bioihbjkbjnl/mcl2 huggingface dataset:
Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The overall goal of this proposed project is to 1) increase co-management between sickle cell
      specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which
      prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3)
      identify and link patients not receiving primary or SCD specialty care to care, and 4) shift
      healthcare use from EDs and hospitalizations to primary and specialty co-management. Many
      persons with SCD experience a poor quality of life, serious medical complications and
      frequent painful events that require treatment from SCD specialty care, primary care and
      emergency department (ED) providers. There are two dominating models of care in the United
      States; neither are ideal. Many people with SCD have all of their healthcare needs addressed
      by sickle cell specialists who do not typically provide primary care and are often
      geographically distant from the patients' home. Other sickle cell patients receive all of
      their care in EDs. Both models are inadequate and result in an alarmingly high number of ED
      visits for many patients. Current care models are neither cost efficient nor promoting
      optimal patient outcomes. To improve outcomes, the investigators will implement a new model
      of care for SCD using nurse care managers, web based-interactive algorithms, and test if
      additional patient provided coaching can improve outcomes.
    

Detailed description: 
      To inform the model, the investigators will conduct an initial in-depth multi-level
      assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management
      of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider,
      healthcare organization and community levels, the investigators will develop another study
      evaluation interventions that may improve the barriers.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds
        with SCD and healthcare providers of patients with SCD residing in 31 specified counties in
        Central North Carolina.
      
Keywords: Sickle Cell Disease; Needs Assessment; Barriers to care; Access to care; Primary care
Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine if insulin resistance (how well the body uses
      insulin and clears sugar) can affect cortisol levels in normal healthy women and women with
      polycystic ovary syndrome of all body weights.
    

Detailed description: 
      PCOS is a common clinical problem affecting young women, characterized by oligomenorrhea and
      hyperandrogenism. Central obesity and insulin resistance are also prominent features of PCOS,
      and in addition are important risk factors for development of hypertension, hyperlipidemia
      and atherosclerotic heart disease. Previous studies have suggested that cortisol is
      dysregulated in PCOS, primarily through increased hypothalamic-pituitary-adrenal (HPA) axis
      activity and enhanced cortisol secretion. Increased adrenocorticotropic hormone (ACTH)
      secretion could also potentially lead to elevated adrenal androgen production in PCOS.
      Techniques used in previous studies have been inconsistent, however, and a link between
      increased HPA axis activity and the phenotypic changes in PCOS has not been clearly
      demonstrated. Cortisol is also produced from cortisone in peripheral adipose tissue by the
      enzyme 11beta-hydroxysteroid dehydrogenase type 1 (HSD 1), suggesting another potential point
      of dysregulation that may contribute to central obesity and insulin resistance in PCOS.
      Further investigation of both central and peripheral regulation of cortisol is necessary to
      better understand the pathophysiology of PCOS.

      Specific Aim 1: To perform a cross-sectional study of women with PCOS and normal controls
      matched for age and body mass index, and measure insulin sensitivity and visceral fat, as
      well as (a) 24-hour CPR, ACTH, free cortisol, and cortisol binding globulin (CBG), (b)
      adipocyte, liver, and whole body HSD 1 activity, and (c) androgen levels.

      Specific Aim 2: To prospectively administer pioglitazone or metformin to women with PCOS in a
      placebo-controlled trial, and after one month and six months of therapy measure (a) 24-hour
      CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and
      (c) insulin sensitivity, visceral fat, and androgen levels.
    

Intervention name(s): pioglitazone; metformin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg for 2 weeks, then 45 mg daily; 500mg twice daily for 1 week, then 1000 mg twice daily; capsule twice daily
Other intervention name(s): Actos; Glucophage; Glucophage XR
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polycystic ovary syndrome; insulin; PCOS; cortisol regulation; regulation
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Condition: Anemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with end stage renal disease
      undergoing chronic hemodialysis.
    


Intervention name(s): AKB-6548; AKB-6548; AKB-6548
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Intervention MeSH terms: Glycine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia; end stage renal disease; chronic kidney disease; CKD; dialysis; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor propyl-hydroxylase inhibitor; HIF-PHI; pharmacokinetics
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia
      patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital
      therapeutics.
    

Detailed description: 
      This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were
      randomized into the following groups:

        -  WELT-IP group: WELT-IP (insomnia digital therapeutics) use

        -  Control group: sham app use Subjects in both groups continued to receive their
           clinician-directed standard-of-care treatment for insomnia, if applicable, including
           pharmacotherapy. Subjects were randomized and in WELT-IP group used WELT-IP and subjects
           in control group used a sham for a period of 6 weeks.
    

Intervention name(s): WELT-IP; Sham
Intervention type(s): Device; Device
Intervention description(s): WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot.; Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blinded design, with seven points of measurement. The subjects will receive either the WELT-IP app or sham app.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: digital therapeutics
Prophylactic Treatment of Episodic Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether candesartan cilexetil are effective
      prophylactic treatment of episodic Cluster headache
    

Detailed description: 
      Cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to
      12 weeks. The pain is usually unbearable. The attacks are treated with injections of
      sumatriptan (migraine medication)and inhalation of oxygen.

      The most common prophylactics today has limited effect and a risk of side effects.

      Candesartan has in one study shown a clinically significant effect in migraine prophylaxis.

      The angiotensin II receptor blocker, candesartan is well tolerated with side-effects not
      significantly different from placebo and with few drug interactions. We therefore wish to
      investigate the prophylactic effect in treatment of cluster in headache patients.

      This will be a multicenter, double-blind, randomized, parallel study where the prophylactic
      effect of candesartan is compared to placebo in a period of 3 weeks. First week 16 mg and the
      following 2 weeks 32 mg.
    

Intervention name(s): candesartan cilexetil; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): angiotensin II receptor blocker
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Angiotensin II; Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: prophylactic; episodic; cluster; candesartan; angiotensin II receptor blocker; randomized placebo controlled parallel study; headache diary
A Study of LY3079514 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and how well the body will handle a
      single dose of study drug, LY3079514. This study will last about 12 weeks for each
      participant.
    


Intervention name(s): LY3079514; LY3079514; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered IV; Administered SC; Administered IV
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Augmentation of Locomotor Adaptation Post-Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This project will evaluate two different methods of normalizing the center of mass
      acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of
      recovery to analyze walking-specific adaptations as precursors to motor learning. In
      addition, the proposed project seeks to establish the optimal configuration of electrodes to
      activate neural circuits involved in post-stroke locomotion. Once the better method of
      training COMa and optimal parameters of electrode placement for tDCS are identified, the
      investigators will evaluate the effects of tDCS on locomotor adaptations during single
      sessions and over a five-day training period.
    

Detailed description: 
      The project seeks to establish the optimal configuration of electrodes to change the
      excitability of neural circuits involved in post-stroke locomotion, identify effective
      strategies for training a specific locomotor adaptation, and improve adaptations via
      adjunctive non-invasive brain stimulation. Tools to improve neural excitability may increase
      potential for locomotor skill learning, thereby improving rehabilitation outcomes.
      Non-invasive brain stimulation with transcranial direct current stimulation (tDCS) has
      recently emerged as a simple to administer, low-cost, and low-risk option for stimulating
      brain tissue. Cortical excitability is increased after application and preliminary results
      imply a relationship to increases in motor activity in those post-stroke. However, inhibition
      of the contralesional hemisphere is also shown to improve paretic motor output through
      inhibition of excessive maladaptive strategies, and combining the two electrode
      configurations may provide additional benefit for locomotor tasks requiring interlimb
      coordination. Furthermore, the effects of tDCS on walking function in conjunction with
      physical intervention strategies aimed at improving locomotor ability post-stroke are yet
      unstudied.
    

Intervention name(s): tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain. Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.; Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current. Evaluating immediate effects during 20 minutes walking on a treadmill.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Stroke ( > 6 months); non-invasive brain stimulation; rehabilitation; walking; kinetics
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the tolerability of 3 treatment regimens containing
      Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5%
      Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The
      efficacy of the four treatment regimens will also be evaluated.
    


Intervention name(s): Adapalene BPO Gel standard daily overnight application; Adapalene-BPO 3-hour daily application before bedtime; Adapalene-BPO Gel every other day application; Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week; Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks; Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks; Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Other intervention name(s): Standard; 3-hour before bedtime; every other day; Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acne
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Participants
Condition: Dose Finding Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438
      following multiple oral doses to healthy adult Japanese male participants
    

Detailed description: 
      The drug being tested in this study is called TAK-438. TAK-438 was being tested to assess
      side effects and how TAK-438 moves throughout the body after multiple doses have been
      administered. This study looked at lab results and side effects in people who took TAK-438.

      The study consisted of 5 steps covering dose ranges of TAK-438 from 10, 15, 20, 30 and 40 mg
      once daily for 7 days. The study population for each step included 12 participants. Within
      each step, 9 participants were randomized to TAK-438 and 3 participants were randomized to
      placebo. A total of 60 participants were enrolled.

      The dosing groups in this study took place in sequential order. Therefore, the TAK-438 15 mg
      group did not start until the TAK-439 10 mg group had completed, etc. All participants in
      each dosing group were asked to take the study drug in the morning, after fasting for at
      least 10 hours, each day throughout the study.

      This single-centre trial was conducted in the Japan. The overall time to participate in this
      study was up to 43 days. Participants made 3 visits to the clinic, including one 11-day
      period of confinement to the clinic, and a final visit 7 days after last dose of study drug
      for a follow-up assessment.
    

Intervention name(s): TAK-438; TAK-438 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-438 tablets; TAK-438 placebo-matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant
      therapy for type 2 Diabetes Mellitus.
    

Detailed description: 
      Background: Cosmos caudatus (C. caudatus) ethanol extract has been reported to have
      extraordinary high antioxidant capacity compared to other plants. Furthermore it has been
      shown to reduce the plasma blood glucose and lipid profile significantly in an animal model.
      However, no study has been reported on its effectiveness in human. Therefore, we plan to
      conduct a randomized controlled trial to evaluate the effectiveness and safety of C. caudatus
      on glycemic status, oxidative stress markers, inflammatory markers, lipid profile in patients
      with type 2 diabetes. Besides, metabolomics approach will be carried out to compare the
      metabolite changes between diabetic C. caudatus treated and control patients.

      Methods: A single-center randomized, controlled, two-arm parallel design clinical trial will
      be carried out in Malaysia. This study enrol 92 patients diagnosed with type 2 diabetes.
      Diabetic patients who meet eligibility criteria will be randomly allocated to two groups,
      which are C. caudatus treatment group and control group. Both groups will be compared on the
      primary and secondary outcomes at baseline, 4, 8, and 12 weeks. The serum and urine
      metabolome of both groups will be examined using proton NMR spectroscopy.

      Discussion: The study will provide insights into the potential beneficial effect of C.
      caudatus in type 2 diabetic patients. In addition, the therapeutic effect of C. caudatus
      towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.
    

Intervention name(s): Cosmos Caudatus
Intervention type(s): Dietary Supplement
Intervention description(s): 15g of Cosmos caudatus consumed with lunch or dinner
Other intervention name(s): Ulam Raja
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Cosmos Caudatus; Ulam Raja; Metabolomic profiling; antioxidant
A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
Condition: Bioavailability of ASP015K; Pharmacokinetics of ASP015K; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative bioavailability and pharmacokinetic
      profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the
      safety and tolerability after a single dose of three different strengths of a new tablet
      formulation.
    

Detailed description: 
      Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each
      subject will receive a single dose of study drug per the defined treatment periods on the
      mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each
      consecutive dose group. Any subject discontinuing the study prior to completion should have
      all end of study evaluations completed.
    

Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; healthy subjects; bioavailability; rheumatoid arthritis; psoriasis; transplantation
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
Condition: Breast Cancer; Mobile Community
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to investigate the effect of the formation of social networks using
      smartphones can help increase physical activity and reduce stress in survivors after breast
      cancer treatment surgery.
    


Intervention name(s): Mobile community; No Mobile community
Intervention type(s): Device; Other
Intervention description(s): Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.; No Mobile community
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast cancer survivors; mobile community; distress