bioihbjkbjnl/mcl2 huggingface dataset:
Xanthohumol and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN).
      Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found
      in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids
      such as triglycerides, which can contribute to heart disease. The purpose of this study is to
      see how much of the XN is absorbed into the blood and how fast it leaves the body when taken
      by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if
      xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.
    


Intervention name(s): Xanthohumol
Intervention type(s): Dietary Supplement
Intervention description(s): PK study with one capsule of one of the three doses randomly assigned
Intervention MeSH terms: Xanthohumol
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women in the Portland, Oregon area
      
Keywords: Xanthohumol; Metabolic syndrome
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
Condition: Schizophrenia; Schizoaffective
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning
      and quality of life. Although insomnia is most often treated with medication, a growing
      number of studies have demonstrated the efficiency of a variety of relaxation techniques,
      cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the
      oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims
      to restore and maintain health through the stimulation of specific points on the body.
      Previous studies have demonstrated that acupuncture has a positive influence on a number of
      diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the
      aim of the present study is to examine the effects of acupuncture as a treatment for insomnia
      in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period,
      followes by an 8-week experimental period. During the experimental period, subjects receive
      acupuncture treatments twice a week. During the first week of the study (no-treatment period)
      and the last week of the experimental period, subjects' sleep is monitored with a wrist
      actigraph, and subjects complete a wide spectrum of questionnaires.
    


Intervention name(s): acupuncture
Intervention type(s): Device
Intervention description(s): 16 sessions of acupuncture treatment, twice a week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acupuncture; schizophrenia; insomnia
Pain Management and Safe Opioid Use
Condition: Opioid Use
Study type: Observational

Summary: 
      The purpose of this study is to examine what patients currently know about opioids, including
      their role in pain management, side effects, risks of abuse, and proper storage and disposal.
      It is critical for patients to be properly informed about opioid usage in treating
      postoperative pain, but current gaps in patient knowledge are not well understood.

      This study will help identify knowledge deficiencies and guide future patient education.
      Additionally, this study will examine possible patient factors that may be associated with
      these gaps. Evaluation of patient knowledge will be assessed through interviews conducted
      before patients' day of surgery.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing primary total hip replacement surgery.
Enhancing the Outcome of Skills Training for People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will determine the effectiveness of skills training in people with schizophrenia
      and the applicability of the acquired skills in the "real world."
    

Detailed description: 
      People with schizophrenia have a large number of social and symptom management training
      programs available to them. Studies suggest that these training programs are effective, but
      their generalizability and effectiveness in outpatient settings has not been thoroughly
      examined. This study will examine the treatment outcomes of a skills training approach in
      schizophrenic individuals taking antipsychotic medication.

      Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly
      assigned to receive either intensive symptom management and social skills training or group
      therapy for 12 months. A verbal memory test will be used to stratify the randomization
      procedure and to control for neurocognitive functioning.
    

Intervention name(s): Social skills and symptom management training
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotic Disorders
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Relapsed/Refractory Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of
      cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML.

      Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response
      rate, response duration, event-free survival (EFS) and overall survival (OS).

      Determine the number of transplant-eligible subjects who are successfully bridged to stem
      cell transplantation or donor lymphocyte infusion.
    

Detailed description: 
      This is an open label phase 1 study of fixed dose ATO (Arsenic Trioxide) and escalating doses
      of cyclophosphamide using a standard 3+3 dose escalation design. All subjects will be treated
      with sequential cycles of 3 days of ATO at 0.15 mg/kg/d IV followed by Cyclophosphamide as a
      single IV dose on day 4 along with mesna at a dose equal to the cyclophosphamide (for doses
      ≥1000 mg/m2) and hydration for a maximum of 6 cycles. ATO and Cyclophosphamide will be
      repeated every 28-42 days. Treatment will be given inpatient for the first cycle, with the
      option of outpatient treatment for subsequent cycles. Subjects may remain on study in the
      absence of disease progression or unacceptable toxicity for a maximum six cycles. Toxicity
      assessments will be performed continuously; DLT determination will be made based on adverse
      events (AEs) that occur during cycle 1 (day 1-28). An expansion cohort of ten subjects at the
      maximum tolerated dose will occur at the conclusion of dose escalation.
    

Intervention name(s): Cyclophosphamide
Intervention type(s): Drug
Intervention description(s): ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide on day 4 as a single IV dose along with Mesna (in subjects receiving >1000mg/m2 Cy) and hydration for a maximum of 6 doses in the following dose escalation schema:
Cohort -1 (3-6 subjects, if needed): Cyclophosphamide 500 mg/m2
Cohort 1 (3-6 subjects): Cyclophosphamide 1000 mg/m2
Cohort 2 (3-6 subjects): Cyclophosphamide 2000 mg/m2
Cohort 3 (3-6 subjects): Cyclophosphamide 3000 mg/m2
Cohort 4 (3 subjects): Cyclophosphamide 4000 mg/m2
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Intervention model description: Cohort -1 (3-6 subjects, if needed): Cyclophosphamide 500 mg/m2
Cohort 1 (3-6 subjects): Cyclophosphamide 1000 mg/m2
Cohort 2 (3-6 subjects): Cyclophosphamide 2000 mg/m2
Cohort 3 (3-6 subjects): Cyclophosphamide 3000 mg/m2
Cohort 4 (3 subjects): Cyclophosphamide 4000 mg/m2
ATO and Cyclophosphamide will be repeated every 28 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arsenic Trioxide; Cyclophosphamide
Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284)
Condition: Allergic Airway Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a placebo controlled study designed to evaluate the effectiveness of desloratadine
      in relieving symptoms of allergic airway disease during the pollen season. Patients received
      desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and
      side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping
      study drug).
    


Intervention name(s): Desloratadine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Desloratadine 10 mg daily x 28 days; Placebo daily x 28 days
Other intervention name(s): Clarinex, SCH 034117
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers
Condition: Transplant Rejection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of belatacept on the pharmacokinetics
      of caffeine, losartan, omeprazole, dextromethorphan and midazolam
    


Intervention name(s): Caffeine; Losartan; Omeprazole; Dextromethorphan; Midazolam; Belatacept
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Biological
Other intervention name(s): Nulojix; BMS-224818
Intervention MeSH terms: Abatacept; Losartan; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of LY2484595 on the Electrical Activity of the Heart
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect on the electrical activity of the heart
      as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to
      10 days of placebo in relation to a single dose of moxifloxacin. Information about any side
      effects that occur will also be collected.
    


Intervention name(s): LY2484595; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally once daily for 10 days.; Administered orally once daily for 10 days.; Single dose administered orally.
Intervention MeSH terms: Moxifloxacin; Evacetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Alcohol Consumption on Central Adiposity
Condition: Alcohol Drinking; Weight Loss; Adiposity; Obesity; Visceral Obesity
MeSH terms: Obesity; Obesity, Abdominal; Weight Loss; Alcohol Drinking
Study type: Interventional

Summary: 
      The objective of the proposed study is to enroll women with obesity that will undergo a
      controlled, energy restricted feeding intervention to test the effects of chronic ethanol
      consumption on adipose distribution and circulating testosterone during weight loss.
    

Detailed description: 
      Alcohol (i.e. ethanol) is one of the most widely used recreational substances by humans and
      is consumed regularly by much of the U.S. population. Despite the high prevalence of alcohol
      intake, the metabolic health effects associated with use have not been firmly established.
      There is a paucity of data from longitudinal studies in humans that examine the metabolic
      response to routine alcohol consumption in a randomized controlled trial (RCT).

      This is a novel pilot study to examine, for the first time, the effects of ethanol
      consumption on fat distribution and testosterone during weight loss in a RCT. Findings from
      this study would provide insight into an interesting and unanswered question -- does routine
      alcohol intake exert unfavorable health effects despite the expected beneficial outcomes of
      caloric restriction and weight loss? This research may provide new knowledge of the metabolic
      outcomes resulting from alcohol intake and pathways that may be involved leading to potential
      new therapeutic targets of treatment.

      The objective of the proposed study is to enroll women with obesity that will undergo a
      controlled, energy restricted feeding intervention to test the effects of chronic ethanol
      consumption on adipose distribution and circulating testosterone during weight loss. Women
      will be randomized to an ethanol-free control group or an ethanol-consuming group, and all
      will consume 30% energy-restricted diets.
    

Intervention name(s): Alcohol; No Alcohol
Intervention type(s): Other; Other
Intervention description(s): The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.; This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
Other intervention name(s): Etoh; No Etoh
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a between-subjects parallel study design. All women will undergo a 30% energy restriction for 8-weeks and will be randomized to an ethanol-consuming group or a non-ethanol control group at the start of the study.
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
Condition: Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Cataract is a leading cause of blindness in the world. Cataract surgery is one of the most
      commonly performed ocular procedures. We aim to compare the newer generation biometry
      formula; the Kane formula with the commonly used SRK-T formula for intraocular power
      calculation in uneventful phacoemulsification surgery to assess the post-operative refractive
      outcomes at one month post-surgery.
    

Detailed description: 
      Purpose: To compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical
      (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients
      Study Design: Prospective, interventional study Place and Duration of Study: Department of
      Ophthalmology, Fauji Foundation Hospital, Rawalpindi Material and Methods: A total of a 70
      eyes, 35 in each group will be included in our study. The patients will be randomly divided
      into two groups. In cases of bilateral cataract, one eye will be included in each group for
      better control. IOL power calculation in Group A will be done with the SRK-T formula and in
      group 2 with the Kane Formula. Autokeratometry and A-scan ultrasound will be done for
      biometry. Inclusion criteria will be uncomplicated cataract in both genders. Exclusion
      criteria will be ocular trauma, uveitis, previous intraocular surgery, or any retinopathy.
      All patients will undergo phacoemulsification with foldable lens implantation by two
      experienced surgeons. Post-operative refractive outcome will be evaluated at one month after
      surgery. The two groups will be compared.

      Results: The results will be calculated by SPSS. Conclusion: A conclusion will be drawn on
      the basis of our results.
    

Intervention name(s): Biometry with Kane formula; Biometry with SRK-T formula
Intervention type(s): Other; Other
Intervention description(s): Kane formulae for intraocular lens (IOL) power calculation in cataract patients; Sanders Retzlaff Kraff theoretical (SRK T) formulae for intraocular lens (IOL) power calculation in cataract patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, interventional study
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Condition: Stroke; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether the combination of bihemispheric ("dual")
      transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days
      facilitates motor recovery in chronic stroke. Results will be compared to a matched group of
      patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional
      and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3
      month follow-up will help investigating neural correlates of expected changes in motor
      function of the affected upper extremity.
    


Intervention name(s): tDCS; Motor training
Intervention type(s): Device; Behavioral
Intervention description(s): transcranial direct current stimulation (tDCS); Motor training of the affected upper extremity (5 days, 25 min/day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Hemiparesis; tDCS; Motor cortex
Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a
      subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who
      were enrolled in study NCT01998841 (GN28352). Participants will receive up to three
      intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and will undergo a tau
      positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of
      this substudy is to increase the understanding of disease progression in the preclinical
      stage of familial Alzheimer's Disease (AD).
    


Intervention name(s): Crenezumab; Placebo; [^18F]GTP1
Intervention type(s): Drug; Drug; Other
Intervention description(s): Crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.; Placebo matched to crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.; IV [^18F]GTP1 will be administered up to three times. The first primary [^18F]GTP1 tau PET scan will occur during any visit in the main protocol NCT01998841 (GN28352) from Week 130 to Week 224 and the second [^18F]GTP1 tau PET scan from Week 248 to Week 260. The third and optional [^18F]GTP1 tau PET scan will supplement the two primary scans.
Other intervention name(s): MABT5102A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults
Condition: Health Behavior; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Previous studies suggest self-regulatory techniques including self-monitoring, and SMS
      text-messaging as an intervention modality, can modify health behaviors including physical
      activity (PA). The primary purpose of this study was to examine change in objectively
      measured PA in a randomized controlled pilot trial that tested a wearable sensor/device
      (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in
      overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One
      and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided
      to facilitate self-monitoring with a wearable tracker for instant feedback and website of
      daily PA summaries. Outcome measures were number of steps and minutes of PA by
      intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week
      follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that
      text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA
      compared to only the Fitbit One at 6-week follow-up.
    


Intervention name(s): SMS Text Messages & Fitbit One; Fitbit One Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One.; Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
Other intervention name(s): Fitbit One; SMS text-messaging; SMS text-messages; wearable sensor; wearable device; text message reminders; text message prompts; Actigraph GT3X+; self-monitoring; self-regulation; physical activity; website; tracker; mobile application; mobile app; MVPA; fairly active minutes; very active minutes; Fitbit One; wearable sensor; wearable device; text message reminders; text message prompts; Actigraph GT3X+; self-monitoring; self-regulation; physical activity; website; tracker; mobile application; mobile app; MVPA; fairly active minutes; very active minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Fitbit One; wearable sensor; wearable device; web-based intervention; SMS text messages; randomized controlled trial; physical activity; behavioral intervention; text message prompts; text messaging; technology; exercise