bioihbjkbjnl/mcl2 huggingface dataset:
Buprenorphine's Dose Response Curve
Condition: Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a residential study that looks at the effects of buprenorphine in persons who abuse
      but are not dependent on opioids. Animal studies show that very high doses of buprenorphine
      produce less effects than mid-range doses. This suggests that buprenorphine can be a very
      safe medication. However, no studies in humans have tested higher doses in a similar way. The
      goal of this study is to show the effects of single doses of buprenorphine, across a range of
      doses, in persons who are not physically dependent on opioids (but do abuse opioids).
    

Detailed description: 
      Preclinical studies have demonstrated for a variety of measures that buprenorphine has a
      bell-shaped dose response curve. However, human studies with buprenorphine have not shown
      such an effect, although controlled studies have generally not tested higher acute doses of
      buprenorphine. Current clinical recommendations generally place an upper limit of daily
      buprenorphine dosing at 32 mg of sublingual tablets, although considerably higher acute doses
      have been administered to humans (primarily in clinical studies of less than daily dosing).
      Determining the relationship between higher doses of buprenorphine in humans and effects
      produced would be valuable; it would be scientifically interesting to demonstrate a
      bell-shaped curve in humans, and it would help guide clinical practice (for example, with
      respect to dosing, safety, and side effect considerations. The purpose of this study is to
      characterize the dose response curve for buprenorphine in humans, utilizing acute single
      doses of parenteral buprenorphine.
    

Intervention name(s): Buprenorphine; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week.; Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind; Intramuscular; double blind; once per week
Intervention MeSH terms: Morphine; Buprenorphine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid addiction; Opioid dependence; Buprenorphine
ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety and tolerability of single and multiple oral
      doses of ERX1000 in obese subjects.
    


Intervention name(s): ERX1000; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension; A suspension containing magnesium hydroxide carbonate in polysorbate
Other intervention name(s): Magnesium hydroxide carbonate
Intervention MeSH terms: Magnesium Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ERX1000; Obesity
A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, two treatment, parallel group study to
      investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a
      gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed
      celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo
      twice daily with food for 28 days (Days 1 to 28).
    


Intervention name(s): Placebo; RO5459072
Intervention type(s): Drug; Drug
Intervention description(s): With the exception of the mornings of Days 7 and 21, placebo capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, placebo will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).; With the exception of the mornings of Days 7 and 21, RO5459072 capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, RO5459072 will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).
Other intervention name(s): RG7625
Intervention MeSH terms: Petesicatib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      patients who have advanced cancer of the urothelium with decreased kidney function.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate of patients with progressive regional or metastatic
           transitional cell carcinoma of the urothelium with renal insufficiency when treated with
           paclitaxel and gemcitabine.

        -  Determine the toxicity of this regimen in this patient population.

      OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV
      over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3
      courses in the absence of unacceptable toxicity or disease progression.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27
      months.
    

Intervention name(s): gemcitabine hydrochloride; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Gemcitabine
Primary purpose: Treatment
Keywords: stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; recurrent urethral cancer; distal urethral cancer; proximal urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to evaluate the immunogenicity and safety profile of a single
      dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW)
      Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A,
      C, W 135 and Y (NIMENRIX®) Conjugate vaccine.

      Observational objectives:

        -  To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present
           in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using
           baby rabbit complement (rSBA) and by serum bactericidal assay using human complement
           (hSBA)

        -  To evaluate the antibody responses against tetanus in participants who received MenACYW
           Conjugate vaccine or NIMENRIX® vaccine

        -  To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
    

Detailed description: 
      All participants received 1 dose of MenACYW Conjugate vaccine or NIMENRIX® on Day 0 and were
      evaluated for immunogenicity and safety profile. The duration of each participant's
      participation in the trial was 30 to 44 days.
    

Intervention name(s): Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 milliliter (mL), Intramuscular (IM); 0.5 mL, IM
Other intervention name(s): MenACYW Conjugate vaccine; NIMENRIX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; NIMENRIX®
Effects of Implementing a High Potassium Diet in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study evaluates the safety and physiologic effects of increasing dietary potassium
      intake in individuals with heart failure.
    


Intervention name(s): High potassium diet
Intervention type(s): Other
Intervention description(s): An increase in consumption of high potassium fruits and vegetables
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Potassium; Nutrition
Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus
Condition: Cataract; Diabetes Mellitus
MeSH terms: Cataract; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study investigate the change of the corneal endothelial cells in patients with type 2
      diabetes after phacoemulsification with intraocular lens implantation.
    

Detailed description: 
      The investigators do the clinical prospective study including 30 patients with type 2
      diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The
      corneal endothelial cell density, variation in endothelial cell size (CV), percentage of
      hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months
      postoperatively.Then, the investigators compared the two sets of data. At last observing the
      change of the corneal endothelial cells in patients with type 2 diabetes after
      phacoemulsification with intraocular lens implantation.
    

Intervention name(s): specular microscope
Intervention type(s): Other
Intervention description(s): The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Among the 60 patients enrolled in this study, the experimental group was 77.5 ±9.2 years
        old, and the control age was 76.3±8.7 years, with no statistical difference (P = 0.87). All
        patients were treated for 3 months.
      
Keywords: cataract; phacoemulsification; type 2 diabetes mellitus; corneal endothelial cells
Treatment for Cellulite Appearance
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with
      masked evaluation.
    

Detailed description: 
      Eligible patients will receive 2 treatments (4-6 weeks apart) on one side (right or left) of
      the lateral/ posterior upper thigh / buttocks using Sofwave System.

      Treatment may be administered after the enrollment and screening at the first visit, or it
      may occur later following the enrollment and screening activities based on site scheduling
      availabilities.

      All patients will return to the clinic for one follow up visits at 3 months ± 3 weeks post
      last treatment (FU1). Optionally, additional follow-up visit will be conducted 6 (± 4 weeks)
      months following end of treatment (FU2).

      Methodology described in the protocol to evaluate efficacy and safety of treatments will be
      carried out at each visit at the clinic.
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Other intervention name(s): SUPERB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: upper thigh, buttock, skin laxity
Juvenile Idiopathic Arthritis in Children in Estonia.
Condition: Epidemiology
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      Aims of the study:

        -  to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical
           subtypes in Estonia for the years 1998-2000;

        -  to examine the course and short-term clinical outcome of JIA.

      Method: a prospective population-based study carried on in 14 counties of Estonia
    


Intervention name(s): Blood collecting for storage of samples
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        During years 1998-2000, 162 newly-diagnosed juvenile idiopathic arthritis cases from 14
        counties of Estonia, were included to the study, among them 76 boys and 86 girls.
      
Biospecimen description: 
      Sera and plasma.
    
Keywords: juvenile idiopathic arthritis; incidence rate
A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
Condition: HBeAg(+) Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence
      compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine
      and peg-interferon sequential treatment in patients with chronic Hepatitis B who have
      HBeAg(+)
    


Intervention name(s): Clevudine; Clevudine + Peg-interferon
Intervention type(s): Drug; Drug
Intervention description(s): 30mg,QD; 30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Other intervention name(s): Levovir; Levovir + Pagasys
Intervention MeSH terms: Interferons; Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This primary purpose of this study is the evaluation of the immunological persistence
      following completion of the 3-dose primary vaccination course with either a clinical or a
      commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In
      addition, the study will also assess the safety, reactogenicity and immunogenicity of a
      fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when
      co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study
      NCT00808444.

      The primary vaccination study was conducted in Malaysia and Singapore. The booster
      vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine
      GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be
      offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia
      and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally
      recommended regimen. Administration of the booster dose will be outside the set-up of a
      clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
    


Intervention name(s): Pneumococcal vaccine GSK1024850A; Infanrix-IPV/Hib
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, one dose; Intramuscular injection, one dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; Streptococcus pneumoniae; immunogenicity; Pneumococcal conjugate vaccine; Haemophilus influenzae
Effects of the Breath Stacking Technic in Healthy Individuals
Condition: Hemodynamic Instability
Study type: Observational

Summary: 
      This study aims to Analyze and compere the hemodynamic and respiratory variables before,
      during and after the applying of technic as well as evaluate respiratory pressures generated
      during applying of this same technic and correlate them with the effort noticed by device
      user.
    

Detailed description: 
      The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed
      alveoli and, consequently, improves oxygenation and, therefore, used by respiratory
      physiotherapy aiming promoting lung re-expansion being. The BS was described by Marini as an
      attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has
      been considered a way of incentive spirometry that provides high lung volume, in situations,
      in which, inspiratory maneuver duration can be as important as the volume reached, composing
      an alternative incentive of inspiration technic4. The system used is composed by an interface
      (facial mask) connected to the patient, an inspiratory unidirectional valve and the
      respiratory branch which is kept occluded during the carrying out of maneuvers.
    

Intervention name(s): Breath stacking
Intervention type(s): Other
Intervention description(s): During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        52 healthy young volunteers The volunteers at the age of 18 to 30, sedentary: absence of
        neuromuscular and/or cardiac respiratory diseases were included, the smokers, overweight,
        claustrophobic or the ones with difficulty in carrying out the technic were excluded
      
Keywords: hemodynamics; physiotherapy; breath stacking
Hydroxychloroquine and Unexplained Recurrent Miscarriage
Condition: Unexplained Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial
      dysfunction and immunological impairment are associated with recurrent miscarriage To date,
      there is no effective or optimal therapeutic approach for these condition. Hydroxychloroquine
      has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or
      direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory
      agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated
      with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid
      syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis,
      hydroxychloroquine has therapeutic potential to improve placental function in pregnancies
      associated with heightened inflammation.
    


Intervention name(s): Hydroxychloroquine; Folic Acid; Low-dose aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400mg; 5 mg; 75 mg
Intervention MeSH terms: Aspirin; Folic Acid; Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety of Intravenous Thrombolytics in Stroke on Awakening
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety of intravenous tissue
      plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and
      presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting
      standard criteria for treatment with IV tPA for acute stroke.

      The hypothesis is that patients that wake up with stroke symptoms may have developed the
      stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the
      ED within that time, therefore IV tPA should be safe and effective in this population.
    


Intervention name(s): tPA
Intervention type(s): Drug
Intervention description(s): IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
Other intervention name(s): Activase; Alteplase
Intervention MeSH terms: Tissue Plasminogen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Wake up; IV tPA; Thrombolytic
Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending
      doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety,
      tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are
      planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of
      ZP4207 or placebo in a 3:1 treatment allocation at trial site.
    


Intervention name(s): ZP4207; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment