bioihbjkbjnl/mcl2 huggingface dataset:
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy Type II
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on
      the quality of life of children, specifically in the psychological and care dimensions. Other
      objectives are to evaluate changes at the physical and functional level.
    


Intervention name(s): Use of the ATLAS 2025 exoskeleton at home
Intervention type(s): Device
Intervention description(s): Each participant will use the ATLAS 2025 exoskeleton at their homes, 5 days a week during a period of two months, for walking with the device and performing motor activities in 60 minutes duration sessions..
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exoskeleton; spinal muscular atrophy; care; quality of life; robotics
Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the vasoconstriction response profile and
      bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic
      lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).
    

Detailed description: 
      Study Type: Interventional Study Design: A single blind, single-exposure study on healthy
      adult male and female subjects.

      Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction
      Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy
      Adult Subjects: Pivotal Bioequivalence Study

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Vasoconstrictor Response
    

Intervention name(s): Halobetasol Propionate 0.05% Ointment, single exposure; Ultravate® 0.05% ointment, single exposure
Intervention type(s): Drug; Drug
Intervention description(s): A: Other Subjects received Alpharma/Purepac USHP formulated products; Subjects received Bristol-Myers Squibb Company formulated products
Other intervention name(s): Halobetasol; Halobetasol
Intervention MeSH terms: Clobetasol; Halobetasol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: bioequivalence; Vasoconstriction; Halobetasol; Healthy subjects
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study whether a herbal-based medication is superior to
      placebo for prevention of acute otitis media in pre-school children with upper respiratory
      tract infection.
    

Detailed description: 
      This is a prospective, controlled parallel-group comparison for superiority of Otovowen®.

      Patient will be identified by screening of patient cards. Patients with recurrent AOM aged 12
      to 59 months will be randomly assigned either to Otovowen® or placebo. Randomization will be
      stratified by age at enrolment (12-35 versus 36-59 months).

      The observation period per subject will be 6 months. Data collection and documentation will
      be performed weekly via online diary by the parents/legal representative(s) and by the
      investigator via eCRF.

      Patients will be seen by the doctor at baseline and at end of study. Unscheduled visits in
      case of AOM or severe URI or any other disease are initiated by the parents/legal
      representative(s).

      Study medication will be sent to the patient/parents/legal representative(s) after
      randomization. and will be administered at first signs or symptoms of URI (e. g. elevated
      temperature, common cold, influenza, coughing, sore throat, hoarse voice, frequent sneezing,
      running or stuffy nose, sinusitis, fever, headache, etc.) until resolved (maximally 8 weeks
      of continuous application).

      AOM will be diagnosed during unscheduled visits according to the criteria detailed in the
      study protocol. An AOM will be considered as resolved through confirmation by the
      investigator only.

      Compliance will be assessed by weighing contents of bottles of IMPs.
    

Intervention name(s): Herbal-based medication; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis; Aqueous ethanol solution non-distinguishable from verum
Other intervention name(s): Otovowen(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean
      intervention for health improvement in patients with type 2 diabetes.
    

Detailed description: 
      The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and
      nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients
      will be assigned to control or intervention group (A diet including triticale and mung bean;
      B diet including adzuki bean). Blood and urine samples will be collected at baseline and
      after 30 days of intervention.
    

Intervention name(s): triticale and mung bean; adzuki bean
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects are assigned to intake of triticale and mung bean for 30 days; subjects are assigned to intake of adzuki bean for 30 days
Other intervention name(s): M1 triticale and mung bean; M2 adzuki bean
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Changing Eating Behaviors in Young Children: Should Healthy Foods be Increased or Unhealthy Foods Decreased?
Condition: Obesity
Study type: Interventional

Summary: 
      Recommendations for treatment of childhood obesity in a primary care setting have been
      developed. These recommendations include beginning treatment with young children, focusing
      treatment on the parent so the parent can assist the child in making changes, and changing 2
      or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less
      calories). The effectiveness of these recommendations has never been evaluated. This
      project's goal is to develop, implement, and evaluate a 6-month childhood obesity
      intervention meeting these recommendations. Another goal of the project is to compare two
      different approaches, focusing on either decreasing intake of two unhealthy foods or
      increasing intake of two healthy foods, for changing eating behaviors during treatment. Two
      hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or
      overweight, based upon weight and height standards, will be randomized to one of three
      treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2)
      a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and
      sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits
      and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children's
      height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine
      if the recommendations for treatment are effective, and if focusing on decreasing intake of
      unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss
      outcome.
    


Intervention name(s): diet
Intervention type(s): Behavioral
Intervention description(s): diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Therapy to Sustain the Antidepressant Effects of Intravenous Ketamine in Treatment-resistant Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The goals of this study are: 1) to investigate the efficacy of combining ketamine with
      intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of
      ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to
      explore the relationship between any ketamine-induced changes in learning and memory and
      duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a
      diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to
      pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the
      study.
    


Intervention name(s): Cognitive behavioral therapy (CBT) and medication; Psychoeducation and medication
Intervention type(s): Other; Other
Intervention description(s): Sixteen sessions over 14 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The metabolic syndrome is rising worldwide as a consequence of the continued obesity
      epidemic. The current obesogenic environment makes the regulation of energy intake difficult
      and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb
      hunger and reduce energy intake are critically needed. We hypothesize that inclusion of
      protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity
      adults.
    

Detailed description: 
      The main objective of our study is to assess the effects of protein and prebiotic fiber
      intake on changes in adiposity in an overweight and obese adult population.

      Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber
      (16 g/day) intake on changes in body composition, chiefly body fat.

      Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day)
      or prebiotic fiber (16 g/day) intake.

      Other outcomes includes changes in quality of life ratings and gut microbiota.
    

Intervention name(s): Protein; Prebiotic fiber; Protein plus prebiotic fiber; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A food containing 5 grams/serving of supplemental protein.; A food containing 8 grams/serving of supplemental prebiotic fiber.; A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).; An isocaloric food not containing the test protein and fiber.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss; Appetite; Overweight; Obesity; Dietary fiber; Dietary protein
CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The aim is to develop, test and evaluate an educational intervention with the purpose to
      strengthen Child Health Services (CHS) Nurses clinical competence in detecting signs of
      postpartum depression in non-native-speaking immigrant mothers. The pilot study has a
      pre-post experimental design. Data are collected before and after the intervention. The
      differences in the values of the collected data are used to estimate the effect of the
      intervention.
    

Detailed description: 
      To be eligible for the study the CHS nurse must perform screening of immigrant mothers for
      postpartum depression with help of an interpreter according to the Edinburgh Postnatal
      Depression Scale (EPDS) method more than three times a year. The EPDS is a likert form scale
      with ten statements and is used in combination with a Clinical interview.

      Approximately 40-45 CHS nurses will be enrolled in the pilot study. The number of nurses are
      calculated in comparison to two other published studies within the same context. The
      instruments Clinical Cultural Competence Training Questionnaire (CCCTQ) and General
      Self-Efficacy scale (GSE) will be used as primary outcomes measures. Data are collected
      before the first education day and after the second education day. Secondary outcomes are
      also collected in connection to the educational intervention and consists of reported yearly
      statistics; how many mothers were are offered screening, participated in screening, number of
      screenings preformed with help og an interpreter and number of mothers offered follow-up
      after participating in screening.
    

Intervention name(s): Education in clinical competence in detecting signs of postpartum depression in immigrant mothers
Intervention type(s): Other
Intervention description(s): Groupbased educational intervention aimed at nurses in the Child Health Services in strengthening clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers
Intervention model: Single Group Assignment
Intervention model description: The study has a pre-post experimental design.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: postpartum depression; immigrant women; Child Health Services; nurse; Edinburgh Postnatal Depression Scale
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the visual outcomes and patient satisfaction after
      bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare
      it to a historical control group of patients implanted bilaterally with the spherical ReSTOR
      multifocal
    

Detailed description: 
      The purpose of this study is to evaluate the visual outcomes and patient satisfaction after
      bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare
      it to a historical control group of patients implanted bilaterally with the spherical ReSTOR
      multifocal.
    

Intervention name(s): Aspheric Acrysof ReSTOR intraocular lens
Intervention type(s): Device
Intervention description(s): Bilateral implantation of Aspheric Acrysof ReSTOR
Other intervention name(s): Acrysof ReSTOR
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects 18 years or older who had cataract surgery.
      
Keywords: Cataract; cataract extraction; intraocular lens; age related
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg
      maraviroc in healthy male Japanese volunteers.
    


Intervention name(s): maraviroc (Selzentry, Celsentri)
Intervention type(s): Drug
Intervention description(s): 12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.
Other intervention name(s): Selzentry, Celsentri
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics, Japanese, healthy volunteer, maraviroc
Safety and Tolerability of SYNB1020-CP-001
Condition: Healthy Volunteer; Urea Cycle Disorder
MeSH terms: Urea Cycle Disorders, Inborn
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized,
      Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate
      Safety, Tolerability, Dosing, and Pharmacodynamics
    

Detailed description: 
      This Phase 1, dose-escalating, randomized, double-blinded study will evaluate SYNB1020 in
      placebo-controlled cohorts within the following 2 study parts:

      Part 1: A single-ascending dose (SAD) study conducted in an inpatient setting over 6 days in
      healthy volunteer male and female subjects evaluated in up to 7 dose cohorts to identify the
      maximum tolerated dose (MTD) within the single dose range studied; and Part 2: A
      multiple-ascending dose (MAD) study conducted in an inpatient setting over 22 days in healthy
      volunteer male and female subjects evaluated in up to 4 dose cohorts that were proven
      tolerable in the SAD part of the study to identify the MTD of SYNB1020 within the
      multiple-dose range studied. Up to 48 subjects may be enrolled in this part of the study.

      Subjects will be screened for eligibility within 30 days prior to enrollment, with
      evaluations of exercise habits, gastrointestinal (GI) signs and symptoms, fecal patterns
      (frequency, consistency), recent or current antibiotic exposure, and laboratory measurements.
      Eligible patients will be admitted to an inpatient facility for investigational product (IP)
      administration, safety monitoring, and collection of blood, urine, and fecal samples for
      pharmacokinetic and pharmacodynamic evaluations.
    

Intervention name(s): Placebo; SYNB1020
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Investigational Product
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blinded, Placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
Condition: C23.550.767.700; C23.550.470
Study type: Observational

Summary: 
      The aim of this study is to investigate the relationship of preoperative
      Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR
      level on timing of epidural analgesia in thoracotomy.
    

Detailed description: 
      The study was conducted prospectively in 60 patients aged 18-75 years, ASA I-III, who
      underwent thoracotomy. The patients were divided into 2 groups as NLR level above 2 (Group A)
      (n:32) and NLR level below 2 (Group B) (n:28). Each group was divided into subgroups with
      equal numbers of Prempative analgesia group and control group. Local anesthetic was
      administered to the preemptive analgesia group (Group P) 20 minutes before the surgical
      incision through the epidural catheter, and to the control group (Group K) 20 minutes before
      the patient was awakened from the epidural catheter. NRS levels and additional analgesia
      needs were recorded at 2, 4, 8, 12 and 24 hours postoperatively.
    

Intervention name(s): Neutrophil Lynphosite ratio
Intervention type(s): Diagnostic Test
Intervention description(s): The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28).
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        A total of 60 female and male patients aged 18-75 years, in the ASA I-III risk group, who
        will undergo elective thoracotomy
      
Keywords: Preemptive Epidural Analgesia, Neutrophil/Lymphocyte Ratio, İnflammation
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram
      (mg) pimodivir in adult participants with impaired hepatic function compared to adult
      participants with normal hepatic function.
    


Intervention name(s): Pimodivir
Intervention type(s): Drug
Intervention description(s): Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other intervention name(s): JNJ-63623872
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a safety and efficacy study of Keppra® extended release formulation - XR in patients
      with epilepsy.
    


Intervention name(s): Keppra® extended release formulation - XR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg extended release oral tablet, 2 tablets once daily; oral tablets, 2 tablets once daily
Other intervention name(s): Levetiracetam XR
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Keppra® XR; Levetiracetam XR; Extended release