bioihbjkbjnl/mcl2 huggingface dataset:
Personal Activity Intelligence in the Treatment of High Blood Pressure
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of
      routine physical activity (PA) needed to improve health and reduce cardiovascular (CV)
      mortality. The PAI metric can be integrated in PA monitors to promote and track PA. The
      present pilot study is a 12-week randomized controlled trial designed to test the efficacy of
      PAI in the treatment of high blood pressure. The primary aim is to investigate how routine PA
      (expressed as PAI level) affect ambulatory blood pressure by comparing the effect of the
      intervention (≥100 PAI per week) with a control recommended to follow national PA guidelines.
      The secondary aims are to investigate the effect on a comprehensive CV risk profile, and to
      model the effect of PAI level on multiple CV parameters. The CV risk profile includes office
      BP, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular
      resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum
      markers of glucose metabolism, kidney failure and systemic inflammation.
    


Intervention name(s): Personal Activity Intelligence; Physical Activity Guidelines
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group is provided with a PAI monitor (wristband) with a user interface (app) to track their own PAI level and are instructed to obtain at least 100 PAI on a weekly basis.; The control group is recommended to follow national PA guidelines, meaning 150 minutes of moderate-intensity PA or 75 minutes of vigorous-intensity PA, or a combination there of. The control group is provided with a PAI monitor (wristband) without any user interface and are thus blinded to track their own PAI level.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Exercise Therapy; Blood Pressure Monitoring, Ambulatory; Physical activity monitoring
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
Condition: Congenital Diseases; Diaphragmatic Hernia; Pulmonary Hypoplasia
MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial investigates whether prenatal intervention improves survival rate of fetuses with
      isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to
      expectant management during pregnancy, both followed by standardized postnatal care.
    


Intervention name(s): fetal endoluminal tracheal occlusion; watchful waiting during pregnancy
Intervention type(s): Procedure; Other
Intervention description(s): percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks; pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
Other intervention name(s): Balt Goldbal 2 balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Isolated Congenital Diaphragmatic Hernia; Fetal Surgery; Pulmonary Hypoplasia
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847
    


Intervention name(s): BI 44847; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
BIS Monitoring to Detect Deep Sedation
Condition: Disorder; Mental, Sedative; Depressed Level of Consciousness; Mechanical Ventilation Complication; Psychosis Associated With Intensive Care
MeSH terms: Consciousness Disorders; Mental Disorders
Study type: Observational

Summary: 
      Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes
      in adult intensive care unit (ICU) patients. The revised guidelines for management of pain,
      agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that
      adult ICU patients should be maintained at a light level of sedation. The key point in light
      sedation strategy is the assessment of depth of sedation. At present, sedation is monitored
      mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's
      Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the
      subjective and intermittent nature of these scales instruments has limited their application
      in light sedation algorithm. Consequently, objective and continuous measurement of the level
      of sedation would be more desirable in clinical practice. In recent years, objective measures
      of brain function have been of great interests in the evaluation of sedation level, and
      bispectral index (BIS) has been the most investigated instrument.

      Several studies compared BIS with subjective sedation scales in adult ICU patients, and
      yielded conflicting results. The different approaches to select BIS value may be the most
      important reason for these inconsistent agreements between BIS and subjective sedation
      scales. A formal scheme of subjective assessment of the depth of sedation and level of
      consciousness should incorporate exerting verbal and physical stimuli and observation of the
      patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS
      in detecting early deep sedation against the reference standard of subjective scale
      instrument. We hypothesize that BIS monitoring will provide accurate, subjective and
      continuous evaluation of deepen sedation.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients admitted to a 22-bed general ICU in a University Affiliated Hospital will be
        screened daily and enrolled consecutively.
Family Inclusive Early Brain Stimulation
Condition: Brain Stimulation
Study type: Interventional

Summary: 
      Social interaction (in the form of serve and return exchanges) between child and parent are
      crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan
      countries are ill-equipped to maximize the benefits from this interaction. The investigators
      approach builds on the traditional outlook that "it takes a village to raise a child" i.e.,
      not only the parents but other extended family members play a role as caregivers to young
      children. The investigators intention is to use the existing post-natal/child welfare clinics
      to deliver an intervention, which uses culturally acceptable videos and active skills
      building, to deliver health messages and practical skills to women, with the intention that
      they will subsequently engage and teach their partners and other caregivers about early brain
      stimulation and child development.
    

Detailed description: 
      A two arm cluster randomized control design will be used to select a total of about 400
      participants each of the control and intervention groups. The participants will be drawn from
      primary health care (PHC) centres offering immunization services in Ibadan. In the
      intervention group, mothers will be trained on early brain stimulation using group video
      sessions followed by individualised question and answer sessions. These sessions will take
      place at 6 week and 10 week post natal immunisation visits. The control arm will receive the
      standard of care - routine immunization care- group health talks.

      The child's development will be assessed using the Survey of Wellbeing of Young Children
      (SWYC) instrument.

      Outcome variables will include changes in self-reported early child brain stimulation
      behaviour and increase in the awareness of parents and significant others on the social and
      emotional difficulties of children.
    

Intervention name(s): Edutainment based intervention
Intervention type(s): Behavioral
Intervention description(s): Edutainment intervention package
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Cognition; Brain Stimulation; Early Child Development
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of
      CLONICEL (clonidine HCl sustained release) when administered chronically under regular
      clinical conditions either as monotherapy or in combination with stimulant therapy to
      children and adolescents with attention deficit hyperactivity disorder (ADHD).
    


Intervention name(s): CLONICEL (Clonidine HCl sustained release)
Intervention type(s): Drug
Intervention description(s): 0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4
Intervention MeSH terms: Clonidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLONICEL; Attention Deficit Hyperactivity Disorder; clonidine HCl sustained release
Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the presence of a hang-over effect in healthy volunteers the day after the
      administration of Songha® Night
    


Intervention name(s): Songha® Night; Oxazepam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Oxazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
Condition: Cerebral Embolism; Stroke
MeSH terms: Stroke; Intracranial Embolism; Embolism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether autologous bone marrow mononuclear cells
      transplantation after stroke is safe and/or effective to improve neurological outcome.
    


Intervention name(s): autologous bone marrow mononuclear cells; autologous bone marrow mononuclear cells
Intervention type(s): Biological; Biological
Intervention description(s): intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period); intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; bone marrow; mononuclear cell; angiogenesis; neurogenesis
Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure
Condition: Bladder Disease
MeSH terms: Urinary Bladder Diseases
Study type: Observational

Summary: 
      The objective of the study is to obtain bladder tissue specimens from patients otherwise
      undergoing cystoscopy for use in research at Tengion, Inc.
    


Intervention name(s): Bladder biopsy
Intervention type(s): Procedure
Intervention description(s): provision of bladder tissue via cystoscopic biopsy during planned TURBT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients otherwise undergoing TURBT
      
Biospecimen description: 
      Tissue
    
Keywords: Transurethral resection of bladder tumor; TURBT
Pharmacokinetic Properties of Isosorbide-5-mononitrate Under Fasting and Fed Condition in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg
      in sixty healthy Korean male subjects.
    

Detailed description: 
      This study is to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg
      in sixty healthy Korean male subjects. Thirty subjects will be participating in a fasted
      state and other thirty subjects will be in a fed state. Elantan SR 60 mg and Imdur 60 mg are
      two formulations of Isosorbide 5-mononitrate.
    

Intervention name(s): Elantan SR 60 mg; Imdur SR 60 mg
Intervention type(s): Drug; Drug
Intervention description(s): Trade Name: Elantan
Active Substance: Isosorbide 5-mononitrate
Pharmaceutical form: Tablet
Concentration: 60 mg
Route of Administration: Oral administration; Trade Name: Elantan
Active Substance: Isosorbide 5-mononitrate
Pharmaceutical form: Tablet
Concentration: 60 mg
Route of Administration: Oral administration
Other intervention name(s): Isosorbide 5-mononitrate; Isosorbide 5-mononitrate
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Isosorbide 5-mononitrate; Elantan; Imdur; Korean; Healthy
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Condition: Urogential Chlamydia Trachomatis Infection
MeSH terms: Infections; Communicable Diseases; Chlamydia Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day
      for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7
      days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary
      efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events,
      changes in vital signs and laboratory test results.
    


Intervention name(s): Doxycyline Hyclate tablet; Vibramycin (doxycyline hyclate) capsule
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg tablet, once daily for 7 days; 100 mg capsule, twice daily for 7 days, over-encapsulated
Other intervention name(s): WC2031; doxycycline
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chlamydia
Detection of Human Cytomegalovirus in the Saliva
Condition: Cytomegalovirus
Study type: Observational

Summary: 
      Direct DNA amplification, viral isolation and specific antibody measurement in saliva

        1. From children in day care centers (samples collection will take place during a single
           week)

        2. From children coming at the emergency department of our hospital during a three months
           period.

      Sample collection will be done by the pediatrician the nurse, or one of the authorized
      investigators of the study.
    

Detailed description: 
      Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for
      DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        child aged from 3 month to 6 years in day care centers or in emergency department.
      
Keywords: Children in day care centers; cytomegalovirus excretion
A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin
Condition: Capsaicin; Ultaviolet B Light Burn; Neuropathic Pain; Lidocaine
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The aim of this project is to study the role of transient receptor potential (TRP-) channel
      V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal
      Ultraviolet-B damage. Moreover, in this project the investigators want to evaluate if the
      capsaicin-desensitization action can still be induced in a skin area pretreated with topical,
      local anesthetic lidocaine.
    

Detailed description: 
      In this project the Ultraviolet- B pain model, a model using type B ultraviolet rays to
      induce a first-degree sunburn, will be used to induce a non-specific inflammation in the
      skin. This model is well-known to produce both peripheral and central hyperalgesia through
      sensitization of peripheral and central nociceptors. Capsaicin, the active substance in chili
      peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of
      8% capsaicin patch causes profound desensitization to painful heat stimuli and itch
      provocations. Therefore, the investigators would like to monitor the development of
      unspecific UVB-cutaneous inflammation and consequent neurogenic flare in a capsaicin
      pre-treated area. Moreover the investigators want to test if pre-treating the skin with
      lidocaine can reduce the pain associated with the capsaicin application without affecting its
      desensitization action.
    

Intervention name(s): Capsaicin Topical; Ultraviolet-B (UVB) irradiation; Histamine 1%; Lidocaine
Intervention type(s): Drug; Radiation; Other; Drug
Intervention description(s): Capsaicin patches (dosage form: patch 8% Qutenza) will be applied on 4x4 cm squared areas on the volar forearm. The patches will be left in place for 24h and 3 hours after which they will be removed.; Two circular areas (Ø 2 cm) on the forearm are irradiated with 2 x MED (Minimal Erythema Dose) dose of UVB using a calibrated UVB machine (290-320nm wavelength), Saal Mann Multi Tester (Mann Saal, LT SBC 400 Herford, Germany).; To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction.; Cutaneous anaesthesia will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine)
Intervention MeSH terms: Lidocaine; Capsaicin; Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability and Pharmacokinetic Study of Asthma Treatment Drug Litapiprant
      Tablets in Healthy Male and Female subjects.
    

Detailed description: 
      This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center
      Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in
      Healthy Male and Female subjects. A total of 60 healthy subjects were divided into 7 groups.
      Group 1 consist of 4 subjects, 3 subjects will receive Litapiprant Tablets and 1 subject will
      receive placebo.Group 2,3,5,6 consist of 8 subjects respectively, in each group, 6 subjects
      will receive Litapiprant Tablets and 2 subjects will receive placebo.Group 4,7 consist of 12
      subjects respectively, in each group, 10 subjects will receive Litapiprant Tablets and 2
      subjects will receive placebo.
    

Intervention name(s): Litapiprant Tablet
Intervention type(s): Drug
Intervention description(s): Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Buteyko Based Remedial Breathing Therapy With Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      A randomized, controlled trial to investigate the effects of a buteyko based remedial
      breathing therapy on children with asthma regarding to their symptoms, use of medication and
      lung function tests.
    


Intervention name(s): Buteyko based Remedial Breathing Therapy
Intervention type(s): Behavioral
Intervention description(s): Buteyko based remedial Breathing Therapy after Dr. Buteyko
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; Buteyko; remedial breathing; children
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and
      reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism
      (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with
      placebo. Subjects must not have previously been treated with testosterone products within the
      last 6 months.
    

Detailed description: 
      Protocol ZA-301 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study
      to evaluate normalization of morning testosterone levels in overweight men with acquired
      hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10
      to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration.
      Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve
      morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham
      titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks
      total). A schedule of procedures and assessments is displayed in Section 4. The study will
      enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38
      randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone
      treatments within the last 6 months.

      Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH
      below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart,
      another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2
      samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo
      serial T assessment for determination of the Cavg. Safety assessments will include collection
      of adverse events, eye examinations, physical examinations and clinical laboratory
      assessments.
    

Intervention name(s): Androxal; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, capsules, taken one time daily, for 3 months; Oral capsule taken one time daily for 3 months
Other intervention name(s): Enclomiphene citrate; Dummy
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment