bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers
Condition: Insomnia Chronic
MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers
      report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute
      to morbidity and mortality risk. This is the first intervention trial in AD caregivers to
      target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and
      cellular aging
    

Detailed description: 
      This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness
      Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on
      outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in
      older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific
      aims of this project are:

      Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective
      dimensions of insomnia.

      Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of
      inflammation.

      Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.

      Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity
      Inventory, STRAIN, number & experienced intensity of stress exposure) on insomnia outcomes,
      and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical
      morbidity and related medication use at follow-up.
    

Intervention name(s): CBT-I; MAP-I
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT-I is a behavioral treatment for insomnia; MAP-I is a mindfulness meditation treatment for insomnia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, non-inferiority design
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Methotrexate, Trimetrexate Glucuronate, and Leucovorin in Treating Patients With Refractory or Recurrent Osteosarcoma
Condition: Sarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and
      leucovorin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate
      glucuronate when given together with methotrexate and leucovorin in treating patients with
      refractory or recurrent osteosarcoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of trimetrexate glucuronate when administered with
           high-dose methotrexate and leucovorin calcium in patients with refractory or recurrent
           high-grade osteosarcoma.

      Secondary

        -  Determine the dose-limiting toxic effects of this regimen in these patients.

        -  Determine, preliminarily, the antitumor activity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of trimetrexate glucuronate.

      Patients receive high-dose methotrexate IV over 4 hours on days 1 and 8 and oral trimetrexate
      glucuronate twice daily on days 2-6 and 9-13. Patients also receive leucovorin calcium IV
      continuously over 24 hours or orally 2 or 4 times daily on days 9-14. Courses repeat every 28
      days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of trimetrexate glucuronate until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 2 years.
    

Intervention name(s): leucovorin calcium; methotrexate; trimetrexate glucuronate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Trimetrexate; Methotrexate; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: recurrent osteosarcoma
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      For patients with prostate cancer and a high risk of lymph node involvement or confirmed
      pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option.
      However, conventional radiotherapy of the pelvis has limited by gastrointestinal and
      urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of
      the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is
      given during each session to the prostate or the prostate bed and to confirmed lymph node
      metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are
      required, and continuation during radiotherapy and for a further two years are strongly
      recommended.
    

Detailed description: 
      The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1:
      Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the
      prostate.

      Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3:
      Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the
      prostate bed.

      Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with
      previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage
      above the previous treatment fields with integrated boost to macroscopic lymph node
      metastases.
    

Intervention name(s): Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
Intervention type(s): Radiation
Intervention description(s): The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy
Condition: Leber's Hereditary Optic Neuropathy
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center
      study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of
      elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the
      conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an
      Open Label Extension for up to 48 additional weeks of treatment.
    

Detailed description: 
      This was a prospective, randomized, double-masked (DM), vehicle-controlled, single-center
      study plus open label extension period (OLE) in which approximately 12 subjects with LHON
      having the genetic mtDNA mutation m.11778G>A were randomized in a masked manner into 1 of 3
      groups in a 1:1:1 ratio: one drop of elamipretide 1.0% topical ophthalmic solution twice
      daily (BID) in the: left eye, right eye, or both eyes.

      After completion of the 52-week treatment period or the Week 56 follow-up period, subjects
      were invited to participate in the OLE period for up to 108 weeks. During the OLE
      participants received 1% topical opthalmic elamipretide in both eyes (OU) daily. If a subject
      did not consent to the OLE, he/she completed the study at the Week 56 (±7 days) visit. There
      were 4 periods in this study: (1) screening period (up to 6 weeks); (2) double-masked
      treatment period (52 weeks); (3) OLE period (up to 108 weeks), and (4) follow-up period (4
      weeks) after completion of End-of-Treatment (EOT) visit.
    

Intervention name(s): elamipretide (MTP-131) 1% topical ophthalmic solution; Vehicle topical ophthalmic solution
Intervention type(s): Drug; Drug
Other intervention name(s): MTP-131; Bendavia
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LHON; Ocuvia™; elamipretide; MTP-131
Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
Condition: Corneal Deformity; Macular Degeneration Advanced; Surgical Menopause
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The aim of this study is to investigate the early changes in macular thickness, corneal
      thickness and intraocular pressure in young women undergoing surgical menopause.

      Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural
      menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye
      disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and
      no migraine in addition to non smokers were included in the study. Women using any hormone
      and obese women ( BMI >25 kg/m2) were excluded. Macular and corneal thickness and intraocular
      pressure (IOP) were measured in both eyes of the women
    

Detailed description: 
      This prospective case control study was conducted in a tertiary gynecology and obstetrics
      clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ).
      Informed consent form was obtained from all participants. All participants were outpatients
      who applied to obstetrics clinic in Batman Training and Research Hospital.

      The study started with 105 patient. Based on the study exclusion criteria, 7 patients were
      excluded from the study. Every patient in the surgical menopause group underwent a
      hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients
      included in the study were menstruating women with preoperative natural ovarian appearance
      and benign non ovarian indications, who had undergone hysterectomy and bilateral
      salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52
      years of age who have undergone oophorectomy are patients whose ovaries have been removed
      either because of patient anxiety due to a family history of cancer or because of adhesions.
    

Intervention name(s): Optic coherence tomography
Intervention type(s): Diagnostic Test
Intervention description(s): Eye examination of patients with optic coherence tomography test by an ophthalmologist
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient selection was made between surgical menopause, natural menopause and healthy women
        who have given birth before.
Impact of a Sleep Debt in Middle-Aged and Older Adults
Condition: Sleep Restriction
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This project has 6 aims.

        1. To examine the impact of recurrent partial sleep loss in young, middle-aged and older
           men and women. Sleep will be restricted to 4 hours.

        2. To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse
           the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting
           from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep
           restriction.

        3. To test the hypothesis that there are age and gender differences in the total amount of
           sleep recovery obtained during the week of 12-hour bedtimes.

        4. To test the hypothesis that there are age and gender differences in sleep capacity (the
           amount of time an individual can sleep per night when there is no sleep debt).

        5. To test the hypothesis that sleep capacity is partly determined by baseline levels of
           slow-wave sleep and slow-wave activity.

        6. To determine whether sleep capacity is related to sleep need by examining metabolic,
           endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual
           sleep debt.
    


Intervention name(s): Sleep restriction
Intervention type(s): Other
Intervention description(s): Sleep restriction.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sleep; young adults; middle-age adults; older adults
A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects
Condition: Healthy Japanese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose study in healthy male and female (of non-child bearing
      potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib.
      Fostamatinib is being developed for the treatment of rheumatoid arthritis.
    

Detailed description: 
      A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy
      Japanese Subjects After Single and Multiple Doses
    

Intervention name(s): Fostamatinib 100mg; Fostamatinib 200mg
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fostamatinib; FosD; Japanese Healthy volunteers; Phase 1; Single and Multiple Dose Study
Age-dependency of Cornea Biomechanics Using OCT Vibrography
Condition: Cornea
MeSH terms: Corneal Diseases
Study type: Interventional

Summary: 
      The aim of this pilot study is to assess the ability of a new optical coherence tomography
      system to obtain information on biomechanics of the cornea.
    

Detailed description: 
      The cornea, the clear front window of the eye, consists of finely intertwined collagen
      fibers, which give the cornea a microstructure that provides mechanical integrity necessary
      to maintain its typical dome-shape against the intraocular pressure (IOP). Changes in the
      biomechanical properties can lead to an abnormal corneal shape and refractive errors. As a
      result, light is not perfectly focused onto the retina and the vision is affected. A typical
      example of alterations in the cornea's biomechanical properties is found in patients with an
      eye disorder called Keratoconus, which leads to progressive thinning of the cornea. Numerous
      studies have shown that promising interventions like collagen crosslinking (CXL) can slow
      down an arrest progression of ectatic eye diseases. Keratoconus, as a typical example,
      although it cannot be cured, could be at least halted by CXL. Therefore, early diagnosis of
      ectasia is crucial for the patient. Current diagnostic methods of ectasia are based on
      morphological rather than biomechanical analysis. The irregular patterns of the cornea can be
      detected by pachymetry and topography before clinical signs occur, but these tests cannot
      reliably differentiate truly weak or keratoconic corneas from atypical normal ones.

      These are compelling needs for improved diagnostic methods. More recently, and triggered by
      those unmet needs, an interest in the mechanical properties of the cornea has emerged.
      Typical examples of mechanical properties are elastic modulus and corneal stiffness.

      In this pilot study the investigators will test the ability of a new OCT Vibrography system
      to determine cornea material parameters. More precisely, the investigators will study the
      oscillation response in human corneas in-vivo using a stimulus mechanism used to induce
      vibrations by touching the surface of the cornea. A localized vibration source paired
      together with phase-sensitive OCT to measure the frequency response function of the human
      cornea and to analyze the dependency of the frequency response function on age. Additionally
      the investigators will use Brillouin Microscopy data for computer simulations to validate OCT
      Vibrography results.
    

Intervention name(s): Optical imaging of the cornea in healthy subjects
Intervention type(s): Device
Intervention description(s): OCT vibrography and Brillouin microscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: biomechanics; cornea; optical coherence tomography; vibrography; brillouin microscopy
Efficacy and Safety Study of Ginseng Polysaccharide Extract
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from
      the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its
      function as an immunomodulatory molecule. The present study performed to evaluate the safety
      and beneficial effects of Y-75 on immune function in a group of healthy adults.

      The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of
      natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear
      phagocytes, and serum levels of monocyte-derived mediators.
    


Intervention name(s): Y-75; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package; Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
Other intervention name(s): Ginsan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Panax ginseng CA; ginsan; polysaccharide; immunity; natural killer cell
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
Condition: Skin Laxity; Wrinkles
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.
      Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the
      left side. Group B will receive Thermage on the right side of the face and neck and
      Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.
      Study images will be obtained pre-treatment, immediately post-treatment, and at each
      follow-up visit.
    

Detailed description: 
      This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A
      triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects
      to the full half face, neck, and submental areas. Changes in face and neck skin laxity and
      wrinkles, from baseline and between study treatments, will be assessed at study follow-up
      visits. Patient satisfaction questionnaires will also be obtained.
    

Intervention name(s): Ulthera System Treatment; Thermage
Intervention type(s): Device; Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin; Radiofrequency treatment focusing radiofrequency energy
Other intervention name(s): Ultherapy™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Preventing Overweight in USAF Personnel: Minimal Contact Program
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The prevalence of overweight in the United States Air Force (USAF) is about 22%. The
      objective of this study is to compare the effectiveness of a minimal contact behavioral
      therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual
      care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW)
      and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as
      compared to UC.
    

Detailed description: 
      The objective of this study is to compare the relative effectiveness of two approaches to
      weight management, using a controlled comparison experiment. The two approaches are: Minimal
      Contact Behavior Therapy Plus Usual Care (MCBT+UC) which includes an orientation meeting,
      provision of a self-help book, use of an interactive weight management web site for 6 months,
      and 2 brief motivational interviewing telephone follow-ups, plus usual care;and Usual Care
      (UC) which includes and orientation meeting and usual care (consisting of required USAF
      annual physical and fitness exam, participation in any mandatory weight loss or fitness
      programs, and the requirement to stay below a Maximum Allowable Weight [MAW], with penalties
      or separation as potential contingencies for failure to remain below MAW). The primary
      outcome is weight loss.Additional outcomes include body mass index, percent body fat, and
      waist circumference.
    

Intervention name(s): Lifestyle Intervention; control group
Intervention type(s): Behavioral; Other
Intervention description(s): lifestyle intervention .; waiting list control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prevention of overweight; Prevention of obesity; Treatment of overweight; Treatment of obesity