bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Condition: Binge-eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the effectiveness and relative efficacy of behavioral and pharmacologic
      treatments, alone and in combination, for the treatment of binge eating disorder (BED) in
      patients with obesity. This is an acute treatment comparing behavioral weight loss alone or
      in combination with naltrexone/bupropion medication.
    

Detailed description: 
      Binge eating disorder (BED), the most prevalent formal eating disorder, is associated
      strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients
      with BED are needed that can produce sustained clinical outcomes and promote weight loss.
      This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss
      (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved
      anti-obesity combination medication), alone and in combination, for the treatment of BED in
      patients with obesity. The acute treatment stage stage RCT will provide new findings
      regarding the effectiveness of NB medication and whether this specific combination of BWL and
      NB medication is effective for patients with obesity and BED. N=160 patients with BED and
      obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design
      trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study
      will produce important new information about the relative efficacy of BWL and this recently
      FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with
      obesity.
    

Intervention name(s): NB medication (Naltrexone Bupropion combination); Behavioral Weight Loss (BWL) counseling; Placebo
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): NB medication; BWL counseling; Placebo
Other intervention name(s): Contrave
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Condition: Influenza A Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in
      combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to
      adults (aged 18 to <= 64 years) with influenza A infection.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), double-blind
      (neither the researchers nor the participants know what treatment the participant is
      receiving), placebo-controlled, multicenter (when more than one hospital or medical school
      team work on a medical research study) study to evaluate the effect of JNJ-63623872 in
      combination with oseltamivir in participants with influenza A infection. The study consists
      of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be
      randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and
      follow up Phase (21 Days). The duration of participation in the study for each participant is
      approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-63623872; Placebo; Oseltamivir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.; Participants will be administered placebo tablets orally twice daily for 7 days.; Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Influenza A virus; JNJ-63623872; Oseltamivir
Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
Condition: Incretins
Study type: Interventional

Summary: 
      The distal ileum, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, is
      an important organ in mediating glycemic control. However, the distal ileum is not easy to
      access and the correspond in vivo research remains to be difficult. The investigators intend
      to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and
      evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion,
      and quantify the glucose absorption rate within the distal ileum.
    


Intervention name(s): intraileal infusion
Intervention type(s): Dietary Supplement
Intervention description(s): intraileal glucose or intraileal saline infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Condition: Fracture Healing
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate the effect of romosozumab compared with
      placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in
      the midsection of the shinbone).
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 785; Evenity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fracture Healing; Tibial Diaphyseal Fracture
Efficacy of Celecoxib vs Placebo to Prevent Pain in a Paced Walk
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis
    

Detailed description: 
      This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib
      to placebo measuring the time to onset of acute pain in a paced 20-minute walk.

      40 subjects will be enrolled
    

Intervention name(s): celecoxib
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pain; osteoarthritis
Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
Condition: Obesity; Lifestyle, Healthy; Community Based Programs; Primary Care Referrals
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purposes of this study is to evaluate the feasibility of providing a community based
      referral to Mayo Clinic Employee and Community Health patients for weight loss.
    


Intervention name(s): Referral to weight loss program
Intervention type(s): Behavioral
Intervention description(s): 16 weeks Diabetes Prevention Program based weight loss program at a local community partner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Microwave and Radiofrequency Ablation for Liver
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      According to randomized controlled trial requirement, the therapeutic effectiveness of
      cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular
      carcinoma is compared to find a better approach for minimally invasive thermal ablation.
    

Detailed description: 
      According to following enrollment standard, about >400 cases of biopsy-proved hepatocellular
      carcinoma(HCC) patients will be involved in the study. They will be treated with
      percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of
      patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3,
      Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile
      duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is
      selected for the patient according to the sequence of their visit to the hospital based on
      randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic
      effectiveness will be compared between two modalities.
    

Intervention name(s): microwave ablation; radiofrequency ablation
Intervention type(s): Device; Device
Intervention description(s): ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients; ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microwave; radiofrequency; ablation
Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced
      mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of
      social situations, and the Buddhist practice of self-compassion aimed at reducing harsh
      judgment and self-criticism that is characteristic of people with social anxiety disorder.
    

Detailed description: 
      The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an
      enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following
      components: training in classical mindfulness, including concentration and insight
      (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim
      of the study is to evaluate the effects of the mindfulness intervention on biological markers
      of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a
      two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD
      delivered in a group format versus a wait-list control (WLC).
    

Intervention name(s): Mindfulness Meditation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Community Sample
Effect of Dapagliflozin on Glycemic Variability
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when
      added to insulin therapy. The primary objective of this study is to assess the effect of
      dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type
      2 diabetic patients with inadequate glycemic control on insulin.
    

Detailed description: 
      This study is a multicenter, randomized, double-blind, placebo-controlled phase 4 study to
      evaluate whether treatment with dapagliflozin add-on to insulin reduces glucose variability
      in type 2 Diabetes Mellitus. The study will recruit type 2 Diabetes Mellitus patients with
      inadequate glucose control on insulin treatment with or without metformin or sulphonylurea.
      It is estimated that 90 type 2 diabetic patients will be enrolled. After randomization, a
      total 12 week treatment of dapagliflozin or matching placebo will be administered. Before and
      after treatment, tests for efficacy and safety outcomes will be performed.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dapagliflozin; glucose variability
Effect of the Consumption of a Fermented Dairy Drink on the Immune Function
Condition: Healthy Free-living Elderly
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the regular consumption of the active
      product enhances the immune function, in comparison to the control product.
    


Intervention name(s): 1-Fermented Dairy Product (test); 2-Milk-based non-fermented dairy product (control)
Intervention type(s): Other; Other
Intervention description(s): 1 = Intervention 1 (test product); 2 = Intervention 2 (control product)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Probiotic - dairy product - influenza vaccination - healthy elderly
Social and Emotional Brain Function in Cannabis Users
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and
      how social and emotional brain function are altered in dependent cannabis users relative to
      healthy non-using control subjects after a 28 supervised abstinence period. Previous research
      in cannabis users has predominantly focused on cognitive functions. Moreover, studies have
      implicated that observed deficits in cannabis users may regenerate after a prolonged
      abstinence period. Findings might provide important information with respect to relapse
      vulnerability.
    


Intervention name(s): fMRI
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cannabis dependent individuals
      
Keywords: addiction; cannabis; fMRI
Measuring Cortisol Levels in Persons With Parkinson's (PD)
Condition: Parkinson Disease; Huntington Disease
MeSH terms: Parkinson Disease; Huntington Disease
Study type: Observational

Summary: 
      The objective of this study is to evaluate the cortisol awakening response with persons with
      Parkinsons Disease (PD), Huntingtons Disease (HD), and controls. These data are desired so
      experience can be gained with measuring stress levels subjectively and objectively in persons
      with PD, HD, and controls.
    

Detailed description: 
      Telephone consent will be obtained.

      Participants will collect saliva at twelve time points - four times a day for three days.

      Visits will be conducted virtually (over the internet).

      The virtual visit is to assess Parkinson's or Huntington's disease status, stress, mood, and
      quality of life.
    

Intervention name(s): No Intervention - Observational Study
Intervention type(s): Other
Intervention description(s): No Intervention - Observational Study
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators plan to enroll seven groups: (1) person with PD and moderate levels of
        self-reported stress, (2) persons with PD and low levels of self-reported stress, (3)
        controls and moderate levels of self-reported stress, (4) controls and low levels of
        self-reported stress, (5) persons with HD and moderate/high levels of self-reported stress,
        and (6) persons with HD a low levels of self-reported stress, and (7) those that completed
        the study prior to COVID-19 restrictions in March of 2020.
      
Keywords: Movement disorders; Metabolic Stress; Basal Ganglia Disorders
Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I trial investigating the safety of using thioridazine in addition to
      cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.
    


Intervention name(s): Thioridazine
Intervention type(s): Drug
Intervention MeSH terms: Thioridazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Thioridazine; Phase I; Clinical Trial
The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability
Condition: Healthy
Study type: Interventional

Summary: 
      An altered permeability has been proposed to play an important role in the pathogenesis of
      several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel
      disease. Nutrients derived from food are able to influence the permeability of the intestine
      and can therefore also affect gastrointestinal symptoms. In this study, the investigators
      will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot
      peppers and cinnamon, respectively, on gastrointestinal physiology.

      Objective:

      To obtain more information about the effects of capsaicin and cinnamaldehyde on the
      intestine, these substances will be infused directly in the duodenum. Hereafter, the
      permeability of the intestine, gallbladder motility and the effects on satiety will be
      assessed.

      Hypothesis:

      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial
      barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin
      from enterochromaffin cells as determined by the multi sugar permeability test
    


Intervention name(s): Capsaicin; Cinnamaldehyde; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1.5 mg capsaicin administered intraduodenally; 70 mg per intervention administered intraduodenally; Physiological saline
Intervention MeSH terms: Cinnamaldehyde; Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: capsaicin; cinnamaldehyde
Effect of Milk Ingredients on Glucose Regulation and Inflammation
Condition: Glucose Regulation; Low-grade Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Background: Recent advances in science have established a fundamental role for low grade
      chronic inflammation in mediating all stages of most of the non-communicable diseases
      associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy
      and its components are known to exert beneficial effects on postprandial hyperglycemia. This
      study investigates if dairy, normal and enriched, can reduce chronic inflammation via
      improvement in glucose regulation.

      Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose
      regulation and postprandial inflammation with the effect of a standard milk drink, within a
      population of overweight, apparently healthy subjects.

      Study design: The study is designed as a double-blind randomized placebo-controlled parallel
      trial during 7 weeks, during which the test and reference products will be consumed at home.

      Main study parameters/endpoints: The difference in absolute change in fasting blood plasma
      concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in
      postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the
      treatment period, between subjects consuming the test and reference product.
    


Intervention name(s): nutrient-enriched milk; regular milk
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dairy; glucose; inflammation
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide
      (NO) production. Both are associated with poor outcome. This study will examine the safety
      and effect of escalating doses of arginine in falciparum malaria. It will determine whether
      arginine can increase NO production and have an effect on NO-dependent physiological
      measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will
      return plasma arginine concentration to normal/supranormal levels; will increase systemic and
      exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological
      measures of relevance to malaria.
    


Intervention name(s): intravenous (IV) arginine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: falciparum; malaria; arginine
Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs
Condition: Covid19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been
      recommended to detect the virus. This procedure has been reported to be painful by 85% of
      children The aim of the study was to assess whether pretreatment with topical lidocaine
      reduces the discomfort experienced by children during a nasopharyngeal swab.

      This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was
      pain intensity as measured by the Visual Analog Scale .
    


Intervention name(s): Xylocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle; The control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery
Other intervention name(s): Xylocaine spray
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment