bioihbjkbjnl/mcl2 huggingface dataset:
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
Condition: Diabetic Foot; Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetic Foot
Study type: Observational

Summary: 
      The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical
      Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic
      peripheral neuropathy standard of care (SOC), and observe step count, pressure, temperature,
      and adherence data through remote patient monitoring (RPM). This will provide insights into
      patient engagement and the benefits of offering remote, preventative care.
    


Intervention name(s): Orpyx SI® Sensory Insole System
Intervention type(s): Device
Intervention description(s): Orpyx SI Sensory Insole System consists of Orpyx Custom Insoles and Orpyx Sensory Technology. The Orpyx Custom Insoles are precisely fabricated for an individual's feet. The Orpyx Sensory Technology, a powered limb overload warning technology, is compatible with the Orpyx Custom Insoles. It is intended for monitoring physiological parameters, such as plantar pressure, motion and temperature, and providing real-time cues for pressure offloading as the patient goes about their daily activities
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participant population to be studied will be subjects 18 years of age or older who have
        been diagnosed with diabetes (Type I or Type II) and neuropathy and who are at moderate to
        high risk of foot ulceration based on the International Working Group on the Diabetic Foot
        (IWDGF) guidelines.
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
Condition: Ricin
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the
      safety and immunogenicity of the RVEc vaccine.

      The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety
      profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin
      G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA)
      anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine
      recipients.
    


Intervention name(s): RVEc
Intervention type(s): Biological
Other intervention name(s): Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ricin; RVEc
A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability of lomitapide when administered by sprinkling the
      contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral
      intact capsule dose of 20 mg lomitapide in healthy subjects.
    


Intervention name(s): lomitapide
Intervention type(s): Drug
Other intervention name(s): Juxtapid; Lojuxta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Comparative; Bioavailability; lomitapide
Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
Condition: HIV Infection; Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the influence of posaconazole on unboosted
      fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is
      to determine the safety of combined use of fosamprenavir with posaconazole in healthy
      volunteers.
    

Detailed description: 
      Infections with fungi and yeast frequently occur in patients infected with the human
      immunodeficiency virus type 1 (HIV-1).

      Fosamprenavir is a PI that is used to treat HIV-infection in combination with ritonavir. Once
      hydrolyzed to amprenavir, this substance is a substrate for CYP3A4. Ritonavir is an extremely
      potent inhibitor of CYP3A4 and serves as a booster of the pharmacokinetics of amprenavir.
      Posaconazole is a very potent CYP3A4 inhibitor and therefore might enhance amprenavir
      pharmacokinetics in a similar way as ritonavir.

      The current study is designed to test this hypothesis. When there is an indication for
      antifungal therapy in an HIV-infected patient, temporal replacement of ritonavir by
      posaconazole would be an attractive option for combined treatment of HIV and fungal
      infection.
    

Intervention name(s): Posaconazole; Fosamprenavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Posaconazole oral solution 40mg/mL; 400mg BID treatment for 10 days, including dose escalation; fosamprenavir tablet 700mg; 1 tablet BID for 10 days; Ritonavir 100mg capsule; 1 capsule BID for 10 days
Other intervention name(s): Noxafil; Telzir / Lexiva; Norvir
Intervention MeSH terms: Ritonavir; Fosamprenavir; Posaconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interaction; pharmacokinetics; boosting; drug-drug interaction; safety
Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is
      designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers
      of treatment response associated with vilazodone use in adult patients diagnosed with MDD by
      the DSM-IV-TR criteria.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is
      designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers
      of treatment response associated with vilazodone use in adult patients diagnosed with MDD by
      the DSM-IV-TR criteria. This study will enroll approximately 470 patients at approximately 10
      clinical sites. Safety and efficacy will be assessed at each visit. A DNA sample will be
      collected and analyzed for response to vilazodone.
    

Intervention name(s): vilazodone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): titration to 40 mg tablets qd (once a day) for 8 weeks; placebo
Other intervention name(s): EMD68843, SB-659746
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is conducted in Asia. The aim of this observational study is to evaluate the
      safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino
      patients with Type 1 and Type 2 Diabetes Mellitus.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention description(s): Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other intervention name(s): Levemir™
Intervention MeSH terms: Insulin Detemir
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Type 1 and Type 2 Diabetes
Stimulating the Social Brain
Condition: Healthy Adults
Study type: Interventional

Summary: 
      This study investigates whether the way in which individuals process social stimuli can be
      altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by
      stimulating the brain's regulatory regions via transcranial Direct Current Stimulation
      (tDCS).
    

Detailed description: 
      Although paranoid ideation is typically associated with severe mental illnesses such as
      schizophrenia or bipolar disorder, 10-15% of individuals in the general population report
      experiencing paranoid thoughts on a regular basis. These individuals who are high in
      sub-clinical paranoia can show impaired work and social functioning as compared to
      individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional
      impact of heightened paranoia reinforces the need to develop interventions that may help to
      reduce problematic patterns of paranoid thinking in both healthy individuals and those with
      mental illness.

      Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation
      which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS
      therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and
      specifically paranoia. This study will compare experiences of paranoid ideation in
      individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS
      and sham tDCS.
    

Intervention name(s): active anodal tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Hypothesis:

      The overall hypothesis is that women with PCOS, both obese and non-obese, have larger
      adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these
      changes are associated with high sympathetic nerve activity, hyperandrogenism
      hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular
      disease (CVD) as well as psychological distress and reduced quality of life. Physical
      exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare
      menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced
      disturbances.
    

Detailed description: 
      Primary outcome: Changes in androgen concentrations and menstrual pattern

      Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian
      morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and
      health related quality of life and symptoms of anxiety and depression.
    

Intervention name(s): Electroacupuncture; Physical exercise; Untreated control
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Androgens; Menstrual pattern; Insulin resistance; Adipocytes; Obesity; Stress; Muscle sympathetic nerve activity; Psychological distress and quality of life
Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
Condition: To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.; To Prevent Hypothermia During Opthalmology Surgery.
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators hypothesize that this modified ophthalmic draping will reduce the
      accumulation and rebreathing of carbon dioxide during eye surgery.
    

Detailed description: 
      Majority of eye surgery has been widely done under local anesthesia provided by the
      ophthalmologist with or without sedation.The surgical drapes used often covers the patients
      face and beyond in order to maintain sterility of the surgical field. This can lead to
      accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide
      escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the
      ambient air surrounding the patient's head.This causes an increase in arterial carbon dioxide
      partial pressure and thus hyperventilation and patient discomfort with restlessness and
      unable to stay still during the surgery.

      In recent years,several types of ophthalmic drapes have been produced.This study is look for
      possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes
      compared to the modified draping.
    

Intervention name(s): forced air warmer (Bair Hugger); warming blanket
Intervention type(s): Device; Device
Intervention description(s): forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.; warming blanket placed on torso of patient under the drape.
Other intervention name(s): Forced air warmer brand - Bair Hugger; warming blanket brand - Thermamed warming system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs
      value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline
      NLR is correlated with overall survival after curative treatment for BC and 2) that baseline
      NLR is correlated with the survival benefit of NAC. The study will look at the data from
      participants of the SWOG 8710 study.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects enrolled in SWOG 8710
Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, placebo-controlled, cross-over trial comparing the the effects of
      approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on
      several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women
      diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment
      will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with
      secondary hypotheses that there will be a significant increase in de novo cholesterol
      synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and
      increase global RCT.
    

Detailed description: 
      The study will compare the effects of approximately 7 weeks of placebo treatment to 7 weeks
      of ezetimibe (10mg/day) on: 1) the efficiency of endogenous (plasma-derived) cholesterol
      excretion (%/day) 2) de novo cholesterol (DNC) synthesis ((%/day) 3) cholesterol efflux from
      tissues into blood (Ra), and 4) global RCT (efflux from tissues that is excreted as fecal
      sterols). Subjects will receive 7 weeks of either treatment or placebo, undergo RCT and DNC
      measurements, taking 10 days, then cross-over to the alternate placebo or treatment for an
      additional 7 weeks, followed by a second set of RCT and DNC measurements.
    

Intervention name(s): ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet,10mg, once a day, for 7 weeks; 1 tablet, once a day, for 7 weeks
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolic diseases; metabolic disorder; dyslipidemias; lipid metabolism disorders
Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section
Condition: Post Partum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to demonstrate that the combined used of low dose of oxytocin
      and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol
      alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing
      elective or emergency lower segment cesarean section under spinal anesthesia were included in
      this study. The patients were randomly allocated to one of three groups of 50 each. The
      oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after
      delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved
      in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately
      after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually
      and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined
      misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously
      immediately after delivery of the neonate . The main outcome measures were blood loss at
      cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related
      side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and
      added to volume from suction bottle. Hemoglobin values were determined both before surgery
      and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during
      surgery .The need for additional oxytocic therapy, operating time, infusion volume given
      intraoperatively, need for blood transfusion, side effects of study drug and any significant
      puerperal morbidity were also recorded.
    


Intervention name(s): Misoprostol; Oxytocin; Oxytocin and Misoprostol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it); The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate; The combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate .
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post partum haemorrhage at cesarean section
Relationship Between Musculoskeletal, Sensorimotor and Functional Factors and Nonspecific Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Several factors have been associated with neck pain. Controversy exists regarding the degree
      of association between some of these factors and neck pain. Information regarding the degree
      of association of each factor to neck pain is needed for effective prevention and appropriate
      treatment strategies. The aim of this study is to investigate the association among
      musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic
      nonspecific neck pain.
    


Intervention name(s): assessment
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        subjects with and without neck pain
Lumbar Manipulation for Hip and Muscle Strength
Condition: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate
      the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free
      deep squat range of motion in order to answer several conceptual and practical research
      questions
    

Detailed description: 
      This prospective, double-blind, randomized control trial clinical will use a multigroup
      pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within
      the biopsychosocial model and the International Classification of Functioning, Disability and
      Health (ICF) framework, this research will measure the outcomes between patellofemoral pain
      syndrome (PFPS), the health condition, and contextual factors, particularly personal factors.
      It will address personal factors such as gender and age but will not address environmental
      factors. This research includes tests and measures of two of the three levels of human
      functioning, or domains, impairments to body functions and structures and activity
      limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat
      range of morion (ROM) is an activity limitation-level measure.
    

Intervention name(s): Lumbar Spine Manipulation; Lumbar Spine Manipulation Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): • The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.; The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
Other intervention name(s): Sidelying lumbosacral thrust joint manipulation; Sidelying lumbosacral thrust joint manipulation placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spine Manipulation