bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Levetiracetam; Epilepsy; Nonpsychotic behavior

Summary:

      Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects
      with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side
      effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis
      testing will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with well-characterized Epilepsy according to the 1989 International League
             Against Epilepsy (ILAE) classification

          -  Subject with Epilepsy who the investigator expects will benefit from Levetiracetam
             (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic
             behavioral side effects following the introduction of LEV

          -  Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging
             from 1 g/day to 3 g/day)

          -  Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs)
             including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
             concomitant AED

          -  Female subjects without childbearing potential (postmenopausal for at least 2 years,
             bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female
             subjects with childbearing potential are eligible if they use a medically accepted
             contraceptive method

        Exclusion Criteria:

          -  Subject has a lifetime history of suicide attempt (including an actual, interrupted or
             aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a
             positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide
             Severity Rating Scale (C-SSRS) at Visit 1

          -  Subject whose seizures could not be reliably counted on a regular basis due to their
             fast and repetitive occurrence (clusters or flurries)

          -  Subject has history or presence of status epilepticus during the year preceding Visit
             1 or during Baseline

          -  Subject has history or presence of known psychogenic nonepileptic seizures

          -  Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic
             disease, and/or severe renal impairment) which impair reliable participation in the
             study or necessitate the use of medication not allowed by protocol

          -  Subject is pregnant or lactating
Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Idebenone; Placebo
Intervention description: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).
Intervention MeSH terms: Idebenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: randomized withdrawal; idebenone; friedreich's ataxia; Miconos; Patient reported outcome; ICARS

Summary:

      This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to
      further investigate the effects of idebenone in patients with Friedreich's ataxia.

      The objective of the PROTI study is to establish whether patients can correctly determine
      which treatment assignment (placebo or idebenone) they received during the randomised phase
      of the trial, and identify any potential changes on symptoms or activities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension
             study

          -  Patients who in the opinion of the investigator are able to comply with the
             requirements of the study

          -  Body weight ≥ 25kg

          -  Negative urine pregnancy test

        Exclusion Criteria:

          -  AE during the course of the MICONOS extension study which in the opinion of the
             investigator is attributable to idebenone and precludes further treatment with
             idebenone

          -  Clinically significant abnormalities of clinical haematology or biochemistry
             including, but not limited to, elevations greater than 1.5 times the upper limit of
             normal SGOT, SGPT or creatinine

          -  Parallel participation in another clinical drug trial

          -  Pregnancy or breast-feeding

          -  Abuse of drugs or alcohol

          -  Any change of concomitant medication within the last 30 days that in the opinion of
             the investigator the intake could negatively impact the study
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: SOF; RBV; Placebo to match SOF; Placebo to match RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); Placebo to match SOF administered orally once daily; Placebo to match RBV administered orally in a divided daily dose
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Genotype 2; Genotype 3

Summary:

      This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with
      ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 with chronic genotype 2 or 3 HCV infection

          -  HCV RNA > 10,000 IU/mL at screening

          -  Subjects must be treatment naive or treatment experienced

          -  Presence or absence of cirrhosis; a liver biopsy may be required

          -  Healthy according to medical history and physical examination with the exception of
             HCV diagnosis

          -  Agree to use two forms of highly effective contraception for the duration of the study
             and 6 months after the last dose of study medication

        Exclusion Criteria:

          -  Prior use of any other inhibitor of the HCV NS5B Polymerase

          -  History of any other clinically significant chronic liver disease

          -  Evidence of or history of decompensated liver disease

          -  HIV or chronic hepatitis B virus (HBV) infection

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of immunosuppressive agents or immunomodulatory agents

          -  History or current evidence of any condition, therapy, laboratory abnormality or other
             circumstance that might confound the results of the study, or interfere with the
             subject's participation for the full duration of the study or not be in the best
             interest of the subject in the opinion of the investigator
Prevention of Recurrence of Diverticulitis
Condition: Diverticulitis
MeSH terms: Diverticulitis; Recurrence
Intervention: SPD476, MMX™ mesalazine, 1.2g extended release tablet; SPD476, MMX™ mesalazine, 2.4g extended release tablet; SPD476, MMX™ mesalazine, 4.8g extended release tablet; Placebo
Intervention description: SPD476 1.2g administered Once Daily (QD); SPD476 2.4g administered Once Daily (QD); SPD476 4.8g administered Once Daily (QD); Placebo administered Once Daily (QD)
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SPD476 is effective in reducing recurrence
      of diverticulitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females =>18yrs of age.

          2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG
             (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any
             applicable contraceptive requirements of the protocol

          3. An episode of acute diverticulitis that resolved without colonic resection.

          4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at
             least three diverticula noted

        Exclusion Criteria:

          1. Previous colorectal surgery, including surgical intervention for diverticular disease
             (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)

          2. Active peptic ulcer disease

          3. History of or current presence of inflammatory bowel disease (IBD)

          4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication

          5. Allergy or hypersensitivity to aspirin or related compounds

          6. Allergy to radiologic contrast agents

          7. Use of another Investigational product within 30 days of Baseline

          8. Use of antibiotic therapy within 4 weeks of Baseline

          9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well
             as drugs active at the 5HT-receptor or anti-spasmodic agents

         10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal
             steroids is acceptable

         11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except
             for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis

         12. History of alcohol or other substance abuse within the previous year

         13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to
             Baseline

         14. Females who are lactating
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: CB-5945; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Constipation; Chronic; Pain

Summary:

      The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment
      of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer
      pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily
             dose (METDD) for chronic non-cancer pain

          -  Has constipation that is caused by the chronic use of opioids

          -  Is willing to use only the study provided laxative(s) and to discontinue use of all
             other laxatives, enemas, stool softeners, and other medications to treat constipation
             (e.g., lubiprostone) from Screening until the last study assessment

        Key Exclusion Criteria:

          -  Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for
             example [e.g.], obstruction) or contribute to bowel dysfunction

          -  Has evidence of intestinal obstruction

          -  Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of
             screening

          -  Has an active malignancy of any type (participants with a history of successfully
             treated malignancy >5 years before the scheduled administration of study medication
             and participants with treated basal or squamous cell cancer may be enrolled)

          -  Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide),
             prokinetics (e.g., metoclopramide), or locally acting chloride channel activators
             (e.g., lubiprostone)

          -  Is taking non-opioid medications known to cause constipation (e.g., iron sulfate
             therapy, tricyclic antidepressants)
Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol; Placebo
Intervention description: Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22); Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Moderate to Low Disease activity; Certolizumab pegol

Summary:

      To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with
      stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission
      in patients with moderate to low disease activity rheumatoid arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
             currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
             months and not longer than 10 years

        Exclusion Criteria:

          -  All the concomitant diseases or pathological conditions that could interfere and
             impact the assessment of the study treatment, or with the safety of the patient

          -  Previous clinical trials and previous biological therapy that could interfere with the
             results in the present clinical trial

          -  Patients must not have received any previous biological therapy for rheumatoid
             arthritis (RA)
Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: dapagliflozin; Glimepiride; metformin hydrochloride; pioglitazone hydrochloride; Rosiglitazone
Intervention description: tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks; tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks; rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice; rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice; rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Intervention MeSH terms: Metformin; Pioglitazone; Dapagliflozin; Glimepiride; Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dapagliflozin; efficacy; safety; sulphonylurea; Type 2 diabetes

Summary:

      This study is being carried out to see if dapagliflozin in addition to glimepiride
      (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared
      to glimepiride alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes

          -  Treatment with a stable sulphonylurea monotherapy dose that is at least half the
             maximal recommended dose for a minimum of 8 weeks prior to study

          -  Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

        Exclusion Criteria:

          -  Type 1 Diabetes

          -  Hepatic (liver) impairment

          -  Renal (kidney) failure or dysfunction
An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: rosiglitazone/glimepiride fix dose combination; glimepiride
Intervention description: oral, once daily, dosage is titrated according to FPG and hypoglycemia events; oral, once daily, dosage is titrated according to FPG and hypoglycemia
Intervention MeSH terms: Glimepiride; Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: rosiglitazone/glimepiride, fix dose, type 2 diabetes

Summary:

      The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose
      combination tablet will safely and effectively control glycemia as first-line oral therapy in
      drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of
      treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary
      objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in
      lowering Glycosylated Hemoglobin (HbA1c).
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  HbA1c between 7.5% and 11.0% at screening

          -  FPG between 7.0mmol/L and 13.3mmol/L at screening and at randomization visit

          -  subject was treated with diet and/or exercise alone

          -  QTc<450mesc or QTc<480msec for patients with bundle branch block

          -  Body Mass Index (BMI) >19kg/m2

          -  Subject has given written informed consent

        Exclusion Criteria:

          -  Documented history of significant hypersensitivity to thiazolidinediones,
             sulfonylureas, or compounds with similar chemical structures

          -  Ongoing edema or history of edema requiring pharmacological treatment in the 12 months
             prior to screening

          -  Presence of ischemic heart disease and/or peripheral arterial disease, or NYHA grade
             I-IV congestive heart failure

          -  Taking nitrates

          -  Clinically significant renal or hepatic disease

          -  Anemia

          -  Severe hypertriglyceridemia (TG>=5.65mmol/L)

          -  Use of oral corticosteroids and Nicotinic acid

          -  Systolic blood pressure <170mmHg, or diastolic blood pressure > 100mmHg while on
             anti-hypertensive treatment

          -  Hyperthyroidism requiring treatment

          -  Diagnosed macular edema

          -  Women who are lactating, pregnant, or planning to become pregnant

          -  Presence of an active cancer or recently treated for cancer

          -  Drug/alcohol abuse

          -  Unwilling or unable to comply with the procedures described in the protocol
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
Condition: Obesity
MeSH terms: Obesity; Overweight
Intervention: Lorcaserin 10 mg BID; Matching Placebo BID
Intervention description: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.; Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3182.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obesity; Weight loss; lorcaserin; APD356; BLOOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena

Summary:

      The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the
      first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight
      loss at the end of the second year of treatment (Week 104)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9
             kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia,
             cardiovascular disease, glucose intolerance, sleep apnea)

          -  Ability to complete a 2 year study

        Exclusion Criteria:

          -  Diabetes

          -  Pregnancy

          -  History of heart valve disease

          -  Serious or unstable current or past medical conditions