linjc16/ctgov huggingface dataset:
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia. This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

Official Title
-----------------
A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia

Conditions
-----------------
Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases

Intervention / Treatment
-----------------
* Drug: CAT-2003
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 74 years at Screening Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening Body mass index (BMI) ≤ 45 kg/m2 Exclusion Criteria: History of any major cardiovascular event within 6 months of Screening Type I diabetes mellitus or use of insulin History of pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAT-2003 or Placebo<br>All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period. | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events | Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications. | 4 weeks | 
| Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels |  | 4 weeks |
Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC

Study Overview
=================
Brief Summary
-----------------
The isolate samples will be collected over a period of one year once IRB approval has been obtained. These isolates were collected as part of the patient's clinical care and once all clinical testing is complete, all isolates will be discarded. The honest broker of our area will collect the isolates and deidentify all information once all clinical testing is complete. The isolates will be obtained from the microbiology lab.

Detailed Description
-----------------
The study will collect two hundred pseudomonas and 20 acinetobacter baumanti consecutive bacterial isolates from microbiology. These isolates are collected as part of the patient's clinical care and are discarded once all clinical testing is complete. The honest broker will obtain these samples after all clinical testing is complete. All isolates will be deidentified. These isolates will be tested using standardized susceptibility methods for meropenem and imipenem. The activity of doripenem, a carbapenem currently being studied, and arbekacin an aminoglycoside, will also be tested. The honest broker will also collect limited patient data including underlying condition, presence of a solid organ transplant, ward location, and antibiotic history over the three months prior to organism isolation. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Official Title
-----------------
Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms

Conditions
-----------------
Gram Negative Organism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.
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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meropenem, imipenem, gram negative organism
TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material

Study Overview
=================
Brief Summary
-----------------
TOMOGRAM is a European multicentric, prospective, experimental, controlled study that aims to increase our understanding of the causative mechanisms of operational tolerance in kidney transplantation through the achievement of several multimodal whole-genomic analysis in human biological samples.

Official Title
-----------------
TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Genetic: High throughput DNA and RNA sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recipient of an allogenic renal allograft, have experienced (whatever ongoing or not) at least a whole year with blood creatinine <1.7 mg/dL and proteinuria </=1g/day or /g creatinine despite the COMPLETE discontinuation of immunosuppressive drugs, alternatively, have experienced (whatever ongoing or not) at least a whole year with stable blood creatinine (max 20% variation) and proteinuria above these criteria despite the COMPLETE discontinuation of immunosuppressive drugs Exclusion Criteria: Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Exome-wide association study Transcriptomic analyses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases (tolerant patients)<br> | Genetic: High throughput DNA and RNA sequencing<br>* High throughput DNA and RNA sequencing<br>|
| Experimental: Controls<br> | Genetic: High throughput DNA and RNA sequencing<br>* High throughput DNA and RNA sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of moderately to highly damaging exonic variants |  | Through study completion, an average of 2 year |
Movement Disorders Analysis Using a Deep Learning Approach

Study Overview
=================
Brief Summary
-----------------
Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging. In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III protocols. Using a Deep Learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III.

Official Title
-----------------
Movement Disorders Analysis Using a Deep Learning Approach

Conditions
-----------------
Bradykinesia, Parkinson Disease, Hypokinesia, Akinesia, Parkinsonian Syndrome, Parkinsonian Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Exclusion Criteria: Refusal of participation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score | Automatic Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III for hand bradykinesia including the three following specific tasks (finger tapping, hand movements and pronation-supination movements of hand). The minimum score is 0. The maximum score is 12 Higher scores mean wors outcome | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Learning, Bradykinesia, Parkinson Disease
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.

Official Title
-----------------
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: azathioprine or adalimumab and infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150) Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old) Exclusion Criteria: Contraindication for infliximab, adalimumab, or azathioprine Lactating woman Presence of malignancy Within 3 month from intestinal surgery Presence of an end stoma Planned surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: step up<br>Procedure: MREC patients receive therapeutic step up | Drug: azathioprine or adalimumab and infliximab<br> <br> |
| No Intervention: observation step up<br> | |
| Active Comparator: step down<br>Procedure: MREC patients receive therapeutic step down | Drug: azathioprine or adalimumab and infliximab<br> <br> |
| No Intervention: observation step down<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of clinical remission at 104 weeks. |  | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of hospitalization and operation |  | 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
Cognitive Correlates of Substance Abuse - 11

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the cognitive performance of methamphetamine abusers by comparing them with cocaine abusers and normal controls.

Official Title
-----------------
Cognitive Correlates of Substance Abuse, Part 1

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F . Meet DSM-IV criteria for cocaine or methamphetamine dependence. Agree to conditions of the study and sign informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: counseling|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
-----------------
amphetamine dependence
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.

Official Title
-----------------
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Conditions
-----------------
Cutaneous T-Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Tazarotene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides. Exclusion Criteria: Patients with Stage >IIA CTCL at the time of enrolment Women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception Patients who were treated with topical retinoid therapy in the past 3 months Patients who received any systemic CTCL therapy or systemic corticosteroid therapy within 30 days of the study start date Patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date

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

| Intervention/Treatment |
| --- |
|Drug: Tazarotene|Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To evaluate therapeutic potential of tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study, Stage I-IIA disease CTCL
Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the relationship between hard and soft tissue advancement during orthognathic surgery. The use of typical pre and post operative imaging consisting of con-beam computed tomography will be used, in conjunction with a 3D camera to evaluate hard and soft tissue points before and after surgery.

Official Title
-----------------
Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery

Conditions
-----------------
Dentofacial Deformities

Intervention / Treatment
-----------------
* Procedure: Orthognathic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's undergoing orthognathic surgery for correction of a dentofacial deformity Exclusion Criteria: patients with previous orthognathic surgery patients with cranio-facial syndromes
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orthognathic Surgery Patients<br>The study cohort will be patients undergoing orthognathic surgery for correction of an existing dentofacial deformity. | Procedure: Orthognathic surgery<br>* Patient's pre and post operative hard and soft tissues will be evaluated retrospectively through the use of con-beam computed tomography imaging for hard tissue evaluation and 3DMd three dimensional photography for soft tissue imaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hard and soft tissue change | The difference between standard pre and post operative hard and soft tissue positioning will be evaluated. Comparisons will be made between the actual bony advancement of a particular bony landmark, and compare that advancement to the advancement seen with a corresponding soft tissue landmark. | pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively. |
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients

Study Overview
=================
Brief Summary
-----------------
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Detailed Description
-----------------
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Official Title
-----------------
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Atimos®
* Drug: Serevent™
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical diagnosis of COPD Post bronchodilator FEV1 between 30% and 80% predicted values at screening Post-bronchodilator FEV1/FVC < 0.7 Exclusion Criteria: Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12% History of another medical condition contraindicating participation in the study Clinical evidence of heart failure

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formoterol 12 μg pMDI (Atimos®)<br> | Drug: Atimos®<br>* Formoterol 12 μg pMDI<br>|
| Active Comparator: Salmeterol 25 µg pMDI HFA (Serevent™)<br> | Drug: Serevent™<br>* Salmeterol 25 µg pMDI<br>|
| Placebo Comparator: Matched Placebo<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Impedance by Impulse oscillometry |  | from 5 minutes to 8 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Nitric Oxide |  | from 30 minutes to 8 hours post dose | 
| Multiple Breath Nitrogen Washout |  | from 30 minutes to 8 hours post dose | 
| Forced Expiratory Volume in the 1st second |  | from 30 minutes to 8 hours post dose |