bioihbjkbjnl/mcl2 huggingface dataset:
Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity; Body Weight
Study type: Interventional

Summary: 
      Participants will be randomized to an evidence-based healthy lifestyle program alone or a
      healthy lifestyle program with mindfulness meditation added. The purpose of the study will be
      to determine if mindfulness improves BMI outcomes more than the program alone due to the
      stress-reduction benefits of mindfulness.
    

Detailed description: 
      The study will randomize 44 adolescents (aged 11-17 yo) with BMI >95th percentile to
      traditional Bright Bodies Healthy Lifestyle Program or Lifestyle Program plus mindfulness
      meditation (6 sessions within the 12-week program) (22 per group). The traditional program
      includes exercise two evenings per week and nutrition/behavior modification one evening per
      week for 12 weeks. Mindfulness session topics include breathing meditation, body scan
      meditation, mindful eating techniques, and identification of hunger verses satiation. The
      primary outcome measure with be (1) BMI, while secondary outcomes include changes in (2)
      percent body fat, (3) perceived stress scale (questionnaire), (4) physical stress (saliva
      cortisol levels), and (5) overall caloric intake (pre and post food records). After the 3
      month intervention, participants will engage in post measures and be asked to return 6 months
      later (9 months) for longer-term follow-up measures.
    

Intervention name(s): Traditional Healthy Lifestyle Program; Mindfulness Meditation Instruction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twice weekly meetings that focus on nutrition and exercise for 12 weeks.; Participants receive six mindfulness sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric obesity, stress
Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of antacid administration, and its timing,
      on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.
    

Detailed description: 
      The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat XR
      is being tested to assess if antacids affect how the drug moves throughout the body. This
      study will look at lab safety and side effects in people who take febuxostat XR.

      This cross-over study will enroll approximately 36 patients. Participants will be randomly
      assigned to one of four treatment sequences. All participants will receive the following
      study medications by the end of the study:

        -  Febuxostat XR 80 mg capsules

        -  Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium
           Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

      All participants will be administered one dose of one or both of the study medications on Day
      1 of four separate study periods.

      This single-centre trial will be conducted in the United States. The overall time to
      participate in this study is up to 84 days. Participants will make 5 visits to the clinic
      including four 4-day periods of confinement to the clinic, and will be contacted by telephone
      30 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Febuxostat XR; Maalox Advance Regular Strength liquid
Intervention type(s): Drug; Drug
Intervention description(s): Febuxostat extended-release (XR) capsules; Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Shear-wave Elastography of Hip Stabilizers in Healthy Individuals
Condition: Shear-wave Elastography of Hip Stabilizers in Healthy Individuals
Study type: Observational

Summary: 
      The aim of this study is to provide a scientific basis for Shear-wave elastography
      measurements of hip stabilizing muscles on healthy individuals. To assess the inter- and
      intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by
      two experienced physiatrists.
    


Intervention name(s): Shear-wave elastography
Intervention type(s): Diagnostic Test
Intervention description(s): Shear-wave elastography using a manual ultrasound with a 9L-Probe in B-mode.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        12 Healthy Individuals, 4 male and 8 female.
Auditory Verbal Hallucinations in Schizophrenia
Condition: Schizophrenia
MeSH terms: Hallucinations; Schizophrenia
Study type: Observational

Summary: 
      Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant
      external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring
      would cause the verbal thoughts of the patient to be perceived as external voices resulting
      in AVHs.

      In order to examine whether AVHs correspond to self-generated inner speech, the present study
      aims at collecting speech muscle activity during covert AVHs (without articulation), overt
      speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and
      control subjects to detect any speech muscle activity during AVH.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        in- and out-patients
Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy
Condition: Endocrine Disorder; Deficiency; Medication Overuse Headache; Migraine
MeSH terms: Headache Disorders, Secondary; Endocrine System Diseases; Headache
Study type: Observational

Summary: 
      The project will be conducted to investigate the hormonal homeostasis in men and women, with
      a special emphasis on sex hormones in men and AMH level in women, before and after withdrawal
      of the overused analgesics among MOH patients. Additionally, a more broad endocrine profile
      will be explored before and after withdrawal.

      It is hypothesized that patients with MOH have disturbed hormone levels, which is normalized
      after withdrawal of the medication-overuse.
    


Intervention name(s): Standard withdrawal therapy
Intervention type(s): Other
Intervention description(s): All painkillers are abruptly stopped for a 2 months period.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50
        women.
      
Biospecimen description: 
      Blood samples and urine collection
Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
Condition: Healthy; Sleep
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats,
      which suggests that PF-04457845 is active in rat's brains. This study is designed to see
      whether this is also the case in man.
    


Intervention name(s): PF-04457845 / matched placebo; PF-04457845 / matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-04457845 4 mg tablet once daily / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Double-Blind; Randomized; Placebo-Controlled; 2-Way Crossover; Polysomnographic Endpoints
Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK)
      and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
    

Detailed description: 
      Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo.
      Samples will be collected to measure how DISC-0974 is processed by the body and how the body
      responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day
      1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is
      observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.
    

Intervention name(s): DISC-0974; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose; Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age
Condition: Cervical Cancer; Condylomata Acuminata
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the immunogenicity of a novel recombinant human
      papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen
      Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.
    


Intervention name(s): Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli); Gardasil®9
Intervention type(s): Biological; Biological
Intervention description(s): Three doses administered intramuscularly at 0, 45 day and 6 month.; Three doses administered intramuscularly at 0, 45 day and 6 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine; immunogenicity
Thrombosomes® in Bleeding Thrombocytopenic Patients
Condition: Thrombocytopenia; Hematologic Diseases; Bone Marrow Aplasia
MeSH terms: Thrombocytopenia; Hematologic Diseases; Anemia, Aplastic; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the safety and potential early signals of efficacy of allogeneic
      Thrombosomes in bleeding thrombocytopenic patients
    

Detailed description: 
      The primary objective of the present study was to assess the safety of increasing dose levels
      of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to
      explore early signals of clinical efficacy of Thrombosomes in this population. The secondary
      objectives included: 1) Evaluation of the impact on WHO (World Health Organization) bleeding
      scores at various timepoints; 2) number and type of blood products infused through day 6
      follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.
    

Intervention name(s): Thrombosomes
Intervention type(s): Biological
Intervention description(s): Freeze-dried platelets
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thrombocytopenia; bleeding
Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics,
      in comparison to placebo and entacapone.
    

Detailed description: 
      Single-centre, double-blind, randomised, parallel-group study in 80 young male and female
      healthy subjects.
    

Intervention name(s): BIA 9-1067 5 mg; Entacapone; Placebo; levodopa/carbidopa; BIA 9-1067 15 mg; BIA 9-1067 30 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BIA 9-1067 OPC, Opicapone 5 mg; Entacapone 200 mg; placebo (four times a day); standard release levodopa/carbidopa 100/25 mg (single-dose); BIA 9-1067 OPC, Opicapone 15 mg; BIA 9-1067 OPC, Opicapone 30 mg
Other intervention name(s): OPC, Opicapone; PLC, placebo; OPC, Opicapone; OPC, Opicapone
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Entacapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
Condition: Postoperative Pain; Breast Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe
      neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations
      in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami
      of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy
      to perform, not time consuming and generally well tolerated by the patients. So, the
      investigators believed that the ESP block may be an effective and safer alternative to
      paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast
      surgery and designed a prospective, randomised, placebo-controlled trial for pain management.
    


Intervention name(s): Erector spinae plane block; sham block
Intervention type(s): Procedure; Other
Intervention description(s): Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.; A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Caspase Inhibition in Islet Transplantation
Condition: Diabetes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will
      receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556
      following their first islet transplant. Two pilot studies are proposed to establish the
      optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose
      of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day
      0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot
      studies will receive islet cell transplants under the University of Alberta's
      standard-of-care therapy.

      Secondary objectives include:

        1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain
           insulin independence after the first or subsequent islet transplant.

        2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate
           immunological protection against both allo- and autoimmunity of islet transplant
           recipients.
    


Intervention name(s): IDN-6556
Intervention type(s): Drug
Intervention description(s): 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556 following first islet transplant at 50mg twice daily.
Other intervention name(s): Emricasan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I Diabetes
Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Multiple Sclerosis is known as an inflammatory central nervous system disease characterized
      by demyelination and axonal damage.
    

Detailed description: 
      Individuals with MS cannot perform self-care in many areas due to the problems they encounter
      during their daily life activities, and they need an individual who will take care of them
      and a lifelong care.
    

Intervention name(s): Pilates Exercise; Mckenzie Exercise
Intervention type(s): Other; Other
Intervention description(s): Pilates exercises target the deep muscles of the core, including the abdomen, lower back, hips, and glutes, while also engaging the whole body.; The McKenzie Method emphasizes self-treatment and active patient involvement in the management of their condition. It involves a systematic assessment process to determine the most appropriate exercises and interventions for an individual based on their specific symptoms and movement responses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: back pain; multiple sclerosis
The Safety and Efficacy of Recombinant Human Prolactin
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Medications used to increase breast milk production increase prolactin secretion, the main
      hormone of lactation. There are no FDA approved medications used to improve breast feeding,
      but metoclopramide is used off-label and can have intolerable side effects. We examined the
      biological activity and safety of recombinant human prolactin (r-hPRL) as a potential
      medication to augment lactation. In this study, the effect of r-hPRL on breast milk
      production in women who did not recently deliver a baby and its effect on the bones and
      menstrual cycle were tested.
    

Detailed description: 
      There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is
      used off-label but can have intolerable side effects. We examined the biological activity and
      safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment
      lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7
      day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of
      bone turnover, calcium homeostasis and gonadal function were measured and side effects
      recorded.
    

Intervention name(s): Recombinant Human Prolactin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: galactorrhea; prolactin; bone turnover; menstrual cycle; Control Groups; Women
Visual Outcomes for Toric Efficacy Study
Condition: Astigmatism; Myopia
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This is a crossover study of two types of contact lenses (toric orthokeratology and soft
      multifocals). Primary aims are to quantify correction of astigmatism, subjective and
      objective visual performance, aberrometry, peripheral refraction and bacterial bioburden
      between toric orthokeratology and soft toric multifocal contact lenses.
    


Intervention name(s): Contact lenses (Orthokeratology); Contact lenses (Soft Multifocal)
Intervention type(s): Device; Device
Intervention description(s): Contact lenses; Contact lenses
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
Masking: None (Open Label)
Primary purpose: Other
Sweat Patch Validation
Condition: Sweat Analysis
Study type: Interventional

Summary: 
      To determine the validity of a prototype patch in measuring sweating rate and sweat
      electrolyte concentration during moderate intensity exercise against well-established
      reference methods in a controlled laboratory and in field conditions.
    


Intervention name(s): Sweat patch
Intervention type(s): Other
Intervention description(s): Flexible, epidermal, wearable skin patch to collect and analyze sweat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Each subject subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sweating rate; sweat electrolytes; sweat patch; wearable; epidermal; sweat electrolyte concentrations
Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway
Condition: Obesity
MeSH terms: Behavior, Addictive; Food Addiction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task
      context based on food choice making
    

Detailed description: 
      Obesity is a worldwide epidemic associated with many complications. The treatment of obesity
      is a failure if it does not take into account eating disorders. Among them, food addictions
      seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches
      depend on presence of these FA. Moreover, eating disorders are associated with visible brain
      abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.
    

Intervention name(s): fMRI; Indirect calorimetry; Bioimpedance; Lipid profile, glucose, HBA1c, metabolomic analysis; YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Intervention type(s): Device; Device; Device; Biological; Behavioral
Intervention description(s): Brain MRI; Resting energy expenditure; Measurement of body composition; Blood sample; Questionnaires to characterize eating habits and depression
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Food addictions; Functional magnetic resonance imaging (fMRI); Metabolomics