bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an
      inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High
      blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus,
      low-phenylalanine diets help patients to manage their condition but it is not clear whether
      they have an impact on appetite, energy intake and changes in body weight. This is important
      to explore as prevalence of obesity in this population is rising high. This study aims to
      find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy
      expenditure. The investigators will recruit 26 healthy adults and ask them to participate in
      two experimental trials. On one occasion the participants will be asked to consume a
      PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement
      and lunch will be based on normally consumed foods. Series of blood samples will be taken and
      appetite will be assessed during both experiments. Both experimental trials will finish with
      consuming an "all-you-can-eat" buffet.
    


Intervention name(s): Phenylketonuria-type diet; Normal (control) diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Breakfast, lunch and open buffet dinner; Breakfast, lunch and open buffet dinner
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: low Phenylalanine diet; PKU supplements; diet induced thermogenesis; appetite; body weight
Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat®
      in Subjects With Persistent Asthma
    

Detailed description: 
      A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy
      and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects
      With Persistent Asthma
    

Intervention name(s): GP MDI 28.8 μg; GP MDI 14.4 μg; GP MDI 7.2 μg; Placebo MDI; Spiriva Respimat 2.5 μg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID; GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID; GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID; Placebo taken as 2 inhalations BID; Spiriva Respimat 2.5 μg QD (open-label)
Other intervention name(s): GP; GP; GP; Placebo; Spiriva Respimat
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Linear repeated measures model
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sensory Reconstruction of the Digits
Condition: Soft Tissue Defect of Digit
Study type: Interventional

Summary: 
      A retrospective study is conducted with 151 patients who has a soft tissue defect of digit
      treated with the sensate flaps from February 2005 to March 2014. Based on the different
      regions of soft tissue defects, the patients in the study are divided into four groups: (1)
      thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal
      finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal
      finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region
      group treated with Litter flap. The main outcomes are static 2-point discrimination and
      Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.
    

Detailed description: 
      At final follow-up, sensory restoration of the flap is measured using the static 2PD test and
      Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a
      10 cm line, patients are asked to report pain sensations of the recipient site. Patients
      report their satisfaction with functional recovery of the injured finger according to the
      Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.
    

Intervention name(s): innervated sensate flap
Intervention type(s): Procedure
Intervention description(s): sensory reconstruction via digital nerve repair with the donor nerve of the flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dorsal digital island flap; sensory reconstruction
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Condition: Double Lumen Infection; Hemodialysis
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether cloxacillin lock is effective in
      prevention of double lumen infection.
    

Detailed description: 
      Double lumen infection is one of the causes of morbidity and mortality in hemodialysis
      patients. Many strategies used to prevent it and one of them is antibiotic lock. Thus we
      select chronic hemodialysis patients and divided them into 2 groups. One group received
      cloxacillin and heparin as catheter lock and the second group received only heparin lock.
    

Intervention name(s): cloxacillin; heparin
Intervention type(s): Drug; Drug
Intervention description(s): cloxacillin 100mg/ml as catheter lock at the end of hemodialysis; heparin 1000iu/ml as catheter lock at the end of hemodialysis
Intervention MeSH terms: Cloxacillin; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      the aim of this study are to explore the characteristics of mean airway pressure, oscillatory
      amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by
      various loaded and flow rate during expiration and inspiration in healthy subjects and to
      explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX®
      device
    

Detailed description: 
      For inspiratory group, the resistive load 3, 4, 5, 6 and 7 cm H2O were test with three flow
      rate: 0.2, 0.4, and 0.6 L/sec in each load. In each flow rate, the subjects were instructed
      to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory
      pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation. For
      expiratory group, the resistive load and flow rate were test similar inspiratory group. In
      each flow rate, the subjects were instructed to inspire as deeply as possible through the
      nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to
      1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit
    

Intervention name(s): BreatheMAX breathing device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section
Condition: Cesarean Section; Hemodynamic Instability
Study type: Interventional

Summary: 
      The primary aim of this study was to compare the effects of two different low-dose
      bupivacaine used in spinal anesthesia on intraoperative hemodynamics in cesarean section
      operations.Investigators think that low-dose bupivacaine and fentanyl mixture applied in
      cesarean section cause fewer hemodynamic changes,provide adequate anesthesia and analgesia
      quality,cause fewer side effects,and postoperatively,patients may return to their daily
      activities more quickly.This study was conducted on 80 pregnant women undergo an elective
      cesarean section.Patients were randomly allocated in GrupA and GroupB. Combined
      spinal-epidural anesthesia was performed in the sitting position using the
      needle-inside-needle technique.After cerebrospinal fluid flow was observed, GroupA patients
      were given a solution containing 5 mg isobaric bupivacaine+15 µg fentanyl (1.3 ml),and Group
      B was administered a solution containing 7 mg isobaric bupivacaine+15 µg fentanyl
      (1.7ml).Hypotension,bradycardia,duration of analgesia,postoperative nausea and vomiting were
      recorded.
    


Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): Two Different Low-Doses Of Isobaric Bupivacaine ( Group İzobarik bupivakain (5 mg) + fentanil and Group İzobarik bupivakain (7 mg)+ fentanyl ) were administered to the subarachnoid space
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Ceseaean section; Spinal anesthesia; Hemodynamics
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data
Condition: Venous Thromboembolism; Pulmonary Embolism; DVT
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates through standard practice. Investigators assume
      that the RCT provides the reference standard treatment effect estimate and that failure to
      replicate RCT findings is indicative of the inadequacy of the healthcare claims data for
      replication for a range of possible reasons and does not provide information on the validity
      of the original RCT finding.
    

Intervention name(s): Rivaroxaban; Apixaban
Intervention type(s): Drug; Drug
Intervention description(s): Any rivaroxaban dispensing claim is used as the reference group; Any apixaban dispensing claim is used as the exposure group
Other intervention name(s): Xarelto; Eliquis
Intervention MeSH terms: Rivaroxaban; Apixaban
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort study design comparing rivaroxaban to apixaban users. The patients will be required
        to have continuous enrollment during a baseline period of 180 days before initiation of
        rivaroxaban or apixaban (index date). Analysis is restricted to patients hospitalized with
        a VTE.
A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of
      midazolam and 1-hydroxymidazolam.
    

Detailed description: 
      A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the
      Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in
      healthy volunteers
    

Intervention name(s): BV100; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Rifabutin for Infusion; Syrup for oral administration
Intervention MeSH terms: Midazolam
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, 3 period fixed-sequence, Phase 1 clinical study to evalu-ate the effect of multiple doses of BV100 on the Pharmacokinetics on midazo-lam and its metabolite 1-hydroxymidazolam in healthy volunteers.
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the time of onset of analgesic effect of
      Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include
      determining the relationship between analgesic effect and plasma levels for Tramadol
      Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol
      Contramid® OAD.
    


Intervention name(s): Tramadol Contramid® OAD 200mg
Intervention type(s): Drug
Intervention description(s): 1 Tramadol Contramid® OAD 200mg tablet daily.
Intervention MeSH terms: Tramadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back Pain
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Endocarditis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent
      acute kidney injury following open heart surgery in infective endocarditis patients.
    


Intervention name(s): sodium bicarbonate; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: sodium bicarbonate, renal function, infective endocarditis, open heart surgery
AMPLEX Ankle Fusion and Hindfoot
Condition: Arthrodesis Surgery Involving the Hindfoot or Ankle
Study type: Interventional

Summary: 
      To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in
      a population indicated for single, double, or triple hindfoot arthrodesis or ankle
      arthrodesis surgery with supplemental graft material.
    


Intervention name(s): AMPLEX; Autogenous Bone Graft (ABG)
Intervention type(s): Device; Procedure
Intervention description(s): A bone graft substitute; Control material administered by surgical implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for
      the prevention of nosocomial diarrhea.

      TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a
      daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery
      stools in a 24 h that will occur more than 72 h after admission).
    

Detailed description: 
      Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been
      documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming
      units (CFU) compared with placebo had no effect on the overall incidence of nosocomial
      diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938
      have such effects needs to be substantiated in further randomized trials.
    

Intervention name(s): Lactobacillus reuteri DSM 17938; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10(9) CFU/daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nosocomial diarrhea; Lactobacillus reuteri DSM 17938; rotavirus diarrhea; probiotics
13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer
Condition: Drug Toxicity; Lung Cancer
MeSH terms: Lung Neoplasms; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.

      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis
      retinoic acid with or without vitamin E for chemoprevention or observation of cancer in
      persons at high risk of developing lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic
           acid administered for one year.

        -  To access the adequacy of the collected specimens for studies of intermediate endpoint
           markers.

        -  to establish a depository of biologic specimens for future studies of new biomarkers.

             -  Arm 1: Patients receive oral 13-cis retinoic acid daily.

             -  Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.

             -  Arm 3: Patients undergo observation only. Treatment continues in arms I and II for
                1 year in the absence of unacceptable toxicity.

      Patients are followed annually for 2 years.

      PROJECTED ACCRUAL: A total of 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued
      for this study within 3 years.
    

Intervention name(s): 13-cis retinoic acid; Tocopherol
Intervention type(s): Drug; Dietary Supplement
Other intervention name(s): Isotretinoin, AccutaneT; Vitamin E
Intervention MeSH terms: Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Tretinoin; Isotretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer; drug/agent toxicity by tissue/organ
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
Condition: Headache; Migraine; MR-Angiography; Healthy Volunteers; GTN; Middle Cerebral Artery
MeSH terms: Headache
Study type: Interventional

Summary: 
      To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular
      response during the GTN-induced headache in healthy volunteers.
    

Detailed description: 
      The only intra cranial structures innervated by sensory nerves, and therefore a possible
      source of the headpain are the meninges and the large intracerebral arteries. The dilatation
      of the cerebral vessels may not be the origin of the head pain per se, but measurements of
      the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and
      has helped elucidate the basis for the migraine aura (Olesen, Friberg et al. 1990). The
      effects of different signal molecules on the intra cerebral vasculature continue to be an
      important field in the migraine research, in the search for possible pain causing signaling
      molecules.

      Therefore we have set up at study to examine if MR-Angiography (MRA) can be used for
      monitoring of the vascular response after challenge with the known vasodilator GTN. This drug
      was chosen because it is well characterized and a large body of evidence from earlier studies
      could serve as background data (Thomsen 1997).
    

Intervention name(s): MR-angiography, GTN
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Headache; migraine; MR-angiography; healthy volunteers; GTN; Middle cerebral artery
Ex Vivo Effect of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The effect of surfactant protein D under native and altered conditions will be investigated
      in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma
      following segmental allergen challenge. The goal of this study is to elucidate the pro-
      versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have
      treatment potential in allergic asthma.
    

Detailed description: 
      Following a baseline BAL, allergen (3×) and saline (1×) will be instilled into four different
      lung segments during a first bronchoscopy. After 24 hours during a second bronchoscopy BAL
      will be collected in these challenged segments to harvest invaded cells for in-vitro
      experimentation. In addition, bronchial biopsies and epithelial brushes will be taken to
      assess the degree of local inflammation in bronchial mucosa and to study the activation of
      airway epithelium following allergen challenge.
    

Intervention name(s): Bronchoscopy
Intervention type(s): Procedure
Intervention description(s): Bronchoscopy with segmental allergen challenge
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma GINA 1