bioihbjkbjnl/mcl2 huggingface dataset:
Quality of Friendships in Children With Neurofibromatosis
Condition: Neurofibromatosis
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Observational

Summary: 
      The aim of this study is to determine if children with a higher disease severity have lower
      quality friendships than children who are less severely affected and children who are
      unaffected. Researchers will test the hypothesis that the quality of friendships is inversely
      related to their disease severity.

      Specific Aims:

        1. To use the FQQ to determine if the quality of friendships in children with NF1 is lower
           than the quality of friendships in unaffected children.

        2. To use a disease severity scale and the FQQ to determine if children who are less
           severely affected have higher friendship qualities than children who are more severely
           affected.
    

Detailed description: 
      You (your) child will be asked to complete a short questionnaire (40 questions) about their
      relationship with their best friend. Doctors will review your (child's) medical chart to find
      out how severe the disease is, so that this may be compared to the answers you have (your
      child has) given on the friendship questionnaire.

      This is an Investigational Study. About 90-100 children and adolescents with NF-1 will be
      asked to take part in this study. All will be enrolled at M.D. Anderson.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Questionnaire about the patient's relationship with their best friend.
Other intervention name(s): Survey
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years
        old.
      
Keywords: Neurofibromatosis; Quality of Friendships; Disease Severity; Questionnaire; NF-1
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no
      standard regimen. Some data showed that platins could improve the efficacy of advance TNBC.
      In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better
      efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).
    


Intervention name(s): EC-T; TP
Intervention type(s): Drug; Drug
Intervention description(s): four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1); six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TRIPLE-NEGATIVE; BREAST CANCER
Functional Outcome Anterior Cruciate Ligament Reconstruction
Condition: Complications of Surgical Procedures or Medical Care
Study type: Observational

Summary: 
      The purpose of this study is to compare hop performance and jump landing strategy in soccer
      players with higher level sports activities after ACLR using either BPTB or STG and controls.
    

Detailed description: 
      The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains
      controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone
      (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional
      outcomes. The objective of the current study was to compare hop performance and jump landing
      strategy in soccer players with higher level sports activities after ACLR using either BPTB
      or STG and controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients with ACL deficiency were invited to participate in a randomized trial
        comparing ACLR with either a BPTB or STG graft.
      
Keywords: Anterior Cruciate Ligament; Hamstrings versus patellar tendon; Hop test; Return to sports
COVID-19 Antibodies Among Healthcare Workers
Condition: COVID-19; SARS-CoV 2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody
    

Detailed description: 
      All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14
      days or more had passed from their first entrance to contaminated areas were included. They
      were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used
      for antibody detection, and selected participants were subject to real time polymerase chain
      reaction (qPCR) for SARS-CoV-2.
    

Intervention name(s): COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)
Intervention type(s): Diagnostic Test
Intervention description(s): a blood sample is drained for detection of IgG and IgM antibody
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthcare workes of any category that are 18 years of age or older, who work in the
        COVID-19 unit at the University Hospital and hve been diagnosing and treating suspected or
        confirmed cases of COVID-19
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone
      gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration
      will be approximately 12 months and will involve ovarian suppression/stimulation protocols as
      well as egg retrieval.
    


Intervention name(s): DR-2011; Crinone 8%
Intervention type(s): Drug; Drug
Intervention description(s): Progesterone vaginal ring for approximately 10 weeks; progesterone vaginal gel for approximately 10 weeks
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: In vitro fertilization
Photodynamic Therapy for Papulopustular Rosacea
Condition: Rosacea; Papulopustular Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      Rosacea is a chronic inflammatory disorder that is characterized by severe flushing
      (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical
      therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid
      recurrence is common following the use of systemic antibiotics, resulting in the chronic use
      of these medications to control the disease. Although the exact pathogenesis of rosacea is
      unknown, treatment for this condition has been investigated based on its similarity to acne
      and photodamaged skin. Case reports have shown promising results in rosacea patients treated
      with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which
      observed significant improvement of papules, pustules, erythema, and flushing following 5 -
      aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the
      role of ALA-PDT in the treatment of rosacea has not been reported.

      We have designed a pilot study investigating the efficacy of ALA-PDT in treating
      papulopustular rosacea. The objectives of the study are as follows:

      Primary objective:

        1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules),
           erythema, and telangiectasia of rosacea as assessed by the Investigator's Global
           Assessment (IGA).

        2. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of
           rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).

           Secondary objectives:

        3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical
           Erythema Assessment (CEA) scale.

        4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of
           rosacea as measured by a difference in inflammatory lesion count.

        5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.
    


Intervention name(s): Aminolevulinic acid topical solution 20%; Blu-U Light Therapy; Placebo vehicle only
Intervention type(s): Drug; Device; Other
Intervention description(s): Intervention used in the experimental arm only; Intervention used in experimental and sham arms; Intervention only includes the placebo vehicle solution
Other intervention name(s): Levulan Kerastick
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosacea; Photodynamic Therapy; Aminolevulinic Acid; Papulopustular Rosacea; Blue Light
Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
Condition: Sexual Aggression; Heavy Drinking
MeSH terms: Aggression
Study type: Interventional

Summary: 
      Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the
      majority of these assaults. Despite well-intentioned prevention efforts, this pandemic
      continues unabated, warranting the development of novel and innovative approaches to the
      reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two
      brief online emotion regulation interventions for reducing alcohol-related sexual aggression
      in heavy episodic drinking young men with a sexual aggression history. Previous research
      suggests that emotion regulation difficulties are associated with both alcohol consumption
      and aggressive behavior. Despite the potential prevention utility of improving sexually
      aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual
      aggression, this approach has yet to be explored. Thus, this study evaluates the effects of
      two brief online ER interventions - cognitive restructuring and mindfulness - on men's
      emotion regulation during a sexual aggression-related analogue. Additionally, these effects
      will be evaluated during both sober and intoxicated states through a laboratory- based
      alcohol administration experiment.
    


Intervention name(s): Cognitive Restructuring; Mindfulness; Alcohol consumption
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.; Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.; Participants consume an alcoholic beverage in the lab.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy
      menstrual bleeding.
    

Detailed description: 
      This study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS
      for treatment of heavy menstrual bleeding.
    

Intervention name(s): Levonorgestrel 52 mg intrauterine system
Intervention type(s): Combination Product
Intervention description(s): Levonorgestrel 52 mg intrauterine system
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Commercial ziprasidone capsules show a large increase in bioavailability with food. The
      formulation tested in this study aims to reduce or eliminate that increase.
    


Intervention name(s): ziprasidone; B16 Fasted; B16 Fed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg capsule, single dose x 3; 40 mg tablet, single dose X 3; 40 mg tablet, single dose X 3
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: schizophrenia, pharmacokinetics, bioavailability, food effect
Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous
      glucose production) and plasma glucose concentration in diabetic subjects. Researchers will
      examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and
      fall in plasma glucose concentration.
    

Detailed description: 
      This study will examine whether the coadministration of exenatide plus dapagliflozin will
      prevent the increase in EGP and result in an additive or even synergistic decrease in plasma
      glucose concentration compared to each agent alone.
    

Intervention name(s): Dapagliflozin; Exenatide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10mg; Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly); Placebo for Dapagliflozin
Other intervention name(s): Farxiga; Byetta, Bydureon
Intervention MeSH terms: Dapagliflozin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to assess the safety, tolerability, efficacy,
      pharmacokinetics and pharmacodynamics of GLPG3667 in multiple daily oral doses in subjects
      with moderate to severe plaque psoriasis.
    


Intervention name(s): GLPG3667; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3667 capsules; Matching placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with
      allergic rhinitis
    


Intervention name(s): Dymista Nasal Spray; Fluticasone propionate nasal spray
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of an Inactivated Yellow Fever Virus Vaccine
Condition: Yellow Fever
MeSH terms: Yellow Fever; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose
      escalation Phase 1 trial, evaluating dosages of 1 mcg and 5 mcg of HydroVax-002 YFV vaccine
      given intramuscularly on Day 1 and Day 29 in up to 25 healthy adults healthy adults ≥ 18 and
      < 50 years of age. The primary objective is to assess the safety, reactogenicity, and
      tolerability of the HydroVax-002 YFV vaccine administered intramuscularly in a two-dose
      series on Days 1 and 29 at a dose of 1 mcg or a dose of 5 mcg.
    

Detailed description: 
      This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose
      escalation Phase 1 trial evaluating dosages of 1 mcg and 5 mcg of HydroVax-002 YFV vaccine
      given intramuscularly on Day 1 (the day of first vaccination is defined as Day 1) and Day 29
      in healthy adults ≥ 18 and < 50 years of age. The study will consist of two dosing groups of
      HydroVax-002 YFV vaccine to be enrolled sequentially. Each dose group will consist of 10
      individuals who receive HydroVax-002 YFV, as well as 5 total subjects who receive placebo.
      Each dose-group will include a sentinel subgroup consisting of 3 vaccine and 1 placebo
      recipient. In each of the two (1 mcg and 5 mcg) dose phases, enrollment is halted after the
      dose 1 vaccination of the sentinel subgroup. Following assessment of safety and
      reactogenicity data of Group 1 by the Safety Monitoring Committee (SMC), the vaccine dose
      will be increased to 5 mcg for Group 2.
    

Intervention name(s): HydroVax-002 YFV; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Inactivated YFV vaccine; NaCl 0.9%, Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HydroVax; Yellow Fever virus; dose-ranging; double blind; Placebo-Controlled; Vaccine
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, 2-period crossover, inpatient study to be performed in
      healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel
      cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or
      AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will
      be administered after an overnight fast of at least 10 hours.
    


Intervention name(s): pharmacokinetic (how the body absorbs and eliminates) interaction
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Health
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
Condition: Schizophrenia; Auditory Hallucinations
MeSH terms: Hallucinations; Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary outcome of this study is to evaluate the effects of low frequency subthreshold
      repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of
      patients with refractory schizophrenia on the severity of auditory hallucinations.

      The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of
      life, functionality and general psychopathology.
    

Detailed description: 
      Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups.
      First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over
      the left temporoparietal cortex (LTPC).

      Second group received sham (placebo) stimulation over the LTPC for the same period of time.
      All patients were considered as having refractory schizophrenia and in use of at least
      400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.
    

Intervention name(s): Active rTMS x sham (placebo) rTMS; sham rTMS; (1Hz) rTMS applied over the left temporoparietal cortex
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.; same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region; 20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Other intervention name(s): EMTr; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: refractory schizophrenia; rTMS; auditory hallucinations
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
Condition: Folliculogenesis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects
      of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve
      and to assess the effect of elagolix on selected endocrine/hormone levels.
    

Detailed description: 
      This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years
      to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence
      of significant gynecological disorders. The objective of the study is to determine the
      effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian
      reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the
      first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of
      up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal
      ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating
      hormone, estradiol, progesterone, and inhibin B will be performed three times weekly.
      Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed
      frequently throughout the study. Subjects will be required to use nonhormonal dual
      contraception consistently during the study, and will be counseled on appropriate and
      effective forms of birth control to promote pregnancy prevention.
    

Intervention name(s): Elagolix; Elagolix; Elagolix; Elagolix; Elagolix; Elagolix; elagolix
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Elagolix Dose Regimen 1 for 84 days; Elagolix Dose Regimen 2 for 84 days; Elagolix Dose Regimen 3 for 84 days; Elagolix Dose Regimen 4 for 84 days Other interventions may be added; Elagolix Dose Regimen 5 for 84 days; Elagolix Dose Regimen 6 for 84 days; Elagolix plus Activella Dose Regimen 7 for 84 days
Other intervention name(s): ABT-620, elagolix sodium; ABT-620, elagolix sodium; ABT-620, elagolix sodium; ABT-620, elagolix sodium; ABT-620, elagolix sodium; ABT-620, elagolix sodium; ABT-620, elagolix sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; elagolix; endometriosis; ovarian reserve; gonadotropin-releasing hormone antagonist; ovulation; ovarian activity