bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the tolerability of peanut protein in
      pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability
      is defined as the proportion of patients who safely pass a double-blind placebo-controlled
      food challenge (DBPCFC) at week 24.

      The secondary objectives are:

        -  To determine whether dupilumab treatment improves peanut tolerability, defined as a
           change in the cumulative tolerated dose (log transformed) of peanut protein during a
           DBPCFC

        -  To evaluate the safety and tolerability of dupilumab treatment in peanut allergic
           patients

        -  To evaluate the effects of dupilumab treatment on the levels of peanut-specific
           Immunoglobulin E (IgE)

        -  To evaluate the treatment effect of dupilumab on the average wheal size after a titrated
           skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size
           induced by peanut extract at different concentrations

        -  To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in
           patients over time
    


Intervention name(s): Dupilumab
Intervention type(s): Drug
Intervention description(s): Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
Other intervention name(s): REGN668; IL4R; Dupixent; SAR231893
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy
      of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One
      hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer
      will be enrolled in this trial.
    

Detailed description: 
      The primary study endpoint is objective response rate. The study has been designed following
      Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental
      treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25%
      (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1,
      Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective
      responses are observed in exemestane arm, recruitment will continue until 100 patients have
      been recruited. After this second recruitment phase, at least 7 objective responses must be
      observed to confirm the expected exemestane level of activity.
    

Intervention name(s): Exemestane; Anastrozole
Intervention type(s): Drug; Drug
Intervention description(s): 25mg/day until progression disease; 1mg/day until progression disease
Other intervention name(s): Aromasil; Arimidex
Intervention MeSH terms: Anastrozole; Exemestane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer; First line of hormone treatment; Postmenopausal women; Positive hormone receptor tumours
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher
      amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The
      reason for this higher drug exposure has not been determined. The primary purpose of this
      study is to examine whether the pharmacokinetics (factors that determine the amount of drug
      in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women
      and ultimately result in higher amounts of drug in the body compared with men. In other
      words, we plan to examine whether changes in sex hormones throughout the menstrual cycle
      affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir,
      tenofovir and emtricitabine will be studied. This study will be conducted in healthy women
      since HIV may change the pharmacokinetics of anti-HIV drugs.
    


Intervention name(s): tenofovir; emtricitabine; atazanavir; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tenofovir 300 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle); emtricitabine 200 mg on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).; atazanavir 300mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).; ritonavir 100 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers
Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the addition of infliximab to standard
      primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce
      resistance to therapy in acute Kawasaki disease (KD).
    

Detailed description: 
      KD, an orphan disease of low prevalence in U.S. children, causes significant long term
      cardiac sequelae in a subset of patients. KD patients that are resistant to therapy are more
      likely to develop coronary artery abnormalities. This phase III placebo-controlled,
      multicenter, randomized clinical trial of infliximab plus standard therapy vs. placebo plus
      standard therapy in acute KD will determine if the addition of infliximab to primary therapy
      can reduce the percentage of children resistant to therapy.
    

Intervention name(s): Infliximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg/kg IV over 2 hours once; Placebo (same volume as active drug)
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kawasaki disease; Infliximab; Remicade; Pediatrics
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Condition: Transient Ischemic Attack; Stroke
MeSH terms: Stroke; Ischemic Attack, Transient
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to explore the safety of low doses of oral levosimendan in patients
      with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus
      will be on the evaluation of proarrhythmic potential of the different dose regimens.
    

Detailed description: 
      This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled
      2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for
      13-18 days. The study population will be randomly allocated either to the levosimendan group
      or to the placebo group. The double-blind phase with either placebo or levosimendan is
      preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study
      consists of 9 visits (screening visit, 7 visits during the treatment period and an
      end-of-study visit). Each subject will be on study treatment (including placebo run-in) for
      78-108 days and the duration of the study for each subject, including the screening and the
      end of study visit, is approximately 17 weeks.
    

Intervention name(s): Levosimendan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): from 0.125 mg to 2 mg in escalating doses; Placebo capsules are identical in appearance to active capsules
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: An ischaemic cerebrovascular event (stroke or TIA)
First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders
Condition: Healthy Subjects
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this first-in-man study is to investigate whether a new drug for
      neurological disorders is safe and well-tolerated when administered orally to healthy male
      adults
    


Intervention name(s): AC-083; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg; Placebo capsules matching AC-083 capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
Condition: Injury of Upper Limb
MeSH terms: Arm Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through
      intravenous infusion，in order to improved the quality of block in regional anesthesia. In
      this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed
      with ropivacaine in coracoid approach brachial plexus block.
    


Intervention name(s): ropivacaine; ropivacaine mixed with dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): 40 ml 0.375% ropivacaine was injected after Locating brachial plexus.; 40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dexmedetomidine; coracoid; brachial plexus block
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
      for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
      combination product including these actives for the treatment of acne vulgaris.

      You may be suitable to take part in this study because you have acne vulgaris on your face.
      Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
      legs, and back.
    

Detailed description: 
      The study subjects must have acne vulgaris and will apply study drug to their face for 12
      weeks.

      Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be
      assessed at every visit to determine how the study drug is working. Safety will be assessed
      by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals
      from the study.
    

Intervention name(s): Benzoyl peroxide gel; Clindamycin gel; Tazarotene cream; Vehicle gel; Vehicle cream
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5% benzoyl peroxide in a gel applied topically once a day; 1% clindamycin phosphate applied topically once a day; 0.1 % tazarotene in a cream applied topically once a day; Vehicle gel is an identical gel without the active ingredients; Vehicle cream is an identical cream without the active ingredients
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne; Acne Vulgaris; Pimples
A Non-drug Study Profiling Cutaneous Lupus
Condition: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
Study type: Observational

Summary: 
      The purpose of this study is to characterize the clinical and molecular profiles of patients
      with cutaneous lupus.
    

Detailed description: 
      This is a Phase 0, multiple-center observational study of biomarkers and clinical parameters
      in patients with lupus, including discoid lupus erythematosus (DLE), subacute cutaneous LE
      (SCLE) and active systemic lupus erythematosus (SLE). There is no study-related therapeutic
      intervention and this protocol will not restrict or introduce any medical interventions
      including medications. Study participants will undergo procedures that include collection of
      urine, blood samples, and skin biopsy. At least 30 participants (≥10 DLE, ≥10 SCLE, and ≥10
      SLE) will be enrolled in this study. All participants will continue to be managed by their
      personal physicians per their standard of care. The data obtained in this study will help in
      the evaluation of new therapeutics for lupus and may facilitate lupus drug discovery. A blood
      sample for genomic analysis will be collected for research purposes from patients who provide
      consent and where local regulations permit. There will be a single sample collection time
      point for each patient. The safety assessments will include laboratory measurements (serum
      chemistry and hematology), monitoring of adverse events (AEs) related to study procedures,
      and physical examination.
    

Intervention name(s): No intervention, skin biopsy; No intervention, blood collection; No intervention, urine collection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).; Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.; Urine will be collected from all participants.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants have CLE (either DLE or SCLE) or SLE with cutaneous manifestations
      
Biospecimen description: 
      Blood from participants with discoid lupus erythematosus (DLE), subacute cutaneous lupus
      erythematosus (SCLE), and active systemic lupus erythematosus (SLE) with cutaneous
      involvement.
    
Keywords: Lupus Erythematosus, Subacute, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Active Cutaneous Lupus Erythematosus; Systemic Cutaneous Lupus Erythematosus; Skin Biopsy; Lesions
SF-QUALIVEEN Turkish Validity and Reliability Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence
      has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a
      significant deterioration in the quality of life of people with MS. In chronic diseases such
      as MS, patients experiences need to be measured directly in order to have information about
      patients perceptions about the effect of the disease on quality of life. However, there are a
      small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated
      scale for patients with MS who assess the urinary-specific quality of life by examining the
      impact of a wide range of bladder problems.The aim of our study is to make the Turkish
      cultural adaptation, validity and reliability of the SF-Qualiveen scale.
    

Detailed description: 
      The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability
      of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory
      (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple
      sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients
      with multiple sclerosis.
    

Intervention name(s): Questionnaire administration pre test; Questionnaire administration validation and reliability
Intervention type(s): Other; Other
Intervention description(s): After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.; After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pre-test: 10 patients with multiple sclerosis will be evaluated.Inclusion and exlusion
        criteria listed above.

        Validation and reliability: 70 patients with multiple sclerosis will be evaluated.Inclusion
        and exlusion criteria listed above.
      
Keywords: multiple sclerosis; urological dysfunction; assessment; scale
Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with
      different manufacturing process in healthy male subjects. Another purpose is to determine
      safety, and immunogenicity of bevacizumab with different manufacturing process.
    


Intervention name(s): bevacizumab with new manufacturing process.; bevacizumab with old manufacturing process.
Intervention type(s): Drug; Drug
Intervention description(s): 3mg/kg,I.V.,single dose; 3mg/kg,I.V.,single dose
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of
      multiple ascending doses of M201-A administered by multiple continuous intravenous injection
      in Healthy Japanese subjects.
    


Intervention name(s): M201-A Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance: M201-A Route of administration: continuous intravenous injection; Placebo: M201-A Placebo Route of administration: continuous intravenous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of this study is to find out whether the hypoglycemic and improving insulin
      resistance effect will appear or not, when EA applying on specific acupoints of NIDDM
      patients.
    

Detailed description: 
      Some previous animal model studies reveal that electroacupuncture (EA) applying on specific
      acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and
      encourage insulin secretion, even improve insulin resistance. In this study, we want to
      observe these results on type II diabetic patients who have been diagnosed in five years
      under a study design of randomized control trial (RCT) to obtain evidence on clinical.

      We undertook a randomized, single blind and sham group controlled study to evaluate the
      effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint.
      A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are
      randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA
      treatment, and the other 13 patients are divided into control group (CG) with sham treatment.
      The main outcome is the changes of laboratory parameters between before and 30 minutes after
      the test.
    

Intervention name(s): electroacupuncture
Intervention type(s): Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: electroacupuncture, plasma glucose, plasma insulin
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The investigators hypothesize that children with spastic cerebral palsy will show greater
      improvements in gross motor function, associated developmental skills and growth after the 3
      months of myofascial structural integration treatment, a form of deep massage, than they
      showed after a 3- or 6-month pre-treatment waiting period.

      The investigators further hypothesize that children with spastic CP will maintain their gains
      in gross motor function for ≥ 3 months after completion of MSI treatment.
    

Detailed description: 
      -  The investigators will talk to you by telephone to determine if your child is eligible
           for the study.

        -  The study lasts for a total of 12 months with the massage treatment period lasting 12
           weeks.

        -  The study entails a total of 10 sessions of Myofascial Structural Integration therapy
           over the 12-week period. Each session will last one hour.

        -  The child will have an evaluation of motor functions and development on enrollment and
           at three-month intervals for a total of 5 evaluations.
    

Intervention name(s): Rolfing / Myofascial Structural Integration
Intervention type(s): Other
Intervention description(s): Rolfing is similar to deep massage. It is also known as "myofascial structural integration."
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spasticity; cerebral palsy; hemiplegia; hemiparesis; diplegia; paraplegia; quadriplegia; quadriparesis