Kornimate/medical-research-clean huggingface dataset:
an observational study to evaluate safety and efficacy of remsima™ in patients with ra

Conditions: Rheumatoid Arthritis

Summary: an observational, prospective cohort study to evaluate safety and efficacy of remsimatm in patients with rheumatoid arthritis.

this is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of remsimatm in patients with ra in comparison with patients receiving non-biologic treatmentsor other anti-tnf drugs. for the remsimatm cohort data will be collected for patients who commence treatment with remsimatm in accordance with the product label at the time of enrolment (3 mg/kg of remsimatm by iv infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). for patients who have been treated with remicade® prior to enrolment, their dosing schedule will be continued appropriately. this observational study allows drug switching between anti-tnf drugs. if switched to remsimatm, data will be collected until the end of study for each patient. if switched to other anti-tnf drugs (infliximab (remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.

Eligibility criteria:
inclusion criteria: 1. adult patients 2. patients with active ra diagnosed according to the revised 1987 acr or 2010 acr/eular classification criteria exclusion criteria: 1. patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins. 2. patients with a current or past history of chronic infection 3. patients with moderate or severe heart failure (nyha class iii/iv).
effect of dose, safety, tolerability of a new smallpox vaccine in adults without previous smallpox vaccination

Conditions: Smallpox

Summary: the purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

the objective of this study is to determine the minimum dose of acam2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. specifically, the objectives of this study are to: 1. compare the safety and tolerability of four dose levels of acam2000 and a standard dose of dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis. 2. determine the immunogenicity of four dose levels of acam2000 and a standard dose of dryvax® in healthy adults 18-29 years of age by comparing: 1. the proportion of subjects at each dose level who develop a major cutaneous reaction; 2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between baseline and day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on day 30. 3. determine the minimum dose of acam2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.

Eligibility criteria:
inclusion criteria: * females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. * agree to be available for the entire study and agree to comply with all requirements. exclusion criteria: * military service prior to 1989. * history of previous smallpox vaccination. * children 1 year of age or younger in the household or be in close contact * smallpox vaccination within ten years * known or suspected human immunodeficiency virus (hiv) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. * renal disease * current or past history of eczema or a household member or direct contact who has eczema. * known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin b * known allergy or past allergic reaction to blood products. * known allergy to cidofovir or sulfa-containing drugs. * history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or stevens-johnson syndrome. * transfusion of blood or treatment with any blood product. * current or history of drug or alcohol abuse * inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Keywords: smallpox
study to evaluate the safety of asoprisnil in the treatment of uterine fibroids

Conditions: Leiomyoma; Menorrhagia; Metrorrhagia

Summary: the objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

no medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. the objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in m01-390 or m01-394. the safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs. some subjects receiving asoprisnil developed endometrial changes. as a result, dosing was prematurely discontinued for all subjects. to ensure safety, subjects will remain on study and will undergo scheduled study procedures. in most subjects, endometrial changes reversed after asoprisnil discontinuation.

Eligibility criteria:
inclusion criteria: * women who have completed 12 months of treatment in study m01-390 or study m01-394 and their visit 12 procedures, respectively * otherwise in good health * premenopausal based on estrogen and fsh levels * agrees to use of double barrier method of contraception * adequate endometrial biopsy with no significant histological disorder exclusion criteria: * any abnormal lab or procedure result(s) the study-doctor considers important * significant gynecological disorder such as confirmed endometrial polyp * hemoglobin \< 8.0 g/dl * history of a blood-clotting disorder * any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.

Keywords: symptomatic uterine fibroids excessive uterine bleeding uterine hemorrhage asoprisnil
electrical acupoint stimulation reduces intrathecal anesthesia induced hypotension

Conditions: Hypotension During Surgery

Summary: the parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. acupuncture was reported to treat hypotension both in human and animal studies. possible mechanisms include modulating cardiovascular and sympathetic system. in this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (teas) on hypotension in parturients undergoing cesarean section.


Eligibility criteria:
inclusion criteria: * age ≥18 years * american society of anesthesiologists physical status ⅰ-ⅱ * singleton pregnancy * full-term gestation (≥38 weeks) exclusion criteria: * parturients suffering from preeclampsia * parturients with hypertension, diabetes, or cardiac dysfunction

Keywords: transcutaneous electrical acupoint stimulation spinal anesthesia hypotension
improved clinical and microscopy diagnosis at primary health care in tanzania

Conditions: Malaria

Summary: general objective: to improve the quality of fever case management in children in government health facilities in tanzania hypothesis:the training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

phc facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from muhimbili university college of health sciences (muchs), dar es salaam all children attending the 16 phc facilities under the study during daytime were enrolled if they fulfilled the following criteria: 1. below five years of age 2. fever (temperature≥37.5◦c) and/or reported history of fever in last 2 days 3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur 4. the mother/guardian or caretaker consented to participate. patients with severe disease and/or general danger signs requiring inpatient care according to the imci guidelines were admitted or referred to the health centers or the district hospitals

Eligibility criteria:
inclusion criteria: 1. below five years of age 2. fever (temperature≥37.5◦c) and/or reported history of fever in last 2 days 3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur 4. the mother/guardian or caretaker consented to participate exclusion criteria: a) n/a

Keywords: malaria microscopy primary health care children
naet screening for food allergy, sensitivity and intolerances using ige-specific antigen test and nst- naet®

Conditions: Food Sensitivities; Headache; Backache; Indigestion; Eczema, Acne, Hives and Itching of the Skin

Summary: food allergy reactions cause various health disorders in sensitive people. these reactions may be ige-mediated,cell-mediated, energy disturbance-mediated, or a combination of the three. certain laboratory diagnostic procedures have been able to identify most ige-mediated or cell-mediated food reactions, but so far there is no test available in traditional medicine to test the energy-mediated allergies and sensitivities. naet® procedures have been able to identify food substances triggering to energ disturbances in sensitive people causing related health disorders. naet uses one of the testing procedures called nst (neuromuscular sensitivity testing).the efficacy of nst-naet to screen food sensitivity will be evaluated in comparison with one of the well accepted, established, traditional medicine allergy testing known as the ige-specific antigen test.

forty-two volunteers responded for an advertisement posted on the naet web site and in the community college news bulletin board inviting them to take part in the study. they were asked to complete the naet® allergy symptom-rating (asr) questionnaire upon arrival at the research center. observing inclusion and exclusion criteria, a total of 32 subjects from both sexes with varied health problems were selected out of the forty-two who volunteered for the study. all 32 subjects were tested for 21 commonly used food substances via nst. out of 32 tested, 26 subjects tested positive for one item each, from the 21 items tested and six subjects tested positive for multiple items from the selected food list. the 32 subjects had a total of 50 positive nsts out of 672 (21x32) tests performed. the items that produced positive results by nst were further evaluated via laboratory blood serum analysis for ige-specific antigens. according to nst the percentage of observed total food reactions in this group of 32 was 7.44%. soon after the completion of nst the laboratory technicians collected blood from 32 subjects for ige-specific antigen study on 50 positively tested items. the ige-specific antigen tests were found positive on a total of 49 out of 50 tests performed.

Eligibility criteria:
inclusion criteria: a history of previous allergic reactions to one or more food substances from the selected list ( almond, apple, banana, beef, carrot, celery, chocolate, corn, cow's milk, crab, egg white, lobster, orange, oyster, peanut, salmon, shrimp, soybean, string bean, tomato, and wheat) was considered as the primary important factor for the study. - exclusion criteria: 1. serious illnesses e.g.. cancer, chronic obstructive pulmonary diseases, kidney diseases, heart diseases, history of anaphylaxis to any of the listed item in the inclusion criteria, mental disorders, and pregnancy. 2. previous treatment for food allergies. 3. knowledge of procedure -

Keywords: nst-naet testing food ssensitivities eczema acne indigestion
multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * bmi above or equal to 25 and below or equal to 40 kg/m\^2 * subjects diagnosed with t2d (type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening * hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) exclusion criteria: * subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants * history of chronic pancreatitis or idiopathic acute pancreatitis * chronic malabsorption, regardless of aetiology * history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease * treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
a study of zolpidem tartrate sublingual tablet in adult patients with insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate sleep onset following administration of transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.


Eligibility criteria:
inclusion criteria: * insomnia as defined by dsm-iv criteria and supported by subject diary * male or female between the ages of 18-64 years * body mass index (bmi) between 18-34 kg/m\^2 * females of childbearing potential must use a medically acceptable method of contraception * capable of understanding and willing to comply with study procedures and has provided informed consent exclusion criteria: * females who are pregnant, breast-feeding or have a positive pregnancy test * any circadian rhythm disorder including planned travel across several time zones during the study period * known hypersensitivity to zolpidem * has performed regular shift work with the past several months prior to screening * an acute clinically significant illness or surgery as determined by the pi within 30 days of screening * patients that have used any central nervous system (cns) medication or other medication known to impact the sleep/wake cycle * a history of psychiatric disorder as defined by dsm-iv * a history of drug addiction or alcohol abuse * any current significant disease, unless adequately controlled with a protocol allowed medication * known history of hiv or hepatitis b or c * patients who have received an investigational drug within several months of screening

Keywords: insomnia
assessment of visual acuity in refugee population

Conditions: Visual Acuity; Refractive Errors; Low Vision; Vision Disorders

Summary: the present research process is a prospective clinical study that will be conducted under the auspices of the democritus university of thrace (duth) in the open accommodation structure for refugees and immigrants of kavala, kavala, greece, and the pre-removal detention center (prokeka) for foreigners of kos, kos, greece. the study aims to assess the basic ophthalmological condition of the refugee/immigrant population and is developed in two main areas: 1. the recording of the ophthalmological care that the refugee/immigrant has received until his/her inclusion in the study through a structured questionnaire (eg previous examinations, spectacle utilization, pharmaceutical or other interventions, etc.) 2. the measurement of monocular best-spectacle corrected visual acuity in both eyes using a web-based visual acuity chart. adult participants living in the two aforementioned centers will be recruited in a consecutive-if-eligible basis. all age groups will be proportionally represented (proportional age distribution).

study protocol will adheres to the tenets of the helsinki declaration and written informed consent translated in the language of each examinee will be obtained by all participants. subsequently, participants will complete a questionnaire about demographic and general clinical information. then, the best spectacle-corrected distance visual acuity of each participant's both eyes will be evaluated monocularly via a web-based digital chart in a high-resolution screen. the same environmental lighting conditions and the same screen brightness will be applied. the examination will be performed at the same predetermined viewing distance. finally, according to each participant's visual acuity, appropriate instructions will be given for the improvement of his/her eye care.

Eligibility criteria:
inclusion criteria: * adult refugees or immigrants exclusion criteria: * visual acuity lower than 1.0 logmar * age \<18 years * refugees or immigrants living in the accommodation structures without yet having the appropriate legal documents

Keywords: distance visual acuity refugee immigrant
reproducibility of 18f uptake by solid tumors using pet imaging following intravenous administration of (18f) injection

Conditions: Solid Tumors; High Grade Gliomas; Lung Cancer; Head and Neck Cancer; Sarcoma; Renal Cell Carcinoma; Breast Cancer

Summary: study aimed to assess the reproducibility of pet imaging using ah111585 (18f) injection. subjects are evaluable if they undergo 2 administrations of ah111585 (18f) injection (3 to 8 days apart) and the corresponding pet acquisitions, and tumors demonstrate detectable levels of 18f uptake on pet.


Eligibility criteria:
inclusion criteria: * the subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to nsclc, rcc, gbm, melanoma, sarcoma, breast and h\&n cancers. * the subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first \[18f\]ah111585 pet scan. * the subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care. exclusion criteria: * the subject has known hyper- or hypo-coagulation syndromes. * the subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first \[18f\]ah111585 pet scan. * the subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second \[18f\]ah111585 pet scans. * the subject is scheduled to undergo biopsy for the target tumour between the first and second \[18f\]ah111585 pet scans. * the subject has intra-hepatic tumour(s) only. * for the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first \[18f\]ah111585 pet scan.
movement for depression - an rct assessing the effects of physical activity promotion for people with mdd

Conditions: Major Depressive Disorder

Summary: randomized clinical trial that aims to increase physical activity levels in people with depression and to evaluate if the increase on pa levels has impact on clinical and biological measures.

the contacts will be made by face-to-face interviews and telephone calls

Eligibility criteria:
inclusion criteria: * age: 18 - 65 years; * diagnosis of major depressive disorder (dsm-iv), assessed by a trained psychiatrist; * score 7 or more in the ham-d; * do not present clinical comorbidities that limit or contra-indicate the practice of physical activity; * be starting depression treatment at the programa de transtorno do humor (prothum) ; * have acess to a computer and have a facebook account; * be able to read and sign the consent term. exclusion criteria: * present other psychiatric diagnosis such as bipolar disorder, schizophrenia or use of alcohol or other drugs; * be not liberated to the practice of physical exercises by the assistant psychiatrist.

Keywords: exercise physical activity behavioral change depression major depressive disorder health promotion
incidence of severe respiratory syncytial virus infections in preterm brazilian children

Conditions: Respiratory Syncytial Viruses; Respiratory Tract Infection

Summary: the primary objective of this study is to determine the incidence of severe rsv lrti requiring hospitalization among infants born \< 35 weeks gestational age for one year of follow-up.

this is an epidemiologic study of the incidence of severe rsv lrti among brazilian children born \<35wga. the study will enroll competitively 350 subjects from 3 sites in brazil. preterm children will be identified after birth and up to 72 hours after hospital discharge and followed for one year after the enrollment. subjects will be seen monthly for the first 6 months and bimonthly until one year of follow-up. at each visit, a medical and social history will be updated and a physical examination will be performed. legal representative will notify study personnel in the event of a respiratory illness or hospital admission at which time the subject will be seen by an investigator. children with lrti diagnosed by physical examination will have viral diagnostic tests performed. subjects with a lrti not requiring hospitalization will be followed by telephone weekly until illness resolution. hospitalized children with a lrti will be followed daily while hospitalized and followed by telephone until illness resolution. all medical interventions and outcomes will be recorded.

Eligibility criteria:
inclusion criteria: * male and female infants that were born \<35 weeks gestational age * the inclusion must be done during the following period: * 24 hours prior confirmed maternity hospital discharge date, or * up to 72 hours after documented maternity hospital discharge date. in this case, rsv rapid test must be performed and subjects should be enrolled only if the results is negative. * less than 6 months of age at screening * born into or transferred to a participating hospital * able to receive follow-up medical care at the participating site and provide information during the follow-up period * the legal representative is capable of understanding and complying with parameters as outlined in the protocol and able and willing to participate in this study, by signing the informed consent approved by an independent ethics committee (iec)/institutional review board (irb), after all the aspects of the study that might be relevant for his/her decision to participate are explained and all his/her questions and doubts are elucidated, and prior to the initiation of any screening or study-specific procedures. exclusion criteria: * rsv infection prior inclusion. * receipt of palivizumab or other immunoglobulin preparation containing rsv specific antibodies (i.e. rsv hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella-zoster hyperimmunoglobulin)

Keywords: epidemiological study incidence of severe respiratory syncytial virus preterm brazilian children