linjc16/ctgov huggingface dataset:
REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy

Study Overview
=================
Brief Summary
-----------------
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.

Official Title
-----------------
REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy

Conditions
-----------------
Coagulopathy, Hemorrhage

Intervention / Treatment
-----------------
* Biological: Prothrombin Complex Concentrate
* Biological: Whole Blood, Plasma, Packed Red Blood Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥15 years old anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2 Exclusion Criteria: Cardiopulmonary Resuscitation > 5 minutes Penetrating cranial injury or exposed brain matter Anticoagulation treatment Transfer patients Known pregnancy Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 15 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: PCC<br>single dose of 4-Factor PCC in addition to standard resuscitation methods | Biological: Prothrombin Complex Concentrate<br>* single dose of 25 IU/kg of 4-PCC at time of enrollment<br>|
| Active Comparator: Standard of Care<br>standard resuscitation methods only | Biological: Whole Blood, Plasma, Packed Red Blood Cells<br>* site's standard resuscitation protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Mortality | Assess if patient is alive at 24 hours post treatment | 24 hours after enrollment |
LRRK2 G2385R Leucocyte and Urine Biomarker Study

Study Overview
=================
Brief Summary
-----------------
Given the emerging evidence on LRRK2-related biomarkers, this project will focus on identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using immunoblotting and mass spectrometry.

Official Title
-----------------
Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: This is a non-interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's disease assigned by a movement disorder specialist according to clinical diagnostic criteria Age above 18 year-old Provision of a written informed consent Exclusion Criteria: - Physical or mental incapacity to complete study protocol

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients positive for LRRK2 G2385R<br> | Other: This is a non-interventional study<br>* This is a non-interventional study<br>|
| PD patients negative for LRRK2 G2385R<br> | Other: This is a non-interventional study<br>* This is a non-interventional study<br>|
| Non-PD controls negative for LRRK2 G2385R<br> | Other: This is a non-interventional study<br>* This is a non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of monocyte-based biomarkers for LRRK2 G2385R variant |  | Two years | 
| Identification of urine-based biomarkers for LRRK2 G2385R variant |  | Two years |
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections). Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.

Official Title
-----------------
Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections

Conditions
-----------------
Infections, Child

Intervention / Treatment
-----------------
* Drug: telithromycin (HMR3647)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients of weight from 7.0 kg. For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings. For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings. For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: telithromycin (HMR3647)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Tract Infections, Skin Diseases, Sinusitis
DuoPACT Pilot Intervention

Study Overview
=================
Brief Summary
-----------------
The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention acceptability and feasibility.

Official Title
-----------------
Relationship Factors and HIV Treatment Adherence

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Behavioral: DuoPACT
* Behavioral: Life Steps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gay male couple. One or both partners must be HIV positive and on antiretroviral medications. Exclusion Criteria: Must be able to consent to and follow study protocol.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DuoPACT<br>A 6-session HIV medication adherence support program for couples. | Behavioral: DuoPACT<br>* Intervention sessions are administered weekly by a counselor.<br>|
| Active Comparator: Life Steps<br>A 3-session HIV medication adherence support program for individuals. | Behavioral: Life Steps<br>* Intervention sessions are administered weekly by a counselor.<br>|
| No Intervention: Treatment as usual (TAU)<br>HIV positive individuals will continue to follow their current HIV treatment plan. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the intervention | All participants are assessed post intervention to evaluate intervention satisfaction and acceptability. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | All participants are assessed post intervention to evaluate the study's feasibility. | 3 months |
Early Detection of Cognitive Dysfunction in Diabetes

Study Overview
=================
Brief Summary
-----------------
The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.There are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete.

Detailed Description
-----------------
Clinically relevant cognitive decrements in relation to diabetes mainly occur during two crucial periods in life: the period of brain development in childhood, and the period when the brain undergoes neurodegenerative changes associated with ageing.Potential leads for treatment are to optimise glycaemic control and avoid and treat vascular risk factors.we want to detecte early clinical dementia in diabete by MMSE and Olfactory function.

Official Title
-----------------
Study of Cognitive Dysfunction and Diabetes

Conditions
-----------------
Dementia, DM, MCI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes(Age>50 years) Exclusion Criteria: with stroke or other complications.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| control,MCI, Olfactory dsfunction<br>There are different groups:control,MCI, Olfactory dsfunction. | |
| control, MCI<br>control and MCI group.Glycaemic control | |
| control and MCI<br>treatment and without treatment | |
| MCI and Olfactory function<br>observation between MCI and Olfactory function groups. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE Olfactory function dementia | MMSE,Olfactory function and PET(fMRI) were observed. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Olfactory
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

Study Overview
=================
Brief Summary
-----------------
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed: Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test. Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

Detailed Description
-----------------
Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive). 22 SCI manual wheelchair users. 22 caregivers (healthy subjects)

Official Title
-----------------
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Device: SmartDrive assisting device
* Device: Standard manuel wheelchair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women aged between 18 and 70 years spinal cord injury having given free and informed consent Exclusion Criteria: No affiliation to a social security scheme Refusal to participate in the clinical trial Patient under guardianship Major cognitive disorder Bedsores Acute complication or systemic organ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spinal cord injury<br>use a wheelchair with and without a assisting device to power manuel wheelchair | Device: SmartDrive assisting device<br>* oxygen consumption<br>Device: Standard manuel wheelchair<br>* oxygen consumption<br>|
| Other: volunteer<br>push a wheelchair with and without a assisting device to power manuel wheelchair | Device: SmartDrive assisting device<br>* oxygen consumption<br>Device: Standard manuel wheelchair<br>* oxygen consumption<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of oxygen consumption per unit time (VO2) during propulsion |  | 30 minutes |
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).

Detailed Description
-----------------
A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk

Official Title
-----------------
Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk

Conditions
-----------------
Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative

Intervention / Treatment
-----------------
* Drug: GW597599


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known risk factors for PONV. Undergoing gynecological or gallbladder surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW597599|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative nausea and vomiting, PONV
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices

Study Overview
=================
Brief Summary
-----------------
zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.

Detailed Description
-----------------
Intra-thoracic impedance will be obtained at programmed intervals by using an investigational monitoring feature in the CRT-D device. To obtain impedance values, the device delivers a sub-threshold impulse that measures the resistance between 2 electrodes.

Official Title
-----------------
zWedge Clinical Feasibility IDE Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT-D (Intra-thoracic Impedance Monitoring)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a SJM PROMOTE CRT-D (Model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per ACC/AHA/HRS guidelines. Have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation. Have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar LV lead. Exclusion Criteria: Be less than 18 years of age. Have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia. Have a contraindication for right heart catheterization. Have a contraindication for the delivery of IV Nitroglycerin. Be pregnant or planning a pregnancy for the duration of their study participation. Be currently participating in a clinical investigation that includes an active treatment arm. Have a life expectancy of less than 12 months due to any condition. Be unable to perform the Valsalva maneuver with airway pressure > 40 mm Hg for ≥10 seconds. Are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.

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

| Intervention/Treatment |
| --- |
|Device: CRT-D (Intra-thoracic Impedance Monitoring)|Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.|

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
-----------------
Heart Failure, Impedance Monitoring, Wedge Pressure
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia. OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR. PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

Official Title
-----------------
Promoter Methylation in MLL-Rearranged Childhood AML

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: DNA methylation analysis
* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Available cryopreserved cells from diagnosis At least 2 x 10^7 viably cryopreserved cells One of the following biologically defined cytogenetics/molecular cohorts: t(9;11) t(11;19) Other 11q23 translocations Normal cytogenetics PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies