linjc16/ctgov huggingface dataset:
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More

Study Overview
=================
Brief Summary
-----------------
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. Goal: The aim of the current study is to find out if these respiratory complications extend to later life. Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.

Detailed Description
-----------------
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results. Goal: The aim of the current study is to find out if these respiratory complications extend to later life. Method: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist.

Official Title
-----------------
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More

Conditions
-----------------
Respiratory Complications

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have. Exclusion Criteria: Children with respiratory congenital defect that was not known at the first week of life.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 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 |
| --- | --- |
| 37-38 weeks<br>Children who were born by elective Cesarean section after 37-38 gestational weeks. Intervention: No intervention. | Other: No intervention<br>* No intervention<br>|
| 39 week or more<br>Children who were born by elective Cesarean section after 39 gestational weeks or more Intervention: No intervention. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There are respiratory complications. | Respiratory complications are defined as any of: asthma, inhalation therapy, systemic steroids therapy, consultation by a pulmonologist | Age 4-8 years |
Effects of Virtual Reality Based Training on Posture Stability in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The present study is to examine the effects of a virtual reality based balance training using the Kinect sensor on postural stability and functional balance in individuals with Parkinson's disease.

Official Title
-----------------
Effects of Virtual Reality Based Training on Posture Stability in Individuals With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Virtual reality based intervention
* Behavioral: Conventional intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hoehn and Yahr stages I through III A score of more than or equal to 24 on the mini-mental state examination Stable medication usage Freedom from any other problems that might affect training Exclusion Criteria: Unstable medical conditions Histories of other diseases known to interfere with participation in the study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality based intervention<br>Virtual reality based balance training | Behavioral: Virtual reality based intervention<br>* Virtual reality based balance training<br>|
| Active Comparator: Conventional intervention<br>Conventional balance training | Behavioral: Conventional intervention<br>* Conventional balance training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limits of stability test |  | Change from Baseline at 8 weeks | 
| One-leg stance test |  | Change from Baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale |  | Change from Baseline at 8 weeks | 
| Timed up and go test |  | Change from Baseline at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Postural Stability, Balance Training, Parkinson's Disease
Study of Intensive Care Units in India

Study Overview
=================
Brief Summary
-----------------
There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most of the available data comes from single centre studies. There is a dire need to have data from Indian ICUs to reflect the vast spectrum of critical care illness, services and practices. INDICAPS planned to collect data of all patients in the ICU on one particular day, and four such days spread throughout a one-year period were selected: the second Wednesday of July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the country as possible were asked to participate. The investigators aimed to gather information about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic modalities used, types of infections,mortality rates, etc.

Detailed Description
-----------------
The following information will be analysed: Case-mix, severity of illness, prevalence of infection, hemodynamic monitoring and therapy, mechanical ventilation practices, nutrition and outcome Seasonal and regional variations in the above Epidemiology and variations in antibiotic use Patterns of microorganisms and outcome Prevalence and outcome of specific tropical febrile illnesses, including malaria, dengue fever, leptospirosis, scrub typhus Prevalence and outcome of toxins and poisonings Relation of ICU and hospital organizational issues to prevalence of infection and outcome Organisation of intensive care services End of life - Ethical decisions

Official Title
-----------------
Indian Intensive Care Case Mix and Practice Patterns Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br>All patients present in the ICU on the selected days | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of stay | Stay in ICU till 30 days | 30 days | 
| Hospital length of stay | Stay in hospital till 30 days | 30 days | 
| Hospital survival | Survival at hospital discharge or at 30 days | 30 days |
Feasibility Clinical Study of NLA Tool-US

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

Detailed Description
-----------------
Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status; Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength and endurance performance (33% +/- 10% of target group)

Official Title
-----------------
Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 65 and 90 years, able to walk with or without walking aid, having obtained the subject's written informed consent free of cognitive impairment (3MSE), Exclusion Criteria: self reported restriction to exercise(by a physician or other). unable to carry out performance tests and questionnaires correctly, self reported lower or upper extremity surgery or fracture in the last 3 months self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment uncontrolled hypertension (>150/90 mm Hg) self reported congestive heart failure unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| NLA feasibility | Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the average time required for completing the NLA | Measure the time required to complete the NLA. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Independent living, walk with or without walking aids
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain

Study Overview
=================
Brief Summary
-----------------
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: lower segment cesarean section and double lock closure of rectus sheath
* Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first cesarean section Exclusion Criteria: urgent cesarean section previous abdominal surgery previous cesarean section obstetric and medical complications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group a<br>This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath. | Procedure: lower segment cesarean section and double lock closure of rectus sheath<br> <br> |
| Active Comparator: group b<br>This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath. | Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheath<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain evaluated by VAS |  | first week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  | intraoperative |
Renal Replacement Therapy in Neonates

Study Overview
=================
Brief Summary
-----------------
The circumstances for setting up dialysis in the neonatal period are multiple: congenital anomaly of the kidney and urinary tract (CAKUT), secondary acute renal failure whose etiologies are multiple (sepsis, hypovolemia, respiratory distress syndrome, neonatal asphyxia, Arterial or venous renal thrombosis, nephrotoxic drugs, etc.), metabolic diseases (mainly hyperammonemia and leucinosis) and post-operative management of heart disease: analysis of the characteristics of the patients in our study and comparison with existing epidemiological data in the literature. The decision to set up dialysis in a newborn whose recovery of renal function is uncertain or in a context of acute multi-visceral failure is not always obvious and must be discussed carefully. multidisciplinary in connection with neonatologists, resuscitators and nephrologists as well as families with the consideration of the future quality of life of the child.

Official Title
-----------------
Renal Replacement Therapy in Neonates : a Retrospective Monocentric Cohort Study

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Minor under 28 days old Having benefited from a renal purification technique in the pediatric intensive care unit of the University Hospital of Strasbourg Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes. Exclusion criteria: - Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| Description of clinical characteristics of patients, survival and technical modalities of dialysis in children undergoing neonatal dialysis at the Strasbourg University Hospital |  | Files analysed retrospectively from January 01, 2010 to December 31, 2021 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal, Dialysis, Extra-renal purification, Neonatal resuscitation
Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

Detailed Description
-----------------
The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit. The question of immunotherapy's imputability in the acute disease is becoming more frequent.

Official Title
-----------------
Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.

Conditions
-----------------
Cancer, Critical Illness, Immunotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = 18 years old; with a solid tumor; Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping; Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason. Exclusion Criteria: Minors; Pregnant or lactating woman; Admission after surgery of a scheduled surgery or for the security of procedure; Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months; Subject under guardianship or deprivation of liberty; Refusal of consent; No affiliation to a health insurance scheme.

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 |
| --- | --- | --- |
| To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy. | Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy | At ICU discharge (maximum 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care. | immunosuppressive treatments in intensive care unit | At ICU discharge (maximum 30 days) | 
| Description of ICU survival | ICU survival | At ICU discharge (maximum 60 days) | 
| Description of hospital survival | Hospital survival | At hospital discharge (maximum 60 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, intensive care unit, checkpoint inhibitors, adverse event
Study of ZIO-201 in Advanced Sarcoma

Study Overview
=================
Brief Summary
-----------------
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.

Official Title
-----------------
A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma

Conditions
-----------------
Advanced Sarcoma

Intervention / Treatment
-----------------
* Drug: ZIO-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Metastatic and /or unresectable disease state after previous standard chemotherapy

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: ZIO-201<br>* ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | 6 months |
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Study Overview
=================
Brief Summary
-----------------
This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Detailed Description
-----------------
Study Design:

Official Title
-----------------
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Have at least 1 year of enrolment in the electronic database. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dabigatran etexilate<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions. Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF. SPAF:Stroke & systemic embolism in adult patients with non-valvular AF | Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015. |