bioihbjkbjnl/mcl2 huggingface dataset:
Marijuana Treatment Project - 3
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The goal of this research is to improve treatment outcome for marijuana-dependent
      individuals. The current study builds on the findings of our prior NIDA-funded marijuana
      treatment study in which improved client outcomes were associated with greater treatment
      attendance, greater client self-efficacy, and greater use of coping skills. We will use a
      contingency management paradigm to provide tangible reinforcement for completing homework
      assignments that are designed to enhance coping skills. It is anticipated that this will
      result in greater homework compliance, leading to greater self-efficacy regarding one's
      ability to cope with high-risk situations. Improved self-efficacy will enhance the likelihood
      of employing coping skills in high-risk situations, thereby increasing the probability of
      achieving and maintaining abstinence.
    

Detailed description: 
      Participants will receive an intervention combining one session of motivational enhancement
      therapy with eight sessions of cognitive-behavioral coping skills therapy (MET+CBT). A
      contingency management procedure will be added to this intervention, providing reinforcement
      for completion of homework, as verified by call-ins to an Interactive Voice Recording (IVR)
      system. Outcomes will be compared to an MET+CBT intervention in which reinforcement will be
      provided for marijuana-free urine specimens, and to a control group that receives Case
      Management. Recruitment of 234 marijuana-dependent participants will occur over a three-year
      period. They will be randomly assigned to one of the three 9-session interventions. Treatment
      will be individual, manualized, and provided on an outpatient basis. Pretreatment assessments
      will obtain baseline data; follow-up assessments at three-month intervals for one year will
      evaluate marijuana use outcomes, other drug or alcohol use, and psychosocial functioning. It
      is anticipated that the intervention in which completion of homework is reinforced will
      result in the best outcomes. The mechanisms by which the interventions result in behavior
      change will be the specific focus of attention in this study.
    

Intervention name(s): Reinforcement for homework completion; Reinforcement for Abstinence; Case Management
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills; Provides contingent reinforcement for submitting marijuana-free urine specimen; Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: marijuana dependence; self-efficacy; coping skills; attendance; marijuana abstinence
Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
Condition: Joint Disease
MeSH terms: Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the
      treatment of knee osteoarthritis.
    

Detailed description: 
      Several studies have shown the positive effects of the autologous "Preparation Rich in Growth
      Factors" (PRGF) in different clinical situations involving connective tissues and also in OA
      synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive
      proteins essential to natural repair including anabolic factors for cartilage such as
      transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and
      insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of
      cartilage to repair itself encouraged the idea of treating degenerative joint conditions with
      this autologous preparation.

      The present study was undertaken to assess the efficacy and safety of the intra-articular
      injection of PRGF and to obtain useful information about the clinical effects. Since pain is
      the most pressing problem facing people with OA, a significant improvement in pain would
      indicate the potential of the proposed treatment. We will also evaluate functionality and
      quality of life. In addition we will examine changes in novel serum and synovial fluid
      biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
    

Intervention name(s): PRGF Intraarticular injection; Hyaluronic Acid Intraarticular injection
Intervention type(s): Device; Device
Intervention description(s): Three consecutive PRGF injections each one week apart.; Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; PRGF; autologous plasma; plasma preparations; treatment
A Better Choice for Patients Undergoing Endovascular Coil Embolization
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a double-blind, randomized placebo-controlled study to determine
      the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled
      to undergo endovascular coil embolization.
    


Intervention name(s): sevoflurane and 0.5 μg/kg dexmedetomidine; sevoflurane and 1 μg/kg dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.; After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Other intervention name(s): DEX1; DEX2
Intervention MeSH terms: Dexmedetomidine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine, endovascular coil embolization
Safety, Tolerability and Pharmacokinetics Study of LY03005
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating single
      oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of
      escalating single oral doses of LY03005.
    


Intervention name(s): LY03005; Placebo; Meal; Pristiq
Intervention type(s): Drug; Drug; Other; Drug
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases; Birth Weight
Study type: Observational

Summary: 
      Human milk is the best source of enteral nutrition for the preterm infant. However during the
      infants first hours and days of life breastmilk from the own mother is usually not available.
      Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical
      University Vienna was to start with formula feedings within the first 6 hours of life of a
      premature infant and switch over to breastmilk as soon it was available. In June 2012 the
      investigators changed this feeding regimen and started to use single donor milk of mothers of
      preterm infants for the first hours and days of the preterm infants life. In a prospective
      observational study the investigators evaluated the impact of single donor milk from preterm
      infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in
      preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data
      will be compared with a historical control group starting with preterm formula as source of
      enteral nutrition. The investigators hypothesize that starting enteral nutrition with single
      donor milk of mothers from preterm infants with shorten time to full enteral feedings.
    


Intervention name(s): Control Group; Preterm Single Donor Milk Group
Intervention type(s): Other; Other
Intervention description(s): Infants received preterm formula during their first days of life until breastmilk from their own mother was available; Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        inborn very low birth weight infants with a birthweight <1500g and a gestational age <32
        weeks
      
Keywords: preterm single donor milk; human milk; very lo birth weight infants; enteral feedings; NEC
Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers
Condition: Bioequivalence; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine the bioequivalence of two different formulations
      of sitagliptin/ metformin after a single oral dose administration under fed conditions.
    


Intervention name(s): Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
      2009 (swine flu) vaccine in healthy young children
    


Intervention name(s): MF59-eH1N1_f; MF59-eH1N1_f; MF59-eH1N1_f; MF59-eH1N1_f
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.; 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.; 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.; 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Intervention MeSH terms: MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Swine Flu; Flu; Vaccine; Children; Adjuvant; A/H1N1 2009 Influenza
A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
Condition: Progressive Metastatic Castrate-Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in
      participants with metastatic castration-resistant prostate cancer (mCRPC).
    

Detailed description: 
      This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in
      participants with mCRPC. Participants in each arm will be stratified by the presence of
      measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours [RECIST
      v1.1]) or bone-only metastasis (per Prostate Cancer Working Group 3 [PCWG3 criteria]). There
      will be no formal comparisons between treatment arms.

      AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated
      with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or
      participants who are taxane ineligible.

      AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC
      previously treated with docetaxel and one prior NHA.

      As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the
      program level, not related to any safety issues. Ongoing participants in Arm A may continue
      treatment as planned.
    

Intervention name(s): AZD4635; Durvalumab; Cabazitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive AZD4635 orally daily; Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.; Subjects will receive intravenous cabazitaxel every 3 weeks
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer
DHEA Replacement in Adrenalectomized/Hypoadrenal Patients
Condition: Aging; Dehydroepiandosterone Replacement; DHEA Replacement
Study type: Interventional

Summary: 
      The role of dehydroepiandosterone (DHEA) and its sulphated ester (DHEAS) [together known as
      DHEA(S)] in humans remains to be fully elucidated. They are the most abundant circulating
      steroid hormones in humans with the principle source of production being the adrenal glands.
      In adrenalectomised or hypoadrenal subjects it is not standard clinical practice to replace
      this hormone. Whilst this lack of DHEA(S) is clearly not life threatening, the published
      literature on the psychological effects of replacement in this population has shown some
      benefit in quality of life but data concerning the metabolic effects is conflicting and
      incomplete. We wish to carry out a study to measure the effect of DHEA(S) replacement in a
      group of adrenalectomised / hypoadrenal subjects and measure the outcome of a number of
      psychological and metabolic parameters both prior to and after twelve weeks of 50 mg/day
      DHEA(S) in a double blind randomised cross over design.

      Mood, quality of life and sexual well being will be assessed using validated questionnaires.
      In addition, we will utilise the GCRC facility to measure body composition using total body
      water and DEXA. We will measure insulin sensitivity, exercise performance, muscle
      fatigability and VO2 max. Pre- and post- intervention muscle biopsies will assess DHEA(S)
      effects on myosin heavy chain isoform expression; skeletal muscle mitochondrial ATP
      production and be used to assess muscle enzyme levels.
    


Intervention name(s): DHEA Replacement
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Beta-Cell Function After Near-Normalisation of Blood Glucose
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to
      impaired potentiation of beta-cell responsiveness to glucose by glucose dependent
      insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present
      study was to investigate whether 4 weeks of near-normalization of blood glucose could improve
      the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.
    


Intervention name(s): glucagon-like peptide-1,; glucose dependent insulinotropic polypeptide; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.; continuous infusion of GIP (1½ pmol/kg/min) for 120 min.; continuous infusion of Saline for 120 min
Intervention MeSH terms: Glucagon; Gastric Inhibitory Polypeptide; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
RFA for Small HCC With No-touch Technique Using Octopus Electrode
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      In this study, the investigators are going to prospectively compare the clinical outcomes
      (technical success rate, 12 month local tumor progression rate, complication rate, tumor
      seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique
      for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method
      with the same device.
    


Intervention name(s): No-touch RFA; Conventional tumor puncture RFA
Intervention type(s): Procedure; Procedure
Intervention description(s): No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.; Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HCC; RFA
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of
      N91115.
    

Detailed description: 
      This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability,
      and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat
      meal were compared for PK.
    

Intervention name(s): N91115; Placebo; N91115; Placebo-Day 1 only
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Given PO daily for 14 days; Given PO daily for 14 days; Given PO only on Day 1; Given PO- only on Day 1 (single dosed to match single dose treatments)
Other intervention name(s): Cavosonstat; Cavosonstat; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N91115; GSNORi; SNO; Cavosonstat
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes
      mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and
      physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these
      subjects.
    


Intervention name(s): pramlintide acetate
Intervention type(s): Drug
Intervention description(s): single subcutaneous doses of 15mcg and 30mcg
Other intervention name(s): Symlin
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; pediatric; pramlintide; Symlin; Amylin
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Mindfulness Training specifically for pain to be offered to migraine patients
    

Detailed description: 
      Patients with high frequency migraine will be randomized to UC or intervention. Those in
      intervention will attend a multi session training on Acceptance and Commitment Therapy. All
      participants will track responses.
    

Intervention name(s): ACT
Intervention type(s): Behavioral
Intervention description(s): mindfulness intervention for patients with pain/migraine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; high frequency; ACT
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
Condition: Prescription Opioid Misuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The goal of this study is to prevent prescription opioid misuse among high school athletes by
      developing, demonstrating the feasibility, and evaluating the outcomes of an innovative
      digital intervention.
    

Detailed description: 
      The goal of this proposal is to prevent prescription opioid misuse among high school athletes
      by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative
      digital intervention. The new program, the Student Athlete Wellness Portal (SAWP), will be a
      brief, web- and smartphone-based curriculum, and will encourage resistance to cultural
      influences to misuse prescription opioids. This portal, which was created based on formative
      interviews with athletes, coaches, athletic trainers, and school administrators, will be
      tested in a feasibility trial. One hundred and two high school athletes completed a pretest,
      participated in the treatment (the SAWP) and completed posttest assess their knowledge,
      perceptions, and behaviors relating to opioid medication.
    

Intervention name(s): Student Athlete Wellness Portal
Intervention type(s): Behavioral
Intervention description(s): A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Intervention model: Single Group Assignment
Intervention model description: Participating athletes assigned to treatment condition.
Masking: None (Open Label)
Primary purpose: Prevention