Kornimate/medical-research-clean huggingface dataset:
post-marketing surveillance (special use-results surveillance) on long-term use with ozempic®

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety of long-term treatment with ozempic® in patients with type 2 diabetes mellitus. people will get ozempic® as prescribed by their doctor. people will be in this study about 3 years. people above the age of 18 will be asked to fill in the quality of life (qol) questionnaire (the qol questionnaire is for the assessment of the influence of diabetes treatment on people's life). there is a possibility that people's blood sample would be provided to novo nordisk from their doctors in case of severe allergic reaction that might be caused by ozempic®.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available ozempic® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. * patients with diabetes mellitus, type 2 (t2dm) who the physician has decided to start treatment with ozempic®. * male or female, no age limitation. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * patients who fall under contraindications to the label. * patients who are or have previously been treated with ozempic®. * female who is pregnant, breast-feeding or intends to become pregnant.
vitamin d supplementation in tb prevention

Conditions: Latent Tuberculosis

Summary: the goal of this clinical trial is to determine whether vitamin d supplementation reduces risk of acquiring latent tuberculosis infection (ltbi) in school age children in mongolia. the investigators hypothesize that (1) vitamin d supplementation will reduce risk of acquisition of ltbi, (2) vitamin d supplementation will safely reduce risk of developing active tb and improve other secondary efficacy outcomes, and (3) children with the lowest vitamin d status at baseline will gain most from the intervention.


Eligibility criteria:
inclusion criteria: 1. boys or girls aged 6 to 13 years at enrolment 2. attending participating school in ulaanbaatar at enrolment 3. child gives informed assent to participate in the study 4. child's parent/legal guardian gives informed consent for child to participate in study exclusion criteria: 1. chronic medical conditions 2. presence of ltbi on screening, as evidenced by a positive qft-g 3. clinical signs of rickets, or diagnosis of any other condition requiring vitamin d supplementation 4. known primary hyperparathyroidism or sarcoidosis 5. taking immunosuppressant or cytotoxic therapy, or vitamin d supplement \> 400iu / day 6. plans to move away from study area within 3 years of enrolment
autologous vaccine for follicular lymphoma

Conditions: Lymphoma, Follicular

Summary: this phase i study will evaluate the safety and tolerability of an autologous idiotype vaccine manufactured by magnicon technology for patients with relapsed follicular lymphoma who are in complete or partial remission following non-anticd20 containing salvage therapy. data in terms of idiotype-specific immune responses will also be obtained.


Eligibility criteria:
inclusion criteria: * subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment * subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, r-chop, r-cvp, r-fnd, etc) * at least 4 months since last rituximab exposure * subjects may have had any number of prior treatment regimens. if enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen * eastern cooperative oncology group (ecog) performance status of 0-2 * life expectancy of at least 12 months * presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine * measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (ct) scan such that response to 2nd line chemotherapy can be defined by the criteria of cheson et al (jco 2007; 25:579, see appendix 15.2 and ref 65). pet scan results are not required for enrollment exclusion criteria: * exposure to rituximab or anticd-20 directed therapy within the 4 months prior to enrollment * history of human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection * active clinically serious infections (\> grade 2 national cancer institute common toxic criteria \[nci-ctc\] version 3.0) * symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry * history of organ allograft * patients undergoing renal dialysis

Keywords: autologous vaccine follicular lymphoma magnicon plant-made vaccines immune response
dexmedetomine as adjuvant for spinal anesthesia in elective cesarian sections : a pilot study

Conditions: Analgesia; Analgesics, Opioid; Anesthesia, Obstetrical; Anesthesia, Spinal; Analgesics, Non-Narcotic; Dexmedetomidine; Analgesia, Obstetrical

Summary: the proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.the aim of this pilot project is to evaluate the feasibility of a phase iii study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. the target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. this study will be carried out at a single site, the chu sainte-justine as part of a research internship as part of the anesthesiology residency program at the university of montreal.

52 patients will be recruted for this study, and will be randomized in two equal groups. all the interventions carried out will be standardized. medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics. in the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine. in the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment. the patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics. the patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her qor15 questionnaire. this will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.

Eligibility criteria:
inclusion criteria: * patient will receive an elective c-section under spinal anesthesia * gestational age \> 37 weeks exclusion criteria: * asa score ≥ 3 * allergy or contraindication to receiving opioids (morphine or fentanyl) * allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, naprosyn) * allergy or contraindication to receiving acetaminophen * height \ 183 cm * weight \ 110 kg * contraindication to spinal anesthesia * conversion to general anesthesia * combined spinal-epidural anesthesia * inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (inability to understand english or french) * need for transfusion or other major complication
tool to improve treatment adherence and outcomes at grady liver clinic

Conditions: Hepatitis C

Summary: the purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis c medications.

the goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of hepatitis c (hcv) and associated interventions based on identified barriers can improve treatment adherence and outcomes. hcv remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. while these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. in this study, we will administer the psychosocial readiness evaluation and preparation for hepatitis c treatment (prep-c) tool, a free, online survey developed at the mount sinai school of medicine to determine psychosocial readiness for treatment.

Eligibility criteria:
inclusion criteria: * seen in the grady liver clinic during the study time period * have a confirmed chronic hepatitis c infection (hepatitis c antibody positive and detectable hepatitis c viral load) exclusion criteria: * no chronic hepatitis c infection * co-infection with hiv or hepatitis b * non-english speaking * unable to consent to participate * already started hcv therapy

Keywords: psychosocial readiness evaluation and preparation for hepatitis c treatment tool
a study to evaluate the safety and efficacy of abt-450/ritonavir/abt-267; (abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) coadministered with ribavirin (rbv) in hepatitis c virus (hcv) genotype 1-infected adults with compensated cirrhosis

Conditions: Chronic Hepatitis C Infection; Compensated Cirrhosis

Summary: the purpose of this study is to evaluate the safety and efficacy of abt-450/ritonavir/abt-267 (abt-450/r/abt-267; abt-450 also known as paritaprevir; abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) coadministered with ribavirin (rbv) in hepatitis c virus (hcv) genotype 1-infected adults with compensated cirrhosis.

during the treatment period of the study, participants received treatment with abt-450/ritonavir/abt-267 and abt-333 coadministered with rbv for either 12 or 24 weeks. upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Eligibility criteria:
inclusion criteria: * females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * male or female between 18 and 70 years, inclusive, at time of screening. * chronic hcv-infection prior to study enrollment. * screening laboratory result indicating hcv genotype 1-infection. * compensated cirrhosis defined as a child-pugh score of less than or equal to 6 at screening * subject has plasma hcv rna level greater than 10,000 iu/ml at screening. exclusion criteria: * significant liver disease with any cause other than hcv as the primary cause * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) at screening. * prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir and boceprevir. * any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy. * a positive screening ultrasound for hepatocellular carcinoma (hcc) confirmed with a subsequent ct scan or mri during the screening period.

Keywords: cirrhosis hepatitis c child pugh a compensated cirrhosis hepatitis c genotype 1 cirrhotic chronic hepatitis c hepatitis c virus ombitasvir paritaprevir dasabuvir interferon-free viekira pak
a non-interventional study in patients with rheumatoid arthritis who are treated with roactemra/actemra (tocilizumab)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the use and efficacy of roactemra/actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. eligible patients initiated on roactemra/actemra treatment according to the approved label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised (1987) acr criteria * patients in whom the treating physician has made the decision to commence roactemra/actemra treatment in accordance with the local label; this can include patients who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit * patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe roactemra/actemra as monotherapy * patients who were previously on a tnf inhibitor as monotherapy, and the treating physician has made a decision to prescribe roactemra/actemra as monotherapy * concomitant treatment with corticosteroids (orally and intra-articularly) and/or nsaids is allowed exclusion criteria: * patients who have received roactemra/actemra more than 8 weeks prior to the enrolment visit * patients who have previously received roactemra/actemra in a clinical trial or for compassionate use * patients receiving concomitant dmard treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) * patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
study of ngx-4010 for the treatment of painful hiv-associated neuropathy (hiv-an) or postherpetic neuralgia (phn)

Conditions: Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases

Summary: the purpose of the study is to evaluate the safety and efficacy of ngx-4010 administered at intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for the treatment of painful hiv-an and phn. participation is limited to former study subjects from previous trials of ngx-4010 at selected sites.

study c118 is a multicenter, open-label, single-arm study for subjects who successfully completed a previous ngx-4010 study and have not received open-label or blinded ngx-4010 study patches within the 12 weeks prior to study entry. one hundred eligible subjects will receive an initial open-label ngx-4010 study patch application and up to three additional open-label ngx-4010 applications at intervals of no less than 12 weeks, based on the presence or return of pain. eligible subjects will have moderate to severe neuropathic pain secondary to hiv-an or phn, with average pain levels deemed appropriate for further treatment with ngx-4010 as judged by the investigator.

Eligibility criteria:
summary eligibility criteria: * subjects must be in good health and have successfully completed a past trial of ngx-4010 with no past occurrence of adverse events that would contraindicate further treatment. * the time between the last study patch on the previous study and the first study patch on this study must be at least 12 weeks. * topical pain medications are exclusionary and require washout prior to study patch application for this study. * chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application. * other specific inclusion and exclusion criteria must be met prior to enrollment on the study.

Keywords: analgesics capsaicin neuropathic pain neuropathy phn shingles
study on dynamic ctdna analysis in pediatric soft tissue sarcoma

Conditions: Pediatric Soft Tissue Sarcoma

Summary: pediatric soft tissue sarcoma is made up of different subtypes, some of which have distinct genetic alterations. fusion variants were found in about 43% of bone and soft tissue sarcoma samples. ewing sarcoma is characterized by recurrent chromosome translocation, with up to 95% of cases showing ews-ets translocation. the genetic features of the tumor can change as it spreads or shrinks, and can also be influenced by treatment. to better understand treatment response and predict relapse early, our study collects liquid samples such as blood, bone marrow, or cerebrospinal fluid at various points during treatment. we then use next-generation sequencing to dynamically monitor the unique genetic profile of the tumor. additionally, our research may identify new genetic targets and suggest potential treatment options.


Eligibility criteria:
inclusion criteria: * (1) pediatric patients with soft tissue sarcoma confirmed by pathology(including but not limited to rhabdomyosarcoma, ewing sarcoma, bcor rearrangement undifferentiated sarcoma, cic rearrangement undifferentiated sarcoma, epithelioid sarcoma and synovial sarcoma. * (2)younger than 18 years old. * (3)ecog status: ps score0-2. * (4)measurable lesions on ct/mri according to recist 1.1 criteria : long diameter≥10mm; the longest diameter on ≥ one lymphnode ≥1.5 cm. * (5)sufficient clinical and pathological information. * (6)candidates can receive evaluation on time and provide samples during the trials. * (7)candidates should be informed and provide informed consents. exclusion criteria: * sufficient samples at baseline point can not be obtained including pre-operation plasma, tissues, bone marrow aspirate and cerebrospinal fluid. * plasma samples can not be obtained during monitoring. * ineligible candidates at the discretion of researchers.

Keywords: pediatric soft tissue sarcoma ctdna ngs
lidocaine injection and ischemic compression on chronic pelvic pain treatment

Conditions: Pelvic Pain

Summary: our hypothesis is that with comparison of effectiveness of two most common techniques of treatment for myofascial pain syndrome (injection of local anesthesia and ischemic compression) we could choice the most adequate to treat this disease. this way we could decrease the expenses with medicines, examinations, consultations and the time that women remains without a diagnosis and treatment.

after evaluation and diagnostic confirmation, the patients will be randomized and submitted to the treatment with lidocaine injection or ischemic compression. each treatment will be placed once a week, for four weeks. women randomized for treatment with ischemic compression, will be first subjected to transcutaneal electrostimulation(tens), in order to receive analgesia on trigger point. the analgesia will be used to inhibit the painful stimulation. the device used for this will be the dualpex 961, with 100 hertz of frequency and pulse of 250ms. the intensity will be vary according the painful threshold of each patient. the electrostimulation will be made for 30 minutes. the electrodes will be applied around the trigger point. after analgesia, the ischemic compression will be applied. this therapy consists in a continuous pressure on trigger point. for this we will use one algometer to get maximum of homogeneity on therapy. the pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. this therapy will be applied three times with duration of 60 seconds each with a 30 seconds of rest between the applications. injection of anesthesia: this therapy will be applied directly in trigger points with two ml of lidocaine 0.5% with needle of 22 gauges directly and perpendicularly in trigger point. the evaluations for each treatment will be carried immediately before the randomization; in one month: immediately after the four weeks of treatment; - three months: three months after the treatment; - six months: six months after the treatment.

Eligibility criteria:
inclusion criteria: 1. women with chronic diagnosis of pelvic pain; 2. women in menacme; 3. presence of the diagnostic criteria for abdominal myofascial syndrome; 4. agreement with the term of free and clarified assent. exclusion criteria: 1. endometriosis, interstitial cystitis, syndrome of the irritable intestine or another illness that it justifies or it contributes for chronic pelvic pain; 2. endometrioma or hernia evidenced to the ultrasound of the abdominal wall.

Keywords: lidocaine ischemic compression chronic pelvic pain myofascial pain syndrome
study of avelumab and cetuximab plus gemcitabine and cisplatin in participants with nsclc

Conditions: Squamous Non-Small Cell Lung Cancer

Summary: the main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous non-small-cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically-confirmed stage iv metastatic or recurrent (stage iv) nsclc of squamous histology * availability of formalin-fixed paraffin-embedded (ffpe) block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides (cut within 1 week) suitable for programmed death ligand 1 (pd-l1) expression and epidermal growth factor receptor (egfr) expression/amplification assessments * at least 1 measurable lesion per response evaluation criteria in solid tumors (recist) v1.1 criteria * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 at study entry * adequate hematological, hepatic and renal function * estimated life expectancy of at least 3 months * can give signed informed consent * other protocol defined inclusion criteria could apply exclusion criteria: * participants whose tumor disease harbors an activating egfr mutation or alk rearrangement. participants with tumors of unknown egfr or alk status will require testing only in never smokers * all participants with brain metastases with protocol defined exceptions * previous malignant disease (other than nsclc) within the last 5 years (except adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and the participant was deemed to have been cured with no additional therapy required or anticipated to be required * active infection requiring systemic therapy * known history of human immunodeficiency virus or known acquired immunodeficiency syndrome * hepatitis b virus (hbv) or hepatitis c virus (hcv) infection at screening (positive hbv surface antigen or hcv ribonucleic acid (rna) if anti-hcv antibody screening test positive) * active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * interstitial parenchymal lung disease * pregnancy or lactation * known alcohol or drug abuse as determined by the investigator * history of uncontrolled intercurrent illness * clinically significant (that is active) cardiovascular disease * known history of inflammatory colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis * any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements * prior/concomitant therapy as described in protocol * use of any investigational drug within 28 days before the start of study treatment * other protocol defined exclusion criteria could apply

Keywords: avelumab cetuximab cisplatin gemcitabine non-small cell lung cancer