bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether or not marijuana blunts will produce
      comparable plasma THC levels as marijuana joints and if blunts will produce larger
      cardiovascular and subjective effects.
    

Detailed description: 
      There has been a rapid increase in marijuana use during the 1990s, with the most recent
      generation often smoking marijuana in the form of 'blunts' as opposed to more traditional
      routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a
      cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains
      tobacco and nicotine, which may interact with the cardiovascular and subjective effects of
      the marijuana to produce a different set of effects and risks than cigarette paper.
      Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have
      been no controlled studies addressing whether blunts enhance the subjective-effects and
      health-related consequences of marijuana use. We are proposing to do a within-subject,
      placebo-controlled study directly comparing the cardiovascular, subjective and
      pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of
      marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each
      will participate in six, 4-hour outpatient sessions. After baseline data have been collected
      (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine
      levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana
      cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity
      and strength of marijuana. Participants will be blind to the type of marijuana cigarette
      smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and
      blood pressure repeatedly over the course of 180 minutes following smoking. This study is the
      first controlled investigation of the consequences of this new method of marijuana smoking;
      the data obtained may be useful in guiding future development of marijuana pharmacotherapy.
    

Intervention name(s): Marijuana blunt; marijuana cigarette
Intervention type(s): Drug; Drug
Intervention description(s): Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).; Marijuana cigarettes were provided by the National Institute on Drug Abuse.
Other intervention name(s): Blunt; Joint
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Marijuana; Comparison between joints and blunts; Pharmacokinetic effects
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
Condition: Hepatitis C; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and affect on blood levels
      of miravirsen and telaprevir when administered together.
    


Intervention name(s): Miravirsen sodium; Telaprevir
Intervention type(s): Drug; Drug
Intervention description(s): Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.; Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
Other intervention name(s): Miravirsen; SPC3649; Incivek
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antisense; miR-122 antagonist; Safety in healthy volunteers; Hepatitis C
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery
Condition: Acute Cholecystitis; Endothelial Dysfunction
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This study examines if remote ischemic preconditioning in patients undergoing minor acute
      abdominal surgery (laparoscopic cholecystitis due to acute cholecystitis) is associated with
      a modulation of endothelial dysfunction. half of the patients will receive remote ischemic
      preconditioning prior to surgery, the other half will serve as controls.
    

Detailed description: 
      Remote ischemic preconditioning (RIPC) consists of cycles of forearm or leg ischemia and
      reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for
      brief periods. The procedure is simple, safe and with no clear side effects. In clinical
      studies covering acute cardiology RIPC has effectively reduced myocardial injury,
      postoperative cardiovascular complications and cardiac mortality. Recently, the effect of
      RIPC on attenuating ischemia-reperfusion injury has been investigated in non-cardiac surgery
      as well. The organ specific ischemia-reperfusion injury, systemic oxidative stress and
      inflammatory response were attenuated due to the intervention but a complete understanding of
      the underlying protective mechanisms of RIPC is however still lacking.

      Experimental and clinical studies have implicated that the stimulus of RIPC is transmitted
      from the preconditioned tissue to other tissues and organs by humoral, neural and systemic
      anti-inflammatory mediators. The humoral and neural pathway are thought to be dependent on
      endogen substances such as adenosine, bradykinin, nitrogen oxide (NO) and
      calcitonin-gene-related-peptide (CGRP).
    

Intervention name(s): Remote Ischemic Preconditioning (RIPC)
Intervention type(s): Procedure
Intervention description(s): Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remote ISchemic Preconditioning (RIPC); Acute surgery; Acute cholecystitis; Endothelial dysfunction; Heart Rate Variability (HRV)
Stress-induced Scratching in Healthy and AD
Condition: Healthy; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to examine scratching behavior and identify brain areas
      responsible for stress-induced spontaneous scratching in patients with atopic dermatitis
      (AD).
    


Intervention name(s): Trier Social Stress Test (TSST); Landscape Video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to receive the acute stress condition will undergo the TSST wherein the participant will be introduced to an upcoming task (i.e., job interview) and allowed to prepare (2 minutes). The participant will then be required to speak (job interview) for 4 minutes in front of 2 experimenters. After completion of the interview, participants will be asked to perform a mental arithmetic task for 4 minutes.; Participants randomized to receive the control condition will be watching a landscape video for 10 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomization within the arms.
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Estrogen on Fear Extinction R61
Condition: Fear; Fear; Examination, Phobic
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this project is to examine how estrogen may influence the resting-state
      connectivity and the extinction-induced activation of the fear extinction network.
    

Detailed description: 
      The aim of the study was to examine the influence of exogenous estrogen administration on the
      activation of the fear extinction network in women. Functional MRI data and
      psychophysiological indices were collected to test the influence of estrogen on women's
      ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm
      using classical fear conditioning. The first day was conducted outside the scanner, while
      days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall
      in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before
      extinction learning test on day 2. No followups were conducted after women completed the 3
      day study.
    

Intervention name(s): Estradiol 2Mg Tablet; Estradiol 4Mg Tablet; Placebo Pills
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),; two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),; inactive placebo pills
Other intervention name(s): Estrace® Tablets; Estrace® Tablets; Estrace® Tablets
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of LY2951742 in Healthy Japanese and Caucasian Participants
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of the study drug known as LY2951742
      in healthy Japanese and Caucasians. The study will also investigate how the body processes
      the drug and how the drug affects the body. The study is expected to last about 5 to 7
      months, depending on the arm.
    


Intervention name(s): LY2951742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously.; Administered subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the altered nutrient exposure to the GI tract
      after bariatric surgery reveals a negative incretin effect of ghrelin.
    


Intervention name(s): Oral Glucose Tolerance Test (OGTT); Human Ghrelin; Saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.; Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.; Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
Other intervention name(s): OGTT; Ghrelin; NaCl, sodium chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obesity; Bariatric Surgery
Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency
Condition: Acute Hepatitis; Chronic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluate on how well the ELAD system works in treating people with liver failure.
    

Detailed description: 
      This is a multicenter, open-label, randomized, concurrent control study of subjects with
      acute on chronic hepatitis. Subjects meeting the eligibility requirements of the study will
      be randomly assigned in a 2:1 ratio to receive either standard medical therapy for acute
      liver failure plus the ELAD system, or standard medical therapy alone, with the latter
      defined as conventional therapy for acute on chronic hepatitis determined to be clinically
      appropriate by the treating physician.

      Immediately prior to treatment initiation, subject eligibility will be confirmed. Treatment
      with ELAD will continue for a minimum of 3 days and up to a maximum of 10 days or until
      clinical status improves relative to study entry. Subjects will be followed until 30 days has
      elapsed since study enrollment (control) or 30 days has elapsed since cessation of ELAD
      therapy (ELAD group), whichever comes first.
    

Intervention name(s): ELAD plus standard of care treatment; Standard of care treatment
Intervention type(s): Biological; Other
Intervention description(s): ELAD is a liver assist system - Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated); Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis, acute; Acute Hepatitis OR Chronic Hepatitis
Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
Condition: Healthy
Study type: Observational

Summary: 
      Purpose of the study is to examine the vessel density of healthy adults' optical coherence
      tomography angiography images with two semi-manual methods and an automated quantification
      program.
    

Detailed description: 
      Optical coherence tomography angiography (OCTA) is a software upgrade on conventional
      spectral-domain or swept-source optical coherence tomography devices that enables
      non-invasive, dye-free, three dimensional analysis of the retinal vessels.

      Vessel density is a very important parameter almost in all retinal disorders. In the recent
      past, automated quantification software was built into some OCTA devices which can
      automatically calculate the retinal vessel density as well.

      In this study two semi-manual techniques are used in order to analyze the vessel density of
      healthy subjects' OCTA images. Vessel density is also measured with a new automated
      quantification program, and results of the three methods are compared.

      OCT machines are approved in the EU and the US and are not experimental devices.

      The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex
      5000 that operates with spectral-domain technology.
    

Intervention name(s): Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)
Intervention type(s): Device
Intervention description(s): Non-invasive, non-contact optical coherence tomography angiography scans of the retina are done per built-in device protocol using the Zeiss Cirrus HD OCT 5000 AngioPlex machine.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        White Caucasian
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Condition: Post Surgical Incisions From Abdominoplasty Procedures
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      This study will evaluate a new dressing to be used for post-incision care for abdominoplasty
      patients. The hypothesis is that this dressing will minimize scar formation.
    

Detailed description: 
      This study will evaluate a new dressing in up to 30 patients who have undergone an
      abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the
      scar will be evaluated at 3 months post surgery.
    

Intervention name(s): GLYDe Dressing
Intervention type(s): Device
Intervention description(s): Wound dressing intended to minimize scar formation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: incision; abdominoplasty
Bone Marrow Stem Cell Treatment for Asherman's Syndrome and Endometrial Atrophy
Condition: Asherman's Syndrome; Endometrium; Atrophy, Cervix
MeSH terms: Gynatresia; Syndrome; Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may
      improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or
      Atrophic Endometrium.
    

Detailed description: 
      This novel technique refers to the use of CD133+ autologous bone marrow stem-cells to
      regenerate the endometrium in patients with Asherman's Syndrome, Endometrial Atrophy or any
      condition that produce a destruction of the endometrium or its de novo creation in a
      bioengineered uterus.

      It requires a previous mobilization in the peripheral blood of CD133+ autologous bone marrow
      stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of
      the uterus with the aim to regenerate de novo the endometrium. This technique represents a
      new therapeutical approach for the treatment of endometrial regeneration problems such
      Asherman Syndrome and the endometrial atrophy since currently no specific treatment for these
      endometrial pathologies exist.

      A prospective experimental non controlled study has been designed in order to assess the
      effectiveness of these technique as a new tool for treat Asherman's Syndrome and Endometrial
      Atrophy.
    

Intervention name(s): Bone Marrow CD133+ Stem Cell Transplantation
Intervention type(s): Biological
Intervention description(s): Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days.
BMSC recollection with apheresis procedure and positive selection of the CD133+ cells.
The selection procedure will be performed for a maximum of 3 hours or until at least 50 million cells are collected.
CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization
Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients
Hysteroscopy will be performed 2-3 months after stem cell transplantation
Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation
Other intervention name(s): Neupogen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Condition: Epilepsy, Complex Partial
MeSH terms: Epilepsy, Complex Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide ganaxolone to those patients deriving significant benefit
      from current treatment in protocol 1042-0601.
    


Intervention name(s): ganaxolone
Intervention type(s): Drug
Intervention description(s): liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Other intervention name(s): CCD 1042; CAS 383-98323-2; 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one
Intervention MeSH terms: Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epileptic Seizures; Seizure Disorder; Seizures; Convulsions; Anticonvulsant; Anticonvulsive; Antiepileptic; Ganaxolone
Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      There are two parts to this study: (1) an information gathering phase leading to development
      of a new decision aid (phase 1); and (2) a study to test the newly developed decision aid
      (phase 2).
    

Detailed description: 
      Phase 1 - The purpose of this part of the research study is to conduct individual interviews
      and focus groups (group discussions) to learn more about the things or behaviors that help
      men to stay healthy and the decision making process for prostate cancer screening. We will
      discuss men's general health concerns, knowledge, beliefs, and concerns regarding prostate
      cancer and screening for prostate cancer. We will use the results from this study to develop
      a decision aid to help first-degree relatives of prostate cancer patients make informed
      decisions about whether to undergo testing or not to undergo testing for prostate cancer. The
      new decision aid will include a digital videodisc (DVD) and an accompanying booklet. We hope
      to learn from you the needs and concerns of first-degree relatives, what information to
      include in the decision aid, what language to use, and the best way to present this
      information.

      Phase 2 - The purpose of this part of the research study is to test the usefulness and
      acceptability of a new decision aid we developed specifically for first-degree relatives
      (FDRs) of prostate cancer patients. We will compare the new decision aid to another widely
      available decision aid that was not developed specifically for first-degree relatives. The
      goal is to see if the new decision aid will change knowledge (about prostate cancer and
      screening) and increase satisfaction with decision making (intention or decision made). If we
      find some evidence that the new decision aid is relevant (useful) and acceptable, we will
      then do a larger study with several hundred men to determine more definitively whether the
      new decision aid is better than already existing general decision materials and for which men
      it works best.

      Because the correct decision (whether to undergo screening or not to undergo screening) is
      not known at this time, the goal of decision aids is to present both (in a balanced manner)
      the potential harms and benefits of screening. Therefore, this study focuses on the informed
      decision making (knowledge and satisfaction with decision).
    

Intervention name(s): Information Gathering; Decision Aid
Intervention type(s): Other; Other
Intervention description(s): An information gathering phase leading to development of a new decision aid.; To test the newly developed decision aid.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate Cancer