linjc16/ctgov huggingface dataset:
Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).

Detailed Description
-----------------
Hydroxychloroquine (HCQ) is usually used in Patients with Systemic Lupus Erythematosus (SLE) in order to treat mainly arthralgia or skin manifestations of this disease. A few studies have previously shown that HCQ could also be useful for treating autoimmune cytopenia and particularly autoimmune thrombopenia associated with SLE. In this retrospective study, the investigators have selected patients followed in our center and who have received HCQ either for an authentic SLE or because they had positive antinuclear antibodies (> 1/160e on HEP2 cells) without a definite SLE according to the American College of Rheumatology. The main goal of this study is to compare the efficacy of HCQ in these two subgroups of patients.

Official Title
-----------------
Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients

Conditions
-----------------
Immune Thrombocytopenia, Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011 Positive antinuclear antibodies > 1/160e on Hep2 cells Exclusion Criteria: Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients achieving a response (Platelet count > 30x10^9/L and doubling of the baseline count) or a complete response (platelet count > 100x10^9/L for a t least 6 months) | Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Hydroxychloroquine | allergy, myopathy HCQ induced | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secondary ITP, hydroxychloroquine, Systemic Lupus Erythematosus
Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This study will perform a targeted metabolic analysis in blood and urine samples from subjects attending the Baylor AT&T Memory Center. The aim is to identify novel biomarkers that can distinguish normal aging subjects with no cognitive impairment from those with mild, moderate or severe cognitive impairment associated with Alzheimer's disease. Subjects will also be screened for B-vitamin deficiencies that may correlate with other metabolic biomarkers and Alzheimer's disease.

Detailed Description
-----------------
All subjects will be clinically assessed using standard measures of clinical care. Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA). Disease severity will be assessed by the Clinical Dementia Rating Scale (CDR). Social function will be assessed by the Functional Activities Questionnaire (FAQ). Based on clinical assessment, subjects will be classified into one of the following groups. Normal (Spouse or Caregiver) Mild cognitive impairment Alzheimer's disease A. Mild B. Moderate C. Severe The investigators plan to enroll 60 subjects in each group from 1 and 2; 40 subjects in each of the groups 3A and 3B and 20 subjects in group 3C.

Official Title
-----------------
Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease

Conditions
-----------------
Mild Cognitive Impairment, Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A. Both Males and females B. Patients at least 40-years of age C. Mild Cognitive Impairment D. Alzheimer 's disease Mild Moderate Severe Exclusion Criteria: A. No recent major surgery within the last 6 months B. Free of any malignant disease C. No chronic renal disease D. No other major neurodegenerative disorders (i.e. Parkinson's disease, multiple sclerosis)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Group 1 Normal<br>Spouse or Subject's caregiver. Blood and urine samples will be collected. | |
| Mild Cognitive Impairment<br>Subjects with MCI: Blood and urine samples will be collected. | |
| Alzheimer's disease<br>Subjects with Alzheimer's disease A. Mild B. Moderate C. Severe Blood and urine samples will be collected from these three sub-groups. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery of novel biomarkers that will lead to the early detection of Alzheimer's disease. | The primary goal of this proposal is to identify metabolic biomarkers in plasma and urine that can distinguish normal or mild cognitively impaired subjects from subjects at different severities of AD. | 6 months |
An Observational Study on the Sorin Group New Brady Leads XFine and Beflex

Study Overview
=================
Brief Summary
-----------------
This observational study is a non-interventional multi-centre, prospective study. The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances

Detailed Description
-----------------
The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant. Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.

Official Title
-----------------
Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice

Conditions
-----------------
Pacing Leads Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead. Included patients may receive more than one lead under evaluation. Exclusion Criteria: Any contraindication to endocavitary lead implantation; Inability to understand the purpose of the study or refusal to co-operate. Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan. Patient of minor age (<18) Pregnancy.

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 |
| --- | --- | --- |
| Lead dislodgment rate in acute phase | Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04% | Lead dislodgment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evaluate the Sorin Group new passive- and active- fixation pacing leads
Determination of Blood Tumor Cells

Study Overview
=================
Brief Summary
-----------------
Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood .

Detailed Description
-----------------
Magnetic nanoparticles, coated with epithelial cell adhesion molecule (EpCAM)-antibodies are designed to interact with epithelial tumor cells. Aim of this study is to see if circulating tumor cells (EpCAM as marker)can be removed out of the blood with the help of these particles. Patients suffering from prostate, colon, lung or pancreatic cancer will be asked to test their blood. Similarly, magnetic nanoparticles will be coated with antibodies, directed against non-solid tumors in the blood such as lymphoma or leukemia (CD52 as marker).

Official Title
-----------------
Determination of Blood Tumor Cells Using Magnetic Nanoparticles

Conditions
-----------------
Leukemia, Lymphocytic, Chronic, B-Cell, Abnormalities Cell Epithelial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epithelial cell cancer, advanced stage Non-solid tumors (lymphoma, leukemia) Exclusion Criteria: Inability to understand the language of the center (German)

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 |
| --- | --- | --- |
| Number of CTC / lymphocytes removed |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epithelial Cell Adhesion Molecule, Magnetite Nanoparticles, Tumor cells
French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire

Study Overview
=================
Brief Summary
-----------------
Low back pain is a very common disease. Among the persons suffering of acute low back pain, about 10% are at risk of developping chronic pain. A screening questionnaire assessing this risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french translation of this questionnaire. Patients suffering from acute low back pain will be asked to fill in several questionnaires at day 0, and 6 and 12 month later.

Official Title
-----------------
Validation of a French Translation of the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ): A Prospective One-year Follow-up Study

Conditions
-----------------
Acute Low Back Pain, Chronic Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients presenting at the clinical care setting with acute low back pain pain lasting for less than three months cumulated sick leave less thant six months Exclusion Criteria: unability to sufficiently read and understand French presence of red flags as according to the New Zealand Acute Low Back Pain Guide

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Pain |  | 6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Professional status |  | 6 and 12 months | 
| functional status |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain
Postoperative Analgesic Effect of Nefopam

Study Overview
=================
Brief Summary
-----------------
Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA). The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: Nefopam
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early or advanced gastric cancer Exclusion Criteria: Refusal Use of preoperative analgesic drugs Pregnancy Recurred gastric cancer Seizure Cardiac disease Monoamine oxidase inhibitor Urologic disease Previous intrabdominal surgery Body mass index > 30 or < 16

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia. | Drug: Saline<br> <br> |
| Experimental: Nefopam<br>Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia. | Drug: Nefopam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day |  | postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the pain score from postoperative 6 h to postoperative 5 day |  | postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day |
Nitrates and IL-8 in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.

Official Title
-----------------
The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma

Conditions
-----------------
Barrett Esophagus, Esophageal Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD). Exclusion Criteria: Comorbid inflammatory medical condition. Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week. Use of nitrate containing medication in the past 1 week. Consumption of nitrate rich foods in preceding 24 hours. Known allergy to meat or nitrates

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 |
| --- | --- |
| Group 1-NSE<br>Patients found to have grossly normal squamous epithelium during endoscopy | |
| Group 2-EEG<br>Patients found to have grossly apparent erosive esophagitis >1cm with Los Angeles Classification A-D | |
| Group 3-NDBE Short<br>Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Short Segment) | |
| Group 4-NDBE Long<br>Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Long Segment) | |
| Group 5<br>Barrett's Esophagus (BE) with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) | |
| Group 6-Esophagectomy<br>Patients undergoing resection of esophageal cancer | |
| Group -7 Pilot and Feasibility<br>Patients undergoing EGD with NSE, NDBE, BE-HGD, or EAC for feasibility of analytical techniques | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrate Levels | Nitrate levels in serum, saliva and tissue in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or EAC | Baseline | 
| Serum and Tissue Biomarkers | Levels of IL-8 in patients diagnosed BE dysplasia and EAC | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers and disease progression | Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE | Baseline |
Risk Factors for Linezolid Resistance in Staphylococcus Aureus

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review study. The proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.

Detailed Description
-----------------
This is a retrospective chart review study. The proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.

Official Title
-----------------
Risk Factors for Linezolid Resistance in Staphylococcus Aureus

Conditions
-----------------
Linezolid Resistance, Staphylococcus Aureus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with linezolid resistance to staphylococcus aureus Exclusion Criteria: those that don't meet entry criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Linezolid, Staphylococcus Aureus, Infections
Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.

Detailed Description
-----------------
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.

Official Title
-----------------
Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects

Conditions
-----------------
Elderly, Frail

Intervention / Treatment
-----------------
* Drug: Vitamin D + Sham Exercise
* Procedure: Vitamin D Placebo + Exercise
* Procedure: Vitamin D Placebo + Sham Exercise
* Drug: Vitamin D + Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly subjects with moderate frailty residing in assisted living facilities. Exclusion Criteria: Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

Ages Eligible for Study
-----------------
Minimum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C<br> | Procedure: Vitamin D Placebo + Exercise<br>* Vitamin D placebo + Exercise<br>|
| Experimental: B<br> | Drug: Vitamin D + Sham Exercise<br>* 1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise<br>|
| Experimental: A<br> | Drug: Vitamin D + Exercise<br>* 1000 IU per day of Vitamin D + Exercise<br>|
| Placebo Comparator: D<br> | Procedure: Vitamin D Placebo + Sham Exercise<br>* Vitamin D placebo + Sham (equivalent to placebo) Exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. |  | Throughout trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects. |  | throughout trial |