bioihbjkbjnl/mcl2 huggingface dataset:
Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to define a ratio of Caffeine and albuterol that gives a
      synergistic increase in metabolic rate.
    

Detailed description: 
      The study consists of 2 screening visits and 8 study visits. Screening visit 1: about 1 hour
      fasting from 9pm the prior night. Height and weight is measured, vital signs taken and
      questionnaires completed. Women will have a urine pregnancy test. Blood draw for chemistry
      panel and blood count.

      Screening visit 2: about 1 hour, Medical history, physical examination, and electrocardiogram
      (a heart tracing).

      Visit 1-8 about 4 hours each. 8 separate occasions, with about 7 days between each visit. ON
      each visit, blood pressure, pulse and temperature is recorded. A resting metabolic rate (RMR)
      is measured. After a baseline measurement of about 30 minutes of breathing is taken , a pill
      will be swallow and metabolism(measured by breathing with a clear plastic hood over the upper
      body to measure metabolic rate ( the oxygen inhaled and the carbon dioxide exhaled).
    

Intervention name(s): 2mg of Albuterol; 4mg of Albuterol; 100mg of Caffeine; 200mg of Caffeine; Albuterol 2mg & Caffeine 100mg; Albuterol 2mg and Caffeine 200mg; Albuterol 4mg and Caffeine 100mg; Albuterol 4mg and Caffeine 200mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2mg of Albuterol on metabolic rate; 4mg of Albuterol on metabolic rate; 100mg of caffeine on metabolic rate; 200mg of Caffeine on metabolic rate; Albuterol 2mg and 100mg of Caffeine; Albuterol 2mg and Caffeine 200mg on metabolic rate; Albuterol 4mg and Caffeine 100mg on metabolic rate; Albuterol 4mg and Caffeine 200mg on metabolic rate
Other intervention name(s): Albuterol; Albuterol; Caffeine; Caffeine; Caffeine; Albuterol; Albuterol; Caffeine; Albuterol; Caffeine; Albuterol; Caffeine
Intervention MeSH terms: Caffeine; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This study evaluates the efficacy of auricular neurostimulation via an non-invasive
      percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea.
      A neurostimulator is applied to the outer ear and stimulates several nerves that are thought
      to be involved in transmission of nausea and vomiting signals. Half of the study subjects
      will receive an active nerve stimulator while the other half will receive an inactive one.
    

Detailed description: 
      By stimulating branches of several cranial nerves in the outer ear, this study aims to
      improve symptoms and quality of life in adolescents with functional nausea.

      The study has the following specific aims:

        1. To define adolescent functional nausea into subtypes based on clinical characterization
           and physiologic testing.

        2. Evaluating the efficacy of auricular neurostimulation via PENFS for functional nausea.
           Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They
           will receive either an active or non-active (sham group) device for 5 days each week x 4
           weeks total. Those who do not improve will receive an additional 4 weeks of therapy with
           active stimulation.

        3. Investigate possible brain functional connectivity changes induced by auricular
           neurostimulation compared to patients with irritable bowel syndrome and healthy controls
    

Intervention name(s): Active Auricular Neurostimulation; Sham Auricular Neurostimulation
Intervention type(s): Device; Device
Intervention description(s): Active auricular neurostimulation for 4 weeks. Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.; Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
Other intervention name(s): Percutaneous Electrical Nerve Field Stimulation (PENFS); Neuro-Stim System-2; Sham neurostimulation without electrical charge
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Modes of Ventilation During Laparoscopic Bariatric Surgery
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical
      visualization. Although effective in facilitating the procedure, there are respiratory
      consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure
      (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and
      increase closing capacity resulting in increased resistance, decreased compliance, and
      increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will
      evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to
      determine which is better able to support oxygenation and ventilation while limiting the peak
      inflating pressure (PIP).
    


Intervention name(s): Pressure controlled ventilation; Volume controlled ventilation; PRVC ventilation
Intervention type(s): Other; Other; Other
Intervention description(s): For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.; For volume controlled ventilation, the tidal volume is set.; Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Bariatric surgery patients
Phase I Trial of DAR-901
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of
      DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative
      and HIV positive adults previously vaccinated with BCG. The goals of the trial are to
      determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at
      different dose levels, ranging from 0.1 to 1 mg.
    


Intervention name(s): DAR-901; BCG; Sterile saline
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis; BCG; HIV; TB Vaccines
Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to study the side effects of PF-00299804 and determine
      the highest dose that can be safely administered in patients with advanced cancer.
    


Intervention name(s): PF-00299804
Intervention type(s): Drug
Intervention description(s): investigational drug by oral route (escalating doses depending on safety) administered until progression
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of B+ Surface on Early Loading
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The trial is designed as a consecutive enrollment prospective one-center study. A minimum of
      30 patients will be included in the study. At implant installation, the implant will be
      randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading,
      4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be
      collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months.
      Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the
      impressions are taken.
    


Intervention name(s): Early Loading; Conventional Loading
Intervention type(s): Procedure; Procedure
Intervention description(s): The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.; The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Does Oral Intake Decreases Postoperative Pain Score in Children
Condition: Fasting; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Pain score after inguinal hernia repair surgery in children decreased as time passed in
      previous studies. Postoperative oral intake is usually resumed two hours after minor surgery
      in most of institutions, that may influence children's behavior and pain score.

      A recent study suggest that oral intake one hour after minor surgery does not increase the
      incidence of postoperative nausea and vomiting.

      The investigators primary endpoint is to clarify whether postoperative oral intake influences
      postoperative pain score in children.
    


Intervention name(s): two hours; one hour
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS)
      applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.
    

Detailed description: 
      Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%)
      in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation
      (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by
      plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement
      in the craving of food.
    

Intervention name(s): MagVenture MagPro R30
Intervention type(s): Device
Intervention description(s): the subjects will receive 1500 or 5000 pulses at 5Hz
Other intervention name(s): repetitive Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Binge Eating Disorder; Transcranial Magnetic Stimulation; Food Craving
Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients
Condition: Anesthesia; Reaction
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations
      used in hepatic patients with child-Pugh classification (class A), and early (class B)
      undergoing UGIE.
    

Detailed description: 
      70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine
      (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as
      loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP):
      ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1
      mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control
      group.
    

Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.; participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
Other intervention name(s): ketamine; ketamine
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
Condition: Hypertriglyceridemia; Obesity
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      Hypertriglyceridemia is a serious condition in the Mexican population and it is considered a
      major risk factor for cardiovascular disease. Current efforts to prevent dyslipidemia and
      lipids alteration include the development of functional products as an alternative for the
      management of hypertriglyceridemia. Common beans (Phaseolus vulgaris L.) are a recognized
      good source of bioactive compounds, mainly phenolic compounds, total dietary fiber (insoluble
      and soluble fiber, resistant starch and oligosaccharides), saponins, and phytosterols that
      exert hypolipidemic effects. In this sense, the development of beans-based food products is
      an alternative for improving the general health status. In previous work, a beans-oats snack
      bar formulation was found to be a promising potential functional product. In order to
      validate those results, the aim of this works was to assess a clinical trial was conducted
      with Mexican women to assess the effect of daily consumption of the functional product on
      serum triglycerides and certain plasma proteins involved in lipids metabolism in a clinical
      trial. The clinical trial was 2 months, randomized parallel study where 32 women with
      elevated triglycerides were randomized into the treatment group and control group. The
      Control group received nutritional orientation whereas the treatment group received the
      orientation and consumed 50 g of the product per day. Fasting blood samples were collected at
      baseline and the end of the study, obtaining serum and plasma for analysis of lipids profile,
      glucose, and biomarkers. To determine changes in plasma proteins, a 182 protein Human Obesity
      Antibody Array was used, and the results were analyzed using a bioinformatic-based analysis
      from Ingenuity Pathways Analysis (QIAGEN)
    


Intervention name(s): BOSB
Intervention type(s): Dietary Supplement
Intervention description(s): BOSB consisted on a oats (26 %), common beans (30 %), water and emulsifier-based snack bar, administered daily (50 g/day) during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Common beans; Oats; Proteomic Analysis; Phenolic compounds; Dietary Fiber
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
Condition: Stomatitis, Aphthous
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Interventional

Summary: 
      The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in
      reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were
      included to the study. For each patient, ulceration were randomly assigned to the test or the
      control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In
      the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was
      evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.
    


Intervention name(s): Er,Cr:YSGG Laser
Intervention type(s): Device
Other intervention name(s): Waterlase MD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of fluconazole and isavuconazole on the PK of
      acalabrutinib and its active metabolite, ACP-5862.
    

Detailed description: 
      This is a 2-period study. On Day 1 of Period 1, all participants will be randomized to 1 of 2
      treatment sequences and will receive a single oral dose of 100 mg acalabrutinib (Treatment
      A). In Period 2, the participants who participated in Period 1 will receive either Treatment
      B (fluconazole) or Treatment C (isavuconazole). In Period 2 Treatment B, participants will
      receive a single oral loading dose of 400 mg fluconazole on Day 1 one hour before a single
      oral dose of 100 mg acalabrutinib. In Period 2 Treatment C, participants will receive oral
      dose of 200 mg isavuconazole three times daily (TID; approximately 8 hours apart) on Day 1
      and 200 mg isavuconazole once daily (QD) from Day 2 to Day 5 with a single oral dose of 100
      mg acalabrutinib coadministered on Day 5. There will be a washout of at least 8 days between
      Period 1 and first dose in Period 2. All participants will return to the study site
      approximately 7 days after the last study drug for follow-up procedures and adverse event.
    

Intervention name(s): Acalabrutinib; Fluconazole; Isavuconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Modify as "Participants will receive a single oral dose of 100 mg (1 X 100 mg capsule) acalabrutinib either on Day 1 of Period 1 (Treatment A) and Day 1 of Period 2 (Treatment B) or Day 5 of Period 2 (Treatment C).; Participants will receive 400 mg fluconazole (2 × 200 mg tablets) on Day 1 Period 2 (Treatment B).; Participant will receive oral dose of 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) three times daily on Day 1 and 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) once daily on Days 2 to 5 in Period 2 (Treatment C).
Intervention MeSH terms: Fluconazole; Isavuconazole; Acalabrutinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Acalabrutinib; ACP-196, Active metabolite; ACP-5862; Fluconazole; Isavuconazole; CYP3A4 Inhibitors; Pharmacokinetics; PK; Safety
Insulin Glargine in Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the protocol is to demonstrate that the new regimen (insulin
      glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro
      insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the
      secondary purpose is to compare the two study regimens as far as the glycemic control
      (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic
      excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data,
      are concerned and to verify the safety of basal insulinization with Lantus.
    


Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, randomised phase III trial, to compare the efficacy and safety
      profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor
      receptor 2 (HER2) negative, node positive breast cancer patients.

      Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4
      cycles of T 100 mg/m2 day 1 every 3 weeks.

      Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by
      4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a
      one-week rest period.

      Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen
      after the end of chemotherapy.

      Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or
      aromatase inhibitors (or both) after the end of chemotherapy.

      Patients may receive radiotherapy when clinically indicated.
    

Detailed description: 
      Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental
      arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha
      error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17%
      post-randomization drop-out, 691 patients per arm are needed.
    

Intervention name(s): Docetaxel; Capecitabine; Epirubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Taxotere; Xeloda; Ellence; cytoxan
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Capecitabine; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER2 negative breast cancer; Node positive breast cancer; Adjuvant treatment; Oral chemotherapy
AZD3293 Thorough QT Study in Healthy Male Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A thorough QT study of AZD3293
    

Detailed description: 
      A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to
      Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to
      Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male
      Subjects
    

Intervention name(s): AZD3293; AZD3293; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AZD3293 oral solution - one single dose (low dose).; AZD3293 oral solution - one single dose (high dose).; Placebo oral solution - one single dose; Moxifloxacin tablet - one single dose
Other intervention name(s): beta secretase inhibitor
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Thorough QT study