Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rexlemestrocel-l combined with ha* in participants with moderate to severe chronic low back pain

Conditions: Degenerative Disc Disease

Summary: the primary purpose of this study is to evaluate the efficacy of rexlemestrocel-l+ha compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-l+ha injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.


Eligibility criteria:
inclusion criteria: * participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care. * participants who have moderate radiographic degeneration of an intervertebral disc from l1 to s1, with a single disc suspected of causing chronic lower back pain (clbp). exclusion criteria: * participants who have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc. * participants with low back pain duration of less than 6 months or greater than 60 months. * participants who have not received at least 3 months of conservative treatment for back pain without adequate pain relief. * participants taking systemic immunosuppressants. * participants with osteoporosis. * participants with alcohol or substance abuse problems. * participants with severe depression or anxiety. * participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc. * participants having undergone a surgical procedure affecting the structure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion, laminectomy, etc.) at the index or adjacent levels. * participants who have received any lumbar intradiscal injection into the index disc or adjacent discs within three months prior to the start of screening, other than injection of contrast medium for discography. * participants who received an epidural steroid injection within 6 weeks prior to informed consent. * participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline. * participants with sacroiliac (si) joint pain, as determined by a targeted physical exam, or si joint injection. * participants with facet joint pain, as determined by a medial branch block. * participants with more than a single painful level. * participants with a full thickness annular tear observed on magnetic resonance imaging (mri) or discography. * participants with low back pain that is less than moderate in severity. * participants with extreme low back pain. * participants who lack moderate to extreme functional limitations/disability. note: other exclusion criteria may apply.
the expression of immune checkpoint cd28 rs1980422-related single-nucleotide polymorphisms in the primary immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: primary immune thrombocytopenia (itp), one of the most common bleeding disorders, is characterized by reduced platelet count and an increased risk of bleeding itp is an acquired autoimmune disease, in which platelets are opsonized by auto-antibodies and destroyed by phagocytic cells itp pathogenesis involves a hyper-activated t cell response, which is important for cell-mediated cytotoxicity and igg production therefore, investigating t cell abnormalities in itp patients may reveal the mechanism of pathogenesis and development of itp. the costimulatory molecules of t cells consist of cd28, inducible costimulatory (icos), tnf superfamily member 4 (tnfsf4), and dnam1 (cd226), and the co-inhibitory molecules contain tim3, cytotoxic t-lymphocyte associated protein 4 (ctla4), programmed death-1 (pd1), and lymphocyte activating 3 (lag3) among these, cd28 and ctla4 represent the best-studied costimulatory pathways. cd28 and ctla4 interact with two ligands (cd80 and cd86) on the surface of antigen-presenting cells (apcs), introducing a positive stimulatory and a negative inhibitory signal into t cells, respectively


Eligibility criteria:
inclusion criteria: * approval to sign an informed written consent * patient with newly diagnosed itp * platelet count of peripheral blood \< 100×109/ l on at least two consecutive routine blood tests, normal or increased megakaryocyte count in bone marrow (as previously diagnosed) * no other disease or condition related to thrombocytopenia * patient age \> 1 year and \< 65 years exclusion criteria: * refusal to sign an informed written consent * patients with other autoimmune or hemorrhagic diseases (e.g., sle, severe anemia), or thrombocytopenia due to pregnancy, viruses (e.g., hepatitis c virus, human immunodeficiency virus) * active infections * vaccinations, or drugs (e.g., heparin) .
migalastat therapy adherence among fabry patients: a prospective multicentral observational study

Conditions: Rare Diseases; Fabry Disease; Adherence, Medication; Quality of Life

Summary: this study evaluates adherence to the oral chaperone therapy migalastat in patients with fabry disease.

fabry disease is a rare disease and part of the group of lysosomal storage disorders. since 2016, chaperone therapy as a new therapeutic approach is available. this study is a prospective cohort study and observes patients under therapy with migalastat. this study is suggested to help estimating the adherence of the oral therapy. all patients in treatment with migalastat in the fabry center wuerzburg (fazit) and selected patients of other cooperating fabry centers are included in this study if informed consent is provided.

Eligibility criteria:
inclusion criteria: * fabry disease (genetically confirmed) * signed informed consent * 18 years and older exclusion criteria: * no informed consent * withdrawal of informed consent

Keywords: fabry chaperone therapy migalastat pharmacological adherence
mri-guided biopsy of recurrent prostate cancer after radiotherapy

Conditions: Recurrent Prostate Cancer

Summary: in this study we will test a new procedure to guide needle biopsies into the prostate gland based on mri. this study will be conducted in patients who may have recurrence of their cancer in the prostate gland after radiation therapy in order to map out the location of the recurrence. using this technique, we will be able to measure the accuracy of mr images in identifying the site of tumour recurrence.

this study involves the technical development and clinical testing of a novel technique for magnetic resonance imaging (mri) guided prostate biopsy in a 1.5t horizontal bore scanner using a dedicated interventional table. we primarily hypothesize that the integration of diagnostic and interventional mri enables needle biopsy targeting to foci of tumor recurrence after radiotherapy, and will enable a determination of the diagnostic accuracy of mri in mapping sub-sites of tumor recurrence after radiotherapy. relevance to public health: patients with recurrence of their prostate cancer after radiotherapy currently face difficult choices. standard second line treatments target the entire prostate gland and are associated many side effects. this study will directly improve the detection, spatial delineation, and characterization of prostate cancer persistence after radiotherapy. if anatomic patterns of disease persistence are found across patients, radiation delivery techniques will be suitably modified, which may translate to improved cure rates. importantly, this study will establish a procedural platform for mri-guidance of minimally invasive local salvage therapies. by precisely focusing salvage therapy to sites of tumor persistence within the prostate gland, side effects may be reduced in the future.

Eligibility criteria:
inclusion criteria: * biochemical failure \> 18 months after definitive external beam radiotherapy (astro definition - revised version 2006: rise by 2 ng/ml or more above the nadir psa) * psa \<20 prior to initial course of external beam radiotherapy * psadt \>3 months at failure * age ≥ 18 years * ecog performance status 0 or 1 with \>10 year life expectancy * fit for local anaesthesia * informed consent: exclusion criteria: * contraindications to mri * severe claustrophobia * bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding brachytherapy * previous brachytherapy * active hormonal therapy * radiologic evidence of ln or distant metastases * other urinary or medical conditions deemed by the pi or associates to make the patient ineligible for mri-guided prostate biopsy. * contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery * contraindications to conscious sedation * contraindication to iv gadolinium administration * latex allergy

Keywords: prostate cancer, magnetic resonance imaging, guided imagery
a dose-escalation to rash study of tarceva (erlotinib) plus gemcitabine in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study will compare the efficacy and safety of escalating versus standard doses to rash of tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. during a 4 week run-in period, all patients will receive tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. after 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. group 1 will receive a starting dose of tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. group 2 will continue to receive tarceva 100mg/day po. all patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease; * ecog performance status of 0-1. exclusion criteria: * local, or locally advanced, pancreatic cancer; * prior systemic treatment for metastatic pancreatic cancer; * \<=6 months since last adjuvant chemotherapy; * other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
expanding the potential of couples hiv testing: adjunct modules to reduce drug use among vulnerable male couples

Conditions: Substance Use; HIV Infections

Summary: this study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples hiv testing and counseling (chtc): a communication skills training video and a substance use module. participants are randomized in a full-factorial design to one of 4 conditions: chtc as usual; chtc + communication skills training videos; chtc + substance use module; or chtc plus both adjunct components.


Eligibility criteria:
inclusion criteria: * · have a main partner who is another male and have been in a relationship for 3 month or longer * one participant must be between 17 and 29; main partner can be any age above 17. * one participant must be hiv negative (as confirmed by rapid test) * one participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, ghb) * one participant must have engaged in transmission risk behavior (trb) in the past 90 days o defined as condom-less anal sex (cas) with a casual partner and/or cas with a non-monogamous or serodiscordant main partner * live in the nyc or detroit metropolitan area * speak english exclusion criteria: * · any signs of serious mental illness or cognitive deficit * history of ipv with their main partner and safety concerns in the current relationship.
sodium fluoride (naf) positron emission tomography/computed tomography (pet/ct) in patients with metastatic castrate-resistant prostate cancer (crpc) with microtubule directed chemo or ar-directed therapy

Conditions: Prostate Cancer

Summary: the purpose of this research study is to evaluate a newer imaging technique, called 18f-sodium fluoride (naf) positron emission tomography (pet). naf is a tracer (dye) that is very sensitive for changes in bone. by using this tracer with positron emission tomography/computed tomography (pet/ct) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.

the study will look at how repeatable the naf pet scans are before treatment. scans will also be performed after standard chemotherapy or hormone-directed treatment. this will allow evaluation of how the naf pet scans change with the chemotherapy or hormone-directed therapy. in addition, naf pet scans will be compared with standard computed tomography (ct) and bone scans, as well as prostate specific antigen (psa). this information could be used to develop better ways to measure prostate cancer bone lesions. in turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone * patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer or * patients must be starting a ar-directed regimen (e.g. abiraterone, mdv-3100, tak-700, etc) for treatment of metastatic castrate-resistant prostate exclusion criteria: * concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen * patients who have received radiotherapy less than 4 weeks prior to registration. * patients who have received prior strontium-89, samarium-153, or other radioisotope. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride f-18 (naf).

Keywords: androgen receptor-directed therapy naf pet/ct antimicrotubule directed chemotherapy
respiratory and quadriceps muscle fatigability after an icu acquired weakness

Conditions: ICU Acquired Weakness

Summary: muscle dysfunction can be lead to poor outcomes moreover icu muscle weakness recovery are not correctly described. the investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.


Eligibility criteria:
inclusion criteria: * mechanically ventilated at least at 24 hours * maximal inspiratory pressure \< 30 centimeter of water * mrc score \< 48/60 exclusion criteria: * age \< 18 years * patients with neurological pathology or pre existing neuromuscular dysfunction * patient unable to walk 50 meters before icu admission * patient with a thoracic or abdominal surgery * inability to carry out maximal voluntary contraction

Keywords: icu acquired weakness muscle strength fatigability respiratory muscle quadriceps muscle
a randomized phase iii trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage iiib/iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: a randomized phase iii trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage iiib/iv nsclc.


Eligibility criteria:
inclusion criteria: histologically or cytologically confirmed nsclc stage iiib/iv no prior treatment measurable disease ecog ps 0-1 adequate organ function age 20-74 written informed consent exclusion criteria: pregnancy or breast feeding past history of drug hypersensitivity svc syndrome pleural or pericardial effusion that required drainage active infection interstitial pneumonia or active lung fibrosis symptomatic brain metastasis active concomitant malignancy uncontrolled diabetes uncontrolled heart disease
effect of assessing risk for osteoporosis on physician and patient behaviors

Conditions: Osteoporosis; Osteopenia

Summary: the study seeks to determine the impact of assessing risk for osteoporosis in women on patient and physician behaviors through a pharmacist directed osteoporosis screening program. women will be offered a heel ultrasound to screen for their bone density and may or may not be asked questions about their risk for bone fracture. pharmacists will counsel and educate all women on ways to prevent the onset of osteoporosis. women will be telephoned three months after the screening and asked a series of 10 questions to follow up on decisions made by their physicians or changes made to their health behaviors related to bone health.

a maximum of 90 participants will be recruited and randomized to the frax® assessment intervention group or the control group to a total of 45 participants in each group. the number of participants was chosen based on the simple randomized design of the study and use of basic statistics (versus regression analysis). subjects will be recruited from the employee population of duquesne university, clients visiting the spirit of health mobile health unit, and the downtown pittsburgh community and surrounding neighborhoods of duquesne university. participants will be recruited through posted flyers at these various screening venues. data collected will be the t-score at baseline screening in both groups. the percent risk for fracture as determined by the frax® tool will be determined for the intervention group. after 3 months have elapsed, a questionnaire will be administered via telephone to both the intervention and control groups, a series of 12 yes/no questions. fisher's exact test will be used to analyze the data. data collected will be nominal data with n in each group at 45 for a total of 90 participants. descriptive statistics will also be employed.

Eligibility criteria:
inclusion criteria: inclusion criteria: 1. postmenopausal female participants over the age of 45 years up to and including 65 years of age. the participant will be required to have a medical doctor and covered by an insurance plan in case a dxa-scan is ordered by the physician. 2. ability to be screened at the center for pharmacy care or at other community screenings on the achilles® heel ultrasound bone densitometer. 3. after heel ultrasound is conducted, include those individuals as participants in the study who present with a t-score equal to or less than -1.0. exclusion criteria: 1. unable to participate in the follow-up survey conducted over the telephone. 2. age less than 45 years or over 65 years. 3. any individual currently taking biphosphonates for osteoporosis treatment. 4. after heel ultrasound is conducted, if t-score is greater than -1.0. 5. males

Keywords: osteoporosis pharmacist behavior change frax osteopenia
cone beam ct scanning in lung and bladder cancer.

Conditions: Lung Neoplasm; Small Cell Carcinoma; Bladder Carcinoma

Summary: to study changes in tumor and normal organ size and/or position which occur during a course of radiation treatments.


Eligibility criteria:
inclusion criteria: * patient has biopsy proven limited stage sclc * receiving radical concurrent chemoradiotherapy * no prior chest rt * no prior surgical resection of lung tumor * no prior chemotherapy * patients' lung tumors should be centrally-located to minimize the effect of respiratory motion * patient has biopsy proven tcc bladder * receiving radical concurrent chemoradiotherapy or rt alone * no prior chemotherapy * patient signs study-specific consent form exclusion criteria: * mixed small cell and non small cell histology * patient not being treated with concurrent chemoradiotherapy * chemoradiotherapy given sequentially * previous chest rt * previous chemotherapy * prior surgical resection of lung mass * patient ineligible for pelvic rt * patient does not sign study consent

Keywords: small cell lung cancer bladder cancer conformal radiotherapy
in vitro studies on pharmacological regulation and genetic risk factors of peripheral human nociceptors

Conditions: Pain

Summary: this protocol is for a number of in vitro studies using human surgical biopsies and evaluating the pharmacology and genetics of human nociceptors ("pain detecting") neurons

purpose/objectives a. specific aims specific aim 1: characterize in humans the effects of inflammation and neuronal degeneration on peripheral levels of npy, and related y receptors (y1, y2, y5) in periradicular tissue. specific aim 2: determine whether npy inhibits neurosecretion from peripheral terminals of capsaicin-sensitive neurons innervating normal versus inflamed tissue. specific aim 3: determine whether peripheral administration of npy is analgesic and/or anti-allodynic in patients experiencing spontaneous pain and mechanical allodynia in a clinical model of inflammation with associated neuronal degeneration. specific aim 4: evaluate whether population characteristics are associated with altered pain reports. first, we will determine whether patients with the c1128 single nucleotide polymorphism (snp) of the prepronpy gene, whose phenotype confers substantially augmented peripheral npy neurosecretion, report less pain compared with patients without this genetic polymorphism. second, we will determine whether ethnic/cultural factors associated with an underserved minority population (hispanics in the san antonio area) are associated with altered pain reports.

Eligibility criteria:
inclusion criteria: * willingness to participate; identified indication to have a tooth extraction; 16-90 years old; diagnosis of normal pulp; or diagnosis of irreversible pulpitis requiring a symptom of spontaneous pain and positive and lingering response to pulp vitality test. exclusion criteria: * history of taking steroids within the last month; history of taking analgesics in the last four hours.

Keywords: pain in teeth
a study with nly01 in subjects with type 2 diabetes

Conditions: Type2 Diabetes; Diabetes Mellitus, Type 2

Summary: this is a phase 2a study designed to assess the effect of nly01 in patients with type 2 diabetes. patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.


Eligibility criteria:
inclusion criteria: * male or female subject with type 2 diabetes for at least one year * willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic * body mass index (bmi) 22.0 to 35.0 kg/m\^2, exclusion criteria: * history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. * any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator * any prior exposure to an exenatide-based product (byetta and bydureon) * history of gastroparesis * history of severe hypoglycemia in the past 6 months * if female, pregnant or breastfeeding