bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of 3 different skin temperature placement probe
      in the case room on the admission temperature to the NICU in preterm infants. The authors aim
      to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).
    

Detailed description: 
      It's a prospective randomized trial conducted at Maisonneuve Rosemont Hospital, neonatal
      tertiary center located in Montreal with over 2600 annual deliveries. All pregnant women who
      are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will
      be eligible to be enrolled into the study and informed consent is obtained.

      Simple randomization is accomplished by opening a sealed pre-set envelope with group
      assignment before delivery.

      Group 1: The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and
      in side position to the flank between the hips and the ribs.

      Group 2: The probe is placed on the chest, 1 cm above the left nipple. Group 3: The probe is
      placed deep in the left axilla

      At birth, all the preterm are immediately placed under a radiant warmer and resuscitated as
      per Neonatal resuscitation program (NRP) guidelines. Application of a skin temperature probe
      set at 36.5°C, for servo-controlled thermoregulation by 2 minutes of life. Probes will be
      fixed with an insulated reﬂective water-soluble gel probe.

      No changes are made to the routine delivery room management and resuscitation for this study.
      After initial delivery room management, babies are transported in a heated radiant warmer
      (Panda) to the NICU.

      In the delivery room, when the baby has a skin temperature servo-controlled stable at 36.5°
      C, the baby is ready to be transferred to NICU. All babies admitted to the NICU are routinely
      cared for by the attending neonatologist.

      Data collection:

      The temperature displaced on the servo controlled table is collected when the baby is the
      NICU just before transfer from the radiant table to the incubator.

      The right axillary temperature will be taken by a thermometer.
    

Intervention name(s): The Back; Chest; Left Axilla
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Temperature-Probe Placement-preterm infant-case room
Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with
      chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.
    


Intervention name(s): lapatinib; trastuzumab; paclitaxel; fluorouracil; epidoxorubicin; cyclophosphamide
Intervention type(s): Drug; Biological; Drug; Drug; Drug; Drug
Intervention description(s): Arm B 1250mg/d PO Arm C 750mg/d PO; First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins; 80mg/sqm 1 hour infusion for 12 weeks; 600mg/sqm iv day 1 q21 days for four coursess; 75mg/sqm iv day 1 q21 days for four courses; 600mg/sqm day 1 q21 days for four courses
Other intervention name(s): Tyverb/Tykerb; Herceptin; Taxol
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Fluorouracil; Trastuzumab; Lapatinib; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neo-adjuvant trastuzumab early breast cancer lapatinib
Couples Fertility and Pregnancy Awareness
Condition: Fertility; Decision to Get Pregnant
Study type: Interventional

Summary: 
      Recent evidence has shown that young people that want to have children have low fertility
      knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge,
      on changes in lifestyle and on the decision to start to get pregnant.
    

Detailed description: 
      This study will compare the efficacy of a video intervention versus control (no video) in
      couples that intend to have children in the next three years. The couples will be randomized
      to the two groups. The video contains information concerning age-related fertility decline,
      fertility risk factors, the success of infertility treatments, and emotional consequences of
      childlessness.
    

Intervention name(s): Health educational video
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: infertility; fertility awareness; preconceptional care; health interventions; couples
Dose-Response of Adenosine for Perioperative Pain
Condition: Perioperative Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and
      represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit
      sensory transmission by inhibiting the slow ventral root potential, which is the
      C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit
      intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory
      nerve terminals to inhibit the release of substance P and perhaps glutamate. Although
      adenosine A3 receptors are not found in the nervous system, adenosine is also known to have
      anti-inflammatory properties that may contribute to pain relief in the peripheral setting of
      inflammation.
    


Intervention name(s): adenosine
Intervention type(s): Drug
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Lesinurad Interaction Study With Ranitidine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study in healthy volunteers to evaluate the potential
      pharmacokinetic (PK) effects of ranitidine on lesinurad.
    

Detailed description: 
      This study will evaluate the potential effect of ranitidine on the pharmacokinetics of
      lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both
      calcium-containing and magnesium- and aluminum-containing antacids. The current study will
      assess whether raising gastric pH, without the presence of these cations, affects lesinurad
      PK and PD under the fasted state. If an impact is seen, then the optional second cohort will
      be conducted under the fed state.
    

Intervention name(s): lesinurad 400 mg; ranitidine 150 mg; lesinurad 400 mg + ranitidine 150 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lesinurad; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Inflammation
Study type: Observational

Summary: 
      This open-label, Phase IV prospective, observational study will evaluate patients, who have
      been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received
      either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and
      compare information regarding post-injection inflammatory (irritation in the eye)2-3 days
      post-injection.

      Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.
    

Detailed description: 
      Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for
      treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300
      subjects from one site in the United States will be enrolled.

      Inclusion Criteria:

        -  Ability to provide written informed consent and comply with study

        -  Age 65-90 years

        -  Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with
           intravitreal ranibizumab or aflibercept

      Exclusion Criteria:

        -  Previous intraocular inflammation

        -  Treatment with systemic anti-inflammatory agents

        -  Known systemic autoimmune diseases

        -  Treatment with intraocular steroids in the past 3 months

        -  History of intraocular surgery in the past 3 months

        -  Age greater than 90 years

        -  Patients who were switched between either therapies in the past 3 months
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Private practice patients referred to retinal specialist for treatment of Neovascular
        Age-Related Macular Degeneration
      
Keywords: Macular; Degeneration; Age related; Neovascular
A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this research study is to explore the relationship between the gut microbiome
      and hormone levels in women diagnosed with PCOS and determine whether there are differences
      in the gut microbiome between women with PCOS and women without PCOS.

      Consented, enrolled participants will complete a health questionnaire, complete a fasted
      blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for
      comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.
    


Intervention name(s): No intervention study
Intervention type(s): Other
Intervention description(s): This observational study will only collect data, not provide any intervention to participants.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have
        not been using hormonal therapy for at least 3 months and without other significant health
        issues or medications affecting hormones. Women must be previously diagnosed with PCOS or
        considered Healthy and not currently pregnant or nursing. Women will be referred to the
        study by their Physician or word of mouth.
      
Biospecimen description: 
      Whole blood, saliva, vaginal microbiome, stool microbiome
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine
      134612 when given in an experimental co-administration versus vaccine 134612 alone and versus
      the experimental co-administration alone in healthy subjects aged 11 through 17 years. There
      will be 3 groups in this study.
    

Detailed description: 
      All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will
      have 3 blood samples taken.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      September 2007.
    

Intervention name(s): Nimenrix (Meningococcal vaccine 134612); Twinrix
Intervention type(s): Biological; Biological
Intervention description(s): Single dose intramuscular injection; 3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: non-inferiority; adolescents; meningococcal vaccine
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
Condition: Nail Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of indigo naturalis oil
      extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo
      naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an
      effective alternative for those who do not respond well to traditional therapy.
    

Detailed description: 
      In the literature, the efficacy of traditional Chinese medicine in treating nail psoriasis is
      rarely reported. Recently, the investigators developed a new product, indigo naturalis oil
      extract, which worked well in nail disease. In our randomized, observer-blind,
      vehicle-controlled trial showed that indigo naturalis oil extract is effective and safe in
      treating nail psoriasis. This study aims to compare the efficacy and safety of indigo
      naturalis oil extract with calcipotriol solution in patients with nail psoriasis using
      controlled, bilateral comparison

      The investigators will enroll 33 patients with nail psoriasis from the ambulatory department
      of Chang Gung Memorial Hospital. Indigo naturalis oil extract will be consistently applied on
      either the left or right affected nail folds, while calcipotriol will be applied on the
      opposite side, both twice daily for 24 weeks, allowing intra-patient comparison. The nails
      will be assessed by two dermatologists before treatment and at week 2, 4, 8, 12, 16, 20, 24.
    

Intervention name(s): Indigo Naturalis Extract in Oil; Calcipotriol Solution
Intervention type(s): Drug; Drug
Intervention description(s): The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.; The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Other intervention name(s): Lindioil; Calcipotriol
Intervention MeSH terms: Calcitriol; Calcipotriene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nail Psoriasis; Indigo Naturalis; Indirubin; Calcipotriol; Nail Psoriasis Severity Index
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to
      Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH)
      Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)
    

Detailed description: 
      The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis
      use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group,
      outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals.
      Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random
      block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will
      receive motivational interviewing for 2 weeks before being randomized to receive study
      medication to make a quit attempt within the first week of treatment. Participants will
      receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated
      weekly in face to face visits. In addition, daily assessment of adherence to study medication
      and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure
      (self-reported and urine toxicology), and problems related to the use of cannabis, will be
      assessed.
    

Intervention name(s): PF 04457845; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Study medication will be administered at 4mg by mouth daily for eight weeks.; Placebo comparator will be administered by mouth daily for eight weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2B
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
Condition: Diabetes; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that
      the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to
      fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common
      complication of diabetes treatment and is a major barrier to the maintenance of healthy
      glucose levels in individuals with diabetes. The primary purpose of the study is to test the
      proof-of-concept that there is an association between the rate of GAM and susceptibility to
      insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be
      measured in a patient population known to frequently experience hypoglycemia, i.e.,
      individuals with type 1 diabetes mellitus (T1DM).
    


Intervention name(s): 13C-MRS procedure/Acetate infusion; Continuous glucose monitoring
Intervention type(s): Other; Device
Intervention description(s): Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.; Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
Other intervention name(s): CGM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Condition: Tachyarrhythmia; Atrial Fibrillation (AF); Syncope; Cryptogenic Stroke
MeSH terms: Syncope; Ischemic Stroke; Atrial Fibrillation; Tachycardia
Study type: Interventional

Summary: 
      This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual
      risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered
      or remain even after risk analysis, risk mitigation and successful conformity assessment.
      Furthermore, this study will also provide additional data as required by regulatory
      authorities outside of the CE-region.
    


Intervention name(s): BIOMONITOR III and BIOMONITOR IIIm
Intervention type(s): Device
Intervention description(s): Insertion of BIOMONITOR III or BIOMONITOR IIIm
three scheduled in-office follow-ups
48-hour Holter ECG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
Condition: Healthy Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841
      (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy
      female participants who are not of childbearing potential.
    

Detailed description: 
      This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect
      of multiple doses PF-06700841 on single dose combination oral contraceptive (OC)
      pharmacokinetics (PK) in healthy female participants aged 18-60.

      The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods
      during which participants are resident in the Clinical Research Unit (CRU) and a final
      follow-up telephone contact, which will be conducted after 28-35 following administration of
      the last dose.

      Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female
      participants (9 in each treatment sequence) will be enrolled in the study. Each treatment
      sequence will consist of 2 periods in a single fixed sequence. Participants will be screened
      within 28 days of the first dose of investigational product. Participants will report to the
      Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment
      sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment
      Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days
      and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence
      2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in
      treatment sequence 2 will have an outpatient washout period of at least 10 days between
      Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent
      tablet will be administered in one of the two periods (reference treatment) and in the
      alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13
      days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax
      and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing.

      Safety assessments will be conducted at the CRU.
    

Intervention name(s): PF-06700841; Ethinyl estradiol (EE) and levonorgestrel (LN)
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg by mouth (PO) once daily (QD).; Oral tablet containing 30 mcg EE and 150 mcg LN.
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol; PF-06700841
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nutritional Restriction and Activity Thermogenesis
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      These studies will provide us with enormous insight regarding how obese patients adapt
      energetically during negative energy balance. We will gain fundamental information regarding
      the metabolic implications of combining food restriction with a walking program compatible to
      that advocated by statutory agencies. These studies will lead to improved understanding of
      the energetic adaptation that occurs during negative energy balance and how best to treat
      patients with obesity.
    


Intervention name(s): Exercise and behavior modification
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Physical activity