bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
Condition: Breast Neoplasms; Stomach Neoplasms
MeSH terms: Neoplasms; Breast Neoplasms; Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in
      combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the
      efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2
      overexpressing metastatic breast cancer.
    


Intervention name(s): Herceptin; afatinib; trastuzumab; Herceptin; afatinib; afatinib
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3-weekly; at MTD level; 3-weekly; weekly; at MTD level; escalating dose
Intervention MeSH terms: Trastuzumab; Afatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery
Condition: Psychological Predictors
Study type: Observational

Summary: 
      All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction
      will complete a psychological questionnaire prior to surgery. The 3 month outcomes including
      pain and function will be examined using regression analysis to identify psychological
      variables that may predict outcomes.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18 yrs
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on
      intestinal permeability in pediatric patients with Crohn's disease.
    

Detailed description: 
      Children with Crohn's disease have altered intestinal permeability. A pilot study in children
      showed that probiotics may decrease intestinal permeability. In this double blind, randomized
      controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a
      double sugar absorption test. PCDAI was monitored, but not analyzed.
    

Intervention name(s): VSL#3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 packet BID; 1 inactive packet BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease; Pediatric; VSL#3; Permeability; Probiotic; Zonulin
Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of
      uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with
      Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will
      be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected
      participants.
    


Intervention name(s): Uprifosbuvir; Placebo; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth.; Matching placebo to uprifosbuvir capsule administered by mouth.; Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.
Other intervention name(s): MK-3682/IDX21437; Sporanox®
Intervention MeSH terms: Itraconazole; Uprifosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C virus; HCV
Health Status of Workers in Photocopier Units
Condition: Exposure to Photocopiers on a Professional Basis
Study type: Observational

Summary: 
      Photocopiers are indispensable in today's working environment. However, photocopiers emit a
      number of harmful chemicals during their operation. Photocopier toners also contain a number
      of potentially toxic substances. Chronic exposure to these substances may compromise the
      health of photocopier operators. This study is aimed to understand if chronic exposure to
      photocopier emissions is harmful to human health.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        exposure to photocopier emissions
Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation
Condition: Atelectasis; Intensive Care Unit; Children
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Statement of the problem:

      • Does the thoracic block technique has effect on arterial blood gases, vital signs and lung
      compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no
      effect of thoracic block technique on arterial blood gases, vital signs and lung compliance
      in children with atelectasis on mechanical ventilation.
    

Detailed description: 
      Subjects:

      The study targets the children from both sexes.diagnosed with atelectasis in intensive care
      unit. Sample size estimation will be carried out to determine the recruited number of
      children, selected randomly from Cairo University pediatric specialized hospital, Cairo to
      participate in the study,

      Study design:

      Randomized controlled clinical trial. Children will receive intervention type randomly, 22
      child received percussion, vibration, modified postural drainage and the other 22 child will
      receive percussion, vibration, modified postural drainage and thoracic block technique.

      Children will be assessed by measuring heart rate, respiratory rate,which reflect the
      physiological status, arterial blood gases which include partial pressure of oxygen (PaO2),
      partial pressure of carbon dioxide (PaCO2) and oxygen saturation (SaO2) and dynamic lung
      compliance which reflect clinical improvement of chest condition before and after ten days of
      receiving intervention
    

Intervention name(s): Thoracic block technique; Designed chest physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation; Percussion, vibration and modified postural drainage
Other intervention name(s): Technique of insufflation to reverse atelectasis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
Condition: Mid-facial Volume Deficit Related to Aging
Study type: Interventional

Summary: 
      Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety
      and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct
      age-related volume deficit in the mid-face.
    


Intervention name(s): Juvéderm® VOLUMA XC
Intervention type(s): Device
Intervention description(s): Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis
      Medical Center are currently conducting a study on the effects of vitamin D supplementation
      during pregnancy on maternal health and immune function. The investigators believe that
      vitamin D supplementation at levels greater than the current recommendation is beneficial for
      maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency
      during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due
      to an imbalance in immune function at the placenta. This randomized, double-blind study is
      designed to test this hypothesis. Pregnant women who participate in the study receive either
      400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The
      investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28
      weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The
      investigators are also collecting data on clinical parameters, such as blood pressure and
      glucose tolerance.
    


Intervention name(s): 400 IU vitamin D3; 2,000 IU Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.; Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: pregnancy; immune function
Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position
Condition: Endotracheal Intubation
Study type: Observational

Summary: 
      Nowadays endotracheal intubation is considered a fundamental management procedure during
      emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation
      and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity
      and mortality in emergency intubations. The aim of this study is to determine the diagnostic
      accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the
      rapid verification of endotracheal tube position in the intensive care unit (RICU) with
      reference to Co₂ monitors (capnography) (the gold standard technique)
    


Intervention name(s): Ultrasonography
Intervention type(s): Device
Intervention description(s): Tracheal, diaphragmatic and lung ultrasonography
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients intubated with a cuff ETT
      
Keywords: ETT
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single
      tablets of empagliflozin and metformin XR when administered singularly
    


Intervention name(s): 1 tablet Empagliflozin/2 tablets Metformin XR; 10 mg Empagliflozin/1000 mg Metformin XR; 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR; 2 tablets 5 mg Empagliflozin/750 Metformin XR; 1 tablet Empagliflozin/2 tablets Metformin XR; 10 mg Empagliflozin/1000 mg Metformin XR
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet; Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets; Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets; Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ridge Augmentation With Simultaneous Implant Placement Using Bone Blocks With Autogenous Tooth Graft
Condition: Ridge Augmentation; Implant; Autogenous Tooth Graft
Study type: Interventional

Summary: 
      Autogenous bone, with its osteogenic, osteoinductive, and osteo-conductive characteristics
      has been used for bone grafts with optimal integration into host tissues. For this reason,
      autogenous bone has been often considered the gold standard of bone regeneration material.
      However, the amount of autogenous bone that may be harvested is limited, and the harvesting
      procedure is traumatic.

      Bone substitutes, including allografts, xenografts, and alloplasts have been used
      successfully as alternatives to autogenous bone grafts in ridge augmentation procedures.

      In 2008, autogenous tooth bone graft (ATG) was introduced and used for the first time as a
      bone grafting material for GBR. The tooth contents are extremely similar to that of the
      alveolar bone. The enamel inorganic, organic, and water contents are 95 percent, 0.6 percent,
      and 4 percent, respectively. However, in the dentin, the percentages are 70 to 75 percent, 20
      percent, and 10 percent, respectively. They are 65 percent, 25 percent, and 10 percent,
      respectively, when compared to the alveolar bone content.

      The aim of this study is to compare ridge augmentation using autogenous bone block (ABB) with
      immediate implant placement and filling the generated gap with autogenous bone graft (ABG) or
      ATG, or ridge augmentation using xenograft bone block (XBB) with immediate implant placement
      and filling the generated gap with ATG.
    


Intervention name(s): ABB and ATG with simultaneous implant placement; XBB and ATG with simultaneous implant placement; ABB and ABG with simultaneous implant placement
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement; Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement; Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes
Condition: Aphakia
MeSH terms: Neoplasm Metastasis; Aphakia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the intraocular stability and safety of secondary
      iris-fixated IOLs in aphakic patients.
    

Detailed description: 
      18 eyes of 16 patients received secondary anteriorly iris-fixated intraocular lenses (IOLs)
      to correct for aphakia without capsular support, partly combined with anterior or complete
      pars plana vitrectomy. Primary outcome measurements included visual acuity (6m Snellen
      charts), central endothelium cell count (cECC) and postoperative intraocular position of the
      IOL assessed with anterior segment optical coherence tomography (OCT).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with long standing Aphakia and eligibility for secondary IOL implantantion were
        retrospectively examined
      
Keywords: Aphakia; Secondary IOL-Implantation; Iris-Fixated IOL; Artisan; Anterior Segment OCT; Aphakia - secondary iris-fixated IOL position
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
Condition: Smith-Magenis Syndrome; Circadian
MeSH terms: Dyssomnias; Parasomnias; Smith-Magenis Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of
      individuals with Smith-Magenis Syndrome.
    


Intervention name(s): tasimelteon; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SMS
Carbetocin at Elective Cesarean Delivery Part 4
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the
      most commonly used uterotonic drug to prevent and treat PPH in North America. However
      oxytocin has a very short duration of action, requiring a continuous infusion to achieve
      sustained uterotonic activity. Moreover large doses are associated with adverse effects like
      hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and
      Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at
      elective cesarean delivery to promote uterine contraction. In three studies recently
      performed at Mount Sinai Hospital, the investigators have found no difference in uterine
      contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus
      a larger trial comparing the minimum effective dose determined in the previous three trials
      with the standard 100 mcg dose is necessary to confirm these findings.
    

Detailed description: 
      The current oxytocin regimen requires the administration of a continuous infusion to achieve
      sustained uterotonic activity, which can be associated with a number of side effects and
      unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy,
      with a similar side effect profile to that of oxytocin. In addition, some studies have also
      shown that there is less blood loss and less requirement for additional uterotonic drugs when
      carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have
      shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the
      investigators study, the investigators are going to compare those two doses of carbetocin to
      determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective
      cesarean delivery. This study will be a randomized, double - blind, non inferiority study.
    

Intervention name(s): Carbetocin
Intervention type(s): Drug
Other intervention name(s): Duratocin
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin
Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus; Pregnancy
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems
      for both mothers-to-be and their babies such as causing a large baby and difficult birth.
      Gestational diabetes in the mother may also lead to effects on the long term health of the
      baby.

      Most people today use mobile phones. Our research is looking at using a mobile phone app to
      help with diabetes care in pregnancy. In particular, the investigators are using phones which
      connect to the standard blood glucose monitoring machines given to all women with gestational
      diabetes to see if sending the hospital team blood test results between clinic appointments
      can result in the need for fewer clinic visits. The investigators are also testing to see how
      acceptable using mobile phones in this way, is to our patients and that the control of the
      blood glucose and outcomes for the mother and baby are at least as good as standard care.

      The investigators are planning to recruit 200 women who receive care for their gestational
      diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be
      randomised so that 100 will receive standard care, and 100 will have a mobile phone "app"
      linked to the blood glucose machines to send blood glucose readings directly to the diabetes
      care team to review.

      Both groups will be asked to test their blood glucose levels at home regularly with a
      glucometer. All participants will also be given lifestyle advice to reduce the chance they
      will need medication. Blood glucose control will be measured also by the percentage of
      glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before
      delivery.
    


Intervention name(s): Blue tooth enabled glucose meter with smart phone application; Self home blood glucose monitoring
Intervention type(s): Device; Behavioral
Intervention description(s): Fingerprick testing of blood glucose levels before and 2 hours after meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Gestational diabetes mellitus; m Health; Smartphone; Blood glucose monitoring
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10
      mg Tablets under fasting conditions
    


Intervention name(s): Oxymorphone
Intervention type(s): Drug
Intervention description(s): 10 mg tablet
Other intervention name(s): Opana
Intervention MeSH terms: Oxymorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether bazedoxifene acetate is safe and effective
      in the treatment of osteoporosis in postmenopausal women.
    


Intervention name(s): Bazedoxifene Acetate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): BZA 20mg, daily, oral; Placebo, daily, oral
Intervention MeSH terms: Bazedoxifene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoporosis; Postmenopause