bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effectiveness of soft palatal implants with
      placebo and continuous positive airway pressure treatment in obstructive sleep apnea.
    

Detailed description: 
      Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent
      disorder which is increasingly recognized by health care providers and lay people alike as an
      important factor in impaired daytime executive function as well as cardiovascular disease
      risk. Along with an increase in its recognition and diagnosis have come a growing pool of
      patients with milder disease and the associated challenge of ideal management. Positive
      airway pressure (PAP) is well established as the mainstay of treatment for OSA since it is
      effective at reversing daytime neurocognitive sequelae and may be a useful adjunct to therapy
      in those with cardiovascular disease coexisting with OSA. In patients with mild OSA, however,
      the response to PAP therapy appears muted, which is related in part to poor adherence to
      treatment. In response, a number of alternative treatments have evolved. The most recent
      innovation is soft palatal implants, which, in non-randomized, uncontrolled studies have
      demonstrated reasonable efficacy in the treatment of snoring and mild to moderate OSA. How
      the implants compare with standard therapy and their effect on cardiovascular variables are
      unknown. Because of the ease and rapidity with which this system is implanted, and because
      treatment effect is independent of patient compliance, there is high potential for widespread
      use in patients with milder OSA. We therefore are conducting a randomized, placebo-controlled
      clinical trial to compare the impact of palatal implants with PAP on sleep disordered
      breathing, daytime symptoms and blood pressure, as well as patient / bed partner acceptance.
    

Intervention name(s): soft palate implant; Positive airway pressure (PAP)
Intervention type(s): Device; Other
Intervention description(s): which is air delivered by a mask worn over the nose during sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral
      dose administration.
    

Detailed description: 
      This is a double-blind (neither physician nor participant knows the treatment that the
      participant receives), randomized (the study drug is assigned by chance), placebo-controlled
      (an inactive substance is compared with a medication to test whether the medication has a
      real effect in a clinical study) trial that will be conducted in two parts. Thirty two (32)
      healthy participants are planned to be included in total, in four cohorts (groups).
      Participants in each cohort will receive JNJ-42165279 (n=6) or placebo (n=2) once-daily for
      10 consecutive days. In Part 1, two cohorts of healthy male participants, 18 to 55 years of
      age, will be enrolled. Cohort A will receive 50 mg JNJ-42165279 or placebo for 10 days, and
      Cohort B will receive 30 mg JNJ-42165279 or placebo for 10 days. In Part 2, Cohort C will
      consist of 8 healthy female participants of non-childbearing potential (surgically sterile or
      postmenopausal), 18 to 58 years of age, who will receive 100 mg JNJ-42165279 or placebo for
      10 days. Cohort D will consist of 8 healthy elderly male or female participants, from 65 to
      85 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. The dose may be
      adapted before each cohort starts based on available data. The maximum dose will not exceed
      100 mg once-daily. For all participants, this study will consist of an eligibility screening
      examination (between 28 and 3 days prior to the first dose administration), a double-blind
      treatment phase consisting of 2 days before dosing, 10 dosing days (Day 1 to 10), 4 days
      after dosing (Day 11 to 14), and a follow-up examination (within 7 to 14 days after last dose
      administration). The total study duration for each participant will not exceed 8 weeks.
    

Intervention name(s): JNJ-42165279 50 mg; JNJ-42165279 100 mg; JNJ-42165279 30 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JNJ-42165279 50 mg orally administered once daily for 10 days.; JNJ-42165279 100 mg orally administered once daily for 10 days.; JNJ-42165279 30 mg orally administered once daily for 10 days.; Matching placebo orally administered once daily for 10 days.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42165279; Pharmacokinetics; Elderly; Young
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral
      administration.
    

Detailed description: 
      The present study was adopted to evaluate the pharmacokinetics of sulpiride after
      administration of single oral doses of 50 mg in an open-label, one-way study.
    

Intervention name(s): Sulpiride
Intervention type(s): Drug
Other intervention name(s): Dogmatil
Intervention MeSH terms: Sulpiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sulpiride; Therapeutic drug monitoring; Pharmacokinetics
Assessment of Knee Arthrosis After Bariatric Surgery
Condition: Bariatric Surgery Candidate
MeSH terms: Osteoarthritis; Joint Diseases
Study type: Observational

Summary: 
      Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal
      of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious
      sub-chondral bone) before and one year after bariatric surgery.

      Knee MRI is not currently part of the investigations preceding bariatric surgery.
    

Detailed description: 
      Assessment of knee arthrosis in severely obese patients after bariatric surgery.

      Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal
      of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious
      sub-chondral bone) before and one year after bariatric surgery.
    

Intervention name(s): knee MRI
Intervention type(s): Other
Intervention description(s): knee MRI before surgery (inclusion) and one year after
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inclusion Criteria:

          -  bariatric surgery

          -  IMC >= 35

        Exclusion Criteria:

          -  those of bariatric surgery

          -  contra-indication to MRI

          -  pregnancy
      
Keywords: knee arthrosis; obesity; MRI; bariatric surgery
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
Condition: Visual Fatigue
MeSH terms: Asthenopia; Fatigue
Study type: Interventional

Summary: 
      This study aims to examine the specific effect that 3D game play has on the control of the
      eyes horizontal movements. It will examine the youngest group of consumers this technology is
      marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this
      study as per Nintendo's hardware guidelines, which recommends that children under 7 years of
      age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes on
      horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.
    

Detailed description: 
      This study will be a prospective blind randomised control trial. The participants will be
      randomised into one study group, with participants playing a game in 3D; and a control group,
      with participants playing the same game in 2D. The study is blind due to the use of an
      independent assessor, reducing testing bias by ensuring that the tester does not know the
      randomisation results. The known dependant variables are the total horizontal fusional
      amplitudes at 1/3m and 6m and the independent variable is the use of 2D or 3D game play.
    

Intervention name(s): Nintendo 3DS gameplay
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Microbiome Individuality and Stability Over Time
Condition: Diet
Study type: Interventional

Summary: 
      Microbial derived uremic solutes (p-cresol sulfate, indoxyl sulfate, and
      phenylacetylglutamine) are present in blood and excreted into the urine. Uremic solutes have
      high inter-individual variability of unclear etiology, that the investigators hypothesize is
      due to intestinal microbiome variation and/or dietary variation between people. In this
      study, the investigators will collect baseline samples on participant's habitual diet. The
      investigators will then administer a homogenous diet to all participants for 7 days and
      examine levels of uremic solutes in the urine via 24-hour urine collection during this
      period. In parallel, the investigators will monitor microbiome composition. The investigators
      predict that during the period subjects are consuming the same, homogenous diet, their
      excretion of uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine)
      into the urine will have less inter-individual variation.
    

Detailed description: 
      Participants will be asked to eat exactly the same meal for one week and to eat this same
      meal three times each day. Subjects will be allowed to eat as much of this meal as they want
      and to eat enough so that they do not lose weight. The food will provide a nutritionally
      adequate diet, designed by a registered dietitian. Participants will be asked not to eat
      anything else including candy, snacks, etc. and not to drink anything except water including
      coffee, tea, sodas, or alcoholic drinks.

      Samples will be collected at 5 time points:

      2 weeks prior to starting test diet, Baseline (day 1 on diet), day 4 on the diet, day 7 on
      the diet, 7 days after end of diet.

      Samples collected include:

      Blood sample Stool sample 24 hr urine collection Diet and Gastrointestinal questionnaires
    

Intervention name(s): Standardized diet
Intervention type(s): Other
Intervention description(s): Standardized diet is prepared in a commercial kitchen and packaged in single serve portions to provide to participants to consume for 7 days
Intervention model: Single Group Assignment
Intervention model description: All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
Condition: Lupus Erythematosus Systemic Exacerbation
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      Systemic lupus erythematosus is a serious and potentially life-threatening condition with
      significant unmet medical need. The aim of this Investigator Initiated, single center,
      open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ)
      injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for
      non-responders after day 10 dose. The primary objective of this study is to evaluate whether
      the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity
      of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
    

Detailed description: 
      This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P. Acthar
      Gel.

      The primary objective is to evaluate whether the addition of H.P. Acthar Gel to standard
      treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI
      score, Patient and Physician global assessments.

      The secondary objective is to evaluate any changes to the subjects BILAG scores and markers
      of inflammation, e.g. ESR and/or CRP.

      The Exploratory objective will determine the feasibility of a long-term double-blind study
      using H.P. Acthar Gel versus other usual treatments for lupus.
    

Intervention name(s): H.P. Acthar Gel
Intervention type(s): Drug
Intervention description(s): Open-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing
Other intervention name(s): ACTH
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus; SLE; ACTH; Acthar
A Study to Evaluate the Effects of JNJ-54861911 on Amyloid Beta Processing in Cerebrospinal Fluid and Plasma in Patients With Prodromal Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).
    

Detailed description: 
      This will be a multicenter, double-blind (neither investigator nor patient knows which
      treatment the patient receives), placebo-controlled (placebo is an inactive substance that is
      compared with a drug to test whether the drug has a real effect in a clinical trial),
      randomized (patients are assigned different treatments based on chance), multiple-dose,
      proof-of-mechanism (POM) study in pAD. Approximately 24 outpatients (n=8/treatment group)
      diagnosed with pAD, according to the inclusion and exclusion criteria, will participate in
      this 4-week treatment study. For all enrolled patients, this study will consist of an 8-week
      eligibility screening period, a 4-week double-blind treatment period, and a follow-up
      examination (7-14 days after the last dose). Patients will be assigned randomly to 1 of 3
      treatment groups: placebo, JNJ-54861911 10 mg once daily, or JNJ-54861911 50 mg once daily.
      Safety assessments will be performed throughout the study. The maximal study duration for a
      patient will be 14 weeks.
    

Intervention name(s): JNJ-54861911 10 mg; JNJ-54861911 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-54861911 10 mg will be administered as two 5 mg oral tablets once daily.; JNJ-54861911 50 mg will be administered as two 25 mg oral tablets once daily.; Matching placebo will be administered as 2 oral tablets once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer Disease; Prodromal Alzheimer Disease; Safety; Tolerability; Pharmacokinetic; Proof of Mechanism; JNJ-54861911
Embryonic Ploidy Status in the Oncofertility Population
Condition: Oncology; Fertility
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      looking at aneuploidy rates in embryos from patients who are going to or have undergone
      treatment for a malignancy with gonadotoxic treatment.
    

Detailed description: 
      The study involves oncofertility patients--individuals who are undergoing or have undergone
      therapy for a malignancy--who are interested in pursuing or preserving fertility. In
      particular, it investigates chromosomal abnormalities or aneuploidy in the embryos of those
      individuals as compared to the general infertility population. Embryonic aneuploidy is
      largely due to reproductive senescence. As such the investigators will discuss oncofertility
      prevalence and treatment as well as reproductive senescence and assessment of embryonic
      aneuploidy. The study will seek to determine if there are changes in embryonic aneuploidy
      rates in oncofertility patients that differ from simple age related risks.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        oncofertility patient undergoing controlled ovarian hyperstimulation and embryo
        cryopreservation
      
Biospecimen description: 
      blood specimens and buccal swabs
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open label, parallel group comparison study. Following a 1-week
      screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to
      ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of
      10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg,
      atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the
      evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education
      Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.
    


Intervention name(s): Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin); Double Statin (simvastatin, atorvastatin, or pravastatin)
Intervention type(s): Drug; Drug
Intervention description(s): ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks; simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe; Pravastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to assess the safety and efficacy of adalimumab prior to
      surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were
      surgical candidates.
    

Detailed description: 
      This was an interventional, randomized, double-blind (DB), placebo-controlled study. The
      study duration included a 30-day Screening Period, an initial 12-week DB treatment
      pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB
      study drug administration (Period B), and a subsequent 10-week DB treatment post-operative
      period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline
      Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e.,
      axilla versus inguinal region). The projected size of the surgical excision established by
      the designated surgeon during the Screening Period (calculated from a tracing of the outer
      perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated
      surgeon measured and recorded the surface area of the actual surgery, with surgery occurring
      during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound
      care) was per local practice. No study drug was administered at Week 24, the final study
      visit. Participants were able to begin commercial product (as prescribed by the
      participants's physician) after all Week 24 procedures were completed.
    

Intervention name(s): Placebo; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injections administered as described in arm description; Subcutaneous injections administered as described in arm description
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hidradenitis Suppurativa; Axilla; Inguinal region; Hurley Stage I, II, or III; Adalimumab; Secondary intention; Abcess and inflammatory nodule (AN) count
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The aim of this study was to investigate the immediate effect of neural mobilization
      techniques, one of the manual therapy methods that can be used in the treatment of cervical
      radiculopathy.
    

Detailed description: 
      This study was designed as a randomized controlled experimental study and was conducted in
      the Physiotherapy and Rehabilitation Department of Istanbul Medicana International Hospital.
      Population: The study included patients diagnosed with cervical disc herniation who were
      referred to physiotherapy sessions by a physician Patients were assigned to the Control
      Group(CG) or Neural Mobilization Group(NMG) by simple randomization. The control group
      received conventional physiotherapy while the neural mobilization group received neural
      mobilization of the ulnar median and radial nerves. The pain of the patients was evaluated
      with Numeric Pain Rating Sacale (NPRS) and Neuropathic Pain Questionnaire (NPQ) at the
      beginning and end of the intervention, while hand grip strength and pinch grip strength were
      evaluated with digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) and digital
      pinchmeter (JAMAR Plus Pinch Gauge). Pre- and post-intervention data were statistically
      analyzed and compared.
    

Intervention name(s): Neural Mobilisation; Conservative physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Transcutaneous Electrical Stimulation, hotpack, ultrasound and neural mobilization(radial,ulnar,median); Hotpack,Transcutaneous Electrical Stimulation ,Ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,