bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents
Condition: Human Immunodeficiency Virus (HIV); Acquired Immunodeficiency Syndrome (AIDS)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The primary objective of this project is to assess the study population's acceptance of two
      medication adherence support strategies: incentive-based programs and electronic medication
      monitoring. The study population is adolescents (ages 16 - 24) positive for human
      immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St.
      Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio
      Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be
      10-20 minutes. Patient identifiers will not be attached the survey.
    

Detailed description: 
      Whether or not patients take their medications is one of the most noticeable and important
      predictors of treatment success or failure for HIV infection. Ways to improve compliance,
      specifically rewards-based programs and electronic medication monitoring, have shown some
      success in limited clinical research studies focused on adult subjects. Because the social
      and developmental factors in adolescents are different from adults, adolescents may not
      respond to these interventions in the same way as adults. This study will investigate
      adolescent acceptance and the effectiveness of these programs.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Participants who consent to participate in this study will complete a short questionnaire. The survey will be completely anonymous (not matched with the participant's name). Estimated time to complete the survey is 10-20 minutes.
Other intervention name(s): Survey
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-positive adolescents between the ages of 16 and 24 years who are currently undergoing
        treatment with antiretrovirals at St. Jude's HIV clinic.
      
Keywords: Adolescents; Medication Compliance; Rewards-Based Incentive Programs
The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders
Condition: Affective Disorder; Major Depressive Disorder; Bipolar Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mood Disorders
Study type: Interventional

Summary: 
      The aim of the present study, is to evaluate the effect of a supported employment
      intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or
      education, when offered to people with onset mood or anxiety disorders who are not likely to
      be able to return to work within three month.

      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and
      more people returning to work or education, compared to treatment as usual.
    

Detailed description: 
      Background: The IPS-MA method is a modified Individual Placement and Support (IPS)
      intervention, aiming at supporting people with mood or anxiety disorders regain their
      workability and return to work or education. Previous studies have showed, that IPS has an
      effect on employment when offered to people with severe mental illness. Further studies are
      crucial to demonstrate whether the modified IPS, the IPS-MA method, has an effect when
      offered to people with mood or anxiety disorders who are not yet chronified.

      Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the
      IPS-MA method in addition to treatment as usual compared to treatment as usual alone for 326
      participants diagnosed with a mood or anxiety disorder, living in the Capital Region of
      Denmark. The primary outcome is competitive employment or education. Secondary outcomes are
      days of competitive employment or education, disease symptoms, level of functioning, and
      quality of life at follow-up 12 and 24 months after baseline.
    

Intervention name(s): The IPS-MA method
Intervention type(s): Behavioral
Intervention description(s): During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the IPS-MA intervention is 12 months, but since the needs of the participants are very individual, this may vary.
Other intervention name(s): IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Supported employment; Individual Placement and Support; Workability; Return to work
SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
Condition: SLAP Lesions
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether there is a difference between conservative
      and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.
    

Detailed description: 
      Treatment of superior labral lesions is controversial. Some authors advocate labral repair,
      some advocate biceps tenodesis,and others again questions whether these lesions should be
      repaired at all. There are no randomized studies comparing operative treatment and
      conservative treatment(i.e. physical rehabilitation), and likewise no randomized studies
      comparing labral repair and biceps tenodesis.

      In this study;all patients who have a patient history, clinical signs of a SLAP lesion,a MRI
      study revealing an isolated superior labral lesion and have agreed to participate in the
      study, will have a diagnostic arthroscopy performed.

      If a SLAP lesion is diagnosed, the patients are randomized to three different groups:1) SLAP
      repair with suture anchors 2) Biceps tenodesis 3) Physical therapy
    

Intervention name(s): labral repair; biceps tenodesis; diagnostic arthroscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): labral repair with suture anchors; biceps tenodesis with suture anchor; diagnostic arthroscopy
Other intervention name(s): lupine anchor; suture anchor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: SLAP lesions; labral repair; bicepstenodesis; conservative treatment
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic
      disorder that slows or stops the passage of food from the stomach to the small intestine. The
      purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric
      emptying time in diabetic subjects with gastroparesis.
    

Detailed description: 
      This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in
      diabetic subjects with gastroparesis. The length of study participation for a subject is up
      to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath
      test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period,
      subjects will complete 4 overnight drug assessment visits (treatment arms) where they will
      receive a randomized single dose of study drug and the GEBT. Each overnight visit will be
      separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4
      dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
    

Intervention name(s): TC-6499; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
Condition: Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma
MeSH terms: Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE
      study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense
      temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the
      management of adult patients with malignant glioma who have failed following at least 2
      cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200
      mg/m^2).
    


Intervention name(s): Temozolomide
Intervention type(s): Drug
Intervention description(s): Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
Other intervention name(s): SCH 52365
Intervention MeSH terms: Temozolomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease
Condition: Cardiovascular Risk Factors
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and
      insulin sensitivity but the impact of NEFA composition is unknown.

      The objective was to test the effect of acute elevation of NEFA enriched with either
      saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3
      PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser
      Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a
      hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.
    

Detailed description: 
      To investigate potential diet-gene interactions, potential subjects (n=370) were
      prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150
      were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two
      were unsuitable according to selection criteria and one subject subsequently withdrew from
      the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected,
      balanced for gender, age and BMI.
    

Intervention name(s): Absence or presence of fish oil
Intervention type(s): Dietary Supplement
Intervention description(s): Oral dose of saturated fat with or without fish oil and a heparin infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Endothelial function; Non-esterified fatty acids; Insulin sensitivity
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Condition: Headache; Migraine; Aura
MeSH terms: Migraine Disorders; Migraine with Aura; Headache; Hypoxia
Study type: Interventional

Summary: 
      In this study the investigators will investigate the following hypothesis

        -  that hypoxia induce migraine headache and migraine aura

        -  the aura phase is associated with a spreading reduction in cerebral blood flow

        -  the migraine headache is associated with dilatation of intra- and extracerebral arteries

        -  the migraine headache is associated with changes in brain metabolism

        -  the pre-ictal stage of a migraine attack with aura is associated with specific patterns
           in neural activity.
    

Detailed description: 
      To investigate migraine with aura symptoms during and after hypoxia.

      With magnetic resonance imaging the investigators will investigate changes in

        -  regional cerebral blood flow (rCBF)

        -  resting state functional connectivity

        -  circumference of the middle cerebral artery(MCA), internal carotic artery, superficial
           temporal artery, medial meningeal artery, external carotic artery

        -  brain metabolism

      And compare these changes with a aged match healthy control group.
    

Intervention name(s): Hypoxia; Placebo
Intervention type(s): Other; Other
Intervention description(s): Inhalation of hypoxic air (8-12% oxygen content); Inhalation of atmospheric air
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Headache; Migraine; Aura; Cerebral hemodynamics
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD)
      tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are
      bioequivalent.
    


Intervention name(s): Amlodipine; Amlodipine; Amlodipine; Amlodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3rd OD 5 mg tablet single oral dose administered with water; 2nd OD 5 mg tablet single oral dose administered with water; 3rd OD 5 mg tablet single oral dose administered without water; 2nd OD 5 mg tablet single oral dose administered without water
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
Condition: Influenza; Orthomyxoviridae Infections; Influenza A Virus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open, randomized, multicenter clinical trial.

      Objectives:

        -  To describe the safety profiles during the 21 days following each primary and booster
           injection.

        -  To describe the immune response 21 days after each primary and booster injection of each
           formulation.

        -  To describe the antibody persistence after the first vaccination
    


Intervention name(s): A/H5N1 Inactivated, split-virion pandemic influenza vaccine; A/H5N1 Inactivated, split virion pandemic influenza vaccine; A/H5N1 Inactivated, split virion pandemic influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.25 mL, Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza A/H5N1 Virus; Influenza Pandemic; Orthomyxoviridae Infections
The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults
Condition: Auditory Perception; Psychoacoustics
Study type: Observational

Summary: 
      The aim of this study was to establish parameters for the Gaps-in-Noise test in
      normal-hearing young adults. One hundred subjects (50 males and 50 females) received an
      audiological evaluation to rule out hearing loss and auditory processing disorder. The
      Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was
      4.19 msec. A psychometric function by gap duration was constructed, revealing that the
      percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec,
      10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for
      gap durations of 5 msec or longer. The results suggest that the data obtained can be applied
      as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test
      proved to be consistent with low variability.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal-hearing adults between 18 and 31 years of age were evaluated, including 50 males
        (mean age 24.72 years) and 50 females (mean age 23.77 years). The youngest male subject was
        18 years old, and the youngest female subject was 18.16 years old. In contrast, the oldest
        male subject was 31.5 years old, and the oldest female subject was 31.83 years old. All of
        the participants in the study were students or employees of the University of Guarulhos.
      
Keywords: GIN test; gap detection; temporal resolution; auditory perception; psychoacoustics
A Food Effect Study of SHR2554 on Healthy Chinese Male Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of high-fat diet on
      pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554
      tablets.

      The secondary objective of the study is to evaluate the safety of single dose of SHR2554
      orally in healthy subjects.
    


Intervention name(s): SHR2554
Intervention type(s): Drug
Intervention description(s): SHR2554
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Condition: Epilepsy; Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the safety and tolerability of long-term
      administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with
      Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
Formulation: Tablet
Frequency: twice daily during the study period (until the date of approval)
At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide; Epilepsy; Partial-onset Seizures
A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate safety and tolerability of BI 764198 in
      healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the exploration of pharmacokinetics (PK) including dose
      proportionality of BI 764198 after single oral dosing.
    


Intervention name(s): BI 764198; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule; capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Platelet-rich Plasma for Chronic Lateral Ankle Instability
Condition: Ankle Instability; Platelet-rich Plasma
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle
      instability by comparing the imaging and clinical outcomes between patients receiving PRP and
      those receiving whole blood during the modified Broström-Gould procedure.
    

Detailed description: 
      Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been
      linked to recurrent ankle pain, swelling, and even early degenerative change if not properly
      treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the
      mainstream in treatment of CAI. Early mobilization is related to better functional outcome,
      and rapid healing of the repair is the key point to shorten the immobilization time.
      Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple
      growth factors concentrated at high level. Because activated platelets have the potential to
      release growth factors, PRP has been clinically used to accelerate wound healing and tissue
      regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This
      clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly
      assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The
      postoperative imaging and clinical outcomes will be compared and analyzed.
    

Intervention name(s): Platelet-rich plasma; Control
Intervention type(s): Other; Other
Intervention description(s): Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament; Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet-Rich Plasma; Ankle Injuries; Lateral Ligament, Ankle