bioihbjkbjnl/mcl2 huggingface dataset:
Immunologic Action of a Single Dose Cholecalciferol
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D receptors are expressed in activated different immune cells. It is not known, which
      immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals
      will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a
      double-blind placebo controlled setting. Immune cells will be monitored from the blood over
      time.
    

Detailed description: 
      Vitamin D-deficient individuals will receive once

        -  double-blind, placebo controlled 100.000 I.U.vitamin D3

        -  intramuscular or subcutaneous

      Blood will be taken over time and

        -  immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by
           flow-cytometry

        -  vitamin D-metabolites will be monitored
    

Intervention name(s): single administration of 100.000 I.U. vitamin D; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vitamin D; vitamin D deficiency; immune cells; pharmacokinetic; < 50 nmol/L 25(OH)D serum concentration
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Condition: Growth Disorders; Intrauterine Growth Retardation
MeSH terms: Fetal Growth Retardation; Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of continuous and intermittent administration of Genotonorm on stature
      in short prepubertal children with intra-uterine growth retardation
    


Intervention name(s): Genotonorm; Genotonorm; Genotonorm
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection; 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection; 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short height; intra-uterine growth retardation; Genotonorm; continuous treatment; intermittent treatment
Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker
Condition: Pacemaker
MeSH terms: Respiratory Aspiration; Heart Failure
Study type: Interventional

Summary: 
      It is well-known that not only peripheral muscles, but also respiratory muscles muscle
      weakness and deconditioning play an important role in low exercise capacity of patients with
      Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and
      quality of life in patients with heart disease. However, hearth failure patients with
      pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization
      pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing
      exercise. No study investigated the effects of different inspiratory muscle training
      protocols. For this reason, we aimed to investigate the effects of inspiratory muscle
      training on outcomes in hearth failure patients with pacemaker
    

Detailed description: 
      Heart failure patients with pacemaker will be included. Primary outcome measurement is
      respiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral
      muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life,
      depression, physical activity.
    

Intervention name(s): Inspiratory muscle strength training; Inspiratory muscle endurance training
Intervention type(s): Device; Device
Intervention description(s): Treatment group will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 50% of maximal inspiratory pressure (MIP).
The MIP will be measured at supervised session each week, and 50% of measured MIP value will be the new training workload.
The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.; Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP).
The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: pacemaker; inspiratory muscle training; exercise capacity; Quality of Life; Respiratory Muscle Strength
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
Condition: SLEEP APNEA SYNDROME
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      Study objetives : The aim of this study is to assess the impact of a combined therapy
      treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on
      symptoms and quality of life in patients with OSAS, as an alternative or addition to
      therapeutic treatment with nocturnal CPAP.
    

Detailed description: 
      The obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction of the
      upper airway during sleep. OSAS is associated with a wide range of health consequences such
      as daytime sleepiness, cognitive impairment and metabolic and cardiovascular diseases. In
      Spain the prevalence of this disease is 3 to 6%, constituting a public health problem. The
      recommended first line treatment for OSAS is continuous positive pressure airway (CPAP).

      Physical exercise has been shown to ameliorate the consequences of OSAS such as
      cardiovascular disease, glucose intolerance and fatigue. Scientific studies have shown that
      vigorous physical activity is associated with a decrease in the prevalence of OSAS, improved
      sleep efficiency and the Epworth Sleepiness Scale.

      Moreover, recent evidence has shown that oropharyngeal exercises can be useful in the
      treatment of OSAS decreasing neck circumference, snoring, subjective sleepiness and AHI as
      well as improving the quality of life and saturation oxygen.

      The 60-70% of patients with OSAS is overweight or obese showing that a high body mass index
      (BMI) is an independent risk factor for the occurrence of OSAS. Many studies have shown that
      weight loss is associated with significant reduction in AHI.

      However, despite the scientific evidence to justify the inclusion of these modalities, there
      is no study that has analyzed the impact of performing together all these interventions. It
      is expected that the combination can produce a cumulative effect that impacts significantly
      on improving indicators of OSAS.

      The investigators will include patients with a recent diagnosis of moderate or severe OSA.
      Patients will be randomized to interventional or control group.

      Patients included in the study will be followed for almost three months and they will be
      examined at baseline and after time of follow-up or intervention.
    

Intervention name(s): Exercise; Control
Intervention type(s): Other; Other
Intervention description(s): Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education; Dietary and general recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: SLEEP; APNEA; EXERCISE
Treatment of Keratoconus With Advanced Corneal Crosslinking
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether mechanical compression of the cornea
      during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve
      the optical outcomes of the treatment.
    

Detailed description: 
      The study is designed as a prospective, open, randomized controlled trial involving patients
      aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine
      corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå,
      Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive
      either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified
      treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured
      to the cornea during the treatment to flatten the corneal curvature and potentially improve
      the optical outcome after the treatment. Patients are randomized utilizing a list of unique
      random numbers between 1 and 60. All patients are informed about the procedures before
      consenting to participate in the study. The study also involves 60 eyes of healthy age- and
      sex-matched control subjects.

      At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best
      spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann
      applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are
      assessed with applanation resonance tonometry and the ocular response analyzer. The
      investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.
    

Intervention name(s): Corneal reshaping/crosslinking (CRXL); Corneal Crosslinking (CXL)
Intervention type(s): Procedure; Procedure
Intervention description(s): The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.; The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keratoconus; Corneal crosslinking; Corneal biomechanics; Corneal densitometry; Scheimpflug photography
Hypoglycemia in Hospitalized Patients
Condition: Diabetes; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Observational

Summary: 
      Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at
      risk for losing the ability to develop symptoms that warn them that they are having a low
      blood sugar. There is almost no available information investigating how the inability to feel
      symptoms of a low blood sugar contributes to the risk of this happening when people with
      diabetes are hospitalized. The purpose of this study is to develop a symptom score model that
      will help to identify patients at risk for low blood sugars in the hospital and to examine
      what happens to patients who do experience a low blood sugar in the hospital.
    

Detailed description: 
      Patients who develop recurrent hypoglycemia are predisposed to developing
      hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no
      information investigating the contribution of HAAF as a risk factor for hypoglycemia in
      hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic
      symptom score model to examine HAAF and its correlation with cognitive dysfunction,
      re-hospitalization rates, inpatient morbidity and mortality.

      This will be a prospective non-blinded study performed in a tertiary care center that will
      include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify
      patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (<
      40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants
      will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing
      within 24-36 hours post event. Participants will be contacted at 6 and 12 months following
      the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia,
      need for re-hospitalization, and occurrence of any new diabetes related complications.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-critically ill hospitalized patients with a diagnosis of diabetes at time of admission
        using established ADA criteria or prior physician diagnosis who experience a documented
        episode of hypoglycemia, defined as a blood glucose < 70 mg/dl.

        .
      
Keywords: Type 1 diabetes; Type 2 diabetes; Hypoglycemia; Cognition disorders; Inpatient
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Physicians might be concerned that Adempas may have a metabolic interaction with oral
      contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information
      regarding lack of potential pharmacokinetic interaction has been communicated; there is a
      need for more re-assurance and further data that there is no interaction between Adempas and
      OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least
      vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered
      adequate to inform about safe use of Adempas with OCs.
    


Intervention name(s): Microgynon; Riociguat (Adempas,BAY63-2521)
Intervention type(s): Drug; Drug
Intervention description(s): single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted); multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Hemodynamic Repercussions of Noninvasive Ventilation
Condition: Haemodynamic Rebound
Study type: Interventional

Summary: 
      The noninvasive ventilation (NIV) is a method of ventilatory support that does not require
      artificial airway. Its application is associated with complex hemodynamic repercussions,
      therefore is important to identify them for safety and effectiveness of the technique
      application.

      The main objective of this research is to evaluate the hemodynamic repercussions using
      doppler echocardiography in healthy volunteers submitted a different values of positive end
      expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway
      pressure (CPAP) and Bilevel.

      The study hypothesis is that the positive end expiratory pressure (PEEP) may cause
      hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after
      load, cardiac output and reduction in the diameter of the superior vena cava, due to the
      increase in the intrathoracic pressure and pulmonary volumes.
    


Intervention name(s): Noninvasive ventilation
Intervention type(s): Other
Intervention description(s): Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively
Other intervention name(s): Continuos positive airway pressure; Bilevel; Positive end expiratory pressure
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: hemodynamic; mechanical ventilation; respiration with positive pressure
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of
      GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
    


Intervention name(s): GSK1399686
Intervention type(s): Drug
Intervention description(s): Safety and tolerability dose escalation in normal human volunteers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pharmacokinetics; Phase 1; first time in humans; IBD; safety; human volunteers
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
      study evaluating the PK of single doses of WTX101 in healthy participants based on the
      measurement of plasma total Mo concentration.
    


Intervention name(s): ALXN1840 Enteric-coated Tablet; ALXN1840 Non-coated Capsule; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.; ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.; Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.
Other intervention name(s): WTX101 (formerly); Bis-choline tetrathiomolybdate; Tiomolibdate choline; WTX101 (formerly); Bis-choline tetrathiomolybdate; Tiomolibdate choline; Prilosec
Intervention MeSH terms: Molybdenum; Tetrathiomolybdate; Choline; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN1840; WTX101; Omeprazole
Intrathecal Morphine in Robot-assisted Prostatectomy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study will investigate the efficacy and safety of intrathecal morphine for the patients
      undergoing robot-assisted prostatectomy
    

Detailed description: 
      Prostatectomy is the treatment of choice for prostate cancer. The robot-assisted
      prostatectomy is becoming the most popular surgical method for prostate cancer. The small
      incision after robot-assisted prostatectomy is thought to reduce the postoperative pain.
      There is few investigations for the strategy to reduce the postoperative pain of
      robot-assisted prostatectomy.

      The intrathecal morphine injection is known to reduce postoperative pain for surgeries like
      hepatectomy, myomectomy and open prostatectomy. This method, however, is not yet studied for
      the robot-assisted prostatectomy. This study will investigate the efficacy and safety of
      intrathecal morphine for the patients undergoing robot-assisted prostatectomy.
    

Intervention name(s): The intravenous patient-controlled analgesia; The intrathecal morphine injection
Intervention type(s): Drug; Drug
Intervention description(s): The intravenous injection of morphine using the patient-controlled analgesia machine; A single injection of morphine intrathecally
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prostatic Neoplasms; Laparoscopy; Injections, Spinal; Morphine
A Study of Oral Hymecromone and Hyaluronan Synthesis
Condition: Healthy; Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to add further understanding to the doses of hymecromone that
      effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will
      investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using
      sputum samples as a non-invasive surrogate.

      This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy
      adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be
      treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and
      pharmacodynamic response will be monitored during therapy.
    


Intervention name(s): hymecromone
Intervention type(s): Drug
Intervention description(s): Oral Hymecromone
Other intervention name(s): 4-Methylumbelliferone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to one of three treatment groups, each including up to 6 participants, with treatment over 4 days of different doses of oral hymecromone. Following a wash-out period, participants are allowed to re-enroll into different treatment groups to provide intra-patient dose comparisons.
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Condition: Depressive Disorder, Major; Diabetic Neuropathies; Fibromyalgia; Vasomotor Symptoms
MeSH terms: Fibromyalgia; Diabetic Neuropathies; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR)
      and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess
      the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to
      healthy subjects.
    

Detailed description: 
      This is a randomized, open-label, inpatient/outpatient, 3-period crossover study in healthy
      subjects.The study will consist of 3 treatment periods. In treatment period 1, subjects will
      be randomly assigned on study day 1. A single 60-mg dose of codeine will be administered to
      all subjects. In periods 2 and 3, subjects will receive either DVS SR 100 mg/day or
      paroxetine 20 mg/day until the steady state is reached. At steady state, subjects will
      receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg, depending
      on the treatment sequence to which they are assigned. DVS SR 100 mg or paroxetine 20 mg
      administration will continue for an additional 2 days. In treatment period 3, subjects will
      receive the alternative treatment sequence.
    

Intervention name(s): desvenlafaxine sustained release (DVS SR); Paroxetine; Codeine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Codeine; Paroxetine; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment