bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels
Condition: Protein Metabolism
Study type: Interventional

Summary: 
      Dietary protein is digested in the stomach and intestines to smaller peptides and 20
      individual amino acids which, when absorbed by the gut into circulation and taken up by
      skeletal muscle, help stimulate muscle protein synthesis (MPS). Amino acids also provide the
      building blocks for muscle proteins that contribute to lean mass gains and increased strength
      following resistance exercise. Therefore, strategies to efficiently maximize amino acid
      exposure without overconsumption are warranted.

      Oral enzyme supplementation is a candidate approach to optimize amino acid absorption from
      dietary protein and protein supplements. Microbial proteases, approved for dietary supplement
      use, can theoretically speed up the conversion of protein and peptides to amino acids.
      Protease supplements have been marketed to promote muscle strength by optimizing amino acid
      absorption, however the clinical evidence is limited. This work will support that ingestion
      of protease supplements with a meal can allow individuals to more efficiently increase amino
      acid levels from a given amount of dietary protein.
    


Intervention name(s): Protease + Protein; Placebo + Protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participant will consume a microbial protease supplement (31,875 Hemoglobin Unit Tyrosine base (HUT); protease activity) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F); Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Protein; Amino Acids; Branched Chain Amino Acids; Leucine; Postprandial
A Study of Ixekizumab in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare three different formulations of ixekizumab. One
      formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two
      formulations (Test 1 and Test 2) have not been approved. This study will compare how much of
      each of the three formulations get into the blood stream. Information about any side effects
      that may occur will also be collected.
    


Intervention name(s): Ixekizumab
Intervention type(s): Biological
Intervention description(s): Administered SC
Other intervention name(s): LY2439821
Intervention MeSH terms: Ixekizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
Condition: Systemic Juvenile Idiopathic Arthritis (SJIA)
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy observed with canakinumab dose
      reduction in a subgroup of patients in the extension study CACZ885G2301E1.
    

Detailed description: 
      This two-part open-label study was to assess 2 different canakinumab taper regimens in
      patients with clinical remission (inactive disease for at least 24 continuous weeks) on
      canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The
      study was also to collect long term safety and tolerability data on SJIA patients treated
      with canakinumab.
    

Intervention name(s): ACZ885 150 mg (Canakinumab)
Intervention type(s): Drug
Intervention description(s): Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Other intervention name(s): ACZ885 150 mg
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A two-part open-label study that collected long-term efficacy, safety, and tolerability data from SJIA patients receiving canakinumab treatment who had inactive disease at the last visit in Study CACZ885G2301E1 (Cohort 1), and from SJIA patients who were canakinumab treatment-naïve and had active disease at the time of screening for this study (Cohort 2)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA)
Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is
      effective in the treatment of Borderline Personality Disorder.
    

Detailed description: 
      Borderline personality disorder represents a sever clinical condition that affects 1-2% of
      the community and is characterized by a pervasive instability of interpersonal relationships,
      self-image, and affects, as well as a marked impulsivity; up to 10% of the patients commit
      suicide.

      Transference-Focused Psychotherapy (TFP) is one psychotherapeutic approach among five that
      have been manualized and evaluated in RCTs. So far, TFP has not been compared to a control
      condition which is a crucial step in the evaluation of the efficacy of a psychosocial
      intervention.

      This study is an RCT that compares one year of outpatient TFP to treatment by experienced
      community psychotherapists for borderline personality disorder.
    

Intervention name(s): Transference-Focused Psychotherapy; treatment by experienced community psychotherapists
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week; Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: borderline personality disorder; randomized controlled trial; Transference-Focused Psychotherapy; treatment by experienced community psychotherapists
Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.
Condition: Cesarean Section; Shivering
Study type: Interventional

Summary: 
      Shivering is very common after spinal anaesthesia. Many studies have investigated the role of
      adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal
      shivering. Non of the studies n the literature review have investigated the role of different
      dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the
      present study the investigators aimed to compare the effect of different local anaesthetic
      dose in reducing post-spinal shivering.
    

Detailed description: 
      After approval of the ethics committee, department of anaesthesia, Menoufia University and
      written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean
      section were enrolled in this study.

      The pregnant ladies were randomly assigned using a computerised software to one of two
      groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according
      to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine)
      Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).

      Vital signs including heart rate and mean arterial blood pressure intra-operatively until the
      end of surgery.

      The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no
      shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group
      of muscle; 3, muscular activity in more than one muscle group but not generalized movement;
      and 4, shivering involving the movement of the whole body. Shivering score was recorded for
      the whole study period.
    

Intervention name(s): Low dose bupivacaine 0.5% (8mg); High dose bupivacaine 0.5% (10mg)
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml; 10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5
Other intervention name(s): Bupivacaine for spinal anaesthesia.; Bupivacaine for spinal anaesthesia
Intervention MeSH terms: Bupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
Condition: Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study,
      which is planned to enroll 220 subjects with advanced cervical cancer who have failed or
      cannot tolerate first-line or above platinum-based chemotherapy
    


Intervention name(s): IBI310; Placebo; Sintilimab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IBI310 3 mg/kg,Q3W, for a total of 4 cycles; Placebo Q3W, for a total of 4 cycles; Sintilimab 200mg,Q3W
Other intervention name(s): IBI308
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heart Rate Variability in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to understand if there is a relationship between the way that
      emotions are regulated by the brain and the way that heart rate is regulated by the brain.
      The study also seeks to understand whether having depression changes the way that emotions
      and heart rate are regulated.
    


Intervention name(s): Video Task; Imaginal Task
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects are asked to watch a series of six two-minute video clips. The video clips are designed to induce sad or happy emotions or no emotion (neutral) and are taken from movies, documentaries, or instructional videos. There are two videos for each emotion condition. Videos and fixation cross screens are viewed on a laptop computer. In between video clips, patients are asked to quietly look at a fixation cross for one minute, describe their emotional reaction to the video for up to one minute, then again attend to a fixation cross for one minute. A video recording of the frontal view of the participant's face will be made during task performance.; Subjects are asked to think about happy or sad memories for 2 minutes. Subjects are asked to imagine performing neutral tasks, such as buying groceries. Subjects are then asked to think about a memory that makes them feel angry. A video recording of the frontal view of the participant's face will be made during task performance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Heart Rate
A Vasoconstriction Study With LEO 90100
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with
      Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar®
      ointment and LEO 90100 vehicle using a human skin blanching test.
    


Intervention name(s): LEO 90100 Aerosol, foam; Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle; LEO 90100 Aerosol, foam, vehicle; Daivobet® ointment; Dermovate® cream; Synalar® ointment
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Hemophilus Influenzae B
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent
      vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
    


Intervention name(s): DTwP-HepB-Hib Vaccine
Intervention type(s): Biological
Intervention description(s): Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infants,; Immunogenicity,; Safety
Optical Coherence Tomography (OCT) Normative Data Collection Study (S-2013-2)
Condition: Healthy
Study type: Observational

Summary: 
      This study is being initiated to create a normal database including measures of optic nerve
      head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg
      Spectralis OCT device. The range will be determined for each structural parameter across
      normal eyes in Japanese subjects, and the measurements stratified according to age.
    

Detailed description: 
      This multi-center, prospective, observational (non-interventional) study is the second in a
      series to measure structural parameters of the optic nerve head, the peripapillary retinal
      nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is
      conducted in normal Japanese volunteers. The main goal of the study is to provide the range
      of these structural parameters in normal eyes. The study will include at least 224
      (enrollment target: 249) normal volunteers; each study site will recruit 32 to 40 subjects
      with an age range of 18 to 90 years and an approximately equal number of females and males.
      All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination,
      disc photography and visual field testing in one single visit. All examinations performed on
      the subjects are non-significant risk procedures because the medical devices are cleared for
      marketing in Europe and in the U.S.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        At least 224 Japanese subjects (enrollment target: 249 subjects) will be selected from
        qualifying normal volunteers. Age ranges will be from ≥18 to 90 years. Recruitment will be
        from persons who respond to recruitment initiatives at the individual centers or have
        signed a release saying that they are willing to be approached for participation in
        research.
      
Keywords: Normal subjects
Gestation Diabetes N'Teractive Media-based Education (GDnME)
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a prospective randomized controlled trial. Subjects with newly diagnosed
      gestational diabetes will be randomized to either standard of care diabetes education versus
      standard of care plus an interactive educational application.
    

Detailed description: 
      Gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to
      rise. Diet and exercise can effectively control blood sugar levels in 70-85% of women
      diagnosed with gestational diabetes according to the American Diabetes Association. At the
      investigator's institution, only 50-54% of women with this diagnosis effectively reach the
      target blood sugar levels with diet and exercise alone. This has become a more commonly seen
      problem throughout the US. Those that fail to achieve target blood sugar levels require
      medication and have higher risks of poor maternal and neonatal outcomes. Studies have shown
      that an increase in education can increase compliance to diet and education. Specifically,
      media based education that are interactive may more effectively lead to changes in a person's
      behavior.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Media; Education; Gestational diabetes; Pregnancy
Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
    

Detailed description: 
      Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS)
      development based on elaboration of the new methods of clinical diagnostics of МS components
      and highly effective МS clinical management in comparative studying of clinical, laboratory
      and cost effectiveness.

      Participants and methods: This clinical study included 351 adults (184 female) in the
      Scientific research institute of cardiology and internal diseases (Almaty, the Republic of
      Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating
      Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.
    

Intervention name(s): Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin; "Analimentary detoxication"
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day; Vegetable and salt diet
Other intervention name(s): Conventional Patient group; Experimental Patient group
Intervention MeSH terms: Orlistat; Diltiazem; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Diabetes mellitus,; Hypertension; Overweight; analimentary detoxication
Ciropractic Care and Pregnant Women
Condition: Pain, Back; Pregnancy Related; Sleep; Quality of Life
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on
      pain, quality of life and sleep in pregnant women compared to a control group.

      The study is designed as non-randomized controlled trial. Forty-two pregnant women at least
      on the 14th week of gestation will be included. Control group will include women receiving
      regular care, but no chiropractic care. Care will extend for 4 weeks.

      Outcomes measures include sleep quality, pain and quality of life questionnaires.
    


Intervention name(s): Chiropractic adjustments
Intervention type(s): Procedure
Intervention description(s): Chiropractic adjustment is a procedure in which trained specialists (chiropractors) use their hands or a small instrument to apply a controlled, sudden force to a spinal joint. The goal of this procedure, also known as spinal manipulation, is to improve spinal motion and improve your body's physical function.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chiropractic
A TQTc Study for Omaveloxolone
Condition: Health Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled
      study in healthy subjects to assess the effect of the supratherapeutic exposure of
      omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be
      administered as open label. Omaveloxolone and placebo will be administered in a blinded
      fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc
      (C-QTc) analysis is the primary analysis for the study.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone; Moxifloxacin
Intervention type(s): Drug; Drug
Intervention description(s): Omaveloxolone capsules; Moxifloxacin capsules
Other intervention name(s): RTA 408
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: C-QTc; omaveloxolone; TWTc; moxifloxacin
A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an 2-part study. Part 1 will assess the safety, tolerability and pharmacokinetics of
      single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the
      safety, tolerability and pharmacokinetics of repeated doses of FDL176 with and without
      co-administration of FDL169 .
    

Detailed description: 
      This is an open-label, non-randomised, single-sequence 2-part study. Enrolment into Part 2 of
      the study will begin after Part 1 is complete, and a review of safety and pharmacokinetic
      data has been completed.Part 1 will assess the safety, tolerability and pharmacokinetics of
      single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the
      safety, tolerability and pharmacokinetics of repeated doses of FDL176 once daily (QD) with
      and without co-administration of FDL169.
    

Intervention name(s): FDL176 & FDL169 coadministration
Intervention type(s): Drug
Intervention description(s): CFTR corrector and potentiator
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis