linjc16/ctgov huggingface dataset:
Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.

Official Title
-----------------
Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients

Conditions
-----------------
Noninvasive Cardiac Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Weight - 36-136 Kilograms Height - 1.52 meters - 1.92 meters (5'- 6'4) Scheduled for open heart surgery during the study period Exclusion Criteria: ECG lead adhesive allergy or sensitivity Pregnant Patients Prisoners Cognitively impaired Patients requiring mechanical cardiac support, or requirement for hemodialysis Patients not requiring pulmonary artery catheters for medical management. Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography

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 |
| --- | --- | --- |
The Effectiveness of Vestibulectomy

Study Overview
=================
Brief Summary
-----------------
Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination before and 6 months after vestibulectomy. The investigators hypothesize that pain will decrease.

Conditions
-----------------
Vulvodynia

Intervention / Treatment
-----------------
* Procedure: vestibulectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vulvodynia, scheduled for vestibulectomy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vulvodynia<br> | Procedure: vestibulectomy<br>* Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 6 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual function |  | 6 months afater surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vulvodynia, vestibulectomy, surgery, vestibulitis
A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.

Detailed Description
-----------------
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study. A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014. Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals

Official Title
-----------------
A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China

Conditions
-----------------
Gastric Carcinoma, Carcinoma of the Lungs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients using Shenqifuzheng injection from 2013 to 2014 Exclusion Criteria: 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 |
| --- | --- | --- |
| Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction | All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge. Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shenqifuzheng | to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng |
MSCs For Treatment of Azoospermic Patients

Study Overview
=================
Brief Summary
-----------------
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Detailed Description
-----------------
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Official Title
-----------------
Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Biological: Stem Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Non obstructive Azoospermic Patients. Azoospermic Patients due to Administration of Chemo/Radiotherapy. Exclusion Criteria: Patients with Testicular Cancer. Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laboratory and Clinical<br>60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis. | Biological: Stem Cells<br>* 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.<br>* Other names: 3-5 Million Autologous MSCs Injected into rete testis.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cases Improvement | Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency. | One Year (12-Month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cases Fertility Improvement | Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency. | One Year (12-Month) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Azoospermia, Spermatogonial Arrest, Maturation Arrest.
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.

Official Title
-----------------
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Procedure: echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is ASA (American Society of Anesthesiologists) class I, II or III The patient has not been fasting for more than 6 hours at the time of inclusion The patient is schelduled for a gynecological or visceral surgery Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding The patient is ASA class IV The patient has insulin dependent diabetes The patient has a cardiac or respiratory dysfunction The patient has a heart rhythm disorder The patient has renal insufficiency with dialysis The patient is being treated with diuretics The patient has had a bowel preparation Emergency surgery Outpatient surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| The study population<br>Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries. | Procedure: echocardiography<br>* Echocardiography is performed for all patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence / absence of a hypovolemia following preoperative fasting | Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a presence. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preoperative fasting
Survey of Thai-Muslim Health Status

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the prevalence and risk factors of diabetes, hypertension, hyperlipidemia among Thai muslim population aged 35-75 years.

Detailed Description
-----------------
This was a cross-sectional study conducted in Bangkok and surrounding provinces. Approximately 1500 participants were enrolled. Study staff interviewed participants on basic demographic data, health status, physical activities, food frequency and 24-hour recall. Anthropometry (body weight, height, hip and waist circumference) and physical assessment (blood pressure)were measured. Ten milliliters of venous blood was drawn by venipuncture after a 12 h overnight fast for determination of fasting plasma glucose (FPG) and blood lipid concentrations (total cholesterol, triglyceride, and HDL-cholesterol). FPG was measured by the enzymatic colorimetric method with glucose oxidase.21 Total cholesterol was determined by the cholesterol oxidase method and serum triglycerides concentration was determined by standardized enzymatic procedures using glycerol phosphate oxidase assay.22, 23 HDL- cholesterol was measured by enzymatic assays.24 LDL cholesterol was calculated according to the method of Friedwald et al.25 All samples were analyzed when internal quality control met the acceptable criteria. Intra-and inter-assay CVs were 2.01% and 3.01% for FPG, 1.87% and 4.24% for total cholesterol, 0.93% and 11.6% for triacylglycerols, and 0.99% and 1.49% for HDL cholesterol, respectively.

Official Title
-----------------
Survey of Thai-Muslim Health Status

Conditions
-----------------
Diabetes, Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 y and older muslim free from severe communicable diseases and mental disorders Exclusion Criteria: not able to complete the interviews or obtain blood samples for analysis

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 95 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 |
| --- | --- |
| 1<br>Healthy participants (physically and mentally). | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of diabetes, hypertension and hyperlipidemia |  | after a 12 h overnight fast | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thai-muslim, Thai-HALAL, Diabetes, Hypertension, Hyperlipidemia, Metabolic syndrome
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)

Study Overview
=================
Brief Summary
-----------------
The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).

Conditions
-----------------
Levels of DHA in the Blood

Intervention / Treatment
-----------------
* Other: Nutritional beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is 18 to 36 months of age Participant's current weight and height within the 10th to 90th percentiles Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis Participant lives at home with parent(s) or other family member(s) Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI) Exclusion Criteria: Participant who is receiving any breast milk at time of randomization Participant with an active infection. Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant. Known or suspected intolerance to cow's milk protein Participant diagnosed with diabetes Participant is from a multiple birth and the sibling(s) are still living Participant with a sibling that has participated in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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 |
| --- | --- |
| Placebo Comparator: Milk-based beverage w/out DHA<br> | Other: Nutritional beverage<br> <br> |
| Experimental: Milk-based beverage with DHA<br> | Other: Nutritional beverage<br> <br> |
| Experimental: Milk-based beverage containing DHA at a higher level<br> | Other: Nutritional beverage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  |  | 
| Determination of nutrient status, including iron and vitamin D status |  |  | 
| Adverse Events |  |  |
Effect of Kinesio Tape in Muscle Fatigue Measured by Biering-Sorensen Test

Study Overview
=================
Brief Summary
-----------------
Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it. The aim of this study is to determine the influence of the Kinesio taping (KT) application in the paravertebral muscle fatigue in a sample of healthy young subjects.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Kinesio Taping
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years They were motivated to be included in the study Exclusion Criteria: History of Low Back Pain (LBP) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick Back surgery Been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis Had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham tape<br> | Other: Placebo<br>* The placebo taping consisted of two 10 cm length strips of the same material, adhered transversely to the skin of the paravertebral muscles fibers<br>|
| Experimental: Kinesio Tape<br> | Other: Kinesio Taping<br>* The taping consisted of two strips of material in the form of I on both sides of the lumbar spine, from the sacroiliac joint to the ipsilateral transverse process of D12.<br>* Other names: Bandage;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maintenance in the Biering-Sorensen Test | Duration in seconds of the Biering-Sorensen Test | Seconds |
Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Study Overview
=================
Brief Summary
-----------------
This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD). The study will compare the outcomes of LVAD patients with low sodium levels who take Tolvaptan to those who do not take Tolvaptan. Tolvaptan is FDA approved for use in the study population and is commonly used to treat low sodium levels in heart failure and LVAD patients. It is not known if taking Tolvaptan or not taking Tolvaptan is better at improving outcomes in newly implanted LVAD patients with low sodium levels. By doing this study, the Principal Investigator (PI) hopes to learn which is better at improving outcomes.

Official Title
-----------------
Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Conditions
-----------------
Heart Failure, Heart Assist Device, Hyponatremic

Intervention / Treatment
-----------------
* Drug: tolvaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with American College of Cardiology (ACC) and the American Heart Association (AHA) Stage D heart failure and plan to undergo LVAD implantation Age greater than or equal to 18 years old Exclusion Criteria: No plan for LVAD implantation Age less than 18 years old

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 |
| --- | --- |
| tolvaptan (TLV)<br>LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L). Eligible patients took tolvaptan 15 mg daily as part of a routine care treatment plan. | Drug: tolvaptan<br>* LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L). Subjects took tolvaptan 15 mg daily as part of their standard care.<br>|
| no tolvapton (no-TLV)<br>LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L). Eligible patients did not take tolvaptan as part of routine care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up. |  | one month | 
| Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up. |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tolvaptan