bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to look at concentrations of GSK189075 in blood when
      single doses of the drug are taken by mouth in combination with basal insulin. The clinical
      effects of the drug in combination with insulin on the body will also be studied. The results
      will help determine doses of GSK189075 can be studied in the future in the type I diabetes
      mellitus population.
    


Intervention name(s): GSK189075; placebo
Intervention type(s): Drug; Drug
Intervention description(s): investigational drug; placebo comparator
Other intervention name(s): GSK189075
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 1 Diabetes mellitus, pharmacokinetics,; pharmacodynamics; Adult male and females,
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants
      suffering from mild to moderate acute low back pain.

      Secondary Objectives:

        -  To assess the efficacy of ITP FIRTECH on participant disability

        -  To assess the efficacy of ITP FIRTECH on the degree of participant mobility

        -  To assess the safety of ITP FIRTECH
    

Detailed description: 
      Duration of study participation is up to 6 days per participant.
    

Intervention name(s): ITP FIRTECH
Intervention type(s): Device
Intervention description(s): Infrared Therapy Patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)
      treatment on retinal functions, especially the cone function, and retinal structure in
      patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial

      Setting: Primary Care clinical trial

      Participants: 120 RP subjects will be recruited from Ophthalmology department at The
      University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly
      allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1
      year. After the 1st year, both groups will stop the treatment and all subjects will also have
      the same eye exam in 6-month period for the 2nd year.

      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4
      programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave
      amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct
      component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual
      acuity.
    

Detailed description: 
      The study was a randomized controlled trial with a double-masked, placebo-controlled design.
      All the subjects were randomly allocated into either LB (treatment) group or placebo
      (control) group.

      All the eligible subjects had the eye examination, including VA using the Early Treatment of
      Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal
      ocular health assessments, and fundus photo-documentation. Three additional tests were
      conducted to investigate the functional and structural changes in the RP patients, including
      Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and
      Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).
    

Intervention name(s): Lycium Barbarum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Traditional Chinese Herbs; Placebo
Other intervention name(s): Wolfberry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Retinitis pigmentosa; Lycium barbarum; Antioxidation; Visual field; Electroretinogram
CEI Van Outreach Screening Study
Condition: Glaucoma; Macular Disease; Keratoconus
MeSH terms: Glaucoma; Keratoconus
Study type: Observational

Summary: 
      The primary goal of the trial is to show that optical coherence tomography (OCT) technology
      can be used to effectively screen for diseases of the eye including glaucoma, macular
      diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is
      usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision.
      Keratoconus is a disease that affects the cornea (clear surface covering the colored part of
      the eye).
    

Detailed description: 
      The identification of many eye diseases would significantly benefit from earlier detection
      than is available with typical eye exams. Optical coherence tomography (OCT) is an imaging
      technology that can perform non-contact cross-sectional imaging of tissue structure in real
      time. It is similar to ultrasound B-mode imaging, except that OCT measures the intensity of
      reflected light rather than sound waves.
    

Intervention name(s): OCT imaging, the FDA Cleared iVue
Intervention type(s): Device
Intervention description(s): The OCT system scans a beam of light across the eye to take a picture. OCT imaging does not touch the eye. This is a test that is performed using an FDA approved system, and is regularly used to take pictures of the back of the eye.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be performed enrolling participants from the Casey Eye Institute outreach
        van.
      
Keywords: Optical coherence tomography; Glaucoma; Macula; Keratoconus; Screening
Pulmonary Vein Isolation in Athletes
Condition: Athletes; Atrial Fibrillation; Catheter Ablation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Pulmonary vein isolation (PVI) has become a common and effective treatment for paroxysmal and
      persistent atrial fibrillation (AF), particularly in patients with drug-refractory disease.
      Intense endurance exercise is a known risk factor for atrial fibrillation. In general, these
      athletes poorly tolerate most common antiarrhythmic drugs used for atrial fibrillation
      control and often PVI is recommended for durable management. While the efficacy of PVI in
      athletes is similar to the general AF population, some athletes with lone atrial fibrillation
      report a reduction in subjective exertional capacity following PVI, despite maintenance of
      sinus rhythm and absence of pulmonary vein stenosis on imaging. The investigators hypothesize
      that PVI may alter pulmonary vein function and affect peak exercise performance.

      The investigators propose a small, prospective study of endurance athletes undergoing antral
      PVI for treatment of lone atrial fibrillation. Peak metabolic performance and pulmonary vein
      function will be assessed pre- and post-PVI by metabolic stress testing and cardiac MRI,
      respectively.
    

Detailed description: 
      Endurance athletes with paroxysmal or persistent atrial fibrillation undergoing primary
      pulmonary vein isolation will be prospectively enrolled prior to PVI.

      Patients will undergo metabolic exercise stress testing as well as resting CMR 1-4 weeks
      prior to PVI. Metabolic stress testing and CMR will be repeated at 6 month follow-up. Quality
      of life questionnaires will also be collected at pre- and post-PVI visits. Metabolic
      treadmill stress testing will follow standard protocol and measure hemodynamics with
      escalating metabolic output and characterize peak exercise capacity (METs) and oxygen
      consumption (VO2 max).

      CMR evaluation will include standard anatomic imaging of pulmonary vein and left atrial
      anatomy at rest. Additional cine CMR sequences willbe included for focused evaluation of
      dynamic pulmonary vein cross-sectional area. 3D navigator whole heart imaging and MRA (single
      gadolinium dose) will be obtained to measure pulmonary vein flow. CMR sequences to
      characterize left atrial function, including phasic volumes and emptying fractions (total,
      passive, active) will also be performed.

      Data on heart rate variability will additionally be collected at pre- and post-PVI clinic
      visits, as well as the morning after PVI (hospital day 1).
    

Intervention name(s): Pulmonary Vein Isolation
Intervention type(s): Procedure
Intervention description(s): Standard antral pulmonary vein isolation using radiofrequency ablation catheters
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation, Athletes, Pulmonary Vein Isolation
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Condition: Rib Fractures; Rib Fracture Multiple
MeSH terms: Fractures, Bone; Rib Fractures; Fractures, Multiple
Study type: Interventional

Summary: 
      The purpose of this study is to compare the advantages and disadvantages of video-assisted
      rib planting and traditional internal fixation of rib fractures in chest wall stabilization.

      The investigators design a new surgical method of video-assisted thoracoscopic surgery for
      rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with
      a prospective study.
    


Intervention name(s): video-assisted rib planting
Intervention type(s): Procedure
Intervention description(s): Give the patient intercostal nerve block and laryngeal mask anesthesia, after that, put the patient in lateral position. Make a 4-6cm posterolateral incision along the lower edge of the scapula，sever latissimus dorsi and serratus anterior and reach the rib surface. Lift the scapula with the abdominal retractor (or xiphoid retractor), Free adhesion tissue inside the scapula and put in the thoracoscopic lens. Free the tissue of the upper and lower edges of the ribs carefully, reset ribs and insert rib plate, which is fixed by 90° electric drill and locking screw.
Other intervention name(s): video-assisted thoracoscopic surgery for rib fractures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: internal fixation; video-assisted; chest wall stabilization; prospective study
Protein Supplementation in Pilates Training
Condition: Exercise Training; Dietary Supplements
Study type: Interventional

Summary: 
      Pilates training, a type of mind and body exercise that focuses on muscle strength and
      flexibility, has become increasingly popular in recent years. Research has shown that Pilates
      could be an effective exercise form to improve body composition, particularly in obese
      individuals, while beneficial effects on flexibility, muscular strength, and muscular
      endurance have also been observed in young and older adults. It is well documented that
      protein supplementation can augment the effects of resistance training on body composition
      and performance. While there is an abundance of studies investigating the effect of protein
      supplements on adaptations to resistance exercise, there is a knowledge gap regarding their
      effectiveness in Pilates training.

      The aim of this research is to investigate the effects of protein supplementation, compared
      to placebo (maltodextrin) on body composition and performance in healthy young and
      middle-aged, eumenorrheic (regular menstrual cycle) women who perform Pilates. Participants
      will be randomly assigned to receive either 0.6 g of whey protein or maltodextrin per kg body
      weight per day for 10 weeks. Participants will be asked to avoid modifying their dietary
      habits for the duration of the study to limit the effect of diet on the measured parameters.
      To check for this, participants will record their diet for 3 days (2 weekdays and one weekend
      day) on the first, middle, and last weeks of the intervention. Dietary records will then be
      analyzed. Pilates classes will be performed at least two times per week, while specialized
      Pilates equipment (Reformer or Cadillac) will be used according to the Pilates principles.
      The duration of each workout will be set at around 50 min.

      Participants will undergo measurements of body composition, strength endurance of core
      muscles, and flexibility at the beginning and end of the study. In addition, hematologic
      parameters, clinical chemistry parameters, hormones, and plasma amino acids will be measured.
      All these outcome measures will be compared between the whey protein and maltodextrin groups
      to determine the effectiveness of protein supplementation in Pilates training.
    


Intervention name(s): Whey protein; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intake of whey protein; Intake of maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Sublingual Analgesia for Acute Abdominal Pain in Children
Condition: Abdominal Pain
MeSH terms: Abdominal Pain; Abdomen, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute abdominal pain is a frequent symptom in children admitted to the emergency department .
      In the past the fear of masking a surgical condition has justified withholding analgesia in
      patients with acute abdominal pain. By the 2000s, some clinical trials established that
      opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome
      in children with acute abdominal pain. Despite this, acute abdominal pain is still
      undertreated in this setting. Published paediatric trials studied the effect of opioid
      analgesia administered by parenteral route or by mouth. To the best of our knowledge no study
      investigated the effectiveness of sublingual analgesia.

      The purpose of this randomized controlled trial is to assess the effectiveness of three
      different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in
      children complaining of acute abdominal pain.
    


Intervention name(s): Ketorolac; Tramadol; Acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Ketorolac; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Abdominal Pain; Sublingual Analgesia; Children; Ketorolac; Tramadol; Paracetamol; Analgesia
Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of itraconazole on
      singledose tepotinib pharmacokinetics in healthy participants. Study details include:

      Study Duration: up to 48 days Treatment Duration: single dose of tepotinib on Days 1 and 12,
      11 days of treatment with itraconazole (Days 8 to 18) Visit Frequency: residence in the
      Clinical Research Unit from Days -1 to 4 and Days 11 to 15, ambulatory daily visits from Days
      5 to 10 and 16 to 20
    


Intervention name(s): Tepotinib (HydroChloride hydrate); Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Tepotinib (Hydrochloride hydrate) Film-coated tablet with food on Day 1 and 12 in the morning.; Participants will receive Itraconazole Hard-gelatin capsule with food once daily at the same time in the morning from Day 8 to Day 18; on Day 12 itraconazole is administered concomitantly with tepotinib.
Intervention MeSH terms: Itraconazole; Tepotinib
Intervention model: Sequential Assignment
Intervention model description: This is a single sequence cross-over trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical pharmacology; Metabolite; Induction of metabolism
Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter
      study assessing the efficacy and safety of durvalumab versus placebo following SoC
      chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post
      surgery
    

Detailed description: 
      Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are
      confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of
      care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm.

      The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy
      compared to placebo+ SoC chemotherapy as measured by DFS in all patients.
    

Intervention name(s): Durvalumab + SoC chemotherapy; Placebo + SoC chemotherapy
Intervention type(s): Drug; Other
Intervention description(s): Experimental Treatment; Placebo Comparator
Other intervention name(s): MEDI4736; Placebo
Intervention MeSH terms: Durvalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NCSLC; Double-blind; PD-L1; MEDI4736; Durvalumab; DFS; OS; MRD+; MRD-; Completely Resected Lung Cancer
Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
Condition: Cervical Cancer; Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study of rucaparib, a small molecule inhibitor poly (adenosine diphosphate
      [ADP]-ribose) polymerase (PARP), being tested in combination with bevacizumab in patients
      with recurrent cervical or endometrial cancer. The objective of this study is to determine
      the proportion of these patients who survive progression-free for at least 6 months while
      receiving this drug combination.
    

Detailed description: 
      Patients who consent to participate in this study will receive treatment with rucaparib and
      bevacizumab until unacceptable toxicity or tumor progression. Subjects will take one
      rucaparib pill will be taken twice daily, and bevacizumab will be adimistered via IV onDay 1
      of each 21 day cycle. Subjects will receive tests and procedures that are part of regular
      cancer care as well as those required for the purposes of this study. If there is no cancer
      found in scans after 6 cycles of treatment, patients may continue with study treatment for 1
      year. Follow up visits will occur every 3 months for the first 2 years after treatment is
      completed and every 6 months for 3 additional years.
    

Intervention name(s): Rucaparib; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Rucaparib 600mg PO BID daily; Bevacizumab 15mg/kg IV on day 1 of each cycle
Intervention MeSH terms: Bevacizumab; Rucaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
Condition: Renal Failure; ESRD; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated
      as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD
      patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a
      superior profile of PD effluent mesothelial cell marker and a lower degree of systemic
      inflammation as compared to conventional PD solution. The investigators propose a prospective
      randomized control study to compare the arterial stiffness, nutrition and body fluid status
      between PD patients treated with conventional solution and those with neutral pH low GDP
      solution. The investigators plan to study 100 new PD patients. They will be randomized to be
      treated with neutral pH low GDP solution or conventional solution. All patients will be
      followed for 52 weeks. In addition to routine clinical measurements, the investigators will
      measure their body water composition by bioimpedance spectroscopic method, arterial pulse
      wave velocity by pressure transduction method, as well as radiographic parameters of
      intravascular volume status, based on the routine chest radiograph. The study would help to
      define the clinical benefit of biocompatible PD solution.
    

Detailed description: 
      (see above)
    

Intervention name(s): double-chamber bag Stay-Safe Balance system; glucose-based dialysis solution
Intervention type(s): Other; Other
Intervention description(s): 2-L exchange; three times a day; 2-L exchange; three times a day
Other intervention name(s): Stay-Safe Balance system; Stay-Safe, Fresenius
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malnutrition; fluid status; survival
Study of BGG492 in Patients With Chronic Subjective Tinnitus
Condition: Chronic Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy of a two week treatment with BGG492 in patients with
      chronic subjective Tinnitus.
    


Intervention name(s): BGG492A; BGG492A
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinnitus; AMPA Receptor antagonist