bioihbjkbjnl/mcl2 huggingface dataset:
Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
Condition: Frail Elderly Syndrome
Study type: Interventional

Summary: 
      Aging generates immune, muscular and functional changes. In the pre-frail elderly these
      changes may be increased and, therefore, preventive interventions are indicated to minimize
      the consequences of sarcopenia in this population. This study aims to evaluate the effects of
      a whole body vibration training associated with the training of inspiratory muscles on the
      inflammatory, muscular and body composition outcomes in pre-frail elderly women.
    


Intervention name(s): WBV + IMT; WBV + IMTsham; WBVsham + IMTsham
Intervention type(s): Other; Other; Other
Intervention description(s): The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.; The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.; Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aging; whole body vibration; respiratory muscle training
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in
      male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract
Condition: Allergy Dermatophagoides Pteronyssinus; Allergic Rhinitis; Allergic Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Dermatophagoides
      pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used
      as in-house reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a
      positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a
      glycerinated phenol saline solution, respectively, will be tested in every patient in
      duplicate on the volar surface of the forearm.
    

Intervention name(s): Prick test Dermatophagoides pteronyssinus allergen extract
Intervention type(s): Biological
Intervention description(s): This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: standardization; skin prick test; inmunotherapy
Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)
Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a
      alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of
      3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that
      carvedilol will attenuate the cardiovascular and subjective response to MDMA.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE
      release is thought to mediate the cardiovascular effects of MDMA and may also contribute to
      its psychostimulant effects. However, the functional role of adrenergic postsynaptic
      receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear.
      To determine the role of alpha- and beta adrenergic receptors in the response to MDMA in
      humans the investigators test the effects of the alpha- and beta-receptor blocker carvedilol
      on the physiological and subjective effects of MDMA. The investigators use a randomized
      double-blind placebo-controlled cross-over design with four experimental sessions. Carvedilol
      or placebo will be administered 1 h before MDMA or placebo to 16 healthy volunteers.
      Subjective and cardiovascular responses will be repeatedly assessed throughout the
      experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is
      that carvedilol will significantly reduce the blood pressure response to MDMA.
    

Intervention name(s): 3,4-Methylenedioxymethamphetamine; carvedilol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg per os, single dose; 50 mg per os, single dose; capsules identical to MDMA or carvedilol
Other intervention name(s): MDMA; Ecstasy; Adam
Intervention MeSH terms: Carvedilol; N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; carvedilol; norepinephrine; alpha - beta receptor; Ecstasy; stimulant
Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses
Condition: Glycemic Response
Study type: Interventional

Summary: 
      The aim of this study is to determine whether eating breakfast or having no breakfast has
      subsequent beneficial health effects, specifically in relation to glycemic response
      throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6
      hours after breakfast/lunch.
    

Detailed description: 
      This will be a randomised, crossover study with two treatments in total. 1.) Subjects given
      with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for
      approximately 9 hour (spanning over 3 days), during which the following will take place: On
      Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted.
      CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling
      catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be
      kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be
      collected. Participants with breakfast treatment will then consume the test meal within 15
      minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180
      minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed
      within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360
      minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will
      come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between
      visits.
    

Intervention name(s): Breakfast; No Breakfast
Intervention type(s): Other; Other
Intervention description(s): Glutinous rice (75 grams of available carbohydrate); No food to be served in the morning
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, crossover study with two treatments
Masking: None (Open Label)
Primary purpose: Other
Peanut Allergy Oral Immunotherapy Desensitization
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine how a type of treatment for peanut allergy known as
      oral desensitization works in the immune system.

      Objectives

        1. To determine whether premedication with desloratidine and ranitidine results in fewer
           side effects during desensitization procedure.

        2. To assess quality of life in peanut allergic subjects before and after desensitization.

        3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.
    

Detailed description: 
      Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal
      food allergic reactions, and the only treatment is complete avoidance of peanut. Despite
      avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been
      shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect
      patients who have no other treatment, and may even form the basis for true tolerance to
      peanut in the future.

      Objectives:

        1. To determine whether premedication with desloratidine and ranitidine results in fewer
           side effects during desensitization procedure.

        2. To assess quality of life in peanut allergic subjects before and after desensitization.

        3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.
    

Intervention name(s): Peanut protein; Oat flour; Antihistamine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): 500 mg; 500 mg Oat flour; Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid
Other intervention name(s): Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour; Desloratadine and Ranitidine
Intervention MeSH terms: Ranitidine; Desloratadine; Histamine Antagonists; Histamine H1 Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of the study are to evaluate the safety and efficacy of open label treatment
      with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated,
      non-severe cutaneous leishmaniasis (CL).
    

Detailed description: 
      Patients with suspected CL will be screened up to a 14 day period for eligibility including
      parasitology for confirmation of ulcerative CL. Recruitment will primarily be from patients
      exposed to leishmaniasis. A target enrollment of 30 patients will receive WR 279,396 (15%
      paromomycin + 0.5% gentamicin topical cream) once daily for 20 days.

      The index lesion and all other ulcerated lesions will be assessed for clinical response by
      measurement of the length and width of area of ulceration. A lesion will be considered to be
      completely cured if 100% re-epithelialization is observed. Non-ulcerated lesions will also be
      measured to monitor the total area of exposure of lesions to study drug and will be evaluated
      for cure.
    

Intervention name(s): WR 279,396
Intervention type(s): Drug
Intervention description(s): Paromomycin + Gentamicin Topical Cream
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; Paromomycin + Gentamicin Topical Cream; Safety; Efficacy
Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative
      second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth
      salts are not available. The investigators compare the efficacies of 10-day
      levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients
      after failure of standard triple therapy and to determine what clinical and bacterial factors
      influencing the efficacy of salvage regimens.
    

Detailed description: 
      In this randomized-controlled trial , the investigator recruited participants with H pylori
      infection after failure of first line standard triple therapy. Using a computer-generated
      randomization sequence, the investigators randomly allocated patients to either 10-day
      levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5
      days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5
      days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d.,
      amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the
      eradication rate by intention-to-treat and per-protocol analyses.
    

Intervention name(s): Nexium; Amolin; Cravit; Flagyl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm; Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm; Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm
Other intervention name(s): Esomeprazole; Amoxicillin; Levofloxacin; Metronidazole
Intervention MeSH terms: Amoxicillin; Metronidazole; Levofloxacin; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Proton pump inhibitor; Eradication
Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in
      combination with omeprazole in healthy participants.
    


Intervention name(s): AMG 510; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Capsule
Other intervention name(s): Sotorasib
Intervention MeSH terms: Sotorasib; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMG 510; Healthy Participants; Omeprazole
Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa
Condition: Pseudomonas Infection; Cystic Fibrosis
MeSH terms: Infections; Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Some bacteria that cause disease can produce toxic substances that may worsen the disease.
      Pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special
      interest for patients with cystic fibrosis and repeated long term lung infections.

      The goal of this study is to determine whether specific toxins produced by Pseudomonas
      aeruginosa may be important in the disease process of chronic lung infections of patients
      with cystic fibrosis.

      This study will attempt to measure bacterial production of toxins in blood and sputum and
      immune system response to toxins in the blood....
    

Detailed description: 
      The goal of this study is to determine whether virulence determinants that use the type
      III-secretory pathway may be important in the pathogenesis of chronic Pseudomonas aeruginosa
      lung infections in patients with cystic fibrosis (CF). The studies will quantify bacterial
      effector proteins in serum and sputum and the immune response to specific products as
      reflected by antibodies in serum. Candidate effector proteins include: (1) exotoxin A, a
      non-type III-dependent ADP-ribosyltransferase and cytotoxin that does not use the Type III
      secretory pathway, (2) ExoS, a type III pathway-dependent extracellular
      ADP-ribosyltransferase with cytotoxic activity, (3) ExoU, another type III-dependent
      cytotoxin, that is responsible for epithelial injury in acute lung infections, and (4) PcrV,
      a homolog to the V antigen of Yersinia.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with cystic fibrosis being treated with antibiotics, patients with cystic fibrosis
        who have not undergone antibiotic therapy, and control patients.@@@@@@
      
Keywords: Cystic Fibrosis; Effector Proteins; Cytotoxin; Lung Injury; Genetic Screen; Natural History
A Culinary-Based Intensive Lifestyle Program for Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study team proposes in this pilot to test, in a single-arm mixed-methods study, the
      feasibility, acceptability, and preliminary effectiveness of the 16 modular classes taught by
      a chef, dietitian, and health coach. While the pilot may not have the power to detect
      significant change, it will provide preliminary data for a NIH application to further test
      this curriculum in a pragmatic, community-based, randomized multi-site Teaching Kitchen
      Collaborative Curriculum (TKCC) study planned for Jan 2022 or thereafter. If effective, the
      TKCC has potential to impact population health through translation into teaching kitchens
      nationally and adaptation to clinic /community settings.
    


Intervention name(s): Teaching Kitchen Collaborative Curriculum
Intervention type(s): Behavioral
Intervention description(s): This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury
Condition: Orthostatic Hypotension; Postural Hypotension
MeSH terms: Spinal Cord Injuries; Hypotension, Orthostatic; Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and
      prolonged fall in blood pressure when assuming an upright position, such as transitioning
      from lying to sitting or standing, a condition also known as orthostatic hypotension (OH).
      Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating
      symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness.
      Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI.
      Clinical observations suggest that OH can lead to neurological deterioration in individuals
      who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation
      in 43% of physical therapy treatment sessions in a study of individuals with acute SCI
      despite the use of current treatment options. OH is known to adversely affect health, delay
      rehabilitation and prolong hospitalization in the acute phase of management of individuals
      who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical
      SCI at our center in 2004.

      We plan to research the efficacy of a low-cost, non-invasive device known as transcranial
      electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous
      studies have shown that this device is safe to use in individuals with SCI, and has improved
      blood pressure control in non-SCI individuals.

      We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will
      elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress.
      TES-induced differences will be most pronounced in those individuals with sparing of spinal
      autonomic pathways
    


Intervention name(s): transcranial electrical stimulation
Intervention type(s): Device
Intervention description(s): TES: medical device TRANSAIR: electrodes placed on the forehead and over the mastoid processes using Velcro straps. Treatment protocol: six 30-minute sessions over a two-week period and stimulation variables (bipolar current; 1.0-3.0 milliamp (mA) amplitude, 3.5 ms duration and 77.5 Hz frequency).
Other intervention name(s): TRANSAIR (TES Center, St Petersburg, Russia)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; cardiovascular; orthostatic hypotension; transcranial electrical stimulation; electrotherapy