bioihbjkbjnl/mcl2 huggingface dataset:
Losmapimod in Chronic Obstructive Pulmonary Disease Patients Stratified by Fibrinogen.
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine the effect of Losmapimod on blood vessels in
      patients with Chronic Obstructive Pulmonary Disease (COPD). Although COPD is a lung disease,
      it is also associated with an increased risk of cardiovascular disease (e.g. heart attacks
      and stroke). The investigators believe that this is a result of inflammation within the body,
      which damages the lining (endothelium) and walls of blood vessels. These changes can promote
      the development of fatty deposits within the walls of arteries (atherosclerosis) which can
      rupture and block arteries causing damage.
    

Detailed description: 
      The study aims to enrol sufficient COPD subjects (stratified by fibrinogen level) so that 60
      patients complete the study. Study patients will have a 50% chance of receiving either
      Losmapimod or Placebo. Patients will be expected to attend for up to 12 visits, over a 24
      week period. The visits consist of an initial screening visit, and 2 pre-dose imaging visits
      to include a PET-CT scan and an optional MRI scan. The next 7 visits (at 2-4 weekly
      intervals) involve blood tests and safety evaluations. A number of procedures including heart
      tracings (ECGs), non-invasive vascular measurements and lung function tests at the start and
      at the end of the study. Repeat imaging with PET-CT and MRI will be performed at the end of
      the study and a follow-up visit.

      The purpose of the study is to see if the study medication has a beneficial effect on
      vascular function and structure. It is envisaged that this trial will help define more
      evolutionary biomarkers to focus on to help COPD patients in the future.
    

Intervention name(s): Losmapimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of Losmapimod 7.5mg twice daily; One tablet twice daily
Other intervention name(s): GW856553; Lactose Monohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vascular Inflammation; FDG PET-CT; COPD; Atherosclerosis; p38 MAP kinase inhibitor
Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
Condition: Hypotension; Hypertension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The primary objective of the present investigation is to determine the accuracy of a
      non-invasive non-oscillometric blood pressure wristband device when compared to invasive
      intra-arterial blood pressure monitors. In an intensive care unit patients who already have
      an intra-arterial blood pressure monitor in place, this wristband device will be applied and
      blood pressure readings compared for approximately 15 minutes. Blood pressure readings will
      be gathered and compared.
    


Intervention name(s): Non-invasive non-oscillometric blood pressure wristband device; Invasive intra-arterial blood pressure monitors.
Intervention type(s): Device; Device
Intervention description(s): The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.; Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Central Mechanisms of Intervention for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Body-based interventions have consistently shown clinical effectiveness in patients with back
      pain. The primary objective for this study is to compare the effect of body-based
      interventions commonly used in the management of low back pain on behavioral and cortical
      measures of pain sensitivity and central sensitization of pain. Participants will be randomly
      assigned to receive one of the interventions or be in a control group. The central hypothesis
      for this proposal is that spinal manipulation, a specific form of body-based intervention,
      inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other
      interventions. The completion of the proposed study will elucidate underpinning mechanisms of
      body-based interventions. Identification of these mechanisms will improve the clinical
      application and utilization of these interventions in the management of musculoskeletal pain
      conditions, especially back pain.
    

Detailed description: 
      170 participants will be randomly assigned to receive one of the interventions or be in a
      control group. The investigators will use of a model of experimentally induced low back pain
      to investigate the effects of manipulative and body-based interventions in acute onset low
      back pain without some of the clinical confounds. The investigators will collect fMRI and
      psychophysical data about pain sensitivity before and after the induction of pain, and before
      and after interventions for that pain.
    

Intervention name(s): Spinal Manipulation; Spinal Mobilization; Static Touch
Intervention type(s): Other; Other; Other
Intervention description(s): High velocity low amplitude joint-biased intervention; Low velocity, large amplitude oscillating joint biased technique; The investigators maintains hand contact with both hands over the lumbar area of the participant
Other intervention name(s): SMT; Mobilization; Mobs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Spinal Manipulation; Body-based intervention; Experimental pain
A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
Condition: Heart Failure (HF)
MeSH terms: Heart Failure; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a prospective, open-label, single-arm intervention study in
      African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF).

      There will be a 7-day screening period, a 57-day open-label treatment period, and a safety
      follow-up at day 87 or 30 days after the last administration of the investigational product.
    

Detailed description: 
      The goal of this study is to determine the impact of adding ivabradine therapy to the
      standard of care (SOC) in African-American/Black subjects with Heart Failure (HF) and reduced
      ejection fraction (HFrEF) on changes in heart rate (HR) from baseline (SOC alone). Changes in
      HR from baseline will be correlated with the changes from baseline in activity level of the
      subjects, as measured by both a standard 6-minute walk distance and an accelerometer device.

      The primary hypothesis is that ivabradine effectively reduces HR between baseline and day 57
      in African-American/Black subjects. Because mean reductions of approximately 5 beat per
      minute (bpm) have been observed in the overall placebo-treated subjects in the SHIFT study as
      well as in the placebo-treated subjects of the subgroup analysis of
      non-African-American/Black subjects enrolled in the SHIFT study, we will test whether the
      mean reduction with ivabradine exceeds 5 bpm, and estimate the degree to which the mean
      reduction with ivabradine exceeds 5 bpm.
    

Intervention name(s): Ivabradine
Intervention type(s): Drug
Intervention description(s): Film-coated tablets taken orally with food twice a day. Tablets supplied in strengths of 5.0 mg and 7.5 mg. 5.0 tablets were split into equal halves for dosages of 2.5 mg.
Other intervention name(s): Corlanor®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac; Congestive; Decompensation; Heart Failure; Left-Sided; Myocardial; Corlanor; Ivabradine; African American; Black; Michigan
Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria
Condition: Gastric Subepithelial Tumor
Study type: Interventional

Summary: 
      Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive
      patients who had clinical indications for lesion removal. Following the injection around a
      submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled
      away to form a "tent". The tissue was dissected using an electrocoagulating current. In
      brief, the tumor was dissected from the muscularis propria layer and then carefully removed
      using forceps. Demographic data, indication for intervention, safety of the procedure and
      follow-up will be assessed.
    

Detailed description: 
      After the target lesion was identified, several marking dots were made around the lesion,
      using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and
      indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa.
      Then, a circumferential incision was made along the margin of the targeted lesion, using the
      hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed
      into the submucosal layer. The surrounding tissue was then carefully dissected using the hot
      biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped
      using the forceps and pulled away, forming a "tent". To ensure complete resection, the
      muscular fibers and stalks that connected the tumor to the propria layer were shelled along
      the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating
      forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the
      submucosal layer were directly coagulated using coagulating forceps. After the lesion was
      removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to
      apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However,
      coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany)
      were used to cut muscle fibers adjacent to the tumor or hemostasis.
    

Intervention name(s): Forcep
Intervention type(s): Device
Intervention description(s): Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets
      under non-fasting conditions.
    


Intervention name(s): Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc); Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc); Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-inflammatory
Effects on Maxillary Anterior Dentition Following En Masse Retraction Using Mini-implants and Various Heights of Anterior Power Arm.
Condition: Varying Heights of Power Arm During en Masse Retraction
Study type: Interventional

Summary: 
      The controlled three dimensional movement of anterior dentition during orthodontic treatment
      is a desire of every orthodontist. Maxillary en masse retraction with mini implants has been
      reported to provide absolute anchorage thus utilizing the complete extraction spaces thereby
      enhancing patient's esthetics. Power arm or anterior retraction hook permits the application
      of force close to a desired direction thereby warranting better anterior dentition control.
      Various heights of power arms and proposed centre of resistance for six maxillary anterior
      teeth have been estimated through finite element model and also from a very limited number of
      clinical studies. For a set of teeth, the determination of centre of resistance is complex in
      actual clinical scenario and response of force applied from certain level for better anterior
      dentition control requires sufficient clinical evidence suggestive of further clinical
      studies to endow orthodontists to hasten treatment due to less time consumption during
      finishing stage of orthodontic treatment.
    

Detailed description: 
      This Randomized Control Trial will be conducted to compare the effects of various heights of
      anterior power arm on maxillary anterior dentition following en masse retraction with
      mini-implants by participation of thirty patients meeting eligibility criteria. The
      participants will be divided in three groups through software generated randomization table.
      Group I (control group; height of anterior power arm 6 mm), Group II and Group III
      (experimental groups; height of anterior power arm 3 mm and 9 mm, respectively). Ten patients
      will be allocated in each group. En masse retraction with mini implants and various heights
      of anterior power arm will be carried out immediately after bilateral maxillary first
      premolar extractions using continuous arch sliding mechanics. Horizontal, vertical and
      angular dimensions will be measured on lateral cephalograms while the transverse effects will
      be measured on maxillary dental cast. Both lateral cephalograms and dental casts will be
      obtained at two different point of time; T1, before retraction and T2, after complete
      extraction space closure. The data will be assessed with-in and among groups.
    

Intervention name(s): Anterior Power Arm
Intervention type(s): Other
Intervention description(s): Crimpable stainless steel hook placed on orthodontic base arch wire.
Other intervention name(s): Anterior Retraction Hook
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cerebral Palsy Hip Health Related Quality of Life
Condition: Cerebral Palsy; Patient Undergoing Hip Surgery; Quality of Life
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Children with cerebral palsy are at an increased risk of having their hips move partially or
      completely out of joint. This can cause pain and restrict movement at the hip, making sitting
      in a wheelchair uncomfortable and make personal care difficult. This condition may be treated
      with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or
      not the surgery has been successful. However, it is also important to know whether the
      surgery has improved life from the child or the caregiver's point of view. The investigators
      will also evaluate if waiting for surgery affects the child. This information will be added
      to results from a physical exam and an evaluation of the child's x-rays for a more complete
      picture of how this surgery impacts the lives of our patients. It is predicted that that the
      health-related quality of life of children with cerebral palsy will improve following
      surgery.
    

Detailed description: 
      HRQoL will be measured using the Child Health Index of Life with Disabilities (CPCHILD). Our
      specific hypothesis is that health related quality of life, as measured by the CPCHILD will
      change by at least a mean of 10 points from pre- to post-surgery.
    

Intervention name(s): Cerebral palsy, post hip surgery
Intervention type(s): Procedure
Intervention description(s): All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at
        BC Children's Hospital
      
Keywords: Cerebral Palsy; Hip surgery; Quality of Life
Effect of Betaine and Food on Gastric pH
Condition: Healthy
Study type: Interventional

Summary: 
      Food will decrease stomach acidity due to its buffering effect.This has implications when
      providing drugs that are dosed with food but require higher levels of stomach acid, such as
      some medications commonly used for HIV patients. This study will attempt to determine the
      dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food
      on stomach acid could be countered. Additionally, this study will evaluate the ability of a
      natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized
      meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride
      will have the greatest effect on gastric pH.
    


Intervention name(s): Standardized Meal; Betaine Hydrochloride 1500mg; Betaine Hydrochloride 3000mg; Betaine Hydrochloride 4500mg
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Betaine hydrochloride (natural supplement) administered after standardized meal.; Betaine hydrochloride (natural supplement) administered after standardized meal.; Betaine hydrochloride (natural supplement) administered after standardized meal.
Intervention MeSH terms: Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: betaine; betaine hydrochloride; healthy volunteer; gastric pH
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
Condition: Clinical Pharmacology, Healthy Male Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to compare how long 2 oral formulations (a reference and a test
      formulation) of CC-122 stays in the body, and whether taking the test formulations with a
      high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in
      the study, one for each formulation and one for the test formulation + meal. The subjects
      will be asked to fast for at least 10 hours before taking the capsule formulations. During
      one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being
      given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment
      sequence which will determine the order in which the subject will receive the reference
      formulation, the test formulation, and the test formulation + high-fat meal. Blood samples
      will be taken at intervals during the study to assess the amount of drug at those time
      points. Blood samples will also be collected at certain time points to determine the levels
      of special proteins that may help explain how CC-122 work.
    


Intervention name(s): CC-122; CC-122; CC-122
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CC-122; CC-122; CC-122
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food Effect; Pharmacokinetic; Healthy; Male
The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function
Condition: Healthy Controls
Study type: Interventional

Summary: 
      This study will investigate the effects of particle size of different triglyceride emulsions
      as well as the dynamics of intragastric structure formation and breakdown of the emulsions on
      GI function, the kinetics of the endocrine and the satiation response in healthy volunteers.
      12 healthy participants will be studied on four occasions on four separate days in a double
      blind randomized design
    

Detailed description: 
      The mechanisms by which food structure impacts on lipid digestion and the subsequent
      metabolic processes, including the impact on satiety and satiation, are relatively
      unexplored, but may have great consequences on the development of effective strategies for
      weight management. Data from previous studies suggest that (i) the droplet size of a fat
      emulsion has a distinct influence on GI function and visceral perception (ii) that the
      biomechanical and digestive properties of the human gut may induce micro structural changes
      to specifically designed lipid emulsions resulting in different patterns of lipolysis.

      The study will assess the effects of triglyceride emulsion with different particle (0.6, 30
      μm) sizes and sensitivities to the acidic and shear environment of the stomach on GI function
      and the kinetics of endocrine and satiation response.

      In this study healthy participants will be studied on four occasions on four separate days in
      a double blind randomized design. The assessment of gastric function will be monitored by
      novel MRI techniques and breath tests and neurohormonal response by blood sampling.
    

Intervention name(s): Nutritional intervention
Intervention type(s): Behavioral
Intervention description(s): This study will investigate the effects of particle size of different triglyceride emulsions as well as the dynamics of intragastric structure formation and breakdown of the emulsions on GI function, the kinetics of the endocrine and the satiation response in healthy volunteers.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Multimodal Intervention in Allogeneic Stem Cell Transplantation
Condition: Allogeneic Stem Cell Transplantation; Leukemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise -
      psycho-educational intervention in patients undergoing allogeneic stem cell transplantation
      (allo-HCST). The intervention included structured and supervised exercise, relaxation and
      psycho-educational components. It was hypothesized that the intervention would minimize loss
      of physical capacity during hospitalization.
    


Intervention name(s): Multimodal exercise and psychosocial program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patients undergoing allogeneic stem cell transplantations