Kornimate/medical-research-clean huggingface dataset:
a study to learn about the study medicine (maplirpacept) in people with advanced non-hodgkin lymphoma or multiple myeloma in china

Conditions: Non-Hodgkin Lymphoma; Multiple Myeloma

Summary: the purpose of this study is to learn about the safety and what the body does to the medicine (maplirpacept) when taken for the treatment of non-hodgkin lymphoma or multiple myeloma. non-hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). this study is seeking participants who: * have non-hodgkin lymphoma or multiple myeloma. * have worsened with (or lack of improvement to) a standard treatment taken before. * have relatively normal functioning organs. all participants in this study will receive maplirpacept as an intravenous (iv) infusion (given directly into a vein) at the study clinic every week. participants will continue to receive maplirpacept until: * the cancer worsens. * some serious side effects show up. * the participants do not wish to take the study medicine any more. the experiences of the people receiving the study medicine will be collected. this will help to understand if the study medicine maplirpacept, is safe and can be given to chinese people.

the study is composed of 2 parts. in part a, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in chinese participants. if deemed safe, the enrollment of part b will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent pf-07901801 (maplirpacept).

Eligibility criteria:
key inclusion criteria: * histologically confirmed relapsed/refractory non-hodgkin lymphoma without other effective therapeutic option. or relapsed/refractory multiple myeloma exposed to therapies including pi, imid and anti-cd38 antibody. * with measurable disease * eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2. * adequate organ functions (including hematologic status, coagulation, hepatic, and renal) key exclusion criteria: * active plasma cell leukemia, or poems syndrome. * known, current central nervous system disease involvement. * significant cardiovascular disease. * chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent. * radiation therapy within 14 days of study treatment administration. * hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active gvhd disease. * use of any anticancer drug within 14 days before planned start of study treatment. * prior anti-cd47 or anti-sirp alpha therapy. * participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose * known active, uncontrolled bacterial, fungal, or viral infection.
menopausal ht for women living with hiv (hot)

Conditions: HIV Infection; Menopause

Summary: women living with hiv have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without hiv. this correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without hiv. however, the usefulness of hormone therapy has not been specifically studied in women living with hiv. this trial is being done to see if: * there is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with hiv * hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with hiv * hormone therapy is safe and tolerable for women living with hiv


Eligibility criteria:
* living with hiv * assigned female sex at birth * between the ages of 40 and 60 years * in the late menopausal transition (perimenopause) or early postmenopause * experiencing hot flashes and/or night sweats * willing and able to complete a daily diary * does not have medical condition that would contraindicate hormone therapy * not taking medications to treat hot flashes * not taking medications that cannot be combined with hormone therapy * receiving antiretrovirals (hiv medication) for more than 1 year * not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy * willing and able to provide informed consent after discussion with the research staff
comparing biopsy needles for endoscopic ultrasound guided samples for pancreatic masses

Conditions: Pancreatic Neoplasm

Summary: this is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.

at eus, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22g fna or fnb needle. all patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. however, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. the number of passes needed to achieve diagnostic adequacy using both needles will documented. four dedicated passes will then be performed using the initial randomization sequence for cell block. two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing. if the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. this will also be a maximum of 8 passes. information about the number of needles used, how many passes were performed, any problems with the needles will be collected. if there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.

Eligibility criteria:
inclusion criteria: * scheduled to undergo eus * patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction * able and willing to provide written or verbal consent exclusion criteria: * unable to safely undergo eus for any reason * coagulopathy (prothrombin time \> 18 secs, platelet count \< 80,000/ml) * active alcohol or other drug use or significant psychiatric illness * pregnancy * unable or unwilling to provide consent

Keywords: fine needle biopsy eus solid pancreatic mass
a study on the safety and efficacy of topiramate in the treatment of patients with bipolar i disorder

Conditions: Bipolar Disorder

Summary: this primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with bipolar i disorder.

this is a randomized, double-blind, placebo- and active-controlled study to evaluate the effectiveness of two dose levels of topiramate (200 and 400 milligrams/day) compared with lithium and placebo in the treatment of acute manic or mixed episodes in patients with biplar i disorder. the trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. efficacy assessments include the change from baseline to day 21 for the total young mania rating scale (ymrs) score. also included as efficacy assessments during the 12 week study are the global assessment scale (gas), montgomery-åsberg depression rating scale (madrs), brief psychiatric rating scale (bprs), clinical global impressions (cgi), and health-related quality of life measures at specified time intervals. safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ecgs), and physical examinations at specified times. the study hypothesis is that the change from baseline in young mania rating scale (ymsr) total score at day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. topiramate: oral tablets (50 milligrams\[mg\]); increasing from once daily (50mg) to 3-times daily; target total daily dose 200mg or 400mg, maintained through week 12. lithium: oral capsules (300mg); increasing from once daily (300mg) to three-times daily; target total daily dose 1500-1800 mg.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i disorder by criteria of diagnostic and statistical manual of mental diseases, 4th edition (dsm-iv) confirmed by the structured clinical interview for dsm-iv axis i disorders (scid-i * ) * at least one previous manic or mixed episode * meeting minimum severity criteria (a young mania rating scale \[ymrs\] score of \>=20 at screening and baseline visits) for the current acute manic or mixed episode * females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test exclusion criteria: * dsm-iv diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) * dsm-iv axis i diagnosis of schizoaffective disorder or impulse control disorder * experienced a manic episode while taking an antidepressant or psychostimulant drug * known hypersensitivity to topiramate or previously participated in a topiramate study

Keywords: bipolar disorder bipolar mania topiramate lithium
temporomandibular joint (tmj) positioning accuracy and efficiency using a dental compass.

Conditions: Temporomandibular Joint Syndrome

Summary: this study is being performed to determine if the use of the dental compass articular and its software will produce therapeutic splints for tmd accurately and successfully, compare favorably with a cohort treated without the dental compass (for number of visits, splint modifications, and required cbcts).

standard practice in the treatment of temporomandibular dysfunction (tmd) currently involves non-radiographically-assisted manual repositioning of the jaw followed by either an in-office cone beam computerized tomography (cbct) or tomographic x-ray of both tmjs, and further adjustment as necessary to improve the initial bite impression.\[15\] at follow up visits the therapeutic splint is modified in stages to "walk" the condyle progressively into the ideal position, such as altering side shift, lateral deviation, and rotation. during this process multiple cbcts or tomographic x-rays, and multiple direct dentist interventions, are required to find the precise joint position, involving significant radiation exposure, and significant chair time for the dentist the key advantage of using the dental compass articulator in conjunction with its software, is to identify and suggest corrections for the range of orthopedic imbalances present. software-facilitated identification of imbalances is coupled with manipulation of yaw (anterior, posterior, lateral, or rotational movement of the mandible in a horizontal plane), pitch (rotation of the mandible in a frontal vertical plane), and roll (rotation of the mandible in a lateral vertical plane) to achieve optimal condylar and mandibular position for splint manufacture. the goals of this study are to: 1. determine if the use of the dental compass articular and its software will produce therapeutic splints for tmd accurately and successfully, and will compare favorably with a cohort treated without the dental compass (for number of visits, splint modifications, and required cbcts), and 2. confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.

Eligibility criteria:
inclusion criteria for prospective active participants: * tmj dysfunction and pain * cbct indicates a non-gelb 4/7 position or \< 1.8 mm bone to bone interval between the mandibular condyle and mandibular fossa anteriorly or posteriorly. exclusion criteria: * planning a move within 9 months. * unwilling to provide two phone numbers and two email contacts. * not willing to express a willingness to come in for 4-6 month follow up if they have marked improvement or improvement in symptoms. * not living within 90-minute drive from clinic * transportation not reliable * involved in any other tmd study * life threatening illness or major surgery planned * other major life stress that might interfere with completing the study
study of elderly patients with cancer and seen in consultation of geriatric oncology in the nord pas-de-calais (consog).

Conditions: Cancer

Summary: the aim of this study is to establish a common geriatric oncology medical database. the patients concerned are the patients having benefited from a geriatric oncology consultation in one of the participating centres. this database is designed with a view on the one hand to better describe to better understand this population and on the other hand to facilitate the conduct of future retrospective or prospective studies on this population. the constitution of this observatory of patients seen in consultation should facilitate the development of studies from the analysis of data collected, and occasional surveys by the rapid identification of cases. data from this database could provide clinicians with valuable informative elements of descriptive epidemiology and concerning the organization of care in the geriatric oncology field.

the study is presented during the first consultation of oncogeriatric care or after this consultation (for patients having benefited from the consultation between january 2014 and october 2014) : the patient is informed with an information note and is told that he can express its opposition to the use of its clinical data. in case of no opposition from the patient, the referent geriatrician will complete the patient form with the requested data and will forward it for computerized processing.

Eligibility criteria:
inclusion criteria: * patient seen in consultation of geriatric oncology in one of the participating centres in nord pas-de-calais. * age ≥ 65 years * patient having been informed and not opposing the computerized processing of its data. exclusion criteria: * patient having opposed the use of its medical data.

Keywords: geriatric oncology
tactile massage in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: tactile massage is a gentle form of massage that probably exerts its effect through relaxation. in a pilot study of 11 subjects an effect on hba1c of 0.8%-units was seen. the study aimed at comparing the effect of tactile massage sessions for one hour given once a week for 10 weeks in comparison with relaxation through a relaxation cd performed once a week during 10 weeks. primary outcome was hba1c measured after completed intervention and after yet another 12 weeks. secondary outcomes were quality of life by sf-36, other markers of metabolism (fasting glucose, insulin resistance by homa-model), inflammation (crp, cytokines) and stress (cortisone, catecholamines).

effects of different relaxation techniques on metabolic control in type 2 diabetes have been described. a pilot study indicated an effect by tactile massage, a swedish form of gentle massage given in sessions of around one hours and including treatment of the whole body in general, on metabolic control measured as hba1c and on plasma corticosteroids. the present study aimed at studying the effects in a randomized controlled study, with patients provided with a relaxation cd available at pharmacies in sweden. power calculations found that 20-25 subjects in each group would be sufficient to show effect on hba1c (0.8% vs 0.3%), but that 45-50 subjects would be needed to show clinical relevant effect on quality of life. patients aged 35-75 years with type 2 diabetes and bmi 25-30 and hba1c 6-8%-units (swedish standard, corresponding to 7-9%-units in dcct standard) from primary health care centres in stockholm county were invited to participate, and was randomly assigned to tactile massage or relaxation groups. exclusion criteria was heart or renal failure, treatment with insulin, problems with swedish language. besides, only subjects of swedish ethnicity were included in this first study, in order to refine results and avoid confusional results. examination with laboratory tests, body examination and questionnaire, including sf-36 and questions on smoking, dietary and physical activity habits, was performed before intervention, after the 10 weeks examination and after yet another 12 weeks. urine sampling on catecholamines and corticosteroids was performed, and blood tests on hba1c, fasting glucose, insulin, crp, cytokines (tnf-alpha, il-6), adiponectin, leptin, ghrelin.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * 35-75 years * bmi 25-30, hba1c (swedish standard) * oral antidiabetic treatment exclusion criteria: * heart failure * renal failure * insufficient knowledge in swedish
assess safety, tolerability, pharmacokinetics and clinical activity of amp-110 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of amp-110 in adult subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * must be able to provide written informed consent * body mass index 18.5 to 35.0 kg/m2 * diagnosis of rheumatoid arthritis according to 1987 revised american college of rheumatology (acr) criteria * global functional class i, ii, or iii according to acr 1991 revised criteria * must have at least 4 tender joints and 4 swollen joints (28-joint assesssment) * use of \>/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for \>/= 2 weeks prior to randomization * use of \>/= 1 disease modifying anti-rheumatic drugs (dmard) for \>/= 3 months and a stable dose for \>/= 6 weeks prior to randomization * stable use of low dose oral corticosteroids (\ /= 4 weeks prior to randomization exclusion criteria: * prior to day 0, use of: 1. rituximab within 6 months 2. abatacept within 3 months 3. infliximab, adalimumab, certolizumab, tocilizumab, cyclosporine, azathioprine or mycophenolate mofetil within 2 months 4. etanercept, anakinra, immunoglobulin or blood products within 28 days 5. prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, janus kinase (jak) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer 6. prior exposure to t cell depleting agents such as campath (alemtuzumab) * evidence of any active or recent infection * history of systemic autoimmune disease other than rheumatoid arthritis; secondary sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of ra allowed * history of allergic reactions * history of anaphylaxis or allergic diathesis * clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram * evidence of active or latent tuberculosis * vaccination with live attenuated viruses within the 2 weeks prior to day 0 * pregnant or breastfeeding women

Keywords: rheumatoid arthritis arthritis joint diseases musculoskeletal diseases
transarterial ethanol ablation (tea) versus transcatheter arterial chemoembolisation (tace) for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the current randomized controlled trial comparing lem and tace aims to evaluate the safety and efficacy of lem as compared to tace for treating patients with unresectable hcc.

the standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (tace). however, the drawback of conventional chemoembolization (tace) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. usually multiple treatments are required and tumor recurrences are common. transarterial ethanol ablation (lem) can potentially provide a better treatment outcome with fewer treatment sessions. preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. this study aims to compare survival duration and response rate between the treatments tace and lem.

Eligibility criteria:
inclusion criteria: patient factor * age \> 18 * child-pugh a or b cirrhosis * ecog performance status grade 2 or below * no serious concurrent medical illness * no prior treatment (including surgery) for hcc tumor factor * histologically or cytologically proven hcc (an alphafetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of hcc in a patient with chronic hbv or hcv infection can be considered eligible at investigator's discretion) * unresectable and locally advanced disease without extra-hepatic disease * massive expansive or nodular tumor morphology with measurable lesion on ct * size of largest tumor \<= 15cm in largest dimension * number of main tumor \<= 5, excluding associated small satellite lesions. exclusion criteria: patient factor * history of prior malignancy except skin cancer * history of significant concurrent medical illness such as ischemic heart disease or heart failure * history of acute tumor rupture * serum creatinine level \> 180 umol/l * presence of biliary obstruction not amenable to percutaneous drainage * child-pugh c cirrhosis evidence of poor liver function * history of hepatic encephalopathy, or * intractable ascites not controllable by medical therapy, or * history of variceal bleeding within last 3 months, or * serum total bilirubin level \> 50 umol/l, or * serum albumin level \< 28g/l, or * inr \> 1.3 tumor factor * presence of extrahepatic metastasis * predominantly infiltrative lesion * diffuse tumor morphology with extensive lesions involving both lobes. vascular complications * hepatic artery thrombosis, or * partial or complete thrombosis of the main portal vein, or * tumor invasion of portal branch of contralateral lobe, or * hepatic vein tumor thrombus, or * significant arterioportal shunt not amenable to shunt blockage, or * significant arteriovenous shunt not amenable to shunt blockage