bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of
      enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched
      healthy control subjects with normal hepatic function.

      Degrees of hepatic impairment will be determined during screening by the subject's score
      according to Pugh's Modification of Child's Classification of Severity of Liver Disease
    

Detailed description: 
      Subjects will be enrolled in Groups 1 through 4 as follows:

        -  Group 1: Approximately 6 to 8 male and female subjects with moderate hepatic impairment
           (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 1.

        -  Group 2: Approximately 6 to 8 healthy male and female subjects with normal hepatic
           function will be enrolled in Group 2. Subjects in Group 2 will be matched to subjects in
           Group 1 with respect to sex, age (± 10 years), and weight (± 30 pounds).

        -  Group 3: Approximately 6 to 8 male and female subjects with severe hepatic impairment
           (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3.

        -  Group 4: Approximately 6 to 8 healthy male and female subjects with normal hepatic
           function will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in
           Group 3 with respect to sex, age (± 10 years), and weight (± 30 pounds). This study
           employs a staged design as follows.

        -  At least 4 subjects with moderate hepatic impairment must demonstrate satisfactory
           safety and tolerability for up to 8 days after dosing, before subjects with severe
           hepatic impairment may be dosed.

        -  Two subjects with severe hepatic impairment must demonstrate satisfactory safety and
           tolerability for up to 8 days after dosing, before the remaining subjects with severe
           hepatic impairment may be dosed.
    

Intervention name(s): Enasidenib
Intervention type(s): Drug
Intervention description(s): 100 mg enasidenib (CC-90007)
Other intervention name(s): AG-221; AG-221 mesylate; AGI-12910; AGI-12910 mesylate; CC-90007, IDHIFA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic; Pharmacokinetics; Phase 1; Enasidenib; CC-90007
Safety Study of VBY-036 in Healthy Volunteers After 7 Days of Oral Dosing
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and
      tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to
      receive either a placebo or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days
      in a row.
    

Detailed description: 
      Detailed description is noted in Brief Summary.
    

Intervention name(s): VBY-036
Intervention type(s): Drug
Intervention description(s): Cathepsin S inhibitor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Subjects; Safety; Tolerability; VBY036; maximum; pharmacodynamic; pharmacokinetic
Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      To examine pancreatic islet function and incretin function during intravenous and oral
      stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance.
      We hypothesize that islet cell and incretin function is enhanced in response to oral, but not
      intravenous, stimulation - i.e. incretin released from the gut in response to oral
      stimulation play a key role for the enhanced islet function after gastric bypass surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre
        Hospital (Denmark)
      
Biospecimen description: 
      Plasma and serum specimens are retained
    
Keywords: Obesity; Gastric Bypass; Bariatric Surgery; Incretin Function; Islet Function
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy, safety, and tolerability of different
      doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants
      with diarrhea-predominant irritable bowel syndrome.
    


Intervention name(s): Eluxadoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets twice daily; Oral tablets twice daily
Other intervention name(s): JNJ-27018966
Intervention MeSH terms: Eluxadoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome with diarrhea; Irritable bowel syndrome; Diarrhea predominant irritable bowel syndrome; Colonic diseases; Colonic diseases, functional; Digestive system disease; Gastrointestinal disease; Intestinal disease; Colonic pseudo-obstruction; Diarrhea; Signs and symptoms, Digestive
Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction
Condition: Addiction; Smoking
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The aim of this study is to determine whether a powerful technique of noninvasive brain
      stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking
      and constitute a treatment of tobacco addiction.
    

Detailed description: 
      Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world.
      Although most smokers would like to quit, relapse rates remain high. It seems that this
      relapse is linked with the process of craving, which is a powerful desire to smoke elicited
      by smoking deprivation or exposure to situations or cues that are associated with smoking.
      Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and
      especially the right part, is critically involved in processing the craving of smoking.
      Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated
      to be effective in decreasing craving symptoms in cigarette smokers.

      The aim of this study is to determine whether a powerful technique of noninvasive brain
      stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking.
      tDCS is a painless and safe brain stimulation method capable of modulating cortical
      excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is
      thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas
      cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that
      anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco
      addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized,
      double-blind study.
    

Intervention name(s): sham tDCS; active tDCS
Intervention type(s): Procedure; Procedure
Intervention description(s): sham condition as delivered by the stimulator "study mode" (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day; anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco; smoking; tDCS; DLPFC
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
Condition: Retinal Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin
      affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied
      using the Dynamic Vessel Analyzer.
    


Intervention name(s): COX-inhibitor; Nitroglycerin; COX-inhibitor + Nitroglycerin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated; Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated; Combination of COX-inhibitor and nitroglycerin interventions.
Other intervention name(s): Eye drops diclofenac 1mg/ml; Voltaren eye drops; Glyceryl Nitrate
Intervention MeSH terms: Diclofenac; Cyclooxygenase Inhibitors; Nitroglycerin; Ophthalmic Solutions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to
      a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.
    

Detailed description: 
      Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They
      will perform the following three interventions on consecutive days and will repeat them after
      a week. During these days the time table for prescribed physical activities and therapies
      will be kept in a comparable fashion.

      The following 3 interventions will be performed in randomized order:

      Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as
      prescribed during ADL

      Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL

      Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to
      the prescribed oxygen flow rate, for 12h

      The following week the same measurements will be repeated. The mean of the corresponding two
      measures will be calculated for each approach.
    

Intervention name(s): Oxymizer® compared to CNC; Oxymizer® compared to CNC; Oxymizer® compared to CNC
Intervention type(s): Device; Device; Device
Intervention description(s): Oxygen Saturation measurement for 12 h with CNC; Oxygen Saturation measurement for 12 h with Oxymizer®; Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)
Other intervention name(s): Conventional Nasal Cannula (CNC); Oxymizer; Oxymizer with reduced flow rate (-1l/min)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxymizer; Oxygen conserving device; Conventional nasal cannula (CNC); Idiopathic pulmonary fibrosis
The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial
Condition: HIV
Study type: Interventional

Summary: 
      This randomized controlled trial will explore whether the provision of oral HIV self-test
      kits to women can increase HIV testing among their male partners. The study will recruit
      adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be
      randomized to either receive two HIV self-tests or to receive counseling referring their
      partner to HIV testing (standard of care). Over a 3 month period, we will obtain information
      from study participants on how many sexual partners they offered the tests to, the
      receptivity of their sexual partners to using self-tests, and the incidence of any adverse
      events. We will compare partner testing rates in intervention and control groups.
    

Detailed description: 
      This randomized controlled trial will enroll women, ages 18-39, attending antenatal care
      (ANC) and post-partum care (PPC) at 3 sites in Kisumu, Kenya. The study's purpose is to
      investigate whether offering multiple HIV self-tests to women can increase the likelihood
      that either partner or couples HIV testing takes place.

      Women who are randomized to the intervention group will be provided with multiple oral
      self-tests as well as information about how to use the tests and where to seek care if
      necessary. These women will be encouraged to give the self-tests to their sexual partners and
      encourage those partners to take a self-test. Women who are randomized to the control group
      will be offered the standard counseling to refer their partners for clinic-based HIV
      counseling and testing. Our hypothesis is that the intervention group will have higher uptake
      of HIV testing by women's partners within 3 months of enrollment in the study than the
      control group. Participants in the study will complete a baseline interview and a follow-up
      interview at 3 months post-enrollment. Qualitative in-depth interviews will be conducted with
      a subset of participants in the intervention group.
    

Intervention name(s): HIV self-test
Intervention type(s): Behavioral
Intervention description(s): Two self-test kits will be distributed to women, each containing the following:
One standard OraQuick ADVANCE I/II test kit
Written pre-test information including test instructions in written and pictorial form
A phone number that participants can call to obtain additional information
Two vouchers with unique identifying numbers which can be redeemed at confirmatory testing
Other intervention name(s): Oraquick
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV self-testing; randomized controlled trial; Kenya
Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Mild to Moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blinded, randomized, placebo-controlled study will be performed to evaluate the
      efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease
      for 26 weeks.
    

Detailed description: 
      Alzheimer's Disease (AD) is the most prevalent neurodegenerative disorder in The United
      States affecting approximately 5.4 million Americans. AD is characterized by progressive loss
      in memory and as well as a decline in the ability to learn that is associated with neuronal
      death. Well known hallmarks of AD are neuritic plaques and neurofibrillary tangles and
      extensive inflammation. Currently, no treatment has been developed to fully cure or prevent
      the progression of dementia that is associated with AD.

      AR1001 is a polypharmacological drug candidate being developed as a treatment for AD and
      shows great potential with favorable attributes for a central nervous system (CNS) drug
      (i.e., high specificity and potency, as well as good pharmacokinetic, bioavailability, CNS
      penetration, and ensured safety).

      The clinical study of AR1001 aims to evaluate the efficacy and safety of AR1001 as a
      potential treatment for AD. Based on the preclinical results, AR1001 could be an effective
      treatment option with a mechanism of action that has not been explored for AD indication.
    

Intervention name(s): AR1001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AR1001 Active Oral Tablet; Placebo Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After the first 26 weeks, subjects can participate in an optional extension study to receive either 10 mg or 30 mg AR1001 for another 26 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
Condition: Cardiac Failure; Myocardial Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the experimental medication BMS-986224 in
      participants with varying levels of renal function.
    


Intervention name(s): BMS-986224
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study was to assess the long-term safety of daily doses of ospemifene 60
      mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a
      uterus.
    


Intervention name(s): Ospemifene 60Mg Oral Tablet
Intervention type(s): Drug
Other intervention name(s): Osphena®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopausal symptoms; Vulvar and vaginal atrophy in menopausal women; Vaginal atrophy; Urogenital atrophy
Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
Condition: Central Venous Catheterization; Surgery
Study type: Interventional

Summary: 
      This study aims to find out the effect of contra lateral head rotation to distance and
      overlapping of internal jugular vein and carotid artery at cricoid cartilage level by
      ultrasound guidance on the Malay race in Indonesia
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. 34 subjects were enrolled by using consecutive sampling method.
      Sample size was calculated by using numeric analytic comparative paired formula with repeated
      measurement. Inclusion criteria were patients with ASA score 1 and 2, aged between 18-60
      years old, no anatomical abnormality in neck. Exclusion criteria were patients who were
      either obese, has history of previous central venous catheter cannulation, and limitation on
      contralateral head movement. Drop out criteria was abnormalities of anatomical IJV and CA.
      Basic demographic data, such as sex, age, body weight and height, body mass index were
      recorded. Patients were positioned in Trendelenburg (15°) position. Identification triangle
      of Sedillot at cricoid level in right neck with palpation at angle 0°. USG probe was placed
      upright at the top of triangle of Sedillot at cricoid level. Identification of IJV and CA was
      shown in transversal view then the IJV to CA distance and overlap ratio was calculated.
      Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance
      and overlap ratio of IJV and CA was calculated in each angle.
    

Intervention name(s): Triangle of Sedillot identification using ultrasonography
Intervention type(s): Procedure
Intervention description(s): Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: carotid arteries; central venous catheterization; jugular veins; Malay race; ultrasonography
Management of OAB in Female Patients .
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      The objective of this study is to compare the effectiveness of mirabegron, solifenacin,
      tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a
      double-blinded prospective randomized placebo-controlled trial.
    


Intervention name(s): Solfenacin; Mirabegron; Tadalafil 5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pills taken once day; pills taken once day; pills taken once day
Intervention MeSH terms: Tadalafil; Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery
Condition: Epidural Analgesia, Obstetric
Study type: Interventional

Summary: 
      To evaluate the levels of morphine in a patient's blood when morphine is given into the
      epidural space in the form of DepoDur® either alone or following a dose of lidocaine also
      given in the epidural space.
    

Detailed description: 
      To evaluate the levels of morphine in a patient's blood when morphine is given into the
      epidural space in the form of DepoDur® either alone or following a dose of lidocaine also
      given in the epidural space. Specifically, we are looking at pregnant women undergoing
      cesarean delivery who will be receiving these medications. A secondary objective is to
      evaluate how well DepoDur® works for pain control, as well as its safety, when it is given
      either alone or following a dose of epidural lidocaine.
    

Intervention name(s): DepoDur following epidural lidocaine; DepoDur following spinal anesthetic
Intervention type(s): Drug; Drug
Intervention description(s): All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.
Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration.; Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.
Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug.
Other intervention name(s): DepoDur™; EREM (Extended Release Epidural Morphine); DepoDur; EREM; extended release epidural morphine
Intervention MeSH terms: Lidocaine; Morphine; Anesthetics
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment