bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
Condition: Insulin Resistance
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the efficacy of triflusal in the attenuation of insulin resistance in human
      obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic
      agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced
      insulin resistance by triflusal.
    

Detailed description: 
      Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal,
      placebo-controlled.

      Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days
      placebo, 15 days

      Washout period: 30 days
    

Intervention name(s): Triflusal (DCI)
Intervention type(s): Drug
Intervention MeSH terms: Triflusal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: insulin resistance and inflamation; insulin sensitibity; obesity-induced insuline resistence; obesity-diabetes link; salicylate; insulin resistance in obesity health adults
Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      To conduct a prospective, randomized trial to compare the efficacy of a group
      mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive
      behavior group therapy (CBGT).
    

Detailed description: 
      The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to
      CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self,
      esteem, disability and quality of life. A secondary aim is to examine whether treatment gains
      are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if
      the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if
      changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and
      3) explore moderators of treatment response.
    

Intervention name(s): Mindfulness-based Intervention; Cognitive Behavior Group Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.; Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
Other intervention name(s): CBGT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Condition: Osteoarthritis of the Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to compare the short term effectiveness and return to function
      of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on
      the front part of the hip joint) versus Posterior Approach (incision over back part of the
      hip joint).
    

Detailed description: 
      The anterior approach may provide better early post-operative outcomes because there are
      fewer muscles at the front of the hip so the surgeon works between them rather than cutting
      through muscle fibers. However, the anterior approach is more difficult to access so usually
      requires a specialized table.

      The posterior approach is easier to access, but the incision cuts through muscle fiber. This
      may lengthen recovery time. However, a specialized table, which can be quite expensive, is
      often not required.
    

Intervention name(s): Anterior Approach / Posterior Approach; Anterior versus Posterior Approach for total hip replacement
Intervention type(s): Procedure; Procedure
Intervention description(s): compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach; Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anterior Approach; Posterior Approach
Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the bioavailability of two formulations
      (tablets and granules for dispersion) of the antimalarial drug pyronaridine-artesunate [3:1]
      (Pyramax, PA) in healthy adults. The secondary objective is to compare the safety of the two
      PA formulations and liver function test changes following the first and second
      administrations.
    

Detailed description: 
      This is a Phase I, single centre, open-label, randomised, two-way cross-over study in healthy
      volunteers to compare the bioavailability of two formulations of pyronaridine-artesunate, in
      tablet and in granule formulation. The study population will include 60 healthy volunteers,
      comprising male and female adults aged 20 to 45 years inclusive.

      The volunteers will be randomised equally on Day -1 to one of two sequences: Sequence 1
      (tablets in Period 1, granules in Period 2), or Sequence 2 (granules in Period 1, tablets in
      Period 2). The periods will be separated by a 60-day wash-out period. Each of the two
      pyronaridine-artesunate formulations will be administered as a single dose of either 180:60
      mg pyronaridine-artesunate tablets (3 tablets) or 60:20 mg pyronaridine-artesunate granules
      (9 sachets). The total dose of each formulation administered is 540:180 mg
      pyronaridine-artesunate.

      The study duration from the first study drug administration (Day 1) through to the last
      follow-up will be approximately 103 days. Screening is to be performed within 28 days before
      Day 1. Adverse events will be monitored throughout the study (and to resolution if necessary)
      to assess the general safety and tolerability of the treatments.
    

Intervention name(s): Pyronaridine-artesunate granules; Pyronaridine-artesunate tablets
Intervention type(s): Drug; Drug
Other intervention name(s): Pyramax granules; PA granules; Pyramax tablets; PA tablets
Intervention MeSH terms: Artesunate; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pyronaridine artesunate tablet; Pyronaridine artesunate granules; Pyramax tablet; Pyramax granules; Bioavailability; artemisinin based combination therapy (ACT)
Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students
Condition: Healthy
Study type: Interventional

Summary: 
      Available literature suggests that flavanols-rich foods, and more especially monomeric
      flavanols-rich foods such as grape, can have an acute effect on cognitive functions via
      different mechanisms such as cerebral blood flow improvement.

      The objective of this study is to investigate the effect of a Standardized botanical blend
      rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in
      healthy students. Moreover, in order to provide supportive evidence on the mechanisms and
      biological plausibility to the clinical effects of the product, appropriate biological
      parameters and circulating metabolites will be assayed.

      The study design will be a double-blind, randomised, placebo controlled, crossover study. A
      total of 30 healthy volunteers will be included. Each participant will receive a single dose
      of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced
      order. There will be a 1 week washout period between the 2 experimental visits. During each
      experimental visit, after a training battery volunteers will be administered a cognitive test
      battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90
      min post-dose to 160 min post-dose).
    


Intervention name(s): SBRP; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): SBRP capsules; Placebo capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Students, cognitive functions, memory
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
Condition: Lung Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the bioequivalency of two preparations of
      ensartinib capsules in Chinese healthy volunteers.
    

Detailed description: 
      The main objective of this study is to evaluate the bioequivalency of two preparations of
      ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In
      addition, the safety of single dose administration of ensartinib capsules in Chinese healthy
      volunteers will also be evaluated.
    

Intervention name(s): ensartinib capsules (test product); ensartinib capsules (reference product)
Intervention type(s): Drug; Drug
Intervention description(s): Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals; Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Other intervention name(s): X-396 capsules; X-396 capsules
Intervention MeSH terms: Ensartinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Face of Sleepiness
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Observational

Summary: 
      The purpose of this pilot study is to find out whether successful treatment of obstructive
      sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles
      under the eyes. In addition, this study will help determine whether facial photographs may be
      used to help identify patients who should be tested for sleep apnea and daytime sleepiness.
    

Detailed description: 
      The main symptom of nocturnal sleep disorders is often excessive daytime sleepiness. Although
      sleepiness can be a major contributor to decreased quality of life, and even mortality,
      patients frequently grow habituated to their sleepiness, ignoring it and any underlying
      disorder. One scarcely explored potential consequence that could motivate patients to address
      sleep disorders is a sleepy facial appearance. No peer-reviewed literature, to our knowledge,
      has explored whether inadequate or insufficient sleep actually causes changes facial
      appearance. No published literature has examined the extent to which treatment for sleep
      disorders might improve such facial changes, and perhaps motivate patients to treat their
      sleep disorders.

      To address these questions in a preliminary manner, therefore, the investigators propose to
      use cutting-edge photographic technology to assess subtle changes in facial appearance. The
      investigators will recruit 20 sleepy adult patients who are diagnosed with obstructive sleep
      apnea, an ideal disease model in which subjects can be tested before and after alleviation of
      severe sleepiness by home use of continuous positive airway pressure. Results of this pilot
      study could show for the first time that successful treatment of a chronic sleep disorder
      improves facial features commonly perceived as an undesirable sign of sleepiness.
    

Intervention name(s): CPAP or BiPAP machines
Intervention type(s): Device
Intervention description(s): Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        University of Michigan Sleep Disorders Clinic
      
Keywords: sleep apnea; sleep disordered breathing; CPAP; BiPAP; treatment outcomes
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Condition: Blood Pressure; Prehypertension; Uric Acid
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      This study was a randomized controlled trial study. The aim of this study was to determine
      the effect of soursop fruit supplementation on blood pressure (BP), serum uric acid (SUA),
      and kidney function.

      The definition of prehypertension and hypertension was accepted as delivered in The Seventh
      Report of the Joint National Committee (JNC 7) as the systolic BP was 120 - 139 mmHg and
      diastolic BP was 80 - 89 mmHg for prehypertension, while systolic BP ≥ 140 mmHg or diastolic
      BP ≥ 90 mmHg for hypertension.

      Based on the study by Sja'bani (2014), the cut-off point of (SUA) was divided into 3
      categories, which are normal (< 5 mg/dL), high-normal (5 - <7 mg/dL), and high (≥ 7 mg/dL).

      A number of 143 people with essential prehypertension and high normal uric acid level were
      assigned as subject in this study. Subjects were randomly assigned into two groups which are
      treatment and control group. For a 3 months period, the treatment group was given 2x100 g
      soursop fruit juice per day and the control group was left without treatment.

      Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood
      pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home.
      Subjects were examined in sitting position. Evaluation of laboratory examination was taken at
      week 0, 7 and 13.
    


Intervention name(s): Soursop supplementation; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.; Control group (without soursop group) was left without treatment during study period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: soursop; supplementation; prehypertension; uric acid; randomized controlled trial
The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Condition: Headache
MeSH terms: Inflammation; Headache
Study type: Interventional

Summary: 
      Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects
      on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac
      assessed by magnetic resonance imaging (MRI) on healthy volunteers.
    

Detailed description: 
      The purpose of this research project is to investigate the importance of blood vessel
      (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered
      by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac
      (NSAID). In addition, we will investigate headache-related changes in the brain's network
      connectivity.
    

Intervention name(s): Sumatriptan; Ketorolac
Intervention type(s): Other; Other
Intervention description(s): Receive intravenous infusion of sumatriptan; Receive intravenous infusion of ketorolac
Intervention MeSH terms: Ketorolac; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed as a single-centre, randomized, controlled clinical trial to
      evaluate and compare the clinical efficacy of two local drug delivery systems containing 1%
      ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic
      periodontitis as an adjunct to SRP.
    

Detailed description: 
      Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption
      and were proposed to have osteostimulative properties by causing osteoblast differentiation
      in vivo and in vitro as shown by an increase in matrix formation. The aim of the present
      study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug
      delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony
      defects in patients with chronic periodontitis.

      Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo
      gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD],
      and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months.
      Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was
      calculated on standardized radiographs by using image analysis software at 6 and 9 months.
    

Intervention name(s): SRP and Placebo gel; SRP and Atorvastatin; SRP and Alendronate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After SRP, placebo gel was delivered subgingivally into the pocket; After SRP, Atorvastatin gel was delivered subgingivally into the pocket; After SRP, Alendronate gel was delivered subgingivally into the pocket
Intervention MeSH terms: Alendronate; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Connect for Health Pediatric Weight Management Program
Condition: Overweight and Obesity; Severe Obesity
MeSH terms: Obesity; Overweight; Obesity, Morbid
Study type: Interventional

Summary: 
      The overall aim of this study is to disseminate the evidence-based Connect for Health
      program, specifically targeting pediatric primary care practices that deliver care to
      low-income children in the US who have a disproportionately high prevalence of childhood
      obesity and evaluate the effectiveness of the program implementation and dissemination.
    


Intervention name(s): Connect for Health
Intervention type(s): Behavioral
Intervention description(s): The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.
Intervention model: Single Group Assignment
Intervention model description: The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Overweight; Obesity; Pediatric; Implementation; Dissemination
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed research will determine the effectiveness of curcumin for improving the health
      and function of arteries in children and young adults with autosomal dominant polycystic
      kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery
      health by determining the physiological mechanisms (biological reasons) involved and offer
      exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these
      measurements in children and young adults who are randomized to receive either curcumin or
      placebo for 1 year.
    

Detailed description: 
      Although often considered to be a disease of adults, complications of autosomal dominant
      polycystic kidney disease (ADPKD) begin in childhood. While ADPKD causes the continued growth
      of multiple kidney cysts that ultimately result in loss of kidney function, the leading cause
      of death among patients with ADPKD is cardiovascular disease. Treatment options to prevent
      cardiovascular disease in adults with ADPKD are limited, thus childhood may be an important
      time to reduce risk. Curcumin is a safe, naturally occurring substance found in the Indian
      spice tumeric, which is in curry powder. The proposed research will determine the
      effectiveness of curcumin for improving the health and function of arteries in children and
      young adults with ADPKD. The study also will provide insight into how curcumin improves
      artery health by determining the physiological mechanisms (biological reasons) involved and
      offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing
      these measurements in children and young adults who are randomized to receive either curcumin
      or placebo for 1 year.
    

Intervention name(s): Curcumin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dietary Supplement
Other intervention name(s): Longvida
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment