bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy; Chronic Pain
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability
      data from these studies support further clinical development of AEG33773. The current study
      is proposed as a proof-of-concept study to assess the potential analgesic efficacy of
      AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.
    

Detailed description: 
      Doses of AEG33773 selected for evaluation in this study provide a dose range (i.e., 100-400
      mg) that may potentially include both a minimally effective dose and a maximum tolerated
      dose. Doses up to 400 mg were well tolerated in single- and multiple-dose Phase 1 studies.

      Before initiation of treatment with study drug, other analgesic medications will be
      discontinued during a 7-day Washout Period, and neuropathic pain will be assessed (in the
      absence of analgesic medication) over the next 3 days (Pain Assessment Period). Pain
      intensity level during these 3 days will be recorded daily, and only those subjects who meet
      predefined pain intensity threshold criteria on all 3 days will be eligible to receive study
      drug. Because pain may increase after analgesic medications have been discontinued, the
      combined length of the Washout and Pain Assessment Periods is limited in order that subjects
      who experience increased pain during this time may begin treatment with study drug without
      undue delay. This design will allow for adequate Baseline pain assessment over 3 days while
      avoiding a more prolonged period of increasing pain in the absence of analgesic medications.
    

Intervention name(s): AEG33773 oral dosing
Intervention type(s): Drug
Intervention description(s): AEG33773 capsules: subjects will receive a daily dose of either 100 mg, 200 mg, or 400 mg AEG33773. Placebo capsules: subjects will receive a daily dose of placebo (matching test product). Capsules will be taken by mouth, over 28 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic; peripheral; neuropathy; pain; hyperalgesia; allodynia
Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study
Condition: Food Hypersensitivity; Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional

Summary: 
      Food allergy affects up to 10% of the population. The mainstay of management involves dietary
      avoidance and provision of rescue medication in the event of an accidental reaction. The
      Integrated approaches to food allergen and allergy management (iFAAM) collaboration is an
      EU-funded academic/clinical/industry consortium with the aim to improve allergen risk
      management including food labelling. Much of this work requires the validation of the minimum
      'eliciting dose' for the food-allergic population and how this can be translated into risk
      management.

      A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the
      eliciting dose for peanut allergic patients, using food challenges where peanut-allergic
      individuals are eat incremental doses of peanut under strict medical supervision.

      In this extension study, peanut-allergic subjects will have undergone (in a cross-over
      manner) three double-blind, placebo-controlled food challenges to peanut:

        1. incremental doses of peanut in a water-continuous matrix;

        2. incremental doses of peanut baked into a cookie biscuit;

        3. a single dose of peanut in a water-continuous matrix.

      The differences in eliciting dose, symptom pattern and underlying physiological mechanisms
      will provide essential data on how the presentation and consumption of peanut affects the
      amount needed to trigger an allergic reaction, to inform industry and food regulators as to
      how to best protect the food-allergic population.
    


Intervention name(s): DBPCFC to peanut cookie; Single-dose DBPCFC to peanut flour; Single-dose DBPCFC to peanut butter
Intervention type(s): Other; Other; Other
Intervention description(s): Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.; Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Peanut allergy; Food allergy; Thresholds; Anaphylaxis
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
Condition: Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to
      placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the
      knee. This study includes a maximum 21 day Screening Period followed by a 15-week
      Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are
      eligible for the Double-blind Treatment Period will be randomized to one of following
      treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200,
      300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or
      placebo.
    


Intervention name(s): Cebranopadol (GRT6005) Low-Dose Range; Cebranopadol (GRT6005) High-Dose Range; Placebo; Oxycodone CR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules; Capsules; Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules; Capsules containing oxycodone CR 10 or 20 milligrams
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee; Pain; Chronic; OA; Arthritis
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
Condition: Calculi
MeSH terms: Calculi
Study type: Interventional

Summary: 
      The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to
      eliminate stone completely
    

Detailed description: 
      To evaluate the efficacy and safety of external physical vibration lithecbole for the
      treatment of residual stone in different time (3 days ,7 days and 14 days) after the
      operation of RIRS
    

Intervention name(s): 3 days after; 10days after; EPVL performed in30days after RIRS
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): in 3 days after RIRS.; in10 days after RIRS.; Patients in Group C undergo EPVL in630days after RIRS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: stones; external physical vibration lithecbole
Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnoea Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Overnight rostral fluid shift is one of the contributing factors for worsening obstructive
      sleep apnoea (OSA). Fluid shift has been recognized to play a role in the pathophysiology of
      sleep apnoea. Previous studies shown that fluid from the leg redistributes to the neck at
      night increases the neck circumference, hence indicating fluid accumulation in the neck. OSA
      patients are more susceptible to developing upper airway narrowing in response to fluid shift
      from the leg to the head and neck region.

      Previous studies were mainly done on Caucasian patients. The pathophysiology of OSA in
      Caucasian patients and Asian patients are different but both suffer a similar degree of OSA.
      The investigators would like to investigate if reducing leg swelling by a simple non-invasive
      intervention of wearing compression stocking during the day can attenuate sleep apnoea, and
      whether compression stocking is generally acceptable and well-tolerated among the general OSA
      population in Asia.
    


Intervention name(s): Compression stocking
Intervention type(s): Device
Intervention description(s): A below-the-knee compression stock will be worn daily for 2 weeks from waking up to before sleep.
Bioelectrical impedance will be performed before and 2 weeks after wearing the stocking to assess the total body water content.
Measuring the calf and neck circumference will be done before and after wearing the compression stocking. After 2 weeks, the patient will return back to the clinic for calf and neck circumference measurement.
Sleep test will be done the night before and 2 weeks after wearing the compression stocking. Oxygen Desaturation Index(ODI) will be assessed through a level 4 home sleep apnea testing device.
Patients recruited will have mild excessive to severe excessive daytime sleepiness and/or STOP-Bang score of 3 or more, with underlying conditions such as type II diabetes and hypertensive patients using the Epworth sleepiness scale. Epworth sleepiness scale will be assessed again 2 weeks after to assess for increase sleep efficiency.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
Condition: Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Anxiety Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to test the hypothesis that Quetiapine XR (Extended Release)
      monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression
      and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a
      substance use disorder. The secondary aim is to generate an estimate of effect size to power
      a definitive large-scale, multi-site collaborative R01 and to configure the use of the
      primary and secondary outcome measures in the definitive large-scale study.
    

Detailed description: 
      120 subjects aged 18 and up with Diagnostic and Statistical Manual -IV Generalized Anxiety
      Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and
      the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized.
      Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs
      without SUD. Potential participants will be recruited by means of Institutional Review Board
      -approved advertising or from the clinical psychiatric infrastructure.

      This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine
      sustained-release monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute
      treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or
      without a substance use disorder. Subjects will be assessed weekly for mood changes and side
      effects.
    

Intervention name(s): Quetiapine XR; Placebo for quetiapine XR
Intervention type(s): Drug; Drug
Intervention description(s): Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day; Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Other intervention name(s): Seroquel XR; Placebo for Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders
Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration
Condition: Age Related Macular Degeneration and Stargartd
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the behavior of intravitreal injection of of
      autologous bone marrow stem cells in patients with age related macular degeneration.
    

Detailed description: 
      A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration
      and Stargartd patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200.
      Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24
      (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three
      measures will be used to evaluate the short-term safety of intravitreal of bone marrow stem
      cells: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale;
      2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary
      safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber
      cells and flare higher than 3+ for more than 1 month after injection according to a
      classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal
      tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like
      macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term
      efficiency of intravitreal of Bone Marrow Stem Cells: 1) improvement in ERG response; 2)
      increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or
      choroidal neovascularization; 4) increase > 5 letters on BCVA
    

Intervention name(s): intravitreal injection of autologous bone marrow stem cells
Intervention type(s): Other
Intervention description(s): intravitreal injection of autologous bone marrow stem cells
Other intervention name(s): Cell Therapy
Intervention model: Single Group Assignment
Intervention model description: intravitreal injection of autologous bone marrow stem cells
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular Degeneration
Viagra in the Treatment of Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a
      higher improvement rate when compared to placebo in the treatment of moderate to severe
      primary dysmenorrhea.
    

Detailed description: 
      It is well established that excess prostaglandin production in primary dysmenorrhea leads to
      ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of
      drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid
      anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of
      more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory
      effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate
      (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile
      dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To
      date it has not been used in the treatment of primary dysmenorrhea.
    

Intervention name(s): Sildenafil Citrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.; A single vaginal dose of placebo and monitored for 4 hours.
Other intervention name(s): Viagra; Sugar Pill
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sildenafil
To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Condition: Vaccination; Reaction - Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of sequential
      immunization schedules of Sabin IPV and bOPV.
    

Detailed description: 
      A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different
      sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were
      divided into 3 groups.

      Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

      Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

      Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

      Blood samples were collected before vaccination and 30 days after the third dose.
      Neutralization antibody against type I, Type II and Type III poliomyelitis virus were
      detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The
      safety of the 3 immunization schedule groups were also monitored.
    

Intervention name(s): Sabin-IPV+bOPV+bOPV; Sabin-IPV+Sabin-IPV+bOPV; Sabin-IPV+Sabin-IPV+Sabin-IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively; 197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively; 205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
FTO Gene Variants and Diet in Obesity
Condition: Obesity; Diet Habit; Genetic Predisposition
MeSH terms: Obesity; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity
      is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide
      polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these
      associations were modified by lifestyle factors. The study included 200 obese and 200
      non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity
      traits is likely to be influenced by lifestyle factors in this Turkish population.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        400 unrelated individuals, aged 24-50 years
      
Keywords: obesity; gene-diet interaction; FTO gene variant
A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
Condition: Sleep; Critical Illness
MeSH terms: Inflammation; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the short-term effect of sympatholysis on sleep
      quality and inflammation in critically ill patients.
    

Detailed description: 
      Over 1 million patients receive mechanical ventilation every year in the United States. In
      mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted.
      Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated
      inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been
      associated with delirium, which, in turn, is associated with increased mortality and higher
      healthcare costs. Currently, however, there is very little understanding of the
      inter-relationship between critical illness, sleep, and neuropsychological well-being. The
      purpose of this study is to collect preliminary data on the short-term effects of sedation
      with and without sympatholysis on sleep and inflammation in critically ill patients receiving
      mechanical ventilation. This pilot study will be accomplished by performing sleep studies and
      circulating cytokine measurements in critically ill patients randomized to receive two
      different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate
      goal of this program of research is to identify sedation practices that are least associated
      with adverse short- and long-term consequences, and thereby ultimately help improve sleep
      quality and quality of life in patients surviving critical illness.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sleep; Critical illness; Cytokine
Accuracy of Computer Guided Free Gingival Graft
Condition: Computer Guided; Free Gingival Graft
Study type: Interventional

Summary: 
      A patient specific surgical guide for harvesting of free gingival graft from the palate
    


Intervention name(s): patient specific guide
Intervention type(s): Other
Intervention description(s): harvesting palatal free gingival graft using the patient specific guide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment