bioihbjkbjnl/mcl2 huggingface dataset:
Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
Condition: Intra-articular Knee Fractures
MeSH terms: Fractures, Bone; Knee Fractures
Study type: Interventional

Summary: 
      Decreased range of motion is common after fractures around the knee and can impact a
      patient's ability to perform activities of daily living such as rising from a seated position
      or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine
      that continuously moves a joint (such as the knee) without the patient having to use the
      muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible
      following this injury. This study is a randomized, prospective study to evaluate the
      effectiveness of CPM in maintaining knee range of motion following open reduction and
      internal fixation (ORIF) of fractures around the knee
    


Intervention name(s): Continuous Passive Motion
Intervention type(s): Other
Intervention description(s): at least 48 hours of continuous passive motion following ORIF of fractures around the knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis
Condition: Cholangitis; Complication
MeSH terms: Cholangitis
Study type: Interventional

Summary: 
      Cholangitis is one of the main complications of endoscopic retrograde
      cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of
      post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope
      again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the
      gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of
      this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP
      cholangitis of ERCP in patients with choledocholithiasis.
    

Detailed description: 
      Since its introduction in 1968, endoscopic retrograde cholangiopancreatography (ERCP) has
      become a commonly performed endoscopic procedure, and the first choice in the management of
      choledocholithiasis. Although as an endoscopic minimally invasive procedure, there are still
      certain complications of ERCP, cholangitis is one of the main complications. In European and
      American countries, plastic biliary stent was used to prevent the occurrence of post-ERCP
      cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope again. In
      China endoscopic nasobiliary drainage is usually adopted to prevent post-ERCP cholangitis.
      Although nose bile duct was more convenient to pull out without endoscope again, but patients
      often feel nose pharynx ministry unwell obviously. 8.5 F plastic stent with proximal flap can
      discharge self-driven from biliary to the gut, it has the advantage of avoiding pulling stent
      out with endoscope again. The purpose of this study is to explore 8.5 F plastic stent with
      proximal flap on preventing post-ERCP cholangitis of ERCP in patients with
      choledocholithiasis.
    

Intervention name(s): endoscopic retrograde biliary drainage; endoscopic nasobiliary drainage
Intervention type(s): Device; Device
Intervention description(s): A 8.5 F plastic stent with proximal flap （XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.; A nose bile duct（XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cholangitis; endoscopic retrograde cholangiopancreatography; complication
Breastfeeding and Obesity on Offspring Body Composition
Condition: Obesity; Breast Milk Collection
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to explore the effect maternal obesity and breastfeeding play on
      infant body composition. The investigators hypothesize in the first 6 months of life breast
      fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and
      accumulate fat at a greater rate than breast fed infants from normal weight mothers.
      Furthermore, the investigators postulate that circulating maternal milk adipocytokines will
      positively correlate to total fat mass at six months of age.
    

Detailed description: 
      The objective of this study is to determine if offspring from overweight/obese non-diabetic
      mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at
      a greater rate from ~ 1 month to 6 months of life compared to breastfed infants from normal
      weight mothers.

      Specific Aim 1: Understand how maternal obesity and breast-feeding impact body composition of
      the offspring. Based upon the investigators preliminary data and counter to accepted dogma
      the hypothesis is at six months of age total fat mass, particularly in the trunk will be
      elevated at 6 months of age in infants whose mother was either overweight or obese vs.
      infants from normal weight mothers.

      Specific Aim 2: Identify adipocytokines in breast milk. The postulate is breast milk from
      overweight and obese mothers will have greater levels of insulin, glucose, Ghrelin, IGF-1,
      IL-6, TNFα, high-sensitivity C-reactive protein, and lower Leptin levels than breast milk
      from normal weight mothers and will be correlated with offspring fat mass.
    

Intervention name(s): Exclusively breastfeed
Intervention type(s): Other
Intervention description(s): There is no intervention other than mothers must exclusively breastfeed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 37 mothers whom exclusively breast fed to six-months. Participants
        (mothers/infant) included offspring from mothers with a singleton-term healthy pregnancy
        (37-40 weeks). Both vaginal and cesarean deliveries were included. Infants who are
        exclusively breastfed (defined as no formula in the last 20 days) prior to enrollment will
        be considered.
Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites
Condition: Laparoscopic Cosmesis
Study type: Interventional

Summary: 
      This study wishes to compare patient satisfaction and cosmesis of two different closure
      methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep
      sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl
      transcutaneous stitch, with a Bacitracin and Tegaderm dressing.
    


Intervention name(s): Tissue adhesive
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: laparoscopy, port site, closure, Dermabond
Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women
Condition: Sexual Dysfunction; Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of
      sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual
      dysfunction (SRI-AASD) following the same protocol which previously established efficacy in
      men with SRI-AASD.
    

Detailed description: 
      This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of
      sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual
      dysfunction (SRI-AASD) following the same protocol which previously established efficacy in
      men with SRI-AASD. Women (n=100) with MDD-remission and SRI-AASD were randomized to receive
      sildenafil (50-100mg) or placebo for 8 weeks, followed by 8-weeks open-label extension.
      Sexual function was assessed using the Clinical Global Impression-Sexual Function (CGI-SF),
      with positive response defined as a score <3, and UNM-SFI, ASEX, SFQ-FSD sexual function
      questionnaires. Depression was monitored using the HAM-D17.
      Hypothalamic-pituitary-adrenal-gonadal hormones were measured at baseline and DB-endpoint.
    

Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: antidepressants; sexual dysfunction; women; sildenafil; PDE5 inhibitors; serotonin reuptake inhibitor antidepressants
Mind/Body Medicine and IBD Flare-Up
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling
      disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications
      provide only partial relief, are not successful for at least 30% of patients, and have major
      negative side effects. Mounting evidence indicates that stress is one of the important
      triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The
      primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect
      in reducing stress and affecting the course and severity of UC.

      Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent
      Ulcerative Colitis flare-up.
    

Detailed description: 
      Methods: We will enroll 100 subjects in a Phase I/IIa randomized, double-blind,
      placebo-controlled trial. Subjects will be assigned to one of two Mind/Body courses, each of
      which will be held once a week for 8 consecutive weeks. Each class will last 1.5-2 hours.
    

Intervention name(s): Mind/Body Courses
Intervention type(s): Behavioral
Intervention description(s): 8-week Mind/Body course held once a week for 2 hours at a time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ulcerative Colitis; IBD Flare-Up; Stress
Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were
      examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric
      data were collected, resting metabolic rate was measured, and the patients underwent a panel
      of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart
      ultrasound). Following that, they consumed a test meal and completed visual analog scales for
      the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same
      time points, blood samples were collected for the consequent measurement of glucose, insulin,
      lipids, and gastrointestinal hormones.
    


Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Bariatric surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric surgery, gut peptides, weight loss, glycemia
Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence
      against viral and bacterial stimuli by modulating the immune response. The aim of this study
      was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate
      whether macrolide attenuate its levels.
    

Detailed description: 
      Non-cystic fibrosis bronchiectasis is a respiratory disease characterized by persistent
      airway inflammation and dilation of bronchial wall driven by various causes. Patients with
      bronchiectasis suffer from excessive sputum production, recurrent exacerbations, and
      progressive airway destruction. It was reported that 30%-40% patients were infected with
      Pseudomonas aeruginosa. Major therapy for bronchiectasis is focused on breaking the "vicious
      cycle" of mucus stasis, infection, inflammation, and airway destruction. Currently a number
      of clinical trials have showed that macrolide effectively used in the treatment of non-CF
      bronchiectasis. Evidence has indicated that 14- and 15-membered ring macrolides possess
      immunomodulation and anti-inflammatory functions beyond their antimicrobial properties.
      However, the underlying mechanisms that account for the anti-inflammatory actions of
      macrolides have not yet to be elucidated, and the activities do not appear to be controlled
      by a single mechanism.Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced
      by inflammasomes when activated by a number of pathogen, environmental or host-derived danger
      signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a
      key role in the host immune response of patients with Bronchiectasis. The aim of this study
      was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate
      whether macrolide could attenuate its levels.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Patients with bronchiectasis treated with Azithromycin for three to five days.
Other intervention name(s): macrolide
Intervention MeSH terms: Azithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Condition: Neurological Diseases; Pneumopathy; Major Abdominal Surgery; Acute Pancreatitis
MeSH terms: Pancreatitis; Nervous System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with
      those of a standard polymeric one, in ICU patients
    


Intervention name(s): Crucial (enteral tube feeding)
Intervention type(s): Dietary Supplement
Intervention description(s): Evaluation of new enteral product, Crucial, in ICU patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICU patients
An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known
      hospitals in China. In order to report the efficacy and safety of different dose
      dexamethasone in treating the immune thrombocytopenia (ITP).
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 60 adults with ITP from 7 medical centers in China. Part of the participants are randomly
      selected to receive dexamethasone (given at a dose of 40mg per day for 4 consecutive days)
      ,the others are selected to receive dexamethasone(given at a dose of 20 mg daily for 4 days).

      Platelet count, bleeding and other symptoms were evaluated before and after treatment.
      Adverse events are also recorded throughout the study. In order to report the efficacy and
      safety of different dose dexamethasone for the treatment of adults with immune
      thrombocytopenia (ITP).
    

Intervention name(s): Dexamethasone; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days; Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immune thrombocytopenia; dexamethasone; efficacy; safety
A Study of LY3127760 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to evaluate the safety and how well the body handles
      single and multiple doses of increasing strength of study drug, LY3127760. This study
      includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from
      Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last
      approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days
      prior to enrollment.
    


Intervention name(s): LY3127760; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and
      Caucasian healthy male volunteers administered BI 207127 NA.
    


Intervention name(s): Matching placebo (low dose); BI 207127 NA (medium dose); BI 207127 NA (low dose); Matching placebo (medium dose); BI 207127 NA (high dose); Matching placebo (high dose)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose of matching placebo; Single does of BI 207127 NA; single dose of BI 207127 NA; Single dose of matching placebo; Single dose of BI 207127 NA; Single dose of matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Condition: Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that using Losartan would help decrease proteinuria in
      pediatric chronic kidney disease with tubular proteinuria.
    

Detailed description: 
      Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were
      randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed
      over to the opposite intervention for another three months after a washout period of 2 weeks.
      The primary outcome is the change in urinary protein-creatinine ratio from baseline to the
      end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also
      investigated with additional retrospective review of medical record.
    

Intervention name(s): Losartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of losartan or placebo with crossover to the other; 12 weeks of losartan or placebo with crossover to the other
Other intervention name(s): Cozaar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Losartan; children; proteinuria
BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
Condition: Gastric Ulcer; Duodenal Ulcer; Anastomotic Ulcer; Reflux Esophagitis; Etc.
MeSH terms: Esophagitis; Stomach Ulcer; Duodenal Ulcer; Esophagitis, Peptic; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to
      a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.

      To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of
      percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.

      To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.

      To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
    

Detailed description: 
      The purpose of this study is; To investigate whether a pellets based sachet formulation of
      D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg
      (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time
      with intragastric pH>4 during 24 hours after dose on Day 5.

      To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by
      the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour
      median pH after dose on Day 5

      To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after
      repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss
      of esomeprazole after dose on Day 5.

      To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg
      by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse
      rate and body temperature.
    

Intervention name(s): D961H sachet 20 mg; D961H HPMC capsule 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)".
Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg; Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; pharmacodynamics; pharmacokinetics; safety; tolerability; D961H; Japanese