bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants
Condition: Dermatitis, Atopic; Asthma; Healthy
MeSH terms: Asthma; Dermatitis, Atopic; Dermatitis; Eczema; Blister
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the cell (the basic building block of all living
      things) populations and inflammatory (pain and swelling) mediator responses in suction skin
      blister fluid after allergic skin reaction (ASR) [rash] induction with D. Pteronyssinus
      [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus allergens in
      participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma (AA)
      [breathing disorder in which there is a wheezing and difficulty breathing].
    

Detailed description: 
      This is an interventional (a treatment given during the course of a research study) and
      multicenter (when more than one hospital or medical school team work on a medical research
      study) study. The study will consist of 3 Phases: Screening Phase (Up to 4 weeks), Data
      Collection Phase (9 days) and, Follow-up Phase (7 days). The maximum study duration for each
      participant will not exceed 43 days. Primarily, the cell populations and inflammatory
      mediator responses in suction skin blister fluid after allergic skin reaction (ASR) will be
      assessed. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Allergic Skin Reaction (ASR) Testing and Skin Blister Induction
Intervention type(s): Other
Intervention description(s): Participants will not receive any intervention in this study. Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. The cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) in participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Asthma; Healthy; Skin Blisters; Adult Participants
The Relationship Between Sleep Disorders and Cytokine Levels Among Hemodialysis and Peritoneal Dialysis Patients
Condition: Renal Failure; Sleep Disorder; Hemodialysis; Peritoneal Dialysis
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Observational

Summary: 
      Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and
      peritoneal dialysis and are associated with significant medical, psychological and social
      disturbances. Numerous factors have been suggested as contributing to or associated with the
      high prevalence of sleep disturbance in this population.

      Increasing evidence suggests that cytokines are involved in the regulation of sleep and
      wakefulness and that the communication between the sleep and the immune system is
      bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy
      has the potential to activate mononuclear cells leading to production of inflammatory
      cytokines. These cytokines are believed to play a significant role in dialysis-associated
      morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in
      chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients.
      In the other way, sleep loss may have effects on immune process and secretion of cytokines in
      chronic dialyzed patients. The purpose of this study was to examine the relationship between
      quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.
    


Observational model: Defined Population
Time perspective: Other
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hypertrophy With Outflow Obstruction; Overactive Detrusor
MeSH terms: Prostatic Hyperplasia; Urinary Bladder, Overactive; Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      Persistent detrusor overactivity (DO) after transurethral prostatectomy results in
      symptomatic failure in more than one third of the patients. Storage symptoms are major
      complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate
      (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and
      smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased
      after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with
      benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO
      by the medical or surgical treatment have not been fully investigated. If the elevated
      urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of
      urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the
      operation.

      The aims of this study are to measure the urinary NGF levels in patients with BPO and to
      compare the results between the patients with detrusor overactivity (DO) and without detrusor
      overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate
      (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of
      postoperative 3 months and 6 months, and compare changes between the two groups.
    

Detailed description: 
      -  Investigators are going to enroll age-matched control group and measure the urinary NGF
           levels as a baseline value (30 males).

        -  Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50
           patients).

        -  Administration of the anti-cholinergic agents was reported to decrease urinary NGF
           levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.
    

Intervention name(s): Holmium Laser Enucleation of the Prostate (HoLEP); Holmium laser enucleation system and morcellator
Intervention type(s): Procedure; Device
Intervention description(s): Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.; Holmium laser enucleation and morcellation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign prostatic obstruction (BPO); Detrusor overactivity (DO); Urinary nerve growth factor (NGF)
Video Analysis of Vaginal Deliveries
Condition: Birth Trauma
MeSH terms: Birth Injuries
Study type: Observational

Summary: 
      Video documentation of vaginal deliveries to evaluate the impact of the support of the
      perineum
    

Detailed description: 
      Documentation of support of perineum via video camera, documentation of birth trauma after
      delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women
      
Keywords: perineum; videoanalysis
Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
Condition: Psilocybin; Hallucinogens; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to finalize methods for a larger study being planned for the future.
      This research is being done to characterize performance of tasks, brain functioning, and the
      effects of psilocybin in individuals with a long-term meditation practice.

      There are three different parts of the pilot study:

        1. Effects of psilocybin on psychological function: This version of the pilot study will
           involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment
           visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on
           the Johns Hopkins Bayview Campus).

        2. Performance on behavioral and cognitive tasks: This version of the pilot study will
           involve completing various behavioral and cognitive tasks at our research unit. You will
           make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins
           Bayview Campus).

        3. Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI)
           measurements. You will make a total of about 2 to 5 visits to our research unit (the
           BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the
           F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the
           Johns Hopkins Hospital).

      People who are between the ages of 25 and 80 years old, who have a current, regular
      meditation practice, and who meet the medical requirements may join.
    


Intervention name(s): psilocybin
Intervention type(s): Drug
Intervention description(s): dose manipulation as described in the protocol
Intervention MeSH terms: Psilocybin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Psilocybin; Hallucinogens; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs
Polymorphism C677T MTHFR and Effects of Folate Intake
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The C677T polymorphism in the MTHFR gene is related to several significant biochemical
      changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12
      and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the
      emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially folate,
      is characterized by being beneficial for individuals with this genetic alteration to possess
      anti-inflammatory function, act on and oxidative stress play an important gene function. The
      aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR gene
      and the effect of a diet containing folate on oxidative stress, lipid profile and
      homocysteine levels in adult women are overweight or obese. This is an intervention study,
      double-blind, held in a city in northeastern Brazil. The study included 48 adult women (20-59
      years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated the CAT levels,
      MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition genotyping for the
      C677T polymorphism in the MTHFR gene and the food consumption by the food recall 24 hours,
      being divided by randomization into two groups received daily for 8 weeks, 300g vegetables
      rich in folate containing 191 ug and 90 ug of this nutrient.
    

Detailed description: 
      This work is linked to a population-based survey entitled "Diagnosis and Intervention II
      Cycle Situation Food, Nutrition and Noncommunicable Diseases prevalent over the city of João
      Pessoa Population / PB" (II DISANDNT / PB). For the realization of this dissertation home
      visits and the questionnaires related to anthropometric and food intake assessment were
      conducted by teams of undergraduate researchers and graduates of Nutrition Course, masters
      and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) of UFPB duly
      previously trained at the beginning of data collection and after completion of the pilot
      study.

      After the selection of individuals from the sample of adults who participated in the II
      DISANDNT / JP and considering the inclusion criteria and genotyping of the C677T polymorphism
      in the MTHFR gene, they were invited to participate.
    

Intervention name(s): 191 mcg/day of Folate; 90 mcg / day of Folate
Intervention type(s): Other; Other
Intervention description(s): Diet containing 191 mcg / day of Folate; Diet containing 90 mcg / day of Folate
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Polymorphism; Folate; Oxidative stress; Overweight and Obesity
Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
Condition: Vaginal Atrophy; Urinary Incontinence,Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Atrophy
Study type: Observational

Summary: 
      Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common
      for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no
      study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the
      efficacy of LLLT in alleviating GSM and SUI.
    

Detailed description: 
      Between September 2022 and August 2023, all women who received LLLT for GSM and SUI at the
      gynecologic outpatient clinic of a hospital were retrospectively reviewed. The treatment was
      once a week for eight weeks. Vaginal health index (VHI) and questionnaires before and after
      treatment for evaluation of lower urinary tract symptoms (LUTS) and quality of life are the
      outcome assessment.
    

Intervention name(s): Low-level laser therapy
Intervention type(s): Device
Intervention description(s): The treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The consecutive women who received LLLT at the gynecologic outpatient clinic were
        retrospectively reviewed. Menopause was defined as no spontaneous menstruation for at least
        one year. GSM is defined as vulvovaginal dryness and related symptoms, such as irritation,
        dyspareunia, or lower urinary tract symptoms (LUTS) including urinary urgency, dysuria, and
        recurrent urinary tract infection after menopause. SUI was defined as involuntary loss of
        urine on effort or physical exertion including sporting activities, or on sneezing or
        coughing.
      
Keywords: Menopause; Stress urinary incontinence; Vaginal atrophy; Low-level laser therapy
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Condition: Breast Cancer; Surgery
MeSH terms: Breast Neoplasms; Hyperalgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      After surgery, sensitization and hyperexcitability of central nervous system result in acute
      and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA)
      receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate
      analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential
      components of cells functioning and are also known as allosteric modulators of NMDA
      receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive
      properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free
      diet in women operated on breast cancer versus kétamine
    

Detailed description: 
      This multicentric, single blind study will enrol 160 women (18-75 years old) operated on
      tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be
      randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine
      group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 =
      polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine +
      polyamine-free diet (n = 40).

      The amount of morphine for the 24 first postoperative hours will be compared between each
      group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer).
      Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months
      using adequate questionnaire ( analgesic scale). Diet observance will be controlled
      preoperatively by a dosage of polyamines in circulating red cells blood.

      Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared
      (isobolographic method). Anti-hyperalgesic properties of ketamine have already been
      demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or
      synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve
      better postoperative rehabilitation in reducing chronic pain after surgery.
    

Intervention name(s): polyamine-free diet; Ketamine or placebo
Intervention type(s): Behavioral; Drug
Intervention description(s): Polyamine-free diet in the 7 days befor surgery; Peroperative and post operative (48h) ketamine injection
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polyamines; pain; breast cancer; mastectomy; post operative pain
Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
Condition: Asthma
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on
      respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of
      attacks and effect on serum cytokine levels.
    

Detailed description: 
      Context: Respiratory infections are the major cause of wheezing attacks in children with
      recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been
      proven to prevent respiratory infections about 40 percent in children.

      Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory
      infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use,
      and number and duration of hospitalizations in children with recurrent wheezing and asthma.
      And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.

      Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV
      versus placebo for children 6 months to 6 years of age who have respiratory tract infection
      related recurrent wheezing attacks.

      Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.

      Study Measures: They follow up for 1 year for number and duration of wheezing attacks,
      number, type and duration of respiratory infections, number and duration of beta-2 agonist
      use, number and duration of steroid use and number and duration of hospitalizations. Serum
      cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine
      levels (at the beginning of the trial and sixth months of the trial).
    

Intervention name(s): OM-85 BV (Broncho-Vaxom); OM-85 BV (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months; 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months
Other intervention name(s): Bronchovaxom 3.5 mg capsule; Bronchovaxom 3.5 mg placebo capsule
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: wheezing; asthma; childhood; OM-85 BV; Broncho-Vaxom
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the effect of dosing regimens of multiple
      subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while
      decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.
    

Detailed description: 
      The primary rationale for this study is to define an optimal rAvPAL-PEG dose regimen by
      establishing the therapeutic effect within the shortest time possible time for induction,
      titration and maintenance phases while reducing the severity and frequency of
      hypersensitivity reactions that may lead to dose interruptions. It is hypothesized that these
      goals can be achieved by keeping rAvPAL-PEG doses low when anti-PEG IgM response is predicted
      to be high and titrating to an efficacious dose once the IgG response to PAL has developed.
      Further investigation is needed to determine how early and quickly patients can titrate
      safely to lower blood Phe; therefore, this protocol proposes to assess two Groups using an
      induction/titration and maintenance schedule with an aim towards establishing the therapeutic
      effect safety within an optimal period of time.
    

Intervention name(s): BMN 165 (rAvPAL-PEG)
Intervention type(s): Biological
Intervention description(s): Subcutaneous injection of rAvPAL-PEG administered from 1 time up to 5 times per week between 2.5mg up to a maximum of 375mg for 24 weeks.
Other intervention name(s): Recombinant Anabaena variabilis phenylalanine ammonia lyase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PKU; Injections; PEG-PAL; PAL
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to evaluate the safety and tolerability of ACT-451840
      in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK)
      of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the
      urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.
    


Intervention name(s): ACT-451840 10 mg; ACT-451840 50 mg; ACT-451840 200 mg; ACT-451840 500 mg; ACT-451840 1000 mg; ACT-451840 (Dose to be determined); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water; ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water; ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water; ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water; ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water; ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ACT-451840; Safety; Tolerability; Pharmacokinetics