bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
Condition: ADHD; Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4
      way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation
      in nondependent, recreational stimulant users. The study will consist of an outpatient
      Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an
      outpatient Follow-Up visit.
    

Detailed description: 
      VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled
      4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR
      formulation in nondependent, recreational stimulant users. The study objectives include
      assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of
      manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The
      primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog
      scale.

      A total of 64 subjects demonstrating a confirmed positive response to stimulants will enter
      the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical
      laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).
    

Intervention name(s): ADAIR 10 mg IR tablets; d-amphetamine sulfate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): manipulated ADAIR 3x10mg; crushed d-amphetamine sulfate 3x10mg; placebo for oral and intranasal administration
Other intervention name(s): ADAIR; dextroamphetamine sulfate
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
Condition: Opioid Dependence; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the
      treatment of opioid dependence. A compassionate use study.
    

Detailed description: 
      The objective of this study is to provide follow-up compassionate use treatment and evaluate
      long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate
      dependence treatment for subjects who have completed Cooperative Study 1008 A and B.
    

Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Dependence
The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
Condition: Depression
MeSH terms: Dyssomnias; Parasomnias; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents
      (IPT-A) with depression works to change sleep and related biological markers found in saliva,
      namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is
      to understand the biological mechanisms of recovery from depression in order to assist in
      selecting and guiding personalized psychotherapeutic interventions with the highest
      likelihood of success for individual adolescents with depression.
    

Detailed description: 
      The primary aim of this project is to examine whether adolescent depression and the
      associated symptoms of sleep disturbance are best treated using an empirically supported
      psychotherapy that is augmented with a sleep improvement module. Twenty adolescents (ages
      12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive
      disorder not otherwise specified, or adjustment disorder with depressed mood and also report
      elevated levels of sleep disturbance will receive Interpersonal Psychotherapy for Depressed
      Adolescents (IPT-A) with an adjunctive sleep module that is integrated throughout the
      treatment. Identifying the best approach to treating both the adolescent's depression and the
      commonly associated symptom of sleep disturbance will have significant implications for the
      long-term outcomes of depressed adolescents. Moreover, identifying unique symptom and
      biological profiles at the outset of treatment may enable doctors to predict treatment
      outcome.
    

Intervention name(s): TranS-C and IPT-A
Intervention type(s): Behavioral
Intervention description(s): The goal of IPT-A is to decrease depressive symptoms by focusing on current interpersonal difficulties and helping the adolescent improve his or her relationships and interpersonal interactions. This is accomplished through psychoeducation about the adolescent's depression and its link to interpersonal relationships, review of the adolescent's significant relationships, identification of interpersonal problem areas on which to focus the treatment, development of interpersonal problem solving and communication skills, and role-playing. The sleep disturbances intervention will include several modules selected because they are successful treatments for insomnia, and/or may help promote adherence to some of the recommendations related to sleep.
Other intervention name(s): Transdiagnostic Sleep and Circadian treatment and IPT-A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Adolescence
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the preventive vaccine efficacy, safety, and tolerability of
      ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults
      over 24 months and potentially up to 36 months from enrollment.
    

Detailed description: 
      This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the
      ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative
      South African adults over 24 months from enrollment.

      Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular
      injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C
      gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52.

      In addition to the vaccination visits, participants will attend study visits at weeks 26, 39,
      54, 65, 78, 91, 104, 117, 130, 142, and 156. All study visits, including vaccination visits,
      will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire.
      and pregnancy testing for participants capable of becoming pregnant. Select study visits will
      include a medical history review, physical exam, blood collection, urine collection, HIV
      testing, and pregnancy testing for participants capable of becoming pregnant.

      As of February 3, 2020, vaccinations for this study were suspended. Participants have been
      asked to continue attending follow-up visits for 12 months after the last vaccination they
      received. Participants who become HIV infected will be followed for 6 months after diagnosis.
    

Intervention name(s): ALVAC-HIV (vCP2438); Bivalent Subtype C gp120/MF59; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose > 10^6 cell culture infectious dose 50% (CCIDv50) and < 1 × 10^8 CCIDv50 (nominal dose of 10^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM; Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM; Sodium Chloride for injection, 0.9% delivered IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The primary objective of this study is to develop and validate simultaneous free-breathing 4D
      fat and water quantification and quantitative dynamic contrast enhanced perfusion in the
      liver. Secondary aims include developing and validating free breathing quantification of
      relaxation parameters T1 and T2, and developing and validating a minimal breath-hold (< 8 s)
      high quality diffusion exam using highly accelerated steady state diffusion imaging
      sequences. Investigators aim to scan 100 subjects receiving liver biopsies as a part of their
      standard care and another 70 subjects with known benign lesions. The study is greater than
      minimal risk.
    

Detailed description: 
      The investigators hypothesize that a quantitative and near free-breathing MRI approach with
      Hepatocellular carcinoma (HCC) patients will lead to improved tissue characterization,
      resulting in fewer ambiguous readings and thus fewer biopsies. As each component of the
      proposed methodology has been experimentally validated in the investigators preliminary work,
      the next appropriate step would be to evaluate the clinical feasibility of the exam. The
      investigators goal is to test the ability of quantitative MRI techniques to provide high
      quality images of the liver and to differentiate liver lesions from one another in a time
      frame shorter than a current clinical exam.
    

Intervention name(s): liver biopsy; free-breathing MRI
Intervention type(s): Procedure; Device
Intervention description(s): patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results; All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality
Other intervention name(s): experimental MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatocellular Carcinoma; Hepatoma; Liver Cancer, Adult; Liver Cell Carcinoma; Liver Cell Carcinoma, Adult; HCC
Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy
Condition: Prostatic Neoplasm; Anastomosis
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Traditionally the watertightness of urethrovesical anastomosis after robotic radical
      prostatectomy is controlled by cystogram. However, clinical observations and one previous
      study showed that patients with anastomotic leakage have red coloured urine. If the
      investigators can verify this finding, the most of the cystograms can be avoided. In this
      study the investigators estimate urine colour after cystogram and take a picture from urine
      collecting pag. Later on the pictures are digitally analyzed and compared to cystogram
      finding.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Robotic assisted laparoscopic radical prostatectomy patients. Catheter removal visit.
Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors
Condition: Stress Disorder
MeSH terms: Stress Disorders, Traumatic
Study type: Interventional

Summary: 
      This project evaluates the effectiveness of an intervention sought to reduce the physical
      effects of stress related to those issues that individuals cannot successfully communicate
      with anyone about. To do this, the investigators will be implementing a writing intervention
      over the course of the 6-week study. The investigators will be asking all participants to
      complete questionnaires over the course of the study period. The investigators are also
      asking participants to provide a small blood sample (from a fingerstick procedure) at two
      times during the study as well as saliva samples during that same time. The primary research
      question asks if this intervention procedure is effective. The investigators are evaluating
      total cholesterol, high sensitivity c-reactive protein, and cortisol.
    


Intervention name(s): Expressive Writing
Intervention type(s): Other
Intervention description(s): Writing intervention for cognitive appraisal of stressor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with
      nonspecific low back pain.
    

Detailed description: 
      The main objective of this study is to test the effectiveness of a technique of dynamic
      massage therapy in the hamstrings in patients with nonspecific low back pain. Secondary
      objectives are assess whether the technique of dynamic massage therapy increases the
      extensibility of the hamstrings, assess whether the treatment of hamstrings decreases low
      back pain and determine whether the application of this technique decreases the disability
      associated with nonspecific low back pain.
    

Intervention name(s): Dynamic massage therapy; Massage therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Dynamic massage therapy on hamstring combined with knee extension; Rubbing on hamstrings
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to determine effect of arginine and glutamine on outcome
      of COVID-19 patients. The main questions it aims to answer are:

      -to test the effect of oral nutritional supplements containing arginine and glutamine on
      covid-19 patients outcome Dr. M. Djamil General Hospital Padang

      Participants will given ONS containing arginine and glutamine. Researchers will compare
      intervention group with control group to see if ONS affected outcome of COVID-19 patients
    


Intervention name(s): Neomune
Intervention type(s): Dietary Supplement
Intervention description(s): Neomune containing 4.8 g arginine and 2 g glutamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Oral Nutrition Supplement
Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation
      system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring
      mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and
      stain/culture conversion are also evaluated.
    

Detailed description: 
      Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between
      patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided
      thin bronchoscope.
    

Intervention name(s): Thin bronchoscope and VBN
Intervention type(s): Device
Intervention description(s): targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Safety Study of ARRY-371797 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the
      safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48
      healthy subjects from the US will be enrolled in this study.
    


Intervention name(s): ARRY-371797, p38 inhibitor; oral; Placebo; oral
Intervention type(s): Drug; Drug
Intervention description(s): single dose and multiple dose, escalating; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Physical Literacy and Rehabilitation
Condition: Chronic Conditions, Multiple; Aging; Mobility Limitation
MeSH terms: Chronic Disease; Mobility Limitation; Multiple Chronic Conditions
Study type: Interventional

Summary: 
      With the aging population, the prevalence of chronic conditions continues to rise, affecting
      1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence,
      physical competence and knowledge, to take responsibility for engagement in physical activity
      for life", has emerged as a promising strategy to increase movement for children. However,
      little is known about how physical literacy can impact aging adults. A working definition of
      physical literacy for adults focusing on mobility, function and self-monitoring provides
      opportunity to guide public health programs in addressing the rehabilitation needs of persons
      living with multiple chronic conditions.
    

Detailed description: 
      The objectives of this three stage mixed methods study is to:

        1. Develop a new physical literacy framework, with the help of health professionals and
           end-users that promotes optimal physical functioning for adults.

        2. Develop a population-based health intervention using rehabilitation strategies that are
           delivered virtually to increase physical literacy for adults.

      The first 2 qualitative studies will be used to inform the third quantitative intervention.

      First, an on-line consensus approach with physiotherapy leaders, rehabilitation researchers
      and public health experts will be used to identify a new physical literacy framework as it
      relates to adults.

      Second, virtual semi-structured interviews with working adults who are living with 2 or more
      chronic conditions will determine how aging adults frame physical literacy in their life,
      specifically with the management of chronic conditions.

      Lastly, working adults with 2 or more chronic conditions will participate in a 5-week
      physical literacy program. Multifaceted knowledge translation strategies including; "walk and
      talk" with a neighbour or friend, podcasts and on-line mobility challenges will be utilized.

      It is anticipated the intervention will improve important physical literacy outcomes such as;
      physical competence, function, mobility, motivation, awareness, and self-efficacy.
    

Intervention name(s): Physical Functional Literacy for Adults
Intervention type(s): Behavioral
Intervention description(s): A 5 week physical literacy for program focused on virtual knowledge translation strategies to improve function and mobility for adults with multiple chronic conditions. This is a population -based approach to rehabilitation
Intervention model: Single Group Assignment
Intervention model description: Mixed Methods
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adults; physical function; physical literacy
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD)
      combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with
      uncontrolled blood glucose.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on
      to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite
      treatment with an sulfonylurea as well as diet and exercise therapies.
    

Intervention name(s): Alogliptin and glimepiride; Alogliptin and glimepiride; Glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.; Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Other intervention name(s): SYR-322; Amaryl; SYR-322; Amaryl; Amaryl
Intervention MeSH terms: Glimepiride; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy