linjc16/ctgov huggingface dataset:
A Multi-Center Trial of Nepicastat for Cocaine Dependence

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.

Official Title
-----------------
Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence

Conditions
-----------------
Cocaine Dependence

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Is seeking treatment for cocaine dependence Is able to understand and provide written informed consent Has completed all psychological assessments and procedures required during the 7 - 14 day screening period If female, agrees to use an acceptable method of birth control Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study Exclusion Criteria: Please contact the study site for more information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Active Comparator: Nepicastat<br>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks | Drug: Nepicastat<br>* 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence (Weeks 10 - 11) | Number of subjects that abstained from cocaine from weeks 10 through 11 | Weeks 10 - 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Use (Weeks 1 - 11) | Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11 | Baseline through week 11 |
Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.

Official Title
-----------------
Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome Before and After Surgical Treatment

Conditions
-----------------
Cushing's Syndrome, Insulin Resistance

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Age between 18 and 70 Diagnosed with Cushing's syndrome Exclusion Criteria: Suspected malignancy

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 |
| --- | --- |
| 1<br>Patients recently diagnosed with Cushing's syndrome | Procedure: Surgery<br>* Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Before and after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism. |  | Before and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cushing's syndrome, Glucose tolerance, Insulin sensitivity, Substrate metabolism, Body composition
0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.

Study Overview
=================
Brief Summary
-----------------
Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.

Official Title
-----------------
The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Spinal morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 year or over Patient ASA physical status I-III. Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion Can operate a patient-controlled analgesia (PCA) device. Exclusion Criteria: Known hypersensitivity to morphine History of bleeding tendency. Known case of infection at the back Patient refuse for spinal anesthesia History of cerebrovascular disease. Need mechanical ventilatory support during postoperative period

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal morphine<br>0.15 mg spinal morphine | Drug: Spinal morphine<br>* 0.15 mg spinal morphine<br>|
| No Intervention: Control<br>No spinal morphine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine requirement in 48 hours |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal morphine, VATs lobectomy
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Official Title
-----------------
A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiac function - Clinically significant inflammatory disease - Inadequate renal and/or liver function

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC transfusion during the treatment phase |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to hemoglobin response during the treatment phase |  |  | 
| The FACT-Fatigue score profile over time |  |  | 
| The change in hemoglobin |  |  | 
| Incidence and severity of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-myeloid malignancy, Darbepoetin alfa, Clinical Trial
Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure

Study Overview
=================
Brief Summary
-----------------
purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.

Official Title
-----------------
Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial

Conditions
-----------------
Bleb

Intervention / Treatment
-----------------
* Drug: 5-FU and Mitomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy&phaco which not respond to high frequent topical steroids or removal of releasable sutures Exclusion Criteria: Injected bleb due to complications of surgery such as button hole formation Injected bleb due to blebitis Bleb leakage Flat AC Pregnant or nursing mothers Injected bleb after bleb reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 8 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: 1<br>5-FU injection has been done | Drug: 5-FU and Mitomycin<br>* 5-FU injection 5mg Mitomycin drop 0.02%<br>|
| Experimental: 2<br>Mitomycin drop has been administrated | Drug: 5-FU and Mitomycin<br>* 5-FU injection 5mg Mitomycin drop 0.02%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iop and Bleb height,extent and vascularity |  | At least in 3 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injected bleb, mitomycin drop, 5-Fu injection, early bleb failure
Cardiomyopathy Arrhythmia Risk Evaluation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

Detailed Description
-----------------
Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

Official Title
-----------------
Cardiomyopathy Arrhythmia Risk Evaluation

Conditions
-----------------
Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiomyopathy, primary prevention ICD Exclusion Criteria: brady-pacing requirement
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 |
| --- | --- | --- |
| Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks | Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks) | 2 years |
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

Study Overview
=================
Brief Summary
-----------------
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.

Detailed Description
-----------------
Operations of upper extremities are often performed in regional anesthesia blocks. Single-injection blocks are effective, but time limited. Adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. This effect will result in less opioid use postoperatively.

Official Title
-----------------
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade

Conditions
-----------------
Brachial Plexus Anesthesia, Analgesia

Intervention / Treatment
-----------------
* Procedure: supraclavicular brachial plexus block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 years or older ASA (American Society of Anesthesiologists) physical status I, II or III Exclusion Criteria: refusal of the patients to give informed consent preexisting coagulation disorders local infection at the site of the block neuropathy drug or alcohol abusers known allergy to the drug used in study operation time exceeding six hours

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone with levobupivacaine<br>25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery | Procedure: supraclavicular brachial plexus block<br> <br> |
| Active Comparator: levobupivacaine<br>25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery | Procedure: supraclavicular brachial plexus block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of analgesia | Duration of analgesia after supraclavicular block | 24 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesic consumption |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, regional anesthesia, surgery, duration of analgesia, dexamethasone added to levobupivacaine compared to levobupivacaine alone
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.

Official Title
-----------------
Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Conditions
-----------------
Environmental Enteric Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: PTM202
* Dietary Supplement: micro-nutrient sprinkles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 6 - 9 months old -1> Weight-for-age Z score > -3 Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection Exclusion Criteria: Presence of known kidney, liver, heart, developmental, or neurologic disease Allergy to milk and/or egg (assessed by history) Milk intolerance (assessed by history) Abnormal liver or kidney function tests Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up Child being exclusively breast fed at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 9 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>PTM202 and micro-nutrient sprinkles | Dietary Supplement: PTM202<br>* PTM202 given twice daily for 30 days.<br>Dietary Supplement: micro-nutrient sprinkles<br>* Micro-nutrient sprinkles will be given twice daily for 30 days.<br>|
| Other: Control<br>micro-nutrient sprinkles | Dietary Supplement: micro-nutrient sprinkles<br>* Micro-nutrient sprinkles will be given twice daily for 30 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EED biomarker composite score | composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 4 months | 
| Height gain |  | 4 months | 
| Number of diarrheal episodes |  | 4 months | 
| Glucose hydrogen breath test |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition
Dry Needling in Post-operative Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.

Official Title
-----------------
EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN

Conditions
-----------------
Proximal Humeral Fracture Fixated With PHILOS© Plate, Rotator Cuff Tear Surgical Repair

Intervention / Treatment
-----------------
* Other: Physical therapy plus dry needling
* Other: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proximal humeral fracture rotator cuff tear open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland) rotator cuff tear repair post-operative shoulder pain active TrPs in the neck-shoulder muscles Exclusion Criteria: no active TrPs multiple fracture previous surgery cervical radiculopathy or myelopathy diagnosis of fibromialgia having undergone any physical therapy intervention in the year before the surgery fear of needles any contraindication for dry needling

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical therapy plus dry needling<br>Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles. | Other: Physical therapy plus dry needling<br>* Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles<br>|
| Active Comparator: Physical therapy<br>Best-evidence physical therapy intervention | Other: Physical therapy<br>* Best-evidence physical therapy intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Constant-Murley score before and after the intervention | The Constant-Murley score is a 100-point scoring system that is divided into 4 main sub-scales: pain (15 points); activities of daily living (20 points); range of motion (40 points); and strength (25 points). Higher score represents better function | Baseline and one week after the intervention |