bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Energy Imbalance on Food Intake Behaviors
Condition: Obesity
Study type: Interventional

Summary: 
      This study will determine whether changes in energy balance alter regional neuronal
      activation of brain regions associated with food intake in individuals screened to be either
      resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic"
      value elicit changes in regional neuronal activity in the fasted and fed state in
      "obese-resistant" and "obese-prone" men and women in varying states of energy balance.
    


Intervention name(s): Eucaloric Feeding Period; Overfeeding Feeding Period; Underfeeding Feeding Period
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
Condition: Urticaria Chronic
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic
      Spontaneous Urticaria.
    

Detailed description: 
      This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in
      patients with Chronic Spontaneous Urticaria.
    

Intervention name(s): UB-221
Intervention type(s): Biological
Intervention description(s): UB-221 (75 mg/ml)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UB-221; anti-IgE monoclonal antibody; chronic spontaneous urticaria (CSU)
Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
Condition: Endothelial Dysfunction; Endstage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Purpose of this study is to determine if the Febuxostat has an effect on endothelial
      dysfunction on hemodialysis patients.
    

Detailed description: 
      Aim of The Work:

      1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis
      patients, through detection of:

        1. Primary endpoint:

           • Reduction in Asymmetrical Dimethylarginine (ADMA)

        2. Secondary endpoints:

             -  Assessing the change in serum High sensitivity C-reactive protein (hsCRP)

             -  Assessing the change in serum Uric acid - The criteria for inclusion:

                  1. Outpatients on maintenance hemodialysis.

                  2. Age from 18-70 years old.

                  3. Serum UA level 7.0 mg/dL or more.

                  4. Stable clinical condition (no hospitalization in the previous 3 months)

      The exclusion criteria:

        1. Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)

        2. History of hypersensitivity to febuxostat.

        3. Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.

        4. Participant in an another clinical trial within the past 4 weeks.

        5. Judged to be unsuitable as a subject by the attending physician.

      After two months , the patient will be reassessed regarding:

      A. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.
    

Intervention name(s): Febuxostat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session; Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session.
same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .
Other intervention name(s): Donifoxate
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction
Condition: Biliary Calculi
MeSH terms: Gallstones; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the
      preference for basket or balloon catheters for extraction is operator-dependent It is
      reported that complete endoscopic treatment with a single catheter is more likely when
      choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a
      study comparing the two catheter types in patients with periampullary diverticulum has not
      been performed, and there is no strong basis on which to recommend the balloon catheter as a
      first-line stone removal device. The investigators therefore conducted a multicenter
      prospective randomized trial to compare catheter performance in patients with periampullary
      diverticulum.
    

Detailed description: 
      A prospective, multi-center, investigator sponsored, randomized controlled trial, 80 subjects
      will be randomly assigned to groups that were treated with basket or balloon catheters.

      A descriptive analysis will be performed on primary endpoint, containing frequency of number
      and percentage of patients. A two proportion equality test will be conducted to explore
      whether incidence rates are different.Descriptive statistics including number (N), mean,
      median, standard deviation, minimum and maximum, will be produced for all continuous
      variables. Frequency tables of number (N) and percentage of subjects will be produced for all
      categorical variables.
    

Intervention name(s): Balloon catheter; Basket catheter
Intervention type(s): Device; Device
Intervention description(s): Balloon stone extraction was carried out with a balloon catheter [Extractor Pro RX [M00547000, M00547010, or M00547020]; Boston Scientific,Shang hai,China). The Extractor Pro has multiple sizes (9-12, 12-15, and 15-18mm), the choice being made on the basis of the CBD diameter. It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC).; Basket stone extraction was performed with a basket catheter (Flower Basket V [FG-V435P or FG-V425PR]; Olympus Corp., Shang hai,China).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and
      tolerability of different dose levels of IW-1701 compared with placebo when administered
      daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include
      evaluation of pharmacokinetic (PK) as well as evaluation of the effect of IW-1701 on symptoms
      of SCD, health-related quality of life, and biomarkers of pharmacodynamic (PD) activity.
    


Intervention name(s): IW-1701; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet
Other intervention name(s): Olinciguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; SCD; Olinciguat; IW-1701
Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums
Condition: Pharmacokinetics; Magnetic Resonance Imaging; Administration, Oral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine,
      given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral
      administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml
      grapefruit juice prior to ingestion and to visualize the localization and to measure the
      filling volume of stomach, small intestine as well as ascending, transverse and descending
      colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water
      (non-caloric water), after administration of 240 ml caloric drink and after administration of
      240 ml grapefruit juice.
    


Intervention name(s): Paracetamol; Sulfasalazine; Fexofenadine; Valsartan; non-caloric water; caloric drink; grapefruit juice
Intervention type(s): Drug; Drug; Drug; Drug; Device; Device; Device
Intervention description(s): Oral administration of 250 mg paracetamol; Oral administration of 50 mg sulfasalazine; Oral administration of 120 mg fexofenadine; Oral administration of 40 mg valsartan; Oral administration of 240 ml non-caloric water; Oral administration of 240 ml caloric drink; Oral administration of 240 ml grapefruit juice
Intervention MeSH terms: Acetaminophen; Fexofenadine; Sulfasalazine; Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
Condition: Food Allergy
MeSH terms: Food Hypersensitivity; Anaphylaxis
Study type: Observational

Summary: 
      In Italy, few data about anaphylaxis due to peanuts in pediatric age are available,
      conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been
      collected.

      Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and
      shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory
      (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).

      Parent of food allergic children will compile a food allergy questionnaire (questions about
      general information on the family, on life and food habits, on indoor environment, on health
      status, on clinical aspects of the allergy, on the access to diagnostic and treatment
      resources).

      Parent of healthy children will compile a control questionnaire (questions about general
      information on the family, on life and food habits and on indoor environment) The 1-year
      survey will determine the frequency of anaphylaxis in allergic outpatient children.
    


Intervention name(s): Food allergy questionnaire; Control Questionnaire
Intervention type(s): Other; Other
Intervention description(s): The Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources; The Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        200 Italian children with or without food allergy
      
Keywords: Children; Allergy; Peanuts; Hazelnuts; Walnuts; Mollusks; Shellfish; Food
Everolimus in de Novo Heart Transplant Recipients
Condition: Cardiac Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study, in de novo heart transplant patients, is to evaluate whether
      delayed introduction of everolimus reduces the occurrence of wound healing problems,
      pericardial and/or pleural effusion and early acute renal insufficiency, as compared with
      immediate introduction of everolimus, in the firs six months after heart transplantation.
    


Intervention name(s): Everolimus; Mycophenolate mofetil + Everolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Development of Green Mei Products for the Prevention of Metabolic Syndrome
Condition: Hypertension
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4
      (MGF-4) and Mei-Gin formula-7.
    

Detailed description: 
      It's a randomized, and single-blind trial and was designed to evaluate the effects of MGFs
      (MGF-4 and MGF-4) on blood pressure. 50 participants with hypertension (systolic blood
      pressure between 130-179 mmHg or diastolic blood pressure between 85-109 mmHg) who did not
      accept any hypertension medication were randomized allocated to either MGF-4 or MGF-7 group.
      Participants were instructed to take 4 capsules of MGF-4 or MGF-7 daily throughout the
      duration of the 8 weeks intervention study. After treatment, the change of the blood pressure
      and relative mechanism were analyzed.
    

Intervention name(s): MGF-4; MGF-7
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants were instructed to take 2 capsules of MGF-4 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.; Participants were instructed to take 2 capsules of MGF-7 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Medications Development for the Treatment of Cannabis Related Disorders
Condition: Nicotine Withdrawal; Marijuana Dependence; Cannabis Dependence; Nicotine Dependence; Cannabis Abuse
MeSH terms: Marijuana Abuse; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this application is to test the neurobehavioral mechanisms and
      effects of aprepitant as a new cessation agent for cannabis, tobacco or both.
    

Detailed description: 
      Stress (emotional, physical, social) facilitates drug seeking behavior through the activation
      of the HPA axis, autonomic nervous system, and brain DA systems. Furthermore, alterations
      within several neuropeptide systems (CRF, Substance P, and others) also contribute to the
      role of stress in addiction. Central to this project is that anxiety and stress responses are
      modulated by substance P and its preferred target, the NK1 receptor. Therefore the aim of
      this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin
      1 (NK1) receptor antagonist). We hypothesize that the NK1 receptor antagonist, aprepitant,
      will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and
      reinforcement value for both cannabis and tobacco resulting from the cessation of either or
      both drugs. We will assess this hypothesis in the context of a carefully controlled human
      laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to
      one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco
      only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions:
      placebo or aprepitant (160 mg/day). Medication will be administered for 5 days, followed by a
      cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette
      or money) also on day 5.
    

Intervention name(s): Placebo Aprepitant; Active Aprepitant
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Aprepitant 0 mg once daily for 5 days; Active Aprepitant 160 mg once daily for 5 days
Intervention MeSH terms: Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Marijuana Abuse; Nicotine Dependence; Nicotine Withdrawal; neurokinin Receptor; NK1 Receptor antagonist; Substance P; Recurrence; Substance Withdrawal Syndrome; Substance-Related Disorders; Disorders of Environmental Origin; Mental Disorders; Disease Attributes; Pathologic Processes; Tetrahydrocannabinol; Therapeutic Uses; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Narcotic Antagonists; cannabis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
Condition: Pediculosis
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 4

Summary: 
      A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in
      pediatric subjects 6 months to 4 years of age with an active head lice infestation.
    

Detailed description: 
      A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6
      months to 4 years of age with an active head lice infestation designed to determine the
      topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10
      minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.
    

Intervention name(s): spinosad
Intervention type(s): Drug
Intervention description(s): A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.
Other intervention name(s): Natroba (spinosad) Topical Suspension, 0.9%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pediculosis capitis; Head Lice
MK0462 in Treatment of Migraine With Recurrence (MK0462-022)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Recurrence; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine
      attack and treatment of up to two headache recurrences compared to placebo.

      The long term extension study which pools patients from MK0462-022, -025, and -029 is
      described in NCT01286207.
    


Intervention name(s): rizatriptan benzoate (MK0462); Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.; Placebo to rizatriptan
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Eluxadoline Bile Acid Malabsorption (BAM) Study
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Malabsorption Syndromes; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the possibility of a differential effect of eluxadoline on altered
      bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) participants with and
      without evidence of Bile Acid Malabsorption (BAM).
    


Intervention name(s): Eluxadoline
Intervention type(s): Drug
Intervention description(s): Eluxadoline 100 mg oral tablets BID with food.
Intervention MeSH terms: Eluxadoline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS-D; BAM
Assessing QbTest Utility in ADHD: A Randomised Controlled Trial
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health
      disorders of childhood. Children with ADHD often have poor attention, are restless and
      hyperactive and show impulsive behaviour.

      It is important to detect ADHD so young people can have access to appropriate clinical
      interventions.

      One of the most common ways ADHD is assessed is through the clinician's opinion; however,
      this can vary between clinicians and is thought to be one reason why ADHD may be
      mis-diagnosed. Using a more objective computer tasks may help improve our understanding of
      ADHD. One computer task is the QbTest.

      The test presents different symbols to the child, and the child has to respond by pressing a
      button only when a target symbol appears. The test measures the child's attention,
      impulsivity and movement whilst doing this task.

      Although the test is thought to be a valid measure, more research needs to be conducted on
      this measure to see whether it helps clinicians decision making.

      To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication
      decisions, children and young people will be asked to complete the task as part of their
      initial assessment for ADHD. Half the participants and their clinician will have access to
      the QbTest result; the other half will not have access to the QbTest result until the end of
      the study.

      Participant's parents, teachers and the clinician will also be asked to complete some
      questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD
      and is given medication they will be asked to complete the task again on medication. The same
      set of questionnaires will be completed by the parents/teachers/clinicians.

      The entire sample will be followed up at 6 months and asked to complete the questionnaires.
    


Intervention name(s): Qb Test
Intervention type(s): Other
Intervention description(s): Given to all participants but the results will be open or blind depending on arm allocation
Other intervention name(s): Qb Test of Activity and Attention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: ADHD; QB Test; Activity; Attention; Children; Clinical Decision Making