bioihbjkbjnl/mcl2 huggingface dataset:
Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
Condition: Breast Neoplasms; Carcinoma, Ductal; Adenocarcinoma
MeSH terms: Adenocarcinoma; Breast Neoplasms; Carcinoma, Ductal
Study type: Interventional

Summary: 
      Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for
      breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases
      radiation exposure to the heart during radiation for breast cancer. In this trial cardiac
      perfusion changes or lack thereof will be quantified in women treated with radiation for
      breast cancer while using the ABC device. The control group of the study will consist of
      patients randomized to radiation therapy without the ABC device.
    

Detailed description: 
      50 left sided breast cancer patients will be randomized to receive breast/chest wall
      irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200
      cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation
      to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The
      total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be
      given Monday through Friday.

      After the completion of radiation therapy, patients will be seen on the following schedule:

      A follow up examination will take place every 3-6 months for the first two years, then every
      4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur
      annually. A SPECT scan will be obtained at 6 months post therapy.

      Patients must be 18 and older and must have histologically confirmed (by routine H&E
      staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

      Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.

      Patients must not have received prior radiation therapy to the breast at any time for any
      reason.

      Patients must not be pregnant due to the potential for fetal harm as a result of this
      treatment regimen.
    

Intervention name(s): Active Breathing Coordinator
Intervention type(s): Device
Intervention description(s): A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; SPECT; ABC device; Invasive adenocarcinoma of the left breast; Ductal Carcinoma In Situ of the left breast
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      First in human study
    

Detailed description: 
      Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD)
      parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
    

Intervention name(s): YH4808 30mg; YH4808 50mg; YH4808 100mg; YH4808 200mg; YH4808; YH4808 100mg (repeat dose); YH4808 200mg (repeat dose); YH4808 600mg; YH4808 800mg (single dose); YH4808 400 mg (repeat doses); Placebo; Esomeprazole 40mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): YH4808 30mg (single dose); YH4808 50mg (single dose); YH4808 100mg (single dose); YH4808 200mg (single dose); YH4808 400mg (single dose); YH4808 100mg (repeat dose); YH4808 200mg (repeat dose); YH4808 600mg; YH4808 800mg (single dose); YH4808 400 mg (repeat doses); 10 volunteers will be administered matched placebo.; 24 volunteers will be administered Esomeprazole 40mg
Other intervention name(s): YH4808 30mg (single dose); YH4808 50mg (single dose); YH4808 100mg (single dose); YH4808 200mg (single dose); YH4808 400mg (single dose); 10 volunteers will be administered matched placebo.; 24 volunteers will be administered Esomeprazole 40mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety, tolerability and PK/PD
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Condition: Pain Interference; Depression; Antiretroviral Adherence
MeSH terms: Chronic Pain; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether participation in the study intervention,
      which involves collaboration between the study interventionist and the participant's primary
      care physician, will reduce symptoms of pain and depression in HIV+ patients.
    


Intervention name(s): HIVPASS; Health Education
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; depression; HIV; adherence
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for
      E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK
      characteristics, the proposed study includes a cohort of white subjects treated for
      comparison with the cohort of Japanese subjects treated at the same dose. This comparison
      serves as a key PK bridge in assessing ethnic factors that may contribute to differences in
      plasma concentrations. Pharmacokinetic assessments in the proposed study will include
      confirmation of dose proportionality in Japanese subjects. This study will also evaluate
      safety and tolerability in Japanese subjects.
    


Intervention name(s): E2609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2609 low-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy Japanese subjects, E2609 high-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy White subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Clinical Trial, Phase I; Healthy Volunteers
Piloting a Dietary Vitamin E Intervention During Pregnancy
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      In the last forty years the prevalence of asthma has increased in westernised countries. We
      have hypothesised that this increase may be a consequence of changing diet. Several birth
      cohort studies have now reported an association between reduced maternal vitamin E intake
      during pregnancy and childhood asthma.

      However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy
      reduces the risk of childhood asthma. We are planning a large placebo controlled trial in
      pregnant women, to investigate whether optimisation of dietary vitamin E intake to the
      recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary
      intervention using vitamin E in its natural form of food is more likely to be successful and
      acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women
      can optimise their vitamin E intake using a personalised dietary plan with the help of a
      dietitian however this intervention was complex and could not be translated into everyday
      use. With commercial support we have developed a range of soups containing foods naturally
      rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of
      similar tasting and looking placebo soups has also been developed. In this study we will
      pilot a randomised controlled trial of the active and placebo soups to ascertain whether
      pregnant women are willing and able to optimise their vitamin E intake during pregnancy using
      the soups in order to reduce the risk of their child developing asthma. optimising maternal
      vitamin E intake during pregnancy.
    


Intervention name(s): Vitamin E enhanced soup; Non-enhanced soups
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients; Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: asthma; pregnancy; diet; vitamin E
Incidence and Severity of Cardiorespiratory Events in Infants at Increased Epidemiological Risk for Sudden Infant Death Syndrome (SIDS)
Condition: Sudden Infant Death Syndrome; Apnea
MeSH terms: Syndrome; Death; Infant Death; Sudden Infant Death
Study type: Observational

Summary: 
      OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events
      documented by home monitoring in infants at increased epidemiological risk for sudden infant
      death syndrome (SIDS).

      II. Determine the antecedent medical, demographic, physiologic, and behavioral
      characteristics that predict the incidence of cardiorespiratory events documented by home
      monitoring.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a multicenter collaborative study. Patients are stratified into 4
      groups: healthy term infants, apnea of infancy, subsequent siblings of SIDS victims, and
      preterm infants.

      The caregivers are trained in the use of home monitor equipment and in the graded response to
      monitor alarms (observation, gentle stimulation, more vigorous stimulation, mouth to mouth
      breathing, and full cardiopulmonary resuscitation).

      Caregivers undergo infant cardiopulmonary resuscitation (CPR) training (not required for
      caregivers of healthy term infants).

      Demographic information is obtained on each infant. A 30 second recording of each infant's
      cry is performed at study entry and at 1 month corrected age, and at the polysomnogram. A
      urine sample is collected and frozen.

      The CHIME monitor is used during sleep and whenever the infant is not being observed.

      An overnight polysomnography is performed within 2 weeks of study entry. At 1, 2.5, 6, and 12
      months corrected age, infants participate in a clinical evaluation. Neurodevelopmental status
      is assessed at 1, 4, and 12 months corrected age.
    

Keywords: apnea; cardiovascular and respiratory diseases; neurologic and psychiatric disorders; rare disease; sudden infant death syndrome
A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma
      patients where medical and conventional surgical treatments have failed.
    

Detailed description: 
      Study Design:

      This study is a prospective, single-arm single-center, open-label study.

      Study population:

      Men and women diagnosed with open-angle glaucoma who require glaucoma surgery procedures that
      meet the inclusion/exclusion criteria and provide written informed consent will be enrolled
      in the study.

      Enrollment:

      A total of 30 subjects will be enrolled:

      15 patients will be implanted according to procedure 1 (see section 8.7), at completion
      additional 15 patients will be implanted according to procedure 2 (see section 8.7)

      Investigational sites:

      One (1) center will participate in this study.

      Duration of Subject participation:

      Completion of active enrolment is anticipated to last approximately 6 months. The primary
      endpoint will be achieved when the final study subject has completed 6 months follow-up.

      Study Group:

      A single study group. This is a single-arm design; there is no control device in this study.

      Visits & Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The
      visit will include the subject's qualification assessment for inclusion/exclusion criteria as
      described above. Informed consent must be signed.

      Complete anamnesis will be taken including the subject's medical complaints, medical history,
      and medication use. Ophthalmic examinations as well as ultrasound biomicroscopy.

      Surgical procedure: Procedure will be performed under anesthesia (at physician discretion)
      and a Hanita shunt will be implanted.

      Follow-up: All subjects will have regular follow-up visits at 1 and 7 days and on 1, 3, and 6
      months post-implantation. 1-year post-operative evaluation is optional at the sponsor's
      discretion. All postoperative visits will include a complete ophthalmic examination,
    

Intervention name(s): Hanita Glaucoma shunt Ver.3.2
Intervention type(s): Device
Intervention description(s): The procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt devce will be implanted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women
Condition: Female Reproductive System Disorder
Study type: Interventional

Summary: 
      Undernutrition has a known and well recognized negative impact on reproductive hormones, and
      ultimately fertility. In contrast, much less is known regarding the potential effects of
      overnutrition on the same hormones. Epidemiological data suggest that overnutrition might
      have a deleterious impact as well on the fertile potential of affected women, but very little
      is known about the mechanisms implicated. Such knowledge may be of importance, given the
      increasing prevalence of overweight and obesity worldwide.
    

Detailed description: 
      In the present study, the investigators will perform a very detailed study of the minute to
      minute regulation of hormones of the neuroendocrine reproductive axis in normal young female
      volunteers. These studies will initially be performed at base line during isocaloric diet,
      where the stimulation of LH secretion by exogenous insulin will be tested during
      hyperinsulinemic eugylcemic clamp studies.

      The same studies will then be repeated after a period of one month of controlled hypercaloric
      diet, where volunteers will receive an excess of approximately 30% KCal compared to their
      calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will
      induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the
      effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine
      reproductive hormones will be evaluated.
    

Intervention name(s): Clamp; Hypercaloric diet; Basal; Isocaloric diet
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.; Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.; Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours); Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
Other intervention name(s): Hyperinsulinemic and euglycemic clamp study; Overfeeding; Fasting; Controlled diet
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: LH pulsatility; Insulin sensitivity; Metabolism; hypercaloric feeding
Pilates to Treat Low Back Pain
Condition: Pain; Quality of Life
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of
      Pilates to treat low back pain.

      Hypothesis - the Pilates group will have best results than the control group (usual
      medicament treatment).
    

Detailed description: 
      Background:

      Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult
      population experiences this painful complaint at some point in their lives, making LBP the
      second most common reason for a visit to a clinician. Despite the frequency of this
      diagnosis, conventional treatment does not always provide patients the desired results of
      reduced pain and return of normal function. For these patients, alternative modalities are
      available to assist in the control of pain. These options include chiropractic care, physical
      therapy, massage therapy, and modalities that fall under the auspices of complementary and
      alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the
      efficacy of a variety of interventions for chronic non-specific low back pain indicate
      limited effectiveness for most commonly applied interventions and approaches.

      Objectives:

      To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality
      of life and NHAI consumption for chronic non-specific low back pain patients.

      Methods:

      Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years;
      pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other
      causes of low back pain, fibromyalgia, regular physical activity (three or more times per
      week for at least three months); labor lawsuit and body mass index more than 30. Sixty
      patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG
      participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class)
      and the CG remained with their usual medicament treatment and were included in a waiting list
      for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality
      of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90
      days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.
    

Intervention name(s): Pilates
Intervention type(s): Other
Intervention description(s): Pilates training - twice a week (one hour per class) during 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilates; Exercise; Treatment; Low back pain; Pain; Function
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the
      Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus
      Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or
      Refractory Osteosarcoma.
    


Intervention name(s): Lenvatinib; Ifosfamide; Etoposide; Lenvatinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lenvatinib 14 milligrams per square meter (mg/m^2) capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor.
An extemporaneous suspension of lenvatinib capsules may be used for participants unable to swallow capsules.; Ifosfamide 3000 milligrams per square meter per day (mg/m^2/day) intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Etoposide 100 mg/m^2/day intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Lenvatinib 14 mg/m^2 capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until the next PD (per response evaluation criteria in solid tumors [RECIST] 1.1 as assessed by investigator), development of unacceptable toxicity, participant request, or withdrawal of consent, whichever occurs first.
Other intervention name(s): E7080; E7080
Intervention MeSH terms: Etoposide; Lenvatinib; Ifosfamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteosarcoma; Lenvatinib; Ifosfamide; Etoposide; E7080; Relapsed or Refractory Osteosarcoma; Pediatrics; Chemotherapy
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen
      with culture in Pediatric patients.
    

Detailed description: 
      Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly
      labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was
      processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours
      with the final culture results that ultimately determined the need to continue or discontinue
      treatment.
    

Intervention name(s): Rapid Immunochromatographic streptococcal test
Intervention type(s): Procedure
Intervention description(s): Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Group A streptococcal pharyngitis; Rapid streptococcal test; Throat swab culture