bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome (PCOS); Irregular Menstrual Cycles; Androgen Excess
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome
Intervention: doxycycline; Sugar Pill
Intervention description: 200mg/day in divided doses of 100mg twice daily; 1 pill twice a day
Intervention MeSH terms: Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovarian Syndrome; Irregular Menstrual Cycles; Androgen Excess in Women

Summary:

      The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline,
      on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian
      Syndrome (PCOS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women between 18 and 40 years of age.

          2. History of PCOS with < 8 periods the proceeding year

          3. Clinical or biochemical evidence of androgen excess

          4. BMI <40

          5. Willingness to sign consent for study including participation with collection of blood
             specimens

          6. Willingness to discontinue OCP for duration of study period up to 36 weeks

        Exclusion Criteria:

          1. Pregnancy

          2. Hypersensitivity to doxycycline or tetracycline

          3. History of Cushing's syndrome

          4. History of hyperprolactinemia

          5. History of congenital adrenal hyperplasia

          6. Significant hepatic impairment, including serum AST or ALT >1.5 times upper limits of
             normal.

          7. Significant renal impairment, GFR <60 ml/min

          8. Current use of metformin, statins, glucocorticoids, spironolactone and/or
             anti-estrogens.
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Phleum pratense grass pollen allergen extract; placebo
Intervention description: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days; placebo tablet given once daily over 60 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: GRAZAX

Summary:

      To investigate the immunologic effects and safety of 60-day treatment of the Standardized
      Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass
      pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.

          -  Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.

          -  Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.

          -  If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram
             budesonide or equivalent

          -  Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined
             as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

        Exclusion Criteria:

          -  Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1
             second) of predicted value after adequate pharmacologic treatment) measured at Visit 1
             and Visit 2

          -  Clinical history of uncontrolled asthma within 3 months prior to the screening visit
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; placebo
Intervention description: adalimumab eow; placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis; Psoriasis; Placebo Controlled; Skin Disease; Double Blind

Summary:

      A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate
      to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriasis for at least 6 months.

          -  Must have stable plaque psoriasis for at least 2 months before screening and baseline
             visits.

          -  Participant must have a Psoriasis Area Severity Index score greater than or equal to
             10 at the baseline visit.

          -  Participant must have moderate to severe plaque Psoriasis, defined by Body Surface
             Area involvement greater than or equal to 10% at the baseline visit.

          -  Participant must have a Physicians Global Assessment of at least moderate disease at
             baseline visit.

        Exclusion Criteria:

          -  Diagnosis of other active skin diseases or skin infections.

          -  Participant has known hypersensitivity to adalimumab or it excipients.

          -  Participant has chronic recurring infections or active tuberculosis.

          -  Participant has demyelinating disease (including myelitis) or neurologic symptoms
             suggestive of demyelinating disease.

          -  Participant is known to have immune deficiency or is immunocompromised.
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Intervention: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Intervention description: qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3055.0
Sex: All
Minimum age: 10 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of the study is to determine if an investigational vaccine Gardasil
      (V501) with 4 components will provide an immune response and will be well tolerated in
      pre-adolescents and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents and pre-adolescents with no prior sexual history

          -  Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

        Exclusion Criteria:

          -  Prior Human Papillomavirus (HPV) vaccination

          -  Prior abnormal Paps

          -  Prior history of genital warts
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Propolis; Calcium Hydroxide
Intervention description: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.; it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Intervention MeSH terms: Propolis; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Flare up

Summary:

      This study evaluates the role of propolis paste as compared to calcium hydroxide (when used
      as intracanal medication) in prevention and treatment of pain after root canal treatment in
      necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the
      other half will receive propolis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis
             having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and
             4).

          -  Teeth with favorable root morphology.

          -  Teeth with closed apex.

        Exclusion Criteria:

          -  Teeth with PAI index 1 and 5.

          -  Patients who are on antibiotics.

          -  Patient with recent trauma to the jaw.

          -  Teeth with open apex

          -  Multi-rooted teeth.

          -  Vital teeth.

          -  Non-restorable teeth.

          -  Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or
             obliterated).

          -  Teeth associated with soft tissue abscess or swelling.

          -  Teeth with external or internal root resorption

          -  Re-treatment cases.

          -  Periodontally compromised teeth (like mobile teeth and teeth with excessive bone
             loss).

          -  Teeth requiring endodontic surgery.

          -  Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or
             opposing quadrant.

          -  Medically compromised patients (ASA-III and above), patients with special
             communication needs or who doesn't understand Urdu or English language.

          -  Patients allergic to bee pollen or honey products.
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Alisporivir; Peginterferon alfa-2a; Ribavirin; ALV Placebo
Intervention description: ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; ALV placebo soft gel capsules administered orally
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1081.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C; Cyclophilin inhibitor

Summary:

      This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy
      [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment
      in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic HCV infection

          -  HCV genotype 1

          -  No previous treatment for hepatitis C infection

          -  Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or
             equivalent at screening, no upper limit

          -  Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6
             months

        Exclusion criteria:

          -  HCV genotype different from genotype 1 or co-infection with other HCV genotype

          -  Co-infection with Hepatitis B or HIV

          -  Any other cause of relevant liver disease other than HCV

          -  Presence or history of hepatic decompensation

          -  Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1
             episode of elevated bilirubin (> ULN) in past 6 months

        Other protocol-defined inclusion/exclusion criteria may apply.
Dysport® Pediatric Lower Limb Spasticity Study
Condition: Cerebral Palsy; Muscle Spasticity; Children
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum toxin type A; Placebo
Intervention description: I.M. (in the muscle) injection on day 1 of a single treatment cycle.; I.M. injection on day 1 of a single treatment cycle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine whether Dysport® is effective in the
      treatment of increased stiffness of the calf muscles and to evaluate the safety of this
      treatment in children with Cerebral Palsy. In addition this study will also check whether
      Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 2 to 17 years with cerebral palsy

          -  Equinus foot position

          -  Ambulatory

          -  Intensity of muscle tone equal to or greater than 2 in affected lower limb, as
             measured on the Modified Ashworth Scale

        Exclusion Criteria:

          -  Fixed contracture

          -  Previous phenol, alcohol injection or surgical intervention

          -  Other neurological / neuromuscular disorder

          -  Severe athetoid or dystonic movements
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
Condition: Chronic Plaque Type Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457 300 mg; ustekinumab 45/90 mg; placebo secukinumab
Intervention description: Placebo
Intervention MeSH terms: Ustekinumab; 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: 676.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling

Summary:

      This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have
      plaque-type psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with moderate to severe plaque type psoriasis for at least 6 months before
             randomization

          -  patients eligible for systemic therapy with inadequately controlled psoriasis

        Exclusion Criteria:

          -  forms of sporiasis other than plaque type psoriasis

          -  previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting
             (IL)-17A or IL-17RA

        Other protocol-defined inclusion/exclusion criteria may apply
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: methoxy polyethylene glycol-epoetin beta; Epoetin alfa
Intervention description: 120-360 micrograms intravenous (iv) monthly, starting dose; As prescribed, iv, 3 times weekly
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare 'time and motion' (provider time spent on anemia management)
      and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera)
      and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis.
      Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive
      standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360
      micrograms (iv), monthly. After a titration period, average time spent on anemia treatment
      over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;

          -  CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;

          -  average hemoglobin (Hb) 10-12 g/dL over last 3 months.

        Exclusion Criteria:

          -  failed renal transplant within 12 months prior to screening;

          -  poorly controlled hypertension;

          -  previous treatment with Mircera.
Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
Condition: Idiopathic Pulmonary Fibrosis; Cough
MeSH terms: Pulmonary Fibrosis; Cough; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Thalidomide; Placebo
Intervention description: Thalidomide 50 - 100 mg by mouth daily; Placebo 50-100 mg by mouth per day
Intervention MeSH terms: Thalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: idiopathic pulmonary fibrosis cough

Summary:

      Idiopathic Pulmonary Fibrosis (IPF) is a rapidly progressive lung disorder that is often
      associated with a chronic, intractable cough. The etiology of the cough associated with IPF
      is unclear but it is often so severe that it adversely effects the patient's quality of life.
      We propose that thalidomide specifically suppresses the cough associated with idiopathic
      pulmonary fibrosis via its anti-inflammatory properties, by suppressing the excessive
      functional up-regulation of sensory fibers with in the respiratory tract of patients with
      IPF.

      This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial
      testing the efficacy of thalidomide in suppressing the chronic cough of IPF. The primary
      objective of this study is to determine the efficacy of thalidomide administered daily for 12
      weeks to suppress the chronic cough in patients with idiopathic pulmonary fibrosis as
      measured by cough specific questionnaires, scales and improved quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic pulmonary fibrosis for >3 months <5 years

          -  High resolution CT scan of chest consistent with IPF within the previous 12 months

          -  FVC > 40% and < 90% predicted, TLC >40% <80%, DLCo >30% <90%

          -  Chronic Cough - cough >8 weeks

          -  Age >50

          -  Non-child bearing potential

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Women of child bearing potential

          -  Known etiology of lung fibrosis other than IPF

          -  Significant respiratory toxin exposure

          -  Collagen Vascular Disease

          -  Use of narcotic anti-cough agent in last week

          -  significant peripheral vascular disease or neuropathy

          -  history of seizures

          -  poorly controlled diabetes

          -  allergy to thalidomide
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Regorafenib (Stivarga, BAY73-4506); Placebo; Best Supportive Care (BSC)
Intervention description: 160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off); matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off); BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 760.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer

Summary:

      This is a randomized, double-blind, placebo-controlled multi-center phase III study to
      evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer
      (CRC) who have progressed on/after all approved drugs for CRC
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological documentation of adenocarcinoma of the colon or rectum

          -  Progression during or within 3 months following the last administration of approved
             standard therapies. Patients treated with oxaliplatin in an adjuvant setting should
             have progressed during or within 6 months of completion of adjuvant therapy

          -  Patients with measurable or non measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1

          -  Life expectancy of at least 3 months

          -  Adequate bone marrow, liver and renal function

        Exclusion Criteria:

          -  Unstable/uncontrolled cardiac disease

          -  History of arterial or venous thrombotic or embolic events

          -  Symptomatic metastatic brain or meningeal tumors

          -  Patients with evidence or history of bleeding diathesis

          -  Interstitial lung disease - Persistent proteinuria >/= grade 3

          -  Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding
             alopecia and oxaliplatin induced neurotoxicity </= Grade 2