bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Analgesia for Pediatric Adenotonsillectomy
Condition: Adenotonsillectomy; Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this randomized clinical trial is to assess the safety and effectiveness of
      post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.
    

Detailed description: 
      Patients will be randomly assigned to individualized opioid analgesia regimen group or
      conventional opioid analgesia regimen group.

      Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath
      after sevoflurane induction. A positive result is defined as a decrease of more than 50% in
      spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test).
      Otherwise it is defined as a negative result.

      All the patients are given regular paracetamol and ibuprofen after surgery. The addition of
      rescue oral morphine is given as needed. The dose of oral morphine is determined according to
      the results of fentanyl test in the individualized group, while the patients in the
      conventional group are given the routine dose. The Faces Scale is used to assess analgesic
      effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score > 6,
      the child receive rescue oral morphine analgesia.

      At the preoperative appointment, parents are provided with a pulse oximeter including oxygen
      saturation sensors to take home. The oxygen saturation per night during sleep will be
      monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The
      research team will instruct parents on how to properly apply the oximeter to the child and
      repeat these measurements. The primary outcome measure is desaturation events during sleep
      per night.
    

Intervention name(s): Individualized oral morphine; Conventional oral morphine
Intervention type(s): Drug; Drug
Intervention description(s): Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day).
If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients with positive results of fentanyl test receive oral morphine 100μg/kg per dose, while patients with negative results receive oral morphine 500μg/kg per dose.; Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day).
If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients receive oral morphine 200μg/kg per dose.
Other intervention name(s): Individualized group; Conventional group
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adenotonsillectomy; individualized opioid analgesia; respiratory parameters; children
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a combination of 10 nutritional supplements
      provide health benefits that are consistent with protection against age-related disease. All
      supplements have been shown in previous studies to have health benefits when administered
      alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will
      provide beneficial changes in healthy related measures.
    


Intervention name(s): Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with
      NPC-12T tablets in Japanese healthy Adults
    


Intervention name(s): sirolimus
Intervention type(s): Drug
Intervention description(s): SIngle administration under fasted condition
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
7T MRS in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This study is looking for healthy controls and patients with Parkinson's (PD) to perform an
      MR scan.

        1. The neurochemical profile of the SN of patients with PD as measured by high field MRS
           will differ from that of healthy controls, in that glutathione will be lower due to
           oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis
           markers myo-inositol and glutamine will be higher due to inflammation (glial activation)
           and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.

        2. There will be a relationship between neurochemical changes and disease severity.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's patients and healthy controls
      
Keywords: Parkinson's Disease; PD; magnetic resonance spectroscopy
Phase 2 of HU-045 in Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial
      to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe
      Glabellar Lines
    


Intervention name(s): HU-045; Xeomin®
Intervention type(s): Drug; Drug
Intervention description(s): HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.
White powder; Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Other intervention name(s): IncobotulinumtoxinA; IncobotulinumtoxinA
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glabellar Lines; HU-045; Huons; HuonsBioPharma; Botulinum toxin
The Effects of Faculty/Staff Exercise Program
Condition: Cardiovascular Risk Factor; Sedentary Lifestyle; Physical Activity
Study type: Interventional

Summary: 
      This study focuses on analyzing the data collected from participants in the Faculty/Staff
      Exercise Program to determine the success and quantifying the results of the program. The
      investigators are interested in the effectiveness of this program on multiple levels,
      individual and group, as it is the first of its kind - an exercise program targeting the
      faculty and staff at a university.
    

Detailed description: 
      This study focuses on analyzing the data collected from participants in the Faculty/Staff
      Exercise Program to determine the success and quantifying the results of the program. The
      investigators are interested in the effectiveness of this program on multiple levels,
      individual and group, as it is the first of its kind - an exercise program targeting the
      faculty and staff at a university. Participants were regular attendees in either a 6am or
      12pm exercise program session. Data included both measures of physical health as well as
      cognitive health. Measures of physical health included the assessment of body fat using the
      skin-fold method of analysis (3-site). Cholesterol was measured via blood draw analysis. This
      was done at the Kent State University Exercise Physiology Laboratory by certified research
      staff. A 6 minute walk test was completed to measure aerobic capacity. Flexibility was
      assessed via the sit-and-reach test while anaerobic strength and endurance were assessed
      using sit-up and curl-up tests. Assessment of balance was done using a Biodex Balance System.

      Assessments of cognitive health included several questionnaires that asked questions related
      to sleep habits, stress levels, and mood. In addition, each participant was given a MOVband
      to track physical activity. The device was worn during waking hours for all days of
      participation.The data from the MOVband was auto-uploaded to a computer program for tracking
      so that no manual entry was necessary.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
B0151005 Open-Label Extension Study
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center Phase 2, open label, safety extension study in subjects with moderate
      to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will
      have completed the 12-week induction period of study B0151003 and will be enrolled as either
      responders or non responders.
    


Intervention name(s): PF-04236921; PF-04236921
Intervention type(s): Biological; Biological
Intervention description(s): Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.; Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; safety; efficacy; pharmacokinetics; pharmacodynamics; Crohn's Disease Activity Index (CDAI)
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Condition: Bipolar Disorder; Psychiatric Morbidity; Neonatal Outcome
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to examine risk factors for relapse of bipolar disorder during
      pregnancy and the postpartum period. The main goal of this study is to find the risks that
      may make it more likely for a woman with bipolar disorder to experience a depressive, manic,
      or hypomanic episode during her pregnancy and the postpartum period.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        psychiatrists, referring obstetricians, community-based health centers, triage, and women
        who have previously given written permission to be contacted about research studies within
        the MGH Perinatal and Reproductive Psychiatry Program
      
Biospecimen description: 
      serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk
Impact of 'Samalochana' Program on Women Who Have Experienced Intimate Partner Violence (IPV)
Condition: Domestic Violence; Intimate Partner Violence
Study type: Interventional

Summary: 
      Violence has immediate effects on women's health, which in some cases, is fatal. Physical,
      mental and behavioural health consequences can also persist long after the violence has
      stopped. Violence against women and girls occurs in every country and culture and is rooted
      in social and cultural attitudes and norms that privilege men over women and boys over girls.

      Research consistently finds that the more severe the abuse, the greater its impact on women's
      physical and mental health. In addition, the negative health consequences can persist long
      after abuse has stopped.Present work shares the impact of arsha vidya counselling for women
      who has been victim of violence.
    


Intervention name(s): Samalochana Counselling; Wait list control
Intervention type(s): Other; Other
Intervention description(s): Counselling program was individual, based on advaita vedanta and traditional philosophical grounds to answer individual fears, concerns,conflicts and difficulties in order to cope and recover.; Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
Condition: Healthy Postmenopausal Women
Study type: Interventional
Phase: Phase 1

Summary: 
      THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the
      safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in
      healthy postmenopausal women. The study is expected to identify a safe dose that can be
      further tested in subsequent multiple dose studies comparing the safety, PK and
      pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).
    


Intervention name(s): T121; Zoledronic acid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: oral zoledronic acid
Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Auto-Serum and Cord Blood Serum
Condition: Eye Injuries
MeSH terms: Eye Injuries
Study type: Observational

Summary: 
      Human serum eye drops have been successfully used in the treatment of severe ocular surface
      disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven
      to be effective in treatment of dry eye and persistent corneal epithelial defects. However,
      there are limited studies comparing the corneal epithelial wound healing promoting effects
      between these two blood derived products. The purpose of this study is to test the corneal
      epithelial wound healing promoting effects between auto serum and human cord blood serum.
      Primary cultured bovine corneal epithelial cells were used as the model to investigate wound
      healing, cell proliferation and migration by means of scratch corneal wound healing assay
      evaluation, MTS assay and Boyden chamber migration assay in response to human serum and
      umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared
      between human serum and umbilical cord serum with ELISA kits.
    

Detailed description: 
      Human serum eye drops have been successfully used clinically in the treatment of severe
      ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum
      is also proven to be effective in treatment of dry eye and persistent corneal epithelial
      defects. However, there are limited studies comparing the corneal epithelial wound healing
      promoting effects between these two blood derived products. The purpose of this study is to
      test the corneal epithelial wound healing promoting effects between auto serum and human cord
      blood serum. Primary cultured bovine corneal epithelial cells were used as the model to
      investigate wound healing, cell proliferation and migration by means of scratch corneal wound
      healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human
      serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also
      compared between human serum and umbilical cord serum with ELISA kits.
    

Intervention name(s): venous puncture; obtain serum from perripheral blood or cord blood
Intervention type(s): Procedure; Other
Intervention description(s): venous puncture; obtain serum from perripheral blood or cord blood
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        heahty adult volunteers and donated cord blood
      
Keywords: corneal epithelium
COVID-19 and Lung Ultrasound Utility
Condition: Covid19; Lung Infection
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Ultrasounds are usually done by a specially trained health professional in the hospital or
      emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be
      plugged into an iOS / Android device. The purpose of this research is to assess the
      usefulness of lung ultrasound imaging, performed by the patient in the home setting for the
      management of the COVID-19 disease using this novel highly-portable ultrasound.
    

Detailed description: 
      This will be a prospective self-controlled design. The study subjects will receive a
      telehealth visit from a healthcare provider (HCP) to assess for any change in their COVID-19
      symptoms. The HCP will recommend the patient remain at home, or to go to an emergency
      department based on standard of care and clinical decision making. Subsequently, the study
      subjects will receive a teleguidance session with a Radiologist who is trained in lung
      ultrasound (LUS) in order to obtain images of their chest. The physician performing LUS
      remotely will report LUS findings in a standard quality assurance (QA) document, including
      image quality, interpretation, and recommendations. This QA report will be study data and not
      shared with the patient. The two providers will be blinded, except when there is a
      disagreement between the Telemed LUS and clinical interview.

      The study staff will determine when this disagreement occurs. They will notify the study
      investigators and radiologist, who will then discuss and come to an agreement within 24
      hours. If deemed concerning, they will then contact the HCP and unblind them as to the
      radiographic findings. There will be no delay in medical care advised by the subject's HCP.

      Specifically, the nurse will inform the HCP by a phone call that the physician performing LUS
      remotely found a significant change in LUS findings. The HCP will then be given access to the
      LUS report (as well as images if desired), and will review the decision to seek medical care
      with the telemed doctor.
    

Intervention name(s): Butterfly iQ
Intervention type(s): Device
Intervention description(s): The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of the study is to confirm the results of previous study about the
      usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in
      patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The
      secondary purpose is to evaluate the value of circulating free mutant DNA and circulating
      tumor cells (CTC) and their variations during the treatment.
    

Detailed description: 
      Prospective cohort study of patients treated with systemic chemotherapy for unresectable
      metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological
      evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant
      DNA, CTC represent an alternative approach. A previous study on usefulness of the serum
      Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with
      unresectable metastasis of colorectal cancer has been published (J Clin Oncol
      2008;26:3681-6). The present study is designed to validate the previous data. The secondary
      purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy.
      Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy
      and biotherapy validate in this clinical situation by the French National Cancer Institute
      (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3
      months. Blood samples for CEA and CA 19-9 levels will be performed every courses of
      chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC
      will be performed at day 1 and 42 of chemotherapy.
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: metastatic colorectal cancer; circulating tumor markers; circulating tumor cell; circulating tumor DNA; marker's kinetic
Bosentan in Children With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to demonstrate that the exposure to bosentan in children with
      idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension,
      using a pediatric formulation, is similar to that in adults with PAH and to evaluate the
      tolerability and safety of a pediatric formulation of bosentan in this patient population.
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets
Other intervention name(s): ACT-050088; Ro 47-0203
Intervention MeSH terms: Bosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bosentan; children; pharmacokinetics; pulmonary arterial hypertension