Kornimate/medical-research-clean huggingface dataset:
controlled ovarian stimulation by hp-hmg for ivf / icsi cycles: study on ovarian hyper stimulation syndrome in a cohort of women from 18 to 36 years old.

Conditions: Ovarian Hyperstimulation Syndrome (OHSS)

Summary: ovarian hyper stimulation syndrome (ohss) is a potentially serious complication of ovarian stimulation in ivf (in vitro fertilisation). the main objective of this study is to describe the incidence of moderate or severe forms of ohss in women between 18 and 36 years of age treated with hp-hmg.


Eligibility criteria:
inclusion criteria: * women who present infertility of more than one year and are candidates for a first or second ivf cycle with or without icsi for whom hp-hmg is prescribed for cos. * absence of infertility treatment during the last 3 months before enrolment. * age: from 18 to 36 years old. * bmi between 18 and 30 kg / m². * presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities. * male or female infertility. * ovarian stimulation by hp-hmg with pituitary desensitization by a gnrh agonist or antagonist. * normal ovarian reserve according to physician habitual evaluation. * consent to participate of the no-interventional study and signature of the patients' information sheet. exclusion criteria: * presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation. * known endometriosis grade iii or iv. * contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician. * recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (pgd). * smoking over than 10 cigarettes / day.´ * participation in an interventional study at the time of inclusion. * known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous ivf/icsi cycles and / or abnormal result in ovarian reserve test (amh \< 1 ng/ml with immunotech equipment or amh\<0.7 ng/ml with dsl equipment).
effects of vitamin d in patients with breast cancer

Conditions: Breast Cancer

Summary: this protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin d administration on breast cancer clinical and translational markers in patients awaiting surgery at the ottawa hospital. it takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin d intake.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed female primary breast cancer patients whose surgery is planned for the next 2-8 weeks without neoadjuvant therapy as assessed by multidisciplinary team 2. age ≥18 years 3. clinically palpable tumour(s) (greater than or equal to 2 cm) 4. normal serum and urine calcium and serum pth values at baseline (as defined by ottawa hospital) 5. written informed consent for study exclusion criteria: 1. patients with recurrent or metastatic breast cancer 2. history of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment 3. ecog performance status \> 2 4. hypercalciuria on initial baseline urine, defined as ca/creatinine ratio\> 1.0 5. current or previous history of urolithiasis or hyperparathyroidism 6. abnormal hepatic function according to ottawa hospital norms (total bilirubin \>2x upper limit of normal, alt/ast \>3x upper limit of normal)and/or abnormal renal function (creatinine \> 150 µmol/l) 7. history of granulomatous disease such as tuberculosis or sarcoidosis. 8. intake of vitamin d (cholecalciferol) supplement ≥ 2000 iu/day within the last 2 months 9. inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).

Keywords: breast
employed antithrombotic therapies in patients with acute coronary syndromes hospitalized in italian ccus

Conditions: Acute Coronary Syndrome

Summary: this registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis nstemi or stemi in italian cardiac care units (ccus) during a four-week study period.

eyeshot-2 is a prospective, multicenter, observational, nationwide survey of patients discharged with a diagnosis nstemi or stemi admitted to italian ccus. the survey will be designed to include all consecutive patients, who met the eligibility criteria, admitted in hospitals with or without cardiac catheterization laboratories and cardiac surgery facilities during a period of 4 weeks.

Eligibility criteria:
inclusion criteria: * all consecutive patients aged 18 years or more, discharged with diagnosis of myocardial infarction (nstemi or stemi) admitted to ccus undergoing myocardial revascularization (pci or cabg) or conservative treatment. at presentation, the diagnosis of nstemi will be based on the measurement of troponins and assessment of ecg changes, as suggested by european society of cardiology (esc) guidelines; the diagnosis of stemi will be characterized by an acute chest pain and persistent (\>20 min) st-segment elevation ≥ 1mm in two or more limb leads, or contiguous pre-cordial leads or left bundle branch block. * written informed consent signed. patients who cannot provide the informed consent due to very severe clinical conditions can give their consent some hours/days after admission, when more favourable clinical conditions allow them to receive the appropriate information. patients having died before giving informed consent may also be included unless the local institutional review board (irb) does not allow this procedure. in that case, it is strongly suggested to obtain relative(s) agreement through the collect of a signed informed consent. exclusion criteria: * patients with a diagnosis of unstable angina, * patients developing mi after pci or cabg, * mi following non-cardiac surgery or traumatic causes, * patients with chest pain without elevation of troponin, * patients enrolled in randomized controlled trial (rcts), * patients already enrolled into the study from another ccu
skin cancer screening education study

Conditions: Skin Tumors; Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma

Summary: the overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. the training course aims to increase the accuracy of detecting early stages of skin cancer. screening outcomes of an intervention region (calgary, canada) in which physicians receive training will be compared with screening outcomes of a control region (edmonton, canada) where no physician training is administered. the investigators will determine whether: * clinical screening outcomes are more favorable in the group of trained physicians compared to non trained physicians * there is an increase of knowledge about skin cancer screening among trained physicians, compared to non trained physicians * skin cancer screenings are associated with psycho-social harms * population-based screening has an effect on the overall incidence and stage-specific-incidence of skin cancer in alberta the investigators are aiming to recruit 100 physicians per region (total of 200 physicians) who will screen 40,000 to 80,000 individuals over a period of 20 months.


Eligibility criteria:
inclusion criteria: 1. screenees * male and female residents of alberta mainly living and receiving care in edmonton or in calgary * age 20+ * english-speaking * individuals who consent to participate 2. physicians * registered dermatologists and family physicians administering care either in edmonton or in calgary * english-speaking * physicians who consent to participate exclusion criteria: physicians who have undergone special training in skin cancer screening within the last 2 years

Keywords: skin cancer secondary prevention population screening
a study to evaluate the safety, tolerability, and antitumor activity of incb001158 plus epacadostat, with or without pembrolizumab, in advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to assess the safety and antitumor activity of incb001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * for phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable). * for phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic nsclc, melanoma, urothelial carcinoma, scchn, sclc, and crc. * presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per recist v1.1. * eastern cooperative oncology group (ecog) performance status 0 to 1. * resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to grade 1 or less (except alopecia). subjects with ≤ grade 2 neuropathy are an exception and may enroll. * adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation. exclusion criteria: * participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose. * has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug. * prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment. * prior therapy with an ido1 or arginase 1 inhibitor. * active autoimmune disease that has required systemic treatment in past 2 years. replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * receipt of a live vaccine within 30 days before the first dose of study treatment. * any history of serotonin syndrome after receiving serotonergic drugs. * use of protocol-defined prior/concomitant therapy. * known or suspected defect in the function of the urea cycle. * history of gastrointestinal condition that may affect drug absorption.

Keywords: non-small cell lung cancer (nsclc) melanoma urothelial carcinoma squamous cell carcinoma of the head and neck (scchn) small cell lung cancer (sclc) colorectal cancer (crc) arginase 1 inhibitor indoleamine 2,3-dioxygenase 1 inhibitor programmed death-1 receptor (pd-1) inhibitor
early salpingectomy (tubectomy) with delayed oophorectomy in brca1/2 gene mutation carriers

Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation; Ovarian Cancer

Summary: the purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female brca1/2 mutation carriers.

eligible women will choose for the innovative or standard risk-reducing option themselves.

Eligibility criteria:
inclusion criteria: * premenopausal women with a documented brca1 and/or brca2 germline mutation * age 25-40 years for brca1 mutation carriers, 25-45 years for brca2 * childbearing completed * presence of at least one fallopian tube * participants may have a personal history of non-ovarian malignancy exclusion criteria: * postmenopausal status (natural menopause or due to (cancer) treatment) * wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment) * legally incapable * prior bilateral salpingectomy * a personal history of ovarian, fallopian tube or peritoneal cancer * evidence of malignant disease at enrollment * treatment for malignant disease at enrollment * inability to read or speak dutch brca mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

Keywords: salpingectomy delayed oophorectomy salpingo-oophorectomy quality of life ovarian cancer brca
amniotic membrane visio-amtrix in recurrent macular hole

Conditions: Macular Holes; Retinal Detachment

Summary: the purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.


Eligibility criteria:
inclusion criteria: * man or woman over 18 years of age, less than 75 years * macular hole of all etiologies * patient with history of opened macular hole after previous pars plana vitrectomy * delay between previous surgery and inclusion (relapse or non-closing hole) \> 1 month * patient who received the study information and provided consent * patient who is a members or a beneficiary of a national health insurance plan exclusion criteria: * ocular surgery other than the macular hole surgery in the prior 3 months * participation in other clinical studies in the prior 3 months * any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity * patient with uncontrolled glaucoma on more than 1 intraocular lowering medication * patient with uveitis or other active ocular inflammation or infection * pregnant or breast-feeding woman. women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method * person deprived of liberty by judicial or administrative measures * any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
new serum biomarkers for monitoring early diagnosis of ovarian cancer recurrence

Conditions: Ovarian Cancer

Summary: in this study, mass spectrometry was used to analyze immune inflammation-related protein complexes, post-translational modified glycopeptide omics and tumor-related metabolomics in serum, respectively, in order to find potential metabolic small molecule biomarkers or marker profiles that can be used for early diagnosis of cancer recurrence.

time cohort study: patients with confirmed ovarian epithelial cancer at different time cutoff points before treatment, after surgery, during chemotherapy, and after chemotherapy, until clinically confirmed patients relapse. at least 50 patients are expected to be enrolled.

Eligibility criteria:
inclusion criteria: * female * a diagnosed patient with epithelial ovarian cancer * age ≤ 70 exclusion criteria: * male * suffering from other malignant tumors * non-compliant patient * age above 70
turkish version of the worry about pain questionnaire

Conditions: Pain, Chronic; Musculoskeletal Pain

Summary: pain is one of the main complaints that causes people to apply to health institutions. pain is seen as a passive warning signal of an underlying disease process; when it becomes chronic, it is considered a disease on its own. pain that persists longer than the expected recovery time is defined as chronic pain. pain is associated with a number of psychological, physical, and social factors. clinical observations report that various psychological problems, especially anxiety, and depression, accompany chronic pain, and the long-term persistence of pain significantly impacts a patient's quality of life. chronic musculoskeletal pain causes fatigue, sleep disruption, and activity and participation restrictions. therefore, evaluation of pain originating from the musculoskeletal system and factors that cause and increase pain need to be addressed from a biopsychosocial perspective. chronic pain is an ideal environment for anxiety to develop. if the person's chronic pain cannot be resolved, anxiety increases and the anxiety becomes excessive, the person may lose the ability to distinguish what is dangerous from what is not, as he cannot evaluate pain-related cues properly. anxiety and depression scales are often used to assess the long-term psychosocial consequences of chronic musculoskeletal pain. however, these scales are inadequate to explain the relationship between pain and anxiety. the worry about pain questionnaire is a self-report scale of 15 items specifically developed to assess pain-related pressure. to our knowledge, there is no standard, valid, and reliable turkish questionnaire in the literature that evaluates the pain-related concerns of individuals with musculoskeletal pain and takes into account the cultural differences of turkish patients. for this reason, our study aims to translate and culturally adapt the worry about pain questionnaire into turkish in individuals with chronic musculoskeletal pain and to examine the psychometric properties of the turkish worry about pain questionnaire.


Eligibility criteria:
inclusion criteria: * being able to read and write in turkish * not having any cognitive impairment * having chronic musculoskeletal pain * being over 18 years of age * being willing and volunteer to work exclusion criteria: * having a complaint of pain in the musculoskeletal system due to cancer, fracture or surgery within the last 6 months. * having severe cognitive impairment * having a systemic disease such as rheumatoid arthritis, diabetes mellitus * having any neuromuscular disease (such as ms, myopathy)
humax-cd20 in active rheumatoid arthritis, phase i/ii

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this trial is primarily to investigate the safety profile of humax-cd20 in patients with active ra. furthermore, the trial is designed to identify the dose levels to be used in future trials (based on evaluations of safety, pharmacokinetics and acr and das responses).

this trial consists of a double-blind, placebo controlled, dose escalation part with randomization to trial treatment within each of three sequential cohorts (part a), and a parallel group part with randomization into one of four treatment arms (part b). patients in parts a and b will receive two infusions of either humax-cd20 (300 mg, 700 mg, or 1000 mg) or placebo and will be followed for safety, efficacy, and pharmacokinetic measurements for 24 weeks. hereafter patients will be followed every 12 weeks until b-cells (cd19+ cells) have returned to baseline levels. for patients in part b, the follow-up visits at 36 and 48 weeks after initial trial treatment (follow-up visits 1 and 2) will include additional measurements of safety and efficacy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * active rheumatoid arthritis according to the american college of rheumatology of at least six months duration with six or more swollen and six or more tender joints (of 28 joints) and erythrocyte sedimentation rate (esr) ≥ 22 mm/h and/or c-reactive protein (crp) ≥ 10 mg/l (1 mg/dl). * treatment failure to one or more dmards. * treatment with methotrexate (7.5-25 mg/wk) for at least 12 weeks and at a stable dose for at least 4 weeks prior to planned start of trial treatment. exclusion criteria: * use of dmards other than methotrexate. * current or previous (within four weeks of screening) participation in any other clinical trial. * previous exposure to other biological products within 4 weeks prior to planned start of trial treatment, and/or exposure to anti-cd20 antibodies within two years before screening for this trial. * any use of cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents within five years before screening for this trial. * active autoimmune disease (other than ra and ra-associated secondary diseases) requiring immunosuppressive therapy. * past or current malignancy, except for resected cervical carcinoma stage 1b or less, non-invasive basal cell and squamous cell skin carcinoma, malignant melanoma with a complete response of a duration of \> 10 years, or other cancer diagnoses with a complete response of a duration of \> 5 years. * chronic or current infectious disease including known or suspected positive serology for hiv, hepatitis b, or hepatitis c. * clinically significant cardiac disease, or history of significant cerebrovascular disease. * significant concurrent, uncontrolled medical condition including, but not limited to: renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease. * breast feeding women, women with a positive pregnancy test at screening, or women of childbearing potential not willing to use adequate contraception during the trial.
real-world evidence study evaluating patient-reported outcomes with xermelo

Conditions: Carcinoid Syndrome

Summary: the primary objective of the study is to estimate the proportion of carcinoid syndrome (cs) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (xermelo).

this study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (xermelo) for carcinoid syndrome diarrhea (csd) not adequately controlled by somatostatin analogs in us clinical practice. the primary objective is satisfaction with overall cs symptom control 6 months after starting xermelo. secondary objectives will evaluate satisfaction with control of csd and flushing, cs symptoms, work productivity and activity impairment, ssa use, and weight. this study will provide real-world patient-reported outcomes in cs with xermelo treatment for at least 6 months.

Eligibility criteria:
inclusion criteria: * adult, ≥18 years of age at the time of informed consent * a new, valid prescription for xermelo * initiating xermelo for the treatment of carcinoid syndrome * able and willing to provide informed consent prior to participation in the study exclusion criteria: * unable to understand and read english * unable to access the internet * prior exposure to xermelo

Keywords: neuroendocrine tumors, carcinoid syndrome, telotristat ethyl