bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Microgravity on Human Sperm
Condition: Semen Quality
Study type: Interventional

Summary: 
      It has been described that microgravity affects cellular and molecular structures. Cell
      membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational
      changes. Alterations in the male and female reproductive systems have also been reported in
      mouse and other animals. The effects of microgravity on human reproductive cells remain
      unknown.

      The main objective of this experimental study is to investigate the effect of simulated
      microgravity in human male reproductive cells under in vitro conditions. Induced microgravity
      conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide
      parabolic flights.

      The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and
      apoptosis.
    


Intervention name(s): Parabolic flight
Intervention type(s): Other
Intervention description(s): Sperm analysis (total motility M/ml; grade a+b sperm M/ml, vitality, DNA Frag and apoptosis) will be measured on ground at 1g before the flight and after flight were sperm samples have been exposed to simulated microgravity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Oral Health Training Program for Pediatric Residents
Condition: Preventive Oral Health
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effect of the addition of hands on training by a
      pediatric dentist on the pediatric residents skills, confidence, opinions and practice
      related to preventive oral health.
    

Detailed description: 
      Objectives:

      To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents'
      skills, confidence, opinions and practice .

      Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT
      subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were
      assessed on skills in the performance of an oral exam, by direct observation. Residents'
      confidence regarding oral health counseling, and their opinions about the importance of the
      incorporation of oral health into the well child visit, was measured by surveys utilizing a
      Likert scale. Residents' change in practice was assessed by a retrospective chart audit.
    

Intervention name(s): Hands on training; Web based training
Intervention type(s): Other; Other
Intervention description(s): Hands on training by a pediatric dentist on preventive oral health; Web based training alone
Other intervention name(s): Active educational training with a pediatric dentist; Educational Web Based Training for all residents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: educational research,; instructional methods,; Hands on training,; Web based training,; pediatric residents; preventive oral health,; dental caries,; Instructional strategies in Preventive Oral health; Web-based training on Preventive Oral Health; Hands on Training on Preventive Oral Health
PK and PD Study of Oral F/TAF for HIV Prevention
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral
      tablets to assess systemic and genital tract bioavailability in healthy women. The oral
      tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300
      mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.
    

Detailed description: 
      The purpose of this multi-center Phase I protocol, titled Exploratory Pharmacokinetic and
      Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition is to assess local
      and systemic pharmacokinetics (PK), pharmacodynamics (PD), and safety characteristics of
      three oral tablets: F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg).

      The study will enroll healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50)
      who are not at risk of pregnancy and will have two phases: a Single Dose phase (one site
      only) and a Multiple Dose phase (all three sites).

      The enrollment goal is for approximately 72 participants to complete the study. All 72 women
      are expected to undergo the Multiple Dose phase and the 24 women expected to complete the
      study at the EVMS site are also expected to undergo the Single Dose phase.

      In the Single Dose phase, approximately 24 women will be randomized to one of two products:
      F/TAF (200/25 mg) or F/TDF (200/300 mg), and will undergo blood, cervicovaginal (CV), and
      rectal sample collections before and after a single dose for PK and PD assessments. In the
      Multiple Dose phase, approximately 72 women will be randomized to one of three products:
      F/TAF (200/10 mg), F/TAF (200/25 mg) or F/TDF (200/300 mg), and will undergo blood, CV, and
      rectal sample collections for PK and PD assessments before, during and after two weeks of
      daily dosing.
    

Intervention name(s): Emtricitabine; Tenofovir alafenamide; Tenofovir disoproxil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
Condition: Advanced and Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This dose finding/extension study was designed originally to consist of three parts: Part A
      was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of
      fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/
      metastatic estrogen receptor positive (ER+) breast cancer. Part B was to further characterize
      safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part
      C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet
      combinations. Part C was deleted from the protocol and was not performed.
    

Detailed description: 
      This dose finding/extension study was designed originally to consist of three parts:

      Part A is a Phase 1 triplet-dose finding investigation in 3-6 patients per cohort to
      determine the maximum tolerated dose (MTD) of the triplet.

      Part B is a single arm expansion in approximately 27 patients evaluable for response to
      define the recommended Phase 2 dose (RP2D).

      Part C was intended to investigate the efficacy of the triplet combination at the RP2D in a
      randomized, double-blind, placebo-controlled, stratified, parallel group extension. Part C
      was intended to include ER+, locally advanced and/or metastatic breast cancer patients who
      have progressed following prior non-steroidal aromatase inhibitor (NSAI) endocrine therapy.
      Patients in Part C were to be randomized to receive either the triplet combination (AZD2014 +
      palbociclib + fulvestrant) or the doublet (matching AZD2014 placebo + palbociclib +
      fulvestrant). Patients were to be stratified according to hormone sensitivity, presence of
      visceral metastases, and prior CDK inhibitor treatment. Part C would have been conducted if
      indicated by the emerging data.
    

Intervention name(s): AZD2014; Palbociclib; Fulvestrant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The triplet combination will be comprised of AZD2014 + palbociclib + fulvestrant.; cyclin dependent kinase inhibitor; Fulvestrant hormonal therapy as background
Other intervention name(s): vistusertib; Ibrance; PD-0332991; Faslodex
Intervention MeSH terms: Fulvestrant; Palbociclib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD2014; Palbociclib; Fulvestrant; Hormonal Therapy; Estrogen Receptor Positive; Breast Cancer
The Effects of Inhaled Nitric Oxide After Fontan Operation
Condition: Congenital Heart Defect
MeSH terms: Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pleural effusions continue to be a post-operative complication seen after Fontan operation.
      This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan
      operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after
      Fontan operation will improve fluid balance, thus decreasing the incidence of pleural
      effusions and shortening hospital stay.
    


Intervention name(s): inhaled nitric oxide (iNO)
Intervention type(s): Drug
Intervention description(s): Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Other intervention name(s): Inomax
Intervention MeSH terms: Nitric Oxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fontan
Fibrinogen and Bleeding After Cardiac Surgery
Condition: Complications; Bleeding; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding
      and transfusion requirements after coronary artery bypass surgery (CABG) in patients with
      endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a
      prospective, randomized double-blind placebo-controlled single center study.
    


Intervention name(s): Fibrinogen
Intervention type(s): Drug
Intervention description(s): Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
Other intervention name(s): Riastap; Haemocomplettan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fibrinogen; Postoperative bleeding; Transfusions; CABG
The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
Condition: Tobacco Use; Cigar Smoking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This within-subjects study aims to evaluate the subjective rewarding value, the relative
      reinforcing value, and the absolute reinforcing value of sweet flavored cigarillos across
      three separate laboratory visits among 86 young adults (ages 18-24 years old) who have
      previously smoked > 10 or more cigarillos in their lifetime.
    


Intervention name(s): Flavor
Intervention type(s): Other
Intervention description(s): Sweet flavored vs. non-flavored cigarillos.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
Condition: Glabellar Frown Lines (GL)
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar
      frown lines (GL).
    

Detailed description: 
      This study of EB-001 to measure safety and efficacy in GL. Single doses of EB- 001
      administered through IM injection into procerus at midline and the medial and lateral
      corrugators will be assessed in healthy subjects with glabellar frown lines.
    

Intervention name(s): EB-001 injection; Placebo injection
Intervention type(s): Drug; Drug
Other intervention name(s): Botulinun Toxin Type E; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep & Pain in Juvenile Arthritis
Condition: Arthritis, Juvenile
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Childhood arthritis is an important cause of pain for affected children and youth
      (adolescents). Many youth with arthritis also have trouble sleeping. They often struggle to
      sleep through the night, wake up earlier, and are sleepier during the day compared to healthy
      children. Our research group, among others, has shown a strong link between sleep and pain.
      The main purpose of this study is to assess the impact of changing sleeping patterns on pain,
      and disease activity, in teenagers with arthritis. We think that better sleep will directly
      lead to better health.
    


Intervention name(s): Sleep Manipulation Protocol
Intervention type(s): Behavioral
Intervention description(s): A structured sleep duration intervention will be taught to patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
Condition: Localized Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of
      localized gingival recession (Class I & II) in comparison with the use of connective tissue
      graft
    

Detailed description: 
      Twenty patients, who are candidates for gingival recession coverage, will participate in this
      prospective clinical trial.

      Group 1(10 patients) :

      Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues

      Group 2 (Control group)(10 patients) :

      Coronally repositioned flap will be done with sub epithelial connective tissue Parameters

        -  Clinical evaluation of percentage of root coverage and keratinized tissue width

        -  Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo
           et al. 2009) that include

      Both evaluations will be done at 3, 6 and 9 months
    

Intervention name(s): Leukocyte Platelet rich fibrin membrane
Intervention type(s): Procedure
Intervention description(s): the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Other intervention name(s): sub epithelial connective tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
Condition: Lymphedema Arm; Lymphedema; Surgical
MeSH terms: Lymphedema; Breast Cancer Lymphedema
Study type: Observational

Summary: 
      This study aims to find whether complete decongestive therapy used in breast cancer-related
      lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy
      of the therapy itself. 74 patients with breast cancer related lymphedema were included in
      this study. Patients were taken their demographic and clinical history and were evaluated
      with measurements of extremity volumes and hand grip strengths using a hand dynamometer
      before and after the complete decongestive therapy. Data were then assessed using relevant
      statistical methods.
    


Intervention name(s): Complete Decongestion Therapy
Intervention type(s): Other
Intervention description(s): It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume.
All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema.
Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 18-70 years old with a history of mastectomy or breast conserving surgery
        and lymphedema

          -  Having a certain diagnosis of lymphedema
      
Keywords: Lymphedema; Hand grip strength; Breast cancer related lymphedema; Complete decongestion therapy
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week
      wash-out period and 8-week comparator drug or the drug administration period (with cross-over
      design) for assessment of the drug efficacy, safety and tolerability.
    


Intervention name(s): MK0476; montelukast sodium/Duration of Treatment: 16 weeks; Comparator: theophylline ER/Duration of Treatment: 16 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Theophylline; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Africa. The aim of this trial is to determine if a new formulation
      (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin
      aspart formulation (U100).
    


Intervention name(s): insulin aspart
Intervention type(s): Drug
Intervention description(s): Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations
Condition: Dental Restoration Failure of Marginal Integrity
Study type: Interventional

Summary: 
      Clinical performance of direct fiber reinforced resin composite restorations versus direct
      microhybrid resin composite restorations in endodontically treated molars will be evaluated
      over 12 months using modified USPHS criteria.
    

Detailed description: 
      Restoration of endodontically treated teeth is one of the main challenges in restorative
      dentistry. There are structural changes in endodontically treated tooth: dehydration of
      dentin, mutation of collagen due to the effect of irrigation and reduction of hardness. This
      alteration together with loss of tooth structure inflicts a negative impact on long term
      prognosis of the endodontically treated tooth increases incidence of dental fracture.

      Endodontically treated teeth were restored traditionally by crown but this approach is
      invasive with many technical and clinical steps that prolong the time of treatment. Adhesive
      philosophy and resin composite were developed and enhanced within the last thirty years that
      give clinician conservative option also strengthen, protect the tooth against fracture and
      changed the doctrine of devitalized tooth must be restored by crown. Current studies
      encourage applying conservative approach and restoring endodontically treated teeth with
      bonded restorations, so a lot of classic indications of crown in restoring endodontically
      treated teeth are questioned now.

      Microhybrid resin composite restorations permit application of conservative approach that
      preserves remaining sound tooth structure. Fiber reinforced resin composite improved
      strength, toughness and fracture resistance of conventional resin composite and restored
      teeth.

      Fiber reinforcement of conventional resin composite is introduced aiming to improve their
      physical, mechanical properties and tooth fracture resistance. The improvement of the
      properties was interpreted due to the rule of fibers in stopping crack propagation and
      transferring stress from matrix to fibers, also it was suggested that fiber Reinforced Resin
      Composites decrease polymerization shrinkage and shrinkage stress. fiber-reinforced resin
      composites are used as a dentine substitute combined with conventional resin composites as an
      enamel replacement.
    

Intervention name(s): Fiber reinforced resin composite restoration; Microhybrid resin composite restoration
Intervention type(s): Other; Other
Intervention description(s): a type of resin composite with improved strength due to the fiber's action; a type of conventional resin composite
Other intervention name(s): Ever X posterior
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fiber reinforced composite; Microhybrid composite