bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
Condition: Migraine in Children; Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate how the body absorbs, distributes, and get rid of
      eptinezumab when given directly into a vein.
    

Detailed description: 
      This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a
      single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose
      extension period (Part B).

      The main study period includes a single IV infusion of eptinezumab. The optional extension
      period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended
      dosing interval in adults), for a total of up to 4 infusions over the course of the study.

      At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16
      patients aged 12 to 17 years, inclusive.
    

Intervention name(s): Eptinezumab
Intervention type(s): Drug
Intervention description(s): up to four iv infusions of eptinezumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation
      measurements from a laboratory blood gas analyzer.
    


Intervention name(s): MightySat RX Pulse Oximeter Sensor
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter finger sensor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Condition: Deafness; Pediatric
MeSH terms: Deafness
Study type: Observational

Summary: 
      Deafness significantly affects several auditory tasks of everyday life in children:
      understanding speech in quiet and noisy environments, spatial location of sounds ...

      These difficulties in locating sound sources are often ignored by parents and underestimated
      by children. Nowadays we there is specific tools to evaluate these problems in children.
      Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for
      adults that evaluates auditory abilities, including sound localization, in different tasks of
      daily life. Although robust, this questionnaire includes 49 questions and is too long for
      daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of
      the SSQ questionnaire for adults with only 15 items.

      Based on this model, the aim of this study is to develop and test a paediatric questionnaire
      with 12 items to assess more specifically auditory difficulties in deaf children. This
      questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist
      of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of
      hearing (4 items). These 3 subscales are identical to those defined in long and short form pf
      the adult SSQ questionnaire.
    


Intervention name(s): KID SSQ12 questionnaire
Intervention type(s): Other
Intervention description(s): During a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Children between 7 and 17 years old attending medical appointment for temporary or
        persistent deafness in our ENT department
Dopaminergic Modulation of Cognition and Psychomotor Function
Condition: Dopamine Activity; Episodic Memory Consolidation; Response Preparation
Study type: Interventional

Summary: 
      A recent study at our lab showed increased episodic memory consolidation and response
      readiness after treatment with methylphenidate in healthy volunteers. The investigators seek
      to replicate and extend these findings. Furthermore the pharmacological specificity of these
      effects will be studied. Since methylphenidate has an effect on two neurotransmitters,
      dopamine and noradrenaline, either could be responsible for the observed effects. In order to
      explore the dopaminergic contribution to this effect, the study proposed here includes not
      only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not
      noradrenaline.

      In this study, 20 healthy males and females between 18 and 45 years of age will participate.
      They will be recruited via advertisements at Maastricht University and in local newspapers.

      Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once
      with placebo. All medications will be administered orally with a capsule.

      It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic
      memory consolidation and improve response readiness
    


Intervention name(s): Methylphenidate 40 mg; Levodopa/carbidopa 125 mg; Domperidon 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose 40 mg; oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule; Domperidon 10 mg
Other intervention name(s): Ritalin RVG 03957; Sinemet RVG08740; Domperidon RVG 23565
Intervention MeSH terms: Levodopa; Carbidopa; Domperidone; Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: dopamine; EEG; episodic memory; contingent negative variation; response preparation; levodopa; methylphenidate
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
Condition: Breast Cancer; Breast Surgery; Breast Reconstruction; Breast Reduction; Breast Augmentation
Study type: Observational

Summary: 
      The goal of this study is to develop a questionnaire to measure patient satisfaction with
      their breast surgery. This questionnaire will help surgeons better understand how patients
      feel about their surgical results. We hope that such a questionnaire will improve the
      understanding of breast surgery results and patient care.
    


Intervention name(s): questionnaires; questionnaires
Intervention type(s): Behavioral; Behavioral
Intervention description(s): patients will fill out two questionnaires post surgery; Patient will fill out questionnaire before and 3 to 6 months after treatment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinics at the various sites
Training on Unstable Surfaces and Effects on the Balance of Healthy Young People
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to determine the effects on balance and postural control
      produced by the implementation of a training program that includes work with unstable
      surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those
      achieved with a training of similar characteristics, but implemented on a stable surface. An
      intensive program is proposed, whose target population is young adults.
    


Intervention name(s): Unstable; Stable
Intervention type(s): Other; Other
Intervention description(s): This group will train over unstable surfaces to enhance balance abilities; This group will train over stable surface to enhance balance abilities
Other intervention name(s): Experimental; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Naproxen Sodium/ASA Platelet Study
Condition: Hematology
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory
      effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
    


Intervention name(s): Naproxen Sodium (Aleve, BAY117031); Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention type(s): Drug; Drug
Intervention description(s): Naproxen sodium 220 mg qd or bid; ASA 81 mg qd
Intervention MeSH terms: Aspirin; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug
      combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266
      plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study
      also examines the resistance HIV may have to these drugs and if these drugs are effective
      over a long period of time.
    


Intervention name(s): Indinavir sulfate; Lamivudine; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Indinavir
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; Zidovudine; Drug Resistance, Microbial; HIV Protease Inhibitors; Lamivudine; Indinavir; Genotype; Reverse Transcriptase Inhibitors; efavirenz
Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Observational

Summary: 
      Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients
      will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)
      results and no embryo reported ultrasonography results. Plasma and cervical fluid samples
      will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase
      levels of samples will be compared between patients who have doubt for ectopic pregnancy and
      patients who have intrauterine pregnancy. Concentration of these proteins in samples will be
      evaluated. If any difference will be found between groups in favour of ectopic pregnancy,
      these results might be interpreted as these proteins useful for early detecting of the
      ectopic pregnancy.
    


Intervention name(s): Collecting cervical liquid and sera samples
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who have doubt for ectopic pregnancy will be selected for study group and patients
        who have intrauterine pregnancy will be selected for control group.
      
Keywords: Ectopic pregnancy; Axonemal Dynein Heavy Chain 5; Creatine Kinase; Cervical fluid
Improvement of Endothelial Function by EGCG
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired
      endothelial function (assessed as flow-mediated dilation) represents an early marker for
      later cardiovascular events. Epidemiological and experimental studies suggest that
      consumption of tea is associated with lower progression of atherosclerosis and reduced
      cardiovascular mortality.

      Tea contains high amounts of polyphenols with important biological activities. The green tea
      catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound
      in vitro. However, little is known about its contribution to beneficial effects of tea in
      vivo.

      In this crossover study the impact of a single dose of EGCG applied in different forms (green
      tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in
      healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to
      appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in
      cardiovascular protective effects of green tea in vivo. The outcomes will provide insights
      about the role of EGCG in different application forms to improvements of endothelial function
      in humans.
    


Intervention name(s): Green tea beverage; Green tea extract; EGCG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Green tea; EGCG; Cardiovascular diseases; Endothelial function; Flow-mediated dilation
Comarum Palustre in Knee Osteoarthritis and Diabetes
Condition: Osteoarthritis; Diabetes Mellitus
MeSH terms: Osteoarthritis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates analgesic, antiinflammatory and metabolic effects of Comarum palustre in
      patients with knee osteoarthritis (OA) and diabetes mellitus. Patients with osteoarthritis
      will receive Comarum palustre together with conventional treatment of osteoarthritis and
      diabetes.
    

Detailed description: 
      Comarum palustre have been shown to exert analgesic properties in patients with knee
      osteoarthritis not responding to diclofenac. In animal models comarum palustre showed
      anti-inflammatory, immunomodulatory, analgesic, antioxidant, antihistamine, and
      membrane-stabilizing effects. Thus, pleiotropic properties of Comarum Palustre may provide a
      rationale for this use in patients having both osteoarthritis and diabetes mellitus. In this
      group of patients Comarum Palustre may not only relieve OA-related pain but reduce systemic
      inflammation, decrease progression of atherosclerosis and diabetes complications.
    

Intervention name(s): Comarum Palustre
Intervention type(s): Drug
Intervention description(s): Comarum Palustre tablets 500 mg BID, 1 month
Other intervention name(s): Potentilla palustris
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as Galcanezumab in Japanese participants with migraine.
    


Intervention name(s): Galcanezumab
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
Dip Home-Based Dipstick Analyzer Performance Evaluation
Condition: Urine Detectable Acute and Chronic Diseases
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone
      application. The device will be provided to the subject in a simulated home-use environment.
      All subjects will be asked to complete the urine test by following the application guidance,
      including providing a urine sample and scanning the urine strip after placing it on the
      Color-Board. The user will also complete a questionnaire to collect information regarding the
      use of the HBDA device. Following the usability test performed by the lay user, the subject's
      urine sample will be tested by the professional user using the comparator device. The use of
      the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable
      usability criteria for specific, critical steps will be evaluated.
    


Intervention name(s): Experimental: Dip Home-Based Dipstick Analyzer
Intervention type(s): Device
Intervention description(s): Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if
      the development of hypertension has a connection to our intake of potassium. We know that
      fruit and vegetables contain a lot of potassium and we will simulate this intake by giving
      healthy subjects potassium as tablets.
    


Intervention name(s): Calcium; Potassium
Intervention type(s): Drug; Drug
Intervention description(s): tablets, 1 tablet 2 times per day in 28 days; Tablets, 5 tablets 2 times per day for 28 days
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; potassium; blood pressure
N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators
      currently have effective first-line interventions for pediatric OCD such as Cognitive
      Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs).
      However, roughly half of children with OCD still have clinically significant OCD symptoms
      despite treatment with first-line pharmacological treatments and CBT interventions for OCD.
      Furthermore, all pharmacological treatments for OCD in children have an increased side effect
      burden when compared to adults. Novel treatments for children with OCD are needed.

      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate
      modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in
      this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with
      NAC is nausea and this side-effect is seldom seen in the doses used in this trial.

      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled
      trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an
      obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In
      other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions
      such as bipolar depression, schizophrenia and cocaine dependence.

      The investigators are conducting this trial to determine if NAC is effective in treating OCD.
    


Intervention name(s): N-Acetylcysteine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.; 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
Other intervention name(s): PharmaNAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; OCD
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
Condition: Hyperandrogenism
MeSH terms: Hyperandrogenism
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and
      leuprolide/oral contraceptive therapy in the management of patients with ovarian
      hyperandrogenism.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month
      course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus
      Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.
    

Intervention name(s): leuprolide; Ethinyl estradiol/norethindrone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leuprolide; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Estradiol
Allocation: Randomized
Primary purpose: Treatment
Keywords: endocrine disorders; hyperandrogenism; rare disease
Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
Condition: Cardiometabolic Risk; Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the beneficial effects on gut microbiota composition
      and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for
      three weeks. The first studies about the fiber have shown a favorable gut microbiota
      modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to
      fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases,
      PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15
      grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber
      intake and the intestinal transit modification will be also followed during all the study.
    


Intervention name(s): Kiotransine (chitin-glucan from aspergillus niger); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.; The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: chitin-glucan; gut microbiota; Fecal Short Chain Fatty Acid (SCFA); cardiometabolic risk; nutritional challenge test; biomarkers