linjc16/ctgov huggingface dataset:
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies. The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks. Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo. Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.

Conditions
-----------------
Interstitial Cystitis, Vulvar Diseases

Intervention / Treatment
-----------------
* Drug: capsaicin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No clue cells in vaginal discharge

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

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

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
-----------------
interstitial cystitis, rare disease, renal and genitourinary disorders, vulvar vestibulitis
Influence of Adiponutrin in Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
Increasing evidence attests the influence of multiple metabolic genetic risk factors in the progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as lipid peroxidation and cytokines have been implicated in promoting inflammation leading to fibrosis increase and liver injury progression. The aim of this study was to assess the role of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease patients.

Official Title
-----------------
Study of Metabolism Influence in Human Alcoholic Liver Disease

Conditions
-----------------
Alcoholic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
ALD patients: Inclusion Criteria: Excess alcohol intake Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or a suspicion of cirrhosis related to ALD Caucasian ethnicity Exclusion Criteria: Presence of any other chronic liver disease Co-infection with human immunodeficiency virus Controls: Inclusion Criteria: Caucasian ethnicity Exclusion Criteria: Presence of a disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alcoholic liver disease<br>Alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution | |
| Controls<br>Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fibrosis and steatosis by liver biopsy in alcoholic liver disease patients. | After liver histology assessment for liver liver dammage a potential correlation of fibrosis and steatosis was studied with rs738409 PNPLA3 polymorphism |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PNPLA3, fibrosis, cirrhosis, alcoholic liver disease
Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Study Overview
=================
Brief Summary
-----------------
Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal iron absorption. Renal function caused by Iron overload was studied in a previous study and shows principally tubular disfunction. In this previous study the Iron chelator used was Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess the renal function in Thalassemia Major patients treated with this new oral iron chelator and compare the results with our previous study.

Detailed Description
-----------------
Patients with Thalassemia Major. The laboratory tests that will be studied are: Urine dip stick, Urea, Creatinine, Na, K, Uric Acid, Calcium, Phosphorus in serum and urine, and N acetyl-b-D-glucosaminidase in Urine.Blood gases will be also taken in serum samples. The overall iron accumulation will also be calculated based in the amount of Packed Cells Units transfused. The total iron burden will also assessed by measurement of Transferrin saturation and Serum Ferritin.

Official Title
-----------------
Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Conditions
-----------------
Thalassemia, Iron Overload

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators Exclusion criteria: None relevant

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 45 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 |
| --- | --- |
| Deferasirox<br>The patients will be treated by the primary physician according to clinical status. The Deferasirox dose range is between 20 to 40 mg/kg/day once daily dose. The treatment is a continuous treatment and not a single course. | Drug: Deferasirox<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function in Thalassemia patients treated by Deferasirox | Analysis of renal tubular function in patients treated by Deferasirox compared to patients treated by deferrioxamine | One year study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Function
Sweat Duct Imaging in Mother/Newborn Dyads

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.

Detailed Description
-----------------
In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.

Official Title
-----------------
Sweat Duct Imaging in Mother/Newborn Dyads

Conditions
-----------------
X-Linked Hypohidrotic Ectodermal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO Mother of a healthy term newborn who is enrolled in this study Exclusion Criteria: Congenital abnormalities affecting skin, nails, or hair in the newborn infant Family history of a sweating disorder
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborns<br> | |
| Mothers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns | To demonstrate the ease of use of a non-invasive confocal imaging device in the evaluation and measurement of sweat ducts on the plantar surface of healthy, term newborns. These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia. | Day 1 | 
| To assess the sweat duct density (i.e. the number of sweat ducts) in a 6 x 6 mm area on the plantar surface of healthy, term newborns, males and females, and the palmar surface of their mothers | These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia. | Day 1 |
Effects of Muscle Fatigue and Kinesio Taping on Shoulder Position Sense

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of Kinesio Taping on the position sense of shoulder after muscle fatigue.

Official Title
-----------------
Effects of Muscle Fatigue and Kinesio Taping on Shoulder Joint Position Sense

Conditions
-----------------
Fatigue, Proprioception

Intervention / Treatment
-----------------
* Other: Kinesio taping with tension
* Other: Kinesio taping without tension
* Other: Fatigue protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants Exclusion Criteria: prior shoulder surgery shoulder injury that required rehabilitation in the last 2 years shoulder dislocation ligamentous laxity

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>In this session, participants will be evaluated before and after a muscle fatigue protocol, with no intervention. | Other: Fatigue protocol<br> <br> |
| Experimental: Kinesio taping with tension<br>A kinesio taping technique for the deltoid muscle will be applied before fatigue protocol and removed after in the end of the evaluation session. Subjects will be evaluated before taping, after taping and after the fatigue protocol. | Other: Kinesio taping with tension<br> <br> Other: Fatigue protocol<br> <br> |
| Sham Comparator: Kinesio taping without tension<br>A kinesio taping technique will be applied on the deltoid muscle without tension (tension is considered to be the therapeutic effect) before fatigue protocol and removed after in the end of the evaluation session. Subjects will be evaluated before taping, after taping and after the fatigue protocol. | Other: Kinesio taping without tension<br> <br> Other: Fatigue protocol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in joint repositioning angle errors | The joint repositioning errors will be measured during active repositioning trials of shoulder abduction in scapular plane using an iPod app. | Baseline (in the beginning of the session, without taping), 5 minutes after taping (or equivalent time resting, in the control session) and average of 3 minutes after fatigue protocol. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Proprioception, Shoulder
The Nanowear Wearable Covid-19 Observational and Analysis Trend

Study Overview
=================
Brief Summary
-----------------
The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to Covid-19.

Official Title
-----------------
The Nanowear Wearable Covid-19 Observational and Analysis Trend

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: Observational Study - no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided informed consent Male or female over the age of 18 years The patient is currently hospitalized with a primary diagnosis of Covid-19 Exclusion Criteria: Subject is unwilling or unable to wear the vest during hospitalization. Subjects who are pregnant. Subject is intubated or admitted to ICU Subject has an implantable cardiac device (i.e pacemaker or internal cardioverter defibrillator)

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

| Intervention/Treatment |
| --- |
|Device: Observational Study - no intervention|Observational Study - no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hosptialized patient data | The primary study endpoint is adequate collection of hospitalized COVID 19 patient health metric data through the Nanowear WMDRS | up to 30 days of monitoring leading to discharge or admission to ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trends in COVID 19 exacerbation | Exploratory information will be used to compare the signals obtained from the device to the severity of Covid-19 as measured by clinical evaluation | up to 30 days of monitoring leading to discharge or admission to ICU |
Pediatric Sleep Questionnaire: Use for Collection of Clinical Data

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a questionnaire that can be used for standardized patient information gathering in the clinical setting. This will serve as the information source for a pediatric sleep database.

Detailed Description
-----------------
A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and the Pediatric Sleep Clinic in the DCAM as well as LaRabida Children's Hospital complaining of sleep problems. The questions asked are those routinely obtained in clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Official Title
-----------------
Pediatric Sleep Questionnaire: Use for Collection of Clinical Data

Conditions
-----------------
Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen in the Pediatric Neurology Clinic and at La Rabida Children's Hospital Exclusion Criteria: Adults

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
| Pediatric Sleep Questionnaire | This questionnaire is used to better understand the natural history of sleeping disorders in children. | When data from clinic patients becomes available | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Disorders
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

Study Overview
=================
Brief Summary
-----------------
PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.

Official Title
-----------------
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil

Conditions
-----------------
Diarrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have 3 or greater liquid stools in the past 24 hours. Provide written informed consent from at least one parent in the case of children under 18 years of age. Provide written informed consent for those participants above 18 years of age. Provide assent in the case of children 10 years of age or greater. Exclusion Criteria: Previously enrolled in the study. Parents are unwilling or unable to provide written informed consent. Report using antibiotics in the last 30 days. Adolescent (<18 years old) parent of a child already enrolled in the study.
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
-----------------
Diarrhea, Diagnostic, Pediatric
A Study on Intima Media Thickness (IMT) in Middle-aged Subjects

Study Overview
=================
Brief Summary
-----------------
This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population. Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.

Official Title
-----------------
A Study on Intima Media Thickness (IMT) in Middle-aged Subjects

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 55 years or above. Waist circumference: male more than 90 cm; female more than 80 cm. Exclusion Criteria: Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia. Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease. Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong, |  | during the one single study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the association between IMT value and cardiovascular disease (CVD) risk factors, and blood lipid and glucose profiles in middle-aged centrally obese subjects in Hong Kong. |  | During the one single study visit | 
| IMT results to be compared with what being reported in the recent literature on normal Chinese population. |  | During the one single study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymptomatic atherosclerosis, Intima media thickness (IMT), central obesity, cardiovascular disease