bioihbjkbjnl/mcl2 huggingface dataset:
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Body Weight
Intervention: Ursodiol
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether bile acids are able to increase insulin sensitivity and
      enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance
      glycemic control. These observations will provide the preliminary data for proposing future
      therapeutic as well as further mechanistic studies of the role of bile acids in the control
      of glycemia in T2DM.
    

Eligibility criteria:

        Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin,
        receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on
        treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
        neurological, endocrine (other than T2DM) and unstable psychiatric disease.

        Men or women. Women of childbearing potential will have a negative pregnancy test before
        initiation of medication.
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Haemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Coversin
Intervention description: Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to
      Eculizumab due to complement C5 polymorphisms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with known Paroxysmal Nocturnal Haemoglobinuria (PNH)

          -  LDH >=1.5 Upper Limit of Normal (ULN)

          -  Resistance to Eculizumab proven by both a recognised C5 polymorphism on genetic
             screening and complement inhibition on CH50 ELISA of <100% at concentrations of
             Eculizumab in excess of 50 μg/mL

          -  Willing to self-inject Coversin daily or to receive daily subcutaneous injections by a
             home nurse or in a doctor's office or hospital clinic

          -  Males or females taking adequate contraceptive precautions if of childbearing
             potential, 18 - 80 years of age

          -  Body weight ≥50kg and ≤ 100kg

          -  The patient has provided written informed consent.

          -  Willing to avoid prohibited medications for duration of study

          -  Must agree to take appropriate prophylactic precautions against Neisseria infection.

          -  Must be counselled regarding the possible reproductive risks of using Coversin and be
             advised to use an adequate method of contraception pending further data on
             reproductive toxicology.

        Exclusion Criteria:

          -  Body weight <50kg or>100kg

          -  Pregnancy (females)

          -  Failure to satisfy the PI of fitness to participate for any other reason

          -  Known allergy to ticks or severe reaction to arthropod venom (e.g., bee or wasp venom)
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab; Placebo
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-23 antibody

Summary:

      The main purpose of this study is to test the hypothesis that treatment with mirikizumab is
      superior to placebo in providing clinical benefit to participants with moderate to severe
      ulcerative colitis (UC). This study will also investigate how the body processes the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an
             endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note:
             a partial Mayo score of at least 4 and other eligibility criteria must have been met
             before endoscopy is performed as a study procedure)

          -  Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved
             colon)

          -  Up-to-date colorectal cancer surveillance (performed according to local standard), for
             subjects with family history of colorectal cancer, personal history of increased
             colorectal cancer risk, age >50 years, or other known risk factor

          -  Participants must either: be naive to biologic therapy (eg, tumor necrosis factor
             [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate
             response or failure to tolerate current treatment with oral or intravenous
             corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of
             corticosteroid dependence (an inability to successfully taper corticosteroids without
             return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF
             antagonists or vedolizumab) at doses approved for the treatment of UC with documented
             history of failure to respond to or tolerate such treatment

        Exclusion Criteria:

          -  Have been diagnosed with indeterminate colitis, proctitis (distal disease involving
             the rectum only; less than 15 cm from the anal verge) or Crohn's Disease

          -  Have had surgery for treatment of UC or are likely to require surgery for UC during
             the study

          -  Have received any of the following for treatment of UC: cyclosporine or thalidomide
             within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or
             topical treatment with 5-aminosalicyclic acid within 30 days of screening
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: oxytocin 100 micrograms; Normal Saline (preservative free)
Intervention description: oxytocin 100 micrograms administered intrathecally (IT); Normal Saline (preservative free) administered intrathecally (IT)
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; neuropathic pain

Summary:

      The purpose of the study is to determine the effect of oxytocin given into the spinal fluid
      on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic
      neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight < or equal to 240 pounds

          -  Neuropathic pain for > 6 months: with primary pain area below the umbilicus

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
             or lidocaine

          -  Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the
             Principal Investigator, would place the subject at increased risk (active gynecologic
             disease in which increased tone would be detrimental e.g., uterine fibroids with
             ongoing bleeding), compromise the subject's compliance with study procedures, or
             compromise the quality of the data

          -  Pregnancy

          -  spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment
             for > 3 months at a current dose of > 100 milligram (mg) morphine per day or
             equivalent.
Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Application of topical vitamin d3 (Top-D); Application of Aloe vera gel
Intervention description: Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days; aloe vera gel will be applied
Dosage: 1 gram Duration: 120 days Frequency: Daily
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assignment
Masking: Double (Participant, Investigator)
Enrollment: 550.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      After obtaining the approval from the IRB of University of Dammam and informed consent from
      550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency
      were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical
      examination was performed to rule out any diseases and complete blood picture, serum calcium,
      phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be
      done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and
      ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The
      participants were divided into two groups of 350 in study arm and 200 in control arm. All
      participants were instructed not to change their dietary habits and life style till the study
      was over. The study group of women were instructed to apply to apply Top-D (Proniosomal
      Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram
      of Aloe vera gel. The participants had no knowledge to which group they belong. A second
      blood sample was taken at the end of 4 months and the data was entered in the data base and
      analyzed using SPSS Inc version 19.
    

Eligibility criteria:

        Inclusion Criteria:

        all men and women with vitamin D insufficiency and deficiency Must be able to apple the
        topical vitamin D3 Must be willing to sign and informed consent

        Exclusion Criteria:

          -  Those who have normal 25OHD levels
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Valbenazine; Placebo oral capsule
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's
      optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric
      subjects with TS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Condition: Advanced or Inoperable Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Pamiparib; Placebo
Intervention description: 60 mg orally twice daily; 60 mg orally twice daily
Intervention MeSH terms: Pamiparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BGB-290; PARP inhibitor; Phase 2; maintenance therapy; gastric cancer; oral treatment; PARALLEL 303; PARALLEL; BGB290303; BGB-290-303

Summary:

      This study enrolled participants with previously-treated advanced or inoperable gastric
      cancer who have responded to first line platinum therapy into two treatment arms. In Arm A
      participants received BGB-290; in Arm B participants received placebo. The purpose of this
      study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free
      survival (PFS) in participants with advanced or inoperable gastric cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Signed informed consent.

          3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of
             the stomach or gastroesophageal junction.

          4. Received platinum based first line chemotherapy for ≤ 28 weeks.

          5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

          6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

          7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

          8. Adequate hematologic, renal and hepatic function.

          9. Must be able to provide archival tumor tissue for central biomarker assessment.

         10. Females of childbearing potential and non-sterile males must agree to use highly
             effective methods of birth control throughout the course of study and at least up to 6
             months after last dosing.

        Key Exclusion Criteria:

          1. Unresolved acute effects of prior therapy ≥ Grade 2.

          2. Prior treatment with PARP inhibitor.

          3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days
             prior to randomization.

          4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

          5. Diagnosis of myelodysplastic syndrome (MDS)

          6. Other diagnoses of significant malignancy

          7. Leptomeningeal disease or brain metastasis

          8. Inability to swallow capsules or disease affecting gastrointestinal function.

          9. Active infections requiring systemic treatment.

         10. Clinically significant cardiovascular disease

         11. Pregnant or nursing females.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: rebamipide
Intervention description: 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Rebamipide; Enema; Ulcerative Colitis

Summary:

      The purpose of this study is to examine the safety and efficacy of rebamipide by once daily
      intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with
      active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with active ulcerative colitis

          2. Patients having an insufficient response to ASA oral formulation: (1) Patients whose
             ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration
             is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with
             continuous bloody stools from ≥2 weeks prior to the day before registration, (3)
             Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for
             "endoscopic findings"

          3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and
             rectum (with lesions not extending beyond the splenic flexure)

          4. Outpatients

        Exclusion Criteria:

          1. Patients who have a history of intestinal resection (other than appendiceal resection)

          2. Patients who have a complication of malignant tumor

          3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to
             become pregnant during the study period

          4. Patients who have complications of serious cardiac, hepatic or renal impairment
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Condition: Other Abortion; Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Intervention: Gabapentin; Placebo
Intervention description: 600mg Gabapentin administered orally 1-2 hours prior to procedure; Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uterine aspiration

Summary:

      This is a randomized controlled double-blind placebo-controlled trial evaluating the impact
      of gabapentin given preoperatively on perioperative pain scores for women receiving uterine
      aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a
      prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the
      abortion setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women >=18 years-old

          -  Presenting for a surgical abortion

          -  No contraindication to outpatient abortion

          -  No contraindication to gabapentin

          -  Fluency in English and able to provide informed consent

        Exclusion Criteria:

          -  Allergy, sensitivity or contraindication to gabapentin

          -  Severe renal disease

          -  Currently using gabapentin or pregalabin
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Condition: Anemia; Dialysis-Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: vadadustat; epoetin alfa
Intervention description: vadadustat; epoetin alfa
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; kidney; dialysis-dependent chronic kidney disease; CKD; DD-CKD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI; hyporesponder; hyporesponsive; epoetin alfa; hemoglobin; erythropoiesis stimulating agent; ESA

Summary:

      This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa
      for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease
      (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥18 years of age

          -  Receiving chronic maintenance hemodialysis for end-stage kidney disease

          -  Currently receiving epoetin alfa for anemia

          -  Hb between 8.5 and 10.0 g/dL during screening

        Exclusion Criteria:

          -  Anemia due to a cause other than CKD or presence of active bleeding or recent blood
             loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Anticipated to recover adequate kidney function to no longer require hemodialysis
             during study participation