bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
Condition: Antifungal Agents
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Griseofulvin is an antifungal agent used in treatment of Dermatophytosis caused by
      Microsporum spp. (species), Trichophyton spp., Epidermophyton spp., where topical therapy is
      considered inappropriate or has failed. Approved dose of Griseofulvin in Adults (greater than
      or equal to 50 kg) in India is 500 to 1,000 mg daily, but not less than 10 mg/kg bodyweight
      daily. As per the World health organization (WHO) guidance, Griseofulvin belongs to
      Biopharmaceutical Classification System (BCS) Class 2 ("low" solubility-"high" permeability).
      A Bioequivalence (BE) study will be conducted in India to estimate in vivo behavior
      (Pharmacokinetic characteristics) of Griseofulvin 500 tablets and dose proportionality study
      for Griseofulvin 250 mg and 500 mg tablets. This is an open label, randomized, balanced,
      three treatment period, three sequence, single dose, crossover study that will evaluate the
      bioequivalence of Griseofulvin tablets 500 mg test product (T1) versus Griseofulvin tablets
      500 mg reference product (R) as well as dose proportionality of Griseofulvin tablets 250 mg
      test product (T2) with Griseofulvin tablets 500 mg T1 in healthy, adult participants under
      fed conditions. Eligible participants enrolled will be randomized to either of the three
      treatment sequence periods, T1T2R, T2RT1 or RT1T2 according to 1:1:1 ratio. The total
      duration of clinical phase will be approximately 20 days from Day-1 to Day 19 including a
      washout period of at least 7 days (not more than 14 days) for each treatment period. A total
      of 36 healthy, adult participants will be enrolled in this study and the above mentioned
      doses of Griseofulvin will be administered under fed conditions. Participants will be
      followed up 5 days after last dosing.
    


Intervention name(s): Griseofulvin 500 mg; Griseofulvin 250 mg; Reference Griseofulvin 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition.; Griseofulvin 250 mg will be administered as an oral tablet once in each treatment period under fed condition.; Reference Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition.
Intervention MeSH terms: Griseofulvin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The whole study will be divided into three treatment periods. For each treatment period, eligible participants will be randomized to either T1T2R, T2RT1 or RT1T2 treatment sequence according to 1:1:1 ratio
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Griseofulvin; Bioequivalence; Dose proportionality; Dermatophytosis
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF
      V2 System when treating symptomatic uterine fibroids.

      The ExAblate System is a medical device that involves a focused ultrasound system and an MRI
      scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
      targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each
      sonication is used to heat small spots in the fibroid much like a magnifying glass can be
      used to focus light to heat a spot. The heat created kills a portion of the fibroid with the
      goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are
      performed until the entire fibroid is treated or the treated volume is determined to be
      appropriate.

      The ExAblate system is commercially approved in the United States to treat symptomatic
      uterine fibroids.

      The ExAblate UF V2 System is an experimental device and is being investigated in this study.
      While similar to the commercial system, the ExAblate UF V2 device includes the following
      major changes, among others, which are intended to improve device performance and safety:

        -  Up and down movement of the ultrasound transducer, in an attempt to improve fibroid
           treatment by moving the ultrasound focal point within the targeted fibroid.

        -  Ultrasound energy can be turned off for a specific area in an attempt to minimize amount
           of energy passing through sensitive areas of the body.
    


Intervention name(s): ExAblate Treatment UF V2
Intervention type(s): Device
Intervention description(s): Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine fibroids; MRgFUS; ExAblate; Focused Ultrasound; Symptomatic uterine fibroids
Virtual Reality Training Intervention on Cognitive Function and Quality of Life
Condition: Virtual Reality; Cognitive Impairment; Quality of Life
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The present study aimed to investigate the effects of a Virtual Reality cognitive training
      intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and
      improvement of quality of life in older adults with cognitive impairment in long-term care
      facilities. Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and
      selective attention, memory, cognitive functions, and rule deduction. The passive control
      group received usual care.
    

Detailed description: 
      Objectives: The present study aimed to investigate the effects of a Virtual Reality cognitive
      training intervention (VRCTI) on cognitive function changes measured with a cognitive test
      battery and improvement of quality of life in older adults with cognitive impairment in
      long-term care facilities.

      Method: Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and
      selective attention, memory, cognitive functions, and rule deduction. The VRCTI comprised 12
      different tasks distributed in 8 sessions with different difficulty levels. The passive
      control group received usual care. Older adults were randomly assigned to either VR or
      control groups. An experimental pre-post design was used. Accuracy, error, and repetition
      rates were measured throughout each session. Intervention effects were analyzed using a
      generalized estimating equation model.
    

Intervention name(s): Virtual Reality Cognitive Training Intervention (VRCTI)
Intervention type(s): Other
Intervention description(s): The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display [HMD] in delivering the VR intervention), audio, and motor equipment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual Reality; Cognitive Impairment; Quality of Life; Long-term care facilities
Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
      therapy during and after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during
      and after lumpectomy and to see how well it works in treating women with stage I or stage II
      breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the feasibility and acute tolerability of intraoperative electron
           radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women
           with stage I or II breast cancer treated with breast conservation therapy.

        -  To determine the local tumor control and distant tumor control rates in these patients.

        -  To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed
           and EBRT after lumpectomy in these patients.

      OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo
      intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery,
      patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.

      After completion of study treatment, patients are followed periodically for up to 8 years.
    

Intervention name(s): adjuvant therapy; therapeutic conventional surgery; intraoperative radiation therapy; radiation therapy
Intervention type(s): Procedure; Procedure; Radiation; Radiation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer
A Study of LY2216684 in Healthy Females
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by
      mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral
      contraceptive Ortho Cyclen®. This study will run approximately 93 days.
    


Intervention name(s): LY2216684; Ortho Cyclen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally; Administered orally
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be
      tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of
      obstructive sleep apnea (OSA) in adults..
    

Detailed description: 
      Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to
      10% of obese children. The reported prevalence is likely underestimated due to the lack of
      available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA
      coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in
      a significant strain for in laboratory PSG including children in the greater San Diego
      county. Currently, HST in children is restricted based on the limited availability of HST
      devices on children that have attained clearance by the US Food and Drug Administration
      (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will
      be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the
      diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians.
      Adolescent children will be recruited whose clinically indicated in laboratory PSG will be
      performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have
      their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink
      Air HST at home following their sleep study within one week, and the remaining ten children
      will have their ApneaLink Air HST performed within one week prior to their in laboratory
      clinically indicated PSG.
    

Intervention name(s): ApneaLink Air
Intervention type(s): Device
Intervention description(s): The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients.
ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Antacids on Gleevec® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study that will investigate the effects of antacids (often used to treat
      stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in
      healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to
      complete the study. This research study will compare Gleevec® in the body when taken with and
      without antacids. Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. One
      one occasion they will take the dose of Gleevec® alone. On another occasion, they will take
      the Gleevec® 15 minutes after taking a 20 mL dose of antacids. Several blood samples will be
      drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with
      and without the influence of antacids.
    

Detailed description: 
      This is an open-label, single-institution, randomized cross-over, fixed schedule study of the
      effects of Mg-Al-based antacids on Imatinib Mesylate (Gleevec®) pharmacokinetics. Healthy
      volunteers will be recruited to participate in this study such that twelve subjects (6 men /
      6 women) will complete the study. Gleevec® pharmacokinetics will be assessed after oral
      administration of Gleevec® and after oral administration of Gleevec® with concomitant
      administration of magnesium-aluminum hydroxide-based antacid (Maalox). Gleevec® will be
      administered at a dose of 400 mg, and the antacid (Maximum Strength Maalox®Max®
      Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600
      mg magnesium hydroxide). Half of the subjects will receive Gleevec® and antacid on day 15 and
      Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will
      receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The
      antacids will be administered 15 minutes before the Gleevec® dose.
    

Intervention name(s): Antacids (Mg-Al-based); Imatimib Mesylate (Gleevec®)
Intervention type(s): Drug; Drug
Intervention description(s): the antacid (Maximum Strength Maalox®Max® Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide).; Gleevec® will be administered at a dose of 400 mg. Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The antacids will be administered 15 minutes before the Gleevec® dose.
Other intervention name(s): Maalox; Gleevec®
Intervention MeSH terms: Imatinib Mesylate; Antacids
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy volunteers; No condition; Pharmacokinetics study
Laminar Airflow in Severe Asthma for Exacerbation Reduction
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To ascertain whether home-based nocturnal TLA usage over a 12 month period can reduce
      exacerbations and improve asthma control and quality of life as compared to placebo, whilst
      being cost-effective and acceptable to adults with poorly-controlled, severe allergic asthma.
    

Detailed description: 
      We will include 222 adults, half of whom will be given a TLA device that is working, and the
      other half will be given a device which has been inactivated (the filtering process will be
      switched off, although the participants will not be able to tell that this has occurred).
      Which participant receives the working or deactivated device will be decided by a random
      process and will be unknown to the researcher and the participant. An engineering team from
      the manufacturer will install the device in the participants' home at the beginning of the
      study and be available throughout the study period to deal with any queries.

      All participants will continue receiving their usual treatments. Participants will be in the
      study for 12 months, and will report their asthma attacks to the trial team whenever they
      occur during this period. In addition, they will visit the trial team 4 times (after 3, 6, 9
      and 12 months) to assess their asthma control and quality of life. At the end of the trial,
      we will invite participants at each site to join a group discussion where researchers will
      explore the participant's thoughts about the TLA device. At the end of their participation in
      the trial, all participants who have used the device for more than 6 months, regardless of
      their initial study group, will be offered the opportunity to keep an active device in their
      home free of charge for a further four years.
    

Intervention name(s): Temperature-Controlled Laminar Airflow Device (Airsonett®)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne's Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is designed to evaluate the effects of human umbilical cord mesenchymal
      stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle
      regenerative and anti-inflammatory properties of UC MSCs position them as a possible
      treatment option for DMD. Both of these properties could lead to potential benefits for a DMD
      patient.
    


Intervention name(s): Umbilical Cord Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal; Stem Cells; Umbilical Cord; Duchenne's; Muscular Dystrophy
Nature-based Sensory Stimulation on Pain Levels
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This randomized controlled trial aims to evaluate the effect of a single session intervention
      based on a nature-based stimulation program in patients with fibromyalgia
    

Detailed description: 
      All participants will continue to receive their usual pharmacological treatment as previously
      established by the Andalusian Public Health System. The intervention will comprise
      interaction tasks with biotic and abiotic agents for 30 minutes.
    

Intervention name(s): Nature-based sensory stimuli; Control group intervention
Intervention type(s): Other; Other
Intervention description(s): A program based on stimulation using nature-based sensory stimuli will be implemented; An activity based on a placebo intervention will be implemented
Other intervention name(s): Biogenic sensory stimuli
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Nature-based activities; Pain dimensions; Multisensory stimulation; Quantitative sensory testing
A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma
      (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive
      treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma
      (test drug) in the supportive treatment of lactose intolerance.
    


Intervention name(s): Lactase Oral Tablets
Intervention type(s): Drug
Intervention description(s): 3 tablets/day for 42 days Take with breakfast, lunch and dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effects of Video-Assisted Breastfeeding Education
Condition: Pregnancy Related; Breastfeeding; Breastfeeding, Exclusive; Educational Problems
Study type: Interventional

Summary: 
      The present study was conducted to determine the effects of online video-assisted
      breastfeeding education on breastfeeding self-efficacy in primiparous pregnant women.
    

Detailed description: 
      This two-group parallel randomized controlled study was conducted with pregnant women
      admitted to the pregnancy follow-up outpatient clinics of a university hospital in northern
      Turkey. The study was completed with 80 pregnant women in their second trimester, 40 pregnant
      women each in the intervention and control groups. Pregnant women in the intervention group
      received online video-assisted education which demonstrated first meeting of the mother-baby
      and first breastfeeding in addition to receiving counselling on breastfeeding. Pregnant women
      in the control group did not receive any intervention other than routine care. Data were
      collected face-to-face with the breastfeeding self-efficacy scale at the beginning of the
      study and two weeks later. In data analysis, chi-square test was used for categorical
      variables, independent sample t-test was used for continuous variables and intergroup
      comparison, and paired sample t-test was used for intragroup comparison.
    

Intervention name(s): educational group
Intervention type(s): Behavioral
Intervention description(s): Experimental group received online video-supported breastfeeding education in an online classroom for 6-8 people and individual counselling via phone and Whatsapp application when needed for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pregnancy; Breastfeeding self-efficacy; Breastfeeding education; Video-assisted education