bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this trial is to investigate the effects of delgocitinib, taken as a capsule,
      on the heart rhythms of healthy people, compared to a placebo.
    

Detailed description: 
      The trial will be performed in two parts.

        -  Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)

        -  Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)

      The doses in Part 2 may be adjusted depending on the results of Part 1.

      Participants will be screened within 28 days of their dose. Participants will stay in the
      clinic from Day -1 to Day 2 (1 day postdose) and will be dosed on Day 1. A follow up phone
      call will take place 2 week (±2 days) after dosing.
    

Intervention name(s): Delgocitinib capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule; oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are
      dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate
      the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients
      with R/R ALL
    


Intervention name(s): Clofarabine
Intervention type(s): Drug
Intervention description(s): Clofarabine (Betta Pharmaceuticals Co., Ltd, Zhejiang, China) was administered intravenously at 52 mg/m2 over 2 hours daily for 5 consecutive days. During the first two induction cycles, patients who did not achieve an objective response were taken off the study, and responsive patients continued to receive consolidation for a maximum 11 cycles if non-hematological toxicity was grade 2 or less.
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dispensing Evaluation of Investigational Contact Lenses
Condition: Myopia; Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to
      evaluate the visual acuity, rotational performance, lens fit, stability and subjective
      characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
    


Intervention name(s): Prototype toric lens senofilcon A
Intervention type(s): Device
Intervention description(s): Investigational prototype
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients
Condition: Chronic Stroke
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand
      robotic training device on upper extremity motor and physiological function, daily functions,
      quality of life and self-efficacy in brain injury patients.
    

Detailed description: 
      The purpose of this study was to 1) examine the effects of EMG-driven robot-assisted
      intervention, and 2) examine whether the robot-assisted therapy is as effective as
      conventional intervention. The study was conducted using a randomized, two-period crossover
      design. Participants were randomly assigned to group 1 or group 2 using a computer-generated
      list. Participants in group 1 received 12 sessions of robot-assisted intervention first,
      followed by a one-month washout period, and then received 12 sessions of conventional
      intervention. Participants in group 2 received 12 sessions of conventional intervention
      first, followed by a one-month washout period, and then received 12 sessions of
      robot-assisted intervention. Outcome measures were performed before the intervention, after
      the first 12-session intervention, and after the second 12-session intervention.
    

Intervention name(s): Robotic-assisted intervention; Conventional rehabilitation intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received the 12-session robot-assisted intervention 3 sessions a week for 4 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.; Participants received the 12-session conventional rehabilitation intervention 3 sessions a week for 4 consecutive weeks. The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
Condition: Reflux, Gastroesophageal
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease
      (GERD) participate in the study following the usual preoperative Clinical routines (Medical
      history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration
      ). Patients are randomized to fundoplication according to Nissen or modified Toupet.
      Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.
    

Detailed description: 
      Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the
      study. Patients with recurrent reflux disease following prior surgery, ASA (American Society
      of Anesthesiologists (ASA) Physical Status") class> 3, paraesophageal herniating and / or
      major herniation without reflux and those with other contraindications against laparoscopic
      surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study
      are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen)
      alternatively 270 degree (modified Toupét). Both of these techniques are well established
      clinical routines. General intubation anesthesia is standardized to all study patients.
      Discharge from the hospital is typically on the first postoperative day. At a visit, after
      6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36
      months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL
      protocol completion. The latter also occurs after 24 months and 60 months.
    

Intervention name(s): Nissen; Toupét
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic total (Nissen) fundoplication; Laparoscopic posterior 270 degrees partial fundoplication
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to verify if combination of a healthy diet and orange juice consumption can
      minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)
    

Detailed description: 
      The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects
      (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12
      weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice
      (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The
      recruitment process began in June 2016, the intervention was carried out from September 2016
      to December 2016, and the data analysis started in January 2016. The sample number took into
      account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80%
      power). The minimum sample size should have 32 individuals per group (n = 64). Considering an
      approximately 15% dropout rate, the final sample size of study was constituted by 38
      individuals per group. Primary and secondary endpoints were the reduction of LDL-C and
      modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics
      parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and
      homogeneity of data, respectively. T-test was conducted to identify possible differences
      between OJ and control groups at baseline. A linear mixed-effects model was apply to
      determine the time effect within and between groups (Sidak post hoc) and P significance was
      set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were
      analyzed over a 12-week intervention.
    

Intervention name(s): Orange Juice (500 mL/d)
Intervention type(s): Other
Intervention description(s): Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orange juice; Healthy diet; Metabolic syndrome; Cardiometabolic risk factors; Body composition
Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
Condition: US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
MeSH terms: Trigger Finger Disorder
Study type: Interventional

Summary: 
      Objectives: To compare the efficacy of ultrasonography guided corticosteroid injection at A1
      pulley and percutaneous A1 pulley release as a treatment for trigger finger.

      Methods: 75 patients with idiopathic trigger finger were enrolled in our prospective study.
      Patients with diabetes mellitus, previous history of open release for trigger finger,
      different inflammatory arthritis and multiple trigger fingers affections were excluded. Group
      A 40 patients: Underwent ultrasound guided methyl prednisolone acetate injection, between A1
      pulley and tendons .Group B 35 patients :Underwent ultrasonography-guided percutaneous A1
      pulley needle release .All patients were subjected to the following before and after
      intervention by 1 and 3 months , DASH, trigger finger classification grade & VAS
    

Detailed description: 
      Trigger finger ( TF) is a pathologic problem of the finger leads to a painful tendon snap or
      click on flexion and extension, and/or locking of the metacarpophalangealor proximal
      interphalngeal joint (1) . Entrapment of the affected tendon at the first annular (A1) pulley
      occurs because of a differencein the diameter of the flexor tendon and its sheath as a result
      of thickening of the sheath and or localized tendon thickening.(1) . Most cases of trigger
      fingers are idiopathic and the incidence is around 28 cases per 100 000 population per year,
      or a lifetime risk of 2.6% in the general population and about 10% of patients are diabetics
      (1). Women are usually more affected than men, usually in the fifth and sixth decades(2) it
      is more common in women than in men, usually in the dominant hand, and most often in the
      thumb or ring fingers followed . (2) The diagnosis of trigger finger is based mainly on the
      medical history and clinical examination. The most important characteristic clinical sign is
      the mechanical blocking of the finger when flexed with painful snapping extended. (3).
      Management includes many options such as conservative treatment in the form of splinting,
      physical therapy, non-steroidal anti-inflammatory drugs, and local steroid injections, and
      surgical pulley release
    

Intervention name(s): ultrasonography-guided injection; pullae A1 release
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasonography-guided injection; ultrasonography-guided pullae A1 release
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
Condition: Lymphoma; Myeloma; Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to examine the safety of infusing escalated doses of
      allogeneic (from a relative of the patient), enriched natural killer (NK) cells after
      autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion
      of these NK cells early after an autologous stem cell transplant will help to eliminate and
      eradicate any residual cancerous cells that remain in the body and may have survived the
      chemotherapy or radiation.
    

Detailed description: 
      Natural killer cells are blood cells that are responsible for eliminating cancer cells
      especially when there are only a few. It has been shown that NK cells coming from a
      "mismatched" person (a relative) have a better chance than the patient's own NK cells to
      recognize and kill cancer cells. These cells will be collected from the blood of a parent,
      child or sibling and after preparation in the laboratory, will be given to the patient early
      after an autologous stem cell transplantation like a blood or platelet transfusion. A person
      who has been diagnosed with a blood tumor and received an autologous stem cell transplant has
      the chance of his/her cancer coming back. This study uses NK cells obtained from a relative
      to prevent disease recurrence by potentially eliminating and eradicating any residual
      cancerous cells.
    

Intervention name(s): NK-Cell Infusion
Intervention type(s): Biological
Intervention description(s): The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Natural killer cells; autologous stem cell transplant; immunotherapy
A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-03526299, a novel anti-inflammatory agent should attenuate the effect of a bronchial
      allergen challenge on lung function and hence provide proof of mechanism for this agent.
    


Intervention name(s): PF-03526299; Placebo; Fluticasone propionate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled, two doses 4 hours apart; Inhaled, two doses 4 hours apart; Inhaled
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma Allergen Challenge
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a
      DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be
      randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o.
      Patients receiving metformin before the study will continue on the same dose of metformin.
      The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): Placebo; RO4876904
Intervention type(s): Drug; Drug
Intervention description(s): Placebo po daily.; Escalating doses, at a starting dose of 12.5mg po daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine
      and ketamine in the perioperative period of abdominal surgery.
    

Detailed description: 
      Optimal postoperative pain management facilitates rehabilitation immediately after abdominal
      surgery. Multiple studies have demonstrated that successful postoperative analgesia also
      reduces perioperative complications and improves patient comfort, thereby providing many
      benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or
      ketamine have been advocated because of their morphine-sparing effect.
    

Intervention name(s): Lidocaine,; Ketamine; association ketamine-lidocaine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.; Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.; Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.; The control group (C) received an equal volume of saline 0.9 % during 48 h.
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; postoperative care; intravenous lidocaine; intravenous ketamine; morphine consumption
Apioc Presbyopic Contact Lens
Condition: Presbyopia; Refractive Errors
MeSH terms: Presbyopia; Refractive Errors
Study type: Interventional

Summary: 
      In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way
      you wear your current contact lenses for approximately one month (no more than 35 days).
    

Detailed description: 
      Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved
      by the U.S. Food and Drug Administration (FDA), although the contact lens material, called
      Definitive 74, is already approved and marketed for contact lenses that are similar to
      Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact
      lens the way they wear their current contact lenses for approximately one month (no more than
      35 days).

      Participation in this study will include a minimum of four study visits. The first will last
      up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45
      minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be
      fitting properly at the second visit, then another lens will be ordered for participants and
      they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects
      will participate in this study.
    

Intervention name(s): Apioc-P and Apioc-PT Contact Lens Design
Intervention type(s): Device
Intervention description(s): Novel soft contact lens design
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: contact lens; soft contact lens
Clinic, Family & Community Intervention for Children With Overweight and Obesity (Stanford GOALS)
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Stanford GOALS is a large-scale, community-based randomized controlled trial of an
      innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to
      treating overweight and obese children. Primary Research Question: Will a 3-year, innovative,
      interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based
      intervention to treat overweight and obese children significantly reduce BMI compared to an
      enhanced standard care/health and nutrition education active comparison intervention?
    

Detailed description: 
      Single-blind study with all outcomes assessors (data collectors) and Investigators masked
      (blinded) to intervention assignment. Intention-to-treat analysis.
    

Intervention name(s): MMM; Health and Nutrition Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a theory-based community team sports program designed specifically for overweight and obese children,
a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and
a primary care provider behavioral counseling intervention linked to the community and home interventions.; Enhanced standard care/health and nutrition education intervention:
notification of primary care providers about metabolic measures and blood pressure
state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and "Family Fun Nights"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment