bioihbjkbjnl/mcl2 huggingface dataset:
Brain, Obesity, Dopamine and You Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Central dopamine is thought to play a significant role in obesity. In support of this idea,
      animal studies and one human positron emission tomography (PET) study have found reduced
      postsynaptic D2-like receptor availability in the striatum in obesity, with lower D2 receptor
      availability associated with higher weight. In addition, reward sensitivity and hedonic
      responses, known to be related to dopamine function, have also been implicated in obesity and
      obesity-related eating behavior. These reports have led to the concept that dopaminergic
      abnormalities (e.g. reduced D2-like receptors) influence reward sensitivity, leading to
      altered eating behaviors and eventually obesity. However, there are several critical
      limitations of the human D2 receptor studies that limit the strength of their conclusions and
      thus the interpretations and speculations embedded in literature that relies on this work.
      First, estimates of D2-like receptors in humans have been confounded by potential differences
      in endogenous dopamine release since the PET ligand (raclopride) used is known to be
      displaceable from receptors by endogenous dopamine. Second, failure to rigorously screen
      obese individuals for diabetes confounds conclusions, since diabetes has been independently
      associated with dopaminergic abnormalities such as reduced D2-like receptors and muted
      dopamine release in diabetic rats. Finally, no human studies have addressed whether reduced
      D2-like receptor levels are a risk factor for obesity, a consequence of engaging in
      obesity-related behaviors or being obese or all of the above.
    


Intervention name(s): meal replacements, psychotherapy, dietary education
Intervention type(s): Dietary Supplement
Intervention description(s): After the screening and scan days are completed, obese subjects will begin a lifestyle intervention program that includes dietary (low-calorie diet) and behavioral education topics. Treatment will be provided in individual weekly sessions. Each hour-long session will be led by a behavioral counselor or registered dietitian in the Weight Management Center at Washington University. The behavioral program will use cognitive-behavioral techniques to foster adherence to diet prescriptions and to build a supportive environment for the participant. The program will emphasize strategies of self-monitoring and goal-setting, and will include problem-solving, overcoming high-risk situations for unhealthy eating, relapse prevention, and strategies for long-term weight maintenance. Handouts will be provided for study subjects to allow them to record the setting and reaching of dietary goals, as well as summarize the key points of the educational content.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the clinical efficacy and safety of MRA in a
      double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid
      arthritis (RA) patients with MTX administered.
    


Intervention name(s): MRA(Tocilizumab); MRA placebo; MTX; MTX placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 8mg/kg/4week(i.v.)for 24 weeks; 0mg/kg/4week(i.v.) for 24 weeks; 8mg/week(p.o.) for 24 weeks; 0mg/week(p.o.) for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group
      trial in adults with mild to moderate AD.
    

Detailed description: 
      This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group
      trial in adults with mild to moderate AD. The primary endpoint is the change from the
      baseline CSF Amyloid beta oligomer concentration after dosing with CT1812 versus placebo. The
      change from baseline will be measured through a number of exploratory endpoints as indicated
      below. For each subject, the baseline CSF oligomer concentration will be computed as the
      average of the measurements from hours -4, -3, -2 and -1 and 0.
    

Intervention name(s): CT1812; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Study Drug; Non-active study drug
Other intervention name(s): Study Drug; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease
Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
Condition: Brain Imaging; Functional Dyspepsia; Food
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      In this functional magnetic resonance imaging study, effects of different information of fat
      content of high or low fat will be examined in FD patients and healthy volunteers (n=30,
      respectively). These data will provide a better understanding of symptom generation following
      food ingestion in general as well as in patients with respective functional gastrointestinal
      disorders.
    


Intervention name(s): Yogurt
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects
Condition: Hepatic Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators are doing this study to find out if tucatinib is safe for patients with
      liver problems. This study will look at participants with mild, moderate, and severe liver
      problems. For each participant with liver problems who takes part, a matching healthy
      participant who is of similar age, similar body mass index (BMI), and of the same sex will
      also take part. The study will look at how the drug affects healthy participants compared to
      participants with liver problems.
    

Detailed description: 
      This study is being conducted to provide information to develop dosing recommendations for
      tucatinib in subjects with hepatic impairment. The current study will be carried out in
      subjects with hepatic impairment according to 3 different Child-Pugh (CP) categories (Mild,
      Moderate, and Severe impairment), and in matched-control healthy subjects. The minimum number
      of matched-control healthy subjects will be enrolled in order to ensure that each
      hepatically-impaired subject has a healthy match. Each matched-control healthy subject will
      be enrolled following the enrollment of a Mild and/or Moderate and/or Severe hepatic
      impairment subject and will be matched by age (+/- 10 years), by BMI (+/- 20%), and by sex to
      the enrolled hepatic impairment subject(s). Each healthy subject may be matched with up to 1
      subject within each hepatic impairment group. Based on these criteria, with 3 cohorts of 8
      hepatically-impaired subjects enrolled in the study, the number of healthy control subjects
      required to be enrolled will be at least 8 and not more than 24.
    

Intervention name(s): Tucatinib
Intervention type(s): Drug
Intervention description(s): 300mg oral single dose
Intervention MeSH terms: Tucatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Condition: Partial Epilepsies; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered
      in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with
      partial-onset seizures.
    

Detailed description: 
      This multicenter, open-label trial examined safety and tolerability of rapid initiation of
      adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance
      treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive
      25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400
      mg) administered as a single 15-minute intravenous (iv) loading dose followed by the
      equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose
      12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to
      provide safety data on a total of 50 subjects at the highest well-tolerated dose.
    

Intervention name(s): lacosamide; lacosamide; lacosamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days; Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days; Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
Other intervention name(s): Vimpat; Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; seizures; Lacosamide; Vimpat; intravenous
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of the investigational
      vaccine in the subjects during their participation in the study.
    

Detailed description: 
      MG1109 is purified, inactivated influenza viral antigen.
    

Intervention name(s): MG1109; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Avian influenza
Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study
Condition: Cataracts; Lens Opacities
MeSH terms: Cataract
Study type: Observational

Summary: 
      The purpose of this study is to test the existence of an increased risk of cataracts among
      interventional cardiologists as compared to cardiologists not exposed to X-rays.
    

Detailed description: 
      This cross-sectional study includes cardiologists aged > 40 years: a group of interventional
      cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed
      workers (including cardiologists). Individual information, including risk factors of
      cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For
      the exposed group, a specific section of the questionnaire is focused on the occupational
      history, the description of the procedures (type, frequency, radiation protection tool) and
      will be used for the classification into "comparable exposure level" groups according to
      estimates of cumulative dose. For all participants, eye examinations are performed to
      specifically detect cataracts even in the early stages (lens opacities, LOCS III according to
      the international standard classification).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Interventional and non-interventional cardiologists from public and private French
        hospitals/facilities, both groups of cardiologists being matched for age and gender.
      
Keywords: Radiation cataracts; Lens opacities; X-rays; Interventional Cardiologists; Electrophysiologists
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic
      antagonist propranolol is effective in decreasing gene expression of stress-mediated
      beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic
      stem cell transplant (HCT) for multiple myeloma.
    

Detailed description: 
      This is a randomized controlled pilot study designed to evaluate whether a drug designed to
      block the physiologic effects of stress is effective at blocking stress-related gene
      expression in people receiving autologous stem cell transplants (their own cells) for
      multiple myeloma. Such stress-related gene expression is one way that the body is programmed
      to make specific proteins under conditions of stress. These proteins are believed to
      contribute to worse health outcomes. By using the drug propranolol, we aim to see whether we
      might block these negative health effects of stress as occur in the cancer setting and during
      the transplant process. We hypothesize that individuals taking propranolol will have more
      favorable gene expression.

      We will enroll 40 individuals, randomizing half to receive propranolol and half to serve as
      the control group not on the study drug. Study participants will start propranolol three
      weeks prior to their transplant and continue it until 30 days after the transplant. We will
      explore the effect of socioeconomic status, depression, and anxiety on individuals' gene
      expression response to propranolol with the idea that the more impoverished, anxious, or
      depressed individuals will display an even greater change in their gene expression. Part of
      the purpose of this study is also be to assess whether it is feasible to give this drug to
      individuals with cancer. Results of this study may inform larger trials assessing the effects
      of propranolol on cancer progression.
    

Intervention name(s): Propranolol
Intervention type(s): Drug
Other intervention name(s): Hemangeol, Inderal LA, Inderal XL, InnoPran XL, Inderal
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Recipients
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
Condition: Cytomegalovirus Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional

Summary: 
      This study is designed to determine the influence of food on the absorption and relative
      bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed
      and fasting state at steady state plasma levels.
    


Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Ganciclovir; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Biological Availability
Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
Condition: Chronic Rhinosinusitis; Aspirin Exacerbated Respiratory Disease; Asthma; Aspirin Sensitivity
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Hypersensitivity
Study type: Interventional

Summary: 
      Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and
      nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus
      surgeries and/or aspirin desensitization. However, these treatments have potential adverse
      effects.

      A theory has been postulated that decreasing the level of dietary salicylates may help in
      long-term control of disease. A current trial is in the works to evaluate the clinical
      outcomes of decreased salicylate, but measurements of biochemical markers of disease has not
      yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease
      in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are
      typically elevated in this disease.
    


Intervention name(s): Low salicylate diet; Normal Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants followed a 7 days period under a Low salicylate diet; Participants followed a 7 days period under a Normal Diet
Other intervention name(s): Dietary salicylate
Intervention MeSH terms: Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Rhinosinusitis; Aspirin exacerbated respiratory disease; Asthma; Aspirin sensitivity; Salicylate
Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Condition: Malaria,Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives:

      Primary:

      • To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within
      the standard WRAIR CHMI model as compared to the current lot (historical data)

      Secondary:

        -  To assess safety of the new lot of P falciparum parasites

        -  To assess the kinetics of detecting parasitemia and parasite clearance by quantitative
           polymerase chain reaction (qPCR) as compared to blood smear

        -  To obtain plasma samples to restore the testing control pool for malaria serology
           testing and for future malaria research
    

Detailed description: 
      This is a single center, open label CHMI study. CHMI will consist of exposure to Plasmodium
      falciparum sporozoites through the bites of infected mosquitoes. After the challenge,
      subjects will be evaluated daily for the development of malaria infection using a blood
      smear. Unless previously diagnosed and fully treated, subjects will be required to stay in a
      hotel for a maximum of 12 nights starting on or around the evening of Day 7 post challenge.

      All subjects diagnosed with malaria infection based on smears will be prescribed a standard
      malaria treatment regimen to begin on the day that parasitemia is detected. Subjects who do
      not become parasitemic (via smear) by Day 19 will be empirically treated for malaria.

      After the hotel phase, all challenged subjects will have a final scheduled follow-up visit on
      Day 28 (±7 days).
    

Intervention name(s): Plasmodium falciparum malaria parasite
Intervention type(s): Biological
Intervention description(s): Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The treatment of coronary bifurcation lesions continue to remain challenges. Due to the
      complexity of the anatomical structure and the limitations of imaging, there are poor
      attachment and under-expansion of the stent at the branch ostium, which causes in-stent
      thrombosis and restenosis. The delayed re-endothelialization arise from multi-layer stents.
      The one-stent strategy causes the displacement of the plaques and ridges of the branch
      ostium, and thus insufficient blood flow to the branches. The "L-sandwich" strategy, stents
      were implanted in the main vessel(MV) and the shaft of side branch(SB) respectively, then a
      drug-coated balloon(DCB) was applied to the ostium of the SB, to improve the tedious
      operation process in true bifurcation lesions and reduce postoperative complications. The
      purpose of this study was to explore the feasibility, safety, and efficacy of the "sandwich"
      strategy.
    

Detailed description: 
      This is a study to evaluate the application of L-Sandwich in true bifurcation coronary artery
      disease.All eligible patients were randomly divided into three groups: experimental group 1:
      dual stent group: both main vessel(MV) and side branch(SB) were stented, and DK-Crush or
      Culotte were performed according to different pathological characteristics. Experimental
      group 2: single stent + drug-coated balloon（DCB）: stent was implanted in the MV, and only
      drug balloon was used in the SB.Experimental group 3: L-Sandwich : stent was implanted in the
      MV, and the branch was implanted 3-5mm away from the ostium，and the DCB was implanted in the
      ostium of the branch.IVUS+ angiography was used to guide the operation and evaluate the
      outcome.
    

Intervention name(s): Drug eluting stent; Durg coated balloon
Intervention type(s): Other; Other
Intervention description(s): Put a Drug eluting stent in the blood vessel; Put a Durg coated balloon in the blood vessel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three different strategies for true bifurcation
Masking: None (Open Label)
Primary purpose: Treatment