bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920
      in Subjects with Early Huntington's Disease.
    


Intervention name(s): PF-02545920; Placebo; PF-02545920; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Treatment for 28 days.; - Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.; 5mg dose
Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.; Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, open-label, fixed sequence, two-period pharmacokinetic (PK)
      study to evaluate the safety and relative systemic bioavailability of topical and oral
      tofacitinib formulations in approximately 14 healthy subjects. Participants will receive a
      single oral dose of tofacitinib 5 mg tablet in Period 1 of the study followed by a 7-day
      washout period. In Period 2, participants will receive repeat administration of Tofacitinib
      Citrate Topical Gel 3.2% BID for 14 days.
    


Intervention name(s): Tofacitinib Citrate
Intervention type(s): Drug
Intervention description(s): Period 1: Xelijanz® 5 mg tablet (tofacitinib citrate) for single oral dosing. Period 2: Tofacitinib Citrate Topical Gel 3.2% for repeat topical dosing BID for 14 days.
Intervention MeSH terms: Tofacitinib
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Prevalence of Endometriosis in a Well Defined Group of Infertile Women
Condition: Endometriosis; Infertility
MeSH terms: Infertility; Endometriosis
Study type: Observational

Summary: 
      At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and
      Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological
      prevalence study based on an electronic search of patient files was performed to determine
      the prevalence of histologically proven endometriosis in a subset of infertile women with a
      regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical
      diagnosis of endometriosis.
    

Detailed description: 
      In this study, the electronic files of all patients who consulted the LUFC since 2003 were
      searched to select women with at least 1 year of infertility, a regular cycle (variation 21 -
      35 days), whose partner had normal sperm according to World Health Organization (WHO)
      criteria (n = 304).

      After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of
      endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our
      study.
    

Intervention name(s): Laparoscopy
Intervention type(s): Procedure
Intervention description(s): Laparoscopy
Other intervention name(s): diagnostic laparoscopy; CO2 laser operative laparoscpy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The electronic files of all patients who consulted the LUFC since 2003 were searched to
        select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days),
        whose partner had normal sperm according to World Health Organization (WHO) criteria (n =
        304).

        After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of
        endometriosis before referral to our centre, 221 (72,7%) infertile women were included in
        our study.
      
Biospecimen description: 
      The diagnosis of endometriosis was always confirmed by histological examination of the
      lesions excised.
    
Keywords: endometriosis; prevalence; fertility; pain; ultrasound
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain after bunionectomy.
    

Detailed description: 
      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain after bunionectomy. The results section
      also includes data from the morphine arms.
    

Intervention name(s): TRV130; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TRV130 1 - 4 mg will be administered every 4 hours; Morphine 4 mg will be administered every 4 hours; Placebo will be administered every 4 hours
Other intervention name(s): Morphine sulphate; Dextrose 5% in water; D5W
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: moderate to severe acute pain; bunionectomy
A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared
      to a reference formulation of vadadustat (B)
    

Detailed description: 
      This is a randomized, open-label, single-dose, two-period crossover study in healthy adults
      to assess the bioequivalence of a test formulation of vadadustat compared to the reference
      formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0
      hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.
    

Intervention name(s): vadadustat reference tablets; vadadustat test tablets
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Other intervention name(s): AKB-6548; AKB-6548
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vadadustat; AKB-6548; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Condition: Disorder of Bone Density and Structure, Unspecified
MeSH terms: Bone Diseases; Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral
      density at a time when healthy adolescents are rapidly accruing bone, with implications for
      peak bone mass and fracture risk in later life. They are also deficient in insulin-like
      growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth
      hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of
      insulin-like growth factor 1, a hormone very important for the maintenance of skeletal
      integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic
      effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents
      and young adults with anorexia nervosa have not been studied. The goal of this proposal is to
      investigate the effects of recombinant human insulin-like growth factor 1 on bone density and
      bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a
      6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients,
      being insulin-like growth factor 1 deficient, will respond to exogenously administered
      recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone
      turnover and an increase in bone density and improvement in bone structure, or maintain bone
      density (in contrast to the decrease in bone density expected in adolescent girls and women
      with anorexia nervosa who are not treated).
    


Intervention name(s): Recombinant human insulin like growth factor-1 (rhIGF-1)
Intervention type(s): Drug
Intervention description(s): Twice daily
Other intervention name(s): Tercica
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Mitogens; Mecasermin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone density; Bone turnover markers; rhIGF-1; Bone structure; Anorexia nervosa
A Study of Merestinib (LY2801653) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on merestinib (standard meal and
      high-fat meal) compared to the fasted state. The study will also measure how much of the
      study drug gets into the blood stream and how long it takes the body to get rid of it. In
      addition, the tolerability of the study drug will be evaluated. Information about any side
      effects that may occur will also be collected. The study will last approximately 28 days.
      Screening is required within 28 days prior to the start of the study.
    


Intervention name(s): Merestinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY2801653
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
SQUEEZE Trial: A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results
      in the best outcomes for children treated for suspected or confirmed septic shock. In this
      study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid
      Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock
      Resuscitation Guidelines, with the assigned resuscitation strategy used to guide
      administration of further fluid boluses as well as the timing of initiation and escalation of
      vasoactive medications to achieve ACCM recommended hemodynamic targets.
    

Detailed description: 
      Please see published pilot trial protocol for more information about the SQUEEZE Trial and
      rationale for this study.
    

Intervention name(s): Fluid Sparing Resuscitation Strategy
Intervention type(s): Other
Intervention description(s): Tier 1: Initiate IV/IO vasoactive medication infusion support immediately. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Clinically unacceptable delay in ability to initiate vasoactive medication infusion(s) and/or 2. Documented intravascular hypovolemia.
Tier 2: Vasoactive medication(s) should be preferentially titrated/escalated to achieve recommended ACCM hemodynamic goals. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Documented intravascular hypovolemia.
Intervention end: Patient is free from vasoactive medication support and shock is reversed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sepsis; Shock; Septic Shock; Fluid Therapy; Resuscitation; Pediatrics; Emergency Medicine; Critical Care
Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this clinical study is to evaluate the effect of repeated oral doses
      of avacopan (30 mg and 60 mg twice daily approximately 12 hours apart [BID]) given under fed
      conditions on the PK of a single dose of simvastatin (40 mg) in healthy volunteers.
    


Intervention name(s): Avacopan; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Orally via capsules; Orally via tablets
Other intervention name(s): CCX168
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Avacopan; CCX168; Simvastatin
Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the
      treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
    

Detailed description: 
      The study will consist of a four-week screening period, a 3-day wash-out period (if
      applicable), a five-week open-label, step-wise dose optimization period and two-week double
      blind randomized crossover treatment period with weekly classroom assessments and a safety
      follow-up by telephone 7 - 10 days after last dose of study drug.
    

Intervention name(s): d-Amphetamine Transdermal Patch; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.
Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.; The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.
Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
Other intervention name(s): d-Amphetamine; Amphetamine; Placebo; Sham treatment
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
Condition: Lung Cancer, Small Cell
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st
      line Small Cell Lung Cancer
    


Intervention name(s): Intravenous topotecan/cisplatin; Intravenous etoposide/cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5.
Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.; Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid.
Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.
Intervention MeSH terms: Cisplatin; Etoposide; Topotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First-line Cisplatin; Small Cell Lung Cancer; topotecan; etoposide; Extensive Disease
Total Intravenous Anesthesia With Remifentanil-propofol Admixture
Condition: Total Intravenous Anesthesia; Propofol; Remifentanil; Bispectral Index Monitoring
Study type: Observational

Summary: 
      Background: Application of total intravenous anesthesia (TIVA) may be considered as
      unpractical when compared with inhalational anesthesia. Although it is mostly not
      recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of
      the study was to investigate the possible clinical drawbacks of using remifentanil-propofol
      admixture (MIXTIVA) for TIVA.
    

Detailed description: 
      ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3
      groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions
      separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol
      proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%,
      Group II or Group III respectively).

      This technique may be considered as a practical implementation for busy ambulatory surgery
      centers performing general anesthesia, but delayed recovery may be predicted with longer
      duration of surgery and anesthesia.
    

Intervention name(s): Remifentanil-Propofol admixture
Intervention type(s): Combination Product
Intervention MeSH terms: Remifentanil; Propofol
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3
        groups (n= 32 for each)
Spinal Cord Stimulation in the Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy
      (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial
      'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing
      gait and walking.

      Spinal cord stimulation is currently an important therapeutic option in the treatment of
      neuropathic pain. Experimental and limited clinical data suggest that this technique might
      also be used to alleviate motor symptoms and improve walking in Parkinsons patients.

      This exploratory study aims at measuring the benefits of spinal cord stimulation on the
      walking capacity of a small number of Parkinsons patients who are not adequately improved by
      drug therapy alone.
    


Intervention name(s): spinal cord stimulation (St Jude Medical)
Intervention type(s): Device
Intervention description(s): implantation of a spinal cord neurostimulation system : St Jude Medical Octrode 3183 (R) peridural lead connected to a St Jude Medical EonC (R) primary cell IPG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating Effects in Intestinal Permeability of Rich in Beta-glucans Pleurotus Eryngii Mushrooms Fermentation Supernatants: an Ex-vivo Study
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the ability of Pleurotus eryngii mushrooms
      fermentation products (FS) to counteract induced intestinal hyperpermeability in human
      colonic tissues in an ex vivo system.
    

Detailed description: 
      Collection of colon biopsies through sigmoidoscopy procedure will take place and the
      collected biopsies will be mounted in Ussing Chambers. Already collected fermentation
      supernatants will be added to the mucosal side of the biopsy together with a stressor and two
      permeability markers, in order to investigate the effects of the fibre fractions on both
      paracellular and transcellular permeability.
    

Intervention name(s): Fermented product of Pleurotus eryngii mushroom
Intervention type(s): Other
Intervention description(s): I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: paracellular permeability; transcellular permability; Pleurotus eryngii; beta glucan; prebiotic
COPD in Obese Patients
Condition: Copd; Obese; Obesity, Abdominal
MeSH terms: Obesity, Abdominal
Study type: Observational

Summary: 
      The study included 176 patients with COPD. The first group included 88 normal weight patients
      with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88
      patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. We assessed
      the frequency of COPD exacerbations in last 12 months, the severity of symptoms such as
      dyspnea, sputum production, fatigue. Spirometry, six-minute walk test and analysis of body
      tissue type composition were performed. BODE index was calculated. Levels of leptin,
      adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (CRP), tumor necrosis
      factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor
      alpha (TNF-α) were measured in blood serum.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study included 176 patients with COPD. According to the Global Initiative for Chronic
        Obstructive Lung Disease (GOLD, 2019) classification, all patients belonged to the group D,
        GOLD 2-4 (GOLD 1 = forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, GOLD 2 = 50
        ≤ FEV1 ≤ 80% predicted, GOLD 3 = 30 ≤ FEV1 ≤ 50% predicted, GOLD 4 = FEV1 < 30% predicted).
        Patients were divided in two groups depending on the body mass index (BMI): 18.5-24.99 kg /
        m2 - normal weight, 30 kg / m2 and more - obesity. The first group (group 1) included 88
        patients with COPD and normal weight: 71 (80.68%) men and 17 (19.32%) women aged from 43 to
        72 years (mean age 62.40 ± 8.83 years). The second group (group 2) - 88 patients with COPD
        and obesity: 64 (72.73%) men and 24 (27.27%) women aged from 50 to 72 years (mean age 62.94
        ± 5.96 years).
      
Keywords: spirometry; inflammation; copd