bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Direction of Movement While Walking
Condition: Changes in Blood Flow to the Brain; Changes Depending on the Form of Walking
Study type: Observational

Summary: 
      The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow
      in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of
      walking training - walk forwards and backwards, with closed and open eyes.
    

Detailed description: 
      In the third minute of training walking a significant increase in blood flow velocity was
      recorded, both in right and left middle cerebral arteries. It was observed in the left artery
      during all forms of training. In the right artery it occurred only during three forms of
      difficult training, and was preceded by significant decrease in blood flow in the first
      minute of the gait with eyes closed. The output values of the rate of blood flow in both
      right and left middle cerebral arteries became progressively reduced in the successive stages
      of gait. Pressure and pulse rates did not correlate with the variables of blood flow velocity
      in middle cerebral arteries.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20 healthy subjects (11 men, 9 women, average age 23.94) participated in a study measuring
        the speed of blood flow in middle cerebral arteries using transcranial Doppler
        (transcranial Doppler Sonography) while walking on a treadmill.
      
Keywords: blood flow in the middle cerebral artery of brain
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
Condition: Hepatic Cirrhosis; Alcoholism
MeSH terms: Liver Cirrhosis; Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of varying degrees of hepatic function
      (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in
      subjects.
    


Intervention name(s): Pasireotide
Intervention type(s): Drug
Intervention description(s): Single subcutaneous injection of 600 µg of Pasireotide.
Intervention MeSH terms: Pasireotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pasireotide; PK profile,; Single dose; Pasireotide subcutaneous injection; Safety; Mild hepatic impaired patients; Moderate hepatic impaired patients; Severe hepatic impaired patients
Mechanisms of Psychosocial Chronic Pain Treatments
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Psychosocial interventions are attractive options for treating chronic low back pain, and
      many approaches now have strong support for efficacy. However, few empirical data address
      whether psychosocial pain treatments work because of mechanisms specified by theory, and thus
      investigators know very little about HOW our treatments work. It may be that different
      treatments work via distinct pathways that are specific to a given treatment (single effect
      model), or it may be that different treatments work to the extent they all operate via key
      mechanisms that they share (additive effects model). Examination of specific and/or shared
      effects on outcomes of mechanisms will provide theoretical and empirical rationale for
      enhancing procedures and techniques most closely linked to strong outcomes and incorporating
      them into future interventions, while limiting the use of others that may be revealed as
      inert.
    


Intervention name(s): cognitive therapy; mindfulness training; behavioral therapy; treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain; psychosocial interventions; mechanisms
Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil)
Condition: Helminthiasis
MeSH terms: Helminthiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18
      mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing
      fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing
      (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios
      do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose,
      three-period crossover trial in healthy volunteers.
    


Intervention name(s): T1, T2, T3; T1,T3,T2; T2,T1,T3; T2,T3,T1; T3,T1,T2; T3,T2,T1
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets); T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets); T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets); T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets); T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets); T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
Other intervention name(s): Treatment 1-2-3; Treatment 1-3-2; Treatment 2-1-3; Treatment 2-3-1; Treatment 3-1-2; Treatment 3-2-1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and tolerability of indacaterol maleate/mometasone
      furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate
      asthma.
    


Intervention name(s): indacaterol maleate / mometasone furoate; placebo to indacaterol maleate/mometasone furoate
Intervention type(s): Drug; Drug
Intervention description(s): Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.; Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
Other intervention name(s): QMF149
Intervention MeSH terms: Mometasone Furoate; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; spirometry; lung function; serum cortisol; serum potassium; plasma glucose
Pneumococcal Reference Standard
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the
      pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose
      of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood
      samples in order to increase the reference serum supply. Study participants will include 250
      healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews,
      blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the
      deltoid muscle of the arm. Participants will be involved in the study for approximately 17
      weeks.
    

Detailed description: 
      Serum 89SF is a pooled sera from individuals vaccinated with a 23 valent pneumococcal
      polysaccharide vaccine collected in the late 1980s. The 89SF standard for ELISA is running
      low (2-3 year supply) and is insufficient to serve for opsinophagocytosis assay (OPA), which
      requires large volumes. The objective of this study is to immunize healthy volunteers with
      licensed polyvalent pneumococcal polysaccharide vaccine (Pneumovax 23) with subsequent blood
      donation in a quantity sufficient to make reference sera. Two hundred fifty volunteer
      subjects will be recruited from a total population of up to 600. Study participants will
      include healthy men and nonpregnant females, ages 18-45. Subjects will undergo physical
      examination by a licensed clinician, subject interview, and clinical laboratory and serologic
      testing. Potential subjects must provide written informed consent and meet all eligibility
      criteria. On Day 0, subjects will receive 0.5 mL pneumococcal vaccine (Pneumovax 23) in the
      deltoid muscle. Volunteers will remain in the clinic for 30 minutes following immunization
      for observation of any adverse reactions. Volunteers will return to clinic in 10-35 days
      following immunization to donate 1 unit (approximately 500 mL) of blood. Volunteers will
      return for a second donation of 1 unit of blood not less than 8 weeks and not more than 14
      weeks following the first donation.
    

Intervention name(s): Pneumovax 23
Intervention type(s): Biological
Intervention description(s): Licensed pneumococcal vaccine (Pneumovax 23).
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcal vaccine, Pneumovax, reference sera, serum 89SF
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune
      response to kill cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who
      have chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of vaccination with autologous heat shock protein 70 in
           patients with chronic phase chronic myelogenous leukemia.

        -  Determine the toxicity of this vaccination in these patients.

      OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat
      shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70
      intradermally once weekly for 8 weeks.

      Patients are followed for 2 weeks.
    

Intervention name(s): recombinant 70-kD heat-shock protein
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive
Effects of Iron on Exercise Capacity During Hypoxia
Condition: Healthy Volunteers
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      During alveolar hypoxia, for example at high altitude or in patients with respiratory
      disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit
      exercise performance. Intravenous iron supplementation has recently been shown to reverse
      pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary
      hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized
      that intravenous iron supplementation would enhance exercise capacity during alveolar
      hypoxia.
    


Intervention name(s): Iron sucrose.; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Volunteers will receive an intravenous infusion of 200 mg iron sucrose, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.; Volunteers will receive an intravenous infusion of 100 ml normal saline, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
Other intervention name(s): Iron sucrose = Venofer
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 201335 NA in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK)
      of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS)
      following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20
      mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the
      highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase)
      were assessed in healthy male subjects with GS over a 28-day continuous drug administration
      period.
    


Intervention name(s): BI 201335 NA; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Condition: Uterine Cervical Neoplasms; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to assess the acceptability and effectiveness of utilizing
      vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for
      HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs)
      among sexually active female-to-male (FTM) transgender adults.
    

Detailed description: 
      This observational study will examine sexual health in a bio-behavioral cross-sectional
      mixed-methods design among 150 FTM patients in Boston, Massachusetts, and will determine the
      acceptability as well as collect epidemiologic data on the comparative performance
      characteristics of several biological screening modalities in this patient population.
      Patients and stakeholders are key partners throughout the project and are involved in all
      phases of study development, implementation, and plans for dissemination.

      Eligible participants will participate in a one-time clinical visit. Following written
      consent, the one-time clinical visit will include: 1) Quantitative assessment; 2) Collection
      of biological specimens/biomarkers (HPV DNA vaginal self-swab, HPV DNA cervical swab
      collected by provider, Pap test with cytology, STI testing self- and provider-collected); 3)
      Qualitative Interview.

      A series of national, online focus groups with FTMs, providers, and key stakeholders will
      occur to gather information on the sexual health needs of FTM individuals outside the Boston
      area and to ensure that the dissemination of study findings take differing demographic
      concerns into consideration.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study aims to enroll 150 female-to-male (FTM) individuals, ages 21-64. Participants
        will be recruited from the existing FTM patient population at Fenway Health, as well as via
        community outreach in the greater Boston area. A diverse sample is anticipated; the aim is
        to recruit 40% racial/ethnic minority FTMs.
      
Keywords: transgender; female-to-male; cervical cancer; HPV; sexual health
Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL /
      Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10
      mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to
      intraocular pressure (IOP)-lowering efficacy.
    

Detailed description: 
      This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I
      (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits
      (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and
      Month 3. Following washout of any IOP-lowering medication, subjects who meet all
      inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the
      specified range during this period will be randomized to Phase II.
    

Intervention name(s): Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension; Brinzolamide 10 mg/mL eye drops, suspension; Brimonidine 2 mg/mL eye drops, solution; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inactive ingredients used as a placebo for masking purposes
Other intervention name(s): AZOPT™
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OAG; OHT
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Condition: Hepatitis C, Chronic; Non-Alcoholic Fatty Liver Disease
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      HepQuant tests are new liver tests that are being developed to accurately measure liver
      function with sensitivity and specificity while being safe and non-invasive. The primary goal
      of this study is to define the intra-individual reproducibility of the HepQuant tests, that
      is, to see if a person is given the tests several times that the test results are essentially
      the same each time. Subjects for this study will include healthy controls and patients with
      chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV)
      infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis
      (NASH). The HCV and NASH patients will include men and women, and those with early stage and
      late stage liver disease as defined by the amount of fibrosis observed in their liver
      biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests
      on three separate days within the span of one month. The hypothesis of this study is that
      HepQuant tests will reproducibly report liver function in healthy controls and patients with
      all stages of chronic HCV and NASH liver disease and that liver function will decrease as the
      amount of liver fibrosis increases in the chronic liver disease patients.
    


Intervention name(s): Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
Intervention type(s): Device
Intervention description(s): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:
20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.
40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.
The 3 test visits will be on separate days within a span of 30 days
Other intervention name(s): Cholic acid-24-13C; Cholic acid-2,2,4,4-d4
Intervention MeSH terms: Cholic Acids
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatitis; Fatty Liver
Effect of Propofol on Internal Anal Sphincter Pressure During ARM
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      Background and Aim: An anorectal manometry (ARM) is a common test in the evaluation of outlet
      obstruction in constipation. In children under 6 yo, anesthesia is often used for patient
      comfort and compliance. The choice of anesthesia for ARM varies from center to center and
      includes the use of ketamine, inhalation agents, and propofol. With the increased use of
      propofol, our aim is to determine the effects of propofol on resting anal sphincter pressure
      while performing an ARM under general anesthesia.

      Hypothesis: Propofol administration leads to a decrease in internal anal sphincter pressure.

      Methods: This is a prospective, single center, observational study of the effect of propofol
      on the internal anal sphincter pressure. Pediatric patients between the ages of 2-6 years who
      require an anorectal manometry for chronic constipation will be offered enrollment.
      Anesthesia was required for patient compliance and comfort and conducted by an
      anesthesiologist. Sevoflurane was the inhalational agent used for induction. At Massachusetts
      General Hospital (MGH), 1 mg/kg of propofol bolus is routinely given at completion of the ARM
      test to reduce emergence delirium. The manometric probe was kept in place with continuous
      measurement of baseline internal anal sphincter pressure while propofol was administered. We
      measured changes to internal anal sphincter pressure and time to return to baseline.

      Results: The primary outcomes will be change of internal anal sphincter pressure from
      baseline and time to return to baseline.

      Discussion: The proposed investigation may demonstrate that propofol has an effect on the
      internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal
      manometry.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal
        manometry including propofol per standard of care