bioihbjkbjnl/mcl2 huggingface dataset:
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream,
      twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to
      moderate atopic dermatitis.
    

Detailed description: 
      This is a randomized, double-blind, vehicle-controlled study to evaluate the safety,
      tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of
      VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in
      otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

      Evaluation of three ascending doses in three dose panels is planned for this trial. Dose
      Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and
      randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P).
      Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20
      to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100
      participants will participate in the trial.
    

Intervention name(s): VTP-38543; Vehicle with Transcutol®P; Vehicle without Transcutol®P
Intervention type(s): Drug; Other; Other
Intervention description(s): VTP-38543 topical cream; Vehicle matching VTP-38543 cream with Transcutol®P; Vehicle matching VTP-38543 cream without Transcutol®P
Other intervention name(s): Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.; Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Intervention MeSH terms: Ether
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema
Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
Condition: HIV Infections; Depression; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT)
      and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed
      intravenous drug users.
    

Detailed description: 
      Depression is common among injection drug users (IDUs); it is estimated that up to 50% of
      IDUs meet the diagnostic criteria for major depressive disorder, a severe form of depression.
      The combination of drug abuse and depression increases the likelihood of engaging in HIV
      high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject
      drugs. Research has shown that IDUs who receive treatment for depression have lower rates of
      drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who
      have not received treatment for depression. Combination treatment, which includes cognitive
      behavioral therapy (CBT) and antidepressant medication, has been shown to be the most
      effective treatment for depression. This study will evaluate the effectiveness of combination
      treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted
      IDUs with a diagnosis of depression.

      In this 9-month study, participants will be randomly assigned to either a combination
      treatment group or an assessment only group that will receive no treatment. Participants
      assigned to combination treatment will receive the antidepressant Celexa, and will attend 8
      CBT sessions and 7 psychopharmacology sessions. Each CBT session will last about 60 minutes
      and each psychopharmacology session will last about 15 minutes. If a participant does not
      respond well to Celexa, Wellbutrin or Effexor may be taken instead. Participants in both
      groups will attend 4 study visits during which they will complete standardized psychological
      questionnaires and interviews to assess depression levels, drug use, and high-risk sexual
      behaviors. Blood will be drawn at baseline and Month 9 for HIV testing.
    

Intervention name(s): Cognitive Behavioral Therapy; Psychopharmacology
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Treatment For Depression; Antidepressant Psychopharmacology; HIV Risk Behavior; Injection Drug Use
Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Condition: Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders
MeSH terms: Parkinson Disease; Dyskinesias; Movement Disorders; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's
      Disease L-dopa Induced Dyskinesias (PD-LID)
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; L-dopa; Levodopa; Dyskinesia; Anti-Dyskinesia Agents
Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .
Condition: Post-operative Endodontic Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain
      after a single visit root canal treatment for 74 hours.
    

Detailed description: 
      To evaluate effectiveness of single dose premedication with piroxicam(20mg) and
      prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .

      patient will be recalled every day for 4 days to know the pain scale using visual analogue
      scale .
    

Intervention name(s): Piroxicam 20 mg; prednisolone 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels; prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain
Intervention MeSH terms: Prednisolone; Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cannabidiol and Emotional Stimuli
Condition: Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid
      compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical
      studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects.
      Thus the investigators hypothesize that CBD may reduce responses specifically to negative
      emotional and social stimuli, including pictures and emotional faces, without altering
      responses to positive stimuli. To examine this, the investigators will administer placebo,
      300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study.
      The investigators will measure subjective and subtle physical responses to positive and
      negative stimuli using measures that have been characterized with classic anxiety-reducing
      drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes
      in these measures of emotional response relate to changes in actual behavior in a controlled
      social interaction. These results will allow the investigators to examine the potential
      usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce
      anxiety.
    


Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics
Condition: QTc Interval; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is comprised of two parts. The purpose of the first part of this study is to
      evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization. The
      purpose of the second part of the study is to evaluate the effects of food on the
      pharmacokinetics of psilocybin.
    

Detailed description: 
      Part one of this study will be a double-blind, single-dose, randomized, placebo-controlled,
      4-treatment, 4-period, 12-sequence crossover design in 36 healthy volunteers (adult male
      and/or female subjects). Subjects will be randomly assigned to 1 of 12 different treatment
      administration sequences, whereby each sequence will include 3 double-blind treatments
      (therapeutic dose of psilocybin, supratherapeutic dose of psilocybin, and placebo) and 1
      open-label positive control treatment (moxifloxacin).

      Part two of this study will be an open-label, randomized, 2-period, 2-sequence crossover
      design in 24 healthy volunteers (adult male and/or female subjects). Each assigned treatment
      will be administered under fasting or fed conditions as a single dose on Day 1 of the
      respective study period.
    

Intervention name(s): Psilocybin; Moxifloxacin; Micro-Crystalline Cellulose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).; The positive comparator used in this study is a 400 mg moxifloxacin tablet.; The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
Other intervention name(s): Psilocybine; Psilocibin; Indocybin; Avelox; Moxeza
Intervention MeSH terms: Moxifloxacin; Psilocybin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Psilocybin, Psychedelics
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine whether inducing labor with just one dose of
      misoprostol, followed by treatment with oxytocin, will still be effective enough to increase
      the chances of having a successful vaginal delivery as compared to using more than one dose
      of misoprostol, followed by treatment with oxytocin.
    

Detailed description: 
      This study involves a comparison of two different regimens of prostaglandin use for "cervical
      ripening" prior to induction of labor. Women admitted to the hospital for induction of labor
      who are found to have "unripe" cervixes at the time of admission, and who agree to
      participate in the study will be randomly assigned to one of two treatment groups. In one
      group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours
      later oxytocin induction will be started if clinically indicated. In the second group of
      women, repeat doses of misoprostol will be given every four hours up to six doses unless
      labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed.
      Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and
      cesarean section rates will be compared. Complications such as postpartum hemorrhage,
      episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be
      monitored.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.
Other intervention name(s): cytotec, methotrexate
Intervention MeSH terms: Methotrexate; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unripe cervix
Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious
      diseases of the upper respiratory tract. Its treatment is limited and may be due largely in
      part to a lack of understanding of its cause. The investigators have preliminary data to
      support the notion that pediatric chronic sinusitis is a distinct disease, different from
      acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies
      in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic
      features and immunologic factors involved in the formation of this disease. The study plan
      calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory
      mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing
      and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic
      sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis
      (negative control) and 5 adults with chronic sinusitis (positive secondary control).
    


Intervention name(s): pathogenesis study
Intervention type(s): Procedure
Primary purpose: Diagnostic
Keywords: chronic sinusitis
A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II,
      parallel-group study of up to four weeks in duration. The study consisted of a screening
      visit followed by a one-week single blind placebo period. At next visit, each subject was
      randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180
      mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4
      times a day for 21 days.
    

Detailed description: 
      This was a multicenter, randomized, double-blind, placebo- and active-controlled, Phase II,
      parallel-group study up to four weeks in duration. Seven days of QID (four times a day)
      single-blind, placebo administration (via metered dose inhaler (MDI)) was followed by 21 days
      of QID double-blind treatment. During the single-blind period, rescue medication consisted of
      racemic albuterol MDI (90 mcg per actuation) for all subjects. During the double-blind
      period, rescue medication consisted of double-blind levalbuterol MDI (45 mcg per actuation)
      for all subjects in the levalbuterol treatment groups or double-blind racemic albuterol MDI
      (90 mcg per actuation) for all subjects in the racemic albuterol and placebo treatment
      groups.The study consisted of two periods, an optional follow-up visit, and a final telephone
      evaluation. This study was previously conducted by Sepracor Inc. In October 2009, Sepracor
      Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was
      changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): levalbuterol 90 mcg; levalbuterol 180 mcg; racemic albuterol 180 mcg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID; 180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID; 180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID; Placebo 2 actuations QID
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
Condition: Smoking Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      PRECESTO is a randomized, double-blind, cross-over trial on 34 smokers who do not want to
      stop smoking and get high satisfaction from smoking.

      The primary objective is to assess efficacy of NFL-101 in reducing the positive reinforcing
      properties of cigarettes compared to placebo measured by the modified Cigarette Evaluation
      Questionnaire (mCEQ) "Smoking Satisfaction" (items 1, 2, and 12) subscale.
    

Detailed description: 
      PRECESTO is a monocentric, placebo-controlled, randomized and double-blind Phase 2a
      exploratory study, with a crossover covering two periods of 28 days each, including 34
      smokers who do not want to quit and have high smoking satisfaction. Each participant is his
      or her own control and receives, on a random and alternating basis, either NFL-101 or the
      placebo at the start of each of the two periods. At the end of the study, all the
      participants received one dose of NFL-101 and one dose of the placebo. For each participant,
      the order in which NFL-101 and the placebo are administered is kept secret. For each period,
      the participants receive the treatments on day 1 (D1) then answer, with complete
      independence, the modified Cigarette Evaluation Questionnaire (mCEQ) on days 4 (D4), 7 (D7),
      14 (D14), 21 (D21) and 28 (D28).

      The objective is to assess the safety and efficacy of NFL-101 as a pretreatment for smoking
      cessation, NFL-101 beeing administered a few days or weeks before a quit attempt while
      smokers are asked to smoke ad libitum (meaning to continue either to try to smoke the same
      amount or to smoke freely). It is indeed recognized that reducing satisfaction from smoking
      before a quit attempt begins to undermine the learned association between smoking and reward
      and thus promotes the success of these attempts.
    

Intervention name(s): NFL-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injections; Subcutaneous injections
Other intervention name(s): Tobacco leaf extract; Water for injection
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Food Composition and Palatability
Condition: Fat Taste
Study type: Observational

Summary: 
      This study will investigate fat taste and if free fatty acids (FFA) in food function as a
      signal for fat content. FFA are quite unpleasant - the investigators want to measure if the
      concentration in different foods correlates with hedonic preference. FFA concentration from a
      variety of foods will be used to determine if people who have greater sensitivity for FFA
      find foods with higher FFA concentrations less acceptable. Further, this study with determine
      whether the relationship between fat taste and hedonic food preference is modified by sex and
      body mass index (BMI).
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        unselected convenience sample
      
Keywords: fat taste; food preference; consumption; free fatty acids
HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing
Condition: HIV
Study type: Interventional

Summary: 
      This study seeks to determine whether social networking technologies can be used to increase
      HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a
      diffusion of innovations style intervention to social media to increase HIV testing.
    


Intervention name(s): HIV knowledge Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: HIV; social networking; at-risk populations; sexual risk behaviors