bioihbjkbjnl/mcl2 huggingface dataset:
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Long-Term Follow-Up of Patients who Received Engensis (VM202); Long-Term Follow-Up of Patients who Received Placebo
Intervention description: No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.; No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long term, prospective, non-interventional, safety extension study of phase 3 trial. Double blind, randomized, placebo-controlled, multicenter study/
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetic; neuropathy; shooting pain; burning pain; pins and needles pain; foot pain; ViroMed; Helixmith; Engensis; VM202

Summary:

      The purpose of this study is to explore the overall safety profile and durability of efficacy
      of Engensis (VM202) in painful diabetic peripheral neuropathy.

      All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270
      visit within the prior 90 days will be approached to enroll in the long-term safety extension
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Were randomized and dosed in the VMDN-003 study

          2. Received all IM injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003
             study

          3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90
             days prior to signing consent

        Exclusion Criteria:

          1. Were using an investigational drug or treatment

          2. Were unable or unwilling to give informed consent
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazodone
Intervention description: Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder, GAD

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatient, 18-70 years of age

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder

          -  Minimum score of 20 on Hamilton Rating Scale for Anxiety

        Exclusion Criteria:

          -  Women who are pregnant or who will be breastfeeding during the study

          -  Patients with a history of:

               1. Any manic or hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic or mixed episode

               2. Any depressive episode with psychotic or catatonic features

               3. Panic disorder with or without agoraphobia
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: teduglutide
Intervention description: Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: SBS; Pediatric SBS; Short Bowel Syndrome

Summary:

      This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide
      in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into
      an observational cohort who will receive standard of care. Three doses of teduglutide are to
      be investigated for 12 weeks. All subjects will be screened prior to the start of treatment
      (SOT) to establish baseline characteristics including safety, eligibility and nutritional
      support parameters.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Current history of SBS as a result of major intestinal resection, (eg, due to
             necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for
             at least 12 months prior to screening

          -  Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support

          -  Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion
             of the investigator

        Key Exclusion Criteria:

          -  Serial transverse enteroplasty or any other bowel lengthening procedure performed
             within the past 3 months

          -  Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known
             DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome)

          -  Evidence of obstruction on upper gastrointestinal (GI) series done within 6 months
             prior to screening

          -  Major gastrointestinal surgical intervention within 3 months prior to screening
             (insertion of feeding tube or endoscopic procedure is allowed)
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Tiotropium
Intervention description: QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1; Tiotropium (18 μg o.d.), delivered via Handihaler®
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; QVA149; NVA237; indacaterol; combination bronchodilator

Summary:

      This is a 52-week treatment, multi-center, randomized, open label, parallel group study to
      assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237
      ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with
      moderate to severe chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack
             years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20
             years etc.)

          -  Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30%
             and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity
             (FVC) < 0.7 at Visit 2.

        Exclusion Criteria:

          -  Pregnant women or nursing mothers or women of child-bearing potential not using an
             acceptable method of contraception

          -  Patients requiring long term oxygen therapy

          -  Patients who have had a lower respiratory tract infection within 4 weeks prior to
             Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with history of malignancy of any organ system (including lung cancer),
             treated or untreated, within the past 5 years

          -  Patients with a history of certain cardiovascular comorbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for treatment with, or having a history of reactions/
             hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists,
             sympathomimetic amines

        Other protocol-defined inclusion/exclusion criteria may apply
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Condition: Contraception
Intervention: DR-1011
Intervention description: Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2235.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pregnancy prevention; oral contraceptives

Summary:

      This is an open-label, single treatment study. All subjects will receive one year of oral
      contraceptive therapy with DR-1011. Study participants will receive physical and
      gynecological exams, including Pap smear. During the study, all participants will be required
      to complete a diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal

          -  Not pregnant or breastfeeding

          -  Sexually active at risk of pregnancy

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Pregnancy within the last 3 months

          -  Smoking > 10 cigarettes per day
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Drug: CD07805/47 gel; CD07805/47 gel Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema
      associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once
      daily is more efficacious than vehicle and provides an acceptable safety profile in the
      treatment of facial erythema associated with rosacea
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female who is at least 18 years of age or older.

          2. A clinical diagnosis of facial rosacea.

          3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
             and at Baseline/Day 1 (prior to the study drug application).

          4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
             at Baseline/Day 1 (prior to the study drug application).

        Key Exclusion Criteria:

          1. More than 20 facial inflammatory lesions of rosacea

          2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
             that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
             sedatives, systemic anesthetics, or alpha agonists.

          4. Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac
             glycosides, beta blockers or other antihypertensive agents.

          5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Ezetimibe; Placebo (for Alirocumab); Placebo (for Ezetimibe)
Intervention description: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.; One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.; 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self--injection or by another designated person using the autoinjector.; One capsule orally once daily at approximately the same time of the day with or without food..
Intervention MeSH terms: Ezetimibe; Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
      (proprotein convertase subtilisin/kexin type 9).

      Primary Objective of the study:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in
      comparison with ezetimibe after 24 weeks of treatment in participants with
      hypercholesterolemia.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time
           points

        -  To evaluate the effect of alirocumab on other lipid parameters

        -  To evaluate the safety and tolerability of alirocumab
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with hypercholesterolemia

        Exclusion criteria:

          -  Age < 18 or legal age of adulthood, whichever was greater

          -  LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)

          -  Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L)

          -  Known history of homozygous or heterozygous familial hypercholesterolemia

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA; TEZ/IVA
Intervention description: FDC tablet for oral administration.; Mono-tablet for oral administration.; Fixed-dose combination (FDC) tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX,
      VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
      cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function
      mutation (F/G and F/RF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a
             gating or residual function mutation (F/G and F/RF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; placebo MTX; placebo TCZ; tocilizumab [RoActemra/Actemra]
Intervention description: orally weekly in ascending dosages, starting at 10mg/week; orally weekly; iv every 4 weeks; 8mg/kg iv every 4 weeks
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treat-to-target, tight control, strategy study, TCZ, MTX

Summary:

      This randomized, double-blind, placebo-controlled study will compare the efficacy with regard
      to sustained remission and safety of tocilizumab and methotrexate, in combination or as
      monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be
      randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate
      (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or
      methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample
      size is 300.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  early rheumatoid arthritis (disease symptoms <1 year) according to ACR criteria

          -  disease activity DAS28 >2.6

          -  body weight </=110kg, BMI </=36

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA

          -  current inflammatory joint disease other than RA

          -  previous treatment with any DMARD or biologic drug used in the treatment of RA

          -  intra-articular, parenteral or oral glucocorticoids used for the arthritis
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
Condition: Skin and Subcutaneous Tissue Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial
Intervention: TR-701 FA; Linezolid
Intervention description: Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.; Oral Linezolid 600 mg twice daily for 10 days
Intervention MeSH terms: Linezolid; Tedizolid phosphate; Tedizolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Tedizolid Phosphate; TR-701; Acute Bacterial Skin and Skin Structure Infections

Summary:

      This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA
      200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days
      for the treatment of ABSSSI in adults.

      Approximately 75 to 100 sites globally will participate in this study. Patients with an
      ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be
      randomized 1:1 to study treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with systemic signs of infection diagnosed with acute bacterial skin and skin
             structure infection (ABSSSI)

          -  Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

        Exclusion Criteria:

          -  Uncomplicated skin infections

          -  Severe sepsis or septic shock

          -  ABSSSI solely due to gram-negative pathogens