bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease
Condition: Pompe Disease; Glycogen Storage Disease Type II (GSD II)
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Intervention: alglucosidase alfa
Intervention description: Intravenous (IV) infusion of 20mg/kg body weight every other week (qow)
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No

Summary:

      -  The primary objective of this study was to characterize the pharmacokinetics (PK) of
           alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed
           diagnosis of Pompe disease.

        -  A secondary objective of this study was to evaluate and explore the relationship between
           anti-recombinant human acid alpha-glucosidase antibody titers and the PK of
           alglucosidase alfa.
    

Eligibility criteria:

        Inclusion Criteria:

        A participant was to meet all of the following criteria to be eligible for this study:

          -  The participant and/or the participant's parent/legal guardian was willing and able to
             provide signed informed consent.

          -  The participant had a confirmed acid alpha-glucosidase (GAA) enzyme deficiency from
             skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.

          -  Infant and toddler Pompe disease participants could be included in the study only
             under condition (minimal body weight) that the trial-related blood loss (including any
             losses in the maneuver) would not exceed 3 percent (%) of the total blood volume
             during a period of 4 weeks and would not exceed 1 % at any single time.

          -  The participant, if female and of childbearing potential, must have had a negative
             pregnancy test (urine beta-human chorionic gonadotropin) at screening. Note: All
             female participants of childbearing potential and sexually mature males must have
             agreed to use a medically accepted method of contraception throughout the study.

          -  For participants previously treated with alglucosidase alfa the participant had
             received alglucosidase alfa for at least 6 months.

        Exclusion Criteria:

        A participant who met any of the following criteria was excluded from this study:

          -  The participant was participating in another clinical study using an investigational
             product.

          -  The participant, in the opinion of the Investigator, was unable to adhere to the
             requirements of the study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Condition: Common Variable Immunodeficiency; Agammaglobulinemia
MeSH terms: Agammaglobulinemia; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Intervention: Vivaglobin
Intervention description: Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Year
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Previously Untreated Patient (PUP); Primary Immunodeficiency (PID); CVID; XLA; Subcutaneous immunoglobulin (SCIG); IgG trough level; Quality of life; Common variable immunodeficiency (CVID); X-linked agammaglobulinemia (XLA)

Summary:

      The objective of this study is to assess the efficacy and safety of Vivaglobin in previously
      untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation
      period. The purpose is to investigate whether PUPs will respond to subcutaneous
      immunoglobulin (SCIG) treatment with adequate trough levels without first receiving
      immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg
      body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of
      500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG
      therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent, age-adapted

          -  Male or female aged 1 to 70 years

          -  Diagnosis of primary humoral immunodeficiency

          -  No prior immunoglobulin substitution therapy

          -  IgG level of <5 g/L at screening

          -  Women of childbearing potential must use medically approved contraception and must
             have a negative urine pregnancy test at screening

        Key Exclusion Criteria:

          -  Evidence of serious infection between screening and first treatment

          -  Bleeding disorders that require medical treatments

          -  Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a
             clinically significant defect in cell mediated immunity

          -  Any condition likely to interfere with evaluation of the study drug or satisfactory
             conduct of the trial
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Condition: Hypertension in Pregnancy; Preeclampsia Severe; Gestational Hypertension; Postpartum Preeclampsia; Postpartum
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Intervention: NIFEdipine ER; Enalapril
Intervention description: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.; Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Intervention MeSH terms: Enalapril; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates whether nifedipine or enalapril is better at decreasing the amount of
      medical resources used in the postpartum period by women who have high blood pressure in
      pregnancy and the postpartum period. Half of participants will receive enalapril while the
      other half will receive enalapril. We will compare the two groups in the amount of medical
      resources used which we are defining as prolonged hospitalizations, unscheduled medical
      visits and/or hospital readmissions in the postpartum period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic
             hypertension

          -  provider wanting to initiate antihypertensive in the postpartum period

          -  the patient is not currently on >1 antihypertensive

          -  plans to receive postpartum care at the hospital or affiliated clinic

        Exclusion Criteria:

          -  sustained pulse <60 or >120 BPM over four hours

          -  allergy to any of the antihypertensives

          -  creatinine greater than or equal to 1.5

          -  strict contraindication to any of the antihypertensives

          -  history of failed treatment with any of the antihypertensives
GrafixPL PRIME Evaluation Case Study
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Intervention: GrafixPL PRIME
Intervention description: GrafixPL PRIME
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40)
      that receive optimal treatment including serial wound debridement and off-loading with total
      contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data
      on other potential confounding factors that could affect healing such as medications,
      tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity.
      Wound healing, including wound size and adverse events will be evaluated. The objective of
      this study is to understand the use of this product to evaluate wound healing in 40 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  18-90 years of age

          -  Chronic foot ulceration below the ankle - persistent for 30 days or longer

          -  Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as
             the formal imaging ABI may not be resulted prior to surgery)

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  <18 or >90 years of age

          -  History of poor compliance with follow-up visits

          -  Gangrene

          -  Untreated Osteomyelitis

          -  Widespread malignancy

          -  Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines

          -  Currently Pregnant or planning pregnancy during the course of intended participation
             in the study

          -  Is nursing or actively lactating
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: DEFINITY®
Intervention description: DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1060.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DEFINITY; Safety; Survelliance

Summary:

      The purpose of this registry study is to gather safety information on the current clinical
      use of and the safety of DEFINITY®
    

Eligibility criteria:

        Inclusion criteria

          -  Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to
             suboptimal, unenhanced images.

        Exclusion criteria

          -  Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.

          -  Prior SAE associated with perflutren, DEFINITY®, or administration of other echo
             contrast agent.
Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Condition: Neuromuscular Blockade; Pain; Laparoscopy
Intervention: Rocuronium; placebo
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.
      Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure
      (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

      Primary hypothesis:

      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative
      pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective laparoscopic hysterectomy (total/subtotal)

          -  Can read and understand Danish

          -  Informed consent

        Exclusion Criteria:

          -  BMI > 30 kg/cm2

          -  Known allergy to medications that are included in the project

          -  Severe renal disease, defined by S-creatinine > 0,200 mmol/L, GFR < 30ml/min or
             hemodialysis)

          -  Neuromuscular disease that may interfere with neuromuscular data

          -  Lactating

          -  Impaired liver function

          -  Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)
Does Omeprazole Decrease Intestinal Calcium Absorption?
Condition: Osteoporosis; Achlorhydria; GERD; Hip Fracture
MeSH terms: Osteoporosis; Achlorhydria; Hip Fractures
Intervention: Omeprazole
Intervention description: 40 mg po qAM one-half hour before breakfast for 30 days
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Calcium Absorption; Fractional Calcium Absorption; Omeprazole; Stable Calcium Isotopes; Proton Pump Inhibitor; Intestinal Absorption of Calcium

Summary:

      The purpose of this study is to measure the effect of omeprazole on intestinal calcium
      absorption in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at least 5 years past menopause, defined as the last date of menses

        Exclusion Criteria:

          -  Allergy/Intolerance to orange juice

          -  Allergy/Intolerance to omeprazole or other PPI therapy

          -  Use of drugs that interact with omeprazole including oral anti-fungal agents,
             coumadin, diazepam, phenytoin & tacrolimus

          -  Use of antacids, PPI or H2-blocker therapy within the past two months

          -  Intestinal conditions associated with malabsorption or low gastric acid levels
             including Crohn's Disease, ulcerative colitis, pernicious anemia, bacterial
             overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month

          -  Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute

          -  Use of medications known to interfere with calcium metabolism, including oral steroids
             or anticonvulsants
Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)
Condition: Multiple Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: BF-200 ALA cream; MAL cream
Intervention description: The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then sun protection factor (SPF) 20 cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Ameluz cream on the area. After appropriate absorption time of 30 minutes, the patients will be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.; The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then SPF20 sun protection cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Metvix cream on the area. After appropriate absorption time of 30 minutes, the patientswill be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to compare the efficacy of two photosensitizers,
      methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the
      treatment of facial actinic keratosis. We use randomized, double-blinded prospective study
      design. The efficacy will be assessed clinically, histopathologically and
      immunohistochemically.
    

Eligibility criteria:

        Inclusion Criteria:

          -  actinic keratoses symmetrically on face or scalp

          -  age over 18 years

          -  there must be at minumum one ak sized 6mm2 symmetrically on both sides

          -  patients must be able to make the decision to attend independently

        Exclusion Criteria:

          -  pregnancy

          -  lactation

          -  lack of compliance
Intrathecal (IT) Baclofen Drug Distribution
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Intervention: Baclofen bolus injection
Intervention description: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location.
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: spinal cord injury; cerebral palsy; stroke

Summary:

      The goal of this pilot study to determine whether there is a significant therapeutic
      advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the
      spine. It is also a goal of this pilot study to determine whether the origin of spasticity
      influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located
      in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study
      the impact of catheter location on the reduction in spasticity within a group of patients who
      are scheduled for ITB trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients with spasticity from spinal origin (spinal cord injury)

          2. Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular
             accident)

          3. Adult women of child bearing age with a negative pregnancy test

        Exclusion Criteria:

          1. Patients with spasticity from Multiple sclerosis

          2. Pregnant women

          3. Patients under the age of 18 years

          4. Patients over the age of 50

          5. Patients who are unable to have an MRI scan of the total spine

          6. Patients with spinal deformity that would prevent easy access to the lumbar
             intrathecal space

          7. Patients who have an allergic reaction to IT baclofen

          8. Patients who have significant headache from CSF withdrawal

          9. Patients who have intradural blockage that prevents advancing the IT catheter to the
             level of C4
Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
Condition: Melasma
MeSH terms: Melanosis
Intervention: 20-30% Salicylic Acid peels to the right side of the face; 20-30% Salicylic Acid peels to the left side of the face
Intervention description: Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.; Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face
Intervention MeSH terms: Salicylic Acid; Salicylates
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Melasma; Dark spots on the face

Summary:

      This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream
      twice daily to affected areas on the face for 14 weeks and half the face will be peeled with
      20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20%
      salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the
      study will be to evaluate the safety and efficacy of salicylic acid combined with 4%
      hydroquinone versus 4% hydroquinone alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic women ages 18-65 years of age with moderate to severe melasma

          -  English and Spanish-speaking women

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Subjects who have used 4% hydroquinone within 3 months of study start

          -  Subjects who have used chemical peels, microdermabrasion or facial laser treatments
             within 9 months of study start
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Ribavirin; Peginterferon alfa-2a; Ribavirin; Peginterferon alfa-2a
Intervention description: 1000-1200mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks; 1000-1200mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 569.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc
      weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus
      non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on
      study treatment is 3-12 months and the target sample size is 500+ patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-65 years of age

          -  chronic hepatitis C , genotype 1

          -  serologic evidence of CHC infection by an antibody test

          -  chronic liver disease, consistent with CHC infection on a liver biopsy obtained within
             the past 18 months

          -  compensated liver disease

          -  use of 2 forms of contraception during the study in both men and women

        Exclusion Criteria:

          -  previous interferon or ribavirin therapy

          -  systemic antiviral therapy less than 24 weeks before first dose of study drug or
             expected need for this treatment any time during the study

          -  medical condition associated with chronic liver disease (eg, hemochromatosis,
             autoimmune hepatitis, alcoholic liver disease, toxin exposure)

          -  decompensated liver disease

          -  women who are pregnant or breastfeeding