bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Chronic Hypnotic Use
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      The purpose of the study is to determine how safe and effective it is for people with
      insomnia to use zolpidem on a nightly basis for one year.
    

Detailed description: 
      The acknowledged drugs of choice for the pharmacological treatment of insomnia are the
      benzodiazepine receptor agonist hypnotics (BzRA). Studies show that at therapeutic doses,
      used over the short-term, the abuse liability of BzRAs is relatively low and their efficacy
      outweighs their minimal risks. However, an increasing number of patients use BzRAs nightly
      for longer periods of time than is currently indicated (i.e. 4 weeks) and, minimal data on
      the long-term abuse liability and efficacy of these drugs exist.

      This project, using both prospective and retrospective methods, will address questions about
      the long-term abuse liability and efficacy of the BzRAs. The questions being raised are: What
      are the abuse liability and efficacy of hypnotics currently being used chronically and what
      is the prospective abuse liability and efficacy of hypnotics used chronically? Zolpidem is
      the chosen standard for this project as it is the most frequently prescribed BzRA and also
      arguably the BzRA with the best short-term efficacy and safety profile. The focus of the
      first question is clinical; it is about the long-term abuse liability and efficacy of BzRAs,
      specifically zolpidem, as it is currently being prescribed and about the type of patients who
      receive this drug. The second question addresses the issue of whether a standard BzRA can be
      prescribed efficaciously and safely for the long-term to patients with primary insomnia.
    

Intervention name(s): zolpidem
Intervention type(s): Drug
Intervention description(s): placebo or zolpidem (10mg)daily for one year
Other intervention name(s): zolpidem (Ambien)
Intervention MeSH terms: Zolpidem
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary insomniacs meeting DSM-IV criteria, ages 23-70 yrs. old, were recruited from public
        advisement for a double-blind placebo controlled study. Participants were in good general
        health as determined by a physical exam and laboratory tests. The Structured Clinical
        Interview for DSM Disorders (SCID) and the Hamilton Depression Scale were used to exclude
        those with psychiatric disorders, drug, and alcohol dependence. To confirm the absence of
        illicit drugs, participants underwent a urine drug screen. Additionally, participants had a
        screening sleep efficiency of <85% on an 8-hr nocturnal polysomnogram (NPSG) and had no
        primary sleep disorders. Pregnant or lactating females were excluded from study
        participation.
      
Biospecimen description: 
      urine and saliva
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex
      (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric
      participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex
      is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular
      recovery.
    

Detailed description: 
      This trial will be conducted in two parts: Part A and Part B. In Part A, PK sampling will be
      conducted to identify the pediatric dose providing sugammadex exposure comparable to the next
      oldest age cohort. For Part B participants, the efficacy of sugammadex (i.e. neuromuscular
      recovery / time to extubation) will be assessed. Further, safety analyses will be conducted
      in both Parts A and B. Following completion of Part A, an interim analysis (IA) of the PK and
      safety data will be performed. Once the appropriate doses are confirmed and safety data is
      assessed for the 2 doses of sugammadex, then Part B will commence.
    

Intervention name(s): Sugammadex 2 mg/kg; Sugammadex 4 mg/kg; Neostigmine + Glycopyrrolate; Neostigmine + Atropine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For moderate NMB reversal, a single IV bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.; For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).; For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.; For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
Other intervention name(s): MK-8616; MK-8616
Intervention MeSH terms: Atropine; Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
Condition: Rheumatoid Arthritis; Congenital Hip Dysplasia; Avascular Necrosis
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis
Study type: Interventional

Summary: 
      A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.
    

Detailed description: 
      A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary
      Total Hip Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of
      China
    

Intervention name(s): Total Hip System made in China (SUN, CoCr, Duraloc, Marathon); Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
Intervention type(s): Device; Device
Intervention description(s): SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO); Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      a randomized controlled single-blinded study. the hypothesis of this clinical trial is that
      disjunctive use of diode laser improve the clinical parameters of periodontists , and there
      are significant difference between the conventional treatment and diode laser as an adjunct
    

Detailed description: 
      A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic
      periodontitis, from subjects attending Jordan University of Science and Technology (JUST)
      Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct
      2017. Those patients were enrolled in a randomized controlled single-blinded study. For each
      patient, full medical and dental history and periodontal examination were recorded. Clinical
      parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and
      plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal
      therapy; SRP which was performed using a sonic device and hand instruments and the sites were
      divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the
      contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3
      and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment
      of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.
    

Intervention name(s): Diode laser
Intervention type(s): Radiation
Intervention description(s): Diode laser 810nm, 2W, 20sec, 20 HZ
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: split mouth
Masking: Single (Participant)
Primary purpose: Treatment
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The primary purposes of this study are the following:

        1. To evaluate whether the presence of inflammatory knee osteoarthritis as determined by
           ultrasonography can be used as a clinical predictor of patient response to
           intra-articular corticosteroids.

        2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with
           the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical
           design.

        3. To evaluate whether lower extremity strength is improved with intraarticular
           corticosteroid injection.

      The investigators hypothesize that patients with signs of inflammation by ultrasonography
      such as synovitis and effusion will respond better to intraarticular corticosteroid
      injection.
    

Detailed description: 
      Osteoarthritis (OA) has previously been thought to be a non-inflammatory condition whose
      pathologic hallmark is destruction of hyaline cartilage. It is now realized that OA results
      from a complex interplay of multiple factors, including local inflammatory processes.
      Evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis
      is also frequently present in OA.

      The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid
      injections have been shown to result in clinically and statistically significant reduction in
      osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were
      less likely to have continuing pain and had significantly lower scores on a visual analogue
      scale (VAS) for pain. However, studies have failed to determine clinical predictors of
      response to IA steroid injection, including traditional indices of inflammation (heat, fluid,
      stiffness). One possibility is that local corticosteroids do no act to relieve pain by
      reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more
      plausible explanation is that current methods of assessing local inflammation in OA are
      inadequate.

      Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible
      tool for the detection of synovitis in the knee. It has been shown to be more sensitive than
      clinical examination and is relatively inexpensive and noninvasive.
    

Intervention name(s): Intraarticular steroids
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Ultrasonography; Corticosteroids
The Impact of Citrus Products on Cardiovascular Health
Condition: Healthy; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Epidemiological studies have indicated that the consumption of citrus fruit is inversely
      associated with the risk of cardiovascular disease. However, clinical data regarding the
      effects of blood orange juice upon endothelial function is scarce. This randomised, crossover
      study investigates whether blood orange juice compared to a control drink improves blood
      vessel function and other cardiovascular health indicators (such as blood pressure and blood
      lipids). All the subjects will be asked to consume blood orange juice and a control drink in
      a randomised order, each over a 2-week period, divided by a 1-week wash out period.
    

Detailed description: 
      Endothelial function measured via flow mediated dilation (FMD), blood pressure,
      anthropometric measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) and
      endothelin 1 (ET-1), cyclic guanosine monophosphate (cGMP) will be evaluated in healthy
      overweight/obese Caucasians prior to and following 2-week consumption of blood orange juice
      and a control drink. Evaluation of endothelial function as measured by FMD will be conducted
      on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in
      premenopausal women, which will be monitored in serum samples.
    

Intervention name(s): Blood orange juice; Control drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: endothelial function; flow mediated dilation; lipid profile; blood pressure; flavanones; Caucasian
SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16
      sites in Bulgaria, Germany and Romania.

      A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for
      12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up
      visit will be performed 4 weeks after study drug discontinuation or earlier in case of
      relapse during follow up. Total study duration will be up to 36 (+2) weeks.

      There will be 8 study visits: one screening visit, 6 visits during the treatment period and
      one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10,
      Week 20 (+1) and Week 36 (+2).

      The duration of the entire study (first patient in till last patient out) is expected to be
      about 13 months.
    


Intervention name(s): SC12267 (4SC-101)
Intervention type(s): Drug
Intervention description(s): Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis; SC12267; 4SC-101; Phase II
Otago Exercise Program And Gaze Stability Exercise In Older Adults
Condition: Balance
Study type: Interventional

Summary: 
      Fall occurrences and the associated risk of injury are debilitating and major health concerns
      in the older population. Several interventions have been investigated and implemented to
      address the needs of balance impairments and to reduce the increased risk of falls. This
      study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze
      stability exercises (GSE) on balance and the risk of falls in older adults residing at an old
      age home facility. 30 elderly participants were equally and randomly divided into two groups:
      Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In
      addition, both groups also performed core muscle-strengthening exercises. The Berg balance
      scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.
    


Intervention name(s): Otago exercises and core strengthening; Gaze stability exercises and core strengthening
Intervention type(s): Other; Other
Intervention description(s): Otago exercise program consisted of strengthening and balance exercises. The strengthening exercises focus on major lower limb muscles. Progression of exercises was done by increasing the duration and then intensity.
Balance exercises involved knee bends, backward walking, walking, and turning around, sideways walking, tandem stance (heel to toe), tandem walk (heal to toe walk), one leg stand, heel walking, toe walk, heel to toe walking backward, sit to stand and stair walking. Balance exercises progressed with varying levels of support depending on their balance and confidence. The individuals repeated each exercise 10 times.; The exercise protocol in Gaze Stability exercises included adaptation exercises and substitution exercises. In adaptation exercises, individuals performed rapid, active head rotations while watched a visual target with the target remaining stationary. Substitution exercises, individual performed eye-head movements between targets with the goal of seeing clearly during the task. That target moved in the opposite direction of head movement.
Adaptation exercises included: Horizontal and vertical (stationary target) viewing exercises done with a near target, sitting. Horizontal and vertical (stationary target) viewing exercises done with near and far targets (6-10 feet), sitting. Horizontal and vertical (stationary target) viewing exercises were done with near and far targets, standing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms pretest-posttest design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Berg balance scale; Fall efficacy scale-International; Rehabilitation; Exercises; Older Adults
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The overall goal of this study is to determine if atomoxetine treatment improves selective
      cognitive functions in abstinent cocaine users, compared to healthy controls. The study will
      also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates
      the cognitive effects of atomoxetine.
    

Detailed description: 
      This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine
      users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the
      between-subject factors. Similar to previous studies, we propose to compare individuals with
      two copies of the L4 allele to participants with at least one S4 allele because only less
      than two percent of the general population is homozygous for the S4 allele. Forty cocaine
      users and 40 healthy controls will participate in 3 test sessions, where they will be
      assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include
      physiological, subjective, and cognitive performance measures.

      To date this study has 35 completers and currently in data analysis. (January 2016)
    

Intervention name(s): Atomoxetine; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): Atomoxetine 40mg and 80mg compared to the sugar pill; Sugar pill compared to Atomoxetine 40mg and 80mg.
Other intervention name(s): Strattera; placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abstinent cocaine users; cognitive testing
Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Hematopoietic Organs; Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and
      299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by
      incidence of Lactobacillus plantarum bacteremia.

      Secondary Objectives:

        1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to
           children and adolescents undergoing HSCT.

        2. To describe the overall incidence of bacteremia in HSCT patients who have been
           administered Lactobacillus plantarum.

        3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT
           patients who have been administered Lactobacillus plantarum.
    

Detailed description: 
      Myeloablative regimens are the backbone of hematopoietic stem cell transplantation (HSCT) and
      are associated with prolonged periods of cachexia/anorexia, nausea/vomiting, mucositis, and
      compromised gut integrity (CGI). The toxicities associated with HSCT often lead to prolonged
      periods of poor oral intake and may result in overt malnutrition. CGI decreases oral
      tolerance to foods, reduces Quality of Life (QOL) and functional status, delays the
      transition from the hospital to home setting, and increases the risk of the development of
      gut-derived infections. Probiotics are nutritional supplements that contain a defined amount
      of viable microorganisms and upon administration confer a benefit to the host. Clinical
      trials in adults receiving organ transplants have found probiotics decrease the incidence of
      infection, the duration of antibiotic use, the incidence of multiorgan failure and systemic
      inflammation. Children and adolescents undergoing HSCT, experience similar clinical
      challenges suggesting probiotics may have a therapeutic value in the setting of HSCT. This
      study is to evaluate the safety and feasibility of administering probiotics to children and
      adolescents undergoing HSCT.
    

Intervention name(s): Lactobacillus plantarum strains 299 and 299v
Intervention type(s): Drug
Intervention description(s): Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.
Colony forming units (CFU)
Other intervention name(s): Probiotics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Probiotics; Hematopoietic Stem Cell Transplantation; Pediatrics