bioihbjkbjnl/mcl2 huggingface dataset:
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
Condition: Integrase Inhibitors, HIV; HIV PROTEASE INHIB
Study type: Observational

Summary: 
      While 3-drug regimens remain standard of care, concerns exist regarding the safety of
      multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted
      successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and
      efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to
      have potent activity when patients have few active background drugs; it has a superior lipid
      profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with
      few GI side effects and lipid disturbances and with a high genetic barrier. The investigators
      hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients
      who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor
      tolerability or resistance. The investigators also would like to explore the plasma
      pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected
      patients.
    

Detailed description: 
      Hypothesis

        -  NRTI-sparing regimens are attractive options to avoid NRTI-associated toxicity and to
           provide a full active regimen in patients with some extent of NRTI resistance.

        -  Raltegravir (RAL) and Darunavir (DRV) are potent "third drugs" and they provide a
           synergistic inhibition of 2 different steps in HIV replication.

        -  DRV has a high genetic barrier, and could be an excellent accompanying drug for
           Raltegravir, providing a potent, safe and well tolerated dual therapy to patients who
           are failing NNRTI based treatments.

      Objectives:

        -  To describe the safety, tolerability and efficacy of the combination of Raltegravir and
           Darunavir after 24 weeks of follow up in HIV infected patients failing a NRTI based
           regimen.

        -  To describe plasma pharmacokinetics of Raltegravir when combined with Darunavir 800mg QD
           in HIV-infected patients.
    

Intervention name(s): Raltegravir; Darunavir
Intervention type(s): Drug; Drug
Intervention description(s): Raltegravir, 400 mg bid; Darunavir, 800 mg QD + ritonavir 100 mg QD
Other intervention name(s): Isentress; Prezista, Norvir.
Intervention MeSH terms: Raltegravir Potassium; Darunavir
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 20 HIV-infected patients failing NRTI based regimens will be included . At least
        12 of these patients will undergo a complete pharmacokinetic study.
      
Keywords: Pharmacokinetics, raltegravir, darunavir, NRTI sparing regimen
Topical Vitamin D in Acute Graft Versus Host Disease of the Skin
Condition: Graft Vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a
      synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin
      graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients.
      Calcipotriene will be used as the exclusive topical therapy in addition to standard of care
      GVHD treatment prescribed for the study subject by the primary physician.
    

Detailed description: 
      Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic
      GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a
      major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line
      treatment for cGVHD; however, about one-half of all patients do not respond to this initial
      therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for
      treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.

      Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and
      endothelial cell function, and the investigators hypothesize that topical vitamin D
      application will have a positive effect on acute and chronic skin GVHD. The investigators
      hypothesize that topical vitamin D cream may restore normal cell function and decrease the
      use of steroid creams in acute GVHD of the skin.
    

Intervention name(s): Calcipotriene
Intervention type(s): Dietary Supplement
Intervention description(s): Topical vitamin D cream will be applied to affected areas of the skin.
Other intervention name(s): Dovonex
Intervention MeSH terms: Calcipotriene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cell Transplant; Graft Versus Host Disease
Study to Identify if Chemist Confessions Retinol Cream Works to Improve the Appearance of Early Signs of Aging.
Condition: Wrinkle; Aging
Study type: Interventional

Summary: 
      Chemist Confessions has developed a retinol cream with the aim to improve the appearance of
      early signs of aging, such as fine lines, dark spots, hyperpigmentation, and crow's feet. In
      this phase, Chemist Confessions plans to collect self-reported outcomes and photographic
      images to understand the assessment of the efficacy of treatment from the participant's
      perspective, and if participants see an improvement in their fine lines, wrinkles, dark
      spots, hyperpigmentation, and crow's feet.
    

Detailed description: 
      Based on a review of existing literature and previous studies, retinol has been found to have
      positive effects, however, due to study limitations, there are also conflicting results.
      Therefore, in this study, participants will receive Chemist Confessions retinol cream to
      understand if the Chemist Confessions cream has an impact on the participant's skin, and even
      potentially reduces fine lines, wrinkles, dark spots, hyperpigmentation, and crow's feet of
      the skin, and also to understand concepts considered essential by individuals taking retinol
      products.
    

Intervention name(s): Retinol face cream; Placebo face cream
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Retinol face cream; Placebo face cream
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Split face intervention
Masking: Single (Participant)
Primary purpose: Other
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the
      administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the
      treatment of acute submassive pulmonary embolism.
    

Detailed description: 
      The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the
      peripheral vasculature. Because of the unique design of the catheter, with its six expandable
      infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger
      central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic
      agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a
      catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple
      arms of the basket in the infusion catheter causes fissuring of the clot. The net result is
      that a greater surface area of clot is exposed to both endogenous and exogenously
      administered lytic agents, thereby promoting clot dissolution.

      This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular
      Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter
      directed thrombolysis in patients with submassive PE who have consented and meet all
      eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new
      methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be
      used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).

      The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a
      basket-like formation when expanded, provides an immediate channel for blood flow through the
      thrombus and a greater surface area in the thrombus for the endogenous and exogenous
      thrombolytics to take effect, as described above.
    

Intervention name(s): The Bashir™ Endovascular Catheter; r-tPA
Intervention type(s): Device; Drug
Intervention description(s): The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.; Pulse spray and infusion
Intervention model: Single Group Assignment
Intervention model description: Pulse Spray and Infusion of r-tPA
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Embolism; Catheter Directed Therapy
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate
      responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in
      correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion
      of leukotrienes, response to RABA and laboratory parameters in patients with pre-school
      asthma i.e. asthma phenotypes.
    


Intervention name(s): Montelukast; Fluticasone
Intervention type(s): Drug; Drug
Intervention description(s): Intake of Montelukast; Intake of Fluticasone
Intervention MeSH terms: Fluticasone; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pre-School Asthma; Responder Profiles; Fluticasone; Montelukast; Leukotriene; Children with Pre-School Asthma
Chronic Pain After Scoliosis and Thoracic Surgery in Children
Condition: Thoracic Surgery; Scoliosis; Adolescence; Pediatric ALL; Chronic Pain
MeSH terms: Scoliosis; Chronic Pain
Study type: Observational

Summary: 
      The aim of this epidemiologic prospective study is to determine the prevalence of CPSP
      defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10
      point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant
      thoracic surgery in children aged 6 to 18 years.

      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of
      neuropathic syndrome and the predictive risk factors.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric
        Bordeaux hospital
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate that SLIT administered pre-and
      co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short
      ragweed pollen season.
    


Intervention name(s): Short Ragweed Pollen Allergenic Extract; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.; Placebo: Glycero-COCAs sublingual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203
      in healthy volunteers conducted at one study center in the United States
    

Detailed description: 
      Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each
      cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a
      standard meal. Subjects will participate in only one cohort.

      Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and
      adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples
      will be collected for these assessments. Blood samples will also be collected for the PK
      assessment of Q203.

      Escalation to the next dose level (i.e., initiation of the next cohort) will not take place
      until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor
      have reviewed all available safety and tolerability from the previous cohorts and agree to
      the initiation of the next cohort.
    

Intervention name(s): Q203; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the safety,
      tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following
      administration of single subcutaneous doses in healthy subjects.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic
      profile of single-ascending doses of CC-90006 in healthy subjects.

      This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40
      subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8
      subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2
      subjects).

      Eligible subjects will check into the clinic site on the day before dosing (Day -1) and
      receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will
      be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2),
      22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects
      will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be
      performed and blood samples will be collected for determination of levels of CC-90006 in the
      blood.
    

Intervention name(s): Placebo; CC-90006
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy subjects; Safety; CC-90006; Phase 1; Tolerability
A Clinical Study to Evaluate the Safety of Ospemifene
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and long-term safety of 60mg
      ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
    


Intervention name(s): Ospemifene 60 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.; Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
Other intervention name(s): Osphena®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urogenital atrophy; Menopausal symptoms; Vulvar and vaginal atrophy in postmenopausal women; Vaginal atrophy
Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:
Condition: Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery
Study type: Interventional

Summary: 
      The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and
      surgeon to maintain control of the airway at all times. In the postoperative period the
      patient should maintain a flexed neck position to avoid any traction on the tracheal
      anastomosis. Thus, pain control is essential postoperatively so that patients will be awake
      and cooperative to maintain this position. [1].

      Superficial cervical plexus block can be used in a variety of surgical procedures , including
      superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia
      of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as
      well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures
      1 and 6)[2].

      Thus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients
      undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at
      the conclusion of the procedure.

      The goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within
      the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form
      the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and
      supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages
      over the landmark-based technique include the ability to visualize the spread of local
      anesthetic in the correct plane, which therefore increases the success rate, and to avoid a
      needle insertion that is too deep and the inadvertent puncture of neighboring structures[3].

      Aim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra
      and postoperative analgesia for patients undergoing tracheal resection and anastomosis under
      general anaesthesia.
    


Intervention name(s): superficial cervical plexus block
Intervention type(s): Procedure
Intervention description(s): ultrasound guided injection of local anaesthesia in the superficial cervical plexus
Other intervention name(s): Drug:; Bupivicaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction
Condition: Class II Division 1 Malocclusion; Maxillary Prognathism; Protrusion, Incisor
MeSH terms: Prognathism; Malocclusion; Overbite
Study type: Interventional

Summary: 
      Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to
      their attractive advantages. The current trial aimed to evaluate the efficacy of
      laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary
      aim was to evaluate the patients' responses to laser application. It was postulated that
      canine retraction after laser-assisted flapless corticotomy would be accomplished within a
      shorter period compared with the conventional canine retraction method, with no significant
      degree of pain and discomfort.
    

Detailed description: 
      Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months
      in mild and severe cases. Prolonged treatment time can cause many adverse effects such as
      pain, discomfort, external root resorption, white spots and dental caries. Decreasing the
      treatment time for tooth movement has been the focus of both the clinicians and the patients.
      For the last few decades, investigators have recommended many treatment approaches intending
      to reduce overall treatment time such as low friction and self-ligating bracket systems,
      low-level laser irradiation, electrical currents, pharmacological approaches, local
      platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction
      and selective alveolar decortication or corticotomy
    

Intervention name(s): Er:YAG laser
Intervention type(s): Procedure
Intervention description(s): This application was made before the onset of canine retraction in one side of the mouth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tooth movement; Acceleration of tooth movement; Er:YAG laser-assisted corticotomy
Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Interventional

Summary: 
      This clinical trial will compare how the individualized and fortified human milk feeding will
      help a premature infant grow.
    

Detailed description: 
      A total of 60 premature infants who will be randomized to receive either a standard
      fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable
      fortification regimen encompasses increasing / decreasing the amount of fortifier and adding
      supplemental protein guided by periodic determinations of the protein concentration in human
      milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral
      feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition
      and NICU stays will be measured and compared between groups.
    

Intervention name(s): human milk fortifier
Intervention type(s): Dietary Supplement
Intervention description(s): Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
Other intervention name(s): HMF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment