bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients
Condition: Hemodialysis
Study type: Interventional

Summary: 
      This study is to investigate the acute postprandial effect of a modified versus standard low
      phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent
      hemodialysis (HD) patients
    

Detailed description: 
      Background: Potential dietary strategies for controlling hyperphosphataemia include the use
      of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on
      phosphorus to protein ratios and the avoidance of all phosphate additives.

      Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were
      directly observed eating a standard low phosphorous diet and on the other day, a modified low
      phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to
      protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing
      phytates which reduces phosphorus bioavailability. Both diets were tailored for each
      participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting
      bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals
      for the four hours after the meal, for analysis of phosphate, potassium and intact
      parathyroid hormone (iPTH).
    

Intervention name(s): Standard Diet; Modified Diet
Intervention type(s): Other; Other
Other intervention name(s): Modified Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dietary phosphorus; Hyperphosphatemia; Hyperkalaemia; Phytate; Hemodialysis
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in
      the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)
      who had inadequate response to ustekinumab.
    

Detailed description: 
      This is a randomized (assignment of study drug by chance), double-blind (participants nor
      study staff will know the identity of study drugs), multicenter study to evaluate efficacy
      and safety of guselkumab for the treatment of participants with moderate to severe
      plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist
      of a screening period, open-label and double-blind treatment periods, and a follow-up period.
      The treatment period will have 2 phases: an open-label treatment phase during which all
      participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during
      which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to
      ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through
      Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16
      will continue to receive open-label treatment with ustekinumab every 12 weeks through Week
      40. All participants will complete a follow-up phase through Week 52 for efficacy and through
      Week 60 for safety evaluations. The total duration of the study will be approximately 64
      weeks (includes a 4-week screening period). Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Ustekinumab; Guselkumab; Placebo for ustekinumab; Placebo for guselkumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.; 100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.; Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.; Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Plaque-type psoriasis; Guselkumab; Ustekinumab; CNTO 1959; Monoclonal antibody
Monoclonal Antibodies Elimination in Breast Cancer Patient
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This Study evaluates covariables being able to potentially influence the elimination of the
      monoclonal antibodies (trastuzumab, bevacizumab and denosumab).
    

Detailed description: 
      Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit
      from these antibodies for several years and it is conceivable to wonder about the evolution
      of the pharmacokinetics of these antibodies.
    

Intervention name(s): additional blood sample
Intervention type(s): Other
Intervention description(s): blood sample every 3 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained
      release tablet (300mg) to immediate release capsule(150mg * 2) while multiple dosing.
    


Intervention name(s): Immediate release capsule(lyrica 150mg * 2/day); sustained release tablet
Intervention type(s): Drug; Drug
Intervention description(s): Immediate release capsule; sustained release tablet
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropathic pain; pregabalin
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
Condition: Congenital Hyperinsulinism
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if Exendin-(9-39), an antagonist of the
      glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases
      fasting blood glucose levels in subjects with congenital hyperinsulinism.
    

Detailed description: 
      This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the
      glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases
      fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall
      hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in
      intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this
      disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose
      levels.

      Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose
      levels in subjects with congenital hyperinsulinism due to KATP channel mutations.

      Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of
      exendin-(9-39) during an intravenous short-term infusion in subjects with congenital
      hyperinsulinism due to Adenosine triphosphate (ATP)-sensitive potassium channel (KATP)
      mutations.
    

Intervention name(s): Exendin-(9-39); Vehicle
Intervention type(s): Drug; Other
Intervention description(s): A short term intravenous infusion of the study drug, exendin-(9-39), will be given over 6 hours.; A short term intravenous infusion of normal saline, or the vehicle, will be given over 6 hours.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hyperinsulinism; hypoglycemia; KATP channel; Kir6.2
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of different treatment regimens of rituximab
      (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in
      patients with active rheumatoid arthritis (RA).
    


Intervention name(s): methotrexate; rituximab; corticosteroids; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral or parenteral repeating dose; Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Rituximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rituxan; RA
Japanese Dose-Response Study of Rimonabant in Obese Patients
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to verify the dose-response relationship of rimonabant on body
      weight change.

      The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body
      weight loss and on secondary criteria associated with comorbidities, and to evaluate the
      safety and the pharmacokinetics of SR141716.
    


Intervention name(s): rimonabant (SR141716)
Intervention type(s): Drug
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: weight loss
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Condition: Intrauterine Devices; Cesarean Section
Study type: Interventional

Summary: 
      This is a randomized controlled trial among women who deliver by cesarean at UNC Women's
      Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After
      consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a
      postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the
      Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8
      week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that
      women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months
      later than women who plan on receiving an IUD 4-8 weeks after delivery.
    


Intervention name(s): Immediate Postplacental Placement of an IUD during cesarean delivery
Intervention type(s): Device
Intervention description(s): Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum Contraception; Intrauterine Devices
A Retrospective Chart Review of Three Medifast Weight Control Centers
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump
      Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes,
      and reduction in common markers of coronary heart disease.
    

Detailed description: 
      Portion-controlled meal replacements by themselves have been shown to be an effective weight
      control strategy in overweight and obese individuals. The addition of medical supervision has
      been shown to result in greater weight loss than meal replacements alone. MWCC provides this
      added support through individual weekly counseling sessions. Thus, the investigators plan to
      retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the
      following indices: weight loss, anthropometric changes, and reduction in common markers of
      coronary heart disease.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study was a systematic retrospective chart review of patients participating in the
        Jump Start (5 & 1) Plan at three different MWCC locations in Texas during the years
        2007-2010.
      
Keywords: Obesity; Meal replacements
Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Recurrence
Study type: Observational

Summary: 
      The investigators sought to retrospectively assess whether the use of a intrauterine device
      to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by
      laparoscopy for endometrial cancer
    

Detailed description: 
      The investigators retrospectively collected data regarding patients who received operation by
      laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then
      stratified according to the use or not of the uterine manipulator. The investigators also
      considered the actual type of manipulator used. Then disease-free, disease-specific and
      overall survival were evaluated, as well as all the possible factors associated with
      prognosis.

      Data were retrieved from specifically designed research quality internal surgical databases,
      prospectively updated by trained residents on a regular basis, in order to capture all the
      possible surgical and follow-up data.
    

Intervention name(s): UTERINE MANIPULATOR
Intervention type(s): Device
Intervention description(s): Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women affected by early endometrial cancer
      
Keywords: endometrial cancer; survival; uterine manipulator
FES Assisted Cycling in Children With CP
Condition: Cerebral Palsy Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling
      can improve the cycling ability, muscle strength, cardiovascular health, quality of life,
      self perception and functional mobility of adolescents with CP better than a volitional
      cycling program or a non-intervention control group.
    

Detailed description: 
      Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving
      cardiorespiratory fitness, walking function, self-motivated exercise/recreation,
      self-perception and functional mobility and quality of life of adolescents with spastic CP
      with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs.
      8-weeks of volitional cycling training and a non-intervention control group.

      Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling
      ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of
      volitional cycling training and a nonintervention control group.

      Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after
      8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and
      marginal walking ability.
    

Intervention name(s): FES; Cycling
Intervention type(s): Device; Other
Intervention description(s): FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.; Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Functional electrical stimulation; Cycling
Sorafenib in Relapsed High Grade Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as
      single agent, in terms of percentage of patients with high grade advanced osteosarcoma free
      from progression following 4 months of therapy
    


Intervention name(s): sorafenib
Intervention type(s): Drug
Intervention description(s): 400 mg bid until progression or inacceptable toxicity
Intervention MeSH terms: Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteosarcoma; sorafenib; target therapy
Brief Reminders as Intervention for Greater Engagement of Cochrane Translators
Condition: Knowledge Translation
Study type: Interventional

Summary: 
      The intervention will consist of reminders which will be send to the participants randomly
      via email, with aim to increase the frequency and amount of translated plain language
      summaries (PLS).
    

Detailed description: 
      All study participants who accept participation in the study will be initially assigned 3
      PLSs, and subsequently they will be assigned more PLSs when they translated the previous
      ones. Intervention group will receive one customized e-mail reminder two weeks after the PLS
      assignment if they do not translate it within two weeks. If they still do not translate the
      PLS, they will receive another customized e-mail reminder after every two weeks until they
      translate the PLS or until we reach maximum of 4 bi-weekly reminders (at 2 weeks, 4 weeks, 6
      weeks and 8 weeks post-assignment) or until participants indicate that they are unable to
      translate it anymore. Text of the reminder that will be sent to the study participants is
      available in Supplementary file 1. The reminders will be customized for each PLS, and they
      will contain a name of the PLS indicated in the message. If the participants do not translate
      PLS within 2 months from PLS assignment, we will stop sending them reminders and we will
      consider them as dropouts.

      Control group will receive no intervention, i.e. standard procedure. Participants in the
      control group will receive PLSs for translation, in the frequency they indicated, and they
      will not receive any reminders. They will be assigned new PLSs once they translate the ones
      that were previously assigned.

      All PLSs will be translated in Memsource, a translation management tool that Cochrane plans
      to start using since March 2018 for managing translation of summaries. Participants will be
      followed 6 months from the moment of allocation.
    

Intervention name(s): Reminders
Intervention type(s): Other
Intervention description(s): Personalized email which will aim for reminding of the translator about the PLSs on hold.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All study participants who accept participation in the study will be initially assigned 3 PLSs, and subsequently they will be assigned more PLSs when they translated the previous ones. Intervention group will receive one customized e-mail reminder two weeks after the PLS assignment if they do not translate it within two weeks.
Control group will receive no intervention, i.e. standard procedure. Participants in the control group will receive PLSs for translation, in the frequency they indicated, and they will not receive any reminders. They will be assigned new PLSs once they translate the ones that were previously assigned.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether cenicriviroc is effective and safe in the
      treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.
    


Intervention name(s): Cenicriviroc; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CVC 150 mg, administered orally once daily and taken every morning with food.; Placebo administered orally once daily and taken every morning with food.
Other intervention name(s): TBR-652
Intervention MeSH terms: Cenicriviroc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ATX-MS-1467 in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to
      evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing
      multiple sclerosis (MS) and to assess the maintenance of any such effects.
    


Intervention name(s): ATX-MS-1467
Intervention type(s): Drug
Intervention description(s): Subjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
Other intervention name(s): M2736; IL-10 Inducer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ATX-MS-1467 (MSC2358825A); Relapsing Multiple Sclerosis; Magnetic resonance imaging (MRI); M2736
Sunlight Exposure and Vitamin D in Children
Condition: Healthy Schoolchildren
Study type: Observational

Summary: 
      The purpose of this study is to examine the amount of sunlight exposure and vitamin D status
      of adolescent schoolchildren in each season throughout the year.
    


Intervention name(s): None - observational study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schoolchildren in Greater Manchester