bioihbjkbjnl/mcl2 huggingface dataset:
Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
Condition: Head and Neck Cancer; Carcinoma, Squamous Cell; Neoplasms, Oral; Neoplasms, Pharyngeal
MeSH terms: Carcinoma; Neoplasms; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Mouth Neoplasms; Pharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either
      cisplatin, cetuximab, or carboplatin-paclitaxel)
    

Detailed description: 
      This study aims to significantly improve the acute and late morbidity of patients with
      oropharyngeal and laryngeal squamous cell carcinoma both by tailoring the elective
      irradiation only to regions with a legitimate risk of recurrence (> 5%) and by lowering the
      elective dose to 40 Gy. Level IB will not be electively treated unless it is involved with
      pathologic or suspicious lymphadenopathy. Level V will not be treated unless two or more
      ipsilateral nodal levels are involved (or level V itself has pathologic or suspicious
      adenopathy). Levels III and IV will only be irradiated if the immediately proximal level
      contains pathologic lymphadenopathy (i.e. level III irradiated if level II is positive; level
      IV irradiated if level III is positive). We anticipate that this approach should dramatically
      improve the acute and late complication profile.
    

Intervention name(s): Intensity Modulated Radiation Therapy; chemotherapy
Intervention type(s): Radiation; Drug
Intervention description(s): The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.; chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Other intervention name(s): IMRT; cisplatin, cetuximab, or carboplatin-paclitaxel
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Cetuximab
Intervention model: Single Group Assignment
Intervention model description: radiation therapy
Masking: None (Open Label)
Primary purpose: Treatment
A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of single- and
      multiple-dose of TAK-491 in healthy Chinese participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-491. TAK-491 is being tested to treat
      people who have hypertension. This study will look at the pharmacokinetics of TAK-491 in
      Chinese participants who take TAK-491.

      The study will enroll approximately 64 participants.

      The first 16 enrolled participants have been randomly assigned (by chance, like flipping a
      coin) to 1 of the 2 treatment groups:

        -  TAK-491 40 mg

        -  TAK-491 80 mg

      All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10
      during the study.

      The following 48 randomized participants will be randomly assigned (by chance, like flipping
      a coin) to 1 of the 3 treatment groups:

        -  TAK-491 40 mg

        -  TAK-491 80 mg

        -  TAK-491 placebo

      All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10
      during the study.

      This single-center trial will be conducted in China. The overall time to participate in this
      study is approximately 52 days. Participants will be admitted in the clinic for the first 12
      days, and will be contacted by telephone 14 days after last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): TAK-491; TAK-491 placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-491 tablets; TAK-491 placebo-matching tablets
Other intervention name(s): Azilsartan medoxomil; Edarbi
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug therapy
Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus
Condition: Venous Thromboembolism; Pharmacokinetics; Healthy
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with
      cyclosporine and tacrolimus in healthy volunteers. The study participants will receive
      apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban.
    

Detailed description: 
      Life- and graft-threatening complications in solid organ transplant patients have been
      greatly reduced due to the potent immunosuppressive agents like calcineurin inhibitors (CNI)
      that include cyclosporine and tacrolimus. Venous thromboembolism (clots in legs or lungs) in
      transplant recipients is often difficult to manage due to polypharmacy and potential for drug
      interactions. More than 90% of renal transplant (RT) recipients are maintained on a CNI-based
      immunosuppressive regimen. Cyclosporine is an inhibitor of many metabolic pathways including
      cytochrome P450 (CYP) 3A4, permeability glycoprotein (P-gp) and, breast cancer resistance
      protein (BCRP). Tacrolimus shares some of the distributive and metabolic pathways of
      cyclosporine. Apixaban is a combined substrate of CYP3A4, P-gp and, BCRP and thus has the
      potential for drug interactions with cyclosporine and tacrolimus. Apixaban levels that are
      too high or too low could be a problem for transplant patients. The purpose of this study is
      to determine what happens to apixaban blood levels when given in combination with
      cyclosporine or tacrolimus.
    

Intervention name(s): Apixaban alone; Cyclosporine; Tacrolimus; Apixaban; Apixaban
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 10 mg apixaban administered orally at 0H on Day 1.; Once daily dose of 100 mg cyclosporine administered orally on Days 1 to 3.; Once daily dose of 5 mg tacrolimus administered orally on Days 1 to 3.; A single dose of 10 mg apixaban administered orally on Day 3 immediately following cyclosporine; A single dose of 10 mg apixaban administered orally on Day 3 immediately following tacrolimus
Other intervention name(s): ELIQUIS; NEORAL; PROGRAF; ELIQUIS; ELIQUIS
Intervention MeSH terms: Cyclosporine; Apixaban; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Apixaban; Cyclosporine; Tacrolimus; Cytochrome P450 CYP3A4; Permeability Glycoprotein P-gp; Breast cancer resistance protein BCRP; Factor Xa Inhibitors; Anticoagulants; Enzyme Inhibitors
Orofacial Evaluation in Women With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in
      the physical examination of patients with RA, the joints in the area of the jaw and neck may
      also be affected in this disease and have their involvement usually underdiagnosed. There are
      few studies evaluating the incidence of orofacial alteration in the examination as well as
      the correlation between bite force (BF) and clinical and functional parameters in these
      patients. The aim of our study was to chacacterize the orofacial alterations in RA patients,
      correlate the results of the orofacial evaluation with clinical and disease activity
      parameters, and correlate the bite force with the hand strenght.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        150 individuals, half of them, 75 were rheumatoid arthritis and the others 75 consisted the
        group control
      
Keywords: rheumatoid arthritis; bite force; grip strenght; oral health; quality of life
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation
      to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in
      adult patients.
    


Intervention name(s): Bowel Prep
Intervention type(s): Drug
Intervention description(s): Orally ingested liquid bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Zinc Supplement Before or With Food in Generally Healthy Men
Condition: Zinc Deficiency; Dyslipidemias; Zinc Excess; Inflammation
MeSH terms: Dyslipidemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the influence of food consumption timing on the
      body's response to a zinc supplement
    

Detailed description: 
      This research is a dietary intervention study designed to evaluate the effect of the food
      consumption timing on the absorption of zinc supplement.

      The main objective is to measure plasma zinc in generally healthy male subjects, who will
      consume zinc supplement with food or 30-min before food for 2-weeks.

      In addition to the primary objectives, correlations in enzyme activity with changes in fat
      metabolism, namely circulating triglyceride and cholesterol, will be determined. This will
      enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia.
    

Intervention name(s): Zinc supplement
Intervention type(s): Dietary Supplement
Intervention description(s): 25 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: zinc; nutrition; supplement; food
Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers
      (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

      Secondary objectives:

        -  To evaluate the tolerability of V503 in 9-15 year-old girls.

        -  To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or
           GARDASIL.
    


Intervention name(s): V503; GARDASIL
Intervention type(s): Biological; Biological
Intervention description(s): 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine; Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
Other intervention name(s): 9vHPV vaccine; qHPV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1
      diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling
      updates for Lyumjev and the t:slim X2 insulin pump.
    

Detailed description: 
      This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80
      years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with
      Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.
      After a run-in period, participants will use the study pump with Control-IQ technology 1.5
      and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be
      enrolled so at least 160 complete the study.
    

Intervention name(s): t:slim X2 insulin pump with Control-IQ technology 1.5
Intervention type(s): Device
Intervention description(s): t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; Control-IQ Technology; lyumjev
Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by
      evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro
      fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.
    


Intervention name(s): IVF-M HP Inj.; Menopur® Inj.
Intervention type(s): Drug; Drug
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Angelman Syndrome
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Study type: Observational

Summary: 
      Angelman Syndrome (AS) is a developmental disorder that is caused by a deficiency of a
      maternally transmitted gene. It is inherited at birth, and affects movement, speech, and
      social demeanor. This study will gain a better understanding of the disease progression and
      clinical features of AS by observing children with AS over an extended period of time.
    

Detailed description: 
      AS is a developmental disorder that affects movement, speech, and social demeanor. The
      disorder is caused by a deficiency of a maternally transmitted gene and is inherited at
      birth. Children with AS, however, are often not diagnosed until they are between 3 and 7
      years old. Symptoms of AS may include, but are not limited to, functionally severe
      developmental delay; speech impairments; movement or balance problems; and behavioral
      uniqueness, including any combination of frequent laughter or smiling, apparent happy
      demeanor, easily excitable personality, hand flapping movements, and short attention span.
      There are four molecular variations of AS, but past clinical studies have been inconsistent
      in highlighting the phenotypic differences between them. This study will gain a better
      understanding of the disease progression and clinical features of AS by observing children
      with AS over a period of 5 to 10 years. The study will also attempt to establish
      genotype-phenotype correlations, which might aid in future clinical care of AS patients.

      Participation in this observational study will be limited to current or future patients at
      one of the five study sites. A clinical evaluation will be performed at baseline, including a
      general patient history, physical and neurological examinations, a nutritional assessment,
      neuro-imaging, electroencephalography, laboratory testing, and neurodevelopmental testing. A
      blood sample or mucosal sample will also be taken at baseline to acquire DNA for potential
      genetic testing. All assessments except the neuro-imaging, electroencephalography, and blood
      sampling will be repeated at yearly study visits for as long as funding can be secured. In
      addition, participants will be photographed and perhaps videotaped on a yearly basis in order
      to document clinical phenotypes and any neurologic abnormalities. Participants may be
      followed-up for a total of 10 years.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Angelman syndrome (molecular or clinical diagnosis) between the ages of 1 day
        and 60 years.
      
Biospecimen description: 
      Blood and cheek swab samples
    
Keywords: Developmental Disorders
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of GSK2881078 in Single and Repeat Doses
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK2881078 to humans. The intention of this study
      is to provide sufficient confidence in the safety of the molecule to inform progression to
      further repeat dose and proof of concept studies. This study will include approximately 52
      subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess
      the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of
      GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5)
      will include three cohorts of 12 healthy male subjects to examine the safety, tolerability,
      PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration
      of the study including screening and follow-up, is not expected to exceed 70 days.
    


Intervention name(s): GSK2881078; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hot melt solution within Capsule for oral single ascending doses or repeat dose administration with planned dose level and strength of 0.1, 0.3, 1.0, 2.0, 4.0, 8.0, and 10.0 mg; Hot melt solution within Capsule for oral single ascending doses or repeat doses administration.
Intervention MeSH terms: GSK2881078
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FTIH; pharmacokinetics; SARM; safety
Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in
      patients with distal subungual onychomycosis of the great toenail. Patients will receive four
      PDT treatments with PD P 506 A in weekly intervals.
    


Intervention name(s): PD P 506 A
Intervention type(s): Drug
Intervention description(s): PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm².
Other intervention name(s): Alacare®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurogenic Bladder and Quality of Life in Patients With Stroke
Condition: Stroke, Complication; Neurogenic Bladder
MeSH terms: Stroke; Urinary Bladder, Neurogenic
Study type: Observational [Patient Registry]

Summary: 
      This study investigated effects of the neurogenic bladder on the quality of life in stroke
      survivors. Patients were divided into two groups: the First group consisted of patients with
      neurogenic bladder and the Second group consisted of patients without neurogenic bladder.
    

Detailed description: 
      Neurogenic bladder after stroke is a commonly encountered medical condition which slows down
      the recovery process and exacerbates the functional status of the patient. The neurogenic
      bladder may possibly affect the quality of life of patients with stroke.

      Objectives: The aim of this study is to investigate the relationship between the quality of
      life and the neurogenic bladder in Turkish stroke survivors.

      Methods: 71 patients with stroke were included in the study. Patients were divided into two
      groups: the First group consisted of patients with neurogenic bladder and the Second group
      consisted of patients without neurogenic bladder. Short Form-36 (SF-36), Barthel Index (BI),
      Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory
      (BDI) questionnaires were applied to both groups for clinical evaluations.
    

Intervention name(s): Questionnaires
Intervention type(s): Behavioral
Intervention description(s): Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients who were hospitalised to Istanbul Physical Medicine and Rehabilitation
        Training and Research Hospital.
      
Keywords: urinary bladder, neurogenic; quality of life; socioeconomic factors; stroke rehabilitation
Minerals and Botanicals for Acute Stress
Condition: Stress; Anxiety
Study type: Interventional

Summary: 
      The objective of this acute intervention study is to examine the potential of minerals
      combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain
      activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective
      parameters) under conditions of acute stress in moderately stressed individuals
    

Detailed description: 
      Botanicals in isolation or combined, will be administered with a mineral and vitamin complex
      to moderately stressed, healthy adults in a parallel groups fashion in this randomised
      placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on
      cognitive tasks of attention will be examined after treatment intake under conditions of
      acute laboratory stress. The effects of treatments on stress responses (cardiovascular,
      subjective and cortisol responses) will also be assessed.
    

Intervention name(s): Minerals + Vitamins; Botanical A; Botanical B; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): A mineral and vitamin tablet; Botanical extract administered in capsule form; Botanical extract administered in capsule form; Cellulose crystalline tablet
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Stress; Anxiety; Cortisol; Vitamins; Botanicals; Minerals