bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, single center, parallel group, placebo and active comparator,
      controlled study to characterize the wake promoting effects of single doses of SPD489 in
      healthy adult male undergoing acute sleep deprivation.
    


Intervention name(s): SPD489 20 mg; SPD489 50 mg; SPD489 70 mg; Armodafinil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 20 mg; Single oral dose of 50 mg; Single oral dose of 70 mg; Single oral dose of 250 mg; Single oral dose
Other intervention name(s): Vyvanse; Vyvanse; Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Respiratory Disease Management
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to reduce the number of subsequent hospital admissions and/or
      emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary
      disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM)
      program compared to standard discharge instructions and planning.
    

Detailed description: 
      The investigators propose to carry out a prospective, randomized, trial at Barnes-Jewish
      Hospital (1250-bed urban academic hospital). Eligible patients will be identified by a senior
      study coordinator who will also obtain informed consent for study participation. Adults
      greater than 18 years of age and less than 65 years of age will be eligible for enrollment if
      the lead investigator and the treating physician agree that the patient meets the enrollment
      criteria which include the following: patients with spirometrically confirmed COPD at high
      risk for repeat hospitalization or ED visits as predicted by hospital admission or ED visit
      in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of
      systemic corticosteroid therapy in the preceding 12 months. Exclusion criteria include
      patients not expected to survive their hospitalization, presence of metastatic cancer,
      bed-bound individuals, non-English speaking patients, and patients unable to provide informed
      consent.
    

Intervention name(s): RT management; Ususal care
Intervention type(s): Other; Other
Intervention description(s): Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.; Routine respiratory care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD
Preventing Depression in the Children of Depressed African American Mothers
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to adapt and test the Preventive Intervention Project for urban
      African American mothers with depression and their children.
    

Detailed description: 
      Abstract

      Background: There is limited representation of ethnic minorities in preventive interventions
      for the generational impact of maternal depression.

      Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and
      contextually relevant for urban African American mothers with depression and their children.
      A pilot clinical trial (PIP vs. lecture) was conducted.
    

Intervention name(s): Prevention Intervention Project; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.; Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: African American Mothers; Children; African American Families; Parental Depression; Preventive Intervention
Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation
Condition: Limbal Dermoid
MeSH terms: Dermoid Cyst
Study type: Observational

Summary: 
      This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid
      children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well
      asa to analyze its relationship between visual quality.
    

Detailed description: 
      Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal
      appendages that influence vision and cause visual abnormalities due to the induced corneal
      astigmatism. A large proportion of patients, all of whom had epibular dermoids, has
      amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP
      (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and
      improve visual acuity significantly postoperatively. However, the reestablishment of visual
      acuity and visual function are always ignored by parents after visual appearance recovery.
      Several studies have evaluated the visual acuity and objective and subjective visual function
      of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive
      error, graft clarity, anterior and posterior corneal higher order aberration, and
      vision-related quality of life. Although a subjective visual function assessment has been
      deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite
      clear grafts and relatively good visual acuity, and the visual function evaluation for LD
      were relatively less.

      50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were
      included in this study. All participants underwent an ophthalmic examination that included
      slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life
      quality questionnaire and fundus examination. Then the normal group would be covered by the
      positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to
      compare the visual functions with the keratoplasty patients on the same visual acuity.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There would include 50 eyes of 50 patients with corneal transplantation (the keratoplasty
        group) and 15 eyes of 15 normal subjects (the normal group) in this study
      
Keywords: Keratopathy; Visual Quality; Contrast Sensitivity Function
CSD190103: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after
      using investigational snus products (A19010-W and B19010-F).
    

Detailed description: 
      This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine
      pharmacokinetic parameters after use of two smokeless tobacco products A19010-W and B19010-F
      in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days
      and randomized to one of two investigational product (IP) (A: A19010-W and B: B19010-F) use
      sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a
      PK assessment for plasma nicotine concentrations, and then subjects will use the other
      product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
    

Intervention name(s): A19010-W; B19010-F
Intervention type(s): Other; Other
Intervention description(s): A snus product; A snus product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
ATN 151 Work-to-Prevent: Employment as HIV Prevention
Condition: HIV Prevention
Study type: Interventional

Summary: 
      The investigators aim to pilot-test a novel social and structural-level HIV intervention for
      YMSM and YTW of color ages 16-24.
    

Detailed description: 
      Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel
      social and structural-level HIV intervention for YMSM and YTW of color ages16-24 aimed at
      increasing economic stability (i.e., employment) through youth empowerment and asset
      development, and decreasing HIV risk behaviors (i.e., sex work) associated with social and
      economic marginalization.
    

Intervention name(s): Employment Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will complete 4 workshop sessions in groups of 6-12. The workshop curriculum was based on the pre-existing iFOUR program, and tailored based on feedback from a Community Advisory Board (CAB), Focus Groups, and In Depth Interviews.
Other intervention name(s): iFOUR
Intervention model: Single Group Assignment
Intervention model description: A single-arm longitudinal pre/post study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Youth Empowerment; Employment Intervention; Young Men Who Have Sex With Men; Young Transgender Women
Addressing Nonsuicidal Self-injury in Schools
Condition: Nonsuicidal Self-injury; Suicidal Ideation; Stigmatization; Help-Seeking Behavior; Perceived Social Support; Mental Well-being
MeSH terms: Wounds and Injuries; Suicidal Ideation; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The aim of this study is to study the effectiveness of a whole-school approach that addresses
      non-suicidal self-injury and targets adolescents, parents and teachers. Whether training and
      interventions can influence NSSI will be examined. Furthermore, investigations will be
      conducted to examine whether this whole-school approach can reduce symptoms of mental health
      problems in adolescents, reduce stigma och increase help-seeking and perception of social
      support. Using a clustered waitlist control design, six lower secondary schools were
      randomized to either intervention or waitlist during four months (control groups were then
      given the intervention). Measures of NSSI, suicidality, mental well-being, stigma, attitudes,
      help-seeking and perceived social support were administered at baseline, after the
      intervention and at 6, 12 and 18-months follow-up. Two hundred and sixty-seven adolescents in
      seventh and eight grade participated in the study (135 active group and 132 control group).
      The interventions were delivered during four months. For adolescents, interventions were
      delivered in the class room and consisted of five sessions of the Youth Aware of Mental
      Health (YAM) program and one additional session focusing specifically on knowledge, stigma
      and attitudes toward NSSI (KRAS). Parents were offered an online psychoeducation on NSSI, as
      were all school staff during this time period. School health care personnel, nurses,
      psychologist and counsellors and other school staff, such as teachers' aids, support staff
      and mentors took part in a 2-day workshop on NSSI and suicidality.
    


Intervention name(s): Addressing NSSI in schools; Control condition
Intervention type(s): Behavioral; Other
Intervention description(s): During the four months of active experimental condition, adolescents receive five sessions of the youth aware of mental health program in the class room, and one additional session on NSSI. Parents and school staff receive an online psychoeducation on NSSI. School health care personnel receive a 2-day workshop on NSSI and suicidality.; Participating adolescents, parents, teachers and health care personnel receive no intervention during four months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Whole-school approach; Nonsuicidal self-injury; Suicidality; Stigma; Help-seeking; Mental health
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
      HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.
    

Detailed description: 
      A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the
      Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual
      Onychomycosis of the Toenail
    

Intervention name(s): HTU-520 Patch; Placebo Patch
Intervention type(s): Drug; Other
Intervention description(s): Terbinafine hydrochloride patch; Treatment with Placebo Patch
Other intervention name(s): HTU-520; Sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Onychomycosis
Assisted Intubation
Condition: Intubation Conditions
Study type: Observational

Summary: 
      The study investigates assisted intubation using a videolaryngoscope in anesthesia.
    


Intervention name(s): Intubation
Intervention type(s): Other
Intervention description(s): Intubation, endotracheal
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing general anesthesia with endotracheal intubation
      
Keywords: endotracheal; intubation; video; time
Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional

Summary: 
      The main objective of the study is to investigate the determinants of the quality of life in
      children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific
      impact of neuropsychological deficits. In fact, cognitive impairment is currently considered
      as one of the most pervasive features of this genetic disorder but its relationship with the
      worsening of quality of life found in this population has not been directly investigated to
      date.

      Secondary objectives of this study are (i) to compare neuropsychological and quality of life
      measures between patients and healthy controls matched by age, gender and education level,
      (ii) to contrast neuropsychological deficits incidence between patients and controls, and
      (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.

      The main hypothesis of this study is that the neuropsychological impairment classically
      identified in this clinical population will be associated to the quality of life's worsening
      both in children and adults.
    

Detailed description: 
      The study cohort will consist of 150 patients with NF1 (100 adults and 50 children) recruited
      from the Neurofibromatosis Clinic at the University Hospital in Nantes and Créteil (France).
      A sample of 150 healthy controls (100 adults and 50 children) will also be recruited from
      sport and leisure clubs to serve as a normally developing control group.

      The protocol assessment includes a standard and thorough neuropsychological examination
      specific to children and adults, to investigate the different aspects of cognitive domains:
      language, visuoperceptive and visuomotor abilities, memory, attention, executive function and
      intelligence skills. Quality of life is measured by a questionnaire specifically adapted to
      children and adults.

      Other factors linked to the NF1 disease (familial or sporadic form, severity and visibility)
      and to demographic characteristics (sex, age, education level) will be taken into account to
      study their respective impact on quality of life, as compared with neuropsychological
      measures.
    

Intervention name(s): Neuropsychological examination and quality of life measures
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Quality of life; Neuropsychological disorders; Neurofibromatosis type 1
A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of LY3437943 in participants who have obesity or are overweight. The main
      purpose is to learn more about how LY3437943 affects body weight loss. The study will last
      about 18 months and may include up to 18 visits.
    


Intervention name(s): LY3437943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nutritional or Metabolism Disorder; Weight Loss; Overnutrition; Incretins; Hormones; Physiological Effects of Drugs
Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the safety of a candidate malaria vaccine
      (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50
      μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults
      not previously exposed to the parasite Plasmodium falciparum.
    


Intervention name(s): PfAMA-1-FVO[25-545]
Intervention type(s): Biological
Intervention description(s): Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets
      under non-fasting conditions.
    


Intervention name(s): Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical); Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical); Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-Inflammatory
EMPower: Electronic Media Powering Positive Health Changes in Youth
Condition: Hypertension; Prehypertension; Overweight; Obesity; Hypertrophy, Left Ventricular
MeSH terms: Prehypertension; Hypertrophy, Left Ventricular; Overweight; Hypertrophy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a technology-based behavioral
      Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean
      clinic systolic BP), and heart size (LVM) in comparison to standard care.
    


Intervention name(s): Electronic Media Application; Standard of care education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; Cardiovascular disease; Children; Adolescent; Pediatrics; End-organ damage
Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction
Condition: Stroke; Shoulder Dislocation or Subluxation
MeSH terms: Shoulder Dislocation
Study type: Interventional
Phase: Phase 1

Summary: 
      Hemiplegic shoulder pain (HSP) is a common and disabling complication following a stroke, and
      it may affect the quality of life. It often occurs following two to three months of stroke.
      Upper limb impairment is seen in 90% of patients affected by stroke.

      Numerous causes have been implicated in developing HSP in stroke. This includes muscle
      flaccidity around the shoulder joint, shoulder subluxation, shoulder-hand syndrome, increased
      muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and the thalamic
      syndrome.

      Muscle paresis, abnormal muscle tone and loss of proprioception following stroke may render
      the shoulder complex unstable and therefore prone to misalignment.

      In recent years, high-intensity laser therapy (HILT) has been considered as a treatment
      option for shoulder pain.

      HILT increases microcirculation and tissue regeneration and lowers edema, inflammation, and
      pain with its photomechanical, thermal, electrical, and bio stimulating effects in deep
      tissues that cannot be reached with LILT.

      It has some advantages over LILT, i.e., having higher power, greater tissue penetration
      capacity to deep tissues, the short emission time, and long rest periods preventing heat
      accumulation.

      In recent studies, effectiveness of HILT has been shown in the treatment of subacromial
      impingement syndrome, rotator cuff tendinopathy, and frozen shoulder.
    


Intervention name(s): hight intenisty laser
Intervention type(s): Device
Intervention description(s): 7W(LAZR-207)/15W(LAZR-215&115)HIGH POWER LASER THERAPYUNIT WITH 2 WAVELENGTHMODES,COMBINATION(810+980 NM) AND SINGLE(1064 NM)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke,; Shoulder dysfunction; High intensity laser