bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo Respimat; Tiotropium bromide 5 mcg; tiotropium bromide-low dose-2.5mcg
Intervention description: patient to receive placebo matching active drug once daily; patient to recieve high dose tiotropium once daily; patient to receive low dose tiotropium once daily
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 510.0
Sex: All
Healthy volunteers: No

Summary:

      This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide
      (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on
      lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be
      based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female patients

          2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable
             mutations)

          3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values

        Exclusion criteria:

          1. Significant history of allergy/hypersensitivity

          2. Hypersensitivity to study drug

          3. Participation in another trial

          4. Female patients who are pregnant or lactating

          5. Female patients of childbearing potential

          6. Patients who have started a new medication for CF within 4 weeks of screening

          7. Patients with known substance abuse

          8. Clinically significant disease other than CF
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
Condition: Ichthyosis
MeSH terms: Ichthyosis; Ichthyosis, Lamellar
Intervention: Imsidolimab; placebo
Intervention description: Humanized Monoclonal Antibody; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-36 Receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of imsidolimab in Participants with Ichthyosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Ichthyosis

          -  IASI total score ≥ 18, erythema score ≥ 2

          -  Participant has been using emollient daily for at least 1 week prior to Day 1 and
             agrees to continue using that same emollient daily at the same frequency throughout
             the study

        Exclusion Criteria:

          -  A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis
             will be excluded.
BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: BIBF 1120; BIBF 1120; mFolfox; Bevacizumab; mFolfox 6; bevacizumab
Intervention description: BIBF 1120 100 and 150 mg capsules; BIBF 1120 100 and 150 mg capsules; standard i.v chemotherapy; 100 mg/Kg solution , IV infusion; IV standard chemotherapy; 100 mg/4 ml solution
Intervention MeSH terms: Bevacizumab; Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in
      combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line
      patients with metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age >= 18 years

          2. Histologically proven colorectal adenocarcinoma

          3. No previous oxaliplatin based chemotherapy is allowed unless disease free survival
             after the end of chemotherapy > = 12 months

          4. No previous therapy with VEGFR or EGFR inhibitors

          5. No prior systemic therapy for metastatic CRC

          6. No previous adjuvant therapy with fluoropyrimidines is allowed unless disease free
             survival after the end of chemotherapy > 6 months

          7. ECOG performance status < = 2

          8. Adequate hepatic, renal and bone marrow functions:

          9. No uncontrolled hypertension

         10. Signed and dated written informed consent prior to admission to the study

        Exclusion criteria:

          1. Treatment with any investigational drug within 28 days of trial onset.

          2. History of other malignancies in the last 5 years, in particular those that could
             affect compliance with the protocol or interpretation of results.

          3. Serious concomitant disease, especially those affecting compliance with trial
             requirements or which are considered relevant for the evaluation of the efficacy or
             safety of the trial drug,

          4. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or
             planned surgical procedures during the trial period.

          5. Significant cardiovascular diseases

          6. History of severe haemorrhagic or thromboembolic event in the past 12 months. Known
             inherited predisposition to bleeding or to thrombosis.

          7. Patient with brain metastases that are symptomatic and/or require therapy.

          8. Pregnancy or breast-feeding.
Ganaxolone Treatment in Children With Fragile X Syndrome
Condition: Fragile x Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: Ganaxolone; Placebo
Intervention description: oral suspension, given in 3 divided doses; oral suspension, given in 3 divided doses
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: fragile x syndrome; ganaxolone; anxiety; attention; pediatric

Summary:

      This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,
      crossover study to investigate ganaxolone treatment in children with fragile x syndrome
      (FXS). The objective of the study is to assess the safety, tolerability and efficacy of
      ganaxolone in the treatment of anxiety and attention in subjects with FXS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  molecular documentation of FMR1 full mutation

          -  ages 6-17 yrs, inclusive

          -  sexually active subjects are required to use a medically acceptable form of birth
             control

        Exclusion Criteria:

          -  non-English or Spanish speaking subjects

          -  concomitant systemic steroid, vigabatrin, felbamate and ketoconazole

          -  changes in medications within last 2 months

          -  clinically unstable medical disease, progressive CNS disease/disorder

          -  history of recurrent status epilepticus

          -  unwilling to withhold grapefruit or grapefruit juice for the duration of the study

          -  actively suicidal
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Condition: Breast Cancer; Anxiety; Pain
Intervention: Self-hypnotic Relaxation; Empathic Attention
Intervention description: A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.; A research assistant displayed defined behaviors of empathic attention.
Intervention MeSH terms: Hypnotics and Sedatives
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast; Biopsy; Hypnosis; Relaxation; Anxiety; Pain; Medical and Surgical Procedures

Summary:

      Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing
      breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well
      functioning individuals. Unabated stress during an invasive procedure not only interferes
      with smooth progression of the ongoing procedure, but can also have deleterious effects when
      patients need additional procedures and dread recurrent medical traumatization. The long-term
      objective of this research is to provide patients with a simple coping strategy at the
      vulnerable time of large core biopsy in the hope that this behavioral intervention will carry
      over to recovery and future medical procedures. In the largest prospective randomized study
      of its kind, the researchers showed that a self-hypnotic intervention during percutaneous,
      image-guided vascular and renal interventions resulted in less pain and anxiety, greater
      hemodynamic stability, and fewer procedure interruptions. The positive effects of the short
      initial hypnotic intervention, which was structured in the procedure room, became more
      pronounced the longer the procedure lasted and carried over into the immediate post-procedure
      recovery. The investigators therefore challenge the current paradigms that long-lasting
      effects require intensive presurgical preparation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for large core breast biopsy in the Radiology Department at the
             Beth Israel Deaconess Medical Center Boston.

        Exclusion Criteria:

        Patients are excluded if :

          -  They are unable to give informed consent, or pass screening for impaired mental
             function or psychosis.

          -  They are unable to hear or understand English.
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders; Body Weight
Intervention: liraglutide; orlistat; placebo
Intervention description: Injected s.c. (under the skin) once daily; 120 mg capsule. Administered thrice daily; Injected s.c. (under the skin) once daily
Intervention MeSH terms: Liraglutide; Orlistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 564.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the
      efficacy of liraglutide to induce body weight loss and the purpose of the extension is to
      evaluate the long term safety and tolerability of liraglutide.

      Trial has the following trial periods: A 20-week randomised, double-blind,
      placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open
      label orlistat comparator arm followed by an 84 week extension period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0
             kg/m2

          -  Stable body weight (less than 5% selfreported change within the last 3 months)

        Exclusion Criteria:

          -  Obesity induced by drug treatment

          -  Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin,
             rimonabant) within the last 3 months prior to entering trial

          -  Type 1 or type 2 diabetes
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: POMx; Placebo
Intervention description: Pomegranate supplement (1g) by mouth twice per day for 7 days; Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Pomegranate; Stroke; Neuropsychology

Summary:

      The purpose of this study is to determine whether pomegranate supplements improve cognitive
      functioning following stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suffered an ischemic stroke and admitted to LLUMC Rehabilitation Institute for
             inpatient care

          -  Fluent in English

          -  Between the age of 18 and 89 years old

        Exclusion Criteria:

          -  Less than 6 years of education

          -  Global aphasia

          -  Pregnant

          -  History of allergy to pomegranates

          -  History of traumatic brain injury

          -  Neurodegenerative disease or neurologic condition with known cognitive impact (e.g.,
             Alzheimer's disease)

          -  Active renal disease

          -  Active liver disease

          -  Intracerebral hemorrhage in past 6 months

          -  Neurosurgery in past month

          -  Taking warfarin (Coumadin)
Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement
Condition: Hip Arthroplasty
MeSH terms: Hypersensitivity
Intervention: ketorolac tromethamine opthalmic solution; placebo
Intervention description: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery; placebo will be added to the patient's routine spinal anesthetic for surgery
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total hip arthroplasty; Total hip replacement; Pain, postoperative; Ketorolac; Patients undergoing unilateral total hip arthroplasty

Summary:

      Chronic pain in patients following total hip replacement seems to be a significant problem.
      Previous research has shown that more effective pain management in the early postoperative
      period may decrease the incidence of the development of chronic pain states.

      This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given
      into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light
      touch) following surgery. Patients will be monitored during their postoperative hospital stay
      and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about
      any pain they are having at their surgical site. Patients that are still experiencing pain at
      6 months will be asked to return to the medical center for the study staff to assess their
      pain or sensitivity at the surgical site.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I, II, III

          -  > Age 18

          -  Primary unilateral total hip arthroplasty under spinal anesthesia

        Exclusion Criteria:

          -  Known allergy to study medication

          -  Weight > 300 pounds

          -  Obstructive sleep apnea

          -  Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac,
             amino amide local anesthetic, or contraindications to spinal anesthesia

          -  Patients on dialysis for kidney failure or patients that are jaundice or have a
             diagnosis of liver failure

          -  Patients routinely taking narcotic pain medications for pain other than their primary
             hip pain

          -  Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the
             treatment of seizures
Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: P-321 Ophthalmic Solution; P-321 Ophthalmic Solution placebo
Intervention description: P-321 Ophthalmic Solution 0.017%; Placebo to match P-321 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye
      Symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Male or female subjects aged 18 to 80 years, inclusive

          3. Have a history of dry eye disease (DED) in both eyes

          4. Be on stable regimens of other needed medications

          5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy
             Study (ETDRS)

          6. Have reported symptoms

          7. Have the following signs in at least one eye: Schirmer score without anesthesia of >1
             and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.

          8. Have normal lid anatomy

        Exclusion Criteria:

          1. Have undergone refractive eye surgery in the past 12 months

          2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not
             resulting in exposure or abnormal blinking is allowed)

          3. Have lid irregularities or deformities

          4. Have a history of glaucoma, a history of an elevated lOP within the past year, or an
             lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)

          5. Have any clinically significant, uncontrolled, or unstable medical or surgical
             conditions that could affect his or her ability to participate

          6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct
             obstruction. Removable punctal plugs are allowed if they have been used regularly for
             at least 60 days prior to the screening visit. However, if a plug comes out during the
             study it must be promptly replaced.

          7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye

          8. Are pregnant or breast feeding

          9. Use of any investigational product or device within 28 days prior to the Screening
             Visit or during the study
A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: LY2140023; Placebo; Standard of Care
Intervention description: 40 milligrams (mg), oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg.; Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.; United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether LY2140023, when added to standard-of-care
      antipsychotic treatment, will improve negative symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Participants must have been receiving monotherapy treatment for at least 3 months
             prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole,
             olanzapine, risperidone, quetiapine)

          -  Disease symptoms must meet a certain range as assessed by the clinician

          -  Participants must have evidence of prominent negative symptoms of schizophrenia (for
             example blunted affect, emotional withdrawal, or motor retardation)

          -  Participants must be considered reliable, have a level of understanding sufficient to
             perform all tests and examinations required by the protocol, and be willing to perform
             all study procedures

          -  Participants must be able to understand the nature of the study and have given their
             informed consent

        Exclusion Criteria:

          -  Participants who are actively suicidal

          -  Participants who are pregnant or nursing

          -  Participants who have had electroconvulsive therapy (ECT) within 3 months of screening
             or who will have ECT at any time during the study

          -  Participants with uncorrected narrow-angle glaucoma, history of or current seizure
             disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency,
             uncontrolled thyroid condition or other serious or unstable illnesses

          -  Participants with Parkinson's disease, psychosis related to dementia or related
             disorders

          -  Participants with known Human Immunodeficiency Virus positive (HIV+) status
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
Condition: Follicular Lymphoma; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Umbralisib
Intervention description: - anti-CD 20 monoclonal antibody administered via IV infusion; - PI3K Delta Inhibitor oral daily dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment naïve

Summary:

      This is a phase 2, open label study to assess umbralisib in combination with ublituximab in
      participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma
      (SLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of FL or SLL.

          -  Measurable disease that requires treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Currently or previously received treatment for their lymphoma

          -  Received wide field radiotherapy within 28 days or limited field radiation within 14
             days of Cycle 1 Day 1

          -  Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus
             (HIV) infection