bioihbjkbjnl/mcl2 huggingface dataset:
Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis
Condition: Hysteroscopy
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      This study aims to estimate if performing a small caliber office hysteroscopic cervical
      negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind
      cervical probing done under general anesthesia. Moreover, the investigators test the impact
      of drawing a detailed diagram after this procedure on the success of ET in participants with
      failed mock or actual trials of embryo transfer (ET).
    

Detailed description: 
      It comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the
      office. Participants were divided into 2 groups. Group A comprised 64 cases subjected to
      small-caliber office hysteroscopic cervical negotiation while 58 cases were subjected to
      cervical probing under general anesthesia. Main outcome measures included success to bypass
      primary cervical stenosis and complication rate
    

Intervention name(s): cervical negotiation
Intervention type(s): Procedure
Intervention description(s): trial to bypass severe cervical stenosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: hysteroscopy; cervical stenosis; probing
Biomarkers of Prednisolone Treatment (P05888)
Condition: Insulin Resistance; Hyperglycemia; Glucose Intolerance
MeSH terms: Insulin Resistance; Hyperglycemia; Glucose Intolerance
Study type: Interventional

Summary: 
      Primary objective:

        -  To identify a biomarker or biomarker-set for the adverse metabolic effects of various
           doses of prednisolone treatment.

      Secondary objectives:

        -  To describe the PK of prednisolone and PD of a series of biomarkers.

        -  To identify biomarkers that reflect side effects of prednisolone.

        -  To elucidate part of the mechanisms by which prednisolone induces metabolic changes.
    


Intervention name(s): Placebo; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration, once daily, for 15 days; Oral administration
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prednisolone; Glucocorticoids
Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3
Condition: Diabetes
Study type: Interventional

Summary: 
      This prospective equivalency study compares the performance of two Ophthalmic Cameras, the
      Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained
      technicians will take pictures of the same patients' retinas and the quality of the photos
      will be evaluated. The study includes healthy patients and patients with a spectrum of
      retinal diseases. The study requires that technicians take pictures of the retinas of adult
      patients between 18 and 80 years of age using both the OC and OP. The pictures will be
      reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is
      equivalent to the OP, based on the quality of the images
    

Detailed description: 
      Subjects (patients) will be recruited via word of mouth.

      The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15
      subjects per week. The images will be recorded within 15 minutes and will involve minimal
      disruption to the clinical workflow.

      In the Study Environment setting (Foothill Medical Offices), the User Interface will be
      evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.

      Patient subjects will be given an Information and Consent Form to complete prior to the study

      The technicians employed by Foothill Eye Clinic will operate the device on patient
      participants by taking a retinal picture using OC.

      The technicians will use the predicate device OP to take retinal pictures.

      The Ophthalmologist will compare the results with the pictures taken by OC and OP. The
      Ophthalmologist will be blinded to what picture was taken by which camera and record his
      assessment of the quality for each picture.

      Patient subjects will receive a standard of care exam with or without dilation.
    

Intervention name(s): Eyenez Retinal Camera v200; Volk Pictor Ret 1
Intervention type(s): Device; Device
Other intervention name(s): Optimed Smartscope M5 EY3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up
Condition: Inflammatory Bowel Diseases; Circadian Dysregulation
MeSH terms: Inflammatory Bowel Diseases; Chronobiology Disorders
Study type: Observational

Summary: 
      patients 6-25 years old upon diagnostic evaluation will be recruited . study population will
      comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls.

      upon enrollment, subjects will fill out sleeping habits questioners, demographic data,
      medical history.

      blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal
      biopsies will be snap frozen for clock gene extraction and amplification only for patients
      with IBD.
    


Intervention name(s): no intervention performed- observational only
Intervention type(s): Other
Intervention description(s): no intervention performed- observational only
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients medically treated in our institute.
      
Biospecimen description: 
      blood, stool and intestinal mucosa specimens
Plasma Triglyceride Extraction by The Muscle
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Increased accumulation of fat into the muscles is associated with what is called
      insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to
      find out how fat circulating in the blood following fat consumption is taken up by the
      muscles in healthy people as well as people that are insulin-resistant. The investigators are
      specifically interested in how a hormone called insulin is involved in this process. Findings
      from this research will contribute to our understanding of why insulin-resistant people have
      increased accumulation of fat in their muscles, and ultimately help to design appropriate
      interventions to prevent type 2 Diabetes.
    


Intervention name(s): Insulin; NG-monomethyl-L-arginine
Intervention type(s): Drug; Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore a more efficient and scientific clinical treatment plan for acute
      radiotherapy-induced oral mucositis(RIOM/RTOM).it is hoped that the drug combination can more
      effectively improve the cure rate of acute RIOM,reduce the degree of oral mucosal injury and
      utilization rate of analgesic drugs,and reduce the occurrence of severe acute RIOM. Almost
      all patients with head and neck will have RIOM because of receiving radiation therapy.Studies
      have shown that the incidence of severe acute RIOM accounted for about 34% to 56%.There is no
      specific drug when acute RIOM is often accompanied by varying degrees of pain and infection
      in the mouth.Severe RIOM seriously affects ingestion through the mouth and doesn't conducive
      to the treatment and prognosis of tumor diseases. To further explore the efficiency and
      advantages of the combined application of Jeksung and anti-radiation spray in the treatment
      of acute RIOM at all levels,and provide more data support for relevant clinical
      treatment.Explore whether the Jeksung with combination of anti-radiation spray can
      effectively delay the occurrence of acute RIOM and delay the course of the disease.It will be
      expected to improve the quality of life of cancer patients ,reduce the occurrence of adverse
      events due during radiotherapy.
    


Intervention name(s): Jeksung combined with anti-radiation spray
Intervention type(s): Drug
Intervention description(s): Treat radiation stomatitis with Jeksung combined with anti-radiation spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I trial to evaluate the safety and efficacy of oral encapsulated fecal
      microbiota transplantation (FMT) in the treatment of peanut allergy. In this research the
      investigators would like to learn more about ways to treat peanut allergies. There is
      currently no known cure for peanut allergy. The primary aim is to assess safety and
      tolerability of oral FMT in patients with peanut allergy aged 18-40 years.
    

Detailed description: 
      This is a study of fecal microbiota transplantation (FMT) in the treatment of peanut allergy.
      The primary aim is to assess safety and tolerability of oral encapsulated FMT in patients
      with peanut allergy aged 18-40 years. A total of 15 patients with peanut allergy will be
      enrolled after they fail a screening food challenge to peanut. 10 patients will be given oral
      encapsulated frozen FMT over 1-2 days. 5 additional patients will receive antibiotics prior
      to being given oral encapsulated frozen FMT over 1-2 days. Patients will undergo a second and
      third food challenge after receiving FMT. The expected duration of the study for each subject
      will be one year. Stool collection, skin testing and blood samples will be done serially.
    

Intervention name(s): Fecal Microbiota Capsule
Intervention type(s): Biological
Intervention description(s): We will treat patients with oral encapsulated frozen FMT over 2 days.
Other intervention name(s): FMT Therapy; Fecal Microbiota Transplant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergy, Peanut; Hypersensitivity Peanut; Peanut Allergy; Donor Feces Infusion; Fecal Transplant; Fecal Transplantation; Intestinal Microbiota Transfer; Fecal Microbiota Transplantation; Food allergy
XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI
Condition: Stroke
Study type: Interventional

Summary: 
      The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI
      to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.
    

Detailed description: 
      To develop a better understanding of the cerebral response to a complex somatosensory
      intervention with XNKQ acupuncture and to build a foundation for future studies with stroke
      patients our study aims to evaluate changes of brain activity and brain structure in healthy
      subjects after XNKQ acupuncture in comparison to three control interventions. We will use
      EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal
      responses in 28 healthy subjects to a) strong manual needle-stimulation of the acupuncture
      points DU26, PC6 and SP6 (XNKQ acupuncture), b) insertion of needles on the acupuncture
      points DU26, PC6 and SP6 without stimulation (control 1), c) strong manual needle stimulation
      of three non-acupuncture points (control 2), and d) insertion of needles on three
      non-acupuncture points without stimulation (control 3). With this, our study aims to create
      results which inform future studies in patients and might be helpful for the rehabilitation
      of deficits after stroke.
    

Intervention name(s): XNKQ; Control 1; Control 2; Control 3
Intervention type(s): Other; Other; Other; Other
Intervention description(s): stimulation at 5 acupuncture points according to XNKQ acupuncture; no stimulation at 5 acupuncture points according to XNKQ acupuncture; stimulation at 5 control points; no stimulation at 5 control points
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Vascular Improvement With Olmesartan Medoxomil Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare in patients with primary hypertension, the non-blood
      pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol
      on changes in the vascular structure and function.
    


Intervention name(s): olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure; atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Intervention type(s): Drug; Drug
Intervention description(s): Tablets and capsules for oral administration once or twice daily for up to 52 weeks; Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Intervention MeSH terms: Atenolol; Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil; Hydralazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)
Condition: Hypercholesterolemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effects of pitavastatin and atorvastatin on
      adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.
    

Detailed description: 
      The efficiency of lipid lowering therapy was already proven by the clinical trials of
      statins. According to these results, the target value of LDL-C is recommended under 100mg/dL
      in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy
      to lower LDL-C more than 100mg/dL has not been proven yet.
    

Intervention name(s): Pitavastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): comparison of two drugs in increasing HDL-C and adiponectin; comparison of two drugs in increasing HDL-C and adiponectin
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pitavastatin; Atorvastatin; CAD; HDL-C; Adiponectin
Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE
      products by measurement of Plasma concentrations of Erythromycylamine and calculation of the
      bioequivalence parameters from those measurements followed by ANOVA and 90% confidence
      interval statistical evaluation.
    

Detailed description: 
      An open-label, randomized, two-treatments, two-periods, two-sequences, crossover
      bioequivalence pilot study with a washout period of at least 14 days between doses. Healthy,
      mixed skin Arab & Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5
      to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of
      not more than 10 cigarettes per day).
    

Intervention name(s): DIRITHROMYCIN 500 MG ENTERIC COATED TABLET; DYNABAC 250 MG ENTERIC COATED TABLET
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dirithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fasting condition
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of exercise training on elevated
      C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive
      women and men.
    

Detailed description: 
      BACKGROUND:

      CRP, a marker of systemic inflammation, has been reported to be an independent predictor of
      cardiovascular disease in both women and men. Recently published data from cross-sectional
      analyses showed that CRP is inversely related to cardiorespiratory fitness, and that this
      association is independent of body mass index. Regular exercise may affect CRP levels, and
      can possibly be used as a means of reducing elevated CRP levels. Though there are a number of
      studies focusing on related topics, there are no published reports from randomized clinical
      trials on the effect of exercise training alone on CRP levels.

      DESIGN NARRATIVE:

      An estimated 200 individuals will be randomly assigned to either a no exercise control group
      or an exercise group. Exercising individuals will participate in 3 or 4 training sessions
      each week for 4 months, and will progress to a total energy expenditure of 16 kcal [kg(-1),
      week(-1)], which is an exercise dose at the upper end of current public health
      recommendations for physical activity. The target exercise intensity will be 50-70% of
      baseline volume of oxygen consumed (V02 max). VO2 max is the maximal rate of oxygen
      consumption during exercise, and is a measurement of fitness. The primary outcome measure
      will be plasma CRP concentration. Secondary outcomes will be changes in variables that are
      potential mechanisms through which regular exercise might reduce CRP. These variables include
      visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha
      (TNF-alpha), and heart rate variability as a measure of autonomic balance. Although the
      primary outcome is CRP level, this study will also contribute significantly to the limited
      body of literature examining the effect of exercise on the variables of visceral adiposity,
      cytokines, and heart rate variability.
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Coronary Heart Disease Risk Reduction
Evaluation of Abuse Potential of HORIZANT Taken Alone and With Oxycodone in Healthy, Nondependent Recreational Opioid Users
Condition: Abuse Potential
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate
      release capsules taken alone and in combination with oxycodone in healthy adult,
      non-dependent, recreational opioid users.
    

Detailed description: 
      The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil
      immediate-release (GE-IR), the active moiety in Horizant, taken alone and taken in
      combination with oxycodone, compared to that of oxycodone alone.

      This study is a randomized, double-blind, active- and placebo-controlled, 6-way crossover
      design, aimed to assess the abuse potential, safety, and pharmacokinetics (PK) of GE-IR doses
      when administered alone or in combination with an opioid active control (oxycodone), and
      compared to placebo and oxycodone intake alone, in healthy, nondependent, recreational opioid
      users.
    

Intervention name(s): Placebo; Oxycodone 20 mg; GE-IR 200 mg + Oxycodone 20 mg; GE-IR 450 mg + Oxycodone 20 mg; GE-IR 200 mg; GE-IR 450 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participant will receive oral dose of placebo.; Participant will receive oral dose of oxycodone 20 mg.; Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.; Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.; Participant will receive oral dose of GE-IR 200 mg.; Participant will receive oral dose of GE-IR 450 mg.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 study is a placebo-controlled, double-blind, parallel group study of four
      concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected
      intraarticularly (IA) into the target knee joint of subjects with moderately to severely
      symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of
      laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread
      Pain Index) were identified as confounding variables impacting the overall assessment of both
      radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous
      study designs while assessing strategies to combat the confounding impact of laterality and
      chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes
      (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that
      receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham
      injection (i.e., a needle stick with 0 mL vehicle injected).
    


Intervention name(s): SM04690; Placebo; Sham
Intervention type(s): Drug; Other; Other
Intervention description(s): Healthcare professional-administered intra-articular injection performed once on Day 1 of the study; Healthcare professional-administered intra-articular injection performed once on Day 1 of the study; Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SM04690; Wnt pathway inhibitor; osteoarthritis; Samumed