bioihbjkbjnl/mcl2 huggingface dataset:
Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast
      cancer. The combination, of these three drugs, has been used for approximately 30 years in
      the treatment of breast cancer, and has been shown to be safe and effective. It is usually
      given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this
      type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3
      weeks, may be better. The purpose of this study is to test the safety of these drugs, given
      every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens
      have shown to be more beneficial when the drugs are given more frequently.
    


Intervention name(s): cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim
Intervention type(s): Drug
Intervention description(s): C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cyclophosphamide; methotrexate; fluorouracil; PEG-filgrastim
Evaluation of Efficacy of Sodium Monofluorophosphate (SMPF) Toothpastes on Enamel Lesion Remineralisation
Condition: Enamel Caries
Study type: Interventional

Summary: 
      Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on
      enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study
      will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a
      standard SMFP toothpaste and a negative control toothpaste with no fluoride.
    

Detailed description: 
      Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will
      accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that
      at least 50 subjects will complete the study. All 60 subjects will have two human enamel
      specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial
      denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a
      subset will have an additional two enamel specimens (type N) placed in their partial denture
      for TMR measurement. All enamel specimens will have been partially demineralized using lactic
      acid in the laboratory prior to placement in subjects' dentures.

      Subjects will receive a dental prophylaxis at the start of the trial and then brush their
      teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase
      between each crossover period, subjects will return to brushing with their regular toothpaste
      for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a
      fluoride-free toothpaste for the 2 to 3 days before the next test period.

      During each test period, subjects will be asked to brush with their allocated toothpaste at
      home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing
      procedure will be performed at home each morning following breakfast and right before going
      to bed on each evening. Subjects must wear their partial denture for 24 hours a day during
      the test phase.

      At final visit of each test period, subjects will be instructed to brush their teeth with the
      randomly assigned trial toothpaste. Enamel specimens will be removed from denture and
      transferred to analyst for laboratory analyses.
    

Intervention name(s): Experimental Toothpaste containing 1450ppm SMFP; Toothpaste containing 1450ppm SMFP; Toothpaste with no fluoride
Intervention type(s): Other; Other; Other
Intervention description(s): Experimental Toothpaste containing 1450ppm SMFP; Toothpaste containing 1450ppm SMFP; Toothpaste with no fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Interactive Web-Based Program to Improve Food and Activity Choices of Teens
Condition: Diet; Physical Activity
Study type: Interventional

Summary: 
      This study will test a website for teens designed to help them improve both diet and physical
      activity. The website will have several components: educational messages, role model stories,
      goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet
      and physical activity (PA) assessment questionnaires.
    

Detailed description: 
      Increasing numbers of youth are at risk for becoming overweight because of poor diets and low
      physical activity levels. Prevention is key to reducing the obesity problem. Intervention
      programs must be easily accessible, and include intervention materials in a format that draws
      attention and interest. This study evaluates an 8-week web-based intervention for teens to
      promote healthy food and physical activity choices. The web program includes role model
      stories, nutrition and activity information pieces, goal setting and problem solving, and
      self-monitoring. Students will complete assessments at baseline, 8-weeks post, and then 6 and
      12-months post intervention.
    

Intervention name(s): teen web
Intervention type(s): Other
Intervention description(s): Min web
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
Condition: Anesthesia, General; Neuromuscular Blockade
Study type: Interventional
Phase: Phase 2

Summary: 
      This study administers sugammadex sodium to pediatric patients under general anesthesia with
      rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma
      concentration of sugammadex sodium and monitoring of neuromuscular blockade.
    

Detailed description: 
      This study enrolls pediatric patients undergoing surgery under general anesthesia with need
      for early reversal of neuromuscular blockade, aged between 2 and 18 years old.

      After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance
      of anesthesia with total intravenous anesthesia is commenced. 15 minutes after rocuronium
      administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal
      agent is administered according to randomization table.

      For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with
      recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

      For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after
      rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min
      after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are
      analyzed via high-performance liquid chromatography with mass spectrometric detection.
    

Intervention name(s): Sugammadex Injection 2mg/kg; Sugammadex Injection 4mg/kg; Sugammadex Injection 8mg/kg; Neuromuscular reversal agent injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Other intervention name(s): Bridion 2mg/kg; Bridion 4mg/kg; Bridion 8mg/kg; Atropine and neostigmine
Intervention MeSH terms: Atropine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: sugammadex; pharmacokinetics; pharmacodynamics; pediatric anesthesia
Single Center Food Allergy Oral Immunotherapy Study
Condition: Immune System Diseases
MeSH terms: Hypersensitivity; Food Hypersensitivity; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The Primary Objective of the study is to develop a customized regimen for oral immunotherapy
      that reflects what the subject is allergic in a clinically significant way (i.e., the
      offending food allergen is defined as a food allergen with a positive skin test or positive
      specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and
      multiple food allergy subjects are included in the study.
    


Intervention name(s): Food proteins
Intervention type(s): Drug
Intervention description(s): Oral ingestion of Food proteins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple food allergies
Prevalence, Risk Factors and Consequences Related to Cesarean Scar Defect (Defect in Cesarean Scar)
Condition: Cesarean Scar Defect
MeSH terms: Cicatrix
Study type: Observational [Patient Registry]

Summary: 
      The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS
      is millions every year. CS is one of the most frequently performed operation for women. As a
      consequence many women have a scar in their uterus. Cesarean scar may be associated with
      complications in later pregnancies. In recent years there have also been a few reports
      indicating that cesarean scar could potentially be associated with menstrual disorders and
      infertility. The impact of cesarean scar defect on long term welfare or quality of life is
      not clear.

      In some women with a history of CS it is possible to recognise a defect in the site of
      previous uterotomy years after the performed CS by sonographic examination. This defect in
      the scar, also called as a niche, is a consequence of incomplete healing of the scar in the
      lower part of uterus. To date there is uncertainty relating to the factors that lead to poor
      healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later
      pregnancies are not properly known.

      The purpose of this study is to investigate the prevalence and the risk factors of cesarean
      scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility,
      further deliveries and quality of life will be investigated.

      This study is a prospective observational cohort study. Women at the age of 18-45 years who
      will give birth by elective or emergency CS will be asked to participate. Women are recruited
      within two days of CS. Women with known uterus anomaly or von Willebrand disease will be
      excluded.

      The prevalence of scar defect will be evaluated by transvaginal sonography and
      contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and
      3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after
      the CS.

      The following definition for CS scar defect will be used: myometrial discontinuity with a
      depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical
      cavity as seen on transvaginal sonography with or without saline infusion.

      The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects
      will be asked to report the number of menstrual bleeding days once a month during 3
      consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the
      end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to
      menstruation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women undergoing cesarean section
Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Condition: Chronic Hepatitis c; Metabolic Syndrome
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Metabolic Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine if statin can affect the clinical outcome of chronic
      hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
    

Detailed description: 
      Aim of the work

      To determine the benefits of statin use in CHC patients treated with
      Sofosbuvir/Daclatasvir/Ribavirin through :

      Primary Outcome: Assessment of therapeutic SVR12

      Seconadry Outcome

      1. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome
      through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive
      protein(CRP).

      2- Evaluation of CHC related complications such as fibrosis and cirrhosis

      Patients will be followed up for the whole study period and will be subjected to assessment
      of the following:

        1. CBC , liver function test , lipid profile and CK every month till the end of therapy.

        2. HgA1C and CRP at the end of therapy.

        3. HCV-PCR test 3 months after the end of therapy.

        4. Fibrosis using (FIB-4) 3 months after the end of therapy.
    

Intervention name(s): Simvastatin 10mg; sofosbuvir plus daclatasvir
Intervention type(s): Drug; Drug
Intervention description(s): tablets; sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.
Other intervention name(s): simvastatin; Sovodac
Intervention MeSH terms: Sofosbuvir; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate
      with three quinine regimens in the treatment of severe malaria in children at the Ebolowa
      Regional Hospital located in the South region of Cameroon
    


Intervention name(s): Artesunate; Quinine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Artesunate; Quinine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artesunate; Quinine; Efficacy; Malaria; Children; Cameroon
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
Condition: Schizophrenia Relapse
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional

Summary: 
      To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than
      1000mg/day and to evaluate relationship between relapse and cognitive function.
    

Detailed description: 
      We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The
      dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was
      discontinued if the subjects relapsed. The differences in baseline cognitive function were
      analyzed between the patients with no relapse and relapse groups.
    

Intervention name(s): reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
Intervention type(s): Drug
Intervention MeSH terms: Methotrimeprazine; Haloperidol; Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Haloperidol decanoate; Perphenazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Methadone vs Magnesium in Spinal Fusion
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Significant pain may occur following posterior spinal fusion despite the use of
      conventionally accepted techniques including patient controlled analgesia. If detected, a
      significant reduction in opioid requirements may lead to improved patient satisfaction and
      decreased opiate side effects.

      The current study would use a prospective, randomized trial investigating the efficacy of one
      of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along
      with a third control group. The patients would be randomized to receive remifentanil plus a
      single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of
      magnesium; or remifentanil alone. In addition, the two medications being studied might make
      it easier to determine the efficacy of neurophysiologic monitoring including somatosensory
      evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA)
      required to elicit the response.

      The purpose of this study would be to explore the effects of intraoperative methadone vs
      magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the
      efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of
      desflurane, remifentanil, and the need for intraoperative supplemental agents to control
      blood pressure.
    


Intervention name(s): Methadone hydrochloride; Magnesium Sulfate; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia; This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
Other intervention name(s): Methadone; Magnesium
Intervention MeSH terms: Magnesium Sulfate; Remifentanil; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Spinal Fusion; Scoliosis; Methadone; Magnesium; Adolescents; Back Surgery
Canine-assisted ANxiety Reduction IN Emergency
Condition: Anxiety
MeSH terms: Emergencies; Anxiety Disorders
Study type: Observational

Summary: 
      The purpose of this study is to see if dogs can reduce the anxiety level of patients in the
      emergency department.
    

Detailed description: 
      Patients will score their pain, anxiety, and depression. A dog will then come into the
      patient's room for approximately 15 minutes after which the patient will score his/her pain,
      anxiety, and depression again.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled from Emergency Department that are 18 or older with moderate or greater
        anxiety, per physician Gestalt.
      
Keywords: Anxiety; Dog; Canine; Therapy; Depression; Pain
Online Distance Learning Outcomes Compared to Traditional Classroom Learning in Medicine
Condition: Educational Problems
Study type: Interventional

Summary: 
      To test whether the investigator's educational methodology is associated with increasing
      learning of participants. The investigators second objective is to test the hypothesis that
      learning in an online classroom would result in similar outcomes as the traditional
      classroom.
    

Detailed description: 
      Subjects will be randomized into a "control" group attending a traditional classroom and a
      "trial" group of equal numbers participating in an online synchronous Internet streaming
      classroom.

      Main outcome measures: Pre and post multiple choice examinations of Vestibulo-Ocular Reflex
      (VOR), Movement, Head Turns, Head Tremor, Neurodegeneration, Inferior Olivary Complex,
      Collateral Projections, Eye Movement Training, Visual Saccades, Head Saccades, Visual
      Impairment, Walking Speed, Neuroprotection, Autophagy, Hyperkinetic Movement, Eye and Head
      Stability, Oscilllatory Head Movements, Gaze Stability, Leaky Neural Integrator, Cervical
      Dystonia, Interstitial Nucleus of Cajal (INC) and Head Tilts, Visual Pursuits, Optokinetic
      Stimulation, Vestibular Rehabilitation.

      Methods: All candidates will take a pretest examination of the subject material. Two 9-hour
      and one 8-hour sessions over 3 consecutive days will be given live in the classroom or
      synchronously in the online classroom using the Adobe Connect e-learning platform. Subjects
      randomized to the online classroom will attend the lectures in a location of their choice and
      will view the sessions live on the Internet. A posttest examination will be given to all
      candidates after completion of the course.
    

Intervention name(s): Medical Education; Medical Intervention
Intervention type(s): Other; Other
Intervention description(s): All candidates in the Active Comparator: Traditional Classroom will take a pre course test of the subject material followed by two 9-hour and one 8-hour educational sessions given over 3 consecutive days. Following the educational sessions all candidates in the Active Comparator: Traditional Classroom will take a post course test.; All candidates in the Experimental: Online Synchronous Classroom will take a pre course test of the subject material followed by two 9-hour and one 8-hour educational sessions given over 3 consecutive days. Following the educational sessions all candidates in theExperimental: Online Synchronous Classroom will take a post course test.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomized into a "control" group attending a traditional classroom and a "trial" group of equal numbers participating in an online synchronous Internet streaming classroom.
Masking: None (Open Label)
Primary purpose: Health Services Research
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 4

Summary: 
      We will investigate the process of vitiligo induction and the influence of different commonly
      used cream treatments on this process. Studies comparing different treatments for vitiligo in
      the induction stage of the disease are still missing. The study hypothesis = cream treatment
      can stop actively spreading vitiligo lesions during the early induction stage of the disease.
    


Intervention name(s): topical tacrolimus treatment; topical pimecrolimus treatment; local mometasone furoate treatment; cold cream
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 applications (day 1,day 3, day 6 and day10); 4 applications (day 1, day 3, day 6 and day 10); 4 applications (day 1, day 3, day 6 and day 10); 4 applications (day 1, day 3, day 6 and day 10)
Intervention MeSH terms: Mometasone Furoate; Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitiligo