linjc16/ctgov huggingface dataset:
Substance Use and Fitness

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to estimate the effect size of a contingency management procedure that reinforces walking at rates consistent with the American College of Sports Medicine recommendations of 10,000 or more steps per day in older adults. We expect that participants randomized to the contingency management intervention will increase walking to a greater degree than those assigned to a standard care condition.

Official Title
-----------------
Substance Use and Fitness: A Pilot Study of Contingency Management in Older Adults

Conditions
-----------------
Substance Abuse, Exercise

Intervention / Treatment
-----------------
* Behavioral: contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 55 - 75 years currently not physically active willing and physically able as determined by physician approval to walk 10,000 steps per day blood pressure of 120-159 mmHg systolic or 80-99 mmHg diastolic willing to meet with research staff weekly for 12 weeks Exclusion Criteria: psychiatric or physical illness that could interfere with participation

Ages Eligible for Study
-----------------
Minimum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: walking recommendations<br>Participants assigned to this condition will be instructed to wear a pedometer daily and scheduled for weekly meetings over for the next 12 weeks. Each week, they will be congratulated if they walked the target goal on any days, and encouraged to meet the goals for the upcoming week. However, they will not receive any tangible reinforcement for walking. The meetings will be brief (about 15 minutes) and will include discussions and handouts related to the health benefits of walking. | |
| Experimental: contingency management for walking<br>Participants assigned to this condition will be asked to wear a pedometer daily and scheduled for weekly meetings over for the next 12 weeks. The meeting duration and structure will be similar to that in the standard treatment condition including the handouts, with one exception. Participants in this condition will earn tangible reinforcement in the form of prizes for walking the target number of steps per day. | Behavioral: contingency management<br>* Participants assigned to the experimental group will earn chances to win prizes if they have walked the recommended number of steps.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days on which participants walked the recommended number of steps |  | Weeks 1-12 |
Blood and Tumor Tissue Samples From Young Patients With Acute Myeloid Leukemia

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

Detailed Description
-----------------
OBJECTIVES: To evaluate Mer and Axl expression in samples from pediatric patients with acute myeloid leukemia (AML). To determine if abnormal expression of Mer and Axl is associated with poor clinical characteristics (e.g., induction failure or relapse) of AML in these patients. OUTLINE: This is a multicenter study. Archived samples from pediatric patients with acute myeloid leukemia are analyzed for Mer and Axl expression by flow cytometry and western blot assays.

Official Title
-----------------
Evaluation of Mer and Axl Expression in Acute Myeloid Leukemia Patient Samples

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

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: western blotting
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia Children Oncology Group (COG) patient samples PATIENT CHARACTERISTICS: Available clinical data PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: western blotting|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of Mer and Axl |  |  | 
| Association of abnormal expression of Mer and Axl with induction failure or relapse |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain. This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.

Official Title
-----------------
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Cyanoacryale
* Procedure: Suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included. Exclusion Criteria: Patients with bilateral or sliding inguinal hernia. incarcerated or strangulated hernia recurrent inguinal hernia femoral hernia patients unwilling to participate in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyanoacrylate<br>mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®). | Procedure: Cyanoacryale<br>* mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue<br>|
| Active Comparator: Suture<br>mesh fixation was done with polypropylene 2/0 sutures | Procedure: Suture<br>* mesh fixation was done with polypropylene 2/0 sutures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at 12 months after surgery | Pain assessed by visual pain scale from 0-10 | 12 months after hernia repair |
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Study Overview
=================
Brief Summary
-----------------
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Detailed Description
-----------------
Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.

Official Title
-----------------
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Conditions
-----------------
Hip Fracture, Delirium

Intervention / Treatment
-----------------
* Drug: Zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components Exclusion Criteria: Severe respiratory insufficiency

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of postoperative delirium |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality |  |  | 
| mobilization |  |  | 
| loss of functional ability |  |  | 
| length of stay |  |  | 
| sedation |  |  | 
| nocturnal nursing events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, delirium, sleep disturbance, hypnotic
Implementation of Work in Progress (WIP) Sequences in Magnetic Resonance Imaging (MRI)

Study Overview
=================
Brief Summary
-----------------
Trial of new work in progress (WIP) sequences in MRI.

Official Title
-----------------
Implementation of Work in Progress (WIP) Sequences in MRI

Conditions
-----------------
Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of ischemic or non ischemic cardiomyopathy Exclusion Criteria: claustrophobia irregular heart rhythm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| cardiac MRI<br>Ischemic cardiomyopathy, non ischemic cardiomyopathy, myocarditis, cardiomyopathy | |

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
-----------------
myocardium, Magnetic resonance imaging
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: UB-311
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild Alzheimer's Disease Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive) Clinical dementia rating (CDR) scores of 0.5 or 1 Other inclusion criteria apply Exclusion Criteria: Clinically significant neurological disease other than Alzheimer's disease Major psychiatric disorder Severe systemic disease Serious adverse reactions to any vaccine Other exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 priming doses followed by 4 boosters<br>Subjects will receive 7 doses of UB-311. | Biological: UB-311<br>* Intramuscular injection<br>|
| Experimental: 3 priming doses followed by 2 boosters<br>Subjects will receive 5 doses of UB-311 and 2 doses of placebo. | Biological: UB-311<br>* Intramuscular injection<br>Drug: Placebo<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo<br>Subjects will receive 7 doses of placebo. | Drug: Placebo<br>* Intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events | Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs. | 78 weeks |
Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study

Study Overview
=================
Brief Summary
-----------------
This feasibility study has therefore several aims: construct a dedicated CT perfusion protocol for GIT wall perfusion; used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model; from the image acquired, evaluate current parameters of perfusion including the permeability ones

Conditions
-----------------
Mesenteric Ischemia, Permeability CT Technics

Intervention / Treatment
-----------------
* Radiation: Dynamic contrast enhanced computerised tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution Exclusion Criteria: contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014 inability to provide informed consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic contrast enhanced computerised tomography<br> | Radiation: Dynamic contrast enhanced computerised tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of computerised tomography with interpretable data |  | 2 hours |
Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

Study Overview
=================
Brief Summary
-----------------
Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called Bannwarth syndrome. This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of definite NBL: (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.

Official Title
-----------------
Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

Conditions
-----------------
Lyme Borreliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject having consulted at the HUS between 01/01/2013 and 31/12/2018 Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research Exclusion criteria: Subject who expressed their opposition to participating in the study Subject under guardianship or curatorship Subject under safeguard of justice

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

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 |
| --- | --- | --- |
| Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases |  | Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme borreliosis, Lyme neuroborreliosis, Bannwarth syndrome, Intrathecal CXCL-13
G-CSF and PRP in Patients With Recurrent Implantation Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure

Official Title
-----------------
Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure

Conditions
-----------------
Infertility,Female

Intervention / Treatment
-----------------
* Drug: Granulocyte colony-stimulating factor and platelet-rich plasma group
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred Exclusion Criteria: Endometriosis Uterine anomalies Asherman syndrome

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 35 Years

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

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 |
| --- | --- |
| Active Comparator: Granulocyte colony-stimulating factor and platelet-rich plasma<br> | Drug: Granulocyte colony-stimulating factor and platelet-rich plasma group<br>* Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.<br>|
| Other: Control group<br> | Other: Control group<br>* Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Gestational sac detected by ultrasound examination | Five weeks after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Platelet-rich plasma, Granulocyte colony-stimulating factor, Recurrent implantation failure