Kornimate/medical-research-clean huggingface dataset:
randomized, placebo-controlled study of abobotulinumtoxina (dysport®) for the treatment of cervical dystonia

Conditions: Cervical Dystonia

Summary: the aim of this study is to demonstrate the effectiveness and safety of 500 units of dysport manufactured at a new manufacturing facility in europe.


Eligibility criteria:
inclusion criteria: * cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type a or b with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status * twstrs severity, disability and total scores meeting the defined criteria at baseline exclusion criteria: * pure anterocollis or pure retrocollis * in apparent remission from cervical dystonia * previous poor response to the last two botulinum toxin type a or type b treatments * being treated with type b toxin due to lack of efficacy to type a toxin or have known neutralizing antibodies to type a toxin
a study of jnj-66525433 in healthy participants and participants with ulcerative colitis

Conditions: Healthy; Colitis, Ulcerative

Summary: the purpose of this study is to evaluate safety and tolerability of jnj 66525433 compared with placebo after administration of: 1) single ascending oral doses of jnj 66525433 administered to healthy participants (part 1), 2) multiple, ascending oral doses of jnj 66525433, administered to healthy participants once daily over 14 consecutive days (part 2), and 3) multiple oral doses of jnj 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (uc) (part 3).


Eligibility criteria:
inclusion criteria: for part 1 and part 2, healthy volunteers * have a body mass index (bmi) between 18 and 30 kilogram per meter square (kg/m\^2) (bmi = weight/height), inclusive, and a body weight of no less than 50 kilogram (kg) and maximum weight of 100 kg * have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the bristol stool scale, ranging from 3 to 5 at admission for part 3, participants with ulcerative colitis (uc) * have a clinical diagnosis of uc at least 3 months before screening * have moderately to severely active uc, defined as a week 0 mayo score of 6 to 12, inclusive, based on central read of the video endoscopy performed during the screening * have a greater than or equal to (\>=) 2 endoscopy subscore of the week 0 mayo score based on central read of the video endoscopy performed during the screening exclusion criteria: for part 1 and part 2, healthy volunteers * history of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * known allergies, hypersensitivity, or intolerance to antisense oligonucleotides, jnj-66525433 or its excipients for part 3, participants with uc * has uc limited to the rectum only or to \<20 centimeter (cm) of the colon evaluated by endoscopy at screening * presence of a stoma * presence or history of a fistula at any time covid-related * if a participant is excluded due to recent coronavirus disease (covid-19) related features, the reason for screen failure should be documented in the case report form under the exclusion criterion of having a condition for which participation would not be in the participant's interest or could confound study assessments * the field of covid-related testing (for presence of, and immunity to, the severe acute respiratory syndrome coronavirus 2 \[sars-cov-2\] virus) is rapidly evolving. additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations / guidance from authorities / standards of care
french long term registry with longitudinal follow up of pdgfra d842v-gist patients

Conditions: GIST; GIST, Malignant; PDGFR-Alpha D842V

Summary: gist are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the kit (85%) or the pdgfrα (8%) protein. treatment of localized forms relies on adequate surgery without tumor spillage and sometimes systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. more than 40% of cases may recur and metastasize. advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (tki) of kit and pdgfr such as imatinib (standard treatment), sunitinib (2nd line) and regorafenib (3rd line). nevertheless, imatinib has little or no activity in patients harboring the d842v mutation in the exon 18 of pdgfrα (20% of gastric gist, 6% of all gist patients). consequently, other therapeutic alternatives are needed. results from the phase i single-arm navigator study show that avapritinib has significant efficacy in gist patients with pdgfrα d842v mutation (orr = 86 %). in france, an authorization for temporary use (atuc) starting on september 21st, 2020 has been granted by the national agency for safety of medicines and health products (ansm). it allows the early availability of avapritinib in france while waiting for market authorization approval (amm). this atuc is now being followed by a post-atu period. the objective of this real-life registry is to perform a long-term longitudinal follow up of pdgfra d842v-mutated gist patients and to collect effectiveness and safety data. it will be implemented in parallel to the post-atuc period until june 2023. moreover, this registry fulfills the has's ("haute autorité de santé") request regarding the establishment of an exhaustive registry of patients with gist, harboring the d842v / pdgfra mutation in france. this registry will specifically describe: * patient characteristics, in particular patient age, of the disease characteristics, previous treatments; * the clinical course; * the occurrence of adverse events / effects; * and the therapeutic strategy (endpoint of treatment or continuation). data from the electronic health record (ehr) will be collected. moreover, as per the ansm's requirements, quality of life and cognitive function will be investigated using fact-g, fact-cog and moca questionnaires. undesirable effects will be collected as well. follow-up is envisioned for a minimum of 2 years.


Eligibility criteria:
inclusion criteria: * i1. adult (≥18 years old), male or female * i2. patient with a histologically or cytologically-confirmed diagnosis of unresectable or metastatic gist harboring the d842v mutation in the pdgfrα gene * i3. . diagnosis date later than jan 1st 2010 * i4. non opposition to the use of her/his data exclusion criteria : * e1. patient not meeting all the inclusion criteria
moesin expression in clear cell renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: renal cell carcinoma (rcc) is the most frequently occurring primary renal neoplasm. there are several histological variants of rcc that are associated with variable prognostic outcomes. epithelial-mesenchymal transition (emt) is a phenomenon in which the epithelial cells acquire some mesenchymal criteria as enhanced invasive potential. there are several cell surface molecules that are implicated in emt. moesin is one of these molecules that is involved in emt, which is associated with enhanced invasive potential and poor prognosis. targeting moesin by novel therapeutic agents may prevent emt and improve prognosis of patients with rcc.


Eligibility criteria:
inclusion criteria: 1. all cases of ccrcc. 2. tissue blocks with material adequate for immunohistochemical evaluation. 3. all cases with accessible clinical data. exclusion criteria: 1. cases of renal neoplasms other than ccrcc. 2. patients who received preoperative chemotherapy or radiotherapy. 3. patients with ccrcc who were diagnosed by tru-cut biopsies only and didn't undergo radical operations. 4. cases with insufficient/destructed material. 5. patients with inadequate clinical data.

Keywords: renal cell carcinoma moesin epithelial-mesenchymal transition
head to head trial of mailed cologuard to mailed fit

Conditions: Colorectal Cancer Screening; Fecal Immunochemical Test; Multi-target Stool DNA; Colorectal Cancer (CRC)

Summary: the objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool dna (cologuard) and the fecal immunochemical test (fit) in screening eligible adults ages 45-49 receiving care at the university of california san diego health system.

adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. eligible participants will be randomized to either mailed cologuard outreach, facilitated by exact sciences or mailed fit outreach. colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of cologuard or fit positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and crc incidence, measured within 24 months of randomization.

Eligibility criteria:
inclusion criteria: * adults ages 45-49 with ehr documentation indicating that the patient has an assigned primary care provider at ucsd health * ≥1 ucsd health system health visit within the last year * resides in san diego or imperial county * currently not up to date with crc screening * insured by private, public or other health insurance. exclusion criteria: * up-to-date with screening * prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer. * prior history of colectomy * lack of health insurance

Keywords: screening early detection colorectal cancer stool blood test mailed outreach
evaluation of ave5026 as compared to enoxaparin for the prevention of thromboembolism in patients undergoing hip fracture surgery

Conditions: Venous Thromboembolism

Summary: the primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of semuloparin sodium (ave5026) with q.d. s.c. injections of enoxaparin for the prevention of venous thromboembolic events \[vte\] in patients undergoing hip fracture surgery. the secondary objectives were to evaluate the safety of ave5026 in patients undergoing hip fracture surgery, and to document ave5026 exposure in this population.

randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). the total duration of observation per participant was 35-42 days from surgery broken down as follows: * 7 to 10-day double-blind treatment period; * 28 to 35-day follow-up period. mandatory bilateral venography of the lower limbs had to be performed between 7 to 11 days after surgery.

Eligibility criteria:
inclusion criteria: * standard surgery for fracture of the upper third of the femur including femoral head and neck. exclusion criteria: * estimated time of injury/fracture \> 24 hours before admission to hospital; * any major orthopedic surgery in the 3 months prior to study start; * multiple trauma affecting more than one organ system; * deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome; * high risk of bleeding; * known allergy to heparin, or enoxaparin, or pork products; * end stage renal disease or patient on dialysis; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hip fractures heparin low-molecular-weight randomized controlled trial
adjuvant chemotherapy for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy

Conditions: Triple Negative Breast Cancer

Summary: this study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (tnbc) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

this study is a multi-center, randomized, phase ii study. tnbc patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. at the same time, the blood and tissue samples are collected for relevant tests. follow up every 3-6 months and record recurrences and deaths.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed invasive adenocarcinoma of the breast. * triple negative breast cancer: hormone receptor negative (er \< 10% and pgr \< 10%) and her2 negative (ihc 0/1+ or ish non-amplified), as defined by the local pathology laboratory. * clinical stage at presentation: t1-4, n0-3, m0, with indications for neoadjuvant chemotherapy. * patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred. * patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy. * residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy. * ecog performance status: 0-1. * patients without severe heart, lung, liver and kidney disease. * adequate hematologic and end-organ function. * no more than 6 weeks may elapse between definitive breast surgery and randomization. exclusion criteria: * previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes). * previous neoadjuvant chemotherapy with platinum or taxanes alone. * patients have received other adjuvant therapy. * comprehensive medical examinations have revealed distant metastases before randomization. * patients who are not suitable for anthracycline evaluated by investigators. * prior history of other malignancy (except carcinoma in situ).

Keywords: triple negative breast cancer neoadjuvant chemotherapy residual invasive breast cancer adjuvant chemotherapy
clinical evaluation of the i-stat tbi test

Conditions: Traumatic Brain Injury

Summary: the goal of this study is to evaluate the i-stat tbi test to assist determining the need for a computed tomography (ct) scan in patients with suspected mild traumatic brain injury (tbi). patients will be asked to provide a blood sample.

the purpose of this study is to evaluate the clinical performance of the i-stat tbi test for the proposed intended use; to assist in determining the need for a computed tomography (ct) scan in patients presenting with suspected mild traumatic brain injury (tbi) who are 18 years of age or older. the secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of tbi.

Eligibility criteria:
acute blood biomarker branch subject inclusion criteria: 1. 18 years of age or older. 2. subject or legally authorized representative (lar) provided informed consent for the acute blood biomarker branch (waiver of consent may be acceptable, per irb). 3. subject presented to a health care facility or emergency department with a suspected tbi resulting from an insult to the head by an external force within 12 hours of the injury. 4. subject has a ct scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head ct scan sent from the originating facility. 5. as a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following. 1. any period of loss of consciousness 2. any loss of memory for events immediately before or after the injury 3. any alteration of mental state at the time of the injury 4. focal neurological deficits that may or may not be transient acute blood biomarker branch subject exclusion criteria. 1. previous enrollment in this study 2. current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device) 3. primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke 4. time of injury is unknown and cannot be estimated 5. presented with penetrating head trauma or spinal cord injury (american spinal injury association \[asia\] score of c or worse) at the enrolling facility 6. standard of care head ct scan procedures not completed prior to emergency department (ed) discharge 7. prisoners or patients in custody 8. patients on psychiatric hold

Keywords: i-stat traumatic brain injury biomarkers
the proaktiv study

Conditions: Palliative Care

Summary: the overall objective of this study is to identify whether the systematic anticipation of highly structured specialized palliative home care into primary care influences the quality of care and care utilization. quality of care focusses on the sense of security of patients and family caregivers, satisfaction with care of patients, family caregivers, general practitioners, home care nurses and specialized palliative care nurses, and availability and access to advanced directives. health care utilization focus on the number of hospitalizations and the length of hospital stays.

the university center for palliative care from the inselspital bern conducts this monocentric mixed-methods controlled study and is responsible for informed consent. data consists of questionnaires of patients, their family caregivers, general practitioners, home care nurses and if involved specialized palliative home care nurses. patients and their family caregivers will fill out baseline questionnaires and follow-up questionnaires at 2, 8, 16 and 24 weeks. patient follow-up will end if the patient dies or the study ends. family caregivers will be asked to fill out a questionnaire two months after the patient's death. general practitioners, home care nurses and specialised palliative home care nurses will fill out questionnaires after the patient's death or at the end of the study. patient survival data will be collected from administrative health data after the end of the study. additionally, a nested qualitative study with semi-structured qualitative interviews with patients, family caregivers and care providers will provide an in-depth understanding of preferences, needs, experiences from this phase of life.

Eligibility criteria:
patients inclusion criteria: * 18 years or older * able to read and understand german * able to fill out questionnaires with only minimal assistance * live in the catchment area of sphc * positive screening on the palliative care screening tools * expected survival time of approximately six months or less * have a gp (or gp medical substitute) * registered with spitex care * wish to live at home as long as possible (no plans for long term nursing home uptake) * written informed consent patients exclusion criteria: * planned discharged from hospitals to institutions (e.g. other hospitals, rehabilitations, nursing homes) * live permanently in nursing homes * cognitive impairments that make it impossible to follow the study (e.g. psychological disorders, dementia, loss of judgement). family caregivers inclusion criteria: * 18 years or older * able to read and understand german * familiar with the care situation patient * written informed consent specialized palliative home care team: * provide care in german speaking part of canton bern * 24/7-availability of specialized palliative care * specialized palliative care team including nurses and consulting physician with specialized palliative care certification.

Keywords: palliative care end of life care home care services primary care primary care nursing outpatient care quality of healthcare quality of life advance care planning
fructose in exercising individuals with type 1 diabetes using insulin degludec

Conditions: Type 1 Diabetes Mellitus; Diabetes Complications

Summary: to determine and compare the time-to-hypoglycaemia (defined as plasma glucose \<3.9mmol/l) in individuals with type 1 diabetes treated with ultra-long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.

glycaemic control remains complex and demanding during exercise for type 1 diabetes (t1d) patients. traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. if t1d patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient. as a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. the ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. the present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in t1d patients.

Eligibility criteria:
inclusion criteria: * type 1 diabetes as defined by the world health organization (who) for at least 1 year or confirmed negative c-peptide (\ 4 mmol/l) * male subjects aged between 18-45 years * hba1c \<8.0% (64mmol/mol) based on analysis from the central laboratory unit of the university hospital bern. * basal/bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management * regular physical activity (at least 30 min of moderate exercise 3 times weekly) * written informed consent exclusion criteria: * relevant diabetic complications as judged by the investigator * total daily insulin dose \>2 iu/kg/day * hypoglycaemia unawareness (gold score \> 4) or any episode of severe hypoglycaemia as defined by the american diabetes association within the last 6 months * physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator * current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc. * known fructose-intolerance or malabsorption * known allergy to one of the study drugs

Keywords: type 1 diabetes, fructose, exercise, hypoglycaemia, degludec