bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
Condition: Injury
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to study the effectiveness of an early psychological
      intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of
      children and adolescents
    

Detailed description: 
      Within a randomized controlled design the effects of a brief psychological intervention
      (child, parents) after a road traffic accident shall be examined in a sample of 100 children
      and adolescents. After a baseline assessment 7-10 days after the accident participants are
      randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6
      months after the accident by means of standardized questionnaires assessing posttraumatic
      stress symptoms, depression, and behavior.
    

Intervention name(s): Early psychological intervention
Intervention type(s): Behavioral
Intervention description(s): Psychoeducation, trauma narrative, provision of coping skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: posttraumatic stress disorder; children; injury; road traffic accident
Valproic Acid Sodium Salt in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA)
           levels in patients with bipolar disorders who are within euthimic, depressive or
           manic/hypomanic period and who are not taking drug;

        -  To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on
           total and local gray matter volumes and NAA levels.

        -  To measure the brain electrical response to visual and auditory impulses before and
           after valproate treatment in patients within euthimic, depressive or manic/hypomanic
           period and who are not taking drug, and to compare the data with each other and with
           normal groups.

        -  To determine the cognitive functions before and after the valproate treatment in the
           same patient group, to compare the data with each other and with age- and sex-paired
           normal controls;

        -  To determine the relationship between these effects of valproate and clinical
           improvement;

        -  To investigate the relationship between cognitive ability status and electrical activity
           of brain, to compare this with that in control group; to determine the relationship
           between the data and brain imaging (MRI/MRS) findings in conjunction with localization
    


Intervention name(s): Valproic acid, sodium salt
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall
      Disease Severity and Investigator Global Assessment.
    

Detailed description: 
      Same as above.
    

Intervention name(s): Clobetasol Propionate, 0.05%; Calcipotriene and betamethasone dipropionate ointment
Intervention type(s): Drug; Drug
Intervention description(s): Topical, twice daily for 4 weeks; Topical, once daily
Other intervention name(s): Clobex® Spray; Taclonex® Ointment
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Condition: Thrombocytopaenia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Thrombocytopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part
      3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with
      myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due
      to bone marrow insufficiency from their underlying disease or prior chemotherapy. This
      objective was assessed by a composite primary endpoint that consists of the following: the
      proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or platelet
      transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow
      insufficiency from their underlying disease or prior chemotherapy were enrolled in the study.
      No low or intermediate-1 risk MDS subjects were enrolled in the study. Subjects must have had
      at least one of the following during the 4 weeks prior to enrolment: platelet count <10 Gi/L,
      platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC),
      including hydroxyurea, was allowed as indicated by local practice throughout the study. The
      study had 3 sequential parts. Subjects who were enrolled in Part 1 (open-label) cannot be
      enrolled in Part 2 of the study (randomized, double-blind); however, subjects who completed
      the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) continued in Part 3
      (extension) if the investigator determined that the subject was receiving clinical benefit on
      treatment.
    


Intervention name(s): eltrombopag; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg (150 mg for subjects of East Asian heritage); 100 mg matching placebo daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg matching placebo (150 mg for subjects of East Asian heritage)
Other intervention name(s): Promacta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: acute myeloid leukemia (AML); acute myelogenous leukemia (AML); acute non lymphocytic leukemia (ANLL); myeloproliferative disease (MDS); myelodysplastic syndrome ( secondary acute myeloid leukemia); refractory acute myeloid leukemia
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the comparative bioavailability of a test
      product of dronabinol oral solution administered under fed conditions to the reference listed
      drug (RLD) administered to participants under fed and fasted conditions.

      The secondary objective is to compare the onset of detectable dronabinol concentrations
      between dronabinol oral solution and the RLD.
    


Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dronabinol oral solution, under fed conditions; Dronabinol oral capsule, under fed conditions; Dronabinol oral capsule, under fasted conditions
Other intervention name(s): Marinol; Marinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Comparative Bioavailability
Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet
      under fasted conditions.
    


Intervention name(s): Losartan Potassium
Intervention type(s): Drug
Intervention description(s): 100 mg tablet
Other intervention name(s): COZAAR
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adverse Neurogenic Actions of Dietary Salt
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Excess dietary salt increases the risk for cardiovascular events, even in people that are not
      hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and
      sympathetic nervous system responses to various perturbations and increases blood pressure
      variability. This proposal will examine the effects of low, medium, and high salt diets on
      cardiovascular reactivity and blood pressure variability.
    

Detailed description: 
      Excess dietary salt causes target organ damage and increases the risk for adverse
      cardiovascular (CV) events independent of blood pressure (BP). Recent data in salt-resistant,
      normotensive rodents suggest that high dietary salt enhances the excitability or gain of
      sympathetic circuits, exaggerates sympathetic and CV responses to various stimuli, and
      increases BP variability (BPV). There are limited data regarding the impact of dietary salt
      intake on sympathetic nerve activity (SNA) and CV function in salt-resistant humans as well
      as the underlying mechanisms contributing to these adverse effects. The long-term goal is to
      determine how dietary salt adversely affects BP regulation and CV health. The objective of
      this proposal is to comprehensively evaluate the impact of dietary salt intake on SNA and CV
      reactivity and BPV in normotensive humans. The investigators have 2 specific aims: 1) Aim 1
      will test the hypothesis that high dietary salt increases SNA and CV reactivity in
      normotensive adults, 2) Aim 2 will test the hypothesis that high dietary salt increases BPV
      in normotensive adults. The expected outcome is to demonstrate that dietary salt loading
      increases CV reactivity and BPV through a sympathetic nervous system mechanism that
      originates in the brain. The proposed research is significant, as these studies will provide
      empirical evidence that dietary salt intake impacts neurohumoral control of the circulation
      in salt-resistant humans. The proposed research is innovative because it will identify a
      novel neurogenic action of dietary salt in human CV regulation.
    

Intervention name(s): Low Sodium Diet; Medium Sodium Diet; High Sodium Diet
Intervention type(s): Other; Other; Other
Intervention description(s): Ten days of low sodium diet; Ten days of a medium sodium diet; Ten days of a high sodium diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
High-Volume Vs Low-Volume Preparation in Emergency Department
Condition: GastroIntestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Emergencies; Hemorrhage
Study type: Interventional

Summary: 
      The primary endpoint of this study was to compare the intestinal cleansing of patients with
      LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform
      colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the
      standardized Boston Bowel Preparation Scale (BBPS).

      The secondary endpoint was to evaluate the tolerability and compliance of patients prepared
      with High-Volume in comparison to Low-Volume in the ED.
    


Intervention name(s): Low volume macrogol; High volume macrogol
Intervention type(s): Drug; Drug
Intervention description(s): Clensia 2 lt; Selg 4 lt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Estrogen Deficiency on Energy Expenditure
Condition: Obesity
Study type: Interventional

Summary: 
      Menopause is associated with weight gain, but the reasons why are not clear. In this study,
      the investigators will determine if reducing estrogen levels causes a decrease in the ability
      of the body to produce heat. If so, this would suggest this is one way that menopause may
      cause weight gain.
    

Detailed description: 
      The purpose of this pilot study is to investigate the role of the female sex hormone
      estrogen, on metabolism, thermoregulation and energy expenditure. Weight and fat gain
      increase after the menopause, but reasons for this are not clear. Loss of estrogen may cause
      changes in how women regulate metabolism and thermoregulation, possibly leading to weight
      gain. Specifically, this study will determine how loss of estrogen affects facultative
      thermogenesis. Loosely defined, facultative thermogenesis represents heat production that is
      turned on when needed. For example, when body core temperature falls below a certain
      threshold, a shivering response is invoked in skeletal muscle to increase heat production
      and, thus, energy expenditure. However, exposure over several hours to mild cold temperatures
      that do not trigger shivering (16-20⁰ C) also induces an increase in energy expenditure
      (cold-induced non-shivering thermogenesis). Although several different tissues may contribute
      to this response, the recent identification of functional brown adipose tissue (BAT) in
      humans has promoted an interest in how BAT is activated in humans and its potential role in
      regulating energy balance and body weight. The investigators will measure BAT activity using
      PET/CT scans pre and post three months of estrogen suppression.
    

Intervention name(s): Estrogen suppression
Intervention type(s): Drug
Intervention description(s): Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function
Other intervention name(s): Lupron
Intervention MeSH terms: Estrogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study on the Efficacy and Safety of Gelaspan
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      It is the objective of the study to investigate the efficacy and safety of two different
      volume replacement regimens with gelatine solutions.
    


Intervention name(s): Gelaspan 4%; Gelofusine 4%
Intervention type(s): Drug; Drug
Intervention description(s): Gelaspan 4% combined with Sterofundin ISO; Gelofusine 4% combined with Sodium Chloride
Intervention MeSH terms: Polygeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the determination of blood concentration and the effectiveness
      of esketamine after nasal application.
    


Intervention name(s): esketamine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Esketamine
Keywords: pharmacokinetics; ketamine; Anesthetics, Dissociative
Steroid Injection Treatment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel
      in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured
      with patient evaluated symptoms score.Out of the patients referred by primary care, those
      with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is
      judged by the examining surgeon to warrant surgery are offered to be put on the waiting list
      for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who
      give informed consent will be asked to attend the outpatient clinic for a physical
      examination followed by allocation to one of the three trial groups. Immediately following
      the allocation the patients will receive the assigned treatment.
    

Detailed description: 
      www.biomedcentral.com/1471-2474/11/76
    

Intervention name(s): Methylprednisolone 40 mg; Methylprednisolone 80 mg; Sodium chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Depo-medrol 40 mg , suspension, injection in the carpal tunnel, one time use
1 ml 40 mg Methylprednisolone + 1 ml 10mg Lidocaine + 1 ml saline; Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use.
2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine; Saline solution 0,9%, injection in the carpal tunnel, one time use
1 ml 10 mg Lidocaine + 2 ml saline
Other intervention name(s): Depo-medrol; Depo-medrol; Saline; NaCl
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the clinical study of the medicinal product for medical use: to compare
      efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with
      relapsing-remitting multiple sclerosis.

      Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to
      March 23, 2016.

      Number of patients, involved into the study of the medicinal product for medical use: 158
      patients.
    


Intervention name(s): BCD-063; Copaxone-Teva; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): glatiramer acetate; glatiramer acetate; mannitol
Intervention MeSH terms: Glatiramer Acetate; Mannitol; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Equivalence; BCD-063; Copaxone-Teva
Sugars-sweetened Commercial Beverages on Short-term Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate
      milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when
      compared to cola, a fruit drink and a water control in normal weight and overweight/obese
      9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal
      time satiation to a greater extent than other sugars-sweetened commercially available
      beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water,
      fruit drink, cola or 1% chocolate milk.
    


Intervention name(s): Water; Fruit drink; Cola; 1% chocolate milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: prevention
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine
Condition: Pain
Study type: Interventional

Summary: 
      Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain
      from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the
      present study we investigate primary and secondary hyperalgesia in healthy volunteers
      following an experimental first degree burn injury.

      The objectives are:

        -  to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and
           buprenorphine).

        -  to investigate if these effects are related to the volunteers individual pain
           sensitivity
    

Detailed description: 
      Please refer to:

      Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and
      buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a
      double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38.
      10.2147/JPR.S36827 [doi];jpr-6-023 [pii].
    

Intervention name(s): morphine LO; Morphine Hi; Buprenorphine LO; Buprenorphine Hi; saline
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): intravenous infusion, 10 mg, once, 4 hours; intravenous infusion, 20 mg, once, 4 hours; intravenous infusion, 0.3 mg, once, 4 hours; intravenous infusion, 0.6 mg, once, 4 hours; intravenous infusion, 0.9% saline, once, 4 hours
Other intervention name(s): Morfin SAD; Morfin SAD; Temgesic; Temgesic; 0.9% NaCl
Intervention MeSH terms: Morphine; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: opioids; analgesia; secondary hyperalgesia; quantitative sensory testing; inflammatory injury
Performance and Nutrition Program for Athletes in Adaptive Sports
Condition: Spinal Cord Injuries; Physical Disability
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Researchers are trying to evaluate and recommend sustainable and effective health and
      wellness programs for people with spinal cord injury (SCI) and other physical disabilities.
    


Intervention name(s): Training & Nutrition
Intervention type(s): Behavioral
Intervention description(s): Exercise at moderate to high intensities and diet education/counseling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United states of America (USA). The aim of this trial is to
      compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
    


Intervention name(s): biphasic insulin aspart 30
Intervention type(s): Drug
Intervention description(s): Single dose administrated subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment