bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Aromatherapy Yoga
Condition: Female College Students
Study type: Interventional

Summary: 
      College students, particularly female students, often suffer from severe stress and poor
      sleep. Aromatherapy yoga has become a popular exercise in recent years and may help reduce
      stress and improve sleep quality, although empirical evidence is limited. We investigated the
      effective-ness of aromatherapy yoga intervention in reducing stress and improving sleep
      quality among female college students. Eighty-nine participants (44 in the experimental group
      [aromatherapy yoga] and 45 in the control group [yoga]), with an average age of 19.88 ± 1.13
      years, were en-rolled in this quasi-experimental study. Interventions were performed in the
      respective groups once a week for 12 weeks, for 90 minutes each time. The Wilcoxon
      signed-rank test and Mann-Whitney U test (including effect size) were used to test the
      differences in stress reduction and sleep quality before and after the intervention.
    


Intervention name(s): Aromatherapy yoga; Yoga
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The research assistant diluted the Lavandula angustifolia essential oil with distilled water (1:75) 10 min before the yoga session started. The solution was then atomized by three aroma diffusers, placed in the front, middle, and back of the classroom. The distance from each participant was less than 10 m to ensure that the aroma was absorbed com-pletely. The yoga course for the aromatherapy yoga group was the same as that of the yoga only group. The yoga group only took a yoga course, without aromatherapy.; The design of the yoga lessons was based on a past study and a professional yoga instruction book. Yoga lessons were led by certified yoga tutors.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery
Condition: Scoliosis; Adolescence
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether perioperative intravenous acetaminophen
      administration reduces postoperative pain and opioid consumption in adolescents and pediatric
      patients undergoing spinal fusion surgery.
    

Detailed description: 
      Spinal fusion surgery to correct scoliosis causes severe postoperative pain in adolescents
      and pediatric patients. Thus, appropriate control of postoperative pain has a significant
      impact on postoperative recovery, patient satisfaction and reduction of hospital stay.
      Although pain control was achieved through only opioids, the importance of multimodal
      analgesia has recently been emphasized as opioid addiction and side effects increase.

      Acetaminophen is recommended as a key factor in multimodal analgesia and previous studies
      performed in adult spine surgery showed that intravenous administration of acetaminophen
      reduced the postoperative pain and opioid consumption. In addition, acetaminophen is a drug
      widely recognized for safety in adolescents and pediatric patients and has a fast and
      predictable analgesic effect. Therefore, the purpose of this study is to investigate whether
      perioperative intravenous acetaminophen administration reduces postoperative pain and opioid
      consumption in adolescents and pediatric patients undergoing spinal fusion surgery. Thus the
      specific aim of this trial the investigators will determine is;

        1. The decrease in postoperative analgesic requirement following IV acetaminophen

        2. The decrease in intensity of postoperative pain following IV acetaminophen

        3. The quality of recovery including self-reported recovery, physical and functional
           recovery and length of stay

        4. The preemptive analgesic effect of IV acetaminophen
    

Intervention name(s): intravenous acetaminophen; intravenous acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): experimental(pre): administration of IV acetaminophen; experimental(post): administration of IV acetaminophen; placebo comparator: administration of normal saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scoliosis, acetaminophen
Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the effects of two common hormone medications on the heart and blood
      vessels of healthy post-menopausal women over the age of 45.

      The study will take place over the course of about 5 months. Each subject will take two
      different medications over two six-week periods. They will be randomized at the beginning of
      the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the
      first period, and will receive the other medication the second six-weeks of the study. At the
      very beginning of the study and at the end of each six-week treatment period, subjects will
      come to the hospital various tests including non-invasive blood vessel imaging tests, blood
      draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a
      test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment
      periods, there will be a four-week medication-free washout period.
    


Intervention name(s): Estradiol+MPA; Estradiol+Drospirenone
Intervention type(s): Drug; Drug
Intervention description(s): 1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg; 1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
Other intervention name(s): Estradiol+medroxyprogesterone acetate; Angeliq
Intervention MeSH terms: Medroxyprogesterone Acetate; Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular, vascular
Induction of Abortion in the Second Trimester
Condition: Abortion, Second Trimester
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol
      alone on shortening the time of abortion induction in the second trimester.
    

Detailed description: 
      The study will be conducted on 40 women who will undergo induction of abortion between 13-24
      weeks with positive fetal pulsation. They will be randomly assigned to receive either only
      misoprostol 400 μg under the generic name of misotac tablets produced by Sigma company
      according to FIGO classification 2019 and a halved dose if the patient has a history of one
      or two cesarean sections, or misoprostol 400 μg plus intramuscular administration of hyoscine
      N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company.
    

Intervention name(s): hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company; misoprostol under the generic name of misotac tablets
Intervention type(s): Drug; Drug
Intervention description(s): compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.; compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Other intervention name(s): Buscopan ampules; Misotac tablets
Intervention MeSH terms: Scopolamine; Bromides; Misoprostol; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Condition: Sterility; Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore
      the luteal phase is supported by progesterone. The use of progestogens in IVF is associated
      with an improvement in the live birth rate Standard protocol for luteal phase support has not
      yet been established. Currently vaginal progesterone is widely used, since the classic oral
      progesterone seems to result in a low bioavailability and a lower pregnancy rate. However,
      vaginal administration of progesterone is associated with vaginal irritation, discharge and
      bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe
      treatment that can improve patient satisfaction and compliance.

      Many studies have observed similar pregnancy rate results with dydrogesterone and micronized
      vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that
      dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone
      (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were
      37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.

      Regarding the administration route of progesterone, intramuscular and transvaginal routes are
      the two conventional progesterone administration techniques. However, very few studies have
      compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in
      ART cycles.

      The objective of the investigator's study is to demonstrate the superiority of oral
      dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in
      cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly
      allocated into either one of the study groups using a simple randomization method by
      computer-generated random numbers. Group I will receive the oral dydrogesterone, while group
      II will receive the vaginal microprogesterone.
    


Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Luteal Phase Support; Cryo-warmed Embryo Transfer; Assisted Reproductive Technology
Maternal, Adiposity, Metabolism, and Stress Study
Condition: Obesity; Gestational Weight Gain
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      The MAMAS study is built on the premise that simple recommendations for diet and exercise may
      not be enough to encourage healthy weight gain during pregnancy. Psychological skills
      training may be necessary to help women deal with stress and cravings; learn to regulate
      difficult emotions; increase awareness; and encourage healthy eating and physical activity.
      The goal of this study is to find out whether a behavioral stress reduction intervention can
      help women achieve healthy weight gain during pregnancy and reduce stress.
    

Detailed description: 
      The MAMAS study is adapting and testing interventions - "Moms in Joy," based on Emotional
      Brain Training (EBT) (developed by Laurel Mellin) and "Mindful Moms," (MIND) based on the
      Mindful Motherhood Training (developed by Cassandra Vieten, PhD), Mindfulness-Based-Eating
      and Awareness Training (MB-EAT) (developed by Jean Kristeller, PhD), and other mindfulness-
      and acceptance-based interventions.

      In the first phase of this study, the investigators conducted in-depth focus groups with over
      60 overweight, low to middle-income, pregnant women to learn more about what they might be
      looking for in such an intervention. In the second phase, which began in fall 2010, 48 low-
      to middle-income overweight pregnant women were randomly assigned to one of the
      interventions. Based on the knowledge gained from Phase 2, we refined the MIND intervention
      and are conducting an efficacy trial in Phase 3.

      During Phase 3, we will enroll 220 overweight, low to middle-income, pregnant women in a
      trial of MIND to test feasibility and to examine changes in hypothesized mechanisms (stress,
      opioid tone), non-homeostatic eating, and in health outcomes (abdominal fat, insulin
      sensitivity, weight change) in the intervention group (n=110). Intervention participants will
      complete a battery of psychological and clinical measures (weight, BMI, waist/hip ratio, body
      composition) at baseline, post-intervention, 32-34 weeks gestation, and 3 and 9 months
      postpartum. Control participants (n=110) will complete the same battery of psychological
      measures at baseline and 8-10 weeks after baseline. All study participants will complete
      brief psychological, weight and waist/hip ratio measures at 6 months postpartum.
      Additionally, we will obtain prenatal and labor/delivery medical records for all study
      participants.
    

Intervention name(s): Mindful Moms
Intervention type(s): Behavioral
Intervention description(s): 8 weekly 2-hour sessions, 2 "booster" telephone sessions, and 1 postpartum "booster" session
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Overweight; Obese; Stress; Mindfulness
Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This project explores whether children have better growth and cognitive development when the
      clinic identifies "higher risk" MAM children and support them either with the same treatment
      as SAM children or with the recommended practice: nutrition counseling.
    

Detailed description: 
      This is a cluster-randomized controlled trial taking place in 20 community clinics providing
      malnutrition care in Sierra Leone.

      All participants will be children aged 6-59 months. Control participants will have moderate
      acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-<12.5. High Risk
      MAM will be defined with a MUAC 11.5 to <11.9 or WAZ<-3.5 or Mother not the caretaker or not
      breastfeeding at <2 years old. Low risk MAM defined with a MUAC 11.9 to <12.5 with no risk
      factors.

      Control group and low risk group caregiver's will received nutrition education via mother
      care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks
      post-enrollment.

      High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF
      per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their
      caregiver will also receive nutrition education via the mother care groups. The investigators
      will also follow up with the participant at 12 and 24 weeks post-enrollment.

      A subset of the participants in each group will also be enrolled in a cognitive development
      substudy were the investigators will be using a eye tracking performance assessment.
      Investigators will also enroll health adult participants for eye tracking assessment. Adult
      data will be used as a reference when interpreting results.
    

Intervention name(s): amoxicillin; Ready-to-use therapeutic food (RUTF); Mother Care group
Intervention type(s): Drug; Dietary Supplement; Behavioral
Intervention description(s): At enrollment the child will receive a 1 week course of amoxicillin; 1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed; Nutrition education via mother care groups lead by a respected elder in the local community
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast
      (MK-0476) in participants with mild or moderate asthma.
    


Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg; Placebo dry powder inhaler
Other intervention name(s): Montelukast Sodium; MK-0476
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers
Condition: Advanced Rectal Cancers
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by
      RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse,
      often associated with poor prognosis

      Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with
      concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or
      cN1-2.
    


Intervention name(s): Preoperative chemo-radiation with IG-IMRT dose escalation
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dose escalation, chemo-radiation, rectum cancer, phase 2
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and
      can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge
      with antigen.
    


Intervention name(s): ASP-1001 nasal spray; Placebo for ASP-1001
Intervention type(s): Drug; Drug
Intervention description(s): 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.; 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma
Condition: Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; High Grade Glioma
MeSH terms: Glioblastoma; Glioma; Astrocytoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate an investigational vaccine using
      patent-derived dendritic cells (DC) to treat malignant glioma or glioblastoma.
    


Intervention name(s): Dendritic Cell Vaccine; Tumor Lysate; Imiquimod; Leukapheresis
Intervention type(s): Biological; Biological; Drug; Procedure
Intervention description(s): Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.; Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.; 5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate; Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.
Other intervention name(s): DC Vaccine; Lysate of Tumor; Lysate Boost; Aldara; Pheresis
Intervention MeSH terms: Imiquimod; Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HGG; Dendritic Cell Vaccine; DC Vaccine; Leukapheresis
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of one fixed dose combination (FDC) tablet of
      empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of
      empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single
      dose under fed conditions
    


Intervention name(s): Empagliflozin/linagliptin/metformin HCl; Empagliflozin; Linagliptin; Metformin HCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily; Once daily; Once daily; Once daily
Other intervention name(s): TRIJARDY® XR
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Condition: Muscle Spasticity as a Result of Spinal Cord Injury
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on
      spasticity in spinal cord injured persons.The study will be a phase 2, randomized,
      placebo-controlled crossover study. Each eligible subject will participate for 26
      weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the
      study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the
      first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the
      opposite arm for another 11 week treatment period (phase 2).
    


Intervention name(s): nabilone 0.5 mg; placebo
Intervention type(s): Drug; Drug
Intervention description(s): nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase; placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
Other intervention name(s): Cesamet
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity, Spinal Cord Injury