cyrilzakka/clinical-trials huggingface dataset:
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
* Baseline numerical pain scale (NRS) score \> 4

Exclusion Criteria:

* Recent (i.e., \< 2 months) cervical spine surgery
* Recent (i.e., \< 1 month) cervical epidural or upper extremity corticosteroid injection
* Contraindication or inability to the undergo procedure
* Inability to provide informed consent
* Expected inability to complete follow-up assessment
* Contraindication to receiving contrast material (precluding an epidurogram)
Late In-the-bag intraOcular Lens dislocatioN Surgery

Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.

Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.

In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.

The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.

Eligibility Criteria:
Inclusion Criteria:

* IOL inside the capsule ("in-the-bag")
* Late dislocation (more than 6 months after cataract surgery)
* IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
* Eligibility for both operation methods
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study, e.g. willingness to participate at all control visits

Exclusion Criteria:

* IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
* Eyes with especially thin sclera
* Active uveitis or pronounced iris pathology
* Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
* Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
* Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
* Cases requiring a change in refraction. Risk of severe anisometropia
* Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
* Patients using anticoagulants that cannot be discontinued

For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.
A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

1.1 Primary Objectives

* To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease
* To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts
* To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone
* To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS

1.2 Secondary Objectives:

* To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo
* To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity


Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥ 18 years

  * Multilineage bone marrow failure
  * Serum creatinine ≤ 2.0 mg/dl
  * Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)
  * Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic infiltration
  * Left ventricular ejection fraction ≥ 45%
  * QTc ≤ 470 msec
  * RB expression is required for the action of PD 0332991. Because rb deletions and mutations are rare in acute leukemias and MDS, screening for RB expression will not be required before enrollment. Pretreatment biopsies will be stored and analyzed for RB expression if needed subsequently.

Exclusion Criteria:

* • No more than 5 cytotoxic regimens

  * Previous allogeneic or autologous stem cell transplantation permitted
  * ≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy
  * ≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine
  * If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning PD 0332991
  * No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning PD 0332991
A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma

Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.

Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.

Eligibility Criteria:
Patients with a histologic diagnosis confirmed from a pretreatment biopsy at the Laboratory of Pathology, NCI of one of the following entities: Diffuse small Lymphocytic Lymphoma; Follicular, Small Cleaved cell Lymphoma; Follicular, Mixed Small Cleaved and Large Cell Lymphoma; Follicular Large Cell Lymphoma; Diffuse, Intermediately Differentiated Lymphocytic Lymphoma; Diffuse, Small Cleaved Cell Lymphoma; Diffuse, Mixed Small and Large Cell Lymphoma; Diffuse, Large Cell Lymphoma; Large Cell Immunoblastic Lymphoma; Small Noncleaved Cell Lymphoma.

Presence of CD22 antigen on at least 30 percent of tumor cells.

Presence of objectively measurable sites of disease. Bone marrow positivity and circulating tumor cells in the peripheral blood will be considered evaluable but not measurable disease.

No patients with purely B-cell Lymphosarcoma cell leukemia without nodal or soft tissue involvement.

No patients with B-cell chronic lymphocytic leukemia, or B-cell or pre-B-cell acute lymphocytic leukemia, and hairy cell leukemia.

Patients with objectively measurable disease outside a radiation port or disease which has clearly progressed within a radiation port.

HIV negative.

No CNS disease.

No pulmonary parenchymal disease.

Pleural effusions or ascites may be present.

Patients with progression of disease despite at least one standard combination chemotherapy regimen.

No chemotherapy for at least two weeks prior to entry.

Patients who do not desire or are not candidates for autologous or allogeneic bone marrow transplantation procedures.

Life expectancy of at least 3 months

Creatinine clearance greater than 60 cc per minute.

Total bilirubin less than 1.5 mg/dl.

SGPT less than 2 times the upper limit of normal.

Albumin greater than 75 percent of the lower limit of normal.

If prior treatment with doxorubicin, the radionuclide or echocardiogram ejection fraction shall be at least 35 percent.

Performance status 0-2.

Not in need of current radiation therapy to alleviate local problems.

No prior exposure to murine antibodies.

No need for current corticosteroid treatment.
Brain Function and Structure in Cocaine Dependence

The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.

The Specific Aims of this project are:

Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 1:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.

Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 2:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
3. Significant current suicidal or homicidal ideation
4. Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
5. Taking CNS active concomitant medications
6. Taking medications known to have significant drug interactions with the study medication
7. Having conditions of probation or parole requiring reports of drug use to officers of the court
8. Impending incarceration
9. Pregnant or breast feeding for female patients
10. Inability to read, write, or speak English
11. Having plans to leave the immediate geographical area within 3 months
12. Unwillingness or not competent to sign a written informed consent form
13. Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
14. Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease

The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.

Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158.

In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who have completed the 24-week Study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria:

* Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.

The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient must be skeletally mature with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty
* Meets the Catalyst CSR Shoulder System Indications for Use according to approved labeling

Exclusion Criteria

* Has a history of open surgery to index shoulder prior to treatment with the Catalyst CSR system? (history of previous arthroscopic surgery allowed)
* Has a full thickness rotator cuff tear diagnosed by MFI or marked posterior glenoid wear
* Patient is unwilling or unable to comply with the post-operative care instructions, attend follow visits per the study schedule and complete the study assessments (i.e., Pros)
* The patient is a non-English speaker
* In the opinion of the investigator, is it not in the patient's best interest to participate in this study
* Local or systemic infection, or osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, joint replacement surgery should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support of fixation of the prosthesis
* Osteoporosis
* Neuromuscular disorders that do not allow control of the joint
* Chronic instability, chronic dislocation or deficient soft tissues and other support structures (e.g., brachial plexus or deltoid muscles)
* Vascular insufficiency
* Subject's age, weight or activity level cause the surgeon to expect early failure of the system
* The patient is unwilling to comply or unable to comply with the post-operative care instructions
* Alcohol, drug, substance abuse or other conditions that would affect or impair the patient from complying with post-operative instructions
* Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices
* Any disease that could adversely affect the function or expected longevity of the implants (e.g., metabolic disorders)
Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage

Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early and emergency insertion of external ventricular drain (EVD) is standard treatment of acute post-SAH hydrocephalus. According to the high risk of infection associated with EVD, the study evaluates the outcome of early EVD conversion to ventriculoperitoneal shunt (VPS) in poor-grade SAH patients.

This study was performed on patients diagnosed with high grade SAH (WFNS 4-5) who undergo EVD within 24 hours of their admission. The conversion of EVD to VPS is performed within 7-10 days of EVD insertion, defined as early VPS group. The ventricular catheter is inserted in lateral ventricle using the same burr hole of EVD or the contralateral Kocher's point. All ruptured aneurysms could be closed by endovascular techniques or surgery.

The goal is to discontinuing EVD or its conversion to VPS within 7 to 10 days of insertion. At day 5-7 of EVD insertion, the EVD level is elevated from 15 cmH2O to 25 centimeter of water (cmH2O) gradually. The patients is evaluated during the 48 hours for cerebrospinal fluid (CSF) volume discharge, neurological consciousness, and hydrocephalus within brain CT scan acquired at the end of 48 hours of observation. If the daily CSF fluid discharge will be greater than 100 ml, brain CT scan shows evidence of HCP, there is any CSF leak from around the catheter, or the patient experiences GCS drop for 2 points or more, EVD is converted to VPS.

EVD conversion to VPS is postponed if there is any evidence of CSF infection within the last CSF analysis obtained 48 hours before VPS placement, patient experiences fever (\>38.5° C) without any other source, or there is any evidence of severe vasospasm in transcranial Doppler (TCD) imaging or brain CT angiography. Otherwise, The EVD is discontinued.

For all patients, a brain CT scan is taken to evaluate the location of shunt 24 hours after VPS placement. Forty-eight hours after VPS placement, lumbar puncture (LP) is performed to collect CSF for ruling out the possibility of shunt infection or ventriculitis. Shunt malfunction (approved by imaging or signs of HCP) is reported if it occurred within 3 months of VPS placement.

When VPS malfunction is diagnosed it is revised. CSF infection is considered if there is a positive culture or ratio of CSF white blood cell count (WBC)/ red blood cell count (RBC) to blood WBC/RBC was more than 3. All patients is evaluated for clinical condition using modified Rankin scale (mRs) at discharge and 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and
* patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.

Exclusion Criteria:

* patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,
* patients in whom EVD was inserted in the other hospital,
* patients were successfully weaned from EVD with 7-10 days of EVD insertion
* patients who died during hospitalization.
Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.

As part of this study participants will receive the standard of care treatment for all head and neck cancer patients. The researchers plan to use a software program to see if it will assist in developing the best radiation treatment plan possible. The researchers will also measure the quality of each treatment plan so areas of improvement can be identified.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Ability to provide informed written consent in either English or Spanish.
* Patient planned to undergo radiation therapy for Head and Neck Cancer.

Exclusion Criteria:

* Current pregnancy, as this is a contraindication to receiving radiation therapy.
* History of prior radiotherapy to the head and neck.
* Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy.
Study of Value of Cardiac PET Scans With or Without CT Angiography and/or Measurement of Coronary Flow Reserve

How does PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affect patient care.

The purpose of this research is to determine how PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affects patient care. This research will also compare the effectiveness of these scans to other similar tests and compare the cost-effectiveness of these scans to other similar tests over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to Kettering Medical Center for PET myocardial perfusion imaging with or without CTA and/or coronary flow reserve measurement.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients who do not consent to participate.
Ecological Effect of Arginine Dentifrice on Oral Microbiota

caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited. Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before and after the treatment for laboratory analyses.

21 caries-free (CF) individuals with no clinical evidence of caries experience \[decayed, missing and filled teeth (DMFT) = 0\] and 21 caries-active (CA) individuals (DMFT ≥ 6) will be recruited in the clinical trial. The exclusion criteria are: smoker or former smoker, presence of any systemic disease that could alter the production or composition of saliva, treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months, and presence of dental prostheses or orthodontic devices. Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Volunteers are asked to refrain from brushing and flossing their teeth, eating, and drinking anything other than water for 12 h prior to sample collection visits at the end of both phases. Supra- and subgingival plaque (15 subjects in each group), saliva (21 subjects in each group), and in situ plaque samples (3 subjects in each group) will be collected before and after the treatment. Scraped plaque and saliva samples will be immediately transferred to and dispersed in sterile micro-centrifuge tubes containing 1×phosphate-buffered saline (PBS), and stored at -80 °C until needed for analysis. The in situ plaque samples will be transferred into 4% paraformaldehyde, kept under 4 °C for 16 h, and then stored in 50% (v/v) ethanol at -20 °C.

Eligibility Criteria:
Inclusion Criteria:

* caries-free individuals with no clinical evidence of caries experience \[decayed, missing and filled teeth (DMFT) = 0\] and caries-active individuals (DMFT ≥ 6) were recruited

Exclusion Criteria:

* smoker or former smoker, presence of any systemic disease that could alter the production or composition of saliva, treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months, and presence of dental prostheses or orthodontic devices.