linjc16/ctgov huggingface dataset:
Biomarker Study in Participants With Migraine

Study Overview
=================
Brief Summary
-----------------
This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.

Official Title
-----------------
LY2951742 Biomarker Study in Patients With Migraine

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Capsaicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo Have suitable skin characteristics for the dermal capsaicin challenge Exclusion Criteria: Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (for example, chili peppers) Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period Have excessive hair growth on the volar surface of the forearm or participants currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; has used any topical treatments within 7 days of the start of the study
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: Capsaicin<br>Single topical dose of capsaicin | Drug: Capsaicin<br>* Administered topically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Capsaicin-Induced Dermal Blood Flow (DBF) | Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI). | Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 | 
| Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | The mean Plasma Calcitonin Gene-Related Peptide levels were reported. | On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 |
Registry for Patients Undergoing Pulmonary Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to examine the safety, tolerability, and effectiveness of currently available pulmonary procedures when used to diagnose or treat different diseases. This study will collect information that may influence the outcome of the procedure and identify factors that may affect the procedures yield or safety. The information will be entered into a registry or data storage.

Detailed Description
-----------------
This is a retrospective and prospective data registry of all pulmonary diagnostic and therapeutic interventional pulmonary procedures at a single academic center. All pulmonary procedures upon completion will be entered into a database by the participating investigator performing the procedure. For both diagnostic and therapeutic cases, the data will require additional input 1-4 weeks after the procedure in order to place the diagnosis and follow-up data. Retrospective data will only be collected for patients that had their procedures prior to approval of this registry. Study data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data (CTSA Awared - Award Number UL1RR031990) capture tools hosted at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies. The prison population will also be included in the registry in order to examine the effects of pulmonary procedures on a special population.

Official Title
-----------------
Registry Examining Retrospective and Prospective Data for Patients Undergoing Pulmonary Procedures

Conditions
-----------------
Pulmonary Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADULT PATIENTS (>18 YEARS OLD) that have a planned PULMONARY PROCEDURE Exclusion Criteria: ALL KNOWN PREGNANT PATIENTS WILL BE EXCLUDED FROM THIS REGISTRY.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopy, Interventional Pulmonary, Pleuroscopy, Tracheostomy
Study Evaluating Inhibitor Specificity in Hemophilia A

Study Overview
=================
Brief Summary
-----------------
This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

Official Title
-----------------
A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Procedure: single blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime. Exclusion Criteria: Patients who have had an inhibitor prior to their current inhibitor. Patients with immune disorders.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: single blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the patterns of antibodies and associated epitopes in a subset of |  |  | 
| previously treated patients with hemophilia A. |  |  |
Metabolic Side-effects for Second-generation Antipsychotics

Study Overview
=================
Brief Summary
-----------------
Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as treatment for psychosis. There are increasing concerns about their related metabolic side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a specific condition known as metabolic syndrome. All these side-effects might be associated with the increased risk of cardiovascular diseases and diabetes mellitus. This study is to analyze the simple physical measurements (weight and height) and venous blood tests (for fasting blood glucose and lipid) results collected routinely since 2008 (recommended by the local hospital authority as a territory-wide SGAs Monitoring Program) from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient clinic in Hong Kong. The investigators hypothesized that there should be differential risks on metabolic side-effects amongst these SGAs.

Official Title
-----------------
Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic

Conditions
-----------------
Mental Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: was ≥18 years of age out-patients had received any one of these antipsychotics: aripiprazole, amisulpride, clozapine, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone consented to provide physical measurements and venous blood samples Exclusion Criteria: not consented to provide venous blood samples and/or physical measurement

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 |
| --- | --- |
| SGAs<br>patients receiving SGAs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of metabolic syndrome according to IDF criteria | post treatment with second generation antipsychotics | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in BMI | post treatment with second generation antipsychotics | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic, SGAs, clozapine
Normal Brain Imaging Database for Brain Disorder Studies

Study Overview
=================
Brief Summary
-----------------
Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.

Official Title
-----------------
Normal Brain Imaging Database for Brain Disorder Studies

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

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: N/A Exclusion Criteria: History of any neurological or psychiatric diseases; Abnormal MRI; metal implants or a cardiac pacemaker; Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging). severe hypertension. cardiovascular disease. Family history of epilepsy.

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real Left DLPFC tDCS<br>Real tDCS on the left dorsolateral prefrontal cortex | Device: transcranial direct current stimulation<br>* 15 minute anodal stimulation 1.5mA<br>|
| Sham Comparator: Sham tDCS<br>30sec ramp-up and 30sec ramp-down | Device: transcranial direct current stimulation<br>* 15 minute anodal stimulation 1.5mA<br>|
| Active Comparator: Real Right DLPFC tDCS<br>Real tDCS on the right dorsolateral prefrontal cortex | Device: transcranial direct current stimulation<br>* 15 minute anodal stimulation 1.5mA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional connectivity | The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI. | immediate (less than 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop task performance | the executive function that is thought to involve the caudate nucleus will be examined | immediate (less than 60 minutes) |
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Study Overview
=================
Brief Summary
-----------------
The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age. For those patients with less than moderate degree AR preoperatively, AR progressed rarely and all in those with aortic valvar and subvalvar anomalies.

Detailed Description
-----------------
Progression of aortic regurgitation (AR) in repaired outlet (juxta-arterial, muscular outlet and perimembranous outlet) ventricular septal defect (VSD) remains unclear. From 1987 to 2002, 411 patients with complete follow-up after repair of outlet VSD constituted the study population. Study end point was aortic valve replacement or mortality. Aortic valve replacement was performed in seventeen patients (4.1%), in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors. After excluding the eleven patients with endocarditis from analysis, there were 377 patients with none to mild AR (Group I) and 23 with moderate to severe AR (Group II) preoperatively. Total follow-up was 2,230 person-years. After VSD repair, the 5- and 10-year freedom from aortic valve replacement in Group I was 100%, and in Group II 50.2%. In Group II, ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair. One patient needed valve replacement four years later. Age at VSD repair was the predictor for aortic valve replacement. In Group I, AR progressed in four patients (1.2%, two juxta-arterial and two perimembranous outlet) 3.5 to 7.9 years later and was associated with aortic valvar or subvalvar anomalies. The event-free curves in three outlet types VSD showed no differences. Although AR progressed rarely (probably not in muscular outlet type) in repaired outlet types VSD with none to mild preoperative AR, in the presence of aortic valvar or subvalvar anomalies, early surgical repair of the VSD is still warranted.

Official Title
-----------------
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Conditions
-----------------
Heart Septal Defects, Ventricular, Aortic Valve Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002. follow up more than 1 year after operation Exclusion Criteria: complex cardiac lesions

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventricular septal defect, aortic regurgitation
Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.

Detailed Description
-----------------
Since 1984, the problem of critical illness neuromuscular abnormalities (CINMAs) has attracted considerable interest. According to these studies, CINMAs include the muscular weakness that accompanies critical illness resulting from polyneuropathy and/or myopathy and can be seen in 25-85% of cases of critically ill patients. Clinically, CINMAs present as symmetric flaccid tetraparesis and difficulty weaning off mechanical lung ventilation. However, these data are derived from treating non-specialized intensive care unit (ICU) patients. In this research, we wished to investigate CINMAs in neurocritical care patients. From day one of the patients' participation in the research and until a discharge from the ICU (or death), daily neurological surveys and weekly nerve conduction studies were performed. Based on the results of each nerve conduction study, an index of neuromuscular damage was noted to evaluate the severity of the CINMAs. Needle electromyography and muscle biopsy were not used

Official Title
-----------------
Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit

Conditions
-----------------
Muscle Weakness, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 16 years and older Acute primary cerebral pathology Mechanical ventilation Signs of systemic inflammatory response Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history Exclusion Criteria: Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness Inability to perform high-grade nerve conduction studies

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| incidence of critical illness neuromuscular abnormalities (CINMAs) |  | within the first week of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and neurophysiological characteristics of CINMAs |  | within the first week of mechanical ventilation | 
| influence оf phrenic nerve pathology on weaning from mechanical ventilation |  | during weaning period | 
| dynamics of the neurophysiological characteristics of CINMAs |  | during stay in ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phrenic nerve, neuromuscular diseases, critical illness, mechanical ventilation, nerve conduction studies
The Relationship Between Oxytocin Level and Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.

Detailed Description
-----------------
Introduction and purpose: There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms. Method: The study was conducted with 70 women who met the research criteria. Data collection was done in two interviews. The first meeting is 30-38 at the week of gestation, the second interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a data collection form was applied first and then a saliva sample was taken. Data collection form; The questions prepared by the researchers consisted of the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using SPSS 22.0 program and the significance value was taken as p <0.05.

Official Title
-----------------
The Relationship Between Oxytocin Level Measured During Pregnancy and Postpartum Depression Symptoms

Conditions
-----------------
Oxytocin Deficiency, Postpartum Depression, Prenatal Stress

Intervention / Treatment
-----------------
* Diagnostic Test: Salivary test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older, and having a pregnancy of 30 weeks or more Exclusion Criteria: previous mental illness history, miscarriage or stillbirth history, multiple pregnancy, fetal malformation, antidepressant or anxiolytic drug use, existing chronic disease,preterm labor is the development of maternal or neonatal complications at birth, hospitalization in the neonatal intensive care unit or congenital disease.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnancy<br> | Diagnostic Test: Salivary test<br>* Salivary test for measured of oxytocin levels<br>* Other names: survey application;|
| postpartum<br> | Diagnostic Test: Salivary test<br>* Salivary test for measured of oxytocin levels<br>* Other names: survey application;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxytocin levels | Oxytocin levels in pregnancy and postpartum period | 3-6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, Postpartum Depression, oxytocin and depression