linjc16/ctgov huggingface dataset:
Effectiveness of the Routine Use of Extubation Protocol on the Incidence of Occurrence of Failures Number of Extubation in Pediatric Resuscitation

Study Overview
=================
Brief Summary
-----------------
The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor). The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened. Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes. Exclusion Criteria: Refusal to participate in the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Failure of extubation |  | need for a new intubation within the first 48 hours after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extubation, pediatric resuscitation, reintubation, failures of extubation.
SLV308 for Treatment of Patients With Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease

Conditions
-----------------
Early Stage Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: pardoprunox
* Drug: Pardoprunox
* Drug: Pardoprunox
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's Disease, Early stage of disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) 10 at baseline. Exclusion Criteria: Diagnosis is unclear or a suspicion of other parkinsonian syndromes, Patients who have undergone surgery for the treatment of PD, Presence of dyskinesias, Motor fluctuations or loss of postural reflexes, Clinically significant abnormalities, Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total), Antipsychotic.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: 1<br> | Drug: pardoprunox<br>* fixed dose 6 mg<br>|
| Experimental: 2<br> | Drug: Pardoprunox<br>* fixed dose 12 mg<br>|
| Experimental: 3<br> | Drug: Pardoprunox<br>* 12-42mg<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.

Official Title
-----------------
A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia

Conditions
-----------------
Acquired Aplastic Anemia.

Intervention / Treatment
-----------------
* Drug: Thymoglobulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acquired aplastic anemia Age: younger than 70 years old Severity: SAA, VSAA. Interval between diagnosis and registration <6 months. Written informed consent from the caretakers and/or whenever possible consent from the patient. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 69 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 |
| --- | --- |
| Experimental: 2.5 mg/kg/day of Thymoglobulin for 5 days<br>2.5 mg/kg/day of Thymoglobulin for 5 days | Drug: Thymoglobulin<br> <br> |
| Active Comparator: 3.5 mg/kg/day of Thymoglobulin for 5 days<br>3.5 mg/kg/day of Thymoglobulin for 5 days | Drug: Thymoglobulin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST. |  | day 180 after the start of IST |
Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation

Study Overview
=================
Brief Summary
-----------------
Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.

Official Title
-----------------
Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women

Conditions
-----------------
Focus of Study is Amino Acid Appearace in Blood

Intervention / Treatment
-----------------
* Dietary Supplement: Bacillus subtilis DE111
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-34 years old Participants must have at least 1 year of resistance training experience. Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire. Are free of musculoskeletal injuries Are not taking medications that may interfere with study measurements Exclusion Criteria: Taking any other nutritional supplement or performance enhancing drug. Any chronic illness that causes continuous medical care Taking any other nutritional supplement or performance enhancing drug. Any chronic illness that causes continuous medical care.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days | Dietary Supplement: Bacillus subtilis DE111<br>* 1 x10-9 CFU Bacillus subtilis DE111 probiotic<br>|
| Placebo Comparator: Placebo<br>Maltodextrin placebo was consumed for 28-days | Dietary Supplement: Placebo<br>* Maltodextrin placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Amino Acid response | We measured plasma amino acid concentrations before and after the 28-day intervention | 28-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis. | 28-days |
Proteomic Analysis of HLA Complex in Solid Cancers: Breast, Ovary, Colon, Rectum, Stomach, and Pancreas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

Detailed Description
-----------------
The main objective of the study is to evaluate which proteins are presented by the HLA complex of solid tumors. Secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. Real specimens will be evaluated using PCR and mass spectrometry.

Official Title
-----------------
Proteomic Analysis of Serology and Peptides Presented on the HLA Complex of Breast, Ovarian, Colon, Rectal, Gastric and Pancreatic Adenocarcinoma.

Conditions
-----------------
Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas Exclusion Criteria: Withdrawal of consent Small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation
Sexes Eligible for Study
-----------------
All

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
-----------------
proteomics of solid tumors
Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity: A Prospective Self-controlled Trial Comparing Hilotherapy With Frozen Gloves in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The prevention of taxane-related toxicities at the extremities is highly important for patients' treatment and quality-of-life. Unlike standard cryotherapy with frozen gloves, hilotherapy produces cooling at a constant temperature. Comparative data with frozen gloves are unavailable. This prospective self-controlled study explores the efficacy of hilotherapy at the right hand and foot compared to frozen gloves at the left in patients with early breast cancer treated with weekly paclitaxel 80 mg/m² or three-weekly docetaxel 75 mg/m².

Official Title
-----------------
Hilotherapy vs Frozen Gloves for Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: hilotherapy
* Device: frozen gloves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: adult (≥18 years) patients with breast cancer treated with weekly paclitaxel 80 mg/m² (12 cycles) or three-weekly docetaxel 75 mg/m² (4 or 6 cycles) in an adjuvant or neo-adjuvant setting. Exclusion criteria: peripheral neuropathy or pain in the extremities at baseline, regardless of whether this was related to a prior chemotherapy treatment or another condition Raynaud's phenomenon, cold intolerance or any condition to the nails or peripheral blood vessels that could pose a risk to the compliance with the study interventions insufficient understanding of the Dutch language for self-reporting the side-effects under investigation Patients were excluded from the analysis if they received less than two thirds of planned treatment cycles, for other reasons than the side-effects investigated in this study.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hilotherapy<br> | Device: hilotherapy<br>* continuous cooling of hands and feet at a constant temperature<br>|
| Active Comparator: frozen gloves<br> | Device: frozen gloves<br>* cooling of hands and feet using frozen gloves<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities) |  | 24 weeks |
Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

Detailed Description
-----------------
according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Official Title
-----------------
Non Interventional Study in Slovak Patients With Primary Open Angle Glaucoma and/or Ocular Hypertension Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy Due to Ineffectivity or Intolerance.

Conditions
-----------------
Glaucoma, Open-angle

Intervention / Treatment
-----------------
* Drug: Xalacom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary open angle glaucoma ocular hypertension age >18 years Exclusion Criteria: bradycardia obstructive pulmonary disease hypersensitivity to the drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Xalacom treatment<br>patients with primary glaucoma | Drug: Xalacom<br>* Xalacom 1 drop into the affected eye daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ocular hyperemia |  | 12 months | 
| safety of treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness in IOP lowering |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, open-angle, non-interventional study, safety, tolerability
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Study Overview
=================
Brief Summary
-----------------
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.

Official Title
-----------------
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Conditions
-----------------
Colon Cancer, Lymph Node, Sentinel Node

Intervention / Treatment
-----------------
* Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colectomy for Non metastatic colon cancer Exclusion Criteria: Tumor T4 No medical insurance Pregnant woman Psychiatric disorders

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 |
| --- | --- |
| Patients<br> | Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between immunochemistry and molecular biology | The primary outcome is the rate of concordance between the number of positive sentinel lymph nodes detected by immunochemistry using an anti-cytokeratin antibody (KL1) and molecular biology targeting CK20 on tumoral RNA after RT-PCR. The rate of positivity of the sentinel lymph nodes will be then compared to the standard technique using HES coloration used in routine pathological examination. Only the result using the routine examination will be used to decide whether the patient should benefit from an adjuvant chemotherapy. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, sentinel node
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

Official Title
-----------------
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks
* Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip Has a history of treatment with NSAIDs with positive therapeutic benefit Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity Females who are able to have children must have negative urine pregnancy tests Exclusion Criteria: Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months Requires joint replacement

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks|nan|
|Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study drug will be safe and well tolerated during the course of the study. |  |  |
Neural Correlates of an Olive Oil Essence

Study Overview
=================
Brief Summary
-----------------
The aim of the current study was to investigate the effect of a low fat meal in comparison to a low fat meal dosed with the fatfree essence of olive oil.

Conditions
-----------------
Neural Correlated of Different Foods

Intervention / Treatment
-----------------
* Dietary Supplement: low fat vs. essence yoghurt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male heatly Exclusion Criteria: lactose intolerance fMRI cotraindications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 33 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: yoghurt type<br>low fat yoghurt vs. essence yoghurt | Dietary Supplement: low fat vs. essence yoghurt<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in brain activity (cerebral blood flow change after yogurt intake) |  | 30 minutes before as well as 30 minutes and 120 minutes after yoghurt intake |