bioihbjkbjnl/mcl2 huggingface dataset:
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Oxaliplatin
Intervention description: Oxaliplatin, 130 mg per square meter, on day 1
Intervention MeSH terms: Cytarabine; Methylprednisolone; Oxaliplatin; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: oxaliplatin; ESHAOX; refractory; relapsed; non-hodgkin's lymphoma

Summary:

      Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide,
      methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this
      ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously histologically confirmed aggressive lymphomas, defined according to WHO
             classification (except Burkitt's lymphoma, lymphoblastic lymphoma)

          -  Failure to achieve a complete remission with the initial induction chemotherapy, or
             recurrent disease

          -  Performance status (ECOG) ≤3

          -  Age ≤ 75

          -  Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen

          -  At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by
             conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or
             measurable lesion by physical examination

          -  Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul,
             transaminases < 3 X upper normal values; bilirubin < 2 mg%

          -  Written informed consent approved by Institutional Review Board

        Exclusion Criteria:

          -  Any other malignancies within the past 5 years except skin basal cell ca or CIS of
             cervix

          -  Serious co-morbid diseases

          -  Pregnancy or breast-feeding
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Condition: Parkinson's Disease Psychosis
MeSH terms: Parkinson Disease
Intervention: pimavanserin tartrate (ACP-103)
Intervention description: Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Healthy volunteers: No

Summary:

      This is an open-label extension study to assess the long-term safety and tolerability of
      pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
    

Eligibility criteria:

        Inclusion Criteria-

          -  Patients of any age, male or female with a clinical diagnosis of idiopathic
             Parkinson's disease, who participated in a previous (Phase II) clinical trial that
             evaluated pimavanserin

          -  Patients who may, in the opinion of the treating physician, benefit from continued
             therapy with pimavanserin

          -  Patient is willing and able to provide consent

        Exclusion Criteria-

          -  Female patient of childbearing potential

          -  Patient has a clinically significant concurrent medical illness

          -  Patient is judged by the treating physician to be inappropriate for the study.
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Intervention: atomoxetine; placebo
Intervention description: Once daily oral dosing; Once daily oral dosing - matched placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cocaine; dependence; stimulants

Summary:

      This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate
      atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent
      individuals, who are healthy and are seeking treatment for their substance abuse, will be
      randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial
      lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve
      maintenance on the assigned active dose safely. Contingency management procedures will be
      used to reinforce attendance and compliance with study procedures. Primary outcome measures
      will include urinalysis data assessing cocaine use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seeking treatment for cocaine dependence

          -  Must have used cocaine in the past 30 days

        Exclusion Criteria:

          -  Physical dependence on any drug requiring medical management

          -  Any major medical or psychiatric disorder that would be contraindicated for
             participation

          -  Cardiovascular disease

          -  Seizures or significant head injuries

          -  Currently taking atomoxetine

          -  Pregnant or breast-feeding
Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Ketamine; Exposure and Response Prevention
Intervention description: 0.5mg/kg IV; A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: OCD

Summary:

      This study investigates if a single dose of IV Ketamine can rapidly improve
      Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with
      a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response
      Prevention (EX/RP). You will be compensated for your time and travel. Participants must be
      between the ages of 18-55.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-55

          -  Physically healthy and not currently pregnant

          -  Primary Diagnosis of OCD

          -  Sufficient severity of symptoms

          -  Currently off all psychotropic medication OR

          -  Currently on adequate dose of medication for treatment of OCD, but have not achieved
             at least partial remission

          -  Able to provide consent

        Exclusion Criteria:

          -  Psychiatric conditions that make participation unsafe (schizophrenia [either self or
             first degree relative e.g. siblings, parents], history of violence, severe depression,
             eating disorder, substance dependence [including nicotine])

          -  Female patients who are either pregnant or nursing

          -  Planning to commence EX/RP during the period of the study or those who have completed
             an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8
             weeks prior to enrollment.

        period of the study

          -  Allergy to ketamine

          -  Participants for whom being off of medication is not clinically recommended

          -  Medical conditions that make participation unsafe (e.g. high blood pressure, head
             injury)

          -  Currently on medications that make participation unsafe
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Condition: Influenza A
MeSH terms: Influenza, Human
Intervention: CT-P27; Placebo
Intervention description: Influenza A treatment drug.; Placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: efficacy; safety

Summary:

      This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from
      nasopharyngeal mucosa, compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Male & Female volunteers

        Exclusion Criteria:

          -  Current clinically significant disease

          -  Pregnant or nursing mother

          -  Abnormal pulmonary function, nose or nasopharynx
Tongue Pressure Profile Training for Dysphagia Post Stroke
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Intervention: Tongue Pressure Profile Training; Tongue-Pressure Strength-and-Accuracy Training
Intervention description: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.; 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dysphagia; Viscosity; Tongue; Pressure

Summary:

      People with swallowing impairment experience particular difficulty swallowing thin liquids
      safely; the fast flow of liquids makes them difficult to control. The tongue plays a critical
      role in containing liquids in the mouth, channeling the direction of their flow towards the
      pharynx (throat) and controlling their flow along that channel. The investigators are engaged
      in a program of research to better understand tongue function in swallowing, particularly
      with respect to controlling the flow of liquids. In this study the investigators will compare
      two different tongue-pressure resistance training protocols, to determine whether a protocol
      that emphasizes strength-and-accuracy or one that emphasizes pressure timing work better for
      improving liquid flow control in swallowing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with dysphagia characterized by prolonged swallow response duration for 5
             cc boluses of thin liquid (i.e., > 350 ms, confirmed in videofluoroscopy).

        Exclusion Criteria:

          -  premorbid reported history of swallowing, motor speech, gastro-esophageal or
             neurological difficulties.

          -  prior history of surgery to the speech apparatus (other than routine tonsillectomy or
             adenoidectomy).
An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Condition: Cancer
Intervention: Nivolumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether nivolumab is an effective treatment for
      cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with advanced or metastatic malignancy

          -  Received standard of care treatment for primary malignancy and standard of care
             treatment for relapsed cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody,
             or any other antibody or drug specifically targeting Tcell co-stimulation or
             checkpoint pathways.

          -  Subjects previously treated with investigational anticancer therapies less than 6
             weeks prior to the first dose of Nivolumab

          -  Subjects with an active, known, or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
Condition: Avascular Necrosis
MeSH terms: Osteonecrosis; Necrosis
Intervention: Atorvastatin; MRI, Venipuncture; Placebo
Intervention description: Atorvastatin 40mg vs placebo 40mg daily; MRIs done baseline, four and nine months; Tablets identical to atorvastatin 40mg
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Avascular Necrosis; Lipitor; SLE

Summary:

      This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show
      reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a
      disease resulting from the loss of blood supply to the bones which can cause the bone to
      collapse. The collapse of bone may require a surgical replacement of the joint and can be
      disabling for life. Avascular necrosis is presently not preventable but research has shown
      that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in
      animals. We therefore hypothesize that lipitor will reduce the incidence of avascular
      necrosis in lupus patients taking high dose steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All individuals must fulfill 4 of the revised criteria of the American College of
             Rheumatology for SLE

          -  Patient started on corticosteroids at a dose of at least .5mg/kg for an interval
             greater than two weeks

          -  To be able to come for all follow-up visits for nine months

          -  No contraindications to undergoing MRI

          -  Age 18-75 years

        Exclusion Criteria:

          -  Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than
             2x normal

          -  Elevated CPK at baseline

          -  Pregnancy or Lactating

          -  Allergy to a statin

          -  Current or recent use of a statin within 3 months
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: selenomethionine; finasteride; placebo
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Selenium; Finasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer

Summary:

      RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause
      the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the
      amount of testosterone the body makes. Giving selenomethionine together with finasteride
      before surgery or radiation therapy may be an effective treatment for prostate cancer.

      PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride
      work when given before surgery or radiation therapy in treating patients with stage I or
      stage II prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven adenocarcinoma of the prostate

               -  Diagnosed by sextant or greater biopsy

               -  Clinical stage < T3 (stage I or II) disease

          -  Prostate-specific antigen < 20.0 ng/mL

          -  Gleason score < 8

          -  Scheduled to undergo prostatectomy or brachytherapy

        PATIENT CHARACTERISTICS:

          -  Life expectancy > 5 years

          -  No other prior malignancy (excluding nonmelanoma skin cancer) in the past 5 years

          -  Willing and able to take finasteride, selenomethionine, and/or placebo for 3-5 weeks
             prior to prostatectomy/brachytherapy

        PRIOR CONCURRENT THERAPY:

          -  More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto),
             or any other 5-α reductase inhibitor

          -  No prior hormonal therapy or radiotherapy

          -  More than 30 days since prior and no concurrent participation in any other clinical
             trial involving a medical, surgical, nutritional, or life-style intervention (e.g.,
             dietary modification or exercise)

          -  No concurrent selenium dietary supplement at doses > 200 mg/day, including
             multivitamin supplements

               -  At least 30 days since > 200mg/day of prior selenium dietary supplement

          -  No other concurrent hormonal therapy, including 5-α reductase inhibitors (e.g.,
             finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or
             ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide
             acetate, goserelin acetate, or abarelix)
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Propolis; Metformin; Placebo
Intervention description: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.; Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.; Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.
Intervention MeSH terms: Metformin; Propolis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus type 2; Glycemic control; Propolis; Metformin; Pharmacological treatment-naïve patients

Summary:

      The aim of this study was to evaluate the effect of propolis or metformin on glycemic control
      in patients with type 2 diabetes mellitus without pharmacological treatment.

      All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h
      serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic
      profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index,
      and Matsuda index were measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes

          -  Age between 30 and 60 years

          -  Mild to moderate physical activity

          -  Stable body weight for at least 12 weeks prior to the study

          -  BMI 25.0 - 34.9 kg/m2

          -  Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with
             one of the following criteria (fasting blood glucose levels >126 mg/dl; or
             postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral
             glucose >200 mg/dl

          -  Informed consent signed

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Previous treatment for glucose

          -  Fasting glucose ≥250 mg/dL

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Hypersensibility to ingredients of intervention

          -  Known allergies to bee stings or their derived products

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL
CP-690-550 Ointment For Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550 Ointment 1; Vehicle 1; CP-690,550 Ointment 2; Vehicle 2
Intervention description: 2% CP-690,550 Ointment 1 twice daily for 4 weeks; Vehicle 1 twice daily for 4 weeks; 2% CP-690,550 Ointment 2 twice daily for 4 weeks; Vehicle 2 twice daily for 4 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Multi Site; Randomized; Placebo Controlled; Double Blind; Parallel Group; chronic plaque psoriasis; topical treatment; skin diseases; papulosquamous

Summary:

      The study is being conducted to see whether CP-690,550 ointment has potential as a safe and
      effective treatment for adult patients with mild to moderate chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of
             at least 6 months;

          -  A target plaque of at least 9 sq. cm.

        Exclusion Criteria:

          -  Demonstrates "rebound" or "flare" of chronic plaque psoriasis;

          -  Non plaque form of psoriasis;

          -  Currently have or history of psoriatic arthritis;

          -  Current drug induced psoriasis;

          -  Currently on systemic therapy or was on systemic therapy for psoriasis within the
             previous 6 months;

          -  Currently on phototherapy for psoriasis or was on phototherapy within the previous 3
             months