bioihbjkbjnl/mcl2 huggingface dataset:
Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
Condition: Mild Traumatic Brain Injury; Posttraumatic Stress Disorder; Affective and Somatic Complaints; Cognitive Impairments
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      This longitudinal cohort study aims to detect the topographical nature of the white matter
      microstructure and resting state functional connectivity patterns across the whole brain in
      the evolution of pathology as a function of time following mild TBI. All consecutively
      patients with the non-contrast head CT because of acute head trauma from the local emergency
      department (ED) formed the initial population of this study. Age, sex, education-level
      matched healthy controls will also be enrolled. The initial scan will performed within 7 days
      post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a
      broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1
      month, 3 month, 6-12 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutively patients with the non-contrast head CT because of acute head trauma from
        the local emergency department (ED) formed the initial population of this study. Three
        research assistants (trained, board-certified neurologist or neurosurgeon) monitored the ED
        and hospital wards on a daily basis to identify new admissions. Screening for mild
        traumatic brain injury (TBI) was based on the World Health Organization's Collaborating
        Centre for Neurotrauma Task Force.
Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision
Condition: Healthy Donors for Liver Transplantation
MeSH terms: Surgical Wound
Study type: Observational

Summary: 
      Living donor liver transplantation (LDLT) is an important option for patients with end-stage
      liver disease requiring liver transplantation. When performing LDLT, the safety and well
      being of donors is of the utmost importance. The conventional incision for donor hepatectomy
      is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive
      liver surgery throughout a single 10 cm upper midline incision without laparoscopic
      assistance has been widely applied and considered to be safe and effective. Recently,
      laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been
      suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although
      minimally invasive approach has become the surgical method of choice for many transplant
      centers, little data on comparing the impact of all three different type incision in living
      liver donors. In our center, the investigators have adopted three different incision
      according to surgical teams. The investigators undertook this study with the aims of
      comparing the pain and quality of life of donors according to type of three different
      incisions and assessing any benefits to the donor due to the smaller midline incision during
      the early postoperative period.
    


Intervention name(s): hepatectomy conventional incision; hepatectomy midline incision; hepatectomy transverse incision
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): This study was a single center, nonrandomized, observational comparative analysis of 3 different surgical technique. Three surgical teams operated alternately at our center, and donors undergoing hepatectomy via three different incision
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study was a single center, non-randomized, observational comparative analysis of 3
        different surgical technique. The living liver donors underwent hepatectomy using three
        different type of incisions; 1) right subcostal incision with a midline extension 2) upper
        midline incision without laparoscopic assistance 3) transverse incision with laparosocpic
        assistance
Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to determine the effects of focal muscle vibration on bio-psychosocial
      outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be
      conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second
      step is prediction of outcomes. A qualitative gait analysis will also be done.
    

Detailed description: 
      The literature suggests the positive effects of focal muscle vibration on various motor
      components of cerebral palsy. Although there is a gap regarding it's effects with perspective
      of bio-psychosocial model, which will be the main focus of this study. The study will look
      for the effects of focal muscle vibration on biological, psychological and social aspects of
      subjects with cerebral palsy (CP). The intervention in form of focal muscle vibration and
      standard physical therapy will be provided for 12 weeks and the subjects will then be
      followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of
      outcomes.
    

Intervention name(s): Focal muscle vibration; Stretching; Strengthening; Positioning
Intervention type(s): Device; Procedure; Procedure; Procedure
Intervention description(s): Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.; Stretching of shortened lower extremity muscle; Strengthening exercises for weak lower extremity muscles; Positioning of participant to maintain a good body posture
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 parallel group mixed methods
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Focal muscle vibration; Biopsychosocial; Functional near-infrared spectroscopy; Electroencephalography; Emotional reactivity
Melatonin Production Delay in Preterm Infants
Condition: Melatonin Production
Study type: Observational

Summary: 
      Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months
      of age. This might be related to exposure of preterm infants to continuous lighting in the
      NICU during a critical period of pineal gland development. The investigators aimed to test
      the profile of melatonin production in these infants at 9-12 months of age.

      Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks)
      were studied. The investigators tested nocturnal urinary melatonin excretion, within a
      repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from
      diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by
      ELISA assay.
    

Detailed description: 
      Unlike other organs which show catch up in preterm infants after one year of life, the pineal
      gland shows persistent delay in melatonin production. This field of research has been
      neglected lately although there are published recommendations for decrease of bright light in
      NICUs which prevents melatonin development and production, and also recommendations for
      melatonin treatment in cases respiration recovery in hospitalized preterm infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Design: Forty-six infants (23 full term and 23 preterm babies) infants and their mothers
        were randomly recruited from a successive list of preterm and term labors at a large urban
        medical center in Northern Israel and were assigned to the study. We calculated that a
        sample size of 30 mother-infant dyads is sufficient to show a significant effect of the
        intervention with a power of 90% and 5% risk of type alpha error (Cohen , chen, West &
        Aiken, 2003). This calculation was based on the effect size found in full-term infants
        melatonin secetion (1).
      
Keywords: 6sulphatoxymelatonin; preterm infants; melatonin is low in preterm infants at least until the age of 6 months
Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth
Condition: HIV Prevention
Study type: Interventional

Summary: 
      Youth and young adults in the juvenile justice system have a high prevalence of concurrent
      psychiatric and substance use disorders and are also at high risk for HIV. However, even when
      the disorders and risks are recognized, most programs do not address all of these important
      problems and long-term efficacy for all outcomes simultaneously has yet to be demonstrated
      for these multi-problem youth. Adverse outcomes for youth include partially treated or
      relapsing psychiatric disorders, continued substance abuse, unchanged HIV risk, and further
      legal problems. This project, in collaboration with the Rhode Island Family Court, with whom
      we have existing collaborations, will address these issues by implementing an Integrated
      Treatment Program (ITP) that targets mental health/substance abuse disorders and HIV risk.
      ITP is novel by targeting multiple adolescent problems simultaneously, involving parents to
      augment change, and its delivery within the Family Court. This study will extend our previous
      efficacious interventions among youth with psychiatric disorders to court-involved youth.
      Adolescents and their parents will be enrolled from the Rhode Island Family Court Mental
      Health Clinic where youth aged 13-17 are referred by judges for comprehensive assessment and
      referral for treatment. This randomized controlled trial will test the efficacy, among 200
      sexually active court-involved youth who need outpatient treatment, of the novel, integrated
      treatment (ITP, n=100) as compared to enhanced standard care in community outpatient services
      (ESC, n=100) over an 18-month period (6 months of ITP or ESC and 12 months of follow-up). ITP
      consists of three components: 1) individual cognitive behavioral therapy which includes a
      motivational interviewing component and is modular-based to address concurrent mental health
      and substance abuse issues; 2) family and parent training sessions to address parental
      communication and monitoring to support risk reduction among youth; 3) multifamily group
      workshops to address HIV risk, family communication and peer resistance skills. Youth in both
      conditions (ITP and ESC) will receive similar case management services from the court and
      psychiatric medication management (if needed) from a study psychiatrist. ITP will be compared
      to ESC on reductions in sexual risk behavior, substance use, symptoms of psychiatric
      disorders, and legal offenses.
    


Intervention name(s): Integrated treatment program; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT, psychopharmacological treatment, family treatment, HIV prevention, case management; Treatment in community, case management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Home Nasal Pressure for Sleep Apnea Management in Primary Case
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Primary objectives: To determine the efficacy and cost-effectiveness of a management program
      for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or
      specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be
      made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist
      healthcare arm will use polysomnography (PSG) in a hospital. Patients with an
      intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth
      scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

      Secondary objectives: efficacy of the two SAHS management programs according to the following
      secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical
      wellbeing scale, b) adherence to and compliance with the treatment.
    

Detailed description: 
      Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280
      patients will be randomized for management on the basis of DNP (primary) or PSG (specialist),
      thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will
      undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
    

Intervention name(s): Diagnosis, autoCPAP, follow up.
Intervention type(s): Device
Intervention description(s): comparison between the efficacy of two protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep apnea; portable monitor; primary care; cost-effectiveness; OSAS
Peppermint Aroma and Physiological Parameters
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the
      patient's collar. In the placebo group, peppermint oil will be replaced with water.
    

Detailed description: 
      Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological
      parameters of those patients are affected by stress. Peppermint inhalation reduces stress and
      improves physiological parameters in many studies, but none of these studies used peppermint
      inhalation on mechanically ventilated patients.

      Patients who are conscious on mechanical ventilation via endotracheal via tube will be
      randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated.
      Nothing will be changed in patients' mechanical ventilation data. The intervention group will
      receive peppermint inhalation intervention, and the placebo group received water inhalation
      intervention. Patients in both groups will be assessed for their smell ability by Sniffin
      Sticks-test before starting the interventions.

      Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be
      placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the
      placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for
      one hour.
    

Intervention name(s): Aromatherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Peppermint aroma inhalation; Water inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will test the therapeutic potential of augmenting a stable SSRI regimen with the
      neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients
      diagnosed with PTSD.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Pregnenolone or Placebo
Intervention type(s): Drug
Intervention description(s): Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Pregnenolone; Cognition
Bitter Taste and Weight Loss in Women
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Individual food preferences are not considered in designing weight-loss therapies. This
      project will determine if short-term weight-loss is improved by matching participants with
      diets that reflect their genetically-determined food preferences.
    

Detailed description: 
      Dislike of the diet is a common complaint in weight loss therapy that contributes to poor
      outcomes. Ironically, individual food preferences are rarely taken into account in designing
      weight-loss interventions. In the proposed research, we will utilize genetically-determined
      differences in food preferences, indexed by PROP bitter taste phenotype to develop a novel
      approach to weight loss therapy. The overall goal of this project is to determine if weight
      loss following a 6 month intervention can be substantially improved by matching participants
      with diets that reflect their genetically-determined food preferences. The study is designed
      as a randomized clinical weight-loss intervention trial in women in which PROP non-tasters
      and super-tasters. will be randomized to either the low-carbohydrate or the low-fat diet
      condition
    

Intervention name(s): Low-Carbohydrate Diet; Low-fat Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are provided with a 6-month standard lifestyle intervention where carbohydrate intake is limited to 50 g/day. There is no calorie restriction for participants following the Low-Carbohydrate diet. Gradual increase in physical activity across the trial to > 40 min per day, 5 times/week.; Participants are provided with a 6-month standard lifestyle intervention. They will follow an energy restricted, low-fat diet where the daily energy consumption target is 1,200- 1,500 kilocalories/d. The fat intake target is 28% or less of daily kilocalories. Gradual increase in physical activity until participants are active at least 40 min per day, 5 times/week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; Body Weight Change; Taste; Taste Phenotype; Lifestyle Intervention
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative
      to a fasted state in healthy adult male and female subjects.

      Secondary Objectives:

        -  To evaluate the effect of food on the single-dose pharmacokinetics of the main
           metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult
           male and female subjects.

        -  To investigate the relative bioavailability of sotagliflozin tablet to oral solution
           under fasting conditions

        -  To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted
           conditions in healthy adult male and female subjects.
    

Detailed description: 
      The study duration per subject will be 26 to 83 days and will consist of a screening period
      of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between
      treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational
      Medicinal Product administration in period 3.
    

Intervention name(s): Sotagliflozin (SAR439954); Sotagliflozin (SAR439954)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: solution
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of PF-04965842 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect
      of PF 04965842 on rosuvastatin PK in healthy participants. Participants will be randomized to
      1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female
      participants will be enrolled in the study so that approximately 6 participants will be
      enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In
      both sequences, participants will remain in the CRU for a total of 11 days and 10 nights
      (including Period 1 and Period 2). To adequately remove any drug effects of rosuvastatin from
      Period 1 to Period 2, there will be a minimum 5 day washout period between the 2 rosuvastatin
      dosing events.
    


Intervention name(s): PF-04965842; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg dose of PF-04965842 once daily (QD) for 3 days; Single 10 mg dose of rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium; Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rescue Therapy for Helicobacter Pylori Eradication
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Current guidelines have recommended classical bismuth-containing quadruple therapy including
      proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy.
      However, tetracycline is clinically unavailable in China and the high frequency of adverse
      events of bismuth quadruple therapy often result in poor compliance, which limited the
      applicability of this recommendation. This study aimed to compare the efficacy and
      tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline
      was replaced by minocycline.
    


Intervention name(s): Esomeprazole; Bismuth Potassium Citrate; Tetracycline,Metronidazole; Minocycline,Metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Gastric mucosal protective drug with anti-H. pylori effect; Antibiotics for H. pylori eradication; Antibiotics for H. pylori eradication
Intervention MeSH terms: Metronidazole; Minocycline; Tetracycline; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; rescue therapy; minocycline; tetracycline