bioihbjkbjnl/mcl2 huggingface dataset:
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
Condition: Opioid-use Disorder; Opioid Withdrawal; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome; Opioid-Related Disorders; Substance Withdrawal Syndrome
Study type: Observational

Summary: 
      This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid
      agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use
      disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during
      pregnancy, at birth and for 12 months postpartum. This study has the potential to impact
      health service policy and practices in terms of the treatment options of pregnant women with
      opioid use disorder.
    

Detailed description: 
      Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific
      integrity. They will be included after the trial is complete.
    

Intervention name(s): Medically-supervised withdrawal; Opioid agonist treatment; Comprehensive clinical care
Intervention type(s): Other; Other; Behavioral
Intervention description(s): 6-8 day withdrawal with buprenorphine/naloxone; Induction and maintenance with buprenorphine/naloxone; Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Other intervention name(s): Detoxification; Maintenance
Intervention MeSH terms: Analgesics, Opioid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women seeking treatment for opioid use disorder
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial
      that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L
      tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged
      18-50 years.
    


Intervention name(s): tuberculosis vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live recombinant influenza vectored tuberculosis vaccine; Buffer
Other intervention name(s): TB/FLU-04L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; influenza vector; tuberculosis
CANA/Met in Non-diabetic Women With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia,
      hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the
      adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin,
      a classical and common insulin sensitizer that can reduce both hyperinsulinemia and
      hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel
      glucose-lowering medication, have been shown to have positive effects on reducing body
      weight, blood pressure and cardiovascular events in individuals with diabetes mellitus.
      However, evidences related to its management in non-diabetic PCOS women are limited. Hence,
      we want to give canangliflozin combined with metformin to women with PCOS to see its effect
      on insulin resistance.
    


Intervention name(s): Canagliflozin combined with metformin; metformin
Intervention type(s): Drug; Drug
Intervention description(s): Canagliflozin, a novel glucose-lowering medication, has been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events.
Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.; Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are
      otherwise known as electronic cigarettes devices/systems. These may look like conventional
      cigarettes but do not contain tobacco.

      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or
      glycerol), nicotine, water, and flavours.

      This trial is to evaluate the safety and tolerability of an EVP over two years.
    


Intervention name(s): EVP
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Affective and Cognitive Responses to Acute Bouts of Physical Activity and Mindfulness Training
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      The purpose of the present study is to investigate the benefits of mindfulness training
      during an acute bout of physical activity. We will compare the combination of mindfulness
      training and physical activity to mindfulness training alone and physical activity alone in
      three 20 minute sessions.
    

Detailed description: 
      We will investigate whether mindfulness training during a single bout (20 minutes) of
      physical activity influences ratings of perceived exertion, feeling states and physiological
      response (blood pressure and heart rate) during physical activity. Changes in affect and
      cognitive function pre- and post- physical activity bout will also be assessed. The effects
      of mindfulness training during an acute bout of physical activity will be compared to
      mindfulness training alone and acute physical activity alone. This research will contribute
      to larger questions of how to increase rates of physical activity in the general population
      and make physical activity more enjoyable.
    

Intervention name(s): Mindfulness Training Alone; Acute Physical Activity Alone; Acute Physical Activity and Mindfulness Training Together
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.; Physical activity will include a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.; Participants will listen to a pre-recorded mindfulness meditation which will guide them through a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The order the participants participate in the 3 experimental conditions will be randomly assigned.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Physical Activity
Mixed Nuts and Brain Vascular Function
Condition: Brain Vascular Function; Cerebral Blood Flow
Study type: Interventional

Summary: 
      Impaired brain vascular function precedes the development of reduced cognitive performance,
      while brain insulin-resistance is also associated with cognitive decline. The Mediterranean
      diet, which is rich in nuts, may protect against the development of impaired cognitive
      performance. The hypothesis is that long-term mixed nut consumption increases brain
      insulin-sensitivity thereby improving brain vascular function and cognitive performance. The
      primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut
      consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic
      resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow
      is a robust and sensitive physiological marker of brain vascular function. Secondary
      objectives are to investigate effects on the cerebral blood flow response to intranasal
      insulin delivery - a marker of insulin-sensitivity in the human brain - as quantified by ASL,
      and cognitive functioning as assessed with a neuropsychological test battery.
    


Intervention name(s): Mixed Nuts
Intervention type(s): Dietary Supplement
Intervention description(s): Study volunteers will receive daily 60 g of mixed nuts (15 g walnut, 15 g cashew, 15 g hazelnut, 15 g pistachio) for 16 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Participants will receive, in random order, daily 60 g of mixed nuts (mixed nut treatment) or no food products (control treatment) for sixteen weeks, separated by a washout period of at least 8 weeks.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Brain Insulin Sensitivity; Cognitive Performance
Fenfluramine in CDKL5 Deficiency Disorder (CDD)
Condition: CDD
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be enrolling 10 patients, ages 2-18 years old, with a confirmed
      genetic/clinical diagnosis of CDKL5 Deficiency Disorder (CDD) in an open label trial of
      fenfluramine for seizure control. Patients will be titrated over 14 days to a dose of ZX008
      0.8 mg/kg/day (maximum dose 30 mg/d).
    


Intervention name(s): Fenfluramine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 2.5 mg/mL. Manufactured by Andersonbrecon, Inc. on behalf of Zogenix International Limited.
Other intervention name(s): ZX008
Intervention MeSH terms: Fenfluramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKDL5 Deficiency Disorder
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7
      days treatment with LEO 29102 in adult patients with atopic dermatitis.
    


Intervention name(s): LEO 29102 cream; LEO 29102 placebo cream
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily application for 7 days; LEO 29102 placebo cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by ENDS Consumers
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      This study is being conducted to evaluate nicotine uptake, the potential abuse liability, and
      puffing topography associated with the use of an electronic nicotine delivery system (ENDS)
      with tobacco- and menthol-flavored e-liquids in current ENDS consumers.
    


Intervention name(s): RELX ENDS Tobacco Flavor; RELX ENDS Menthol Flavor; Subject Usual Brand ENDS
Intervention type(s): Other; Other; Other
Intervention description(s): Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions; Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions; Ad libitum use of the usual brand product during 8-hour and 5-minute use sessions
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Nicotine; Pharmacokinetics; Abuse Liability; Topography; E-cigarette
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to
      placebo in participants with non-alcoholic steatohepatitis (NASH).
    


Intervention name(s): Placebo; BFKB8488A
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.; Participants will receive subcutaneous (SC) BFKB8488A.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles
Condition: Intrinsic Aging of Skin
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to evaluate the differences in the performance of two well known
      injectable dermal fillers commonly used for the cosmetic treatment of age lines above the
      lips and on the cheeks when compared to each other in the same patient. The products being
      tested are Juvéderm® Ultra and CosmoDerm® 1.
    

Detailed description: 
      This is a single center, prospective, open label, randomized, comparative, split-face study
      in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm®
      Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip
      rhytids and/or radial cheek lines.
    

Intervention name(s): Juvéderm Ultra; Cosmoderm 1
Intervention type(s): Device; Device
Intervention description(s): Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face; Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face
Other intervention name(s): Juvéderm Ultra injectable gel (crosslinked hyaluronic acid); Cosmoderm 1 human-based collagen implant
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of
      cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in
      young children.
    

Detailed description: 
      The use of complementary and alternative therapies by parents of young children remains
      common despite the lack of clinical trials demonstrating either the efficacy or safety of
      these treatments. Two of the more common complementary therapies used in young children with
      a history of recurrent otitis media are preparations of the herb Echinacea purpurea and
      cranial osteopathic manipulative treatment. This study represents one of the first
      double-blinded, placebo controlled trials of each approach in a population of young children
      who presented with three or more recent episodes of acute otitis media.
    

Intervention name(s): Cranial osteopathic manipulative treatment.; Echinacea purpurea; Sham osteopathic manipulative treatment; "Echinacea purpurea" placebo
Intervention type(s): Procedure; Dietary Supplement; Procedure; Dietary Supplement
Intervention description(s): A series of five cranial osteopathic manipulative treatment sessions scheduled over three months, and provided by osteopathic physicians whose practices are limited to osteopathic manipulative treatment. Treatment modalities were limited to cranial osteopathy, balanced membranous/ligamentous tension, and/or myofascial release (applied directly or indirectly).; 1:1 weight-to-volume 50% ethanol liquid extract of the fresh roots and dried mature seeds of Echinacea purpurea. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.; Sham osteopathic treatment consisted of a series of five osteopathic examinations only (palpation of the cranial bones and muscles and other structures) without treatment maneuvers.; An identically labeled placebo contained 50% ethanol, 45% filtered water, food coloring and thickeners. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Otitis media; Echinacea; Osteopathic Medicine
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy
      [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment
      in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
    


Intervention name(s): Alisporivir; Peginterferon alfa-2a; Ribavirin; ALV Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; ALV placebo soft gel capsules administered orally
Other intervention name(s): DEB025; ALV; Pegasys®; PEG; Copegus®; RBV; Placebo
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Cyclophilin inhibitor
Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
Condition: IGA Glomerulonephritis
MeSH terms: Glomerulonephritis; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of
      a progressive renal injury in patients with IgA nephropathy.

      II. Determine which of these patients are destined to progress to further injury in order to
      target them for therapy.

      III. Elucidate the determinants of progression in those patients who exhibit evidence of
      either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients receive oral enalapril daily. Treatment continues for 5 years in
      the absence of unacceptable toxicity.

      Patients undergo renal function studies every 6-12 months for 5 years. Patients undergo renal
      biopsy at 36-48 months after study entry.
    

Intervention name(s): enalapril
Intervention type(s): Drug
Intervention MeSH terms: Enalapril
Primary purpose: Treatment
Keywords: IgA glomerulonephritis; rare disease; renal and genitourinary disorders
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of co-administration of
      glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in
      hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic,
      or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure
      in an AbbVie parent clinical study.
    

Detailed description: 
      This study enrolled HCV infected adults who had experienced virologic failure following
      treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir
      (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie
      hepatitis C virus parent studies:

        -  M13-594 (NCT02640157)

        -  M13-596 (NCT02692703)

        -  M14-172 (NCT02642432)

        -  M14-242 (NCT02493855)

        -  M14-868 (NCT02243293)

        -  M15-410 (NCT02446717)

        -  M15-592 (NCT03222583)

        -  M16-126 (NCT02966795)

        -  M16-135 (NCT03089944)
    

Intervention name(s): Sofosbuvir; Glecaprevir/Pibrentasvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet for oral administration; Coformulated tablet for oral administration; Tablet for oral administration
Other intervention name(s): SOVALDI; ABT-493/ABT-530; MAVYRET; MAVIRET
Intervention MeSH terms: Ribavirin; Sofosbuvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C (HCV); HCV Genotype 1 (HCV GT1); HCV Genotype 2 (HCV GT2); HCV Genotype 3 (HCV GT3); HCV Genotype 4 (HCV GT4); HCV Genotype 5 (HCV GT5); HCV Genotype 6 (HCV GT6); Compensated Cirrhosis; Non-cirrhotics; Virologic failure