bioihbjkbjnl/mcl2 huggingface dataset:
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
Condition: Healthy
Study type: Interventional

Summary: 
      The objectives of the proposed study are to assess the effect of walnut consumption on
      parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial
      function and blood pressure in healthy men and healthy postmenopausal women
    


Intervention name(s): walnut
Intervention type(s): Dietary Supplement
Intervention description(s): walnut consumption 48 g/d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Utilization of Different Virtual Reality Experiences
Condition: Surgery; Pain, Postoperative; Anxiety; Otolaryngological Disease
MeSH terms: Otorhinolaryngologic Diseases; Pain, Postoperative
Study type: Interventional

Summary: 
      This trial studies differences between a mindfulness and a gaming virtual reality (VR)
      experience as a means for preoperative anxiety management and postoperative pain management
      among patients after head and neck surgery. Investigators will assess differences in anxiety
      scores, pain scores, physiologic measures, and subjective patient experiences.
    

Detailed description: 
      Optimal postoperative pain control after head and neck surgery is vital for recovery, and
      non-pharmacologic strategies to improve pain may help reduce narcotic use. Further,
      preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and
      recovery. In addition to facilitating with postoperative pain control, VR may have a role in
      reducing preoperative anxiety. However, it is unclear whether different VR experiences may be
      more beneficial for different clinical applications.

      This study will evaluate if there are differences in preoperative anxiety and postoperative
      pain when utilizing different VR experiences. Patients undergoing head and neck surgery will
      be randomly allocated preoperatively to first participate in either a mindfulness or active
      gaming VR experience, and then postoperatively will crossover and participate in the other
      experience they did not utilize prior to surgery.
    

Intervention name(s): Oculus Quest: TRIPP; Oculus Quest: Angry Birds
Intervention type(s): Device; Device
Intervention description(s): This is a VR experience that focuses on meditation and mindfulness; This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of the administration of
      Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI),
      behavioral tests and measuring cocaine craving and use among people with active cocaine
      dependence.
    


Intervention name(s): Risperidone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cocaine; dependence; risperidal; MRI
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory
      adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation
      according to recent investigations. Thus, in this study, we sought to demonstrate that the
      treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to
      further evaluate the role of Lgi3 in atherosclerosis.
    

Detailed description: 
      Patients who assigned to the pitavastatin treatment first group will be given the
      pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period
      of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who
      assigned to the life-style modification treatment first group, will be treated with
      life-style modification treatment for 12 weeks after randomization, followed by wash-out
      period of 3 weeks and pitavastatin treatment for 12 weeks.
    

Intervention name(s): Treatment of pitavastatin 4 mg qd for 12 weeks; Life-style modification
Intervention type(s): Drug; Behavioral
Intervention description(s): Treatment of pitavastatin 4 mg qd for 12 weeks; Nutritional support with the meal less than 65% of carbohydrate, less than 30% of fat. Exercise 3-4 times, 30 min
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin, followed by wash-out period and life-style modification treatment. Patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment first, followed by wash-out period and pitavastatin treatment.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dyslipidemia
Equine-assisted Occupational Therapy for Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Children with Autism Spectrum Disorder have difficulty engaging in activities. This study
      examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4
      to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline
      assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.
    

Detailed description: 
      Children with Autism Spectrum Disorder (ASD) have difficulty engaging in activities. Based on
      the literature, the unique features of horses may be beneficial to children with ASD. There
      is limited research supporting the use of horses in occupational therapy interventions. This
      study examined the effects of equine-assisted occupational therapy for 7 children with ASD
      ages 4 to 8 years. A multiple baseline design was used. For each child, there were 9 to 11
      baseline assessments (gross and fine motor play activities), 9 to 12 intervention sessions,
      and 4 follow-up sessions (gross and fine motor play activities). Intervention sessions were
      40 to 60 minutes long and consisted of time spent on the horse and in horse related
      activities. Children were videorecorded in all conditions. Trained coders scored randomly
      selected segments of the video recording. Inter-rater reliability was good.
    

Intervention name(s): Equine assisted occupational therapy
Intervention type(s): Other
Intervention description(s): Intervention was one 40 to 60 minute session per week. Half of the session was spent riding a horse and half was spent doing horse related activities. Children had 9 to 12 sessions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Effects of CBD Products on Anxiety Among U.S. Women
Condition: Anxiety; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The investigators will conduct a retrospective cohort analysis of a consumer trial conducted
      by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and
      involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD)
      products. Participants were randomized to one of 9 groups: 8 groups received one of 8
      different CBD products in the mail, and one group served as the control and did not consume
      any CBD product. The CBD products varied by method of delivery, concentration of
      Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product
      once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.
    

Detailed description: 
      Between October 1-7, 2020, women from across the US were recruited by Rae Wellness to
      participate in a 60-day in-home use test (IHUT) of various Cannabidiol (CBD) products. The
      inclusion criteria were: women; between the ages of 24-44; reported symptoms associated with
      at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low
      libido). Individuals were excluded if they were pregnant or breastfeeding. 1,350 women were
      randomly selected to participate in the study. The participants were randomized to one of 9
      groups in the IHUT (150 in each group): 8 groups received one of 8 different CBD products in
      the mail, and one group served as the control and did not consume any CBD product. The CBD
      products varied by method of delivery (oil or capsule), concentration of Tetrahydrocannabinol
      (THC; less than 0.3% THC or 0% THC), and dosage of CBD (15, 20, 25 and 30 mg). Participants
      were asked to use the product once daily every day for 60 consecutive days, and to complete a
      health questionnaire online on 3 occasions: before initiating the product (baseline), 30 days
      after initiating the product, and 60 days after initiating the product. Those in the control
      group were also asked to complete the health questionnaire at each time point but did not
      receive nor consume any CBD product. The health questionnaire assessed anxiety, physical
      health, digestive health, sleep patterns, general wellness and sexual satisfaction using
      questions drawn from validated health indices.
    

Intervention name(s): Cannabidiol (CBD)- containing consumer products
Intervention type(s): Dietary Supplement
Intervention description(s): Oils or capsules containing CBD which could be purchased commercially within the U.S.
Intervention MeSH terms: Cannabidiol
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1350 women from across the United States
      
Keywords: Cannabidiol; Tetrahydrocannabinol; Anxiety; Women
Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump
      inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the
      hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this
      therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole,
      DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation
      in healthy subjects in oral glucose tolerance (OGTT).
    

Detailed description: 
      Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump
      inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the
      hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this
      therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4
      (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy
      subjects in oral glucose tolerance (OGTT).
    

Intervention name(s): lansoprazole, 30 mg per day for 6 days
Intervention type(s): Drug
Other intervention name(s): Oral glucose tolerance test (OGTT)
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
Condition: HIV Infections
MeSH terms: HIV Infections; Emergencies
Study type: Interventional

Summary: 
      African American (AA) women are more vulnerable to HIV infection than other women. Truvada,
      when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV
      prevention; however, PrEP use among AA women remains low and has not responded to traditional
      interventions. This study proposes for the first time an innovative computer-based
      motivational intervention, increasing PrEP uptake (iPrEP), which couples motivational
      messages woven into a traditional survey to raise awareness of risky sex and substance use
      behaviors.
    


Intervention name(s): iPrEP; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): iPrEP transforms the standard emergency department (ED) visit experience through an intervention presented as a standard assessment that is equipped to: 1) increase knowledge of HIV transmission and 2) provide information on how to reduce an individual's risk for HIV.
Women will receive the iPrEP intervention on an iPAD Air tablet device
iPrEP serves a dual role as a data collection instrument and an intervention--the survey incorporates brief, informational messages into a traditional survey instrument
iPrEP uses qualitative themes
iPrEP is divided into sections addressing factors with historical success at predicting pre-exposure prophylaxis (PrEP) adherence
Scales chosen to measure themes and sections were retained from the original HIV Prevention Trials Network (HPTN) 073 instrument
Scales were modified (in some cases) for cultural competency and tailoring to women; Women will receive usual care
Usual care includes an assessment visit with an emergency department (ED)-assigned social worker who specializes in substance use
Social worker will offer a list of substance abuse treatment referral agencies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: African American women, HIV risk, substance use, sexual risk
Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma
Condition: Rhinitis, Allergic; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Observational

Summary: 
      This is an observational prospective multicenter clinical study, to evaluate the efficacy and
      safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a
      mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation,
      administered in its different available allergenic extracts mixtures (2 pollens or 2 mites),
      and in one of the 2 recommended administration schedules (1 Day or Rapid).
    


Intervention name(s): Allergen Immunotherapy (AIT)
Intervention type(s): Biological
Intervention description(s): Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
Other intervention name(s): Allergovac Poliplus
Intervention MeSH terms: Immunomodulating Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without
        asthma, polisensitized to pollens/mites.
      
Keywords: Allergen immunotherapy (AIT); Rhinitis; Rhinoconjunctivitis; Subcutaneous Immunotherapy (SCIT); Allergovac Poliplus
Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Alzheimer's disease is a medical illness that damages the brain and causes problems with
      memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally
      produced in the body, plays an important role in the normal functioning of the brain. In
      subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are
      three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by
      helping to maintain the level of ACh in the brain. This study will evaluate how much each of
      these drugs changes the levels of certain brain chemicals that are known to, or may play an
      important role in, Alzheimer's disease and its symptoms.
    


Intervention name(s): Rivastigmine
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; memory loss; dementia; senility; forgetful; geriatric; behavior; mood swings
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A
      (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT
      Study) is a randomized, double-blind (with respect to aficamten and matching placebo),
      positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect
      of aficamten administration on QT/QTc interval.
    


Intervention name(s): Aficamten; Aficamten-matching Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet; Oral Tablet
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: CK-3773274; CK-274; Aficamten
Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      No gold standard therapy exists for clearing mucus from the airways of patients with
      bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it
      failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF
      bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF
      bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline
      has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be
      examined as a long term treatment option in bronchiectasis.

      The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with
      inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with
      inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration;
      improvement in quality of life and respiratory symptoms in patients with bronchiectasis and
      pulmonary function in cystic fibrosis. The results of this current study in combination with
      a recently completed 3 month study seek to confirm these early findings and to extend the
      evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

      We hypothesize that mannitol will improve the overall health and hygiene of the lung through
      regular and effective clearing of the mucus load. As a consequence of the reduction in mucus
      load and inflammatory process, the frequency of bronchiectasis related pulmonary
      exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in
      hospital and community health care costs are expected to change in line with improvements in
      respiratory health.

      Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52
      week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against
      control.
    


Intervention name(s): Inhaled mannitol; Matched control
Intervention type(s): Drug; Drug
Intervention description(s): 400mg dose of Mannitol BD (twice a day) for 52 weeks; 50mg dose of Mannitol BD (twice a day) for 52 weeks
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized clinical trial; mannitol; mucoactive
Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Studies of patients with established kidney disease, even when this is mild, appear to show
      that they are at high risk of heart failure, stroke and sudden cardiac death. This may be
      because kidney disease causes stiffening of the arteries in the body which means that the
      heart and brain are damaged by high blood pressure. By studying patients before and after the
      removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for
      the first time in man the effect of an isolated reduction in kidney function on the structure
      and function of the arteries and heart.

      Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is
      associated with long term adverse cardiac and vascular effects which include:

        1. Increased arterial stiffness and left ventricular mass

        2. Abnormalities in left ventricular systolic and diastolic function

        3. Increased oxidative stress, inflammation and collagen turnover
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Renal outpatient clinic
      
Keywords: Chronic kidney disease; left ventricular dysfunction; diastolic dysfunction; hypertension
A Phase 1 Study of S-3304 in Patients With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy
      accessible cancer who have failed previous therapy or to whom no standard therapies are
      available. To determine the pharmacokinetic profile of S-3304 in this patient population
    


Intervention name(s): S-3304
Intervention type(s): Drug
Intervention MeSH terms: S 3304
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neovascularization; matrix metalloproteinases; antiangiogenesis; type IV collagenases