linjc16/ctgov huggingface dataset:
Kisspeptin/GPR54 Pathway and Early Puberty

Study Overview
=================
Brief Summary
-----------------
There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset varies greatly among individuals, and much of this variation is modulated by genetic factors. This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway genes and the risk of early puberty in Chinese Han girls.

Official Title
-----------------
Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty

Conditions
-----------------
Puberty, Precocious

Intervention / Treatment
-----------------
* Other: this study was an observational study and no interventions were given to the participants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Clinical diagnosis of central precocious puberty or early and fast puberty. Exclusion Criteria: The participants who were not the first visit to the hospital and had been treated before. The participants who were with endocrine disorders.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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 |
| --- | --- |
| cases<br>Early puberty cases of Han Chinese | |
| controls<br>Controls were matched to cases at 1:1 by age (± 3 months) | Other: this study was an observational study and no interventions were given to the participants<br>* the participants were recruited and the data as well as blood sample were collected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the polymorphism in the KISS1/GPR54 pathway genes | functional SNP loci of the KISS1/GPR54 pathway genes KISS1, KISSIR, PLCB1, PRKCA, and ITPR1 were selected and detected. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP, kisspeptin, GPR54
Pharmacokinetic Study for PCA Derivate Formulations

Study Overview
=================
Brief Summary
-----------------
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.

Official Title
-----------------
Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: PCA
* Drug: PCA
* Drug: PCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed the informed consent process culminating with written informed consent by the subject. Males Age 18-45 years Abstinence from alcohol for 1 week prior to the study Non smoking BMI > 19 and < 30 No history or evidence of significant cardiovascular, hepatic, renal, hematopoietic, gastrointestinal disease, endocrine, metabolic, psychiatric psychological disorders Normal physical examination Within +/- 10% of normal values in laboratory examinations Exclusion Criteria: Subjects who suffer from a current medical condition. Subjects who smoke. Subjects who drink > 20 grams of alcohol per day. Subjects who take prescription medication. Subjects with an abnormality in screening blood tests Known sensitivity to any ingredients in the study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: PCA<br>* Placebo tablet, once<br>|
| Experimental: 2<br>Slow release PCA derivative | Drug: PCA<br>* PO, 700mg, once<br>|
| Experimental: 3<br>Slow release PCA derivative higher dose | Drug: PCA<br>* PO, 1000mg, once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA derivate blood levels |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comparative, bioavailability, of PCA, formulations
Best Incision Site for Obese Patients - Low Versus High Transverse

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.

Detailed Description
-----------------
Past studies have looked primarily at vertical vs low transverse skin incision. There is data that performing a high transverse skin incision on obese patients leads to better visualization and less wound infection but there are few studies comparing it directly to low transverse skin incision. Retrospective chart review of obese patient's who have had a cesarean section at St Mary's hospital by either a low or high transverse skin incision between January 1, 2009 - July 31, 2014. We will review charts up to 6 week postpartum. Pregnancies will be identified through identifing those who have cesarean sections. They will be narrowed down by those who have BMI of > 30. Maternal prenatal records, postnatal records and delivery records will be reviewed.

Official Title
-----------------
Best Incision Site for Obese Patients - Low Versus High Transverse

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients (BMI of 30 or greater) who have had a cesarean section Exclusion Criteria: Vaginal delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cesarean section<br>Obese pregnant patients who have had a cesarean section. | Procedure: cesarean section<br>* obese patients (BMI of 30 or greater) who have had a cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of skin incision | Identify which type of skin incision has better outcomes in obese pregnant patients | Delivery to 6 weeks postpartum |
Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals

Study Overview
=================
Brief Summary
-----------------
This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.

Official Title
-----------------
The Vitamin D Dose Response Curve in Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Oral vitamin D3
* Dietary Supplement: Placebo equivalent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese adults aged 18-65 years and BMI>35 Exclusion Criteria: chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease) subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program BMI < 35 pregnancy use of medication that influences vitamin D metabolism history of of hypercalcemia, hypercalciuria, nephrolithiasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Vitamin D<br>Vitamin D3 supplementation based on baseline 25(OH)D level | Dietary Supplement: Oral vitamin D3<br>* Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo equivalent<br>* One capsule daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum 25(OH)D level from baseline. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, Vitamin D3, cholecalciferol
Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19

Official Title
-----------------
Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study

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

Intervention / Treatment
-----------------
* Drug: Guduchi Ghan Vati


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hospitalised cases above 18 years of age, Diagnosed with Covid-19 Asymptomatic at the time of admission Agree to give consent Exclusion Criteria: Symptoms relating to Covid-19 Severe vomiting Respiratory failure or requiring mechanical ventilation Patients having alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper range of normal limits Patients with Covid-19 in critical condition or ARDS or NIAD 8 -point ordinal score-2 Patients with uncontrolled diabetes mellitus Malignant, Chronic renal failure or On immunosuppressive medication

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda<br>Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem. | Drug: Guduchi Ghan Vati<br>* Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.<br>* Other names: Guduchi;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic clearance | Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay | Total duration of stay in hospital for complete recovery | 14 days | 
| Clinically relevant adverse effects | Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form | 14 days | 
| Laboratory tests | Routine blood tests were performed to assess complete blood counts, blood biochemistry parameters {Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin} and immunoglobulines. | change from baseline to 14 days |
Clinical Characteristics and Discharge Assessment of Patients From Palliative Care

Study Overview
=================
Brief Summary
-----------------
The number of people having chronic diseases and the demand for palliative care has increased. The factors that have an impact on length of stay and discharge of patient who were admitted to palliative care center will be investigated.

Detailed Description
-----------------
Adult patients admitted to the Diskapi Yildirim Beyazit Teaching and Research Hospitals Palliative Care Unit between August 2018 and September 2020 and discharged to their home will be retrospectively evaluated. Patient's age, gender, diagnosis, conditions/comorbidities, Karnofsky Performance Scale, discharge status (death, intensive care unit or at home), gastrostomy status, presence of tracheostomy and/or mechanical ventilation, nutritional status (total parenteral nutrition or enteral nutrition), pressure ulcers, the lowest and highest recorded hemoglobin concentration, white blood cell count and serum sodium concentration and the education level of the patient and the caregiver will be recorded. Patients will be grouped according to length of stay (LOS) as Group 1: discharged in equal or less than 21 days or Group 2: Prolonged discharged in longer than 21 days and analysed accordingly

Official Title
-----------------
Clinical Characteristics and Discharge Assessment of Patients in a Recent Founded Palliative Care Unit

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Discharged ≤ 21 days
* Other: Prolonged discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult patients admitted to the palliative care unit Exclusion Criteria: • Patients not consenting to participate the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Group 1<br>Discharged from palliative care unit in equal or less than 21 days | Other: Discharged ≤ 21 days<br>* Discharged from palliative care unit in equal less than 21 days<br>|
| Group 2: Prolonged discharged in longer than 21 days<br>Discharged from palliative care unit in longer than 21 days | Other: Prolonged discharge<br>* Discharged from palliative care unit in longer than 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay will be determined after discharge | 24 hours after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical illness, Palliative care, Length of stay
Abundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. The investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. The purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of NAFLD.

Official Title
-----------------
Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

Conditions
-----------------
Nonalcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 year of age Undergoing elective abdominal or bariatric surgery May have normal or elevated ALT/AST levels Exclusion Criteria: Presence of viral hepatitis Significant alcohol use Intercurrent infections Use of any thiazolidinediones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese, bariatric surgery, liver biopsy<br>Obese subjects approved and scheduled for bariatric surgery at Vanderbilt University Medical Center | |
| Normal BMI, abdominal surgery, liver biopsy<br>Normal weight subjects having elective abdominal surgery at Vanderbilt University Medical Center. | |
| Liver transplantation donors and recipients<br>All livers made available for implantation or explantation will be eligible. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify and relatively quantify, using high performance liquid chromatography electrospray ionization mass spectrometry, select lipids and proteins present in human liver biopsies. |  | 2 years | 
| To spatially profile, using matrix assisted laser desorption ionization time of flight mass spectrometry, select lipids and proteins present in human liver biopsies. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), Obesity, Lipidomics, Proteomics
Flaxseed Mucilage and Satiety

Study Overview
=================
Brief Summary
-----------------
The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets will be tested in term of their effect on appetite sensation measured using visual analogue scales over 120 minutes and ad libitum energy intake hereafter in two studies.

Detailed Description
-----------------
Study I: Control drink vs. Flaxseed drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured. Study II: Flaxseed drink vs. Flaxseed tablets+control drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Official Title
-----------------
Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake

Conditions
-----------------
Appetite

Intervention / Treatment
-----------------
* Dietary Supplement: Flaxseed drink
* Dietary Supplement: Flaxseed drink
* Dietary Supplement: Flaxseed tablet
* Dietary Supplement: Control drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults 18-40 years BMI 19-28 Exclusion Criteria: smoking pregnancy or lactation excessive exercise medication (oral contraceptives the only exception)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Study I: control drink<br> | Dietary Supplement: Control drink<br>* Control drink<br>|
| Experimental: Study I: flaxseed drink<br> | Dietary Supplement: Flaxseed drink<br>* Drink containing flaxseed mucilage<br>|
| Active Comparator: Study II: flaxseed drink<br> | Dietary Supplement: Flaxseed drink<br>* Drink containing flaxseed mucilage<br>|
| Experimental: Study II: flaxseed tablets<br> | Dietary Supplement: Flaxseed tablet<br>* Tablets containing flaxseed mucilage consumed with a control drink<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite sensation | Appetite sensation measured by visual analogue scales | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake | Ad libitum energy intake at the next meal | 120 minutes |
The Mini-Screw as Orthodontic Anchoring: Survival, Clinical Efficiency and Experience of the Patient

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial to evaluate the mini-screw as orthodontic anchoring. This trial will study implant survival, clinical efficiency and experience of the patient.

Official Title
-----------------
The Mini-Screw as Orthodontic Anchoring: A Clinical Trial to Study Survival, Clinical Efficiency and Experience of the Patient

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Procedure: Placement of the mini-screw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-70 years of age

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Placement of the mini-screw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient opinion |  |  | 
| Efficacy of treatment |  |  |