bioihbjkbjnl/mcl2 huggingface dataset:
Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The purpose of our study is to image human prostate tissue using a transrectal photoacoustic
      imaging probe.
    

Detailed description: 
      PRIMARY OBJECTIVE(S):

      The primary objective of this pilot study is to assess PAI-performance in a clinical setting
      to understand limitations of our current PAI instrumentation and to help improve the
      next-generation design.

      SECONDARY OBJECTIVE(S):

      To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in
      order to distinguish malignant from benign prostatic tissue as a basis for future studies.
    

Intervention name(s): Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe
Intervention type(s): Device
Intervention description(s): Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Medical oncologists with appropriate patient populations will be informed of the study and
        the inclusion and exclusion criteria. Potential participants will be recruited from the
        Stanford Urologic Oncology Clinic. A study investigator will follow-up with participants
        who are interested in participating in this study. Study information will be posted on the
        Stanford Cancer Center website as well.
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety and efficacy of two doses of MAP0010
      versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week
      treatment period.
    


Intervention name(s): 0.135mg MAP0010; 0.25mg MAP0010; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks; 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks; Placebo delivered by nebulization twice daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: asthmatic children
Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living
      in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown
      great promise in reducing health risk behaviors across a variety of behaviors and population
      groups by enhancing the relevance of the health information. The primary aim of this study is
      to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs.
      a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and
      transgender (LGBT) smokers. The investigators anticipate that the culturally targeted
      intervention will be more effective at helping LGBT smokers to successfully stop smoking than
      will the non-targeted intervention.
    

Detailed description: 
      In Phase 1 of this study we used focus groups to establish the cultural appropriateness and
      acceptability of the targeted elements of the intervention for the LGBT population. For Phase
      2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the
      targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist
      of group counseling sessions combined with nicotine replacement therapy and peer support. We
      expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment
      adherence will be higher among those who received the targeted intervention than those in the
      non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural
      identification and salience of that identity will be associated with more satisfaction and
      adherence to the targeted intervention.
    

Intervention name(s): Culturally Targeted Cessation Program; Non-Targeted Cessation Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.; Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Cigarette Smoking; Tobacco; LGBT; LGBTQ
AOT and ICT for Hemiplegia
Condition: Hemiplegia; Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron
      system (MNS), has been used with promising results on the Upper Limb (UL) function in some
      studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide
      evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP
      (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is
      chosen as primary outcome measure and a sample size of 10 per group is required. The
      rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver,
      manage, monitor and measure a personalized AOT.
    

Detailed description: 
      A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to
      CONSORT guidelines. Each participant will be randomized to either:

        1. Immediate intervention group (Experimental group). Children will receive immediately the
           system for 3 weeks.

        2. Waitlist delayed intervention (Control group). Children will continue standard care for
           3 weeks and then will receive the system as the Experimental group.

      As such, all participants will receive the AOT training. The system will provide an in-home,
      individualized, intensive treatment based on the AOT. The system will be delivered at home
      and the children will perform a 60-minute training session 5 days a week for 3 consecutive
      weeks. For the Immediate intervention group, follow-up assessment (outcome measures) will be
      conducted before (T0) and post-intervention at 3 weeks (T1), and then 8 and 24 weeks after
      T1(T2 and T3). For the Waitlist group, the assessments will be conducted before T0 and 3
      weeks after (T1) the standard care, then they will follow the same timeline of the first
      group (T1 plus, after the AOT intervention) and 8 and 24 weeks after T1 Puls (T2 and T3). The
      primary endpoint will be T1. Clinical assessments will be administered by a therapist blind
      to group assignment in each center. Scoring of videotaped clinical outcome measures will be
      performed by therapists blind to group allocation and assessment order.
    

Intervention name(s): Experimental group
Intervention type(s): Other
Intervention description(s): Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.
Other intervention name(s): AOT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It will be a parallel RCT with a waitlist design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tele-rehabilitation; Action Observation; Mirror neurons; ICT
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the effect of the different degrees of renal
      impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral
      administration of high dose BI10773 as a single dose in Japanese patients with type 2
      diabetes mellitus.
    


Intervention name(s): BI10773; BI10773; BI10773; BI10773
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose
Intervention MeSH terms: Empagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics and tolerability,
      describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD)
      or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent
      MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post
      autologous stem cell transplant and are relapsed/refractory.
    


Intervention name(s): Dose Escalation, MEDI2228, ADC (antibody drug conjugate); Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
Intervention type(s): Biological; Biological
Intervention description(s): Single agent MEDI2228 will be administered to adult subjects with R/R MM. The study aims to evaluate up to 9 planned, sequentially ascending main dose levels; Adult subjects with R/R MM with measurable disease will be enrolled in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase.
Intervention MeSH terms: Antibodies; Immunoglobulins; Immunoconjugates
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma; relapsed/refractory; open-label
Effects of Smoked Marijuana on Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia; Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine if smoking marijuana will reduce neuropathic pain without causing too much
      drowsiness or feeling "too dopey".
    

Detailed description: 
      The case for marijuana's medical use for pain is primarily from experimental studies with
      normal subjects, which have yielded conflicting results. Experimental subjects have been
      shown to have significant dose-dependant antinociception effect that is not reversed by
      opioid antagonism. In contrast to this positive antinociceptive effect, other experiments
      demonstrated hyperalgesic activity and probably enhancement of the perception of pain upon
      acute exposure in chronic users of marijuana.

      In addition to studying spontaneous pain antinociception, it would be useful to evaluate the
      response to marijuana following evoked pain. Such evoked pain is produced by stimulation of
      the skin that is normally not noxious.

      Because of the potential side effects of marijuana administration, one of the aims of the
      present study is to analyze inter-individual variability and the occurrence of dose-dependant
      analgesia of marijuana with an eye on defining tolerable dosing in clinical neuropathic pain
      syndromes.

      Comparisons: Neuropathic and experimentally induced pain scores will be compared after the
      administration of escalating doses of low, high, and placebo marijuana cigarettes as provided
      by the National Institutes on Drug Abuse (NIDA).
    

Intervention name(s): Cannabis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis; marijuana; neuropathy; antinociception; mood; cognition
A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR
      and active metabolic products in blood samples when doses of both drugs are taken by mouth.
      Doses are either taken alone or together. The results will help to determine if doses of
      GSK189075 and WELLBUTRIN SR can be safely taken together.
    


Intervention name(s): GSK189075; Bupropion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK189075 will be available as film-coated tablets with a dose of 250 milligrams.; Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally.; Placebo tablets will be given to subjects.
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics; Healthy adult male volunteers,; pharmacokinetics,
Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Interventional
Phase: Phase 3

Summary: 
      To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma
      levels of several prognostic biomarkers and on endothelial function after an anterior
      myocardial infarction.
    


Intervention name(s): Calcifediol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): calcifediol treatment; placebo control group
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Calcifediol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; Myocardial Infarction; Ventricular remodeling; Biomarkers
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks)
      apart and delivered into the biopsied kidney using a percutaneous approach in participants
      with T2DM and CKD.
    

Detailed description: 
      Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred
      treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to
      receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into
      the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2
      injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects
      will be followed through 23 months after the last injection.

      Study Part 2: An open-label extension study in which eligible subjects will be followed for
      an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part
      2 into a Long Term Follow-Up Master protocol for up to 5 years
    

Intervention name(s): Renal Autologous Cell Therapy (REACT)
Intervention type(s): Biological
Intervention description(s): Autologous selected renal cells (SRC).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
Condition: Healthy Skin
Study type: Interventional

Summary: 
      The main aim of this study is to investigate in a suction blister model, whether the use of a
      basic skin care formulation increases the mechanical integrity/adhesion of the
      dermo-epidermal junction.
    

Detailed description: 
      The process of aging involves numerous structural and functional changes also affecting the
      skin. The skin fulfills a variety of protective and regulatory functions. Compared to other
      organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic
      factors these external factors may accelerate skin aging. Due to its ageing-related loss of
      functional capacity the skin becomes susceptible to develop adverse skin conditions and
      dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care
      depended, and severely ill individuals are at high risk for developing severe skin injuries
      and wounds (e.g. decubitus, skin tears) with high social and economic impact. Empirical
      evidence indicates that the reduced adhesion of the dermal-epidermal junction is a major
      pathophysiological predictor for these types of injuries.

      The suction blister model is an artificial and controlled technique for dermal-epidermal
      separation along the dermo-epidermal junction (DEJ). Empirical evidence suggests that the
      time of the dermal-epidermal separation (blistering time) is a measure of the dermo-epidermal
      adhesion. It has been proposed that the blistering time might be a clinically relevant
      parameter reflecting the mechanical integrity/stability of the dermo-epidermal junction.

      Clinical practice guidelines recommend the use of topical skin care products to reduce the
      risk for pressure ulcer and skin tear development. However, the underlying working mechanisms
      of most basic skin care products are poorly understood. It is known that topically applied
      skin care products exhibit physical and chemical effects on and in the uppermost skin layers
      (e.g. the stratum corneum). Despite a few well known active ingredients (e.g. retinoids,
      vitamin C) exhibiting effects in the dermis, a particular skin protective effect of the vast
      majority of daily basic skin care applications on these deeper skin layers is unknown. The
      primary objective of this study is to test, whether the use of a basic skin care formulation
      increases the mechanical integrity/adhesion of the dermo-epidermal junction.
    

Intervention name(s): Treatment with petrolatum
Intervention type(s): Other
Intervention description(s): Petrolatum is applied twice daily to the intervention arm.
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: skin ageing; suction blister; dermo-epidermal junction
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
Condition: Human Papillomavirus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus
      (HPV) vaccination program to determine if the combination of increased disease and vaccine
      education coupled with the removal of barriers will positively impact the HPV vaccination
      uptake and completion rates among students.
    

Detailed description: 
      The purpose of this study is to evaluate the impact of a school-based HPV vaccination
      program. The intervention will consists of: provision of HPV vaccine information and consent
      forms for parents delivered in the back-to-school packets; school-nurse delivered student
      education; removal of barriers (scheduling, transportation and parental presence); changing
      of social norms; and the provision of free HPV vaccine.
    

Intervention name(s): HPV Vaccine and HPV-related Health Education; Reduction of barriers
Intervention type(s): Other; Other
Intervention description(s): Increased education of HPV-related diseases and HPV vaccine; Eliminate structural and financial barriers to being vaccinated
Other intervention name(s): School based delivery of HPV vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Papillomavirus
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to evaluate the role of pain modulation in GERD patients
      who fail to obtain clinical relief with standard dose (once daily) PPI. The study will
      compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to,
      2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom
      resolution and health related quality of life in GERD patients who fail standard dose PPI and
      are randomly assigned to one of these three groups.
    

Detailed description: 
      To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who
      fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI).
      The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic
      antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine
      the relative symptom resolution and health related quality of life in GERD patients who fail
      standard dose PPI and are randomly assigned to one of these three groups.
    

Intervention name(s): Standard dose (once daily) PPI plus low-dose antidepressant; Double dose PPI plus evening placebo; Rabeprazole , placebo, placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA); 20 mg. twice daily with a placebo; 20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Other intervention name(s): Aciphex-PPI; Nortriptyline-TCA; Aciphex-PPI, rabeprazole; Aciphex-rabeprazole (PPI); Nortriptyline-low-dose tricyclic antidepressant (TCA)
Intervention MeSH terms: Antidepressive Agents; Nortriptyline; Antidepressive Agents, Tricyclic; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acid reflux studies; efficacy of PPI therapy; failing PPI therapy; GERD; Acid Reflux Disease