bioihbjkbjnl/mcl2 huggingface dataset:
Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis
Condition: Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Observational

Summary: 
      Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days
      of treatment.
    

Detailed description: 
      The purpose of this study is to further describe the safety and tolerability of ORALAIR
      tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or
      without conjunctivitis.

      Patients are followed for safety and tolerability during the first 30 treatment days.
    

Intervention name(s): Oralair
Intervention type(s): Drug
Intervention description(s): Observational study, Oralair is used as prescribed by the prescriber phycisian.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of
        grass-pollen-induced allergic rhinitis with or without conjunctivitis.
      
Keywords: Rhinitis; Conjunctivitis; Grass pollen; Sublingual tablet; Allergen immunotherapy; Safety
A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge
Condition: Haemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The
      study aims to show similar levels of Mim8 in blood when using a new pen injector, called
      DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is
      intended to facilitate the administration of Mim8 for patients with haemophilia A. The
      participants will get Mim8 as injection under the skin (subcutaneously) of the belly using
      the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a
      needle and syringe from a cartridge (hereafter called syringe and cartridge). The
      participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or
      with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy
      men can take part in the study.
    


Intervention name(s): NNC0365-3769 (Mim8)
Intervention type(s): Drug
Intervention description(s): Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Modified Cervical Inversion During CS in Placenta Previa
Condition: Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional

Summary: 
      There is an increasing rates of placenta previa nowadays
    

Detailed description: 
      several techniques were described to control bleeding .
    

Intervention name(s): Cervical inversion
Intervention type(s): Procedure
Intervention description(s): inverting the cervical lip after delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using cervical inversion during cesarean section
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy
Condition: Obesity; Analgesia; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall
      analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the
      anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia
      in obese patients because it is superficial and rapidly identifiable and performed in the
      supine position. the aim of this study is to investigate the postoperative analgesic efficacy
      of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve
      gastrectomy.

      Researchers will compare the external oblique intercostal plane block group with control
      group to see if the EOI plane block is effective for postoperative analgesia in patients
      undergoing sleeve gastrectomy.
    

Detailed description: 
      Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2
      groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control
      Group will be received patient controlled analgesia with morphine for postoperative
      analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed
      bilateral External Oblique Intercostal Plane Block before the surgery and received patient
      controlled analgesia with morphine for postoperative analgesia. Morphine consumption for
      first postoperative 24 hours, visual analog scale scores, time to need for first rescue
      analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting
      will be recorded.
    

Intervention name(s): Intravenous morphine patient control device; External oblique intercostal plane block
Intervention type(s): Other; Other
Intervention description(s): 24-hour morphine consumption will be recorded; External oblique intercostal plane block will be administered before the surgery.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
DENTAL GUM TISSUE AGING
Condition: Aging
Study type: Observational

Summary: 
      This is an epidemiological, cross-sectional two-visit study involving 100 Caucasian subjects
      representing 6 different age groups [20 to 24 (20s), 30 to 34 (30s), 40 to 44 (40s), 50 to 54
      (50s), 60 to 64 (60s), and 70 to 74 (70s)]. Medically healthy subjects will receive a
      screening exam to determine their oral status. Subjects without periodontal disease will be
      enrolled in the study where two 2 mm gingival biopsy will be obtained using punch biopsy from
      the healthy attached gingiva around upper premolar teeth. Tissues will be processed and
      analyzed for histological and transcriptomics analyses targeting morphological changes and
      gene expression in gingival tissues with aging.
    

Detailed description: 
      This is an epidemiological, cross-sectional two-visit study involving 100 Caucasian subjects
      representing 6 different age groups [20 to 24 (20s), 30 to 34 (30s), 40 to 44 (40s), 50 to 54
      (50s), 60 to 64 (60s), and 70 to 74 (70s)]. From each group, eighteen subjects (9 females and
      9 males) will be recruited (except for the 60's and 70's groups where 14 subjects/group - 7
      females and 7 males, will be recruited). At the screening visit, subjects will receive an
      oral soft tissue (OST) exam followed by a full periodontal exam including probing pocket
      depth (PPD), the difference between gingival margin and cementoenamel junction, clinical
      attachment level (CAL), and bleeding on probing (BOP). Subjects who meet all
      inclusion/exclusion criteria will receive a professional dental exam to assess the clinical
      status of their mouth; additionally, they will have an image of the anterior teeth taken and
      will fill out a questionnaire on their oral hygiene habits. At the second study visit, a 3 ml
      saliva sample will be collected for a saliva flow rate assessment and biomarkers analysis.
      Subgingival plaque samples will be taken with paper points from the tooth adjacent to the
      selected biopsy area, i.e. the upper second premolar. Additionally, blood (10 ml) samples for
      biomarker analysis and two- 2 mm-punch gingival biopsies for gene expression and
      histomorphology evaluations will be taken from each subject.
    

Intervention name(s): biopsy
Intervention type(s): Other
Intervention description(s): two 2 mm gingival biopsies were obtained.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals between the ages of 20-74 with healthy oral tissues will be included.
Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so
      that it can be removed during surgery.

      PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given
      before surgery in treating children who have localized neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the outcome, in terms of local control, event-free survival, and overall
           survival, of children with localized unresectable neuroblastoma without MYCN
           amplification treated with carboplatin, etoposide, cyclophosphamide, doxorubicin, and
           vincristine followed by surgery.

      OUTLINE: This is a multicenter study.

      Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3
      (courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally on
      days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and 5
      (courses 2 and 4). Treatment repeats every 21 days for 4 courses. Patients then undergo
      surgical resection followed by 2 additional courses of chemotherapy.

      Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.
    

Intervention name(s): carboplatin; cyclophosphamide; doxorubicin hydrochloride; etoposide; vincristine sulfate; adjuvant therapy; conventional surgery; neoadjuvant therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine
Primary purpose: Treatment
Keywords: localized unresectable neuroblastoma
VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults
Condition: Low Caries Experience; High Caries Experience
Study type: Observational [Patient Registry]

Summary: 
      VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and
      susceptibility in adults.
    

Detailed description: 
      To date, genes can be grouped into categories based on the factor influencing dental caries.
      The major candidate gene categories to date include enamel formation genes, immune response
      genes, genes related to saliva, and genes related to taste and dietary habits.

      TFIP11 and VDR genes are related to enamel formation genes
    

Intervention name(s): high caries experience
Intervention type(s): Genetic
Intervention description(s): DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
Other intervention name(s): DNA isolation, genotyping
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study
      
Biospecimen description: 
      DNA for genetic analysis was isolated from buccal epithelial cells
    
Keywords: caries experience, VDR, TFIP11, enviromental risk factor
Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of efficacy of MTS compared to placebo
    

Detailed description: 
      To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by
      the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV),
      in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
    

Intervention name(s): methylphenidate transdermal system; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear; Placebo patch
Other intervention name(s): DAYTRANA; Sham treatment
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Performance-Perceptual Test as a Counseling Tool
Condition: Hearing Impairment
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether a new test of ability to understand speech
      in noise and an associated counseling program can improve hearing aid satisfaction.
      Participants complete routine hearing tests, some hearing-related questionnaires and the new
      speech test. One group of participants receives the new form of counseling, the second group
      does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the
      groups.
    

Detailed description: 
      Hearing aid dissatisfaction continues to be disappointingly high, even though hearing aid
      technology has improved dramatically over the last 10 years or so. Unfortunately, the results
      of most commonly used self-report measures cannot be directly compared with the results from
      performance measures since the modes of testing are very different. Thus, it is hard for
      clinicians to reconcile data from individuals reporting more handicap or less hearing aid
      satisfaction than would be expected from their performance.

      In this study, the investigators use a test known as the Performance-Perceptual Test (PPT) to
      determine whether simple counseling based upon discussion of PPT results can be used to
      better align perceived and measured ability to understand speech-in-noise; and, more
      importantly, whether such counseling can decrease reported handicap and improve hearing aid
      satisfaction.

      Hearing aid users complete the PPT for aided and unaided listening, along with standardized
      questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction.
      Following this, subjects are randomly assigned to one of two groups. Subjects in Group 1
      receive counseling from the experimenter in the form of an explanation and discussion of
      their PPT results. Subjects in Group 2 also participate in a discussion with the
      experimenter, but it does not include an explanation of the PPT. Two weeks after enrollment
      in the study subjects complete a second set of questionnaires. Ten weeks after study
      enrollment subjects return to the laboratory to rerun the test battery. The impact of the
      counseling upon PPT values, reported handicap and hearing aid satisfaction and benefit will
      be compared across the two groups.
    

Intervention name(s): PPT-based Counseling; Standard Educational Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS; Standard educational counseling consisting of explanation of hearing tests
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Audiologic rehabilitation; Counseling
A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)
Condition: HIV-1; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine.
      In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose
      (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10
      vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9
      vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1
      Gag Vaccine will also be measured.
    


Intervention name(s): V520; Comparator: V520 (1x10^9 vp/d); Comparator: V520 (1x10^10 vp/d); Comparator: Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intentionally Blank; 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26; 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26; Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; Preventive Vaccine
Repeat Dosing of Psilocybin in Migraine Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this
      study will investigate single and repeated dosing of psilocybin up to two doses. In seeking
      to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for
      migraine headache will be measured.
    

Detailed description: 
      Migraine headache is a common medical condition and a top cause of disability worldwide.
      Treatment options for migraine headache are many and varied, though an approximated 10% of
      migraineurs is refractory to medication and thus, there is a need to develop alternative
      treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited
      dosing of psilocybin and related compounds in headache disorders. The cause of this unique
      effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a
      biological process relevant to migraine and other headache disorders. In seeking to
      understand the capacity for psilocybin to reduce migraine headache burden, this study will
      investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify
      an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine
      headache will be measured. The results from this study will serve in the development of
      larger investigations seeking to understand the effects of psilocybin and related compounds
      in headache disorders.
    

Intervention name(s): Psilocybin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg Psilocybin; 25mg Diphenhydramine
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psilocybin; inflammation; calcitonin gene-related peptide (CGRP); pituitary adenylate cyclase-activating peptide (PACAP)
Ayurvedic Management of Chronic Kidney Disease
Condition: Diabetic Nephropathy; Hypertensive Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment
      in the patients of various types of chronic kidney disease.
    

Detailed description: 
      Ayurvedic treatment includes some complex classical herbal formulations and Niruha basti
      (procto-colonic administration of ayurvedic medicines mainly contained decoction of
      punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given
      to the patients of chronic kedney disease who are not on dialysis. Patients of CKD of various
      etiology will be grouped accordingly and will get the same treatment.
    

Intervention name(s): Ayurveda treatment
Intervention type(s): Other
Intervention description(s): Gokshuradi Guggulu (compound Ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikatu + Musta) - 1 g, 3 times in a day after food with warm water.
Varunadi kvath (ingredients: Varuna tvak + Bilva moola + Apamarga + Chitrak moola + Arani + Shigru + Bruhati + Kirattikta + Karanja + Shatavari) - 40 ml 2 times in a day after food.
Rasayan Churna (powder of Gokshura + Amalaki + Guduchi in equal quantities ) - 3 g, 3 times a day with water.
Bhumyamalaki (Tamalaki Rasayan) tablet - 1 g, 2 times in a day after food with water.
Uricare (of Punarvasu Pharmacy, Petlad road, Nadiad) tablet - 1 g, 3 times in a day after food with warm water.
Niruha Basti (procto-colonic administration of ayurvedic medicine) with Punarnavadi kvath (decoction) - in the morning, before one hour of the lunch.
Intervention model: Single Group Assignment
Intervention model description: Pre-post design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephropathy; Chronic Renal Failure; Chronic Kidney Disease; Chronic Renal Disease; Ayurveda; Herbal treatment