bioihbjkbjnl/mcl2 huggingface dataset:
A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose escalation, first-in-human study evaluating the safety, tolerability,
      pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects and
      subjects with moderate- to- severe atopic dermatitis
    

Detailed description: 
      This is a phase 1, randomized, two-part, double-blind, placebo-controlled, dose-escalation,
      first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics
      and immunogenicity of AK120 in healthy subjects (part 1, single ascending dose) and subjects
      with moderate- to- severe atopic dermatitis(part 2, multiple ascending dose)
    

Intervention name(s): AK120 or placebo- Part 1- Cohort 1; AK120 or placebo- Part 1- Cohort 2; AK120 or placebo- Part 1- Cohort 3; AK120 or placebo- Part 1- Cohort 4; AK120 or placebo- Part 1- Cohort 5; AK120 or placebo- Part 2- Cohort 1; AK120 or placebo- Part 2- Cohort 2; AK120 or placebo- Part 2- Cohort 3; AK120 or placebo- Part 2- Cohort 4
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects; Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects; Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects; Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects; Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects; Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis; Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis; Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis; Multiple high doses of AK120 or placebo are administered subcutaneously as a bi-weekly dose for a total of three doses to subjects with moderate-to-severe atopic dermatitis.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women
Condition: Postmenopausal Women
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the investigators will test the hypothesis that acute consumption of inorganic
      nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood
      pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal
      women. Understanding and improving artery function and blood pressure regulation in women is
      important because they undergo accelerated arterial stiffening after menopause and have much
      larger increases in blood pressure when they exercise compared with either premenopausal
      women or men of similar age.
    

Detailed description: 
      Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP)
      responses during exercise compared with either premenopausal women or men of similar age.
      Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall
      thickening, future hypertension, adverse cardiovascular events, and mortality. Previous
      studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting
      and exercising BP responses in older adults. However, these studies included both sexes and
      did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control).
      Thus, the potential BP lowering effects of nitrate supplementation per se have not been
      established in postmenopausal women. The present study examines the acute (single dose)
      effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP,
      arterial wave properties, etc), and physiological responses to handgrip exercise in
      metabolically healthy post-menopausal women.
    

Intervention name(s): Beetroot juice; Beetroot juice placebo
Intervention type(s): Drug; Drug
Intervention description(s): This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).; This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
Other intervention name(s): Beet-It Organic Shot; Beet-It Organic placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dietary nitrate supplementation; Beetroot juice
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of terbinafine
      hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet
      under fed conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Terbinafine hydrochloride 250 mg tablets
      and Lamisil® 250 mg Tablets administered as 1 x 250 mg tablet in healthy subjects under fed
      conditions.
    

Intervention name(s): Terbinafine Hydrochloride Tablets, 250 mg
Intervention type(s): Drug
Intervention description(s): Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
Other intervention name(s): Lamisil® 250 mg Tablets
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; crossover; Terbinafine hydrochloride; fed
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to validate [11C]ORM-13070 as an alpha2C-adrenoceptor imaging
      agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor
      occupancy.
    


Intervention name(s): Atipamezole; Atomoxetine; Ketamine; Cold pressor test; Insulin; Placebo
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug
Intervention description(s): Administration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion; A single dose of 1.2 mg/kg of atomoxetine administered orally; A single dose of ketamine (approximately 60 mg) administered as an intravenous infusion; 30-45 min cold pressor test of the foot; Insulin administered as an intravenous infusion to induce hypoglycemia; A single dose of placebo (capsules) administered orally
Other intervention name(s): ANTISEDAN VET; Strattera; Ketalar; Insulin Actrapid
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Ketamine; Atomoxetine Hydrochloride; Atipamezole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: alpha2-adrenoceptor; receptor occupancy; positron emission tomography; [11C]ORM-13070; striatum; brain; noradrenaline; norepinephrine; endogenous; binding; Validation studies
Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15,
      30 and 60 mg after single oral administration in healthy Korean male subjects.
    


Intervention name(s): Tolvaptan 15mg or 30mg or 60mg or Placebo
Intervention type(s): Drug
Intervention description(s): Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Korean male
Enteral Feeding in the Post-Injury Open Abdomen
Condition: Trauma to the Abdomen
MeSH terms: Abdominal Injuries
Study type: Observational

Summary: 
      The purpose of this study is to determine if Enteral Feeding (EN) in patients with a
      traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN
      will be compared to those who remain nil-per-os (NPO). Additionally, an internal study
      control will be performed by analyzing concurrent injured patients requiring an open abdomen
      who did not have a bowel injury.

      Specific aims:

      Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves
      fascial closure rate compared to patients who remain NPO.

      Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces
      infectious complications compared to patients who remain NPO.

      Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a
      lower mortality rate compared to patients who remain NPO.
    

Detailed description: 
      Fascial closure is determine by the primary physician and should be recorded in the operative
      record. This record will be accessed to determine if this variable is accomplished.
      Additionally, any dehiscence complication will be recorded (which would impact the long-term
      fascial closure rate). Infectious complications (abscess, pneumonia, etc) will be adjudicated
      by the primary clinician and any record of this in the patient chart will be recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients requiring an open abdomen following trauma will be prospectively followed.
Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs)
      (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could
      be related to RA disease severity.
    

Detailed description: 
      Rheumatoid Arthritis (RA) is a chronic inflammatory arthritis of substantial morbidity. Serum
      biomarkers such as Rheumatoid Factor and anti-cyclic citrullinated peptide assist with
      disease diagnosis and prognostic assessment of future disease activity. 14-3-3 eta is a
      relatively new RA serum biomarker. The 14-3-3 family of proteins were named based on
      chromatographic elution properites and are ubiquitously expressed intracellular chaperon
      proteins. The isoform relevant in RA is 14-3-3 eta. 14-3-3 eta provides additional
      information about RA to the clinician-it assists in making diagnosis, provides prognostic
      assessment of disease severity, and provides insight regarding response to therapy. Thus,
      14-3-3 eta serves as an important mechanistic biomarker informing the clinician about
      patient's RA.

      14-3-3 eta is the product of the YWHAH gene, located on chromosome 22q12.3. It is about 13
      kilobase long, consisting of two exons separated by a single intron. This gene has been
      implicated in linkage studies to bipolar disorder and schizophrenia. Six YWHAH single
      nucleotide polymorphisms (SNPs) were identified in a prior study: rs2246704, rs2853884,
      rs3747158, rs4820059, rs7291050, and rs933226. rs2246704 was associated with bipolar disorder
      (Odds Ratio (OR) 1.31, p=0.03) and psychotic BP (OR 1.66, p=0.002). All six SNPs are
      intronic. It was hypothesized that one or several of these 6 single nucleotide polymorphisms
      (SNPs) could be related to RA disease severity.
    

Intervention name(s): TaqMan SNP analysis
Intervention type(s): Diagnostic Test
Intervention description(s): TaqMan SNP analysis of the YWHAH gene
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        RA patients at an academic medical center
A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-arm, open-label, non-randomized study will evaluate the effect of
      danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in
      healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and
      escitalopram. The anticipated time of the study is 6 weeks.
    


Intervention name(s): danoprevir; escitalopram; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral doses of danoprevir; oral doses of escitalopram; oral doses of ritonavir
Intervention MeSH terms: Ritonavir; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
Condition: Idiopathic Clubfoot (Talipes Equinovarus)
MeSH terms: Clubfoot; Talipes; Equinus Deformity
Study type: Interventional

Summary: 
      The purpose of this study is to continue the work from the previous review study and
      determine the effectiveness of Botox in treating patients with idiopathic clubfoot by
      comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment
      group) to those treated with manipulation and casting plus placebo (control group).

      The null hypothesis is that manipulation and casting plus Botox is not an effective treatment
      for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting plus Botox
      is an effective treatment for idiopathic clubfoot.
    

Detailed description: 
      The study timeline is divided into five phases which have been defined based on experiences
      with the previous review and with clubfoot treatment in general. These phases are as follows:
      1) study treatment (Botox injection versus placebo); 2) post-treatment manipulation and
      casting; 3) bracing and full-time maintenance; 4) intent-to-treat intervention for management
      of first-time non-responders (NR1) and first-time recurrences (Rec1) post-study treatment;
      and 5) rescue intervention for management of second-time non-responders (NR2) and second-time
      recurrences (Rec2) post intent-to-treat intervention.

      We will utilize a double-blind randomized control trial to assess the efficacy of Botox in
      the treatment of idiopathic clubfoot. Patients, parents, both participating surgeons, and
      members of their clinical and research teams (physiotherapist, occupational therapist,
      orthopaedic technologist, orthotist, research assistant) will be blinded to the study group
      (Botox group versus control group) each subject belongs in. The pharmacist preparing the
      syringes for injection will not be blinded.

      Subjects will be randomly assigned to receive either Botox (Treatment group) or placebo
      injection (Control group). Subjects in the treatment group will receive Botox injections
      dosed at 10 IU/kg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline. If the
      child has bilateral clubfoot, the contents will be divided equally for injection into each
      gastrocnemius. Placebo injections for the control group will contain unpreserved saline at
      0.1cc/kg (such that a 4.5 kg subject will receive 0.45cc).
    

Intervention name(s): Botox
Intervention type(s): Drug
Intervention description(s): See Detailed Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch
           Relief Cream).

        2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially
           available cosmetic product
    


Intervention name(s): Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543); New cosmetic Bepanthen product: Pumpkin (BAY207543); Stelatopia (cosmetic comparator)
Intervention type(s): Device; Other; Other
Intervention description(s): 2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares; Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject; Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Intervention MeSH terms: Pantothenic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety; Efficacy; Atopic dermatitis; Cosmetic products
Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals
Condition: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory
      markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of
      Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg
      zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the
      investigators' diet . At the first and the end of the intervention,weight, body mass index
      (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin,
      hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.
    


Intervention name(s): zinc sulfate; corn starch
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1 zinc sulfate capsule for 15 weeks; 1 corn starch capsule for 15 weeks
Other intervention name(s): placebo
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      pharmacodynamics of MEDI-546 in Japanese SLE patients.
    

Detailed description: 
      A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and
      tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against
      type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus
      erythematosus (SLE)
    

Intervention name(s): MEDI-546; MEDI-546; MEDI-546
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japan; Phase2; Safety; Tolerability; Systemic Lupus Erythematosus; SLE, MEDI-546
Low Back Health Education on Physical Function and Body Awareness in Academicians
Condition: Low Back Pain, Mechanical
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      This study was planned to investigate the effect of back health education given to
      academicians on physical function and body awareness. The participants of the intervention
      group received back health education (Back School) in the classroom. After the education
      program, they participated in exercise training for six weeks (one day a week). The control
      group was only given an informative brochure on back health and asked to read it.
    

Detailed description: 
      This study was planned to investigate the effect of back health education given to
      academicians on physical function and body awareness. The study was completed with a total of
      94 (49 female and 45 male) volunteer academicians (intervention group n=47, control group
      n=47) between the ages of 25-65, with a mean age of 43.22±10.924 years. The participants of
      both groups were evaluated before and after the 6-week education and training. In order to
      evaluate physical functions of the participants, One Leg Standing Test (eyes open and
      closed), Half Squat Test, Curl-Up Test, and Sit and Reach Test were used. The Body Awareness
      Questionnaire (BAQ) was used to assess body awareness of the sample. The participants of the
      intervention group received back health education (Back School) in the classroom. After the
      education program, they participated in exercise training for six weeks (one day a week). The
      control group was only given an informative brochure on back health and asked to read it.
    

Intervention name(s): exercise program
Intervention type(s): Other
Intervention description(s): The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 94 (49 female and 45 male) volunteer academicians divided into two groups:intervention group (n=47) and control group (n=47), randomly.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Academician; physical function; body awareness; low back health; back school