperger Syndrome, Pervasive Developmental Disorders- Not Otherwise Specified