bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Finesse; Pen/Syringe (Usual injection device)
Intervention description: Finesse Insulin Delivery Patch; Pen/Syringe
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Insulin; Metabolic Diseases

Summary:

      The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when
      used in conjunction with basal insulin, achieves equivalent glycemic control when compared to
      multiple daily injections and to evaluate its preference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus on intensive insulin therapy

        Exclusion Criteria:

          -  Insulin pump therapy

          -  Current use of NPH or regular insulin

          -  Severe hypoglycemic episodes in prior 6 months

          -  Unstable cardiac disease, hepatic, or renal function
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Condition: Patellar Tendinitis
MeSH terms: Tendinopathy
Intervention: PRP; Dry Needling; Dry Needling - Sham
Intervention description: Injection of autologous platelet rich plasma (PRP); This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.; This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking description: Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No

Summary:

      The overall goal of this research is to find an effective treatment for patellar tendinopathy
      (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to
      investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function
      scores) and bio-mechanical (knee strength) measures will be correlated with disease
      modification changes assessed using conventional and novel quantitative magnetic resonance
      imaging (MRI) and ultrasound (US) techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age between 18 and 39 years

          2. Chronic (>3 months) PT

          3. Clinical examination consistent with PT

          4. MRI or US confirmation of PT

          5. Pain score of 3 or greater on a 10-point visual analogue scale

          6. Self-report failure of supervised physical therapy

          7. Self-report failure of at least 2 of the most common treatment options for PT (e.g.
             NSAIDs, relative rest, ice and bracing).

        Exclusion Criteria:

          1. Inability to comply with study follow-up requirements

          2. History of bleeding disorders or other hematologic conditions

          3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal
             tear, ligament injury or reconstruction)

          4. Full or partial patellar tendon tear

          5. Current use of anticoagulation or immunosuppressive therapy

          6. Prior knee trauma requiring medical attention or surgery

          7. Worker's compensation injury

          8. Daily opioid use for pain

          9. Contraindication to MRI.

         10. Systemic diseases such as Diabetes and connective tissue diseases.

         11. Prior PRP or DN procedure.

         12. Women that are pregnant
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
Condition: Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
Intervention: R932333; Placebo
Intervention description: R393233 6% (60 mg/g), bid; Placebo, bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Discoid Lupus Erythematosus; Systemic Lupus Erythematosus

Summary:

      The purpose of this study is to determine the safety, efficacy and tolerability of topical
      R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
      patients with active discoid lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).

          -  At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each
             with a minimum Erythema Rating Score of ≥ 2. At least 1 of the active discoid lesions
             must have been present (by history) for ≥ 3 weeks prior to screening.

          -  Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine,
             methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4
             weeks prior to randomization and must remain on the same dose throughout the study.
             Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be
             initiated ≥ 8 weeks prior to randomization.

        Exclusion Criteria:

          -  Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias,
             T cell deficiencies or HTLV-1 infection at any time prior to the study.

          -  Lymphoproliferative disease or previous total lymphoid irradiation.

          -  Uncontrolled or poorly controlled hypertension.

          -  History of psoriasis, eczema, or relevant atopy.

          -  Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing,
             solarium, phototherapy) within 2 weeks prior to randomization or during the study
             period.
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Bococizumab (PF-04950615;RN316); Bococizumab (PF-04950615;RN316); Bococizumab (PF-04950615;RN316); Placebo; Ezetimibe; Bococizumab (PF-04950615;RN316); Bococizumab (PF-04950615;RN316); Bococizumab (PF-04950615;RN316); Placebo
Intervention description: Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week; Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week; Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week; Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week; Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open); 50 mg Q14D SC for 16 week; 100 mg Q14D SC for 16 week; 150 mg Q14D SC for 16 week; Placebo Q14D SC for 16 week
Intervention MeSH terms: Ezetimibe; Bococizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: PF-04950615; Japan

Summary:

      The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C)
      lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two
      weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a
      stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose
      LDL-C is not controlled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population
             A).

          -  Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not
             controlled (Population B).

        Exclusion Criteria:

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality.

          -  Pregnant females; breastfeeding females; males and females of childbearing potential;
             males and females of childbearing potential who are unwilling or unable to use a
             highly effective method of contraception.

          -  Subjects who were administered or prior exposed to PF-04950615 and/or anti-body
             targeting PCSK9.
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
Condition: Influenza; Multiple Myeloma; Waldenstrom's Macroglobulinemia; Plasma Cell Disorders; MGUS
MeSH terms: Influenza, Human; Multiple Myeloma; Waldenstrom Macroglobulinemia
Intervention: Fluzone High Dose Vaccine; Standard of care/Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: influenza; multiple myeloma; Waldenstrom's macroglobulinemia

Summary:

      The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster
      to all patients with monoclonal gammopathies (irrespective of age) will lead to
      seroconversion rates exceeding 50% and more importantly, will reduce influenza-related
      morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the
      end of the flu season
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age ≥18 years at the time of signing the informed consent form.

          -  Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined
             Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active
             Waldenstrӧm Macroglobulinemia (WM).

        Exclusion Criteria:

          -  Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.

          -  Use of any other influenza vaccine for the 2015 to 2016 flu season.

          -  Women who are pregnant or plan to become pregnant in the study period.
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Colesevelam; Colesevelam matching placebo; Insulin glargine (Lantus)
Intervention description: Colesevelam 3.8g for 12 weeks; Colesevelam matching placebo for 12 weeks; Insulin glargine for 12 weeks
Intervention MeSH terms: Insulin Glargine; Colesevelam Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mechanism of action insulin sensitivity

Summary:

      This study is designed to assess the potential mechanism of action by which WelChol®
      (colesevelam) may improve blood glucose control in patients with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between the ages of 18 - 75, inclusive

          -  Diagnosed with type 2 diabetes

          -  Hemoglobin A1c value greater than or equal to 8.0%

          -  Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must
             be withdrawn)

          -  Overweight, obese (body mass index 25-45 kg/m2)

        Exclusion Criteria:

          -  Change of dose of lipid or blood pressure lowering therapy within past three months

          -  Previous treatment with colesevelam for hyperlipidemia

          -  Serum triglyceride greater than 500 mg/dL

          -  Serum low density lipoprotein-cholesterol less than 60 mg/dL
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Administered as intravenous infusion; Administered as intravenous infusion
Intervention MeSH terms: Lasmiditan
Phase: Phase 2
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
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine

Summary:

      This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment
      of migraine headache in order to select a dose range for further studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1
             and 1.2.1 (2004)

          -  History of migraine of at least 1 year

          -  Migraine onset before the age of 50 years

          -  History of 1 - 8 migraine attacks per month

          -  Male or female subjects aged 18 to 65 years

          -  Female patients of child-bearing potential must be using a highly effective form of
             contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)

          -  Able and willing to return to the clinic for treatment within 4 hours of the onset of
             a migraine headache

          -  Able and willing to give written informed consent

        Exclusion Criteria:

          -  History of life threatening or intolerable adverse reaction to any triptan

          -  Use of prescription migraine prophylactic drugs

          -  Pregnant or breast-feeding women

          -  Women of child-bearing potential not using highly effective contraception

          -  History or evidence of coronary artery disease, ischemic or hemorrhagic stroke,
             epilepsy or any other condition placing the patient at increased risk of seizures

          -  History of hypertension (controlled or uncontrolled)

          -  Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at
             screening

          -  Current use of hemodynamically active cardiovascular drugs

          -  History within the previous 3 years or current evidence of abuse of any drug,
             prescription or illicit, or alcohol

          -  Significant renal impairment

          -  Previous participation in this clinical trial

          -  Participation in any clinical trial of an experimental drug or device in the previous
             30 days

          -  Any medical condition or laboratory test which in the judgment of the investigator
             makes the patient unsuitable for the study

          -  Relatives of, or staff directly reporting to, the investigator

          -  Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to
             any excipient of COL-144
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Sofosbuvir; RBV; PEG
Intervention description: Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; Chronic Hepatitis C

Summary:

      The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir
      (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin
      (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate

          -  Naive to previous HCV treatment

        Exclusion Criteria:

          -  Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab

          -  History of any other clinically significant chronic liver disease
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Intervention: linaclotide acetate; Matching placebo
Intervention description: oral, once daily.; oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Constipation; Chronic Constipation; Microbia; linaclotide; linaclotide acetate; MD-1100

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of administration of
      linaclotide acetate in patients with chronic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is 18 years of age or older

          -  Patient meets colonoscopy requirements according to the American Gastroenterological
             Association

          -  Patient meets criteria for chronic constipation including weekly bowel movement
             frequency requirements and reports one or more symptoms of constipation according to
             protocol requirements

          -  Patient has successfully completed study requirements with no clinically-significant
             findings: physical exam, ECG, clinical laboratory tests

          -  Patient is fluent in English

        Exclusion Criteria:

          -  Patient reports loose or watery stools

          -  Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain

          -  Patient may not take prohibited medications per protocol

          -  Medical diagnoses, medical conditions, or family history that would not make the
             patient a good candidate for the study or limit the patient's ability to complete the
             clinical study
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
Condition: HIV-1
Intervention: OZ1 transduced cells
Intervention description: Long term follow up of previously infused OZ1 transduced cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Healthy volunteers: No
Keywords: Gene Therapy; Anti-HIV-1 Ribozyme; OZ1; HIV-1 Infections

Summary:

      The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency
      Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1
      Ribozyme [OZ1]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5
      years from initial infusion of study drug has elapsed and then yearly until withdrawal or
      study completion. The study will monitor for and record any ill effects from the gene therapy
      product to provide long term safety information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who were enrolled (between 18 and 45 years of age) in the base study
             "OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term
             follow-up study

          -  Patients must have received the Final Cell Product infusion in base study
             "OTH/OZ1-INT-1"

          -  Have signed Informed Consent Form

        Exclusion Criteria:

          -  All patients who were enrolled in the OTH/OZ1-INT-1 study and received the final cell
             product will be invited to participate in this long term follow-up study. After
             unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be
             withdrawn from this protocol
ScanBrit Dietary Intervention in Autism
Condition: Autism; Autism Spectrum Disorder (ASD)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Gluten- and casein-free diet
Intervention description: Removal of foods containing gluten (cereal produce) and casein (dairy produce)
Intervention MeSH terms: Caseins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: autism; autism spectrum disorder; diet; gluten; casein; intervention; peptide; randomised; controlled; adaptive design; Autism Diagnostic Observation Schedule (ADOS); Gilliam Autism Rating Scale (GARS); Vineland Adaptive Behaviour Scale (VABS); Attention-Deficit Hyperactivity Disorder (ADHD)-IV Scale

Summary:

      A growing body of research indicates that dietary intervention excluding foods containing the
      proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum
      disorder (ASD) may have a positive effect on behaviour and developmental outcome.

      In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a
      gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD
      concurrently with an abnormal urinary profile. Following random allocation to a diet or non-
      diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight
      months initially - progressing to 12 months if required. A non-diet control group continued
      with a normal diet.

      Assuming significant changes for the dietary group on the various outcome measures of
      behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary
      intervention for a further 12 months when outcome measures were again assessed at study end.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autism Spectrum Disorder (ASD)

          -  Diagnosis received at Centre for Autism or a psychiatric clinic

          -  Abnormal urinary peptide profile

        Exclusion Criteria:

          -  Medical treatment

          -  Epilepsy