bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of S- and R-warfarin; Pharmacodynamics of Warfarin; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics (PK) of warfarin after single dose administration.
    

Detailed description: 
      Subjects will receive a single dose of warfarin on Day 1 followed by a 15 day wash-out period
      (time from warfarin dosing to isavuconazole dosing).

      On Days 16 and 17, isavuconazole will be dosed three times daily (TID). TID doses will be
      administered 8 hours apart. On Days 18 through 28, isavuconazole will be administered once
      daily (QD). All subjects will be administered a single dose of warfarin on Day 20. A follow
      up visit will occur approximately 7 days after the last dose of isavuconazole. Blood samples
      for pharmacokinetics will be collected throughout the study.
    

Intervention name(s): Isavuconazole; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; Coumadin
Intervention MeSH terms: Isavuconazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; warfarin; Healthy Volunteers; BAL8557; Coumadin
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The current guidelines for non-specific CLBP, recommend a conservative approach with exercise
      therapy, as first line treatment. Endurance and resistance training are two examples of
      recommended exercise therapies. However, it appears that none is recommended as superior over
      the other.
    

Detailed description: 
      The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an
      investigation about its effects.

      However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to
      integrate it in the daily practise and future research.

      In a single-center, single-blinded randomized feasiblity study, the investigators aim to
      prove the feasibility and safety of a 12 week HIIT programm.
    

Intervention name(s): HIIT; MICT
Intervention type(s): Other; Other
Intervention description(s): 5 min. warm up
10 × 60 seconds burst
60 seconds recovery after each burst
Burst phase: HRR >90%
Recovery phase: HRR btw. 30-39%
5 min. cool down; 5 min. warm up
20 min. continuous cycling: HRR btw. 40% - 59%
5 min. cool down
Other intervention name(s): high intensity interval training; moderate intensiv continuous training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Horner's SD After Thoracic Epidural Block
Condition: Horner's Syndrome
MeSH terms: Horner Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural
      anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was
      1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.
    

Detailed description: 
      Transient Horner's syndrome has been recognized rare complication of epidural anesthesia and
      the incidence is not exactly well-known in thoracic epidural anesthesia. Therefore, this
      study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural
      anesthesia following continuous thoracic epidural analgesia for mastectomy.

      Six hundred thirty three Patients, who scheduled for mastectomy with/without breast
      reconstruction, were eligible for this prospective observational study from September 2010 to
      December 2013. Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine 15mL
      followed by sedation consisting of propofol without muscle relaxation. After the operation,
      thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of
      ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h. At 1 hour, 2hour, 1 day, 2 day and 3 day
      after the operation, postoperative surveillance consisted of the occurrence of symptoms of
      Horner's syndrome (miosis, ptosis, and hyperemia) were performed by anesthesiologists.
    

Intervention name(s): thoracic epidural anesthesia; mastectomy; Ropivacaine; Propofol; Fentanyl
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy; mastectomy with/without breast reconstruction; Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine; Thoracic epidural anesthesia performed followed by sedation consisting of propofol; thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.
Intervention MeSH terms: Fentanyl; Propofol; Ropivacaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, who scheduled for mastectomy with/without breast reconstruction
      
Keywords: Anesthesia; Epidural; Thoracic Nerves; Horner syndrome
An Evaluation of Re:MIX: a Teen Pregnancy Prevention Program With Young Parents as Peer Educators, EngenderHealth
Condition: Sexual Behavior; Unprotected Sex
Study type: Interventional

Summary: 
      This study uses a cluster-level randomized controlled design to evaluate the efficacy of
      Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex,
      pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy
      prevention program for adolescents covering a broad range of topics related to sexual health
      and youth development, including healthy relationships, communication, gender, consent,
      reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life
      planning. Re:MIX also aims to connect students and peer educators with community resources
      and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades
      8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young
      parent educators delivered the information with professional health educators using
      non-traditional approaches, such as game-based tools, technology, and storytelling. Youth
      received roughly nine hours and 10 minutes of group sessions during the school day over one
      semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders
      attending three public charter schools in Travis County, Texas. Comparison classes either
      received an alternative program that focused on health, nutrition, and fitness, or business
      as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches
      to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office
      of Adolescent Health.
    


Intervention name(s): Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17
Intervention type(s): Behavioral
Intervention description(s): Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dose Range Study of CD5789 in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety of different concentrations of CD5789 cream in participants
      with acne vulgaris for the purpose of dose identification.
    


Intervention name(s): CD5789 25 µg/g cream; CD5789 50 µg/g cream; CD5789 100 µg/g cream; Tazarotene 0.1% gel; Vehicle cream
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): CD5789 25 µg/g cream applied once daily; CD5789 50 µg/g cream applied once daily; CD5789 100 µg/g cream applied once daily; Tazarotene 0.1% gel applied once daily; Vehicle cream applied once daily
Intervention MeSH terms: Tazarotene; Trifarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Integrated Care for Pediatric Obesity Using Telehealth
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing
      childhood obesity is a top priority among pediatricians in primary care settings. However,
      effective treatment typically is multidisciplinary, and most practices currently do not have
      the infrastructure for coordinating integrated care. With the advent of the Affordable Care
      Act (ACA), innovative systems for building multidisciplinary teams to provide integrated care
      through a patient-centered medical home will be at a strategic advantage. The use of
      electronic technologies for delivering health-related information or services, known as
      telehealth, is an innovation with the potential to streamline integrated care and transform
      interventions for chronic diseases. We propose a pilot study to evaluate telehealth for
      treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics).

      Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40) will
      be randomly assigned to an "immediate" intervention group or a "wait list" control group.
      Subjects in the "immediate" intervention group will begin the 6-month telehealth intervention
      at the time of enrollment in the study and then receive general patient/family counseling
      from their primary care providers (PCPs) at routine office visits during a 6-month follow-up
      period. Those in the "wait list" control group will receive general patient/family counseling
      from their PCPs for 6 months followed by the telehealth intervention for 6 months. Thus, the
      total duration of participation in the study for each subject will be 12 months. The
      telehealth intervention will include dietary, physical activity, and behavioral management
      counseling provided by videoconferencing from the OWL clinical providers at Boston Children's
      Hospital to children in their homes, or at a telehealth station at Wareham Pediatrics.
    


Intervention name(s): Telehealth
Intervention type(s): Behavioral
Intervention description(s): Telehealth visits will alternate between a dietitian and behavioral medicine provider for either 30 minutes or 1 hour. Over a 6-month period, 12 telehealth sessions will be scheduled for each participant. The dietitian will provide dietary and physical activity recommendations, and the behavioral medicine provider will counsel on strategies for achieving specific goals. Applying a Chronic Care Model, self-management support will be augmented by linkages to community resources.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric obesity; telehealth
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
Condition: Stroke, Subacute
MeSH terms: Stroke
Study type: Observational

Summary: 
      Stroke is the third common cause of adult disability in dveloped countries. Early
      identification of the potential for motor recovery is important to avoid 'learned disuse' and
      to initiate appropriate therapy with achievable goals. The current cohort study focuses on
      those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on
      prognostication of upper limb motor recovery among subacute stroke patients in a local stroke
      population.
    


Intervention name(s): MEPs induced by TMS
Intervention type(s): Diagnostic Test
Intervention description(s): Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subacute stroke patients
Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate intravaginal culture using the medical device
      INVOcell to generate day 5 blastocysts in comparison to traditional IVF.
    

Detailed description: 
      This is a Phase III, single center, open label randomized comparative trial to evaluate
      intravaginal culture using INVOcell vs. traditional IVF to generate day 5 embryos Pilot: 40
      couples (80 patients), randomized to receive either intravaginal culture (n=20) using the
      INVOcell or traditional IVF (n=20) Primary Endpoints: Blastocyst generation rate: number of
      day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6
      and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading
      System divided by the number of eggs incubated Patient acceptability of INVOcell and
      intravaginal culture.

      Secondary Endpoints: Live birth rate: number of cycles with a live birth divided by the
      number of cycles with embryo transfers.

      Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the
      number of cycles with embryo transfers.

      Fertilization rate: Number of embryos obtained after incubation divided by the number of
      oocytes placed in the device.

      Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo
      transfers Miscarriage rate: Number of miscarriages divided by the number of cycles with
      embryo transfers Multiple rate: Number cycles with twins or triplets divided by the number of
      cycles with embryo transfers Miscarriage rate per clinical pregnancy: Number of miscarriages
      divided by the number of cycles with clinical pregnancy
    

Intervention name(s): INVOcell Culture Device; IVF Incubation
Intervention type(s): Device; Device
Intervention description(s): INVOcell is a vaginal culture device; IVF Incubator
Other intervention name(s): INVOcell, INVOcell Culture Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intravaginal culture; in vitro fertilization; blastocyst; pregnancy
Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of your participation in this study is to help answer the following
      research question, and not to provide you treatment for your condition. Whether duloxetine
      once daily orally is tolerated and safe, in children (aged 7 through 11 years) and
      adolescents (aged 12 through 17 years) with Major Depressive Disorder.
    


Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. Anastrozole may be effective in preventing breast cancer.

      PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing
      breast cancer in postmenopausal women who are at increased risk for the disease.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal
           women at increased risk for the disease.

      Secondary

        -  Determine the role of this drug in preventing estrogen receptor-positive breast cancer
           in these participants.

        -  Determine the effect of this drug on breast cancer mortality in these participants.

        -  Determine the effect of this drug on other cancers, cardiovascular disease, fracture
           rates, and non-breast cancer deaths in these participants.

        -  Determine the tolerability and acceptability of side effects of this drug in these
           participants.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
      Participants are stratified according to participating center. Participants are randomized to
      1 of 2 treatment arms.

        -  Arm I: Participants receive oral anastrozole daily for 5 years.

        -  Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment
           continues in the absence of the development of breast cancer (including ductal carcinoma
           in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility
           fracture.

      Participants are followed for at least a further 5 years.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK

      ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
    

Intervention name(s): anastrozole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): aromatase inhibitor; Arimidex placebo
Other intervention name(s): Arimidex
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: breast cancer, chemoprevention
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
Condition: GERD Without Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and
      75 mg). The secondary objectives are to compare the efficacy between the three doses of
      AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.
    


Intervention name(s): AZD0865
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GERD without erosive esophagitis
To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and
      multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose-ascending study to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of YG1699 following single ascending and
      multiple oral dose administration.

      The study consists of 2 parts: Part 1, SAD dose- ascending; Part 2, multi-dose ascending.
    

Intervention name(s): YG1699
Intervention type(s): Drug
Intervention description(s): YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM.
Drug: Placebo
Placebo is the same appearance as YG1699.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single Ascending Dose and Multiple Dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes
A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.
Condition: Motion Sickness
MeSH terms: Motion Sickness
Study type: Interventional
Phase: Phase 1

Summary: 
      In this comparative bioavailability and in vivo skin adhesion study, the impact of minor
      changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and
      change of the manufacturing line of the micro porous membrane will be tested.
    

Detailed description: 
      This study is a randomized, single-center, cross-over, comparative bioavailability and
      adhesion study, comparing single administrations of a new scopolamine transdermal delivery
      system formulation to the current established reference transdermal delivery system in
      healthy adult participants. The study will consist of an ambulant screening day within 21
      days prior to the first investigational medicinal product (IMP) administration at study Day 1
      and two treatment periods. Each treatment period will consist of 4.5 days (108 hours) of
      in-house confinement.
    

Intervention name(s): Reformulated scopolamine patch; Marketed scopolamine patch
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with deliver approximately 1.0 mg over 72 hours; Marketed scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours.
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other