linjc16/ctgov huggingface dataset:
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Investigate if low carb diet could increase serum testosterone level in hypogonadic men

Detailed Description
-----------------
Randomized controlled trial to evaluate the effect of low carb diet in men with metabolic syndrome and low testosterone level. The inclusion criteria is men with metabolic syndrome and serum total testosterone below 300 ng/dL. They will randomized to perform a low carb diet or a traditional low fat diet for metabolic syndrome. The follow up will be of three months with a once a month visit. Even though these men will be looked at their sexuality and life style. They will be monitoring by urologists and nutritionists during the study.

Official Title
-----------------
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome

Conditions
-----------------
Testosterone Deficiency, Metabolic Syndrome, Diet Modification

Intervention / Treatment
-----------------
* Behavioral: low carb diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome, serum testosterone level below 300 ng/dL Exclusion Criteria: active cancer, diet allergies, psychological incapability

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>low carb diet | Behavioral: low carb diet<br>* low carb diet<br>|
| No Intervention: Control<br>traditional low fat diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| testosterone | serum total testosterone level | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF 5 | International Index of Erectile Function 5 | three months | 
| AMS | Age male Symptom score | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low carb diet, hypogonadism, metabolic syndrome
The Effects of Glucomannan on Weight Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the herb, Glucomannan, is an effective non-pharmacological appetite suppressant for overweight or Class I obese patients. The study design will not include any other lifestyle changes which enhance weight loss in order to completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Glucomannan
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Subjects will be recruited based upon the category of them wanting to lose 50 pounds. Subjects must be able to swallow the capsule whole with water. Exclusion Criteria: Self-reported use of prescription medication other than hormonal birth control (such as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.) Pregnancy Age younger than 21 or older than 60 years of age. Screening for hypertension during the first laboratory visit that reveals a systole greater than 120 and a diastole greater than 90. BMI calculations based upon height and weight measurements at the first laboratory visit that reveal a BMI less than 25 or greater than 35. Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gucomannan<br> | Dietary Supplement: Glucomannan<br>* 750 MG of Glucomannan in capsule form<br>|
| Placebo Comparator: Placebo pill<br> | Other: Placebo<br>* 750 mg of Cellulose powder in a capsule form<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Overweight, Glucomannan
Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital

Study Overview
=================
Brief Summary
-----------------
The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and children in Assiut University Children Hospital using skin prick test and specific serum IgE

Detailed Description
-----------------
Food allergy is a reproducible specific immune response to the exposure to a given food. Cow's milk protein allergy (CMPA) is a clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal., 2010) . According to the European Academy for Allergy and Clinical Immunology (EAACI) and the World Allergy Organization (WAO), a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA.There is difference between CMPA and non-allergic cow's milk intolerance (e.glactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal ., 2013) . CMPA is categorized into immunoglobulin IgE mediated, non-IgE mediated, or mixed CMPA(Sichereretal ., 2001) . 1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of <1% in children aged ≥6 years(Koletzkoetal ., 2012) .

Official Title
-----------------
Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University

Conditions
-----------------
Cow Milk Allergy

Intervention / Treatment
-----------------
* Diagnostic Test: skin prick test - specific serum IgE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age : from first day of life - 2 years exclusively breast feeding,breast-fed infants with supplementary foods and non-breast-fed infants with supplementary foods who complain from either frequentregurgitation,vomiting,diarrhea,constipation)with/without perianal rash),bloodin stool or pallor. Exclusion Criteria: Infant and child with gastrointestinal symptoms due to specific aetiology .

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: skin prick test - specific serum IgE|The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and children in Assiut University Children Hospital using skin prick test and specificserumIgE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of cow's milk protein allergy | The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and children in Assiut University Children Hospital using skin prick test and specificserumIgE | baseline |
Halodine Nasal Antiseptic in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.

Detailed Description
-----------------
This is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial nasopharyngeal samples will then be collected at specified time points after the application. All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.

Official Title
-----------------
A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19

Conditions
-----------------
SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized with COVID-19 Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment Exclusion Criteria: Allergies to iodine-containing compounds

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halodine Nasal Antiseptic<br>Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP Single topical administration | Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP<br>* Single topical administration<br>* Other names: Halodine Nasal Antiseptic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasopharyngeal SARS-CoV-2 Viral Load | Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2 | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal SARS-CoV-2 Viral Load
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Study Overview
=================
Brief Summary
-----------------
A clinical study designed to validate the TrueLabor™ device in monitoring Fetal Heart Rate and Uterine Activity during labor, vs. current standard of care

Official Title
-----------------
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study

Conditions
-----------------
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor (Diagnosis), Uterine Contractions, Obstetric Complication

Intervention / Treatment
-----------------
* Device: TrueLabor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are on >=37w0d of gestation Maternal age > 18 years old Singleton pregnancy Cephalic presentation Patient requiring internal monitoring for obstetric indications Informed consent Exclusion Criteria: Major fetal anomalies Patients with implanted electronic devices of any kind Patients using exterior electronic devices of any kind during the procedure Patients with irritated skin or open wound on the abdominal wall

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cohort<br>Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications | Device: TrueLabor<br>* Non invasive monitoring device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive percent agreement (PPA) compared to Gold Standard | A positive percent agreement (PPA) with Gold Standard | Through labor, until delivery | 
| Sensitivity and specificity compared to Gold Standard | Sensitivity and Specificity compared to Gold Standard | Through labor, until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BMI | Accuracy per BMI subgroup | Through labor, until delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal Heart Rate, Uterine Activity, TrueLabor, OB Tools, Non invasive monitoring
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.

Official Title
-----------------
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines

Conditions
-----------------
Pneumococcal Infections, Meningococcal Infections

Intervention / Treatment
-----------------
* Biological: menjugate
* Biological: Men C conjugate vaccine
* Biological: Men C conjugate
* Biological: Men C Conjugate
* Biological: Men C conjugate
* Biological: Men C conjugate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from parent or legal guardian of infant Age 7-11 weeks at first dose Exclusion Criteria: Any contraindications to vaccination as specified in the UK Handbook Immunisation Against Infectious Disease (Ed 1996) < 7 weeks or > 11 weeks at first dose

Ages Eligible for Study
-----------------
Minimum Age: 7 Weeks
Maximum Age: 11 Weeks

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: Vaccine schedule 1<br>Menjugate vaccine at 2 and 3 months | Biological: menjugate<br>* men C conjugate vaccine<br>|
| Experimental: Vaccine schedule 2<br>Menjugate vaccine at 2 and 4 months | Biological: Men C conjugate vaccine<br>* men C conjugate vaccine<br>|
| Experimental: vaccine schedule3<br>Neissvacc at 2 and 3 months | Biological: Men C conjugate<br>* men C conjugate vaccine<br>|
| Experimental: vaccine schedule 4<br>Neissvacc at 2 and 4 months | Biological: Men C Conjugate<br>* men C conjugate vaccine<br>|
| Experimental: Vaccine schedule 5<br>Meningitec at 2 and 3 months | Biological: Men C conjugate<br>* men C conjugate vaccine<br>|
| Experimental: Vaccine schedule 6<br>Meningitec at 2 and 4 months | Biological: Men C conjugate<br>* men C conjugate vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | SBA men C responses | 3 months after last sample | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Streptococcus pneumoniae, Neisseria meningitidis
Hernia Repair in Multiply Morbid Patients

Study Overview
=================
Brief Summary
-----------------
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.

Official Title
-----------------
A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)
* Device: Proceed Surgical Mesh (Hernia repair)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of either gender must have 2 or more co-morbidities Exclusion Criteria: local or systemic infection expected survival of <24 months non-ambulatory

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strattice Reconstructive Tissue Matrix<br>Use of Strattice Reconstructive Tissue Matrix to support hernia repair | Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)<br>* Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.<br>|
| Active Comparator: Proceed Surgical Mesh<br>Use of Proceed Surgical Mesh to support hernia repair | Device: Proceed Surgical Mesh (Hernia repair)<br>* Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Site Events (SSEs) |  | Postoperative Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hernia repair, surgical mesh, co-morbidities
Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test

Study Overview
=================
Brief Summary
-----------------
To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma. Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.

Official Title
-----------------
Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 15-60 years, male or female. Mild to moderate persistent asthma. Mini AQLQ score ≤6 or ACQ score ≥1. Giving written informed consent. Exclusion Criteria: Current smoker or quitted smoking ≤12 months. Significant allergen exposure. Respiratory tract infection within 2 weeks before or during the study. Cardiovascular disease. History of malignant disease within the preceding 5 years. And/or concomitant pulmonary disease. Pregnant or breast-feed period. Use of leukotrienes receptor antagonist within 5 days

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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 |
| --- | --- |
| montelukast，vitamin C pill<br>leukotriene receptor antagonist:(montelukast)，montelukast (10 mg, once per night)，56 days vitamin C pill:100mg，once per night，56 days | |
| montelukast, vitamin C pill<br>montelukast:10 mg, once per night，56 days vitamin C pill:100mg，once per night，56 days | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether there was improvement in pre-challenge FEV1% | The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control. | from commencement of LTRA therapy to (7±2) days and (56±5) days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether there was improvement in post- treatment FENO | In Logistic regression model, whether there was improvement shown in post-treatment FENO as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. FENO represented fractional exhaled nitric oxide above. | from commencement of LTRA therapy to (7±2) days and (56±5) days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leukotriene, leukotriene receptor antagonist