bioihbjkbjnl/mcl2 huggingface dataset:
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Condition: Infertility
MeSH terms: Infertility
Intervention: Corifollitropin alfa; recFSH (follitropin beta)
Intervention description: Single injection of 150 μg corifollitropin alfa administered under protocol P06029; Daily recFSH 300 IU administered under protocol P06029.
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: Female
Minimum age: 35 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro

Summary:

      The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after
      the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single
      injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle
      stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled
      ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm
      injection (ICSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have provided written informed consent for the trial.

          -  Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which
             at least one embryo is thawed for use in a subsequent FTET cycle.
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Condition: Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Secukinumab 150mg; Secukinumab 300mg
Intervention description: 2 injections of placebo to secukinumab 150mg per dose; Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered; Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
Intervention MeSH terms: 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: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Moderate to Severe Plaque-type Psoriasis; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Summary:

      The purpose of this study was to demonstrate efficacy of autoinjector administered
      secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with
      moderate to severe chronic plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

          -  Severity of psoriasis disease meeting all of the following three criteria:

               -  Psoriasis Area and Severity Index (PASI) score of 12 or greater

               -  Investigator's Global Assessment (IGA) score of 3 or greater

               -  Total body surface area (BSA) affected of 10% or greater

          -  Inadequate control by prior use of topical treatment, phototherapy and/or systemic
             therapy.

        Exclusion criteria:

          -  Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
             pustular, erythrodermic, guttate).

          -  Current drug-induced psoriasis.

          -  Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

          -  Significant medical problems such as uncontrolled hypertension, congestive heart
             failure or a condition that significantly immunocompromises the subject.

          -  Hematological abnormalities.

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             untreated tuberculosis.

          -  History of lymphoproliferative disease or history of malignancy of any organ system
             within the past 5 years.

          -  Pregnant or nursing (lactating) women.
A Study With Pentasa in Patients With Active Crohn's Disease
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Intervention: Pentasa; Placebo
Intervention description: 6 g/day orally, 2 g in the morning and 4 g in the evening; 6 g/day orally, 2 g in the morning and 4 g in the evening
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose
      and a 4 g evening dose is efficacious in active mild to moderate CD.
    

Eligibility criteria:

        Inclusion Criteria (main):

          -  Age: at least 18 years

          -  CD symptoms/onset of disease: ≥ 3 months prior to Visit 1

          -  Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease

          -  A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or
             endoscopy)

          -  A Harvey-Bradshaw score between 5 and 12

          -  Males and non-pregnant, non-nursing women

          -  Mild to moderate active CD, defined by a CDAI score between 180 and 350

          -  Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L),
             or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50
             µg/g)

          -  Estimated creatinine clearance should be above 75 ml/min

        Exclusion Criteria (main):

          -  Any significant disease or disorder which, in the opinion of the Investigator, may
             either put the patient at risk because of participation in the trial, or may influence
             the results of the trial or the patient's ability to participate in the trial

          -  CD located to the upper gastrointestinal tract and/or jejunal part of the small
             intestine, and/or to colon below the left colon flexure and/or isolated proctitis
             and/or anal disease

          -  Prior treatment resistance to Pentasa (mesalazine)

          -  Chronic, dominant arthralgia or rheumatoid arthritis

          -  Palpable abdominal mass

          -  Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1

          -  Continuous usage of systemic steroids (excluding budesonide) for 3 months or more
             within the past year

          -  Positive pregnancy test
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
Condition: Intragastric Acidity
Intervention: Zegerid; Prilosec OTC™ Tablets; Placebo
Intervention description: Zegerid taken once daily for 11 days.; Prilosec OTC™ Tablets taken once daily for 11 days.; Placebo taken once daily for 11 days.
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastric Acid; Human Experimentation

Summary:

      This randomized, crossover study is to evaluate the early effectiveness, defined as effect on
      intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter
      (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional
      purposes are to:

        1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the
           1st, 4th, and 11th days of dosing with each of the indicated treatments;

        2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for
           controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.

        3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4
           hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid
           inhibition at steady-state when administered on the 11th day of dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.

          -  Physical examination findings within normal limits for age.

        Exclusion Criteria:

          -  History of hypersensitivity, allergy or intolerance to omeprazole, or other proton
             pump inhibitors

          -  History of peptic ulcer disease or other acid related gastrointestinal symptoms or
             heartburn with a frequency of more than one/month.

          -  Participation in any study of an investigational treatment in the 30 Days before
             Screening or participation in another study at any time during the period of this
             study

          -  Any significant medical illness that would contraindicate participation in the study

          -  Gastrointestinal disorder or surgery leading to impaired drug absorption

          -  Any abnormal Screening laboratory value that is clinically significant in the
             investigator's opinion

          -  Current use of any prescription or OTC medications that affect gastrointestinal
             function.

          -  Currently using or having a history of frequent use of antacids, OTC or prescription
             (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump
             inhibitors.
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Condition: Jet Lag Type Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Jet Lag Syndrome
Intervention: Tasimelteon; Placebo
Intervention description: Oral capsule; Oral capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy
      individuals after a phase advance in jet lag type insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and acceptance to provide written consent, fluent in English;

          -  Healthy subjects with no medical, psychiatric or current sleep disorders;

          -  Men or women between 18-75 years;

          -  Body Mass Index of ≥ 18 and ≤ 30 kg/m2.

        Exclusion Criteria:

          -  Major surgery, trauma, illness or immobile for 3 or more days within the past month;

          -  Pregnancy or recent pregnancy (within 6 weeks);

          -  A positive test for drugs of abuse at the screening or evaluation visit.
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin; placebo
Intervention description: active; placebo
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To investigate efficacy, safety and tolerability of BI 1356 versus placebo
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients with type 2 diabetes and insufficient glycaemic control.

          -  Age 18 or over and not older than 80 years

        Exclusion criteria:

          -  Use of more than one oral antidiabetic agent within 10 weeks prior to informed
             consent, insulin, glitazones or GLP-1 analogues within 3 months.

          -  Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to
             informed consent.
Use of Varenicline for 4-weeks Prior to Quitting
Condition: Tobacco Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Placebo
Intervention description: Varenicline 1mg twice daily; Placebo 1mg BD
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Tobacco dependence; Varenicline; Preloading

Summary:

      Varenicline (Champix) is a relatively new medicine that is effective in helping people to
      quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24
      weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before
      stopping smoking is better than the standard 1-week of use prior to stopping.

      The study will recruit 100 smokers who want to stop. They will be randomly allocated to
      receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as
      indicated by standard prescribing practice), followed by a 12-week open label treatment
      period where all participants will receive varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokers seeking treatment

          -  Aged 18 and over

          -  Consenting to take part in the trial

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  End-stage renal disease

          -  Used varenicline in the past 6 months

          -  Unable to fill in questionnaires in English

          -  Current psychiatric illness

          -  Current serious illness including uncontrolled hypertension and recent cardiac event

          -  Sensitivity to varenicline currently enrolled in other research projects.
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab; Sham
Intervention description: Participants will receive 10 mg dose of lampalizumab administered intravitreally.; A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal
      injections in participants with geographic atrophy (GA) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular
             Degeneration (AMD) with no evidence of prior or active choroidal neovascularization
             (CNV) in both eyes

        Exclusion Criteria:

        Ocular Exclusion Criteria: Study Eye

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD

          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
             occlusion, and proliferative diabetic retinopathy

          -  Previous intravitreal drug delivery (intravitreal corticosteroid injection,
             anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular
             Exclusion Criteria: Both Eyes

          -  GA in either eye due to causes other than AMD

          -  Previous treatment with eculizumab, lampalizumab and/or fenretinide
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin
Condition: Type 2 Diabetes; Hyperlipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
Intervention: Colesevelam HCl; rosiglitazone maleate; sitagliptin phosphate
Intervention description: coleveselam tablets 625 mg; 6 tablets/day; rosiglitazone tablets 4mg; sitagliptin phosphate tablets 100mg/day
Intervention MeSH terms: Sitagliptin Phosphate; Rosiglitazone; Colesevelam Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colesevelam HCl,; rosiglitazone; sitagliptin; Type 2 diabetes; metformin

Summary:

      A 16 week open-label study with subjects receiving background metformin monotherapy. 150
      subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open
      label rosiglitazone, or open-label sitagliptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other
             (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

        Exclusion Criteria:

          -  Subjects currently treated with a thiazolidinedione are excluded.
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: docetaxel; docetaxel; placebo; nintedanib
Intervention description: intravenous chemotherapy drug; intravenous chemotherapy drug; oral placebo; oral experimental therapy
Intervention MeSH terms: Docetaxel; Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The present trial will investigate the efficacy and safety of nintedanib in combination with
      docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV
      or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based
      chemotherapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients of at least 18 years of age

          -  Histologically confirmed, adenocarcinoma of the lung, after failure of first line
             platinum-based chemotherapy.

        Exclusion criteria:

          -  More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for
             advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.

          -  Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR)
             mutation or anaplastic lymphoma kinase (ALK) translocation

          -  Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR
             inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any
             time

          -  Prior monotherapy with an EGFR inhibitor except as maintenance therapy
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Condition: Pelvic Organ Prolapse; Urinary Incontinence; Pelvic Floor Disorders; Gynecologic Disease; Post-Op Infection; Surgical Site Infection; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Surgical Wound Infection; Urinary Incontinence; Pelvic Floor Disorders; Genital Diseases, Female; Prolapse; Pelvic Organ Prolapse
Intervention: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Intervention description: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urogynecology; Surgery; Antiseptic Preparation

Summary:

      This is a randomized controlled trial to determine if there is a difference between
      chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery
      post operative infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Subjects >18 years of age

          -  English or Spanish speaking/reading

          -  Must be able to provide informed consent

          -  Undergoing urogynecologic procedures or surgery

        Exclusion Criteria:

          -  Pregnant - all patients are verified regarding pregnancy status prior to gynecologic
             surgical intervention at all sites of surgery - for patients who are premenopausal and
             have a uterus, a urine pregnancy test is administered in the preoperative setting.
             Pregnancy status is also determined prior to this in the office setting by interview
             and patient provided history prior to offering surgery to the patient.

          -  Inability to return for follow-up visits

          -  No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation

          -  Lack of telephone

          -  Known allergy to either antiseptic agent

          -  Prisoners will not be eligible to participate in this study