bioihbjkbjnl/mcl2 huggingface dataset:
BRIUS Vs FFA Efficiency
Condition: Dental Malocclusion; Angle Class II; Angle Class I; Crowding, Tooth
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite; Malocclusion, Angle Class I
Study type: Interventional

Summary: 
      The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular
      braces) when to the BRIUS system.
    

Detailed description: 
      This is a randomized controlled trial which aims to identify the effectiveness of alignment
      in the BRIUS group when compared to the full fixed appliance group.

      The secondary aim of the study is to identify any difference in discomfort experienced by the
      patients when undergoing treatment using the two appliances

      The investigators also aim to quantify the extent of tooth movement that is achieved through
      each appliance within a given time frame
    

Intervention name(s): BRIUS
Intervention type(s): Device
Intervention description(s): This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups will receive treatment and be observed over the course of the alignment phase of their orthodontic treatment. Regular photographic records will be taken during appointments and the data will be analysed after the 18 week period is completed for all patients involved in the study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells
Condition: Cancer
Study type: Observational

Summary: 
      Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies.
      Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational
      hormones and pregnancy-related growth factors may induce a more aggressive behavior in
      malignant cells. However, metastasis to the products of conception is rare. In the current
      study investigators wish to analyze the effect of placental explants on cancer cells
      (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death,
      proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.
    

Detailed description: 
      In the Oncogenetic laboratory cancer cells will be exposed to first trimester human placental
      explants or to serum collected from pregnant women. As a control cancer cells will be
      cultured alone or in the presence of sera collected from young (18-45) non pregnant women.

      Placentae, 6-9 weeks gestational age, will be retrieved from terminated normal pregnancies.
      The placenta will be taken after pregnancy termination, thus, no harm will be caused for the
      women.

      The sera will be collected from the women by an authorized physician. It will be taken from:
      1. the vein of the non pregnant women and volunteered pregnant women. 2. from the same
      branula that will be introduced into the pregnant women as a routine during pregnancy
      termination procedure.

      Following culture investigators will analyze the cancer cells phenotype (cell death,
      proliferation, migration, and invasion), signaling pathway, mRNA, miRNA and protein
      expression.

      Sera will be collected from 50 pregnant women and 50 non pregnant women. Placentae will be
      collected from 50 pregnant women.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy women Age 18-45. Pregnant (6-9 weeks) and non pregnant women.
      
Biospecimen description: 
      Placentae will be collected and used in cell culture experiments for a week. Their proteins
      and RNA will be analyzed.
    
Keywords: Pregnancy, Placenta, Cancer
Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents
Condition: Pregnancy in Adolescence; Adolescent Health; Health Services Accessibility
Study type: Interventional

Summary: 
      This protocol describes an evaluation of the CyberRwanda program, a digital health tool
      designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and
      family planning and reproductive health, more specifically. CyberRwanda is a tablet-based
      system that provides information on family planning and reproductive health through a set of
      vignettes. The program also allows users to order and purchase contraceptives, with pick up
      at nearby participating pharmacies. The program will be implemented in schools in eight
      districts in Rwanda. The investigators will conduct a 3-arm, cluster, randomized controlled
      trial to evaluate the impact of CyberRwanda on three primary outcomes: uptake of a
      contraceptive method, initiation of childbearing, and HIV testing. The investigators will
      compare two implementation models (facilitated and self-service) to a control arm at the
      school (cluster) level. The study will enroll 60 schools (20 per arm) and 100 students per
      school, and follow students for 24 months.
    


Intervention name(s): CyberRwanda
Intervention type(s): Behavioral
Intervention description(s): The CyberRwanda intervention consists of three primary components: 1. STORIES: The CyberRwanda curriculum empowers youth to learn about family planning and reproductive health and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. LEARN: Q&As and videos related to family planning and reproductive health. 3. SHOP: Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online. The online health facility finder tool links youth to health facilities for longer-acting methods. All participating pharmacies will be trained to give unbiased, nonjudgmental information and services.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent health; Unintended pregnancy; Global health; Access to contraceptives
To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the single dose pharmacokinetics of avanafil in
      subjects with hepatic impairment and in healthy control subjects.
    


Intervention name(s): avanafil
Intervention type(s): Drug
Intervention description(s): 200 mg avanafil tablets QD
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Avanafil; Hepatic; Erectile Dysfunction; Impairment
IL-17 Neutrophils in CF Lung Inflammation
Condition: Cystic Fibrosis
MeSH terms: Pneumonia; Cystic Fibrosis; Fibrosis; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs)
      are central to the disease pathology in CF. This will be determined by demonstrating that
      IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease
      in patients being treated with IV antibiotics for a pulmonary exacerbation.
    

Detailed description: 
      This study consists of two parts which will be conducted in parallel. In the first part of
      the study, 14 subjects will be recruited for the Clinically Stable Cohort. Subjects will be
      asked to provide 1 gm of expectorated sputum and 40-ml of blood. A cell count and
      differential will be performed on the sputum followed by analysis for IL-17 PMNs by
      fluorescence-activated cell sorter (FACS). IL-17 PMNs also will be isolated by running the
      remainder of the cell pellet through a column of magnetic beads designed for this purpose.
      These neutrophils will be lysed and intracellular cytokines determined. Sputum supernatants
      will be stored frozen until analyzed for the presence of IL-1β, IL-6, IL-8, IL-17A, TGF-β,
      TNF-α, and neutrophil elastase. Clinical data will be captured from the subject's clinical
      outpatient visit including lung function measures and clinical culture results. IL-17 PMNs
      will be correlated with lung function measures and inflammatory mediators at baseline.

      In the second part of this study, 10 subjects will be recruited for the Exacerbation Cohort.
      Subjects will provide at least 1 gram of expectorated sputum and 40-ml of blood within 72
      hours of hospital admission. Sputum and blood will be processed and analyzed as described
      above. Sputum and blood also will be obtained at the end of treatment (within 72 hours of
      completion of IV antibiotics) when the subject is at his or her baseline as determined by the
      managing physician. Clinical data will be captured from the subject's hospitalization records
      including lung function measures and clinical culture results.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen in the cystic fibrosis outpatient clinic (Clinically Stable Cohort) and
        inpatient unit (Exacerbation/IV Antibiotics Cohort) of Cystic Fibrosis Center in Cleveland,
        OH (Rainbow Babies and Children's Hospital/University Hospitals Case Medical Center)
      
Biospecimen description: 
      peripheral white cells, serum, sputum white cells, sputum supernatants
    
Keywords: cystic fibrosis; IL-17 neutrophils
Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy
Condition: Patient Relations, Nurse; Patient Satisfaction; Anxiety State; Breast Cancer
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      A breast biopsy is a cause for anxiety for most women when faced with a diagnosis of breast
      cancer. Physiological and psychological effects of breast biopsy may continue in the
      pre-biopsy and post-biopsy period. The aim of this study is to compare the effectiveness of
      two different aromatherapy methods applied in reducing anxiety before breast biopsy.
    

Detailed description: 
      Anxiety level was evaluated according to objective criteria by pretesting and posttesting
      lavender, lavender-mint and odorless (placebo) aromatherapy tablets applied before the biopsy
      in patients scheduled for breast biopsy.

      The study was conducted with 135 patients, 90 of whom were in the experimental group and 45
      in the control group. Patients were randomly assigned to the experimental and control groups
      according to their sequence numbers.

      Before the biopsy, lavender aromatherapy and lavender-mint aromatherapy tablets were
      administered to the experimental group, and an odorless (placebo) aromatherapy tablet to the
      control group. Aromatherapy tablets 20 minutes after the procedure. First, a small
      (approximately 1x 0.5 inch), rectangular, absorbent, self-adhesive tablet containing 2 ml of
      lavender essential oil (10) was adhered to the patient's shoulder level. Research data were
      collected with the "Spielberger State Anxiety Scale" to determine the level of anxiety before
      and after breast biopsy.
    

Intervention name(s): Lavender Aromatherapy Tablet
Intervention type(s): Other
Intervention description(s): Before the breast biopsy, aromatherapy tablets was adhered to the patient's shoulder in the waiting room and were asked to sniff
Other intervention name(s): Lavender-Mint Aromatherapy Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; aromatherapy; anxiety
Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
Condition: Lateral Canthal Lines; Crow's Feet Lines
Study type: Observational

Summary: 
      This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness
      of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous
      glabellar lines.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Biological
Intervention description(s): Botulinum toxin Type A injected into crow's feet line areas per clinical practice.
Other intervention name(s): BOTOX®; onabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Lateral Canthal Lines (Crow's Feet Lines)
Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea
Condition: Hyperhidrosis; Muscle Spasticity; Glabellar Lines
MeSH terms: Muscle Spasticity; Hyperhidrosis
Study type: Observational

Summary: 
      This post marketing surveillance study in Korea will evaluate the safety and efficacy of
      BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of
      care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar
      lines in clinical practice.
    


Intervention name(s): botulinum toxin Type A
Intervention type(s): Biological
Intervention description(s): Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard
        of care in clinical practice.
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid
      compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM
      inadequately controlled by metformin alone.
    


Intervention name(s): Vildagliptin 50 mg bid; Vildagliptin 50 mg qd; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; HbA1c reduction; vildagliptin; add-on to metformin; Chinese patients
The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics
Condition: Shoulder Arthroscopic Surgery
Study type: Observational

Summary: 
      During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the
      shoulder and trachea, compressing the upper airway. Although the extravasation is generally
      reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or
      life-threatening complications. Furthermore, the soft tissue edema around the shoulder may
      extend to the thoracic cage, compress the chest and induce the respiratory distress
      immediately after surgery. The investigators attempt to determine the effect of shoulder
      arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial
      blood gases were measured and compared before and after the shoulder arthroscopic surgery.
    

Detailed description: 
      Currently, most shoulder surgeries are performed with arthroscopy. The advantages of shoulder
      arthroscopic surgery are decreased blood loss due to minimal incision for scope, a reduced
      operation time, minimization of surgical stress, and rapid recovery time after surgery.
      During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the
      shoulder and trachea, compressing the upper airway. Although the extravasation is generally
      reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or
      life-threatening complications. Furthermore, the soft tissue edema around the shoulder may
      extend to the thoracic cage, compress the chest and induce the respiratory distress
      immediately after surgery. From these facts, the mechanism of respiratory discomfort after
      shoulder arthroscopic surgery may be because the upper airway obstruction or restrictive
      pathology due to direct compression of thoracic cage by the soft tissue edema. There have
      been no studies on the respiratory effect of shoulder arthroscopic surgery. We have observed
      frequent and severe respiratory discomfort after the shoulder arthroscopic surgery.
      Therefore, in this study we attempt to determine the effect of shoulder arthroscopic surgery
      on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were
      measured and compared before and after the shoulder arthroscopic surgery.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing arthroscopic shoulder rotator cuff repair surgery
      
Keywords: shoulder arthroscopic surgery; respiratory discomfort; airway obstruction; restrictive pathology; diaphragm palsy
Mometasone and Markers of Airway Inflammation
Condition: Asthma
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.
    

Detailed description: 
      Patients with asthma and not treated with anti-inflammatory medications were studied. This
      was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on
      markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and
      nitrates/nitrites and pH in exhaled breath condensate.
    

Intervention name(s): Placebo; Mometasone Furoate
Intervention type(s): Drug; Drug
Intervention description(s): 2 puffs, qd; 400 mcg, qd for 8 weeks
Other intervention name(s): asmanex
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Nitric Oxide; Exhaled Breath Condensate; Methacholine Challenge
Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      The objective of this study is to evaluate the electromyographic activity of masseter muscle
      during deglutition in laryngectomized subjects.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        16 subjects underwent total laryngectomy
      
Keywords: electromyography; laryngeal neoplasms; masticatory muscles
Pre Transplant Rapamycin Treatment in Islet Transplantation Alone
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Numerous changes to the original Edmonton protocol have been proposed in the attempt of
      improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early
      inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.

      Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with
      rapamycin in patients with type 1 diabetes receiving islet transplant alone and
      immunosuppression according to the Edmonton protocol.
    

Detailed description: 
      Pre-transplant rapamycin is administered for at least four weeks prior to the first islet
      infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL). During the
      pre-transplant rapamycin treatment rapamycin trough levels, renal and liver function, white
      blood cells count, total lymphocytes and lymphocytes subpopulations, hemoglobin, fibrinogen,
      cross-linked fibrin degradation products, C-reactive protein, exogenous insulin requirement
      every week for the first month, and monthly thereafter are measured. Induction and
      maintenance immunosuppressive regimen after each islet infusion is administered according to
      the Edmonton protocol (daclizumab, rapamycin, target trough levels: 12-15 ng/mL during the
      first 3 months and 10-12 ng/mL thereafter and tacrolimus 2 mg/day,target trough levels: 4-6
      ng/mL). Islets are infused into the liver through the portal vein under local anesthesia
      Portography is performed before and after infusion. The islet function is evaluated measuring
      fasting C-pep, EIR, and HbA1c, immediately before the first islet infusion and subsequently
      every day for the first week, and then weekly for the first month ; every month after the
      last islet infusion for the first year and every 6 month thereafter.
    

Intervention name(s): rapamycin
Intervention type(s): Drug
Intervention description(s): Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL).
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: islet transplantation; insulin independence; C-peptide secretion
Study Investigating Administration of Prevenar for Post-Marketing Surveillance
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Observational

Summary: 
      The purpose of this study is to identify the following problems and questions with respect to
      the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar,
      during the post-marketing period in Korea, as required by Korea Food and Drug Administration
      (KFDA) regulations.

        1. Adverse reactions (especially serious adverse reactions)

        2. Incidences of adverse reactions under routine vaccine use

        3. Factors that may affect the safety of the vaccine
    


Intervention name(s): Prevenar
Intervention type(s): Biological
Intervention description(s): Prevenar 0.5ml/ Vial and PFS
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic, secondary and tertiary medical centers
      
Keywords: Vaccine; heptavalent pneumococcal conjugate vaccine