bioihbjkbjnl/mcl2 huggingface dataset:
Drug Effects on Interpersonal Interaction
Condition: Interaction, Social
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators propose to use a Paired Partner design, in which subjects engage in a
      45-min semi-structured conversation with one (novel) partner under the influence of MDMA and
      with another partner under the influence of placebo. At the end of each session, they will
      rate their feelings about the partner, and on the test day, subjects will be asked which
      partner they preferred and felt closer to.
    

Detailed description: 
      The study will use a within-subject design with three sessions: i) MDMA and conversation with
      Person A, ii) placebo and conversation with Person B, iii) test session (online) assessing
      preference for Persons A and B. The MDMA dose will be 100 mg, administered under double blind
      conditions. The conversation will consist of a 45 min dialog between the participant and the
      partner, a person trained to engage in conversation for this purpose. The dyad will be
      provided with topics to discuss, at their own pace. The order of administration of drug and
      placebo will be counterbalanced, and the partners will be same-sex and varied across
      sessions. The primary outcome measures will be feelings of closeness and connection at the
      end of the two drug sessions, at the online test session and follow-up. After study
      completion, participants will be fully informed about the study.
    

Intervention name(s): MDMA; placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given 100 mg of MDMA; Participants will be given a placebo capsule that will only contain lactose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of the Gastrointestinal Manifestation of Fabry's Disease
Condition: Fabry's Disease
MeSH terms: Fabry Disease
Study type: Interventional

Summary: 
      Patients will undergo a SmartPill test to gain additional understanding of Fabry disease
      manifestation via motility abnormalities in order to improve symptom targeted therapy. An
      additional Endoscopic mucosal resection may be performed on further qualifying patients.
      Tissue analysis from this biopsy will include evaluation of abnormalities of cellular
      structure and morphology with correlation with gastrointestinal complaints for each patient
      and comparison against age matched non-Fabry patient tissue. The hypothesis is that patients
      with fabry disease will have abnormal motility which will correlate with the patients
      symptoms and quality of life as noted on the questionnaires.
    

Detailed description: 
      Background: Gastrointestinal manifestations such as abdominal pain, diarrhea and nausea are
      prominent and, although typically non life-threatening, can frequently cause significant
      morbidity and burden in a patient with Fabry disease. Additional in depth understanding of
      gastrointestinal symptoms pathophysiology in Fabry disease is acutely needed in order to
      develop more specific evaluation of the symptoms and advance the treatment of these patients.

      Hypothesis: Patients with gastrointestinal (GI) symptoms will have delayed motility on the
      SmartPill study, abnormal histologic findings on mucosal resection and symptoms that
      correlate with abnormal histologic and SmartPill findings. By gaining additional insight into
      the characterization of symptoms and the relationship to dysmotility, we anticipate improved
      and more focused adjunct therapies for the patients.

      Methods: This study will consist of a screening visit, a SmartPill testing procedure visit,
      and a follow up visit for all subjects enrolled in the study. Fifteen of these patients, who
      clinically warranted sigmoidoscopy, will be asked to also complete an endoscopic mucosal
      resection (EMR) visit in addition to the other aspects of the study. Thus, each subject will
      report to the study site for at least 3 visits and up to 4 visits.
    

Intervention name(s): Smartpill; Endoscopic Mucosal Resection
Intervention type(s): Device; Procedure
Intervention description(s): The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.; a Sigmoidoscopy is an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fabry's Disease; Fabry
Benralizumab for Eosinophilic Gastritis (BEGS)
Condition: Eosinophilic Gastritis or Gastroenteritis
MeSH terms: Gastroenteritis; Gastritis; Eosinophilic Esophagitis; Enteritis; Eosinophilia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of
      Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.
    

Detailed description: 
      Primary Objective:

      To assess the efficacy of repeat subcutaneous (SC) doses of benralizumab, compared with
      placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with
      Eosinophilic Gastritis

      Secondary Objectives:

      To assess changes in endoscopic score, histological features, blood and biopsy eosinophil
      counts, clinical symptoms, and gastric tissue transcriptome before and after treatment with
      benralizumab.

      26 subjects are planned to be enrolled into the study at Cincinnati Children's Hospital
      Medical Center. Qualifying Subjects will receive subcutaneous injections every 4 weeks (3
      total) of benralizumab/Placebo, followed by optional Open Label Extension periods.
    

Intervention name(s): Benralizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab (anti-IL5Ra) will be injected every 4 weeks in doses of 30 mg (total of 3 injections) in subjects with active Eosinophilic Gastritis.; Placebo will be injected every 4 weeks (total of 3 injections) as a comparator to Benralizumab in subjects with active Eosinophilic Gastritis.
Other intervention name(s): Fasenra
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will receive doses of drug or placebo. Optional open label extensions available following the double blind period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade
Condition: Anesthesia
Study type: Interventional

Summary: 
      Patients undergoing surgery of the hand often are treated with a nerve block in the
      shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last
      for a few hours after surgery and provide pain relief for this period. It may be possible to
      extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties.
      This study will compare the duration of the nerve block when dexamethasone (steroid) is added
      to the anesthetic injected around the nerve.
    


Intervention name(s): Dexamethasone; Mepivicaine
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.; Standard anesthetic solution administered during routine brachial plexus nerve blockade.
Intervention MeSH terms: Dexamethasone; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ultrasound-guided regional anesthesia; nerve block; brachial plexus; mepivicaine; dexamethasone; hand wrist surgery; duration; anesthetic duration following brachial plexus/nerve block for hand/wrist surgery
Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177
      following oral dosing of Form A and Form B
    


Intervention name(s): BMS-986177; BMS-986177
Intervention type(s): Drug; Drug
Intervention description(s): Form A; Form B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
First in Human Study of NI-0701 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic
      profiles of a novel therapeutic drug when administered to healthy volunteers.
    


Intervention name(s): NI-0701; Placebo
Intervention type(s): Drug; Drug
A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER)
      tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release
      formulation 2 (PR2) tablet, in healthy participants.
    

Detailed description: 
      This is a single-dose, open-label (a medical research study in which participants and
      researchers are told which treatments the participants are receiving, "unblinded"),
      single-centre, randomized (like the flip of a coin; 50/50 chance of receiving a study
      treatment), and 2-way crossover (groups of participants receive two or more interventions in
      a particular order) study of a single-dose tapentadol in healthy participants under fasted
      conditions. The study consists of 3 parts: Screening (2 to 21 days before the study
      commences), Open-label Treatment (single-dose treatment on Day 1 of each period separated
      with wash-out period of 7 to 14 days) and End of study (Day 3 of treatment Period 2). The
      duration of participation in the study for an individual participant will be up to 5.5 weeks
      (including Screening). Participants will be randomly assigned to one of the 2 treatment
      sequence groups. Participants assigned to the first treatment sequence will receive
      tapentadol TRF 50 milligram (mg) tablet, and after a washout period, participants will
      receive tapentadol PR2 50-mg tablet. Participants assigned to the second treatment sequence
      will receive tapentadol PR2 50-mg tablet, and after washout period, participants will receive
      tapentadol TRF 50-mg tablet. Bio-equivalence will be primarily evaluated by pharmacokinetics
      parameters. Participant's safety will be monitored throughout the study.
    

Intervention name(s): Tapentadol ER Tamper-resistant Formulation (TRF); Tapentadol ER Prolonged-Release 2 (PR2)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.; Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Bio-equivalence; Tapentadol extended release; Tamper-resistant formulation
Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia
Condition: Brain Hypoxia
MeSH terms: Hypoxia, Brain; Hypoxia
Study type: Interventional

Summary: 
      The primary objective of this research is to measure changes in neurochemical concentrations
      during stimulation of the primary visual cortex, in both conditions of normoxia (normal
      oxygen availability) and induced mild hypoxia (reduced oxygen availability).
    

Detailed description: 
      The goal is to determine the effect of mild hypoxia on human brain energy metabolism of
      healthy young adult subjects. For this purpose, the Investigator will utilize non-invasive
      imaging modalities based on functional magnetic resonance spectroscopy (fMRS) to estimate
      metabolic changes during a visual stimulus, while subjects are exposed to well-controlled gas
      mixtures that resembles conditions of either normoxia or mild hypoxia. Identifying the impact
      of mild hypoxia on functional brain energy metabolism in the healthy human brain is a crucial
      step for generating hypotheses in multiple patient populations that experience mild hypoxia
      as consequence of their pathological condition, such as in sleep apnea and traumatic brain
      injury. The Investigator hypothesize that the energetic demands of neuronal activation as
      revealed by fMRS will not be affected by mild hypoxia.
    

Intervention name(s): Mild Hypoxia
Intervention type(s): Device
Intervention description(s): During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional magnetic resonance spectroscopy (fMRS) while they are presented with visual stimuli.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Functional MRS; Glutamate
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Condition: Post-Menopausal Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly
      compared with placebo in post-menopausal women with osteopenia. Patients will be randomized
      to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study
      treatment is 1-2 years, and the target sample size is 100-500 individuals.
    


Intervention name(s): Placebo; ibandronate [Bonviva/Boniva]
Intervention type(s): Drug; Drug
Intervention description(s): po monthly for 1 year; 150mg po monthly for 1 year
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Inflammation and Treatment of Bacterial Vaginosis Near Term
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Inflammation
Study type: Interventional

Summary: 
      Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm
      birth. Despite this, there is no evidence that screening and treatment of asymptomatic
      bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent
      rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been
      associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this
      reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1
      inflammatory cascade with treatment, however this direct pathway has not been elucidated. The
      approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg
      BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal
      inflammation would be useful in designing strategies to reduce the rates of preterm birth.

      This study proposes to determine the effect of standard treatment of BV carriage on maternal
      serum markers of inflammation. This will be accomplished by giving patients with asymptomatic
      BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be
      drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.
    


Intervention name(s): Metronidazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days; Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
Other intervention name(s): Flagyl, CAS# 443-48-1
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Metronidazole; BV; Pregnancy
Neuroendocrine Response to Oral Alcohol Administration
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study proposes to examine both the peripheral and central nervous system responses when
      light social drinkers and binge/heavy social drinkers are exposed to oral ethanol. The
      findings will provide a greater understanding of the brain mechanisms (cerebral blood flow
      and functional connectivity) underlying the association between stress, cortisol release,
      heart rate variability, alcohol craving, and alcohol stimulant and sedative effects. This
      knowledge could be significant in developing new therapies for the treatment of alcoholism.
    

Detailed description: 
      This study was a single-blind, mixed Between Subjects and repeated measures across Alcohol
      and Placebo conditions in separate sessions in a 2 scan neuroimaging experiment. The two
      groups of participants were Moderate Social Drinkers and Binge/Heavy Social Drinkers,
      categorized on the basis of NIAA criteria for moderate non-binge and binge/heavy drinking.
      Subjects were randomly assigned to receive alcoholic or non-alcoholic beer in scanning
      condition 1 or condition 2. Before each scan, they were exposed to 3 12 Oz. alcoholic beer or
      3 12 Oz. non-alcoholic beer via an Alcohol Taste Test (ATT) during which they were asked to
      taste the beers to determine if they were same or different. The order of the two conditions
      was counterbalanced and randomized across participants. Cerebral blood flow (CBF) was then
      measured using Arterial Spin Labeling. In addition to measuring the different effects of
      alcoholic beer vs. non-alcoholic beer on CBF, the investigators also measured subjective
      alcohol effects, alcohol craving, breath alcohol levels, cortisol, and ACTH. Statistical
      tests were performed to determine if these dependent measures were due to Group, Condition,
      or a Group x Condition interaction. Finally, the relationship between these variables and the
      amount of beer consumed at the second post-scan ATT was examined. The post-scan ATT only
      presented with the choice to drink non-alcoholic beer in order to more clearly predict
      behavioral motivation for alcohol from PreATT alcohol response in cortisol, CBF and
      subjective ratings. Data was obtained by research staff, nurse, and MRI technician who were
      blind to condition as were the subjects but PI and project director were not blind.
    

Intervention name(s): Alcoholic Beverage; Non-Alcoholic Beverage; Ethanol
Intervention type(s): Other; Other; Drug
Intervention description(s): In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.; In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
Condition: Acne Conglobata
MeSH terms: Acne Conglobata
Study type: Interventional
Phase: Phase 2

Summary: 
      Apremilast mediates its clinical effect through the cAMP-PKA-NFkappaB pathway which results
      in a clinical picture changes to a decrease of all signs of inflammation.

      Due to the NFkappaB mediated chronical inflammation in the pathogenesis of acne conglobata, a
      treatment with Apremilast seems to be an effective option.

      In this study, treatment with Apremilast (Otezla®) will be performed in patients with acne
      conglobata to observe its preliminary efficacy and safety in an open label, single-centre
      proof of concept study design.
    

Detailed description: 
      Treatment options for acne conglobata are limited and those which are effective can only be
      used in short term such as systemic steroids, antibiotics or retinoids due to their
      association to side effects or potentially teratogenetic effects.

      Apremilast, a specific inhibitor for PDE-4, mediates its clinical effect through the
      cAMP-PKA-NFkappaB pathway which results in a decrease of pro-inflammatory and increase of
      anti-inflammatory cytokines in several types of leukocytes. The clinical picture changes to a
      decrease of all signs of inflammation.

      Due to the NFkappaB mediated chronical inflammation in the pathogenesis of acne conglobata, a
      treatment with Apremilast seems to be an effective option.

      In this study, treatment with Apremilast (Otezla®) will be performed in patients with acne
      conglobata to observe its preliminary efficacy and safety in an open label, single-centre
      proof of concept study design.
    

Intervention name(s): Apremilast
Intervention type(s): Drug
Intervention description(s): Apremilast twice daily 30 mg
Other intervention name(s): Otezla
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Intervention model description: Patients will be treated with Apremilast
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne conglobata; Phosphodiesterase (PDE)-Inhibitor
A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of
      Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176
    


Intervention name(s): Dolutegravir; BMS955176
Intervention type(s): Drug; Drug
Intervention description(s): Dolutegravir; BMS955176
Intervention MeSH terms: Dolutegravir; BMS-955176
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)