bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Heart Rate Variability Analysis in Realtime
Condition: Individuality; Perioperative/Postoperative Complications; Heart Rate and Rhythm Disorders; Surgical Complications From General Anesthesia
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      This study will record patient electrocardiograms - as well as various other body signals
      (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored
      routinely both during and immediately subsequent to surgical operations performed under
      general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV),
      in concert with the other abovementioned parameters, the investigators seek to forward the
      development of novel mathematical models and tools for on-line detection of cardiovascular
      and autonomic dysfunction in the perioperative setting.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients between the ages of 18 and 80 who are undergoing non-cardiac surgery under
        general anesthesia at Vienna General Hospital may participate.
      
Keywords: Heart rate variability; Electrocardiography; Observational study; Non-interventional study; Risk assessment; Perioperative
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix
      compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or
      without asthma.

      Sublingual immunotherapy has been used during several years and has been shown to provide
      benefits compare to traditional subcutaneous treatment. This study will investigate if
      improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a
      consequence of being treated under specific immunotherapy.

      This study aim also to contribute to the documentation of tolerability and safety profile of
      Pangramin HDM Mix.
    

Detailed description: 
      Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT
      and other SLIT products as named patient products, both with respect to the types and the
      frequencies of the adverse events(AEs) observed. No safety concerns have been found.

      The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the
      allergen after sublingual administration is not known in detail, i.e. to what extent is the
      allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients
      etc. The relationship between dose and effect is thus not fully elucidated. The general
      recommendation is to use a dose inducing a clinical relevant effect in most patients without
      causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that
      allows a single daily intake by the patient at home, the dosage at this trial will be the
      same as marketed product.
    

Intervention name(s): Pangramin SLIT HDM mix.; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.; Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: House dust mite induced allergic rhinitis.
Behavioral Pharmacology of Cannabis and Nicotine
Condition: Cannabis; Nicotine
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic
      effects of smoked cannabis and nicotine.
    

Detailed description: 
      The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research
      Unit (BPRU). All participants will be healthy adult volunteers who are regular
      nicotine/tobacco users, and have prior experience with cannabis use. Participants will
      complete seven outpatient experimental test sessions (completed in a randomized order), under
      double-blind conditions in which participants will first self-administer smoked cannabis
      (either active or placebo), followed by nicotine (via a tobacco cigarette or an e-cigarette);
      there will also be one condition in which participants smoke active cannabis alone (without
      subsequent nicotine use). Nicotine self-administration will occur in an ad libitum fashion
      for 5 hours. Nicotine products will be the individual participant's preferred brand of
      cigarettes or the commercial pod-style e-cigarette the JUUL (pods will contain either 3% or
      5% nicotine pods). Active cannabis will contain 10 mg tetrahydrocannabinol (THC) while
      placebo will contain 0 mg THC. During the ad libitum nicotine/tobacco-use period, various
      puffing behaviors (e.g., puff volume, puff duration, puff number, inter-puff-interval) will
      be measured using specialized equipment. Acute subjective effects of cannabis/nicotine,
      cannabis/nicotine withdrawal symptoms, craving, vital signs, and cognitive/psychomotor
      performance will also be assessed throughout the experimental sessions.
    

Intervention name(s): Cannabis; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Cannabis will be smoked; Nicotine will be smoked or vaporized
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Ketorolac has been marketed for several years in other forms (tablet and injectable) for the
      short-term relief of pain. This study will test whether a new dosage form (nasal spray)
      containing ketorolac is effective at relieving the pain of major abdominal surgery, and will
      also assess product safety. Previous studies with the nasal spray have suggested that it is
      similar to the previously approved injectable form in effectiveness for pain relief and in
      its safety profile.

      Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when
      the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first
      dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to
      4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug,
      subjects will be given morphine sulfate or other standard analgesics. Follow-up safety
      evaluations will occur about 1 and 2 weeks after the start of dosing.

      Subjects will be asked to answer questions about their pain relief and any possible side
      effects of the drug during the study, and will be given physical examinations, including
      nasal evaluations, before and during the clinical trial. A small amount of blood will be
      drawn for routine clinical laboratory testing.
    


Intervention name(s): Intranasal Ketorolac Tromethamine; Intranasal Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal at 30mg; Intranasal Placebo
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The patients about to undergo kidney transplantation will be randomized to one of the
      following two group:

      Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment
      period is 3 months( 12 weeks)
    


Intervention name(s): FK506MR; Prograf; Mycophenolate Mofetil; Methylprednisolone; Prednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral; oral
Other intervention name(s): Advagraf; Tacrolimus modified-release; MR4; tacrolimus; FK506; MMF
Intervention MeSH terms: Mycophenolic Acid; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Tacrolimus; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney Transplantation; Tacrolimus; Methylprednisolone; Prednisolone; Mycophenolate Mofetil
Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
Condition: Breast Augmentation
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study
      is designed to differentiate parameters of pain between randomized laterality using no touch
      technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery
      but will receive a refund of a partial payment. Patients must undergo evaluation at
      consultation and surgical quote is provided.
    

Detailed description: 
      Breast augmentation in the subpectoral position has classically been associated with
      postoperative pain and discomfort within the first two weeks after the operation. Minimizing
      this pain and discomfort and ability to return to normal function soon after the operation
      has been the goal of numerous interventions. Minimal injury no touch dissection techniques
      have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local
      anesthetic infused saline fluid with a built in coagulation function used for dissection of
      soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation
      unilaterally on breast augmentation and mastopexy augmentation patients undergoing
      traditional sub pectoral dissection technique on the contralateral side. Patient's record
      pain scores at regular intervals in the postoperative period. Physical examination performed
      by blinded practitioners assess discomfort and tenderness scores within the two weeks after
      the operation.
    

Intervention name(s): Silicone Implant
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast augmentation; Breast implants; Silicone implants; Breast surgery
Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Condition: Stroke; Chronic Disease
MeSH terms: Stroke; Chronic Disease
Study type: Interventional

Summary: 
      Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10
      years which is in large part due to the cyclical relationship of chronic disease, poor
      health, and mild stroke which has gone largely unnoticed in the United States.
      Self-management intervention has been proven to be an effective intervention to increase
      healthy behaviors, improve overall health status, decrease healthcare utilization/cost,
      decrease depressive symptoms, and improve participation in people with a variety of chronic
      conditions; however, it has never be used with individuals with mild stroke. The critical
      next step and goal of this study is to evaluate if self-management intervention will improve
      health outcomes for persons with mild stroke. The overall hypothesis of this study is that
      self-management intervention will improve outcomes in the mild-stroke population.
    


Intervention name(s): Chronic Disease Self-Management Program (CDSMP)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Self-management; Rehabilitation; Occupational Therapy
Sun Protection Factor Assay (SPF Assay 18677)
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2mg/cm*2 test application.(Formulation-SR15-79_Y73-161)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models
Condition: Orthodontics; Study Models; Intra-oral Scanning; Measurements; Digital; Three Dimensional
Study type: Interventional

Summary: 
      The purpose of this study is to compare the accuracy of measurements derived from a
      commercially available direct intra-oral scanning system with those taken from plaster study
      models, and to compare cost implications of both systems.

      The investigators will test the hypotheses:

        -  There is no systematic difference between measurements taken from the Trios scanner and
           study models.

        -  There is no difference in the cost of producing digital models.
    

Detailed description: 
      Plaster study models produced from moulds of the teeth are a standard component of
      orthodontic records. They are fundamental to diagnosis and treatment planning, evaluation of
      treatment progress and results as well as record keeping. (Santoro et al., 2003) Plaster
      models must be retained for a minimum of 11 years for a medico legal reasons. This leads to
      problems of storage in terms of space and cost, in addition to the risk of damage because of
      the brittle nature of the models. These problems therefore highlight the need for an
      alternative method for producing and storing study models. This study aims to compare the
      accuracy of measurements derived from a new commercially available direct intra-oral (inside
      of the mouth) scanning system (3Shape TRIOS (R)) with those taken from plaster study models,
      and to compare cost implications of both systems. We will use the results to conclude whether
      direct intra¬oral scanning can replace traditional plaster models produced from moulds of the
      teeth.
    

Intervention name(s): 3Shape TRIOS (R)
Intervention type(s): Device
Intervention description(s): Direct intra-oral scan of teeth and dentition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the
      treatment of Visceral Leishmaniasis (VL) in India.
    

Detailed description: 
      The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the
      treatment of VL in India.

      Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal
      amphotericin B to amphotericin B deoxycholate with regards to final cure rates

      Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal
      amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage
      regimens.
    

Intervention name(s): Liposomal Amphotericin B; amphotericin B deoxycholate
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of 10 mg/kg of liposomal amphotericin B; amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
Other intervention name(s): AmBisome
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visceral leishmaniasis; India; Liposomal Amphotericin B; Amphotericin B deoxycholate
Drug-Drug Interaction Study of MLC1501 Using Cocktail of Drugs Acting as Sensitive Clinical Probes/Substrates of Cytochrome P450 Isoenzymes and Transporters in Healthy Subjects
Condition: Stroke
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre phase I study to assess the Drug-Drug Interaction potential of
      MLC1501 with a cocktail of drugs acting as sensitive clinical probe substrates of Cytochrome
      P450 isoenzymes and Transporters in healthy subjects .

      The study will have 2 cohorts, one for the CYP study and the other for the Transporters
      study. Eligible subjects (n=24) will be assigned to one of the 2 cohorts in a 1:1 ratio.
    


Intervention name(s): MLC1501; CYP Cocktail; Transporter Cocktail
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MLC1501 capsules (4 capcules (2000 mg) twice a day); Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg; Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be assigned to either CYP or Transporter cohort in ratio of 1:1.
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multicenter, randomized, double-blind, placebo-controlled study designed to
      assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment
      of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20
      mg) is included as a positive control to confirm the assay sensitivity of the study. A total
      of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to
      obtain approximately 450 randomized subjects.
    


Intervention name(s): OPC-34712; Placebo; Aripiprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral, once daily; Placebo; oral, once daily
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Relapsed
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing empagliflozin and metformin extended release compared to
      the free combination of empagliflozin and metformin extended release under fed conditions.
    


Intervention name(s): metformin; empagliflozin/metformin; empagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of metformin given as tablets; Single dose empagliflozin/metformin given as fixed-dose combination tablet; single dose of empagliflozin given as tablet
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that the combination of aprepitant with dexamethasone will provide
      significantly improved prophylaxis against Postoperative nausea and vomiting compared with
      the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under
      general anesthesia.
    


Intervention name(s): Aprepitant + Dexamethasone; Ondansetron + Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Aprepitant 40 mg + Dexamethasone 10 mg; Ondansetron 4 mg + Dexamethasone 10 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PONV; nausea; emesis; antiemetics; aprepitant; ondansetron; dexamethasone
Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety
Condition: Stress; Brain Activity; Passiflora Incarnata; Test Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity
      during examination stress in 40 subjects suffering from test anxiety. A double-blind,
      randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.
    

Detailed description: 
      Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety
      after single intake by aid of a newly developed, validated method consisting of a combination
      of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time
      resolution of 364 ms).
    

Intervention name(s): Pascoflair; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1 x 2 tablets (single-dose); 1 x 2 tablets (single-dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Artemether/Lumefantrine and Vivax Malaria
Condition: Vivax Malaria
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 3

Summary: 
      The cure rate of artemether/lumefantrine in the treatment of vivax malaria.
    


Intervention name(s): tablets artemether/lumefantrine
Intervention type(s): Drug
Intervention description(s): six doses of oral tablets of artemether/lumefantrine
Other intervention name(s): Quartem
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; vivax; artemether/lumefantrine; Sudan