bioihbjkbjnl/mcl2 huggingface dataset:
A Simplified Questionnaire to Detect OSA in COPD Patients
Condition: OSA; COPD
Study type: Observational

Summary: 
      To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive
      pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a
      simplified questionnaire was developed for identifying those COPD patients with severe OSA.
    

Detailed description: 
      To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive
      pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a
      simplified questionnaire was developed for identifying those COPD patients with severe OSA.

      With patient's BMI, neck and waist circumference, snores, witnessed apnea...

      Time frame suspect to enroll 5 patients in 1 month and complete 4 patients at least we need
      24 months to complete 120 patients
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        develop group : previous COPD cohort study validation group : consecutive COPD patient from
        outpatients clinics
Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Stress is associated with drug craving and relapse in substance-dependent individuals.
      Hormones released from the brain may mediate the behavioral response to stress. For example,
      several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.
      Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet,
      little is known about the potential affects of oxytocin in cocaine-dependent individuals.
      Given these properties of oxytocin, it may have a therapeutic role in ameliorating the
      negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well
      as the anxiety associated with withdrawal. This pilot protocol will provide important
      preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
    


Intervention name(s): oxytocin; saline
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.; Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Other intervention name(s): pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Observational

Summary: 
      This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate
      the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e.
      usual care) in patients with axial spondyloarthritis.
    

Detailed description: 
      This study is reflecting the usual care either in accordance to the treating rheumatologist
      (arm: usual care) or in accordance to the international scientific recommendations (arm: T2T)

      The tight control means that as soon as a treatment is initiated in a patient, the time
      permitting to evaluate its potential efficacy/safety has to be determined. In terms of
      safety, such time frame can be very short based on the occurrence of adverse events. In terms
      of efficacy it is usually recommended to evaluate an NSAIDs after 2 to 4 weeks of treatment
      intake and the TNF blockers after 12 to 16 weeks.

      The Treat to Target means that there is an a priori decision of the target to reach while
      initiating a treatment and more importantly an a priori decision to intensify the treatment
      in case such target is not achieved.

      There will be 2 arms in the study (tight control and treat to target arm and usual care arm).

      160 patients (80 patients per arm) will be included during one year by 18 centers (10 in
      France, 4 in Belgium and 4 in Netherlands). Patients will be followed during 1 year.
    

Intervention name(s): Follow-up every 3 months during 1 year (data collection in eCRF); Follow-up every month to follow the pre-defined strategy
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with a diagnosis of predominant axial spondyloarthritis according to the axial ASAS
        criteria AND the opinion of the treating rheumatologist, and an active disease defined as
        an (ASDAS ≥ 2.1), and non-optimally treated with NSAIDs.
      
Keywords: Treat to Target approach
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
Condition: Macular Telangiectasia Type 2
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety
      of the NT-501 implants in participants with macular telangiectasia type 2.
    


Intervention name(s): NT-501; Sham
Intervention type(s): Combination Product; Procedure
Intervention description(s): Surgery to receive one NT-501 device implant.; Non-penetrating sham procedure to mimic implant procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ciliary Neurotrophic Factor (CNTF); Macular Telangiectasia (MacTel)
Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel
      cleansing solution (MOVIPREP®)
    


Intervention name(s): NER1006; MOVIPREP
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this study, we compared the effects of intermittent pneumatic compression along with
      conventional treatment and cold-pack treatment along with conventional treatment on clinical
      outcomes in patients with knee osteoarthritis.
    


Intervention name(s): Intermittent Pneumatic Compression; Cold-pack
Intervention type(s): Other; Other
Intervention description(s): The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.; The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the ongoing efficacy, safety, and
      tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne
      muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen
      study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers
      for DMD and the clinical status of participating DMD subjects.
    

Detailed description: 
      This is an open label, multiple dose extension study to assess the ongoing efficacy, safety,
      and tolerability of weekly intravenous (IV) infusions of eteplirsen in DMD subjects who have
      successfully completed Study 4658-us 201.

      Subjects will have the opportunity to enroll in this study during the last visit of Study
      4658-us-201 (Week 28). Eligible subjects will receive once weekly IV infusions of eteplirsen
      (50 or 30 mg/kg) for an additional 212 weeks. Subjects will receive the same dose of
      eteplirsen they received in Study 4658-us-201. Subjects will thereafter continue to receive
      once weekly IV infusions of eteplirsen for up to an additional 72 week period (through week
      284). If commercial eteplirsen becomes available during this additional 72 week period,
      participation in the study will be discontinued as subjects transition to commercial
      eteplirsen.

      Safety, efficacy, pharmacokinetic (PK), and biomarker assessments will be performed at
      scheduled visits; adverse events (AEs) and concomitant medications and therapies will be
      continuously monitored.

      If review of data from this open label study suggests that continued treatment with
      eteplirsen is warranted, this study may be extended by protocol amendment or subjects who
      successfully complete this study may have the opportunity to participate in a separate follow
      on, open label eteplirsen study.
    

Intervention name(s): AVI-4658 (Eteplirsen)
Intervention type(s): Drug
Intervention description(s): Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.
Other intervention name(s): EXONDYS 51
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51
Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

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 tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating
      patients with advanced solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with
      irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe
      the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the
      relationship between topoisomerase I expression in peripheral mononuclear cells and
      myelosuppression and/or gastrointestinal toxicity. IV. Investigate the effect of CPT-11 on
      thymidylate synthase expression in tumor.

      OUTLINE: This is a dose-escalating study to determine the maximum tolerated dose (MTD) of ICI
      D1694 (TDX) given in combination with irinotecan. Irinotecan is given intravenously on day 1
      and ICI D1694 intravenously on day 2. Treatment is repeated every 3 weeks until disease
      progression or unacceptable toxicity intervenes. Cohorts of 3-6 patients receive escalated
      doses of TDX until the MTD is defined; an additional 10-12 patients will be entered at the
      MTD to confirm this as a recommended phase II dose.

      PROJECTED ACCRUAL: 30-35 patients will be entered.
    

Intervention name(s): irinotecan hydrochloride; raltitrexed
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irinotecan; Raltitrexed
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)
      or genotype 2 (HCV GT2) infection who were previous treated with pegylated
      interferon/ribavirin (pegIFN/RBV).
    

Detailed description: 
      This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted
      of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b-
      infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV
      treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity,
      safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks.
      The Post-treatment Phase evaluated the evolution and persistence of viral resistance to
      ABT-267 and ABT-450.
    

Intervention name(s): ABT-450/ritonavir, ABT-267
Intervention type(s): Drug
Intervention description(s): ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other intervention name(s): ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ritonavir also known as Norvir; ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japanese; Hepatitis C; Genotype 2; Genotype 1b; paritaprevir; ombitasvir; ritonavir; VIEKIRAX Combination Tablets
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose
      and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety,
      tolerability and pharmacokinetics are also evaluated.
    


Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP1941; Diabetes mellitus; Blood glucose
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily
      (QD), to allopurinol in subjects with hyperuricemia and gout.
    

Detailed description: 
      Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to
      70%. This population represents an unmet medical need as uricosuric drugs are contraindicated
      in these patients, and the only available treatment, allopurinol, may have to be dose reduced
      to avoid overt side effects.

      Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as
      an orally administered agent for management of hyperuricemia in patients with gout.

      Treatment duration will be 6 months.
    

Intervention name(s): Febuxostat; Febuxostat; Allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.; Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.; Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.
Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.
Other intervention name(s): TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric; Zyloprim
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tophi; hyperuricemia; uric acid; Drug Therapy
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the
      pharmacokinetics of BI 409306 when given at bed time.
    


Intervention name(s): BI 409306; BI 409306; BI 409306
Intervention type(s): Drug; Drug; Drug
Intervention description(s): medium dose, oral administration; medium dose, oral administration; medium dose, oral administration
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The purpose of this study was to assess the handgrip strength; fine motor skills; and hand
      sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The
      sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the
      other 21 acted as the control group (group B). The performance of both groups was compared.
      The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein
      monofilaments test and Jamar Dynamometer.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants of the group A were not randomized children and adolescents performing
        hemodialysis treatment in two hospitals of Belo Horizonte. Findings obtained in patients
        were compared to children and adolescents matched by age and sex, which participants were
        recruited in schools of Belo Horizonte and metropolitan region part of the group B.
      
Keywords: Chronic Kidney Disease; Handgrip Strength; Fine Motor Skills; Sensitivity
Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, patients with uncomplicated urinary infection are investigated. It is
      investigated if treatment of only symptoms of the uncomplicated urinary infection is as
      effective as treatment with antibiotics with respect to the outcome of the urinary infection.
      If this is the case, the use of antibiotics in the treatment of uncomplicated urinary
      infections might be reduced.

      Secondary aim of the study is the safety evaluation of both treatment strategies with respect
      to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
    


Intervention name(s): Ibuprofen; Fosfomycin-Trometamol
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg oral once a day from day 0 for 3 days; 8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
Other intervention name(s): Monuril
Intervention MeSH terms: Fosfomycin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bacterial infection
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effect of QAB149 on dynamic and static hyperinflation,
      breathlessness, and health status in COPD patients
    


Intervention name(s): Indacaterol 300μg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device; Matching placebo devices and hard gelatin capsules
Other intervention name(s): Arcapta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: COPD, Indacaterol Maleate, Exercise testing