Kornimate/medical-research-clean huggingface dataset:
a multicenter phase ii study of neoadjuvant docetaxel, cisplatin and capecitabine and protocolized surgery in resectable gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. furthermore, an extended type of removal of lymph nodes will be implemented.


Eligibility criteria:
inclusion criteria: * ib-iva histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma siewert 2 and 3 * asa 2 or less * age 18 years or more * no prior radio- or chemotherapy conflicting with the treatment of gastric cancer * haematology/renal function/liver function within designated range * patient's consent form obtained, signed and dated before beginning specific protocol procedures * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * before patient registration/randomization, written informed consent must be given according to gcp, wmo and local regulations. exclusion criteria: * previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer * other current serious illness or medical conditions * severe cardiac illness (nyha class iii-iv) * significant neurologic or psychiatric disorders * uncontrolled infections * active dic * other serious underlying medical conditions that could impair the ability of the patient to participate in the study * known hypersensitivity to docetaxel (or any drug formulated with polysorbate-80), or cisplatin or capecitabine or 5-fu * definite contraindications for the use of corticosteroids * use of immunosuppressive or antiviral drugs * any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period * pregnant or lactating women * patients with reproductive potential not implementing adequate contraceptive measures

Keywords: neo-adjuvant chemotherapy d1extra-resection
convalescent plasma for covid-19 research donor study

Conditions: Covid19

Summary: convalescent plasma for covid-19 research (concor-donor) study, is a national, natural history study of plasma donors recovered from covid-19. concor-donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. we will also study long-term outcomes from covid-19 infection. results from the study will help define therapeutic strategies for covid-19.

the outbreak caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) led to the global pandemic. there are currently no proven treatments for coronavirus disease (covid-19), however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. convalescent plasma was successfully used for other infections, in small numbers, but there is limited evidence for the efficacy of administering specific, neutralizing antibodies by transfusion of convalescent plasma. the unknown role for convalescent plasma in treating covid-19 necessitates further study. as trials are underway to determine efficacy of using convalescent plasma, we will use this unique opportunity to conduct a national longitudinal cohort study of 1000 persons recovered from covid-19 and volunteer to donate convalescent plasma. our aims are to:1) determine if the variability of titers of viral neutralizing antibody and elisa antibody are associated with clinical and demographic factors; 2) determine duration of protective immunity in recovered persons over 1 year and if modified by clinical and demographic factors; 3) determine genetic risk predictors of the antibody response, and 4) create a biorepository available to researchers from across canada. based on the world health organization (who) coordinated global research map, this project addresses the priority of the natural history of covid-19 and clinical characterization of antibody response in the convalescent phase and beyond.

Eligibility criteria:
inclusion criteria: * recovered from covid-19 infection * have a positive pcr or serology or a positive household contact * signed informed consent form * provide blood sample * ability to complete a questionnaire exclusion criteria: * none

Keywords: covid19 convalescent plasma seroconversion immunity national biorepository observational study
a comparison of seated thoracic manipulation and targeted supine thoracic manipulation on cervical flexion motion and pain

Conditions: Neck Pain

Summary: thirty-nine patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. pain and flexion range of motion measures were taken before and after the intervention.

design: randomized clinical trial objectives: to determine the effectiveness of seated thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and flexion range of motion. there is evidence that thoracic spine manipulation is an effective treatment for patients with cervical spine pain. this evidence includes a variety of techniques to manipulate the thoracic spine. while each of them is effective, no research has compared techniques to determine which produces the best outcomes. methods: thirty-nine patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. pain and flexion range of motion measures were taken before and after the intervention.

Eligibility criteria:
inclusion criteria: * inclusion criteria required patients to be between 18-60 years old with a primary complaint of neck pain exclusion criteria: * identification of red flags suggestive of nonmusculoskeletal etiology, history of whiplash injury within six weeks of the initial visit, diagnosis of cervical spine stenosis, central nervous system involvement, or signs of nerve root compression (two of the following limited at the same level: strength, sensation, reflexes).
sbrt combined with osimertinib compared with osimertinib for stage iv nsclc

Conditions: Stage IV Non-small Cell Lung Cancer

Summary: this is a prospective, multicenter, randomized controlled study to evaluate stereotactic body radiation therapy (sbrt) as a potential treatment for stage iv non-small cell lung cancer (nsclc) that has a mutated epidermal growth factor receptor (egfr) and has been receiving treatment with osimertinib


Eligibility criteria:
inclusion criteria: 1. patients must have biopsy proven metastatic nsclc (stage iv). 2. patients receiving first-line osimertinib for egfr mutant-positive for 3 months and achieved stable disease or partial response. 3. age 18 to 75 years old. 4. patients must have measurable disease at baseline. 5. the amount of metastatic focus \<5. 6. ecog score 0-2 7 adequate normal organ and marrow function for tki treatment and radiotherapy. 8. patients must has sensitizing egfr mutation (e.g. exon 19 deletion or exon 21 l858r) 9. patients must provide written informed consent to participate in the study. exclusion criteria: 1. patients who previously received radiotherapy to the primary site. 2. patient can't tolerate radiotherapy or targeted therapy; 3. pregnant or nursing women
hold parameters on likely cardiovascular depressant medications

Conditions: Asystole; Bradycardia; Hypotension

Summary: this pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient. there are general rules about when it would be appropriate for these types of medications not to be given. however, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent. research question: can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?


Eligibility criteria:
inclusion criteria: * serial evaluation of the first 50 documented events of code blue or call to rapid response team involving hypotension, bradycardia or asystole in the adult inpatient population events beginning january 1, 2006.
a study to evaluate itca 650 compared to sitagliptin for the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: phase 3 study to compare treatment with itca 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * hba1c between 7.5%-10% * on metformin monotherapy * bmi between 25 \& 45 kg/m2 exclusion criteria: * taking thiazolidinedione, sulfonylurea, dpp-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis
brain function in children previously treated on clinical trials pog-9605 and pog-9201

Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity

Summary: rationale: assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects. purpose: clinical trial to compare brain function of children who have been previously treated with methotrexate.

objectives: * compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols pog-9605 versus pog-9201. outline: this is a multicenter study. more than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. patients also undergo mri of the head. projected accrual: a total of 30-54 patients previously treated on protocol pog-9201 will be accrued for this study. a total of 60-108 patients previously treated on protocol pog-9605 will be accrued for this study.

Eligibility criteria:
disease characteristics: * previously enrolled on pog-9201 or pog-9605 * good prognosis by nci risk (9201 and 9605 stratum 1) * eligible for the therapeutic study * completed therapy by 12/31/2000 * no cns3 at diagnosis * no relapsed disease patient characteristics: age: * 1 to 9 at diagnosis performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no down syndrome prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * see disease characteristics

Keywords: neurotoxicity long-term effects secondary to cancer therapy in children
a study of ixekizumab (ly2439821) in chinese participants with moderate-to-severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in chinese participants with moderate-to-severe plaque psoriasis.

study i1f-mc-rhbh is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. during the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.

Eligibility criteria:
inclusion criteria: * present with chronic plaque ps based on a confirmed diagnosis of chronic ps vulgaris for at least 6 months prior to baseline. * have ≥10% bsa involvement at screening and baseline. * have both an spga score ≥3 and pasi score ≥12 at screening and baseline. * are candidates for phototherapy and/or systemic therapy. exclusion criteria: * forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline. * drug-induced psoriasis. * ongoing use of prohibited treatments. * have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (il-17) (such as secukinumab) or the il-17 receptor. * have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to baseline, whichever is longer. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test.

Keywords: plaque psoriasis ixekizumab skin condition skin disease itching psoriasis vulgaris immune-mediated systemic disease skin lesions scaly patches papules
tranexamic acid to prevent heavy bleeding after childbirth in women at higher risk

Conditions: Postpartum Hemorrhage

Summary: heavy bleeding after childbirth, known as a postpartum haemorrhage (pph), causes about 70,000 maternal deaths every year. tranexamic acid (txa) is a lifesaving treatment for women with pph. the i'm woman trial is a research study to see whether giving txa just before childbirth will stop women developing pph. the trial will assess the effects of intramuscular (im) and intravenous (iv) tranexamic acid on pph, side effects and other important maternal health outcomes.

postpartum haemorrhage (pph) causes about 70,000 maternal deaths every year. tranexamic acid (txa) is a lifesaving treatment for women with pph. the woman trial recruited over 20,000 women with pph and found that intravenous (iv) txa given soon after pph onset, reduces bleeding deaths by about a third. early txa also reduces blood loss in surgery and death due to bleeding after traumatic injury. the world health organization recommends that all women with pph should receive txa as a first line treatment. txa is more effective when given soon after the bleeding starts. every fifteen minute delay reduces the survival benefit by about 10%. this suggests that giving txa around the time of childbirth might prevent pph. although several clinical trials have examined the effectiveness of txa for the prevention of pph, the results are inconclusive. trials of tranexamic acid for pph prevention give the trial treatment after cord clamping, which may be too late to prevent bad bleeding in some women, as bleeding tends to happen soon after childbirth. because pph only affects a small proportion of births, the healthcare community need good evidence on the balance of benefits and harms in this population before using txa to prevent pph. the i'm woman trial will evaluate the effects of txa for pph prevention in women with one or more risk factors for pph having a vaginal or caesarean birth. the trial will also evaluate the effect of the route of txa administration. txa is usually given by slow iv injection. however, recent research shows that txa is well tolerated and rapidly absorbed after im injection, achieving therapeutic blood levels within minutes of injection. there may be fewer side effects with im txa because peak blood concentrations are lower than with the iv route, as well as practical advantages.

Eligibility criteria:
inclusion criteria: * women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for pph exclusion criteria: * women who have a clear indication or contraindication for txa

Keywords: tranexamic acid postpartum haemorrhage bleeding pregnancy antifibrinolytic intramuscular
the turkish version of the survey of activities and fear of falling in the elderly

Conditions: Fall; Old Age; Debility; Fear; Activity, Motor; Participation, Patient

Summary: the survey of activities and fear of falling in the elderly (safe) was originally developed in english to determine the level of fear of falling and its interactions with activities of daily living. the purpose of this study was to translate and cross-culturally adapt the safe instrument into turkish and investigate its psychometric properties.

the survey of activities and fear of falling in the elderly (safe) was originally developed in english to determine the level of fear of falling and its interactions with activities of daily living. the purpose of this study was to translate and cross-culturally adapt the safe instrument into turkish and investigate its psychometric properties. one hundred eleven older adults (72 females) with a mean age of 69 years (sd=7.22; range=60-87) were included. for cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. within a 5-to-7-day period after the first assessment, the participants completed the turkish version of safe (safe-t) to evaluate test-retest reliability. cronbach's alpha (α) was used to assess internal consistency. the correlation with the turkish version of the falls efficiency scale-international (fes-t) was determined to check the validity.

Eligibility criteria:
inclusion criteria: 1. age over 60 years old 2. ability to read and write in turkish 3. score ≥24 on the mini-mental state exam 4. \>3 according to the functional ambulation category (fac) 5. no pathology in visual ability and hearing exclusion criteria: 1. neurologist-diagnosed dementia or alzheimer's disease 2. ambulatory only with a wheelchair 3. amputated lower extremity

Keywords: accidental falls activity restriction fear of falling participation restriction psychometrics
clinical trial of mycobacterium w in covid-19 positive patients, hospitalized but not critically ill

Conditions: COVID-19

Summary: this is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of covid-19 disease and for reduction in transfer to icu in covid-19 infected patients admitted to the hospital.

total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either mw+soc or placebo+soc for first 3 days post-randomization. daily clinical evaluation of patient will be performed till discharge from hospital or till icu admission. study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to icu, whichever is earlier.

Eligibility criteria:
inclusion criteria: * covid-19 positive patients with ordinal scale score of 3. * patients of either gender, age ≥ 18 years at the time of enrollment. * female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing. * the patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an informed consent form. exclusion criteria: * patient with ordinal scale of ≥4 at the time of hospital admission and randomization. * pregnant and / or lactating female patients. * a family history of congenital or hereditary immunodeficiency. * any disease condition requiring icu admission. * history of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. * history of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. * history of allergic reactions or anaphylaxis to mw or its component. * presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.
a study of vantictumab (omp-18r5) in combination with paclitaxel in locally recurrent or metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is an open-label phase 1b dose-escalation study to assess the safety, tolerability, and pk of vantictumab when combined with paclitaxel.

once the maximum tolerated dose (mtd) or maximum administered dose (mad) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and pk of vantictumab combined with paclitaxel. up to approximately 34 patients may be enrolled into the study.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o patients with breast cancer overexpressing her2 are not eligible. * availability of tumor tissue, either archival ffpe or obtained at study entry through fresh biopsy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * all acute treatment-related toxicity from prior therapy must have resolved to grade ≤ 1 prior to study entry * adequate hematologic and end-organ function * evaluable or measurable disease per recist v1.1 * for women of childbearing potential, agreement to use two effective forms of contraception exclusion criteria: * known significant dose delays during prior treatment with a taxane due to drug-related toxicities * prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease * treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment

Keywords: locally recurrent metastatic breast cancer