bioihbjkbjnl/mcl2 huggingface dataset:
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
Condition: Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia
Study type: Interventional

Summary: 
      Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in
      the blood are at risk of developing pulmonary hypertension and strain on the right side of
      the heart, both of which are known to increase symptoms and worsen prognosis It is not fully
      established whether interval exercise training in patients with severe COPD and concomitant
      low oxygen levels is beneficial.

      This study aims to evaluate the effects of aerobic interval exercise training in patients
      with severe COPD and low oxygen levels in the blood, with a particular emphasis on such
      effects on the cardiovascular system and pulmonary circulation.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise training intervention as described earlier.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exercise Therapy
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the safety and tolerability of BI 1356
      (5 mg / once daily) given for 78 weeks in different modalities of treatment.

      The treatment modalities are determined by the treatment in the blinded trial in which every
      patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI
      1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin
      background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin
      in combination with a sulphonylurea (patients in 1218.18 study)
    


Intervention name(s): linagliptine 5 mg; linagliptine 5 mg and pioglitazone 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): safety and efficacy of linagliptine 5 mg open label; efficacy and safety of the combination linagliptine and pioglitazone
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perfusion Index and Pain in Ankle Surgery
Condition: Pain, Postoperative; Ankle Fractures
MeSH terms: Pain, Postoperative; Ankle Fractures
Study type: Observational

Summary: 
      Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with
      activation of the sympathetic nervous system, such as by pain stimulation, as a result of
      involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for
      "objective pain measurement", although its practical usefulness and dependability as such
      have not previously been investigated.

      The investigators aim to explore associations between changes in PI and onset of pain
      following cessation of regional anaesthesia in alert patients following ankle fracture
      surgery.

      Methods:

      The investigators report an exploratory, observational analysis of prospectively gathered PI
      data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for
      ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT:
      2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive
      patients already included in the AnAnkle Trial at Herlev University Hospital, evenly
      distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).

      Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial
      and participants register pain scores on a 0-10 numeric rating scale every three hours and
      register the time of cessation of anaesthesia identified by return of sensation to the ankle.
      Morphine consumption is also registered.

      The investigators will explore correlations of changes in PI to increases in pain upon
      cessation of the regional anaesthesia and, secondly, differences in cessation related PI
      changes with SA versus PNB.

      Ethics:

      All participants have already given informed, written consent for use of this data for the
      AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for
      initiation of AnAnkle Trial in July 2015.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients included in the AnAnkle Trial at Herlev University Hospital.
Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This comparative pharmacokinetic study is being conducted to provide supporting evidence for
      inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC
      abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30
      mg pseudoephedrine).
    


Intervention name(s): Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 x 200 mg ibuprofen & 30 mg pseudoephedrine; 2 x 200 mg ibuprofen & 30 mg pseudoephedrine; 2 x 200 mg solubilised ibuprofen
Intervention MeSH terms: Ibuprofen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".
Condition: Rectal Cancer, Adenocarcinoma; Rectal Cancer Stage II; Rectal Cancer Stage III; Distant Metastasis; Local Recurrence of Malignant Tumor of Rectum
MeSH terms: Rectal Neoplasms; Recurrence
Study type: Observational [Patient Registry]

Summary: 
      Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal
      cancer (LARC) patients is considered as the gold-standard of treatment success as it is
      associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume
      cohorts with long term follow-up are scarce.

      This is a multicenter observational study using prospectively collected data from the Spanish
      Rectal Cancer Project database.

      The main objective of the study is to update long-term oncologic follow-up of those patients
      treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a
      pCR.

      Secondary objective is to analyze demographic, clinical, operative and treatment variables in
      search of related factors to adverse oncologic outcomes, like distant recurrence or
      tumor-related deaths.

      The results are reported in accordance with the STROBE (STrengthening the Reporting of
      OBservational studies in Epidemiology) Statement for observational studies.

      All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
    


Intervention name(s): neoadjuvant treatment
Intervention type(s): Procedure
Intervention description(s): We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had
        obtained a pCR
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste
      containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a
      pre-procedure to a professional dental cleaning.
    


Intervention name(s): Arginine/Calcium Carbonate; Nupro - Fluoride Free
Intervention type(s): Device; Device
Intervention description(s): One time treatment; Brush twice daily
Intervention MeSH terms: Calcium Carbonate; Calcium; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D.
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Patients will be screened up to 28 days before start of treatment. During the screening
      visit, the purpose and procedures of the study will be explained to potential patients and
      informed consent will be obtained.

      At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible
      patients will be randomized to treatment of the target area with either 30 minutes (group30)
      or 15 minutes (group15) blue light at 600 milliwatt per square centimeter (mW/cm²).
      Additionally, two study areas with similar clinical symptomatology will be determined and
      will be randomized to blue light treated area and Daivonex (Vitamin D) treated area.

      After randomization, patients will be trained on a demonstrator device (no actual treatment
      to ensure investigator is blinded as to which group the patient is randomized to) as well as
      the Daivonex cream. After patients have been instructed, treatment of the areas will be
      applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks.
      During those 12 weeks, patients will return to the study site for safety and effectiveness
      assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week
      of treatment to check for any adverse events or problems in handling the device or the cream.
      The visit at week 12 serves as end of treatment visit. The patients will be followed-up for
      another 4 weeks. Treatment responses will be photo documented.
    


Intervention name(s): Blue light treatment; Vitamin D
Intervention type(s): Device; Drug
Intervention description(s): Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.; Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain
      patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle
      Soreness (DOMS).
    


Intervention name(s): Loxoprofen Pain Patch; Placebo Patch; No Treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days; One Placebo Patch applied daily for 3 days; No Treatment for 3 days
Intervention MeSH terms: Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has a randomized, double-blind, placebo-controlled design to assess the efficacy,
      pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic
      dermatitis when applied BID to all atopic dermatitis lesions.
    


Intervention name(s): Omiganan; Omiganan; Omiganan; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Omiganan 1%; Omiganan 1.75%; Omiganan 2.5%; Vehicle
Intervention MeSH terms: Antimicrobial Cationic Peptides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC
      90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard
      meal in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose injected subcutaneously (under the skin); A single dose injected subcutaneously (under the skin)
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the
      new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven
      (7) days.
    


Intervention name(s): galyfilcon A prototype lens; enfilcon A lens
Intervention type(s): Device; Device
Intervention description(s): Prototype silicone hydrogel contact lens; Marketed silicone hydrogel contact lens
Other intervention name(s): Avaira® contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy
Condition: Epilepsy; Vitamin D Deficiency
MeSH terms: Epilepsy; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the maintenance dose of vitamin D supplementation required for children with
      epilepsy to maintain normal vitamin D level.
    

Detailed description: 
      children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive
      either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post
      supplementation.
    

Intervention name(s): Vitamin D 3
Intervention type(s): Drug
Intervention description(s): oral drops
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tirofiban in Stenting for Long Coronary Lesion
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Periprocedural myonecrosis or infarction are associated with short, intermediate, and long
      term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural
      CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the
      investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence
      of periprocedural infarciton in elective patients with long coronary lesions treated by
      overlapping use of drug-eluting stents.
    

Detailed description: 
      According to the results of 12.6% occurrence of peri-procedural myocardial infarction after
      long stent implantation by previous report[International Journal of Cardiology 2009;134:
      231-237], the investigator hypothesize the 50% reduction of peri-procedural MI by using
      tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of
      power with α 0.05.
    

Intervention name(s): tirofiban; normal saline solution
Intervention type(s): Drug; Drug
Intervention description(s): 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h; same use as tirofiban
Other intervention name(s): Xinweining, Grand Pharmaceutical Group, Wuhan, China
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary disease; stents; thrombosis; myocardial infarction; prognosis
Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to learn about how different immunosuppressant therapies impact
      on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be
      evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV)
      infection than Tacrolimus.
    

Detailed description: 
      We will address the hypothesis that CSA has a superior antiviral effect against HCV than
      Tacrolimus by assessing serial HCV RNA levels in serum. We plan to address the hypothesis
      that CSA is more efficient in limiting viremia than Tacrolimus and that viremia is predictive
      of long-term clinical outcome of hepatic fibrosis that is known to impact on both graft and
      patient survival
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HCV positive patients undergoing orthotopic liver transplantation
      
Biospecimen description: 
      Serum Tissue
    
Keywords: Hepatitis C Virus; HCV; Liver Transplant; Cyclosporine; Tacrolimus; Myfortic
Short Term Effects of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink on Cardiac Relaxation and Urinary Albumin Excretion in a Group of Diabetic Type 2 Subjects
Condition: Benefits of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink in Patients With Type 2 Diabetes Mellitus Before and After 8 Weeks of add-on Therapy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effects of a Hibiscus Sabdariffa and Stevia
      Rebaudiana drink on cardiac relaxation and urinary albumin excretion in a group of diabetic
      type II patients.
    

Detailed description: 
      The investigators performed a non-randomized single-arm clinical trial with a before and
      after design, carried out from November 2016 and May 2017.

      Intervention consisted of the administration of a Hibiscus-Stevia drink at a dose of 4 mg /
      kg / day for Stevia and 4 g / day for Hibiscus for a period of 8 weeks. Before and after
      intervention, the following were done by the participants: bioelectrical impedance analysis
      (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver
      function tests, kidney function tests, urinary excretion of albumin tests and full blood
      counts. These were followed by morphological workup including Electrocardiograms (ECGs),
      transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done
      before and after intervention.

      Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary
      excretion albumin tests were done at the 30th and 60th days for safety purposes.
    

Intervention name(s): HIBISTEVER1
Intervention type(s): Dietary Supplement
Intervention description(s): During 8 weeks, administration of a Hibiscus-Stevia drink for 8 weeks at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus. Evaluation will take place the 30th and 60th days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diastolic function; Blood pressure; Diabetes mellitus; Hibiscus Sabdariffa; Stevia Rebaudiana
Adhesive Tape Trauma Evaluation of Two Gentle Tapes
Condition: Adhesive Tape Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of this study is to determine the relative gentleness of two tapes recognized
      for gentleness. A three-prong multidimensional evaluation consisting of laboratory
      assessments, expert skin grader and subject discomfort assessment will be used.
    

Detailed description: 
      The objective of this study is to determine the relative gentleness of a new investigational
      tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and
      used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional
      evaluation consisting of laboratory assessments, expert skin grader and subject discomfort
      assessment will be used.
    

Intervention name(s): Skin Trauma
Intervention type(s): Device
Intervention description(s): Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
Other intervention name(s): 3M Micropore; 3M Kind Removal Silicone Tape - Investigational tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Skin condition after wear
Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy
      with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or
      without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization
      against birch pollen. The term "intraseasonal" means that patients will start with
      immunotherapy treatment during the birch pollen season, i.e. when the already experience
      allergic symptoms.
    


Intervention name(s): Depiquick Birch (DPG103); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment