linjc16/ctgov huggingface dataset:
Role of Intermittent Fasting Before ICSI

Study Overview
=================
Brief Summary
-----------------
intermittent fasting could have a role in infertility

Detailed Description
-----------------
intermittent fasting could have a role in infertility and could adjust the body weight before ICSI

Official Title
-----------------
Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: intermittent fasting 4 months before ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with infertility Exclusion Criteria: ovarian factor or uterine factor of infertility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intermittent fasting<br>intermittent fasting before ICSI | Other: intermittent fasting 4 months before ICSI<br>* women will start intermittent fasting before starting ICSI by 4 months<br>|
| Placebo Comparator: No intermittent fasting<br>Usual diet | Other: intermittent fasting 4 months before ICSI<br>* women will start intermittent fasting before starting ICSI by 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will have positive pregnancy test after ICSI | The women who will get pregnant after ICSI with positive pregnancy test | within 6 months |
Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.

Study Overview
=================
Brief Summary
-----------------
this is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism in female patients with peripartum cardiomyopathy.

Official Title
-----------------
FDNC5 Genetic Polymorphism in Patients With Peripartum Cardiomyopathy

Conditions
-----------------
Peripartum Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy Exclusion Criteria: Age less than 18 or more than 45 year old females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Diseased<br>Females with peripartum cardiomyopathy | |
| Control<br>Healthy females | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irisin level | detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl) | 4 months | 
| FNDC5 Genotyping | whether homogenetic or heterogenetic | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripartum Cardiomyopathy, Irisin
Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder

Study Overview
=================
Brief Summary
-----------------
The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.

Conditions
-----------------
Tendonitis, Bursitis

Intervention / Treatment
-----------------
* Drug: Betamethasone Sodium Phosphate
* Drug: 1 cc - Betamethasone Sodium Phosphate
* Drug: 2 cc - Betamethasone Sodium Phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subacromial bursitis tendinitis Calcific Tendonitis Exclusion Criteria: rotator cuff tear osteoarthritis pregnancy local or systemic infection steroid or lidocaine sensitivity

Ages Eligible for Study
-----------------
Minimum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 cc - Betamethasone Sodium Phosphate<br>1 cc - Betamethasone Sodium Phosphate | Drug: Betamethasone Sodium Phosphate<br>* 1cc:2cc<br>* Other names: diprospan;Drug: 1 cc - Betamethasone Sodium Phosphate<br>* Betamethasone Sodium Phosphate<br>* Other names: diprospan;|
| Active Comparator: 2 cc - Betamethasone Sodium Phosphate<br>2 cc - Betamethasone Sodium Phosphate | Drug: Betamethasone Sodium Phosphate<br>* 1cc:2cc<br>* Other names: diprospan;Drug: 2 cc - Betamethasone Sodium Phosphate<br>* Betamethasone Sodium Phosphate<br>* Other names: diprospan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| constant score |  | 9 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder, subacromion, corticosteroid, bursitis, tendinitis, calcific tendonitis, subacromial bursitis, rotator cuff tendinitis
FRailty Among Elderly Emergency Department Patients With Outcome Measures

Study Overview
=================
Brief Summary
-----------------
Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS), Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F), which can potentially be adopted for daily practice in the busy ED. It is timely as we projected that we will be seeing more elderly patients attending the ED for various medical and surgical conditions. Their attendance at the ED would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.

Official Title
-----------------
FRailty Among Elderly Emergency Department Patients With Outcome Measures

Conditions
-----------------
Geriatric, Frailty, Emergency Department

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Elderly patients aged 65 years and above attending ED irrespective of reason for attendance. Exclusion Criteria: Haemodynamically unstable patients Inability to obtain informed consent Inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers) Vulnerable populations (e.g. prisoners) Patients who are planned for hospital admission from the ED

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| 1-month Adverse Event Occurrence (composite) | Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality | At 1 month after index ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month Adverse Event Occurrence (composite) | Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality | At 3 months after index ED visit |
Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

Study Overview
=================
Brief Summary
-----------------
This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months

Official Title
-----------------
A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Influenza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry Exclusion Criteria: Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period. Known or suspected impairment/alteration of immune function History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Children, Vaccine
The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital. The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting mixed growth.

Official Title
-----------------
The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Other: reporting of two different bacteria in urine culture
* Other: reporting mixed growth on urine culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture Exclusion Criteria: Positive blood cultures or no blood cultures taken

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reporting on two bacteria in urine culture<br>The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture | Other: reporting of two different bacteria in urine culture<br>* reporting of two different bacteria in urine culture<br>|
| Placebo Comparator: reporting mixed growth<br>The microbiology laboratory will report on mixed growth in urine culture | Other: reporting mixed growth on urine culture<br>* reporting mixed growth on urine culture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of antibiotic treatment |  | During the episode of urinary tract infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to clinical resolution |  | Duration of urinary tract infection and duration of hospitalization | 
| Increase/decrease in the spectrum of antibiotic |  | Duration of urinary tract infection and duration of hospitalization | 
| Length of stay in hospital |  | Duration of urinary tract infection and duration of hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary tract infection with two bacteria in culture
Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Detailed Description
-----------------
OBJECTIVES: Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum. Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum. Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site. OUTLINE: This is a pilot study. Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

Official Title
-----------------
Gene Expression Profiling of Metastatic Colon Cancer (CCCWFU 89B03)

Conditions
-----------------
Colorectal Cancer, Metastatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 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 |
| --- | --- |
| patients with metastatic colon cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression changes that occur at each metastatic site (i.e., liver, lungs, and peritoneum) |  | day 1 | 
| Development of cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV colon cancer, liver metastases, lung metastases, recurrent colon cancer
Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

Official Title
-----------------
Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants

Conditions
-----------------
Necrotizing Enterocolitis, Very Low Birth Weight Infants

Intervention / Treatment
-----------------
* Drug: Lactobacillus reuteri
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infants < 1500 gr Gestational age < 32 weeks Exclusion Criteria: Genetic anomalies Short bowel syndrome Not willing to participate Allergy to Lactobacillus reuteri components

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus reuteri<br>Lactobacillus reuteri 100 million CFU/day for 3 months | Drug: Lactobacillus reuteri<br>* Lactobacillus reuteri 100 million CFU/day for 3 months<br>* Other names: BioGaia;|
| Placebo Comparator: Control<br>Placebo for 3 months | Drug: Placebo<br>* Placebo for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants | NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Lactobacillus reuteri on culture proved sepsis | Patients with culture positivity will accept as proven sepsis. | up to 6 months | 
| Effect of Lactobacillus reuteri on weight gain | The infants will be weight daily on scales that will calibrated weekly. | up to 6 months | 
| Effect of Lactobacillus reuteri on length of hospital stay | Specified length of hospital stay as days | up to 6 months |
Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Study Overview
=================
Brief Summary
-----------------
Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

Detailed Description
-----------------
The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease. The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.

Official Title
-----------------
Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Conditions
-----------------
Posterior Urethral Valves

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound; megabladder confirmed in a second ultrasound; collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin; written informed consent. Exclusion Criteria: refusal to participate in the study; person protected by law.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal/patient survival at 2 years post-natally. | Defined by the need for dialysis or death. | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function of the survivors at day 4 and 6 and 12 month post-natally. | This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis. | Year 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal function, post natal, peptidome