linjc16/ctgov huggingface dataset:
The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection

Study Overview
=================
Brief Summary
-----------------
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .

Detailed Description
-----------------
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.

Official Title
-----------------
Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Colchicine Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia. Exclusion Criteria: Patient who is not willing to enter in study Known hypersensitivity to colchicine Hepatic failure Renal failure with eGFR<20 ml/min

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment | Drug: Colchicine Tablets<br>* 1.5 mg loading then 0.5 mg BID P.O<br>* Other names: Colchicine;|
| No Intervention: Standard treatment<br>40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRPxN/R ratio change | increasing inflammatory status | 2 weeks | 
| Clinical deterioration by the WHO definition | including change in fever or O2 Saturation | 2 weeks | 
| PCR Viral Load | change in RT-PCR | 2 weeks | 
| CT severity involvement index | change in CT involvement | 2weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDH change | change in LDH | 2 weeks |
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with   7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.

Conditions
-----------------
Nephrocalcinosis

Intervention / Treatment
-----------------
* Drug: Alkaline citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants < 32 weeks gestation age and < 1500 g birth weight Exclusion Criteria: Cardial, renal or gastrointestinal malformations Chronic renal failure Therapy with vitamin B6 High dose treatment with furosemide or dexamethasone Addison's disease Severe metabolic alkalosis Worse clinical condition of preterm infant, which makes oral feeding impossible Participation in other studies

Ages Eligible for Study
-----------------
Minimum Age: 5 Days
Maximum Age: 8 Weeks

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alkaline citrate|Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of nephrocalcinosis | Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration. | First eight weeks of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in urinary citrate excretion | Increase in urinary citrate excretion under prophylactic treatment | First eight weeks of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nephrocalcinosis, premature infants, hypocitraturia, alcaline citrate therapy, Nephrocalcinosis in premature infants
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.

Official Title
-----------------
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: CSG452


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed. Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening. Subject meets all other inclusion criteria outlined in the clinical study protocol Exclusion Criteria: Subject has clinically relevant abnormalities at Screening or at Check-in assessments. Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug. Subject does not meet any other exclusion criteria outlined in the clinical study protocol.

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

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

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

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: K-877 & CSG452<br>K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15 | Drug: K-877<br>* K-877 tablets<br>Drug: CSG452<br>* CSG452 tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | 0 to 24 hours |
Recovery of Serum Creatinine at Discharge Impacts Mortality

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to assess the mortality in the in-hospital patients who have elevated serum creatinine. A registry of patients with increased serum creatinine during hospital was conducted at the Guangdong General Hospital from January 1st, 2007 to December 30th, 2013. The primary clinical outcome is all-cause mortality, followed from the date of hospital discharge to Dec 30th 2018. Patients were divided into three groups, according to the serum creatinine recovery ratio (discharge/max serum creatinine). All-cause mortality, including the date of death, was identified from the electronic hospitalization data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record of registration required by law in China. Baseline characteristics, including primary disease diagnosis, blood pressure, major treatment, drug use and et al, were collected. Demographic data were collected from the electronic hospitalization data and electronic hospital discharge records. All co-morbid conditions were identified using International Statistical Classification of Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic hospital discharge records.

Official Title
-----------------
Recovery of Serum Creatinine at Discharge Impacts Mortality, Long-term and Short-term

Conditions
-----------------
Kidney; Functional Disturbance

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-hospital patients in Guangdong General Hospital in 2007 Age>=18y Patients with increased serum creatinine during hospital Exclusion Criteria: Death during hospital Diagnosed with End-stage renal disease given the renal replace therapy during hospital

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 |
| --- | --- |
| kidney function recovery<br>the registry and follow up of consecutive patients with increased serum creatinine during hospital in 2007 | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | all-cause mortality | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recovery, serum creatinine
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.

Official Title
-----------------
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects

Conditions
-----------------
Postprandial Lipaemia, Postprandial Incretins, Postprandial Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Casein
* Dietary Supplement: Whey Isolate
* Dietary Supplement: Whey Hydrolysate
* Dietary Supplement: Alphalact-Albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 kg/m2 & <45 kg/m2 Exclusion Criteria: Diabetes lipid lowering drugs Liver-, Kidney- and/or Heart Disease Serious Hypertension (160/110)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Casein<br> | Dietary Supplement: Casein<br> <br> |
| Active Comparator: Whey Isolate<br> | Dietary Supplement: Whey Isolate<br> <br> |
| Active Comparator: Whey Hydrolysate<br> | Dietary Supplement: Whey Hydrolysate<br> <br> |
| Active Comparator: Alphalact-Albumin<br> | Dietary Supplement: Alphalact-Albumin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride |  | 0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretins |  | 0h -1h -2h -4h -6h -7h -8h Postprandial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins
Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up. The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.

Official Title
-----------------
Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012

Conditions
-----------------
Persistent Polyclonal B-Cell Lymphocytosis

Intervention / Treatment
-----------------
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PPBL diagnosis established during a previous medical visit 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPBL patients<br> | Biological: Blood test<br>* 30 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relevant medical history |  | Baseline | 
| Complete blood count |  | Baseline | 
| Administration of first-line treatment or not |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocyte phenotype |  | Baseline |
Using Social Media to Enhance the Impact of the Teen Outreach Program

Study Overview
=================
Brief Summary
-----------------
The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.

Official Title
-----------------
Using Social Media to Enhance the Impact of the Teen Outreach Program

Conditions
-----------------
Pregnancy Prevention

Intervention / Treatment
-----------------
* Behavioral: Teen Outreach Program with Media Enhancement (TOP4ME)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: boys and girls club member in metro Denver, age 14-18 Exclusion Criteria: non-english speaking

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOP Program plus Text messaging<br>Boys and Girls Club members who participate in TOP over 9 months will receive regular text messages in addition to TOP | Behavioral: Teen Outreach Program with Media Enhancement (TOP4ME)<br>* Persons participating in TOP will receive text messages weekly in addition to TOP<br>* Other names: Youth All Engaged! (YAE!);|
| No Intervention: TOP Program alone<br>Boys and Girls Club participants will participate in TOP for 9 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy |  | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| school drop out |  | 21 months |
Study of Bone Disease in Older HIV-infected Adults

Study Overview
=================
Brief Summary
-----------------
This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones. The purposes of this study are: to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center to see what are the common causes of bone disease in older HIV infected persons to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.

Official Title
-----------------
A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults

Conditions
-----------------
Osteopenia, Osteoporosis, HIV Infection, Aging, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infection documented by ELISA and confirmed by western blot Treatment with antiretroviral drugs for at least 12 months Age 50-70 years CD4 count > 350 cells/mm3 for at least 6 months HIV-RNA undetectable (< 75 copies/ml for at least 6 months) Exclusion Criteria: Known bone disease (primary or metastatic malignancy, osteomalacia) Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D [> 800 IU daily]).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| HIV older than 50 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment experienced
Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction

Study Overview
=================
Brief Summary
-----------------
Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction

Detailed Description
-----------------
Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS. Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.

Conditions
-----------------
Subclinical Hypothyroidism, Hyperthyroidism, Thyroid Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with subclinical hypothyroidism or hyperthyroidism patients with thyroid nodules and normal thyroid function Exclusion Criteria: patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone patients who had thyroid surgery or radioiodine therapy patients with NYHA class 3 or 4 heart failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>patients with subclinical hypothyroidism | |
| B<br>patients with subclinical hyperthyroidism | |
| C<br>patient with normal thyroid function. | |

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
-----------------
hypothyroidism, hyperthyroidism, thyroid dysfunction, ultrasound, doppler