bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of BI
      685509 given alone under fasted conditions (Reference, R) compared to the intake after a high
      fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under
      fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted
      conditions (Test 3, T3).

      The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters between the treatments.
    

Detailed description: 
      BI 685509 is a substrate of the drug transporters P-gp and Organic anion transporting
      polypeptide 1B1 and 1B3 (OATP1B1/OATP1B3). Inhibition of these transport proteins may result
      in an increased drug exposure which might impact the safety of the patients. Therefore this
      trial should investigate whether and to what extent the inhibition of P-gp (mediated by
      itraconazole) and the inhibition of OATP1B1/OATP1B3 (mediated by rifampin) affects kinetics
      of BI 685509. Itraconazole and rifampin are recommended probe drugs to test in-vivo
      inhibition of P-gp and OATP1B1/OATP1B3.

      Furthermore the food effect will be investigated in this study.
    

Intervention name(s): BI 685509 After Standardised Breakfast; Itraconazole; Rifampin; BI 685509 Fasted Conditions
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): High-fat high calorie breakfast; Administration of itraconazole together with BI 685509; Administration of rifampicin together with BI 685509; BI 685509, given alone
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
Condition: Safety; Bioavailability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, single dose, 3-way crossover study in
      healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet
      formulation of linaprazan glurate in comparison to a previously studied oral tablet
      formulation under fasting conditions, and to assess the effect of a high fat, high calorie
      meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan
      after the administration of the new oral tablet formulation.
    


Intervention name(s): Linaprazan glurate
Intervention type(s): Drug
Intervention description(s): 100 mg
Other intervention name(s): formerly X842
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Emotional Stimuli in Patients With Disorders of Consciousness
Condition: Disorder of Consciousness
MeSH terms: Consciousness Disorders
Study type: Observational

Summary: 
      Disentangling the vegetative state from the minimally conscious state is often difficult when
      relying only on behavioral observation. In this study, the investigators explored a new
      event-related potential paradigm as an alternative method for the detection of voluntary
      brain activity and cognitive abilities in the patients with disorders of consciousness.
    

Detailed description: 
      Auditory emotional stimuli have potential beneficial effects on cognitive functions and
      consciousness in patients with disorders of consciousness (DOC); however, precise and
      accurate quantitative indices to estimate cerebral activation to different auditory stimuli
      remain scarce. In this study, investigators assessed the response of different brain regions
      to emotional stimuli using ERP(Event-related potential),and further investigated the brain
      activation network.
    

Intervention name(s): emotional sound and neutral sound
Intervention type(s): Other
Intervention description(s): Neutral voice is a meaningless sound (namely the interjection "ah") and the emotional stimuli were the same voice pronouncing the same word with an emotional prosody of happiness or sadness.The stimulus material consisted of positive and negative sound selected from the International Affective Digitalized Sounds (IADS) database.In order to identify experimental stimuli sets that were matched for ratings of arousal and valence between the two valence types,investigators used an algorithm to equate normative valence and arousal ratings for the selection of auditory stimuli.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 healthy controls and 30 patients in dicorders of consciousness(15 VS and 15 MCS)
      
Keywords: ERP;DOC;auditory
Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Study purpose:

      The disease course of idiopathic pulmonary fibrosis (IPF) is variable. During the course of
      the disease some patients will get better, some will stay the same, and others will get
      worse. Currently doctors do not have any way to predict an individual patients disease
      course. The purpose of this study is to determine if 'biomarkers' such as proteins or genes
      isolated at the time of diagnosis can be used to predict the disease course. These
      'biomarkers' will be obtained from samples of blood, from a procedure call a bronchoscopy,
      and in some patients from extra tissue obtained by a surgical lung biopsy.
    

Detailed description: 
      The objectives of this study are as follows:

      Specific Aim 1: Assemble a network of clinical centers to procure biologic samples from
      subjects with recently diagnosed IPF and follow these subjects for at least 48 weeks.
      Specific Aim 2: Correlate and integrate biologically plausible biomarkers of disease activity
      obtained from multiple compartments (SLB, BAL, TBB, blood) from the same subject with
      longitudinal measures of disease progression (change in forced vital capacity, change in
      diffusion capacity for carbon monoxide, acute exacerbation of pulmonary fibrosis, and death).

      General Study Design This study will take place in two phases. During the first phase of the
      study we will identify and collect baseline specimens from subjects with either suspected or
      recently diagnosed (within 48 months) IPF. During the second phase of the study subjects with
      IPF will be followed from between 48 and 80 weeks. Subjects will be followed until the end of
      study (2 year grant award) or until they meet any part of a composite endpoint (death, acute
      exacerbation of IPF, relative decline in FVC of at least 10% or DLCO of 15%). This is a
      prospective cohort study. There is no treatment prescribed or studied as part of this
      prospective cohort study. Subjects are able to utilize any treatments prescribed by their
      physician, including participation in clinical trials as long as they are able to comply with
      the follow up schedule in this study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis
      
Biospecimen description: 
      whole blood, tissue
    
Keywords: IPF; Idiopathic Pulmonary Fibrosis
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects
Condition: HBV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects.
      The study will be conducted in two parts sequentially:

      Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of
      single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16
      healthy subjects.

      Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety
      of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will
      consist of 24 healthy subjects.
    


Intervention name(s): Entecavir
Intervention type(s): Drug
Intervention description(s): Study drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw.
Other intervention name(s): placebo
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Toward an Automated Method of Abdominal Fat Segmentation of MR Images
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be
      used to compare two abdominal fat segmentation techniques. The first technique is already
      validated and in use. The second technique was recently developed and has not been validated.
      The hypothesis is that the second technique will be the faster and more reliable of the two.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will have a wide range of body mass index and other physical characteristics.
      
Keywords: obesity
Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
Condition: Surgery
Study type: Interventional

Summary: 
      The primary objective of this study is to determine if the intraoperative distal esophageal
      (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in
      patients undergoing open colectomy under general anesthesia. This is a randomized study.
    

Detailed description: 
      Participants will be randomized into one of two groups. Patients assigned to vitalHEAT
      warming will have the circulating-water sleeve applied to an arm that will not require
      intravenous access. An esophageal temperature probe will be inserted and connected to the
      anesthesia machine monitoring system. Intravenous fluids will be warmed to 40-42°C.

      As soon as practical after induction, the vitalHEAT warmer will be activated in the
      appropriate patients and set to "high" which is 42°C

      An upper-body forced-air warmer will be positioned over the upper body and exposed arms on
      patients assigned to forced-air heating. The forced air blower will be set to "high" which is
      43°C and activated as soon as practical, usually after prepping and draping.

      Patients in both groups will be otherwise draped per surgical routine. Ambient temperature
      will be maintained near 20°C. Active warming will be maintained until just before extubation.
      The esophageal temperature probe will be removed, and the patient extubated after emergence
      from anesthesia. This will conclude the study and subsequent management will be at the
      discretion of the attending anesthesiologist
    

Intervention name(s): a forced-air warming cover; vital HEAT (vH2) Temperature Management System
Intervention type(s): Device; Device
Intervention description(s): A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.; The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: temperature; surgery; heating device
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Condition: Insomnia; Stress
Study type: Interventional

Summary: 
      Therefore, the aim of this study was to confirm by a randomized double-blind controlled study
      the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects
      presenting mild to moderate sleep disorder associated with anxiety.
    

Detailed description: 
      This study has been designed as a randomized double-blind placebo-controlled interventional
      study.

      Sixty-six subjects were randomly allocated to the control (placebo) or test (Saffr'activ®)
      group.

      A screening visit was scheduled within 4 weeks before Day -7 (study inclusion). At Day -7 and
      Day 0, questionnaires were completed to evaluate sleep quality, stress level and quality of
      life. Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered.
      Then, subjects were supplemented during 6 weeks with the placebo or saffron (Saffr'activ®)
      product, depending on their group. Following the baseline period, two other periods of one
      week were scheduled to collect actigraphy data: between 2 and 3 (from Day 14 to Day 21) weeks
      and between 5 and 6 (from Day 35 to Day 42) weeks after the beginning of the intervention. At
      the middle (Day 21) and at the end of the study (Day 42), questionnaires were completed to
      evaluate sleep quality, stress level and/or quality of life.
    

Intervention name(s): Placebo; Saffron
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects orally ingested, with water, one capsule per day (in the evening); Subjects orally ingested, with water, one capsule per day (in the evening)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind placebo-controlled interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Quantitative Heat Loss With Laminar Air Flow
Condition: Healthy
Study type: Interventional

Summary: 
      With approval of the IRB at the Cleveland Clinic and written informed consent, the
      investigators propose to study up to 20 healthy volunteers in the protocol below as this will
      allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient
      power to detect clinically-meaningful differences between laminar air flow treatments.

      The study has been designed to find out whether heat loss increases significantly in laminar
      air flow operating rooms. Furthermore the investigators will find out whether active warming
      minimizes this heat loss. Increased heat loss increases the amount of perioperative
      hypothermia. It has been shown that perioperative hypothermia is associated with severe
      complications such as an increased incidence of surgical wound infections. On the other hand
      laminar air flow is explicitly used to decrease air-borne infections. Our study results will
      help to optimize thermal management of orthopedic patients.
    


Intervention name(s): standard airflow with forced air warming.; laminar airflow with surgical drapes; laminar airflow with forced air warming; standard airflow with surgical drapes
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects will lie on operating room bed with standard airflow and forced air warming.; Subjects will lie on operating room bed with laminar airflow and forced air warming.; Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.
Other intervention name(s): Subjects will lie on operating room bed with laminar airflow and surgical drapes surrounding bed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: heat loss; laminar airflow; operating rooms
A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
Condition: HIV Infections; Leukoencephalopathy, Progressive Multifocal
MeSH terms: Infections; Communicable Diseases; Leukoencephalopathy, Progressive Multifocal; Leukoencephalopathies
Study type: Interventional

Summary: 
      To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating
      progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.
    


Intervention name(s): Interferon alfa-2b; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Zidovudine
Primary purpose: Treatment
Keywords: Leukoencephalopathy, Progressive Multifocal; Interferon Alfa-2b; Drug Evaluation; Acquired Immunodeficiency Syndrome; Zidovudine
Pain Screening in Refugee Survivors of Torture
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The investigators are evaluating refugee torture survivors who are receiving services at the
      Weill Cornell Center for Human Rights. There are two research questions in this study: if the
      current standard of care results in the under or missed diagnosis of pain and pain syndromes,
      and if a validated pain screening tool can supplement the current standard protocol used in
      the assessments of survivors of torture.
    

Detailed description: 
      The research plan consists of three components:

        1. The Weill Cornell Center for Human Rights will coordinate with the research team
           regarding eligible subjects.

        2. Researchers will contact potential subjects utilizing interpreter services.

        3. Interested participants will be scheduled for an appointment for an examination by a
           pain physician and to complete the Brief Pain Inventory.
    

Intervention name(s): Brief Pain Inventory Short Form
Intervention type(s): Other
Intervention description(s): Brief Pain Inventory Short Form
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination
      with metformin IR 1000mg in Healthy male subjects.
    


Intervention name(s): DWP16001; Metformin IR; DWP16001+Metformin IR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, once daily single dose; Metformin IR 1000mg, Tablets, Oral, BID for 7 days; Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Condition: Burns; Sedation
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care
      units. We are studying whether this drug is cardiovascularly safe in pediatric patients who
      have recently been burned.
    

Detailed description: 
      This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine
      bolus/infusions in acutely burned pediatric patients. The study entails a bolus of
      dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters
      including EKG, heart rate, oxygen saturation, blood pressure, are recorded.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; burn; sedation
First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data
      for G1T38 in humans and will allow further development of G1T38 in patients with cancer.
    


Intervention name(s): G1T38 (CDK 4/6 Inhibitor); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CDK 4/6 Inhibitor; Placebo
Other intervention name(s): G1T38
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for
      fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for
      bedtime use. The present trial is designed to assess the safety and tolerability of
      sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in
      increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1
      and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and
      cyclobenzaprine (5 mg tablets, or 2.4 mg iv).
    


Intervention name(s): SL TNX-102 2.4 mg at pH 3.5; SL TNX-102 2.4 mg at pH 7.1; Cyclobenzaprine Tablet; Cyclobenzaprine IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing; 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing; 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water; 1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment