bioihbjkbjnl/mcl2 huggingface dataset:
Efavirenz and Ritonavir on Human Brain P-Glycoprotein
Condition: Drug Effects
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in
      human brain.
    

Detailed description: 
      Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain
      P-glycoprotein, and positron emission tomography (PET), administered after nothing (control),
      oral ritonavir (3d), and oral efavirenz (14d) with washout in between
    

Intervention name(s): [11C] desmethyl-loperamide; Control - no pretreatment; Oral ritonavir; Oral efavirenz
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging; Session 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI; Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI; Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI
Intervention MeSH terms: Ritonavir; Efavirenz; Loperamide; Antidiarrheals
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PET Imaging; Efavirenz; Ritonavir; [11C] desmethyl-loperamide; Healthy volunteers
Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors
Condition: Malignant Solid Tumour
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of Bevacizumab plus allogeneic natural
      killer (NK) immunotherapy to many kinds of recurrent solid tumors.
    

Detailed description: 
      By enrolling patients with recurrent solid tumors adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using Bevacizumab and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Bevacizumab; NK immunotherapy
Intervention type(s): Drug; Biological
Intervention description(s): 7.5 mg/kg, i.v, once every 3 weeks (continuous); Each treatment: 8~10 billion cells in all, transfusion in 3 times, i.v.
Other intervention name(s): Anti-VEGF, Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vascular Endothelial Growth Factor (VEGF) antibody; solid tumor; NK Immunotherapy
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for
      subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".

      Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic
      variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)
    

Detailed description: 
      Glycemic control remains a significant challenge for adult, adolescent and pediatric Type 1
      diabetics. The current first line standard of care continues to be MDI therapy utilizing a
      long acting analog insulin. Continuous Glucose Monitoring (CGMS) is currently used by
      clinicians to record continuous, retrospective glucose measurements, which aid in
      identification of glycemic excursion patterns. This data is then used to make future therapy
      change recommendations. The MiniMed Paradigm REAL-Time System transmits real-time glucose
      measurements to the insulin pump every 5 minutes, allowing users to view their current
      glucose values, as well as to review glycemic excursions and trends over a 24-hour period.
      Additionally, data can be downloaded from the monitor to a personal computer, using
      appropriate software, so that the patient and physician can see a complete picture of glucose
      trends over time. The System will also alert users of high and low glucose levels, and allow
      subjects and their clinicians to treat to a therapeutic target HbA1c under carefully
      monitored conditions.

      Subjects wearing the MiniMed Paradigm REAL-Time System will be compared to subjects that
      continue on their current MDI therapy, that includes a long acting analog insulin, over a 12
      month period to evaluate changes in glycemic control (HbA1c).
    

Intervention name(s): MiniMed Paradigm REAL-Time System
Intervention type(s): Device
Intervention description(s): Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter
Other intervention name(s): Medtronic Paradigm REAL-Time System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycemic control; Sensor
Investigation of the Impact of Burn Injury on Parents
Condition: Burns; Parents
MeSH terms: Burns
Study type: Observational

Summary: 
      Burn injuries are related to longer hospital stay. Patients who have a burned child are
      affected prolonged hospitalization. Social life and quality of life are affected by burn
      injuries. Therefore, the aim of this study is to investigate the effects of burn injury on
      parents.
    

Detailed description: 
      Pediatric burn injuries is commonly seen. Burn injuries are extended from minor injuries to
      severe injuries. The severity of burn injury may affect burn related complications such as
      scar tissue and duration of hospitalization. This process extremely affect parents. Although
      parents are part of this prolonged treatments process, there is no study that evaluated of
      the impact of burn injury on parents. Therefore, the aim of this study is to investigate the
      effects of burn injury on parents.
    

Intervention name(s): Family impact scale
Intervention type(s): Other
Intervention description(s): The family Impact Scale (FIS) will be completed by the parents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parents who have a burned child
      
Keywords: Burn Injury; quality of life; scar
Cortisol in the Treatment of Phobias
Condition: Phobia
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      The aim of this prospective, double-blind, placebo-controlled, randomized study is to
      investigate if glucocorticoid treatment, in combination with exposure therapy, helps to
      reduce phobic fear in patients with phobia.
    


Intervention name(s): Cortisol
Intervention type(s): Drug
Intervention description(s): 20 mg for 3 times
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phobia; cortisol; memory; treatment
Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects
Condition: Skin and Connective Tissue Diseases
MeSH terms: Connective Tissue Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and
      Liquid Paraffin in healthy Japanese male subjects.
    


Intervention name(s): LEO 80185 gel, vehicle, liquid paraffin
Intervention type(s): Drug
Intervention description(s): Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.
Intervention MeSH terms: Mineral Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LEO 80185 gel; calcipotriol; betamethasone
A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
Condition: Heloma Durum
Study type: Interventional

Summary: 
      This is an open-label, single-centre, parallel-group clinical investigation to evaluate the
      symptomatic pain relief, consumer acceptability and in-use tolerability of the Scholl Corn
      Foam Cushion in participants suffering from painful Heloma Durum over a 72-hour at home
      in-use period compared to a no-treatment control group.
    

Detailed description: 
      The investigation design will include an enrolment and randomisation visit followed by an at
      home in-use period and a final follow up phone call. The enrolment visit will include
      confirmation of eligibility and collection of baseline data, including baseline pain scores
      using the Visual Analogue Scale (VAS), medical history, demographics, and baseline Patient
      Reported Outcomes (PRO) assessments. Baseline data collected will be assessed to confirm
      eligibility before randomisation, first product application (treatment group only), initial
      pain (VAS) Participant Perceived Questionnaires (PPQ) and PRO assessments. During the at home
      in-use period, those participants randomised to the treatment group will reapply the product
      daily, complete pain assessments using the VAS (morning and evening), PPQs and PROs (Day 3
      evening only). For participants randomised to the no-treatment group, they will complete pain
      assessments using the VAS (morning and evening) and PROs (Day 3 evening). All participants
      will continuously record Adverse Events (AE) and changes to concomitant medication throughout
      this period. During the follow up phone call, the participants will be contacted to establish
      any further AEs and/or changes to concomitant medication, additionally any queries related to
      diary entries will be made during this phone call. Participants will not need to return to
      the site unless advised to do so by the Principal Investigator (PI) or delegate.

      After completion of the investigation, the Investigator will make an Assessment of Tolerance
      for each subject based on their pain scores (VAS), PPQ responses and AEs reported.
    

Intervention name(s): Corn Foam Cushion
Intervention type(s): Device
Intervention description(s): An anatomically shaped foam pad with a central hole. The upper layer is made from a honeycomb of interconnecting cells, the external facing surface is smooth, the underside is coated with adhesive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An open label, randomized parallel group, no treatment control investigation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VAS Pain Assessment; Symptomatic Pain Relief
Nutritional Intervention for Children With ASD and/or ADHD
Condition: ADHD; ASD; Probiotics; Microbiota
Study type: Interventional

Summary: 
      Based on alterations in the intestinal microbiota in children with ASD and the high
      comorbidity between ASD and ADHD, the aim of this project was to assess whether the
      administration of probiotics with strains related to the production of the neurotransmitters
      dopamine and GABA had a positive effect on social behavior, attention, and behavior.
    

Detailed description: 
      We hypothesized to find differences in the composition and / or function of the microbiota of
      the gastrointestinal tract of children with ASD and / or ADHD. We consider that the
      intervention with probiotics (and specifically with GABA and dopamine producing strains), can
      modify the composition and / or function of the GIT microbiota and change the child's
      behavior, partially reducing the symptoms of attention deficit, anxiety, irritability,
      impulsivity and restlessness associated with diagnoses and consequently, we believe that it
      could improve the quality of life for children and their families. Apart from the clinical
      evaluation of the disorder and associated psychopathological symptoms and neuropsychological
      deficit, the diet, lifestyle and anthropometric characteristics of the child will be
      evaluated, which can influence the composition and / or function of gut the microbiota.

      The sample that will be part of the study will be 80 children, 40 with a diagnosis of ASD and
      40 with a diagnosis of ADHD. These children will randomly receive placebo or probiotic
      intervention for 12 weeks.
    

Intervention name(s): Placebo; Probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).; Children assigned to the groups (ASD/ADHD) will be randomly prescribed supplementation with two GABA- and dopamine-producing strains at a total of 1 x 10 (9) CFU/capsule for 12 weeks (probiotic subgroup).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Enhanced SexHealth Intervention to Improve Adolescent Outcomes
Condition: Sexually Transmitted Diseases; Reproductive Behavior
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This is an adaptive trial with an initial Formative Revision Process followed by a Randomized
      Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6
      completed subjects for the formative process and 86 completed subjects for the RCT.
    

Detailed description: 
      In a randomized controlled trial at a pediatric emergency department, sexually active
      adolescents will receive the control (i.e., printed materials) or intervention (i.e.,
      motivationally-guided facilitation) arm delivered by a health educator. The tablet-based,
      interactive intervention includes motivational techniques to promote risk reduction, condom
      skills training, and tailored service recommendations. The primary outcome is uptake of ≥1
      service at the index visit (i.e., counseling, condoms, emergency contraception for immediate
      or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and
      clinic referral). We assess feasibility (i.e., intervention completion, recommendations
      discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at
      2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.
    

Intervention name(s): SexHealth
Intervention type(s): Behavioral
Intervention description(s): To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in
      patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity
      after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
    

Detailed description: 
      This study aims to evaluate the progression free survival after treatment for patient with
      stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD.

      The treatment consist of 3 phases :

        -  induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin,
           cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated

        -  radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of
           BEACOPP-escalated

        -  consolidation treatment with 8 cycles every 21 days of brentuximab vedotin
    

Intervention name(s): brentuximab vedotin; Cyclophosphamide; Adriamycin; Oncovin; Bleomycin; Etoposide; Procarbazine; Prednisone; G-CSF; 30 Grays
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention description(s): is 1.8 mg/kg administrated by IV infusion; 1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks; 35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks; 1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks; 10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks; 200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks; 100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks; 40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks; 5 µg/kg/j, SC, D9 until GB 1.0x109/L; 30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.
Other intervention name(s): SGN35; Doxorubicin; Vincristin
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Etoposide; Liposomal doxorubicin; Vincristine; Bleomycin; Brentuximab Vedotin; Procarbazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin lymphoma; HL; brentuximab vedotin
The Sleep Improving Effects of Orange Phenolics
Condition: Polyphenols; Sleep; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can
      improve objective sleep duration and/or quality, and/or improve perceived sleep quality and
      feelings of rest.

      Participants will complete a total of 9 test nights, which consist of sleeping with the sleep
      monitoring system after ingestion of the test product or a placebo, and filling out
      sleep-related questionnaires.

      The study has a crossover design, meaning that all participants receive all three
      interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a
      randomized order.
    


Intervention name(s): Lozenge containing citrus flavonoid; Lozenge containing citrus flavonoid formulation; Identical looking placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Polyphenols; Orange; Sleep; Fatigue
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Condition: Osteoarthritis; Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Applying a fibrin spray, after knee device implantation, will help in reducing patient blood
      loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased
      blood loss there should be a reduced need for blood transfusions.
    

Detailed description: 
      Study Design

      Study design and control methods:

      This study is designed as a prospective, randomized, double-blinded controlled clinical trial
      to compare the effect of a fibrin spray applied to the surgical wound as compared to patients
      not receiving the fibrin spray.

      Treatment group:

      The subjects will be randomly assigned to the fibrin treatment group or to the control group
      at the time of the surgery via the opening of a randomly selected sealed envelope. The
      patient and the independent reviewer will be blinded as to which treatment group the patient
      is assigned to. This information will be linked to a confidential database for later review
      by the principal investigator.

      Treatment allocation:

      All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be
      treated and observed per the research protocol. All patients will maintain the right to
      refuse participation and receive a specific treatment of the study if desired.

      Trial Population:

      The target sample size is 70 patients for both the treatment and control groups (140 total)
      with each group split evenly between males and females. There will be one actively enrolling
      surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint
      pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain
      will not direct the subjects' assignment or eligibility at the time of surgery. All 140
      patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All
      indications for TKA will be included unless one of the exclusion criteria is met.
    

Intervention name(s): Evicel Fibrin Spray
Intervention type(s): Drug
Intervention description(s): 10cc syringe dose, once at the end of TKA
Other intervention name(s): Produced by OMRIX Biopharmaceuticals, Ltd.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Blood Loss; Hemoglobin; Hematocrit; Blood Transfusions
Evolution of Analgesic Tolerance With Opioids
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the extent to which analgesic tolerance develops in
      chronic pain patients who are either started on opioids or who receive an increase in
      pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid
      therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of
      tolerance development will be supplemented by periodic assessment of the anti-nociceptive
      effects of opioids using the brief thermal sensitization model.
    

Detailed description: 
      The purpose of this study is to determine the extent to which analgesic tolerance develops in
      chronic pain patients who are either started on opioids or who receive an increase in
      pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid
      therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of
      tolerance development will be supplemented by periodic assessment of the anti-nociceptive
      effects of opioids using the brief thermal sensitization model.
    

Intervention name(s): levorphanol
Intervention type(s): Drug
Intervention MeSH terms: Levorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Chronic Pain