bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette)
Condition: Healthy Smokers; Smoking Cessation
Study type: Observational

Summary: 
      The study's major aim is to investigate the ability of a commercial Electronic Nicotine
      Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers
      unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and
      cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

      The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms,
      and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette
      - "ORIGINAL" 7.2 mg nicotine cartridges).

      The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction
      or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.
    

Detailed description: 
      The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed
      for the purpose of nicotine delivery to the respiratory system where nor tobacco nor
      combustion are necessary for its operation. For these reasons, it is possible that this
      product may be safer than cigarettes. Marketing claims also include that they can be useful
      smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to
      that of tobacco cigarettes and reproduces the gesture component associated with tobacco
      smoking, very little is known about the effect of E-Cigarette on the smoking habits of
      regular tobacco smokers.

      Therefore, we designed a prospective observational study consisting of 8 office-based visits
      (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to
      monitor possible modifications in the smoking habits of a group of well characterized regular
      smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence,
      changes in withdrawal symptoms/cravings and adverse events.

      Specifically, 100 smokers will be given "Categoria" electronic cigarette loaded with
      "ORIGINAL" 7.2 mg nicotine cartridges and followed up for a total of 24 weeks.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Regular smokers from Catania in Italy recruited following the placement of an advertisement
        in a local newspaper.
      
Keywords: electronic cigarette; nicotine; smoking cessation; smoking reduction
Understanding Adaptive Challenges Associated With Male-factor Infertility
Condition: Male-factor Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this study is to understand the experience of men and their partners when
      diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills
      they use to adapt to this diagnosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will recruit a convenience sample of 10 men and their partners seeking
        consultation from a fertility urologist following the detection of male-factor infertility.
Can DFN-15 Terminate Migraine With Allodynia?
Condition: Migraine With Aura; Migraine Without Aura; Allodynia
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura; Hyperalgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The majority of migraineurs seeking secondary or tertiary medical care develop cutaneous
      allodynia during the course of migraine, a sensory abnormality mediated by sensitization of
      central trigeminovascular neurons in the spinal trigeminal nucleus. Triptan therapy can
      render allodynic migraineurs pain-free within a narrow window of time (20-120 min) that opens
      with the onset of pain and closes with the establishment of central sensitization. This calls
      for the development of drugs that can tackle ongoing central sensitization and render
      allodynic migraineurs pain-free after the window for triptan therapy has expired. There are
      two main objectives the investigators seek to achieve from this study: to determine whether
      oral administration of DFN-15 (solution of a COX2 inhibitor, Celecoxib) terminates migraine
      attacks when given to allodynic participants 3 hours after attack onset; and to determine
      whether mechanical and heat allodynia that develop during acute migraine attacks could be
      reversed by late (> 3hrs after attack onset) treatment with DFN-15. Participants will be
      recruited from the Headache Center and randomized in a double-blinded fashion to receive
      either the active drug (DFN-15) or placebo in a ratio of 4:1.The participants will be
      instructed to return to the clinic during a migraine. At the 'during-migraine' visit, which
      will begin 3 hours after onset of headache, the investigators will document headache
      intensity, associated symptoms, and mechanical and heat pain threshold (first) before
      treatment (at 180 min after onset of headache) and (second) at a 120 min after treatment (5
      hours after headache onset). Based on our prior experience studying migraine patients, the
      investigators plan to screen 100 patients to achieve 50 participants completing the 2 study
      visits as planned. The active drug group will consist of 80/100 patients and 20/100 patients
      will receive the placebo. The study will be terminated as soon as the first 40 participants
      who received the DFN-15 and first 10 patients who received placebo completed visit 2.
    


Intervention name(s): DFN-15; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral Solution of 4.8 mL containing 120 mg of DFN-15; Oral Solution of 4.8 mL containing 0 mg of DFN-15
Other intervention name(s): Celecoxib
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Observational

Summary: 
      Vitamin A deficiency remains a major public health problem in developing country worldwide.
      Young Children are considered to be at greatest risk of deficiency. However, there is little
      information on the vitamin A requirement of Chinese children. In the present study, about 400
      children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan
      City were screened before admission by questionnaire and anthropometric measurement. The
      vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction
      and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were
      estimated by weighted-food dietary survey. The dietary vitamin A requirement in young
      children was determined on the basis of dietary vitamin A intakes in Children with adequate
      vitamin A level.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study was carried out in a kindergarten and an elementary school in Shiyan city, Hubei
        province of China. Initially, 201 kindergarten children (4-6 years old) and 202 grade
        children (7-9 years old) were subjected to a questionnaire survey on personal information,
        medical history and dietary habits including dietary supplements.ongoing or previous
        illnesses, having taken nutritional supplements within 3 months, positive results in the
        fat absorption test or parasite test, increased level of CRP (> 8 mg/L), or lower serum
        level of retinol (<1.40 umol/L), and higher ratio in relative dosage reaction test(>20%)
        .After the screening, 123 children were selected and completed the study, but 60 subjects
        were randomly selected for the DRD test to evaluate liver vitamin A storage.
      
Biospecimen description: 
      serum
    
Keywords: Vitamin A; Dietary requirement; Dietary records; Deuterated retinol dilution technique; Chinese children; Dietary intake of vitamin A; Vitamin A liver reserves
Lactate Metabolism After an Endotoxin Challenge in Healthy Humans
Condition: Sepsis
Study type: Interventional

Summary: 
      Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with
      sepsis severity. The pathophysiological mechanisms (increased lactate production vs decreased
      lactate utilization; tissues involved in sepsis-induced lactate production) remain largely
      unknown.

      In this study, the investigators will assess whole body and regional metabolism in healthy
      young male subjects on two occasions, once after administration of an intravenous bacterial
      endotoxin challenge, and once without intervention.

      In one group of subjects, whole body lactate metabolism will be measured over 10 hours after
      the endotoxin challenge

        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)

        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)

        -  Glucose kinetics (measured with 6,6 d2 glucose)

        -  Hemodynamic parameters and body temperature

        -  Blood clinical chemistry In one group of subjects, whole body lactate metabolism will be
           measured over 10 hours after the endotoxin challenge

        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)

        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)

        -  Glucose kinetics (measured with 6,6 d2 glucose)

        -  Hemodynamic parameters and body temperature

        -  Blood clinical chemistry

      In a second group of subjects, regional muscle lactate metabolism will be measured over 10
      hours after the endotoxin challenge by means of muscle microdialysis
    


Intervention name(s): bacterial endotoxin challenge
Intervention type(s): Other
Intervention description(s): iv administration of 2ng/kg bacterial endotoxin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bacterial lipopolysaccharides; hyperlactatemia; muscle lactate
Evaluating the Impact of a Value-based Prescription Drug Formulary
Condition: Value-Based Health Insurance
Study type: Observational

Summary: 
      The objective of this study is to evaluate the impact of the value-based formulary on patient
      out-of-pocket spending and health plan spending as well as the impact of the value-based
      formulary on medication use, emergency department visits, hospitalizations, and outpatient
      office visits.
    


Intervention name(s): Value-based Formulary
Intervention type(s): Other
Intervention description(s): Prescription drug formulary tiers informed by estimated value
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All individuals who satisfy the eligibility criteria are included.
      
Keywords: Cost Sharing / economics; Formularies as Topic; Insurance, Health / economics; Value-Based Health Insurance / economics
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin,
      and to assess the PK of rosuvastatin when administered alone, in healthy participants.
    


Intervention name(s): Rosuvastatin; Sotorasib
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose; Oral dose
Other intervention name(s): AMG 510
Intervention MeSH terms: Sotorasib; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMG 510; Sotorasib; Rosuvastatin; Healthy participants
Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Drug-coated balloon is being used more and more widely for the advantage of intervention
      without implantation.

      But the balloon needs to be released long enough to be effective. Prolonged balloon dilation
      resulting in the cessation of blood flow in the distal vessels, especially large vessels, may
      result in severe ischemia in the patient.

      RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application
      before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus
      increasing the release time of drug balloon and improving the effect.
    

Detailed description: 
      Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the
      release of the drug balloon for a long time and even lead to the occurrence of adverse
      events.RIPC was found to improve tolerance to myocardial ischemia in patients.

      At the same time, it can open collateral circulation and improve the tolerance of myocardial
      ischemia in patients.Therefore, this study designed a parallel control group. The
      experimental group was treated with RIPC before PCI, while the control group was not treated
      before PCI.

      The operator does not know whether the patient has undergone RIPC or not, and the operator
      decides the time of drug balloon release according to the symptoms of the patient during the
      operation.Angiography was performed at 6 months, and QCA was used to determine late lumen
      loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
    

Intervention name(s): RIPC
Intervention type(s): Other
Intervention description(s): RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effects of Legumes on Glucose Regulation
Condition: Dietary Prevention
Study type: Interventional

Summary: 
      Dietary prevention strategies are increasingly recognized as essential to combat the current
      epidemic of obesity and related metabolic disorders. The purpose of the present study was to
      evaluate the potential effects of legumes in relation to cardiometabolic risk markers and
      appetite regulating hormones.
    


Intervention name(s): legume meal; white bread
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Diclofenac Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are
      safe and effective for the treatment of dental pain.
    


Intervention name(s): Diclofenac Test (lower dose); Diclofenac Test (upper dose); Celecoxib 400 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 18-mg Single dose; 35-mg Single dose; Capsules 2 x 200 mg Single-dose; Capsules 2 Single-dose
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor)
      on the pharmacokinetics (PK) of olinciguat
    


Intervention name(s): Olinciguat; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Capsule
Other intervention name(s): IW-1701
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Shared Decision Making for Patients With First-admission Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine whether shared decision making (SDM) intervention improves patient satisfaction
      in patients with first-admission schizophrenia compared with usual care.
    


Intervention name(s): Shared Decision Making
Intervention type(s): Behavioral
Intervention description(s): The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First hospitalization
A Through QT/QTc Study of KW-6356
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of multiple therapeutic and
      supratherapeutic doses of KW-6356 on the QT interval corrected for heart rate in Japanese
      healthy adults.
    


Intervention name(s): KW-6356; KW-6356; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7; KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7; Placebo will be administered once daily at Day 1 through Day 7; Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
Condition: Renal Cancer
MeSH terms: Kidney Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to describe the postoperative outcomes after laparoscopic
      transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with
      a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of
      our experiences from the previous study to optimize the postoperative outcomes.
    


Intervention name(s): Hand assisted laparoscopic nephrectomy
Intervention type(s): Procedure
Intervention description(s): patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic nephrectomy; one day surgery
Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients
Condition: Pain; Depression Anxiety Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients,
      to reduce the level of pain, anxiety and depression. The comparison was made through the
      scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale
      (HADS).
    

Detailed description: 
      Volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to
      hypnosis, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS), will be randomized
      into two groups of 12 participants each. They might or might not present metastasis, whether
      or not performed cancer surgery, regardless of the location of the primary tumor, with or
      without concomitant surgical indication. It will be used the Visual Analogue Scale (VAS) and
      Hospital Anxiety and Depression Scale (HADS) at 3 different times: at baseline, after 7 days
      and after 2 weeks of the first assessment. It will be done, in the hypnosis group, an
      hypnosis intervention. It consists of two 40-minute sessions, with an interval of 7 days
      between them, emphasizing the pain blocking, the well-being of the patient and the reduction
      of the symptoms of anxiety and depression. Then, it will be evaluated the intensity of the
      pain as well as depression and anxiety in both groups. Finally, the results of both groups
      will be compared.
    

Intervention name(s): Hypnosis; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.; The control and experimental groups respond in 3 different moments to Visual Analogue Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting will be made before the hypnosis. In the second meeting, within an interval of 7 days, the scales will be applied in all patients. Before applying the scales, the hypnosis group will be submitted to the session. The third meeting will occur two weeks later, where the scales will be only applied to compare the groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: BEHAVIORAL; HYPNOSIS; ANXIETY; DEPRESSION
A Study of RO5285119 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part, randomized, double-blind, placebo-controlled study will assess the safety,
      pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of
      RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each
      subject.
    


Intervention name(s): RO5285119; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single and multiple ascending oral doses; single and multiple oral doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)