linjc16/ctgov huggingface dataset:
Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients

Study Overview
=================
Brief Summary
-----------------
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.

Official Title
-----------------
Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Procedure: Bone Marrow Transplantation
* Procedure: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose of Acute lymphoblastic leukemia Age between 16 to 50 year New case of ALL Exclusion Criteria: Primary CNS involvement Primary Testis involvement Previously treated

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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: Bone Marrow Transplantation<br> | Procedure: Bone Marrow Transplantation<br>* Allogenic Bone Marrow Transplantation<br>|
| Active Comparator: Chemotherapy<br> | Procedure: Chemotherapy<br>* Cyclophosphamide 1200 mg/m2 D15 Daunorubicin 45 mg/m2 D15-D18 Vincristine 1 mg/m2 D15, D22 Dexamethasone 24 mg/d D12-D28<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival after BMT compare with chemotherapy. |  | 1 year | 
| Disease Free Survival after BMT compare with chemotherapy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, BMT, Chemotherapy, Allogenic
An Observational Study Investigating the Positioning of Epidural Catheters and Their Function During Labour Analgesia

Study Overview
=================
Brief Summary
-----------------
This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function during labour. This information may be useful in guiding the physicians responses to epidurals that do not provide adequate analgesia to aid in deciding on the most appropriate action

Official Title
-----------------
An Observational Study Investigating the Influence of Physical Position of Epidural Catheters and Their Function During Labour Analgesia

Conditions
-----------------
Labour Analgesia, Epidural Anaesthesia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any women in labour requesting epidural anaesthesia Exclusion Criteria: none
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women during labour<br>Women receiving lumbar epidural anaesthesia for pain during birth | Other: No intervention<br>* Retrospective observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Position of epidural catheter | the structural form of the epidural catheter will be noted | directly after removal of the epidural | 
| Analgesia effectiveness | All women will be asked about the effectiveness of the epidural catheter during birth | directly after removal of the epidural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary caesarean section | the proportion of epidurals that were subsequently used for a caesarean section | directly after removal of the epidural | 
| Impact on motor function | the effect of the epidural catheter on leg strength and the ability of women to ambulate | directly after removal of the epidural |
Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.

Detailed Description
-----------------
Aims are to measure Macrophage Migration Inhibitory Factor, Macrophage Migration Inhibitory Factor II and its' soluble receptor CD74 in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.

Official Title
-----------------
Changes of Macrophage Migration Inhibitory Factor and Thyroid Hormones During Liver Transplantation. Association With Graft Dysfunction

Conditions
-----------------
Evidence of Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage liver disease, chronic liver failure, orthotopic liver transplantation Exclusion Criteria: Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 undergoing OLT<br>Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine |  | 24 months |
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine if dronabinol is effective in preventing or treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS patients

Official Title
-----------------
A Double-Blind, Randomized, Parallel-Group, Pilot Study of Oral Dronabinol Versus Placebo in the Treatment or Prevention of Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting

Conditions
-----------------
Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting, HIV Infections

Intervention / Treatment
-----------------
* Drug: Dronabinol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adherence to prior or current HAART was or is being compromised, or HAART was discontinued/interrupted due to nausea/vomiting; or beginning HAART or switching from a regimen at the time of screening for this study that did not produce significant nausea and/or vomiting to a regimen with zidovudine or a protease inhibitor (with or without low dose ritonavir). Exclusion Criteria: Subjects with recent (within 30 days of randomization) or current opportunistic infection or neoplasm characteristic of AIDS (Category C of the CDC Classification System for HIV-1 infection, 1993 Revised Version).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dronabinol<br>* 2.5 mg to 40 mg<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes vomiting/retching |  | 2 weeks | 
| Duration of nausea, vomiting/retching |  | 2 weeks | 
| Intensity of nausea by VAS |  | 2 weeks | 
| Appetite stimulation by VAS |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections
The Effect of Paracetamol on Brain Temperature

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo. The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.

Official Title
-----------------
NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 18-year or older patients Patient hospitalized in neuro-critical care for: Arachnoid hemorrhage Intra parenchymatous hematoma stroke Acute brain Severe injury Post-operative complication of an act of neurosurgery or programmed neuroradiology Sedation and mechanical ventilation planned > 2 days Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®) Brain temperature > 38.5°C for more than 30 minutes Exclusion Criteria Known hypersensitivity to paracetamol or mannitol (excipient with known effect) Severe hepatocellular insufficiency (ASAT or ALAT > 5N, or bilirubin > 2N) Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours. Pregnant or breastfeeding women Previous participation 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol (acetaminophen)<br>patient will receive1 gramme of paracetamol intravenously | Drug: Paracetamol<br>* >50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose >50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose<br>* Other names: acetaminophen;|
| Placebo Comparator: Placebo<br>patient will receive 100 ml of chlorure de sodium 0,9% intravenously | Drug: Placebo<br>* 100mL of chlorure de sodium 0.9% administred intravenously. 1 dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group) | measurement of intracerebral temperature in degrees | Six hours after administration of treatment |
Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses

Study Overview
=================
Brief Summary
-----------------
Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

Detailed Description
-----------------
A non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. Pretests and follow up will contain objective outcome assessments and semi-structured interviews.

Official Title
-----------------
Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.

Conditions
-----------------
Amputation, Traumatic, Prosthesis User

Intervention / Treatment
-----------------
* Device: smartskin non-invasive sensory feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acquired forearm amputation Exclusion Criteria: 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sensory feedback<br>A non-invasive air-mediated sensory feedback system embedded in the prosthesis socket. Group description: Individuals with acquired forearm amputation. | Device: smartskin non-invasive sensory feedback<br>* The sensory feedback system used was a simple non-invasive, non-electronic system based on air-mediated pressure. A silicone glove with bulbs (35 mm in length) volar in every fingertip was made and applied on a VariPlus Speed hand (OttoBock), size 7¾. The sensory feedback system was embedded in the prosthetic socket.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Myoelectric Control - ACMC | An observational assessment where you rate the subjects' capacity of myoelectric control in a bimanual activity. The scoring was made by an experienced external rater. | 2 days | 
| Task performance questionnaire | 21 questions about sensory feedback from the prosthesis, agency, body ownership, performance in activity and phantom limb pain. Self-administered estimation on a 7 grade Likert-scale. | 2 days | 
| Pointing task | A objective measurement of body ownership. The subject are asked to mark on a ruler, with the hand prosthesis hidden, where they estimate the location of the prosthetic index finger. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand prosthesis, sensory feedback, amputation, upper limb
Deep Brain Stimulation and Digestive Symptomatology

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure. Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility. Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite. Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.

Official Title
-----------------
Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Electrode implantation for deep brain stimulation in progress Age <70 yr Motor fluctuations and dyskinesias Motor symptoms improvement with L-dopa > 50% No dementia No depression No major psychiatric symptom Normal brain MRI Exclusion Criteria: Contra-indication of neurosurgery Pregnancy Diabetes Obesity Compulsive eating disorders Organic digestive disease Gastrointestinal resection Prokinetic treatment Coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| the gastric emptying measurement with the 13C-octanoic acid breath test |  | M0 and M6 |
Evaluation of Atorvastatin Treatment on Carotid Plaque.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.

Official Title
-----------------
A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with measurable carotid plaque with lipid and are eligible for statin therapy. Exclusion Criteria: Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL, Subjects currently on high dose statin, and Subjects with contraindications for MRI or statin therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg. |  |  | 
| Comparison of effect of atorvastatin 80mg versus 10mg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US. |  |  | 
| Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology. |  |  | 
| Correlation of biomarkers to carotid changes. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.

Study Overview
=================
Brief Summary
-----------------
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.

Official Title
-----------------
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth

Conditions
-----------------
Pulpotomies Primary Teeth, Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth

Intervention / Treatment
-----------------
* Procedure: MedCem MTA pulpotomies in primary teeth.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children with Asymptomatic primary molars with a deep carious lesion; Exposure of a vital pulp by caries; No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract; Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedCem MTA pulpotomies<br> | Procedure: MedCem MTA pulpotomies in primary teeth.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of MedCem MTA pulpotomy in primary molar | No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction. | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulpotomy, MTA, primary teeth, formocresol