bioihbjkbjnl/mcl2 huggingface dataset:
Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Condition: Renal Transplant; Atherosclerosis; Arterial Stiffness
MeSH terms: Atherosclerosis; Calcinosis
Study type: Observational

Summary: 
      The purpose of this study is to determine the:

        -  Natural history of calcification posttransplantation

        -  Natural history of BMC following renal transplantation

        -  Reverse correlation between calcification score and aortic calcifications following
           renal transplantation

        -  Correlation of IMT, BMC, PWV and biochemical variables

        -  Correlation of IMT, BMC, PWV, biochemical variables and outcome

        -  Predictors of CV disease after transplantation

        -  Predictors of IMT progression, BMC loss and PWV progression after renal transplantation
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        incident renal transplant recipients
      
Biospecimen description: 
      serum, plasma, urine
    
Keywords: calcification; bone lesions
Action Mechanisms of Shock Waves on Pain
Condition: Asymptomatic Condition
MeSH terms: Asymptomatic Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate whether the intensity of pain perceived during the
      application of extracorporeal shockwave therapy (ESWT) is determinant for producing changes
      in pressure pain threshold (PPT) in asymptomatic subjects. The investigators will perform a
      single controlled random trial to three groups. Two of them will receive ESWT whereas the
      third group will get a cold pressure test (CPT).
    


Intervention name(s): Sham Comparator; Experimental Intervention; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): The investigators will apply a light intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 3/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (3/10 in VAS).; The investigators will apply a moderate intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 6/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (6/10 in VAS).; Patients will place their hand, wide open and up to the wrist, into the inner part of the container and will keep it under water for a maximum time of 2 minutes. If pain is unbearable before the time ends, the participant will be able to withdraw the hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial
      recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic
      parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not
      have received treatment with a factor VIII concentrate for at least 3 days. Blood samples
      will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48
      hours post-infusion. A washout period of at least 3 days, but no more than 30 days between
      the last blood draw and the next infusion will be observed. During participation, subjects
      will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII
      concentrate.

      A secondary objective is to investigate the relationship between pharmacokinetic parameters
      at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and
      von Willebrand factor antigen at baseline.
    


Intervention name(s): Antihemophilic factor, recombinant, manufactured protein-free; Antihemophilic factor, recombinant, manufactured protein-free; Antihemophilic factor, recombinant, manufactured protein-free
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15 IU/kg rAHF-PFM; 30 IU/kg rAHF-PFM; 50 IU/kg rAHF-PFM
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
Condition: Soft Tissue Injuries; Contusions; Strains; Sprains; Bruises
MeSH terms: Sprains and Strains; Soft Tissue Injuries; Contusions
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective of this study is:

      to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in
      patients with acute strains, sprains or bruises of the extremities following blunt trauma,
      e.g. sports injuries.

      to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the
      patch has acceptable local tolerability.
    

Detailed description: 
      Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled,
      double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study
      Sites

      The clinical trial population will consist of male or female patients, 18 - 60 years
      suffering from acute; strains, sprains or bruises of the extremities following blunt trauma,
      and meeting all clinical trial entry criteria.

      200 patients will be enrolled (assumes a drop-out-rate of ≤10%).

      The study will be performed in Germany in 3 sites
    

Intervention name(s): Esflurbiprofen Hydrogel Patch
Intervention type(s): Drug
Intervention description(s): Esflurbiprofen is a cyclooxygenase (COX) inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, double-blind, multi-center
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blunt Trauma
Meta-cognitive Functional Intervention for Adults With ADHD: A Pilot Efficacy Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the initial efficacy of a psycho-social,
      metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit
      Hyperactivity Disorder (ADHD).

      It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate
      improvements in measures of executive functioning, occupational performance and quality of
      life.
    

Detailed description: 
      The Cog-Fun - A is a structured occupational therapy intervention for promoting self
      management in adults with ADHD. The protocol comprises three central treatment modules:
      Adaptive self awareness, executive strategies and skill implementation and multi-context
      transfer of strategies and skills.

      The intervention is administered by occupational therapists on an individual basis, once a
      week, over 3-4 months.

      20 participants will be recruited through community advertising. Sample size was determined
      based on expected moderate effect sizes. Data will be collected at the onset and completion
      of the intervention. Data will be analysed using quantitative and qualitative methods.

      Adverse events if occur will be reported to supervising psychiatrist and the Helsinki
      Committee.
    

Intervention name(s): Cog-Fun - A
Intervention type(s): Behavioral
Intervention description(s): Meta-cognitive functional intervention for improved self management in adults with ADHD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      To test the effectiveness of a single 20-30 minute motivational interviewing-based brief
      intervention for substance use within HIV/AIDS settings.
    

Detailed description: 
      The Substance Abuse Treatment to HIV care (SAT2HIV) project, a Type 2
      Effectiveness-Implementation Hybrid Trial, seeks to address this gap in services by providing
      new knowledge regarding the effectiveness of brief intervention (BI) for substance use within
      community-based HIV/AIDS service settings, as well as new knowledge regarding how to address
      the well-documented underutilization of evidence-based practices in real-world settings. The
      specific aims of this project are: Aim 1: To experimentally test the effectiveness of a
      motivational interviewing-based BI for substance use within community-based HIV/AIDS service
      organizations, relative to usual care (UC). Aim 2: To experimentally test the effectiveness
      of adding an organizational-level implementation intervention called Implementation &
      Sustainment Facilitation (ISF) to enhance the effectiveness of the implementation strategy
      currently used by SAMHSA-funded Addiction Technology Treatment Centers (ATTCs; i.e., online
      introductory training, 2-day training workshop, ongoing feedback and coaching).
    

Intervention name(s): Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Effect of a Multi Strain Probiotic on the Gut Microbiota
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Over recent years there has been a lot of research looking at how the bacteria in our gut
      affect our health. Changes to gut bacteria has been linked to several diseases. Taking
      specific live bacteria supplements (sometimes known as 'probiotics'), to change the balance
      of our gut bacteria to result in a health benefit have been trialled as a treatment option
      for many diseases in recent years.

      Bio-Kult Advanced is a live bacteria Food supplement that contains 14 different bacteria
      cultures. The effect of Bio-Kult Advanced on gut bacteria is unknown, therefore, the aim
    

Detailed description: 
      There is rapidly growing interest in the involvement of the microbiome in health. Imbalance
      in human gut microbiota, 'dysbiosis', has been linked to several diseases. Manipulation of
      the microbiome, using specific strains of live micro-organisms, that confer a health benefit
      on the host (probiotics), have therefore become an exploratory treatment option in
      microbiome-associated diseases in recent years. Numerous studies have shown selected strains
      of bacteria to show statistically significant and clinically relevant improvement in
      symptoms, in a number of diseases, including but not limited to infantile colic and atopic
      dermatitis.

      Bio-Kult Advanced (BKA) is a 14 strain live bacteria supplement containing a Minimum 2
      billion live microorganisms per capsule (2x109 CFU/capsule), equivalent to 10 billion live
      microorganisms per gram (1x1010 CFU/gram). A randomised controlled trial of Bio-Kult Advanced
      in the management of diarrhoea predominant IBS demonstrated significant improvement in
      gastrointestinal (GI) symptoms and was well tolerated by participants. Another randomised
      controlled trial of Bio-Kult Advanced, in participants with episodic and chronic migraine
      sufferers, demonstrated significant improvement in frequency and severity of migraines
      compared to placebo. This clinical effectiveness across various conditions, suggest that
      bacterial strains in Bio-Kult could have an effect on the gastrointestinal flora, however
      data has yet to be collected that explores the effect of Bio-Kult on the microbiome. The aim
      of this study is to therefore investigate the effect of Bio-Kult Advanced, on the composition
      of the gut microbiota in healthy adults.
    

Intervention name(s): Fasted breath samples; Daily Diary; Stool sample
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will provide fasted breath samples pre and post Bio-Kult Advanced.; Monitoring stool form, consistency and frequency on a daily basis.; Participants will provide stool sample pre and post Bio-kult Advanced.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Probiotics; Microbiome; Gastrointestinal
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To generate initial information on the pharmacokinetics (blood levels) and dose
      proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess
      the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children;
      and to confirm that the single doses that achieve certain plasma levels in adults achieve
      similar levels in HIV-infected children.

      Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction)
      of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus
      that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious
      adverse effects.
    

Detailed description: 
      Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction)
      of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus
      that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious
      adverse effects.

      Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days
      after the third patient receives the lower dose, three additional patients receive the higher
      dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood
      levels of the drug.
    

Intervention name(s): Nevirapine
Intervention type(s): Drug
Intervention MeSH terms: Nevirapine
Primary purpose: Treatment
Keywords: Benzodiazepines; Drug Evaluation; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Antiviral Agents
Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to to demonstrate the feasibility and tolerability of the use of
      Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated
      dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on
      withdrawal symptoms, craving scores and cannabis consumption during the study period.
    

Detailed description: 
      This will be a one year pilot/feasibility study, assessing the effects of fixed or
      self-titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a
      buccal spray) on withdrawal from cannabis and craving among cannabis dependent subjects.
      Subjects in this study will undergo an 8-week double-blind, placebo-controlled trial.
      Subjects will be regular cannabis-users who are not currently seeking treatment for cannabis
      dependence. Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an
      ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence
      conditions. During each abstinence condition (B, C, D, E conditions), subjects will be
      allocated to one condition including self-titration of placebo, fixed dose of placebo,
      self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed
      dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout
      period where individuals will be requested to smoke cannabis as usual (A condition). The
      experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and
      titration regimen (fixed or self-titrated). This pilot study will allow us to demonstrate the
      feasibility of our approach and to determine the sample size to use secondarily for a larger
      study. Our ultimate goal is to determine optimal conditions to use for a subsequent
      randomized controlled trial assessing the efficacy of SATIVEX® in treatment of Cannabis
      dependence among treatment-seeking subjects.
    

Intervention name(s): Sativex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other intervention name(s): Delta-9-tetrahydrocannabinol and cannabidiol; Ethanol, propylene glycol and peppermint oil with colors
Intervention MeSH terms: Ethanol; Nabiximols; Dronabinol; Cannabidiol; Peppermint oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cannabis dependence; Sativex
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a phase I/II study to determine the safety and efficacy of AMD3100 when
      combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory
      AML.

      We hypothesize that disrupting the interaction between AML blasts and the marrow
      microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.
    

Detailed description: 
      The interaction of leukemic blasts with the bone marrow microenvironment is postulated to be
      an important mediator of chemoresistance in AML. Although a number of receptor / ligand pairs
      have been implicated, the CXCR4 / SDF-1 axis functions as the principal regulator of homing
      and retention of both normal and malignant hematopoietic cells in the marrow. AMD3100 is a
      bicyclam molecule which reversibly blocks CXCR4 binding to SDF-1 and is being developed
      clinically as a mobilization agent for hematopoietic stem cell transplantation. Preclinical
      data from our group has demonstrated that in murine models, plerixafor can disrupt the
      interaction of leukemic cells with the marrow microenvironment and sensitize blasts to the
      effect of chemotherapy. Based on these data, we have initiated a phase I/II study in patients
      with relapsed or refractory AML in which plerixafor is administered prior to salvage
      chemotherapy.
    

Intervention name(s): AMD3100; Mitoxantrone; Etoposide; Cytarabine
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Plerixafor; Novantrone; VP-16; Vepesid; Etopophos; Ara-C; Cytosar-U; Tarabine PFS
Intervention MeSH terms: Cytarabine; Plerixafor; Etoposide; Mitoxantrone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plerixafor; CXCR4; Chemosensitization
Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity
Condition: Preterm
MeSH terms: Retinopathy of Prematurity
Study type: Interventional

Summary: 
      The aim of this study is to evaluate efficacy of bovine colostrum administration as a
      prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in
      preterm neonates of gestational age less than 32 weeks during their hospital stay.
    

Detailed description: 
      This study will include a randomized controlled trial carried out on preterm neonates who
      will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital.
      Evaluation of the outcome will be done only for those who admitted to the neonatal intensive
      care unit (NICU) at Alexandria University Children's Hospital.

      The study will be carried out in 4 phases:

        1. First phase: Enrollment and selection phase.

        2. Second phase: Intervention phase ( enteral bovine colostrum administration) .

        3. Third phase: Evaluation phase.

        4. Fourth phase: collected data analysis and results.
    

Intervention name(s): The bovine colostrum ( trade name : baby steps sachets, 300mg ); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days.
Enteral route, either through nasogastric tube or orally.; distilled water with no bovine colostrum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Premature infants; colostrum; ROP
The Effect of Cold Exposure on Glucose Tolerance
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of cold exposure on an individual's
      glucose tolerance. Previous research has already shown that 10 days acclimation to a mild
      cold environment (14-15°C) can enhance insulin sensitivity. However, the duration in the cold
      environment was 6 hours per day which may not be practical for everyone. Therefore, the
      present study will investigate the effect of a shorter, and more intense cold exposure on an
      individual's glucose tolerance. It is hypothesised that cold exposure before consuming a
      glucose drink will enhance glucose clearance.
    


Intervention name(s): Temperature
Intervention type(s): Other
Intervention description(s): Water-perfused suit.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: It is anticipated that 32 participants will enrol in the study. Specifically, 16 participants will be healthy individuals and the other 16 will be individuals with impaired fasting glucose (5.6 mM to 6.9 mM) and/or blood glucose values 7.8-11.0 mM 2h after glucose drink consumption during the OGTT in screening. Initially, the study will investigate the effect of the cold exposure on healthy individuals, and then depending on the results in these individuals, the intervention may be tested on participants with impaired glucose metabolism.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cold Exposure; Glucose Tolerance