bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Carbohydrate Consumption on Memory Performance and Mood in Children
Condition: Cognitive Ability, General
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of carbohydrates on blood glucose
      levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight
      (NW) and overweight or obese (OW/OB) children.
    

Detailed description: 
      NW and OW/OB children, 9-14 years of age, will participate in the experiment. The effect of 5
      different meals (mashed potatoes, hash browns, French fries, rice, or beans matched by 50g of
      available carbohydrate) and meal skipping will be examined. On six separate mornings, one of
      the meals or no meal will be provided in a random order upon their arrival. Blood glucose,
      subjective appetite, and mood will be measured at baseline, 10, 30, 60, 120, and 180 minutes
      after meal consumption. Cognitive performance will be measured using an immediate and delayed
      word recall test, and two to three executive function tasks at 10, 30, 60, 120, and 180
      minutes after meal consumption.
    

Intervention name(s): Meal Skipping; French fries; Mashed potatoes; Hash browns; Rice; Beans
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): No meal; 50g of available carbohydrates meal; 50g of available carbohydrates meal; 50g of available carbohydrates meal; 50g of available carbohydrates meal; 50g of available carbohydrates meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; dietary carbohydrates; solanum tuberosum; cognition; memory; emotions; blood glucose
Pneumococcal Vaccines in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine
      if they are given Prevnar initially.
    

Detailed description: 
      Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone
      (Active comparator). At the Week 0 time point, the patients will receive either PCV13
      (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment
      of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood
      for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group
      will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype
      titers as well as a blood draw at week 16 and week 24.
    

Intervention name(s): PCV13; PPSV23
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5 ml dose of PCV13 administered via intramuscular injection; Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Other intervention name(s): Prevnar; Pneumovax
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Pneumococcal; Pneumonia
Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants
Condition: Joint Disease
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous
      study which showed the Medial Pivot (MP) system required lower quadriceps activation than
      subjects implanted with a Posterior stabilized (PS) system preforming the same activities of
      daily living.
    

Detailed description: 
      MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous
      study which showed the Medial Pivot (MP) system required lower quadriceps activation than
      subjects implanted with a Posterior stabilized (PS) system preforming the same activities of
      daily living. The propose of the current study is to determine the impact of Total Knee
      Arthroplasty (TKA) design on muscle activation following TKA surgery.
    

Intervention name(s): Group 1 (Medial-Pivot); Group 2 (Posterior-Stabilized)
Intervention type(s): Device; Device
Intervention description(s): EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts; Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts
Other intervention name(s): EVOLUTION® CS TKA System; Total Knee Arthroplasty Sytem; EVOLUTION®; Zimmer® NexGen® PS TKA System; Total Knee Arthroplasty Sytem; NexGen®
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be selected from the orthopedic clinic at The Ottawa hospital for
        implanted patients. Non-implanted subjects will be selected from the community.
      
Keywords: osteoarthritis; correction of functional deformity; procedures; traumatic osteoarthritis; degenerative osteoarthritis; total knee arthroplasty; Healthy Volunteers; electromyography; Musculoskeletal Diseases
"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Observational

Summary: 
      COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a
      multisystem disease which primarily involves the respiratory tract. The first case of
      COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by
      the rapid spread of the disease globally, becoming a present-day pandemic.

      Objectives: The aim of this study was to describe the clinical characteristics, comorbidities
      and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a
      tertiary care hospital in Lahore.
    

Detailed description: 
      Objectives: The aim of this study was to describe the clinical characteristics, comorbidities
      and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a
      tertiary care hospital in Lahore.

      Material & Methods:

      Study design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial
      Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted
      from March 2021 to August 2021.
    

Intervention name(s): Patients with COVID-19 Pneumonia
Intervention type(s): Combination Product
Intervention description(s): Patients were offered with usual care of COVID-19 in ICU and we did retrospective study
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Non-interventional retrospective cohort study of critically sick patients with COVID-19
        pneumonia admitted in the Intensive Care Unit of Fatima Memorial hospital (FMH) in Lahore,
        Pakistan from March 2021 to August 2021 4.3. Sample Size & Technique: Records of 133
        patients admitted to the ICU of the Fatima memorial hospital, Lahore, were studied.
      
Keywords: Comorbidities; Outcomes; Covid-19
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical
      Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis
      patients.

      Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response,
      The satisfaction of the subject, Total usage of Acetaminophen
    


Intervention name(s): HL301; HL301(Placebo)
Intervention type(s): Drug; Drug
Intervention description(s): HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment; HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Bronchitis
Observational Study on Metabolism and Psychopathology in Transsexual Patients
Condition: Transsexualism
Study type: Observational

Summary: 
      Gender identity disorders (also known as transsexualism) is defined as a condition in which a
      person with apparently normal somatic sexual differentiation is convinced that he or she is
      actually a member of the other sex. Most patients therefore undergo so called cross-sex
      hormone treatment. Treatment protocols follow international consensus statements but vary
      considerably between different centres and countries since no prospective and controlled
      trials are available on this subject and recommendations are mainly based on retrospective
      data analysis and experience of the individual centres. Applying high doses of testosterone
      to biological females and vice versa high doses of estradiol to biological males definitely
      impacts myriads of body functions, from which it has to be assumed that only a minority has
      already been elucidated so far. Especially in male-to-female-transsexuals there seems to be
      an increased risk for the development of mood disorders and cardiometabolic comorbidities. In
      this multi-center observational study we want to investigate, if there is any difference with
      regard to these outcomes, according to the varying standards of cross-sex hormone treatment
      between the different centers. Different outcome measures described below will be assessed
      each time during routine visits at the different centers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the outpatient clinics of the corresponding centres. Every
        patient is eligible who has not yet received any cross-sex hormone treatment. Patients will
        be invited to participate at the regular visit after which it is planned to start hormone
        treatment. Further visits will follow the regular check-up visits in the corresponding
        centers.
      
Biospecimen description: 
      -  2 x 10ml serum

        -  10ml urine

        -  Hair sample

        -  7,5ml EDTA-Blood for DNA and plasma

        -  2,5ml blood for mRNA-Analysis

        -  8,5ml stabilized serum

        -  Stool sample (2-5ml)
    
Keywords: Transsexualism; Cross-sex hormone treatment; Sex hormones; Mood; Stress; Cortisol; Cardiovascular; Metabolome
Web-based CBT4CBT for Alcohol
Condition: Alcohol Abuse or Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The investigators are conducting a randomized clinical trial of our new web-based version of
      the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically
      designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling
      at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT)
      focuses on teaching basic coping skills, presenting examples of effective use of coping
      skills in a number of realistic situations in video form, and providing opportunities for
      patients to practice and review new skills while receiving substance abuse treatment.
    

Detailed description: 
      Ninety alcohol using individuals seeking treatment at the Substance Abuse Treatment Unit
      (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient
      counseling at SATU (typically consisting of weekly group counseling), (2) standard outpatient
      counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring.
      Treatments will be delivered over an 8-week period with a six-month follow-up after
      termination of the study treatments. The primary outcome measures will be reduction in
      alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and
      breathalyzers). Secondary outcomes will include treatment utilization and cost, several
      measures intended to detect whether web-based CBT4CBT retains key characteristics of
      traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change
      strategies), participant characteristics which will be evaluated as potential moderators of
      outcome, as well as participant satisfaction and treatment credibility.
    

Intervention name(s): Standard Treatment as Usual (TAU); Web-based CBT4CBT for alcohol plus TAU; Web-based CBT with minimal clinical contact
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time.; Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU; Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavior therapy; computer assisted instruction; alcohol abuse therapy; educational resource design and development
Psilocybin for the Treatment of Migraine Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of oral psilocybin in migraine
      headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately
      14 days apart. Subjects will be randomized to the order of treatment and they will be
      randomized to receive either low or high dose psilocybin. Subjects will maintain a headache
      diary prior to, during, and after the treatments in order to document headache frequency and
      intensity, as well as associated symptoms. This preliminary study will inform on the basic
      effects of psilocybin in migraine headache and inform on the design of larger, more
      definitive studies.
    

Detailed description: 
      The number of arms reflects the design of the enhanced blinding method. The final enrollment
      number reflects the number of subjects participating in study procedures.
    

Intervention name(s): High Dose Psilocybin; Low Dose Psilocybin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.143 mg/kg psilocybin capsule; 0.0143 mg/kg psilocybin capsule; microcrystalline cellulose capsule
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Psilocybin
Effect of Airway Integrated Nasal Packing With Different Material
Condition: Postoperative Respiratory Complications; Pain, Postoperative.
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of integrated airway in nasal packing
      material foe patients receiving nasal septoplasty surgery.
    

Detailed description: 
      Nasal packing with integrated airway had been claimed to improve body oxygenation following
      septal surgery. This randomized control study examined the effect of airway integrated with
      nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal
      deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were
      packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group
      2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic
      parameters were sequentially checked. Nasal pain sensation was recorded using visual analog
      scale.
    

Intervention name(s): Nasopore; airway integrated Nasopore; airway-integrated Vaseline gauze
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Bilateral nasal packing using Nasopore without airway integrated; post nasoseptoplasty with nasal packing using airway integrated Nasopore; post nasal septoplasty with packing using airway-integrated Vaseline gauze
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nasal packing; nasal airway; septoplasty; oxygen saturation; postoperative pain
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of
      recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
    


Intervention name(s): acyclovir/hydrocortisone cream
Intervention type(s): Drug
Intervention description(s): cream applied topically to lesion five times daily for five days
Other intervention name(s): Xerese(r)
Intervention MeSH terms: Acyclovir; Hydrocortisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Xerese; acyclovir hydrocortisone cream; herpes labialis; pediatric
Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,
      but will not be recruiting locally.

      The purpose of this research study is to establish a dose of the combination of drugs,
      Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The
      chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are
      trying to find the highest dose of Topotecan and Sorafenib that can be given safely to
      children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do
      this by testing different doses of these drugs in different groups of children. The
      investigators will also study how the body processes these drugs.
    


Intervention name(s): Topotecan; Sorafenib
Intervention type(s): Drug; Drug
Intervention description(s): Topotecan will be given by mouth as outlined in treatment arm.; Sorafenib will be given by mouth as outlined in treatment arm.
Other intervention name(s): Topoisomerase-I inhibitor; BAY 43-9006
Intervention MeSH terms: Sorafenib; Topotecan; Topoisomerase I Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory; Relapsed; Recurrent; Pediatric; Malignancy
Electrogastrography (EGC) in Premature Infants With Feeding Intolerance
Condition: Infant, Newborn, Diseases
MeSH terms: Premature Birth; Infant, Newborn, Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Serial EGC measurements in premature infants attempting to correlate EGC measurements with
      signs of feeding intolerance and response to metoclopramide therapy.
    


Intervention name(s): metoclopramide
Intervention type(s): Drug
Intervention MeSH terms: Metoclopramide
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: Feeding intolerance; Infant, premature
Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study
Condition: Genetic Hemochromatosis
MeSH terms: Hemochromatosis; Hemosiderosis
Study type: Observational

Summary: 
      The purpose of this study is to describe bone status on patients with genetic
      hemochromatosis, at diagnostic time and his evolution under treatment.
    

Detailed description: 
      Bone diseases have been recognized recently as complications of genetic hemochromatosis.
      Further studies are needed to describe the role of iron in bone injuries. The purpose of this
      study is to describe bone status on patients with genetical hemochromatosis, at diagnostic
      time and his evolution under treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with genetic hemochromatosis diagnosed in western France hospitals
      
Biospecimen description: 
      -  serum

        -  urine

        -  DNA
    
Keywords: genetic hemochromatosis; Iron overload; C282 homozygosity
Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
Condition: Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as
      Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and
      lead to an increase in the quality of life.

      Menorrhagia in young women with bleeding disorders is typically treated with a combination of
      treatments including hormonal contraceptives. However, there are barriers to hormonal
      contraception use in younger adolescents.

      Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.

      The purposes of this study include:

      To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda
      works in decreasing menstrual blood loss. To see if parents and children participating in
      this study think the drug is improving their quality of life.

      Lysteda has been approved by the Food and Drug Administration for use in patients > than 18
      years of age but not for younger patients.
    

Detailed description: 
      This is a multi-center (5 sites) open-label, single-arm, efficacy study of Lysteda in the
      treatment of adolescent females (10-19 years of age) with heavy menstrual bleeding (HMB).
      Each subject will receive oral Lysteda 1.3 grams three times daily during the first five days
      of menses. Subjects will be monitored over the course of four menstrual cycles (1
      pre-treatment cycle and 3 treatment cycles). During all cycles, assessments of menstrual
      bleeding will be performed using the Menorrhagia Impact Questionnaire (MIQ) and Pictorial
      Blood Assessment Chart (PBAC).

      The study will begin as a currently funded pilot study to assess the efficacy of Lysteda in
      32 patients followed to study completion.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.
Other intervention name(s): Lysteda
Intervention MeSH terms: Tranexamic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heavy Menstrual Bleeding; HMB; Lysteda