bioihbjkbjnl/mcl2 huggingface dataset:
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Condition: Pain; Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: DS-5565; DS-5565; DS-5565; Placebo; Pregabalin capsules
Intervention description: Oral tablets administered twice daily; Oral tablets administered twice daily; Oral tablets administered twice daily; DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day; Pregabalin oral capsules 150 mg administered twice a day
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 450.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Diabetic Peripheral Neuropathy

Summary:

      The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared
      to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or Type 2 diabetes mellitus

          -  Painful distal symmetric polyneuropathy

          -  Average daily pain score is great than or equal to 4

        Exclusion Criteria:

          -  HbA1c greater than 9.0
Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: SPARC1102 I; SPARC1102 II; SPARC1102 III; Vehicle
Intervention description: SPARC1102 I will be administered in both eyes; SPARC1102 II will be administered in both eyes; SPARC1102 III will be administered in both eyes; Vehicle will be administered in both eyes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The present study will test if administration of different concentrations of 1334H eyedrops
      will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or
      older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form and HIPAA document

          -  Willing and able to comply with all study procedures

          -  Be at least 10 years of age at the time of enrollment

          -  LogMar 0.7 or better, in each eye

          -  History of ocular allergies, and a positive skin and ocular allergic reaction to
             allergens

          -  A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

        Exclusion Criteria:

          -  have known contraindications or sensitivities to the use of any of the study
             medications(s) or their components;

          -  have any ocular condition that, in the opinion of the investigator, could affect the
             subject's safety or trial parameters (including but not limited to narrow angle
             glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis,
             pterygium or a diagnosis of dry eye);

          -  have a current diagnosis or history of open angle glaucoma or ocular hypertension;

          -  have had ocular surgical intervention within three (3) months prior to Visit 1 or
             during the study and/or a history of refractive surgery within the past 6 months;

          -  have a known history of retinal detachment, diabetic retinopathy, or progressive
             retinal disease;

          -  have the presence of an active ocular infection (bacterial, viral or fungal), positive
             history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;

          -  manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
             at screening or during study

          -  have used an investigational drug or device within 30 days of the study or be
             concurrently enrolled in another investigational drug or device study within 30 days
             of the study
Metformin as an Upstream Therapy in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Metformin
Intervention description: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if the study drug metformin will help patients who are
      overweight and have atrial fibrillation. This study aims to see if metformin helps patients
      stay in normal sinus rhythm after a catheter ablation.

      Metformin is investigational for use in patients with atrial fibrillation. Metformin is
      approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes
      Mellitus. Metformin is used with a proper diet and exercise program to control high blood
      sugar, and has been shown to help people lose weight. This study aims to look at the effects
      of metformin on weight loss and heart rhythm in patients with atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm
             control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the
             study. All subjects must be able to understand and willing to sign a written informed
             consent document.

        Exclusion Criteria:

          -  Individuals who are already taking metformin or other antidiabetic medications
             including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled
             contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other
             clinical diagnosis of advanced renal disease,, have acute or chronic metabolic
             acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2
             drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X
             greater than the upper limit of normal), have a history of New York Heart Association
             (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Condition: Cholangiocarcinoma Cancer; Gallbladder Cancer; Pancreatic Cancer; Ampullary Cancer
MeSH terms: Cholangiocarcinoma; Gallbladder Neoplasms
Intervention: Gemcitabine; Docetaxel; Radiation
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cholangiocarcinoma; Gallbladder; Pancreatic; Ampullary; Cancer

Summary:

      To assess the feasibility of administering induction chemotherapy with gemcitabine and
      docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation
      gemcitabine/docetaxel chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma,
             gallbladder, pancreatic or ampullary adenocarcinoma.

          -  Patients must be 18 years or older.

          -  Patients must have a NCI CTC Performance Status of 0-2.

          -  Patients must not have any prior chemotherapy or radiation therapy for this current
             malignancy.

          -  At least 3 weeks should have elapsed since any surgery requiring general anesthesia.

          -  Patients must have no prior malignancies except for basal or squamous skin cancers,
             cervical carcinoma-in-situ, unless in remission for >5years

          -  Pregnant patients are not eligible. Non-pregnant status will be determined in all
             women of childbearing potential. All patients will be required to use an effective
             means of contraception if sexually active during therapy.

          -  Initial Required Laboratory Values:

          -  Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥
             9 g/dL.

          -  Serum creatinine should be ≤ 2 mg/dL.

          -  Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).

          -  Serum transaminases should be ≤ 5-fold the institutional upper limits.

          -  Patients must not have any co-existing severe medical illnesses, such as unstable
             angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled
             infection.

          -  Patients must be able to sign an informed consent.

        Exclusion Criteria:

          -  None
Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Fludarabine; Cyclophosphamide; Rituximab
Intervention description: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.; 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.; 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Leukemia; FCR; Fludarabine; Cyclophosphamide; Rituximab

Summary:

      The goal of this clinical research study is to learn more about the characteristics of CLL,
      including genes and chromosome abnormalities and proteins expressed by the leukemia cells,
      which may help doctors predict if patients who receive standard treatment (fludarabine,
      cyclophosphamide, and rituximab) for the first time will experience a complete remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (SLL), or CD20
             positive low-grade lymphoproliferative disorder.

          2. All patients with untreated Rai stage III-IV are eligible for this protocol. Prior
             treatment with single-agent rituximab permitted. OR Patients with untreated Rai stage
             0-II who meet one or more criteria for active disease as defined by the International
             Working Group for CLL (IWCLL). Prior treatment with single-agent rituximab permitted.

          3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0-3.

          4. Patients must have adequate renal and hepatic function (creatinine <2mg%, bilirubin
             <2mg%). Patients with renal or liver dysfunction due to organ infiltration by
             lymphocytes may be eligible after discussion with the study chairman.

          5. Patients may not receive other concurrent chemotherapy, radiotherapy, or
             immunotherapy. Localized radiotherapy to an area not compromising bone marrow function
             does not apply.

          6. Patients must be 16 years of age or older.

          7. Patients must sign informed consent indicating that they are aware of the
             investigational nature of this study according to the policies of the MD Anderson
             Cancer Center Institutional Review Board (MDACC IRB).

        Exclusion Criteria:

        N/A
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Condition: Cannabis Dependence; Nicotine Dependence
MeSH terms: Marijuana Abuse; Tobacco Use Disorder
Intervention: Cognitive Behavioral Therapy; Nicotine Replacement Therapy
Intervention description: individual CBT once weekly, 50 minutes, for 10 weeks; 21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks
14 m g patch for 8 weeks, then 7 mg patch for 2 weeks
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cognitive behavioral therapy; nicotine dependence; cannabis dependence; smoking cessation; nicotine replacement therapy

Summary:

      The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to
      develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim
      to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent
      marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT
      intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a
      transdermal nicotine patch, will reduce the use of marijuana and nicotine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age range 18-65 years

          -  current DSM-IV cannabis dependence

          -  current DSM-IV nicotine dependence

          -  express a desire to quit cannabis and nicotine use within the next 30 days

          -  daily use of ≥ 10 tobacco cigarettes

          -  for women of childbearing age, a negative pregnancy test at screening with agreement
             to use adequate contraception to prevent pregnancy and additional pregnancy tests at
             weeks 4 and 8

          -  Expired breath carbon monoxide (CO) determination is greater than or equal to 7 ppm
             over ambient values

        Exclusion Criteria:

          -  Current diagnosis of other drug or alcohol dependence (other than cannabis or
             nicotine)

          -  recent (within 3 months) significant cardiac disease

          -  current serious psychiatric illness or history of psychosis, schizophrenia, bipolar
             type I disorder or significant current suicidal or homicidal thoughts

          -  current use of bupropion

          -  current NRT or other smoking cessation treatment

          -  current CBT or other behavioral treatments for cessation of marijuana or tobacco
             smoking

          -  current smokeless tobacco use

          -  inability to read or write in English
Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Sarilumab
Intervention description: Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with
           ankylosing spondylitis (AS)

      Secondary Objective:

        -  To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant with AS who participated and completed 12-week treatment in study
             DRI11073-NCT01061723.

        Exclusion criteria:

          -  Adverse event(s) having lead to treatment discontinuation in the DRI11073 study;

          -  Event or laboratory abnormality observed at the last treatment visit of DRI11073 study
             that would have adversely affected participation of the participant in this study as
             per investigator judgment.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Oxytocin Intranasal Spray; Placebo Intranasal Spray
Intervention description: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.; The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All members of the research team except the IP dispensing staff will be blinded for the duration of the research study. Once all the subjects have finished in the research study, and all data is data-locked, the outcomes assessor will then unblind the research data for the statistical analysis.
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sleep Apnea; Oxytocin Nasal Spray

Summary:

      In human volunteers intranasal administration of oxytocin significantly increases
      parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease
      with high cardiovascular risk factors, yet this disease remains very poorly treated.

      This proposal, based on the current literature and new basic science results detailed above
      on the role of oxytocin in cardiovascular control, will test if oxytocin administration
      improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with
      OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding
      to test this important hypotheses more thoroughly and in larger clinical trials.

      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in
      patients with sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 years old or older of any ethnic background

          -  Subjects that have recently undergone a standard "in the sleep-lab" diagnostic
             polysomnography (per standard of care medical guidelines), or the "at home" diagnostic
             test, and have been diagnosed with OSA

        Exclusion Criteria:

          -  Pregnant or Breastfeeding women

          -  Women of Child Bearing Potential who are not willing to undergo methods to prevent
             pregnancy

          -  Subjects who are on medications that affect cardiac autonomic function (eg. Beta
             Blockers)

          -  Active smokers

          -  Subjects who are unable to read or answer questions in the English language
Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CD 2027; Calcitriol Vehicle
Intervention description: Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.; Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.
Intervention MeSH terms: Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; spray; calcitriol

Summary:

      This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to
      evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in
      participants with plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area
             (BSA) involved excluding the scalp, with a Global Severity Score of at least 3
             (moderate) at Screening

          -  Participant presents with a representative target lesion that is at least 16 cm² in
             area, is located on the non-bony areas of the skin, has a Scaling Score up to 2
             (moderate), has a DSS of at least 4

        Exclusion Criteria:

          -  Other type of psoriasis (other than plaque)

          -  Significant abnormal lab findings

          -  Hypercalcemia
Application of Auriculotherapy on Nursing Professional Stress Levels
Condition: Stress
MeSH terms: Occupational Stress
Intervention: auriculotherapy by needles; auriculotherapy by seeds
Intervention description: The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.; We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 23 Years
Maximum age: 61 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stress

Summary:

      Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and
      review the auriculotherapy effectiveness through semi-permanent needles and seeds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Average and high score by the List of Stress Symptoms

          -  Voluntary participation in the study

          -  Availability of time for submission to the sessions

        Exclusion Criteria:

          -  Pregnancy

          -  Medical license or vacation during the period

          -  Low score of stress