bioihbjkbjnl/mcl2 huggingface dataset:
Insulin Treatment in Cancer Cachexia
Condition: Cancer Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to evaluate whether daily insulin treatment to weight losing cancer
      patients attenuates progression of cancer cachexia and improves metabolism.
    

Detailed description: 
      Randomized study with long-term follow-up based on survival, health related quality of life,
      food intake, resting energy expenditure, body composition, exercise capacity and measurement
      of metabolic efficiency.
    

Intervention name(s): Insulatard, flexpen
Intervention type(s): Drug
Intervention MeSH terms: Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer cachexia; Tumor host metabolism
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,
      placebo-controlled study.
    

Detailed description: 
      VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic
      transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to
      the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain
      transmission by the brain and reduces nociceptor activation in peripheral nerves, which are
      primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable
      efficacy to morphine in well controlled (blind, complete randomization with a positive
      control) animal studies using rat models of post-operative pain and formalin-induced pain.
      The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects
      will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no
      clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other
      than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure
      level is more than 2,000 ng/ml.
    

Intervention name(s): VVZ-149 Injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental group will receive a loading dose of 1.8 mg/kg VVZ-149 intravenous infusion for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h VVZ-149 intravenous infusion for 7.5 hours.; Placebo group will receive the corresponding amount of placebo.
Other intervention name(s): Opiranserin Injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls
Condition: Accidental Fall
Study type: Interventional

Summary: 
      The goal of this study was to evaluate the effects of reactive balance training (RBT)
      targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build
      upon prior work, the present study included: 1) a control group receiving an alternative
      balance training intervention; 2) separate training and assessment sessions; 3) alternative
      RBT methods that may be more amenable to work outside the lab compared to prior methods, and
      4) older adult participants receiving individualized training to reduce drop-out. The
      investigators hypothesized that slips after RBT would result in improved reactive balance
      kinematics, and a lower incidence of falls, compared to either initial slips before any
      intervention or after a control intervention. The investigators also hypothesized that trips
      after RBT would result in improved reactive balance kinematics, and a lower incidence of
      falls, compared to either initial trips before any intervention or after a control
      intervention. Results were intended to contribute to knowledge regarding the efficacy of
      alternative methods for RBT, and provide additional evidence regarding its efficacy.
    


Intervention name(s): Reactive balance training; Otago Balance Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.; Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A two-group, pretest-posttest parallel design was employed. Participants were first assigned to either the reactive balance training or control intervention using minimization. During the first week, participants completed a pre-intervention assessment involving exposure to a single laboratory-induced slip or trip based upon random assignment. During the second and third weeks, participants completed a total of four sessions of their assigned intervention (two sessions per week for two weeks). During the fourth week, participants completed a post-intervention assessment involving exposure to the other perturbation (slip or trip) that they did not experience during the pre-intervention assessment. This design was selected to evaluate gait and reactive balance prior to any training intervention, and to avoid any unintended training effects induced by exposing participants to the same perturbation more than once.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: balance training; step training; perturbation-based balance training; dynamic balance; aging
Safety and Efficacy of Liraglutide in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the efficacy and safety of liraglutide in the treatment
      of patients with idiopathic Parkinson's disease (PD).
    

Detailed description: 
      This single center, double-blind, placebo-controlled study will enroll 57 participants with a
      diagnosis of idiopathic PD. Subjects enrolled in the study will be randomized to receive once
      daily self-administered injections of liraglutide (1.2 or 1.8 mg, as tolerated) or placebo at
      the same dose range in a 2:1 study design.

      Liraglutide has been approved by the Food and Drug Administration (FDA) to treat adults with
      Type 2 Diabetes (T2D) and to treat obesity, but it is considered investigational in this
      study, as it has not been approved for use in patients with PD. Liraglutide belongs to a
      class of medications able to stimulate receptors of glucagon-like peptide 1 (GLP-1), a
      naturally occurring peptide found throughout much of the brain and able to increase the
      incretin effect in patients with T2D, stimulating the release of insulin. Liraglutide can
      reduce systemic and brain insulin resistance, an abnormality that could help drive PD
      pathogenesis. Indeed, impaired insulin signaling in the brain can cause or exacerbate many
      brain pathologies and behavioral abnormalities seen in PD. Another GLP-1 agonist, named
      exenatide, has been evaluated in patients with PD, showing significant improvement of motor
      and cognitive symptoms. There is reason to believe that liraglutide may prove superior to
      exenatide in treating PD.

      Eligible participants will be followed for up to 14 months and will be expected to complete 9
      in-person visits and 2 telephone visits. The study will measure liraglutide effects on motor
      (assessed by changes in the MDS-UPDRS part III) and non-motor symptoms of PD (assessed by the
      NMSS and MDRS-2) after 52 weeks of treatment. The secondary outcomes include measures of the
      association between liraglutide's effects on peripheral insulin resistance, PD symptoms and
      safety. Collection of blood and urine samples will be obtained to monitor drug safety.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide 6 mg/ml once daily at a maximum dose of 1.8 mg; Placebo (for Liraglutide) 6 mg/ml once daily at a maximum dose of 1.8 mg
Other intervention name(s): Victoza; Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease, Liraglutide; Antidiabetic agents; GLP-1 agonists; Insulin resistance
First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled,
      dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) profile
      of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2) in
      healthy subjects. This study represents the first administration of GSK3389404 in humans to
      define the safety, tolerability and PK following single and multiple doses of GSK3389404 in
      healthy subjects.
    


Intervention name(s): GSK3389404; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3389404 is supplied as solution for injection vial. Each vial contains 100 mg/mL of GSK3389404. It's physical appearance is clear colourless to slightly yellow solution.; Placebo is supplied as solution for injection vial. It's physical appearance is clear colourless solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Single dose; Multiple ascending doses (MAD); Pharmacokinetics; Safety; GSK3389404; Tolerability
Buprenorphine Loading in the Emergency Department
Condition: Opioid-use Disorder
MeSH terms: Emergencies; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Buprenorphine (BUP) is FDA-approved for the treatment of opioid withdrawal and opioid use
      disorder. Few ED providers have received the necessary DEA registration (aka X waiver)
      required to prescribe BUP, and urgent appointments to continue ongoing BUP treatment may not
      be readily available, thus leading to medication discontinuity. A loading dose induction
      strategy with 32mg of BUP may help effectively link ED patients to outpatient treatment while
      minimizing known barriers to ED uptake. Administering a "loading dose" of BUP to saturate
      mu-opioid receptors would extend the duration of action and provide additional time to secure
      ongoing treatment. Further, BUP's ceiling effect on respiratory depression makes it a
      remarkably safe drug even at high doses. In recent years, ED providers have begun to
      incorporate this approach into clinical protocols, however, it has not been formally studied
      in this clinical setting. The investigator's study represents the necessary step of studying
      this novel approach in the ED setting to define the parameters for clinical protocols and
      large-scale studies.
    

Detailed description: 
      A novel induction strategy, in which a loading dose of Buprenorphine (BUP) 32mg is
      administered, has the potential to mitigate barriers to treatment initiation. ED providers
      can treat patients with BUP for opioid withdrawal since DEA registration (X-waiver) is not
      required unless they wish to issue a prescription. Current BUP induction protocols, developed
      for inpatient and ambulatory care settings as well as for unobserved self- administration via
      prescription, usually recommend a first day dose of 8mg given in divided doses of 2- 4mg.
      However, patients discharged with ≤ 8mg SL total dose may experience return of withdrawal
      symptoms and/or opioid craving within only 4 hours.Treatment with a loading dose of 32mg in
      the ED may provide the necessary bridge treatment, relieving symptoms of withdrawal until a
      patient is able to attend a follow up appointment for further treatment.
    

Intervention name(s): Buprenorphine Naloxone
Intervention type(s): Drug
Intervention description(s): Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Other intervention name(s): Suboxone
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Lung Diseases; Hypertension, Pulmonary; Hypertension; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed research study is a cross-sectional study enrolling young children with sickle
      cell disease between 5 and 12 years of age. They will be screened as outpatients for consent
      to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of
      bronchodilator response will be assessed at each session. To estimate presence of pulmonary
      hypertension, echocardiography will be performed at the time of PFT measures.

      Study Design:

        1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta
           plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established patients
           within the Duke Pediatric Sickle Cell Clinic.

        2. Perform a chart review of all enrolled subjects to obtain specific details regarding
           birth history, nutritional status (weight, height), family history, sickle cell
           genotype, parental smoking history, recent laboratory parameters, parental smoking
           history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle
           cell complications and prescribed medications.

        3. Perform spirometry and plethysmography with the administration of albuterol.

        4. Before or after completion the PFT session, the patient will have echocardiography in
           the PFT lab area

        5. Using medical record information, determine number of hospitalizations for any pulmonary
           symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing, hypoxia,
           cough, chest pain). In addition, we will track any respiratory or cardiac symptoms or
           therapies for each subject 6 years after enrollment up to age 18 years using the
           registry.

        6. As standard of care, refer any child identified as having lung disease or pulmonary
           hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment
           and ongoing care.
    


Intervention name(s): Albuterol
Intervention type(s): Drug
Intervention description(s): This medication will be used as routine part of pulmonary function testing to assess for airway hyperreactivity. This is routinely done in a clinical capacity for pediatric patients with various pulmonary disease processes.
Intervention MeSH terms: Albuterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sickle cell disease; pulmonary hypertension; airway hyperreactivity; acute chest syndrome
Meditation Based Lifestyle Modification in Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and
      Meditation in depressive outpatients.
    

Detailed description: 
      As a contribution to the field of Integral Medicine, Meditation Based Lifestyle Modification
      (MBLM) is a holistic therapy for patients with mental disorders. Influenced by Ayurveda and
      Yoga, it uses mantra meditation, ethical conduct and healthy life style to promote physical,
      mental and spiritual health. MBLM explains processes within the body and the mind and their
      relation to diet, exercise, biorhythms, social and personal conduct in an easy but profound
      way and on an experiential level. Besides providing tools for physical, mental and emotional
      self-regulation, MBLM lays ground for personal growth and transcendence of the mind. It is
      intended to be implemented in groups of patients as well as individual daily training, and
      because of its modular structure can be adjusted in intensity, duration and weighting of the
      components according to the specific needs and disorders to be addressed. This makes it also
      eligible for its potential use in prevention of mental disease and treatment of psychic
      comorbidities in patients with chronic somatic illness.
    

Intervention name(s): Meditation Based Lifestyle Modification; Minimal treatment; Multimodal specific treatment:
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 8 weekly modules, each 3.5 hours of Life ethics, Yoga exercises and Mantra Meditation; Drug continuation under medical supervision; Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a three-arm, randomized, active-controlled, unblinded, parallel, exploratory study to compare the outcome in depression between standard specific treatment, multimodal specific treatment and standard treatment plus MBLM. After being screened for eligibility and signing the informed consent patients will be randomized 1:1:1 to either one of the groups. After being enrolled, patients in MBLM group receive an introductory education of the MBLM course and then join group sessions weekly for 8 weeks. They also see a consultant psychiatrist as needed for drug continuation therapy. Patients should practice MBLM related content at home for a proposed duration of 30-45 minutes per day. Patients in the control groups receive standard (control group I) or multimodal (control group II) treatment as administered by their consultant psychiatrist.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
Condition: Suicide; Alcohol Abuse; Drug Abuse; HIV
MeSH terms: Alcoholism; Substance-Related Disorders; Suicide
Study type: Interventional

Summary: 
      This study examines whether an integrated alcohol/substance abuse, suicide, and HIV
      prevention protocol is associated with lower onset and frequency of alcohol and other drug
      use, suicidal behavior, and high risk sexual behavior among adolescents receiving community
      based mental health care.
    

Detailed description: 
      The purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and
      HIV prevention program to an assessment only control condition in a randomized clinical
      trial. This prevention protocol is designed as an "add-on" intervention to standard mental
      health care. We will examine the extent to which the addition of this prevention protocol is
      associated with lower rates of alcohol use and drug use, suicidal behavior, and HIV related
      risk behaviors.
    

Intervention name(s): Prevention program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: suicide; alcohol; marijuana; HIV; prevention; adolescent
Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      To contribute to the understanding of the underlying neurobiological mechanism behind the
      interaction of alcohol and nalmefene
    


Intervention name(s): Nalmefene 18 mg, then placebo; Placebo, then Nalmefene 18 mg
Intervention type(s): Drug; Drug
Intervention description(s): One single oral dose Nalmefene on Day 1 and Placebo on Day 8; One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Other intervention name(s): Selincro®; Selincro®
Intervention MeSH terms: Naltrexone; Nalmefene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thromboelastometry in Assessment of Sepsis Coagulopathy
Condition: Thrombelastography; Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      The purpose of this study is to analyze occurence of bleeding complications during invasive
      procedures in septic patients with normal tromboelastometry results despite prolonged
      standard coagulation tests results
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        ICU patients with sepsis who underwent invasive procedures
SSR240600C Treatment in Women With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of SSR240600C in women with
      overactive bladder compared to placebo using tolterodine as a study calibrator.
    


Intervention name(s): SSR240600C; tolterodine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: urge urinary incontinence
Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects
Condition: Healthy; Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of
      coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4
      inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in
      healthy male and female subjects.
    


Intervention name(s): Itraconazole; Rifampin; KBP-5074
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg itraconazole, given orally as 20 mL × 10-mg/mL solution BID on Day 15, followed by QD dosing on Days 16 through 23, inclusive.; 600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive.; 0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: KBP5074; Healthy Subjects; itraconazole; rifampin