bioihbjkbjnl/mcl2 huggingface dataset:
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Albiglutide; Auto-injector
Intervention description: Albiglutide liquid drug product is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid drug product (50 mg). Subjects will receive albiglutide 50 mg through subcutaneous injection in the abdomen, thigh or upper arm region via auto-injector. Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist).; The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.
Intervention MeSH terms: rGLP-1 protein
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No
Keywords: Extension; Long-term Safety; Pharmacodynamics; Albiglutide; Type 2 Diabetes Mellitus

Summary:

      Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an
      adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and
      has been approved by the United States (US) Food and Drug Administration (FDA), the European
      Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single
      group, multicenter, extension study to Study 200952. This extension study will provide
      extended safety, tolerability and immunogenicity data for the albiglutide liquid drug
      product. This extension study will comprise 2 study periods: treatment (26 weeks) and
      post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part
      in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the 26 week Treatment Phase of Study 200952

          -  Male or female

          -  Able and willing to provide informed consent.

        Exclusion Criteria:

          -  Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: pregabalin
Intervention description: Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to explore whether sensory symptom cluster analysis is useful for
      predicting treatment response in Postherpetic Neuralgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have pain present for more than 3 months after the healing of the herpes
             zoster skin rash.

          -  At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric
             Rating Scale for Pain (1 week recall period).

          -  At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the
             last 7 days and the average pain score must be >=4.

        Exclusion Criteria:

          -  Subjects having other severe pain that may confound assessment or self evaluation of
             the pain due to PHN.

          -  Neurolytic or neurosurgical therapy for Postherpetic Neuralgia

          -  Skin conditions in the affected dermatome that could alter sensation.
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Hyperkalemia
Intervention: Patiromer 25.2 g
Intervention description: Single dose of Patiromer 25.2 g
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Investigator hypothesize that a single dose of patiromer will lower serum potassium
      levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied
      in at least two multicenter randomized controlled trials, the Investigator further
      hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic
      patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate
      for this study because the research staff will enroll patients with moderate (K greater than
      6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this
      population for more effective control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ESRD patients with serum potassium greater than or equal to 6.0 mEq/L

          -  Emergent dialysis not expected to be available for 6 hours

        Exclusion Criteria:

          -  new clinically significant arrhythmia on initial ECG

          -  patiromer is contraindicated

          -  have received SPS
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Condition: Edentulism
Intervention: Ankylos Implants; Biomet 3i Prevail Implants
Intervention description: ANKYLOS Implant System vs Certain PREVAIL Implant
Intervention MeSH terms: Cimetidine
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: subjects with edentulous mandible

Summary:

      Change in crestal bone level implants at 5% significance level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 to 80

          -  male or female (female non-pregnant)

          -  sufficient oral hygiene

          -  no inflammation/disorder in the area of implant site

          -  edentulous mandible and sufficient prosthetic and conservative

          -  sufficient width and height of bone to place implants with diameters of 4.8mm and
             length of 11 mm

          -  provide written informed consent

        Exclusion Criteria:

          -  demonstrate a need for pre-surgical bone or soft tissue augmentation in planned
             implant areas

          -  exhibit angulation requirements of restoration exceeding 15 degrees

          -  systemic metabolic disorder that would compromise post-operative tissue regeneration
             or osseointegration

          -  taking medication that would compromise post-operative healing and/or osseointegration

          -  bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes
             mellitus

          -  oncology treatment

          -  oral infection

          -  acute gingivitis and/or periodontitis

          -  local bone defects in the area of planned implantation

          -  disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)

          -  received investigational drug within 30 days

          -  history of illicit drugs or alcohol abuse

          -  history of addiction to medication

          -  allergic to dental materials

          -  nicotine abuse (> 20 cigarettes/day)

          -  pregnant or nursing

          -  clinical significant or unstable medical or physiological conditions that would
             compromise participation in study

          -  unable or unwilling to return for follow-up visits for a period of 24 months
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Condition: Obesity; Glucose Homeostasis; Postmenopausal Symptoms
Intervention: Bazedoxifene/Conjugated Estrogens (BZA/CE); Placebo Oral Tablet
Intervention description: Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.; Daily placebo tablet
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: Female
Minimum age: 50 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The goal of this pilot clinical study is to perform a randomized placebo-controlled study to
      assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens
      (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women.
      The recruitment will be performed at Tulane Health Sciences Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women (<5y since final menstrual period) with age between 50-60y

          -  Symptomatic (hot flashes, vaginal dryness) or asymptomatic

          -  BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)

          -  Fasting glucose <125mg/dl

          -  Triglycerides <200mg/dl

          -  Normal mammogram within past 12 months

          -  Physician clearance

        Exclusion Criteria:

          -  Amenorrhea from other causes (Hyperandrogenemia and anovulation)

          -  type 2 and type 1 diabetes

          -  Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy,
             antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss
             drugs

          -  ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)

          -  Hysterectomy (partial or complete)

          -  Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic
             disease, bleeding disorder, past/present history of breast or uterine cancer,
             pregnant, breastfeeding)
Comparability and Standardization of Controlled Allergen Challenge Facilities
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Cetirizine; Placebo
Intervention description: Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.; Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits
Intervention MeSH terms: Cetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Allergen challenge facilities have been utilized for many years in clinical drug trials
      studying onset of action, proof of concept, duration of action, and efficacy. Each facility
      has somewhat different design characteristics and pollen dispersal technologies. Facilities
      are located in disparate geographic areas and have populations of participants who are
      sensitized to allergens unique to that area. Therefore, facilities have operated as single
      sites with little effort to evaluate facility comparability or to attempt standardization
      across facilities. The purpose of this study is to compare the two sites and assess whether
      the sites are able to achieve similar symptom scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of rhinoconjunctivitis during ragweed season for a minimum of 2 years,
             including the previous 2 ragweed seasons.

          -  positive skin test to ragweed allergen.

        Exclusion Criteria:

          -  participant is pregnant, lactating or actively trying to conceive.

          -  has a history of receiving immunotherapy containing short ragweed within the last 3
             years.

          -  participant has current allergy symptoms.
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Condition: Bronchospasm; Activity/Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Intervention: Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention description: Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 248.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: asthma; bronchospasm

Summary:

      During this study, your child will need to attend up to 5 office visits and maintain regular
      telephone contact with the clinic. Certain office visits will include physical exams, medical
      history review, exercise challenge test (walking/running on a treadmill), electrocardiogram
      (ECG) tests, and lung function tests. All study related medications and medical examinations
      are provided at no cost. All study drugs are currently available by prescription to patients
      4 years and older.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosed with persistent asthma for 3 months or longer.

          -  Experienced worsened asthma symptoms during physical activity.

          -  Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid,
             Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

        Exclusion criteria:

          -  Used systemic steroids as either liquids, pills, or injections to treat asthma within
             the previous 3 months.

          -  Have only intermittent, seasonal, or exercise-induced asthma, and not persistent
             asthma.

          -  Admitted to a hospital within the previous 6 months due to asthma symptoms.

          -  Any poorly controlled medical conditions that may make study participation unsafe or
             inappropriate in the opinion of the study physician (such as cystic fibrosis,
             congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)

          -  The study physician will evaluate other medical criteria.
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Condition: Prophylaxis of Acute Mountain Sickness
MeSH terms: Altitude Sickness
Intervention: Low Dose Acetazolamide; Normal Dose Acetazolamide
Intervention description: Administration of low dose acetazolamide; Administration of normal dose acetazolamide
Intervention MeSH terms: Acetazolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 4, randomized, double-blinded interventional trial comparing alternative
      doses of Acetazolamide for the prevention of High Altitude Illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  English or Indian speaking

          -  Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt.
             Everest

        Exclusion Criteria:

          -  Low sodium and/potassium blood serum levels

          -  Kidney disease or dysfunction

          -  Liver disease, dysfunction, or cirrhosis

          -  Suprarenal gland failure or dysfunction

          -  Hyperchloremic acidosis

          -  Angle-closure glaucoma

          -  Taking high dose aspirin (over 325 mg/day)

          -  Any reaction to sulfa drugs or acetazolamide

          -  Pregnant or lactating women
DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Condition: Dysfunctional Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Intervention: Medroxyprogesterone 17-Acetate; medroxyprogesterone acetate
Intervention description: Medroxyprogesterone 20mg orally 3 times a day for 3 days; Depo Provera 150mg Intramuscular injection
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the effectiveness and acceptability of high dose
      MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg
      intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been
      identified as being eligible for outpatient management
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18- 50

          -  Non-pregnant

          -  Candidate for outpatient management

          -  Able to understand and follow instructions

          -  Vital signs stable

          -  No severe anemia

          -  No medical conditions requiring transfusion

        Exclusion Criteria:

          -  Pregnancy

          -  Breast cancer current or in last 5 years

          -  Allergy to MPA or DMPA

          -  Previous hormonal therapies

          -  Unstable vital signs

          -  Bleeding excessive enough to require surgical therapy or hospital admission

          -  Desire for pregnancy in next 6 months
The Use of Intranasal Ketoralac for Pain Management (Sprix)
Condition: Postoperative Pain Management; Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Intervention: Intranasal Ketoralac; Placebo
Intervention description: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery; 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sprix; Intranasal ketoralac; Ketoralac; Urolithiasis; Kidney stone; Uretal stone; Ureteroscopic removal of stones; URS; Pain management; Pain

Summary:

      Despite an overall reduction in the perioperative complication rate, post operative pain
      management after ureteroscopic removal of stones (URS) remains a major factor delaying
      discharge of patients. The investigators hypothesize that perioperative usage of intranasal
      ketorolac will provide a reduction in post operative opioid requirements, better post
      operative pain control, higher anesthesia satisfaction and faster recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ureteroscopic stone removal surgeries with stenting

          -  Age ≥ 18 years and < 65 years

          -  Stable patient with stable vital signs

          -  Mentally competent and is able to understand consent form

        Exclusion Criteria:

          -  Unstable patients

          -  Patients with multiple trauma sites

          -  Patients with allergies to ketorolac or any of the components in the nasal spray
             preparation

          -  Patients with active peptic ulcer disease

          -  History of asthma, urticaria, or other allergic-type reactions after taking aspirin or
             other NSAIDs

          -  Renal disease or at risk for renal failure due to volume depletion

          -  Pregnant or nursing mothers

          -  Nasal abnormality or illness that could affect the absorption of intranasal medication
             (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute
             epistaxis, nasal polyp, nasal tumor)

          -  Any other contraindication to the use of Sprix, or in whom use of Sprix would not be
             consistent with the approved package insert
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Condition: Hypothyroidism; Trisomy 21
MeSH terms: Down Syndrome; Hypothyroidism; Trisomy
Intervention: Liquid stable levothyroxine (L-T4) Tirosint-SOL; Oral tablet levothyroxine (L-T4)
Intervention description: Investigation of tolerability, palatability, and adherence of liquid levothyroxine (L-T4) for 8 weeks.; Investigation of tolerability, palatability, and adherence of maintained oral tablet levothyroxine (L-T4) for 8 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase 4, single-center, pilot, randomized, open-label, cross-over study
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 2 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Tolerability; Adherence

Summary:

      Children with levothyroxine (T21) have developmental delay and other functional
      gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For
      an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended
      in water, breast milk or formula for administration in order to treat children with
      hypothyroidism. For this age group, ease of administration may have a significant impact on
      compliance and ability to remain euthyroid. We propose that Tirosint-SOL® will be more
      favorably received due to ease of administration, improved tolerability and palatability,
      therefore leading to improved adherence when compared to L-T4 tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trisomy 21 children age 2 months to less than 5 years of age

          -  Prior confirmed diagnosis of congenital or acquired hypothyroidism

        Exclusion Criteria:

          -  Gestational age ≤ 35 weeks, concomitant anticonvulsant medications, history of
             nonadherence with medication or medical visit schedule

          -  Subjects must be able to take oral medication, no G-tube or parental fed subjects