linjc16/ctgov huggingface dataset:
Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

Study Overview
=================
Brief Summary
-----------------
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.

Official Title
-----------------
Do Epidurals Placed at a Lower Level Improve Labour Analgesia

Conditions
-----------------
Labor Analgesia

Intervention / Treatment
-----------------
* Procedure: epidural placed low
* Procedure: high epidural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women in active labor Exclusion Criteria: known contraindications to epidural analgesia moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher. known abnormalities of the spinal column any neurologic illness multiple gestations, fetal abnormalities or fetal presentation other than vertex recent history of analgesic usage an inability to communicate in English or French Body Mass Index greater than 40 patients in pain requesting an immediate epidural

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low epidural<br>epidural placed in the lower lumbar vertebral column | Procedure: epidural placed low<br>* epidural placed low<br>|
| Experimental: high epidural<br>high epidural | Procedure: high epidural<br>* high epidural<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of epidural medication boluses required |  | 30 minutes and 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labour progress |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidural, labour analgesia
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)

Study Overview
=================
Brief Summary
-----------------
Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: TD-5108


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet ROME III Criteria Exclusion Criteria: Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function Chronic treatment with anticholinergics, narcotic analgesics Irritable Bowel Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: TD-5108|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Clinical response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, chronic, bowel function
A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS

Study Overview
=================
Brief Summary
-----------------
Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about 20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment of refractory low-risk MDS.

Detailed Description
-----------------
Patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments have to live on transfusions which lead to poor quality of life (QoL) and survival. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases both endogenous EPO and iron metabolism, has shown promising results in several phase 3 clinical trials for chronic kidney disease. Roxadustat comprehensively improves iron metabolism by upregulating DCYTB and DMT1 through the HIF pathway, which can promote the iron absorption and utilization. Detail mechanisms include upregulating transferrin receptors to increase iron uptake, upregulating transferrin to promote iron transport and downregulating ferritin levels to indirectly improve iron absorption and transportation. Patients with refractory low-risk MDS were selected and given roxadustat 150mg po qod combined with retinoic acid 20mg po bid.

Official Title
-----------------
A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Roxadustat in combination with retinoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-risk MDS unresponsive to first-line therapy Exclusion Criteria: myelofibrosis Severe heart and kidney function bu'quan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roxadustat combined with retinoic acid group<br> | Drug: Roxadustat in combination with retinoic acid<br>* Roxadustat 150mg po qod combined with retinoic acid 20mg po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate (OR) | Complete and partial remission with roxadustat combined with retinoic acid. Partial remission includes freedom from transfusion dependence or reduction in transfusion volume within 8 weeks | 3, 6 months |
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an important role in mediating neuroanatomical plasticity and functional recovery following traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma Score and prognosis of such patients with traumatic brain injury.

Official Title
-----------------
Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who suffered head trauma and whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) Patients who delivered to hospital within 4 h Exclusion Criteria: Patients who suffered open injuries Patients who had existing prior neurological disease Patients whose serial serum samples could not be obtained Patients less than 18 years of age Patients who suffered severe life-threatening injury to organs other than the brain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Traumatic brain injury<br>Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated traumatic brain injury cases and were included in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale scores | Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome was defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome was defined as a Glasgow Outcome Scale score of > 3. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nogo-A, Traumatic brain injury, Neuroglobin, Prognosis
Effects of Drugs on Responses to Brain and Emotional Processes

Study Overview
=================
Brief Summary
-----------------
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits

Official Title
-----------------
Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits

Conditions
-----------------
Healthy, Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Drug: MDMA
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19 and 30 (no one under 130 lbs) Smokers smoking less than 25 cigarettes per week Have used ecstasy no more than 40 times with no adverse responses. Exclusion Criteria: High blood pressure Any medical condition requiring regular medication Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis Individuals with a history of dependence on stimulant drugs. Women who are pregnant or trying to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo Then MDMA<br>Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg) | Drug: MDMA<br>* Participants will be given 1.5mg/kg of MDMA<br>Drug: Placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|
| Experimental: MDMA Then Placebo<br>Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo. | Drug: MDMA<br>* Participants will be given 1.5mg/kg of MDMA<br>Drug: Placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in responses to affective touch | Participants will complete an affective touch task during which time they will rate pleasantness of touch | time 0 and approximately six weeks later |
ADI-PEG in Patients With Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Detailed Description
-----------------
The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life. In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Official Title
-----------------
Phase I Testing of ADI-PEG in Metastatic Melanoma

Conditions
-----------------
Melanoma, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ADI PEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically confirmed metastatic melanoma Nonresectable disease Measurable or evaluable disease Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy Recovered from prior surgery Karnofsky performance status 70 or higher Expected survival of at least 12 weeks Bilirubin less than 2.0 mg/dL Albumin greater than 3.0 g/dL SGOT less than 5 times upper limit of normal (ULN) Alkaline phosphatase less than 5 times ULN Ammonia less than 55 microg/dL Glucose greater than 60 mg/dL Amylase less than 1.5 times ULN Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Patients must use 2 forms of effective contraception Exclusion criteria: Prior therapy within the past 4 weeks Ascites or pleural effusion Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease) Pregnant or nursing Concurrent enrollment in another IND study Serious infection requiring antibiotics
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ADI PEG|nan|

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
-----------------
Dose-Response Relationship, Drug, Polyethylene Glycol, Arginine Deiminase
Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence in Belgium of Fabry disease in patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to determine in Fabry patients which was the most frequently initial symptom. Actually the early diagnosis is important because a treatment exists that can prevent future complications.

Conditions
-----------------
Left Ventricular Hypertrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unexplained left ventricular hypertrophy Exclusion Criteria: isolated septal hypertrophy

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation |  | 1 day |
Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Study Overview
=================
Brief Summary
-----------------
This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.

Official Title
-----------------
A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Drug: MultiHance
* Drug: Magnevist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent At least 18 yrs of age Moderate to severe peripheral arterial disease Willing to undergo two MRA procedures within 14 days Exclusion Criteria: Pregnant or lactating Known allergies to one or more ingredients in the products Therapeutic intervention in the arterial territory of interest between the two MRA exams Changes in symptoms between the two exams Vascular stent in area of interest Severe claustrophobia Congestive heart failure class IV Scheduled to undergo surgery for PAOD between the two exams Scheduled to undergo DSA between the two exams

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MultiHance MRI contrast agent | Drug: MultiHance<br>* 0.5 mmol/kg as a single dose administration<br>|
| Active Comparator: 2<br>Magnevist contrast agent for MRA | Drug: Magnevist<br>* 0.5 mmol/kg as a single dose administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of global paired diagnostic preference of the two MRA exams |  | Post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization |  | post dose |
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

Study Overview
=================
Brief Summary
-----------------
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge. Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.

Official Title
-----------------
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

Conditions
-----------------
Patient's Outcome Prognostic Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: they were older than 18 years presented FL at diagnosis (Grade 1, 2, or 3a). received high-dose therapy (HDT) with ASCT from 2000 to 2014 Exclusion Criteria: they had already been treated with a 1st ASCT, had a previous history of histological transformation before ASCT if they were rituximab naive prior to ASCT.

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 |
| --- | --- | --- |
| Survival after relapse (SAR) post ASCT in follicular lymphoma | Factors that predicted SAR | Year 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Transformation at relapse | A biopsy was performed at the first relapse or progression after ASCT. | Year 6 | 
| treatment of relapse | Chemotherapy, radiotherapy… | Year 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous stem cell transplantation, rituximab, Follicular Lymphoma, prognosis