bioihbjkbjnl/mcl2 huggingface dataset:
Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
Condition: Healthy Volunteers
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess the relationship between rhinovirus specific
      T-cell immunity and the human host response to primary rhinovirus challenge and subsequent
      secondary challenge with either homologous or heterologous rhinovirus serotypes.
    

Detailed description: 
      The primary objective of this study is to assess the relationship between RV-specific T-cell
      immunity and the human host response to primary RV challenge and subsequent secondary
      challenge with either homologous or heterologous RV serotypes. The overall hypothesis that
      will be addressed by the mechanistic studies in this proposal is that T helper (Th) and T
      follicular helper (Tfh) cells directed against conserved RV epitopes expand upon RV exposure
      and some of these cells persist as stable cross-reactive memory populations capable of
      displaying lineage-specific protective functions upon re-infection with related or unrelated
      strains of RV. The human specimens collected in this study will be analyzed with a variety of
      state-of-the-art techniques to provide an in depth description of T-cell responses to RV
      infection, and the correlation of these responses with viral infection, antibody responses,
      and illness. Beyond this objective, by using a systems biology approach, we aim to gain new
      insight into the role of diverse cell types involved in adaptive immunity to RV. .
    

Intervention name(s): human rhinovirus; no intervention
Intervention type(s): Biological; Other
Intervention description(s): human rhinovirus; 4 volunteers were not re-challenged and did not participate in the second challenge
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers who were infected with RV16 by experimental challenge were eligible for participation by re-challenge with either RV16 or RV39 to assess the host response to homologous or heterologous rechallenge.
Masking: Single (Participant)
Primary purpose: Basic Science
Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Condition: Bladder Cancer; Laparoscopy
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      This study is a prospective randomised controlled study of urinary bladder cancer patients
      presented to urology unit at National Cancer Institute; Cairo University.
    

Detailed description: 
      The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical
      cystectomy and open radical cystectomy. The focus of the study will be a comparison of both
      approaches on the patients' peri-operative outcome.
    

Intervention name(s): Open radical cystectomy; Laparoscopic-assisted radical cystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard open radical cystectomy and urinary diversion; Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaporized Cannabis and Spinal Cord Injury Pain
Condition: Spinal Cord Injuries; Spinal Cord Diseases
MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will demonstrate that vaporized marijuana results in antinociception when compared
      to placebo in subjects with spinal cord injury. To further evaluate potential benefits and
      side effects, the effect of different strengths of cannabis on mood, cognition, and
      psychomotor performance will also be measured.
    

Detailed description: 
      This study will demonstrate that vaporized cannabis can produce antinociceptive effects
      compared to placebo in human subjects with spinal cord injury (SCI). A within-subject
      crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will
      be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor
      performance, and side effects will be obtained to help evaluate the utility of vaporized
      marijuana in SCI neuropathic pain.

      This study will compare the analgesic and side effect profile of low (3.5%) to high dose
      (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is
      hypothesized that a low dose will produce a lesser degree of neuropsychological impairment
      while maintaining a similar degree of pain relief to the higher dose. The use of two
      different strengths will help determine tolerable dosing for the treatment of SCI neuropathic
      pain.
    

Intervention name(s): Vaporization of Cannabis
Intervention type(s): Drug
Intervention description(s): Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC
Other intervention name(s): Medical Marijuana
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis; central neuropathic pain; analgesia
Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal
Condition: Candidemia
MeSH terms: Candidemia
Study type: Observational

Summary: 
      Candidemia has emerged as an important cause of hospital-associated blood-stream infection in
      children. The purpose of this study was to identify differences in distribution of candida
      species, risk factors, treatment, and clinical outcome of candidemia in children. This study
      in children ≤18 years with blood culture proven candidemia identified between 2004 and 2012.
      Analyses included the determination of causative candida species, resistance to antifungals
      and clinical outcome, as well as the identification of potential risk factors associated with
      candidemia.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec
        2012.
      
Keywords: candidemia; children; mortality; risk factors
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic
      modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end
      stage renal disease.

      II. Compare the efficacy of high versus low flux dialyzer membranes.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center,
      age, and diabetes prior to dialysis initiation.

      Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane;
      high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high
      dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is
      1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional
      clearance of urea (eKt/V) calculated with double pool kinetics.

      Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours),
      adjusted for adequate fluid removal. General medical care, protein and calorie intake, and
      dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document
      lists approved dialyzers; no unsubstituted cellulosic membranes are permitted.

      The intervention phase of this study is 5 years. Patients are followed for survival.
    

Intervention name(s): Standard dose, low flux hemodialysis; Standard dose, high flux hemodialysis; High dose, low flux hemodialysis; High dose, high flux hemodialysis
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end stage renal disease; rare disease; renal and genitourinary disorders
Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder
Condition: Mental Health Disorder; Healthy Lifestyle
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower
      than the general population. Among the factors that determine this expectancy are
      cardiovascular risk and the metabolic syndrome. The objective of the present study will be to
      evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology
      and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for
      activities of daily living and psychopathological symptoms.
    

Detailed description: 
      It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit
      from Spain. It will be implemented a intervention program consisted of psychopharmacology +
      psychoeducation on healthy living habits during three months. The patients will be evaluated
      at the beginning, at three months and at six months follow-up for weight, waist
      circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and
      psychopathology.
    

Intervention name(s): Psychoeducation program; Psychopharmacology intervention
Intervention type(s): Behavioral; Drug
Intervention description(s): Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.; Intervention program consisted of psychopharmacology. This will be executed during 3 months.
Other intervention name(s): Mixed treatment program; Standard intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cardiovascular risk; metabolic syndrome; independency; psychopathology
tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study
Condition: Obsessive-compulsive Disorders and Symptoms
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal
      cortex and cathodic stimulation on supplementary motor areas is an effective treatment for
      patients with resistant and severe obsessive compulsive disorders.
    


Intervention name(s): bifocal stimulation with tDCS
Intervention type(s): Other
Intervention description(s): Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Supplementary motor area; Orbitofrontal cortex
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over comparative pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in normal, healthy, adult, human male subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding
      Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma
      Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy,
      adult, human male subjects in a randomized crossover study.

      The study was conducted with 32 healthy adult male subjects. In each study period, a single
      300 mg dose of either test or reference was administered to the subjects as per the
      randomization schedule in each study period with about 240 mL of water at ambient temperature
      in sitting position.

      The duration of the clinical phase was 51 days including washout period of at 18 days between
      administrations of study drug in each study period.
    

Intervention name(s): Allopurinol; Allopurinol
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg tablet once a day; 300 mg tablet once a day
Other intervention name(s): Test Product; Zyloprim®
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Heme Arginate in Healthy Male Subjects
Condition: Healthy Subjects; Heme Oxygenase; Genetic Polymorphism
Study type: Interventional
Phase: Phase 1

Summary: 
      Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor
      modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length
      polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in
      several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1
      stimulation of heme arginate in healthy humans.
    


Intervention name(s): saline solution; heme arginate; heme arginate; heme arginate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous infusion, single dose; intravenous infusion, single dose
0.3 mg/kg heme arginate; intravenous infusion, single dose
1 mg/kg heme arginate; intravenous infusion, single dose
3 mg/kg heme arginate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
Condition: Microcornea Within One Year of Age
Study type: Observational

Summary: 
      This subject is mainly to study difference of Congenital cataract preoperative related
      parameters in children with or without Microcornea within Less than one year old. A total of
      186 eyes of 117 people were collected with relevant ocular biological parameters, including
      age, horizontal diameter of the cornea, Eye axis, intraocular pressure, steep axis of corneal
      curvature, flat axis of corneal curvature, corneal thickness, lens thickness, anterior
      chamber depth. At present, because the definition of patients with small cornea is not clear
      enough, the study subjects are divided into 4 groups according to the horizontal corneal
      diameter of 9.0mm, 9.5mm, and 10.0mm, namely ≤9.0mm group, 9~9.5mm group, 9.5~10.0mm group
      and The >10.0mm group compares the differences between each other, and tries to provide a
      reference for the diagnosis of children with small cornea at a young age.
    


Intervention name(s): Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth
Intervention type(s): Device
Intervention description(s): observation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From May 2015 to December 2020,Congenital cataract children with or without Microcornea
        within one year of age attending the Eye Optometry Hospital of Wenzhou Medical University
Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators will evaluate the safety, pharmacokinetics and effect on
      target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of
      GMI-1271, an E-selectin antagonist, in healthy volunteers.
    

Detailed description: 
      Investigators will evaluate in a single ascending dose (SAD) and multiple ascending dose
      (MAD) fashion, the safety, pharmacokinetics and effect on target biomarkers of coagulation,
      cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist,
      in healthy volunteers.
    

Intervention name(s): GMI-1271; Placebo; Enoxaparin Sodium (Lovenox®)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
Condition: Growth Hormone Deficiency; Turner Syndrome
MeSH terms: Dwarfism, Pituitary; Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims at identifying the predictive markers after one month of Saizen therapy in
      Growth Hormone Deficiency (GHD) and Turner Syndrome children.
    


Intervention name(s): Saizen; Saizen
Intervention type(s): Drug; Drug
Intervention description(s): Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month; Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating
      the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not
      responded to drug treatment.

      Study hypothesis: CBT is an effective treatment for adult ADHD.
    

Detailed description: 
      ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of
      adults. Adults with ADHD are at high risk for academic and occupational underachievement,
      relationship difficulties, and reduced quality of life. This study will determine whether CBT
      is more effective than drug therapy in treating ADHD symptoms in adults who have been
      resistant to previous drug therapies.

      Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or
      drug therapy which may include new or previously taken drugs. Questionnaires will be used to
      assess participants' ADHD symptoms at study start and at study completion.
    

Intervention name(s): Cognitive behavioral therapy; Drug therapy
Intervention type(s): Behavioral; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult; ADHD; ADD
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
Condition: Human Microbiome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on
      the gut microbiome and skin biophysical properties. The fruit is commonly used for skin
      treatments in India. It is thought to have antioxidant properties, reduce inflammation and
      affect the microorganisms in the gut.

      The information the investigators will learn from this study may indicate how and if oral
      dosing can affect the skin and gut microbiome. This may lead to an improved understanding of
      the skin and determine whether these oral products are effective for improving the skin's
      appearance.
    


Intervention name(s): Terminalia Chebula fruit extract; Placebo; Topical Terminalia Chebula; Topical Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Oral TC fruit extract supplement taken by mouth twice per day; Oral placebo taken by mouth twice per day; Applied to both forearms and dorsal hands; Applied to both forearms and dorsal hands
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: gut microbiome; skin; dermatology; terminalia chebula
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess bioequivalence between one test and two reference
      formulations used for treatment of headaches and temporary relief of pain.
    

Detailed description: 
      The study is a single dose, randomized, three-way crossover study in 30 healthy subjects,
      with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not
      be replaced. The three doses of medication given in the study (a single dose in each of the
      three study periods) will each be separated by a washout period of at least 7 calendar days.
      In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken
      over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen
      (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic
      assay. Pharmacokinetic parameters will be calculated from plasma concentration data
      [R-enantiomer, S-enantiomer and total (sum of both enantiomers)]. The rate and extent of
      absorption of the formulations will be compared.
    

Intervention name(s): Ibuprofen; Ibuprofen; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout between visits; A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits; A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits
Other intervention name(s): Not yet marketed; Nurofen Meltlets Orodispersible Tablet; Junior Strength Motrin Chewable Tablet
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science