bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod
      system compared with conventional insulin pump in adults with type 1 diabetes.

      The study will include two consecutive 12 weeks treatment periods. According to
      randomization, each patient will be treated consecutively with both treatment arms: 12 weeks
      with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.
    

Detailed description: 
      A Randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of
      using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes.

      The study will include two consecutive 12 weeks treatment periods. According to
      randomization, each patient will be treated consecutively with both treatment arms: 12 weeks
      with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.

      Study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4
      telephone visits taking place at 4,8,16 and 20 weeks. In addition, patients will be invited
      one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor.
      Patients will complete DTSQ and Comfort & Function questionnaires at weeks 0, 12 and 24,
      before and at the end of each study arm.

      On each clinical visits the following parameters will be evaluated: vital signs, HbA1c, 4 and
      7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related
      technical problems.

      The telephone visits will include pump related technical problems solving and AE/SAE
      reporting.
    

Intervention name(s): OmniPod system; Patient's conventional pump
Intervention type(s): Device; Device
Intervention description(s): Patients will be treated with the OmniPod system for 12 weeks; patients will be treated with their conventional pump for 12 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment satisfaction; OmniPod; Insulin pump; diabetes
A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses
      of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part
      B: TQT study)
    


Intervention name(s): Lucerastat (Treatment A); Placebo; Moxifloxacin; Lucerastat (Treatment B); Lucerastat (Treatment C)
Intervention type(s): Drug; Other; Drug; Drug; Drug
Intervention description(s): 2000 and 4000 mg; hard capsules for oral administration; hard capsules for oral administration; 400 mg; film-coated tablets for oral administration; 1000 mg; hard capsules for oral administration; 4000 mg; hard capsules for oral administration
Intervention MeSH terms: Moxifloxacin; 1-Deoxynojirimycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Role of Metabolites in Nicotine Dependence (2) - 5
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of varying doses of cotinine on
      cigarette self-administration.
    

Detailed description: 
      Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the
      effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects
      of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to
      examine the effects of cotinine. The results generally showed no effects on
      self-administration of cigarettes, although higher serum nicotine levels were observed on the
      highest doses of cotinine compared to placebo or lower doses of cotinine.
    

Intervention name(s): Cotinine fumarate
Intervention type(s): Drug
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nicotine dependence
Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
Condition: HIV
Study type: Observational

Summary: 
      This study aims to determine the feasibility of recruiting and retaining men who have sex
      with men (MSM) in a multi-country prospective cohort study in preparation for human
      immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).
    

Detailed description: 
      HPTN 075 is an observational cohort study. Participants will be accrued over six months at
      four sites in SSA using convenience sampling strategies, with no replacement for participants
      lost to follow-up. Each participant will be followed for 12 months, during which five study
      visits involving structured HIV behavioral assessments, medical examinations, and collection
      of biological samples will be conducted (including enrollment and quarterly follow-up
      visits). Participants who do not complete 12 months of follow-up will be contacted to explore
      reasons for no longer participating.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): HPTN 075 is an observational study in sub-Saharan MSM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men, regardless of HIV infection status, aged 18-44 years living in SSA who report anal sex
        with a man in the past 3 months.
      
Biospecimen description: 
      Plasma samples will be stored from each study visit
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single-dose Bioavailability of Kali and Aventis
    

Detailed description: 
      To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg
      tablets in healthy female subjects under fed conditions
    

Intervention name(s): Leflunomide; ARAVA
Intervention type(s): Drug; Drug
Intervention description(s): tablets, 20mg, single-dose; Tablets, 20mg, single-dose
Other intervention name(s): ARAVA; Leflunomide
Intervention MeSH terms: Leflunomide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence, Leflunomide, fed
Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Several studies have shown that Continuous Subcutaneous Insulin Infusion together with
      Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to
      more traditional approaches; however, in available trials the basal insulin used in
      multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic
      risk than degludec.

      This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion
      (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily
      Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with
      traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1
      diabetes. A crossover design was chosen in order to minimize study sample improving
      statistical power.
    


Intervention name(s): CGM+CSII; MDI with degludec
Intervention type(s): Device; Device
Intervention description(s): Animas Vibe Platinum insulin pump and Dexcom G4 CGM; Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.
Condition: Adverse Events; Pharmacokinetic Variables
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from
      ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.
    


Intervention name(s): ABT-143; ABT-335 and rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): once; once
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adverse events; Pharmacokinetic variables
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH
Condition: InFertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will be performed in approximately 132 women with anovulatory/oligoovulatory
      infertility.
    

Detailed description: 
      This multicenter, randomized, double-blind, placebo-controlled study will be performed in
      approximately 132 women with anovulatory/oligoovulatory infertility. The treatment duration
      will be approximately 4 weeks with pulsatile GnRH or placebo and 5 days with Clomiphene
      Citrate or placebo. All subjects will be screened based on inclusion/exclusion criteria,
      medical/infertility history and general safety assessments. Subjects that complete screening
      will be dispensed 100 mg of oral progesterone twice a day for 10 days to induce uterine
      bleeding. On Cycle Day 5 from the start of bleeding the subject will be randomly assigned to
      1 of 7 treatment groups. All subjects will be monitored weekly throughout the 4 week
      treatment period for ovulation and intercourse will be timed. All subjects will be required
      to return to the study center for a total of 8 visits. In addition, all subjects with a
      confirmed clinical pregnancy will be monitored until fetal heartbeat is confirmed at
      approximately 5-6 weeks gestation
    

Intervention name(s): Pulsatile gonadotropin-releasing hormone (GnRH); Clomiphene Citrate; Placebo Pulsatile GnRH; Placebo Clomiphene Citrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks; Oral clomiphene citrate (over encapsulated) for 5 days; Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks; oral placebo clomiphene citrate for 5 days
Other intervention name(s): Lutrepulse®; Clomid
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene; Hormones; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days
      receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers
      according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme
      with normal function. The study hypothesis is that PM will experience less pain relief than
      EM.
    

Detailed description: 
      Oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain
      management comparable to morphine. Oxycodone is N-demethylated by CYP2D6 to its active
      metabolite oxymorphone, a potent μ-receptor agonist. A genetic polymorphism divides a
      Caucasian population into two groups: 8% with an enzyme lacking activity, poor metabolizers
      (PM) and the rest with normal CYP2D6 activity, extensive metabolizers (EM).

      Many different, single nucleotide polymorphisms (SNPs) are responsible for interindividual
      differences in the effect of opioids. Among these are the A118G SNP in the μ-receptor gene
      OPRM1 and the C3435T and G2677T/A SNPs in the MDR-1 gene of P-glycoprotein. P-glycoprotein is
      responsible for the absorption, excretion and transport of many drugs including opioids over
      the blood-brain barrier.

      Electrical stimulation and cold pressor test are among the most well defined and evaluated
      human experimental pain models. The 32 volunteers will be submitted to the tests before and
      1, 2, 3 and 4 hours after medicine intake.

      To determine the plasma levels of Oxycodone and its metabolites blood will be drawn after
      each pain test. Also the CYP2D6 genotype and the above mentioned SNPs will be determined from
      the blood samples.
    

Intervention name(s): Oxycodone
Intervention type(s): Drug
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid
      organ transplant recipients. The anticipated time on study treatment is 3-12 months and the
      target sample size is less than 100 individuals.
    


Intervention name(s): valganciclovir [Valcyte]
Intervention type(s): Drug
Intervention description(s): po daily (dose based on body surface area and CrCL)
Intervention MeSH terms: Valganciclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck 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.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with
      recurrent or metastatic head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the response rate and toxic effects of paclitaxel by 96 hour
      continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent or
      metastatic squamous cell carcinoma of the head and neck.

      OUTLINE: Patients receive paclitaxel as a 96 hour continuous IV infusion. Courses repeat
      every 3 weeks for a maximum of 12 courses. Patients with disease progression after 2 courses
      or with unacceptable toxicity at any time are removed from study.

      PROJECTED ACCRUAL: Approximately 109 patients will be accrued for this study over 4 years.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Primary purpose: Treatment
Keywords: stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Ozonated Olive Oil and Low-Level Laser Therapy in TMD Treatment
Condition: TMD
Study type: Interventional

Summary: 
      The aim of the present study was to determine the efficacy of ozonated olive oil and
      low-level laser therapy (LLLT) in treating pain in individuals with TMD. In this prospective,
      randomized, split-mouth, double-blind study, two different treatment methods were applied to
      the patients.
    

Detailed description: 
      two different treatment methods were applied to the patients. Group 1 (study group, one side
      of the same patient): topical ozonated olive oil + LLLT; Group 2 (the other side of the same
      patient): Olive oil with topical ozone + LLLT (not activated). The ozonated olive oil was
      applied topically three times a day for four weeks, the LLLT was applied noncontact at a
      distance of 1 cm, and patients attended three sessions per week for four weeks. Before
      starting treatment, and after 6 sessions of laser therapy, the patients were evaluated. (2
      weeks), after 12 laser sessions (1 month), and 3 months after the first session.
    

Intervention name(s): Ozonized Olive Oil Solutions; Low Level Laser LLL Therapy
Intervention type(s): Drug; Device
Intervention description(s): (0.03PPM ozone + 6-6.5 PH olive oil, viscosity at 25°C 55mPas, relative density gr/ml (20°C) 0.98 pycnometer, 100 ml bottle.; (0.03PPM ozone + 6-6.5 PH olive oil, viscosity at 25°C 55mPas, relative density gr/ml (20°C) 0.98 pycnometer, Ozonated olive oil, 100 ml bottle, and 810 nm diode laser, 3.4 j/cm2 energy density, 0.5w power, CHEESE DEN7A/DEN4A 810, 2 min for each side
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cx611-0204 SEPCELL Study
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa
      study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered
      intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy,
      to patients with severe community-acquired bacterial pneumonia (sCABP).

      The completion of this study will contribute to the basic knowledge on stem cells and their
      mode-of-action, and has a large translational character, i.e. to document the safety and
      explore the efficacy of Cx611 in patients with sCABP.
    

Detailed description: 
      The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa
      study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered
      intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy,
      to patients with severe community-acquired bacterial pneumonia (sCABP).

      The key objectives of this study are to:

      Primary objective:

      Investigate the safety profile of two allogeneic Cx611 80 mL infusions administered through a
      central line within 3 days (on days 1 and 3) at a dose of 160 million cells each (320 million
      cells total) and to monitor any adverse event and potential immunological host responses
      against the administered cells during 90 days of follow-up after the first infusion.

      Secondary objective:

      Explore the clinical efficacy of Cx611 in terms of a reduction of the duration of mechanical
      ventilation and/or need for vasopressors and/or improved survival, and/or clinical cure of
      the sCABP, and other efficacy-related endpoints.
    

Intervention name(s): Cx611; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Two intravenous infusions, one on day 1 and another one on day 3.; Two intravenous infusions, one on day 1 and another one on day 3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biologic Therapy
Paper vs. Internet
Condition: Idiopathic Scoliosis; Adolescent
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Research has shown that questionnaires completed on the internet have the potential to
      provide more complete and honest data with fewer errors in a more efficient manner than
      questionnaires completed using the paper and pencil format. Despite the numerous advantages
      of internet-administered questionnaires, it is important to make sure that the internet
      questionnaires will yield comparable results to the well-established paper and pencil
      versions. No one has studied internet administration of scoliosis specific questionnaires in
      adolescents with scoliosis. The investigators will test whether the internet administration
      of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The
      investigators predict that the internet-administered questionnaire will provide the same
      reliability as the paper-administered questionnaires.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with idiopathic scoliosis will be asked to participate during visits to the
        orthopaedic spine clinic at BC Children's Hospital
      
Keywords: Scoliosis; Adolescents; Questionnaire; Reliability
Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer
Condition: Basic Laparoscopic Skills Training
Study type: Interventional

Summary: 
      Training is of great importance in laparoscopy. There are different commercially available
      trainers which are quite expensive and are used by trainees only inside the hospital.

      The aim of this study is to find out whether basic laparoscopic skills training using an
      inexpensive tablet-based laparoscopic box trainer leads to equal training results (=
      improvement of skills) compared to practicing with a conventional commercial box trainer.
      Furthermore, trainee satisfaction with this home-made alternative compared to the standard
      trainer will be assessed.
    


Intervention name(s): Training on low-cost box trainer; Training on standard box trainer
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Surgical education; Laparoscopy; Laparoscopic suturing