bioihbjkbjnl/mcl2 huggingface dataset:
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence
Condition: Cocaine Dependence; Alcoholism
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see whether naltrexone is safe and useful in preventing
      alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of
      alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration
      (FDA) for the treatment of alcohol dependence. However, the medication was not approved as
      yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),
      is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike
      other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone
      will not make you sick if you drink alcohol. Rather, people who are taking this medication
      have reported that it helps decrease the pleasure associated with drinking for them. This
      study is being conducted because the medication (Naltrexone) has not been well studied in
      people with both alcohol and cocaine dependence, so it is still investigational.

      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,
      this may lead to reduced cocaine use. We are also conducting this study to test two different
      types of psychotherapy as a method for reducing cocaine and alcohol use. One type of
      psychotherapy is designed to help people learn to cope with situations that put them at high
      risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use
      focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on
      developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients
      in the study.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: naltrexone; cocaine dependence; alcohol dependence; psychosocial treatment
Selective Effect of Foam Rolling and Manual Massage
Condition: Health Behavior; Health, Subjective; Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      The present double-blinded randomized controlled design aims at comparing the effects of a
      full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were
      randomly allocated to foam rolling, manual massage or a control intervention consisting in an
      autogenic relaxation routine.
    

Detailed description: 
      Self-report ratings of perceived anxiety, muscle pain and relaxation were the psychometric
      outcome variables. Sit-and-reach, toes-touch and mental calculation performances were the
      behavioral variables. Resting-state alpha and beta power recorded using
      electroencephalography and galvanic skin resistance measures were the neurophysiological
      outcome variables.
    

Intervention name(s): Psychometric ratings (Likert-scale); Range of motion measures; Mental calculation task; Resting-state electroencephalography; Resting-state galvanic skin resistance measures
Intervention type(s): Other; Behavioral; Behavioral; Device; Device
Intervention description(s): Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth); Sit-and-reach and toe touch tests; Iterated substractions (for 2 minutes); Alpha and beta oscillation power (4 minutes recordings); Skin conductance during the resting state period
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three independent groups, two measurement points
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: electroencephalography; electrodermal activity; flexibility; alertness
Soreness After Deep Dry Needling of One Latent Myofascial Trigger Point
Condition: Pain After Dry Needling
Study type: Observational

Summary: 
      Pain after dry needling or injection in the muscle is a frequent secondary effect in the
      treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed
      during a 72 hours follow up period. Factors that may contribute to higher levels of pain or
      sensitivity will be evaluated.
    


Intervention name(s): Deep dry needling
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjetct. Community sample from university.
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic
      rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568
      ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal
      allergic rhinitis.
    


Intervention name(s): RV568; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2; Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
Condition: Effect of Hypophosphatemia on Septic Patients
MeSH terms: Hypophosphatemia
Study type: Observational

Summary: 
      Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of
      developing morbidities other than that underlying sepsis and more vulnerable to higher
      mortality rate. Thus, the current study hypothesized that diagnosis and management of
      hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic
      patients admitted to ICU
    

Detailed description: 
      The current study was started since June 2018 till Jan 2020 after approval of the study
      protocol by the Local Ethical Committee. The study intended to include all patients admitted
      to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

      All patients admitted to ICU were eligible to evaluation for demographic and clinical data
      including hemodynamic data. Disease severity and its impact on body organs were evaluated
      using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18)
      scores. Exclusion criteria included maintenance on immunodepressent therapy for any
      indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the
      written concept for study participation. Children and adulthoods younger than 18 years and
      patients who were expected to die were also excluded from the study.
    

Intervention name(s): Phosphorus level
Intervention type(s): Diagnostic Test
Intervention description(s): infusion
Other intervention name(s): sodium-phosphate 10 ml vial
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock.

        All patients included except mentioned above exclusion criteria.
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Prospective, randomized, controlled, parallel group clinical study with blinded assessment
      evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
    


Intervention name(s): Sebacia Microparticles; Nd:Yag Laser
Intervention type(s): Device; Device
Intervention description(s): Topical microparticle suspension; Laser delivering 1064 nm wavelength light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety Study of SRX251 Capsules in Healthy Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of SRX251 when given orally. The amount
      of SRX251 in the blood will also be measured. Healthy women, ages 18-50 years who have been
      surgically sterilized by tubal ligation, will be enrolled in this study.
    

Detailed description: 
      Vasopressin appears to be a key mediating factor in menstrual pain. This position stems from
      findings that the hormone, arginine vasopressin (AVP), causes constriction of uterine blood
      vessels which in turn produces congestion of the uterus resulting in dysmenorrhea. Prior to
      menses, blood vessels in the uterine wall become engorged with blood. Elevated concentrations
      of vasopressin acting through V1a receptors cause constriction of both uterine and vascular
      smooth muscle, contributing to the discomfort and pain of primary dysmenorrhea. Consequently,
      blockade of these receptors with a selective V1a receptor antagonist would be expected to
      provide therapeutic benefits to women with primary dysmenorrhea.

      SRX251 is a new chemical entity with potent V1a receptor antagonist properties, and an
      acceptable safety profile as demonstrated in preclinical studies. This study is intended to
      evaluate the safety and pharmacokinetic profile of a single oral dose of SRX251 in healthy
      human female volunteers in preparation for further studies of the safety and pharmacological
      activity in the amelioration of pain associated with primary dysmenorrhea.
    

Intervention name(s): SRX251
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; Phase 1; pharmacokinetics; SRX251; Azevan; safety in healthy volunteers
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of your participation in this study is to help answer the following
      research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is
      safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major
      Depressive Disorder (MDD).
    

Detailed description: 
      • Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in
      adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD)
      without psychotic features, single or recurrent
    

Intervention name(s): Selegiline Transdermal System; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study; Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other intervention name(s): EMSAM; Matching Placebo Transdermal System
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mental Health; Adolescents; Major Depressive Disorder; Depression; Adolescent Depression; Pediatric Depression
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the immune response of three dose levels of the
      Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four
      treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups
      A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will
      receive a commercially available trivalent influenza vaccine (TIV). The study will also
      evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.
    


Intervention name(s): Quadrivalent VLP Vaccine; Comparator TIV
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Approximately 75,000-150,000 patients each year in the United States undergo intensive
      cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings.
      These patients often have high levels of disability and suffering and account for
      $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence
      from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of
      training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term
      reductions in pain intensity. However, no studies have compared the effects of these two
      treatments on measures of pain, suffering, and disability at post-treatment and over a
      one-year follow-up period.

      Our investigation is a 16-week, randomized controlled outcome study of these interventions
      and their respective placebo control procedures. One hundred and sixty patients are being
      recruited for this study. We will assess the effects of our interventions on patients' pain
      levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month
      follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our
      treatment effects as well as their statistical significance.
    


Intervention name(s): Imipramine; Cognitive-behavior therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Imipramine
Allocation: Randomized
Masking: Single
Primary purpose: Treatment
Keywords: Imipramine; Cognitive-Behavioral Therapy
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      To further characterize the transfer potential of marketed testosterone gel and new 1.62%
      formulation.
    


Intervention name(s): Testosterone gel 1.62%
Intervention type(s): Drug
Intervention description(s): 5 grams applied topically to upper arms/shoulder and abdomen on Day 1
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testosterone replacement therapy
Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      In this study, the effects of dietary intake of cold-pressed turnip rapeseed oil (CTPRO) and
      milk fat are compared in men with metabolic syndrome having already participated in HMS-02
      study.
    

Detailed description: 
      This open and balanced cross-over study consists of two dietary treatment phases (either
      Virgino (R) CTPRO or butter) for 6 to 8 weeks. They are separated from each other with an
      eight-week washout period. At the end of both periods and 12-hour fasting an oral glucose-fat
      tolerance test is carried out. Except glucose, the test consists cream (after the butter
      phase) and CTPRO (after the CTPRO phase).

      Otherwise, the subjects (n=43) are asked to maintain their normal dietary habits.
    

Intervention name(s): Cold-pressed turnip rapeseed oil (CTPRO); milk fat
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In the dietary period of 6 to 8 weeks: CTPRO 37 ml/day.
In the 5-hour oral glucose and fat tolerance test: glucose and CTPRO.; In dietary period of 6 to 8 weeks: 37.5 grams of butter.
In the 5-hour oral glucose and fat tolerance test: glucose and cream
Other intervention name(s): Virgino; Valio butter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dietary; Cross-Over Study; Lipids; Rapeseed oil; Butter; Milk Fat; Unsaturated Fat; Saturated Fat; Oxidized LDL; Platelet Function; Arterial Elasticity
Self-supporting Care Model in Home Environment for Patients With Stroke
Condition: Stroke; Activities of Daily Living
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to administer intervention based on self-supporting care model
      in home environment and to explore the effects of this intervention on stroke patients'
      activities of daily living, movement, cognition, nutritional status, and quality of life.
    

Detailed description: 
      Subjects were randomized to intervention group and control group. The experiment was designed
      as randomized cross-over control trial. The primary outcome included 8 measures: Barthel
      Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer
      Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition,
      Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.
    

Intervention name(s): Self-supporting Care; Home health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition); Individualized home health education
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Self-supporting Care Model; Home Care Services
Low Dose Cyclosporin A in Primary Sjögren Syndrome
Condition: Sjögren´s Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary
      Sjögren Syndrome
    

Detailed description: 
      NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren
      Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in
      Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of
      Sjögren Syndrome.
    

Intervention name(s): Cyclosporine A
Intervention type(s): Drug
Intervention description(s): Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
Other intervention name(s): Sandimmun optoral
Intervention MeSH terms: Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary Sjogren´s Syndrome; Cyclosporine
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
Condition: Helicobacter Infections; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the
      treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine
      clinical practice.
    

Detailed description: 
      An infection of Helicobacter pylori (H. pylori) is a risk factor for many types of
      gastrointestinal diseases and associated with stomach inflammation, ulcer of the stomach or
      small intestine. The recommended treatment for the infection is a triple therapy consisted of
      one proton pump inhibitor, such as rabeprazole, and two antibiotics administered for 7 days.
      This is an open label, nonrandomized study of the safety of rabeprazole in the treatment of
      patients with H. pylori infection. The study consists of 2 phases: the 2-month main phase and
      the 4-month monitoring phase (total duration of 6 months). During the main phase, patients
      are treated for 7 days with three drugs (rabeprazole, clarithromycin, and amoxycillin), and
      the effectiveness of the treatment is assessed 4 weeks later. During the monitoring phase,
      patients are interviewed at monthly intervals to assess symptoms and to report any adverse
      events. Safety assessments include the incidence of adverse events throughout the treatment
      and monitoring phases, and laboratory tests (hematology, biochemistry, urinalysis) and vital
      signs at the start of the study and after 1 month. Assessments of effectiveness include the
      eradication of H. pylori infection, assessed by the urea breath test one month after
      treatment. The primary study hypothesis is that rabeprazole is well-tolerated long-term in
      the treatment of patients with H. pylori infection in routine clinical practice. Rabeprazole
      tablets (20 milligrams[mg]) taken orally twice daily for 7 days. Clarithromycin (500mg) and
      amoxycillin (1 gram) taken twice daily for 7 days.
    

Intervention name(s): rabeprazole sodium
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rabeprazole; proton pump inhibitor; Helicobacter infections; Helicobacter pylori; H pylori; bacterial infections