linjc16/ctgov huggingface dataset:
Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis

Study Overview
=================
Brief Summary
-----------------
This study will examine the effect of cesarean section on perinatal mortality, using data provided by the Canadian Institute for Health Information.

Detailed Description
-----------------
This study will examine administrative data provided by the Canadian Institute for Health Information (CIHI). Maternal obstetrical delivery and neonatal hospitalization records provided by CIHI will be linked before analysis. The primary outcome is in-hospital perinatal mortality. The data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the Generalized Method of Moments. The instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. All analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.

Official Title
-----------------
Substantial Variability Between Traditional and Instrumental Variable Estimates of the Risk of Caesarean Section in Canada: a Population-based Cohort Study

Conditions
-----------------
Pregnancy Complications, Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Cesarean Section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers living in Canada and their infants delivering within the study period at Canadian hospitals outside of the province of Quebec. Exclusion Criteria: Maternal record not linkable to neonatal record. Multiple gestation. Birthweight < 500 gm. Gestational age at delivery < 20 weeks. Deliveries at hospitals with less than 20 cesarean deliveries during study period. Records with missing data for important covariates
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean<br>Mothers delivered by cesarean section | Procedure: Cesarean Section<br> <br> |
| Vaginal<br>Mothers delivered by vaginal delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal Mortality | Includes deaths at any age if infant continuously hospitalized (including transfers) in an acute care facility. Includes deaths up to 7 days of age if infant discharged from hospital then readmitted prior to 7 days of age. | up to 7 days |
Covid-19 at the Regional Medical Center Metz-Thionville: a Descriptive Study

Study Overview
=================
Brief Summary
-----------------
France and especially the region Grand Est have been damaged by the COVID-19 pandemic. This pandemic resulted in a reorganization of the hospitalization sectors. In order to better understand the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient data. This study would notably allow us to identify some prognostic factors. The main objective of this study is to identify individual factors that are associated with a poor prognosis (with ICU admission or death).

Official Title
-----------------
Coronavirus Disease 2019 (Covid-19) at the Regional Hospital Center Metz-Thionville: a Descriptive Study

Conditions
-----------------
COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized in COVID Unit at the Regional Hospital Center Metz-Thionville during the COVID 19 pandemic PCR positive or COVID confirmed with clinical evidence and CT scan Exclusion Criteria: Patients not willing to participate via using their medical files Patient transferred after a brief stay in another hospital
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 |
| --- | --- | --- |
| ICU admission | Number of ICU admission during the hospitalization | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | The duration of the hospitalization | Day 1 | 
| Length of stay at the ICU | The duration of stay at the ICU | Day 1 | 
| Death | The occurrence of death during the stay | Day 1 | 
| CT scan result | Evocative CT scan result | Day 1 | 
| C reactive protein | C reactive protein value | Day 1 | 
| Blood Count | Blood Count value | Day 1 | 
| Sodium | Sodium value | Day 1 | 
| Urea | Urea value | Day 1 | 
| Troponine | Troponine value via biological data | Day 1 | 
| Liver function | Transaminases value | Day 1 | 
| Coagulation test | Quick test result | Day 1 | 
| Creatinine | creatinine value | day 1 | 
| Clearance | creatinine clearance value | day 1 | 
| Potassium | potassium value | day 1 | 
| Calcium | calcium value | day 1 | 
| Gamma-glutamyl transpeptidase | Gamma-glutamyl transpeptidase value | day 1 | 
| Bilirubine | Bilirubine value | day 1 | 
| Alcaline phosphatase | Alcaline phosphatase value | Day 1 | 
| Prothrombine | Prothrombine value | Day 1 |
The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.

Official Title
-----------------
The Effect Of Probiotics From Kimchi (CJLP243) On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer: A Pilot Randomized Controlled Trial

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: CJLP243
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-75 with rectal cancer s/p low anterior resection (double stapled anastomosis) Exclusion Criteria: Metastatic cancer Pregnancy Valvular heart disease s/p intersphincteric resection (index surgery) h/o anastomotic leakage (index surgery) medically unfit (cardiopulmonary dysfunction, sepsis etc)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>2 g sachet (CJLP 243) once a day for 3 weeks 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous) | Dietary Supplement: CJLP243<br>* Perioperative administration till postoperative weeks 3<br>|
| Placebo Comparator: Control<br>2g sachet (near identically appearing placebo) once day for 3 weeks maltodextrin, glucose(anhydrous) | Dietary Supplement: Placebo<br>* Perioperative administration till postoperative weeks 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memorial Sloan Kettering Cancer Center bowel function index | Subscale: frequency score | Postoperative weeks 3 | 
| Low Anterior Resection Syndrome score |  | Postoperative weeks 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memorial Sloan Kettering Cancer Center bowel function index |  | Postoperative week 1 | 
| Low Anterior Resection Syndrome score |  | Postoperative week 1 | 
| Change of bowel functions index |  | Between postoperative week 1 to 3 | 
| EORTC C30 |  | Postoperative week 1 and 3 | 
| EORTC CR (Colorectal) 29 |  | Postoperative week 1 and 3 | 
| Postoperative complication |  | till Postoperative weeks 3 |
Does the TOOKIE Vest Reduce Line Fall Out Rate in Children?

Study Overview
=================
Brief Summary
-----------------
The objective of the trial is to assess whether the TOOKIE vest is an effective intervention in reducing line fall out. All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest.

Detailed Description
-----------------
All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest. Lines will be studied for the duration they are in situ. This will vary depending on the underlying diagnosis and treatment regime. One hundred central line insertions for oncology patients will be prospectively identified and be given the TOOKIE Vest to wear. Data will be collated for each group regarding age, gender, diagnosis, type of central access inserted, duration of line, reason for removal, in cases of infection the infected organism will be documented, date of each fall out.

Official Title
-----------------
A Prospective Study to Assess Whether the Tookie Vest for Oncology Reduces Central Line Fall Out Rate in the Paediatric Oncology Population

Conditions
-----------------
Childhood Cancer

Intervention / Treatment
-----------------
* Device: Tookie Vest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child receiving treatment for malignancy at Royal Manchester Children's Hospital Patients with a tunnelled central line inserted for treatment of their malignancy Exclusion Criteria: • Any child having a portacath inserted as their mode of central access

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tookie vest<br>Participant issued with Tookie vest | Device: Tookie Vest<br>* Tookie Vest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central line fall out rate |  | approximately 1 year |
B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

Official Title
-----------------
Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major

Conditions
-----------------
Asplenia, β-thalassemia Major

Intervention / Treatment
-----------------
* Biological: PCV13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asplenia β-thalassemia major older than 18 years Exclusion Criteria: no previously recorded allergy to PCV no intravenous immunoglobulin (IVIG) given within the previous 6 months no other vaccine given within the previous 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: PCV13<br> | Biological: PCV13<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot) |  | One month post-PCV13 | 
| immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot) |  | one month post PCV13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of B memory cells three years after PCV13 vaccination |  | three years after study vaccination |
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.

Official Title
-----------------
Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions

Conditions
-----------------
Bioequivalency

Intervention / Treatment
-----------------
* Drug: Naproxen Tablets, 500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women, non-smoker, 18 years of age or older willing to participate and sign a copy of the informed consent form Exclusion Criteria: clinically significant illnesses or surgery within 4 weeks prior to study dosing body mass index greater than or equal to 30.0 recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs history or known presence of gastrointestinal ulceration, bleeding and perforation use of tobacco products within 6 months prior to study dosing evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant receipt of any drugs as part of a research study within 30 days prior to study dosing

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Product<br> | Drug: Naproxen Tablets, 500 mg<br> <br> |
| Active Comparator: Reference Product<br> | Drug: Naproxen Tablets, 500 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalency, Naproxen
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Official Title
-----------------
An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy

Conditions
-----------------
Parathyroid Carcinoma, Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: KHK7580


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Personally submitted written voluntary informed consent to participate in the study Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. Corrected serum calcium level is > 11.3 mg/dL at screening. Exclusion Criteria: Patients receiving cinacalcet hydrochloride within 2 weeks before screening Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. Severe heart disease Severe hepatic dysfunction Uncontrolled hypertension and/or diabetes Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening

Ages Eligible for Study
-----------------
Minimum Age: 20 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: KHK7580<br>oral administration | Drug: KHK7580<br>* oral administration<br>* Other names: evocalcet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase. |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase. |  | up to 24 weeks | 
| Serum Corrected Ca Level |  | up to 52 weeks | 
| Serum Intact Parathyroid Hormone Level |  | up to 52 weeks | 
| Serum Whole Parathyroid Hormone Level |  | up to 52 weeks |
To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug

Study Overview
=================
Brief Summary
-----------------
SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment of respiratory infections. The purpose of this study is to estimate the bioavailability of four different formulations and to evaluate the safety of each of the four formulations

Official Title
-----------------
An Open-Label, Randomized, Crossover Study to Estimate the Formulation Effect on the Relative Bioavailability of Single Dose Oral SB-742510 in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by a responsible physician, based on medical evaluations performed at screening. Healthy adults between 18 and 60 years of age, inclusive. Body weight proportional to height. Capable of giving written informed consent. Female subjects must be of non-childbearing potential. QTc less than 450 msec at screening Exclusion Criteria: Any clinically relevant abnormality identified on the screening history and physical or on the 12-lead surface electrocardiogram at screening or pre-dose. The subject has a positive pre-study alcohol/urine drug screen. History of regular use of tobacco, or nicotine-containing products. A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening. Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements. An unwillingness to comply with lifestyle and/or dietary restrictions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
healthy volunteer,, Bioavailability,, safety, Phase I,
Infection Surveillance in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to investigate and quantify known and possible new riskfactors for nosocomiel infection and death in the intensive care setting. As new riskfactors Mannose Binding Lechtin and Procalcitonin are chosen and compared to established riskfactors.

Conditions
-----------------
Infection, Pneumonia, Sepsis, Cross Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Admission to ICU - Exclusion Criteria:Absence of informed consent and age less than 18 years -

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |