Kornimate/medical-research-clean huggingface dataset:
preoperative moderately fractionated imrt for locally extremity or trunk sarcoma

Conditions: Soft Tissue Sarcoma

Summary: to investigate the safety and efficacy of preoperative moderately fractionated imrt and concurrent fluzoparib hydrochloride for primary truncal or extremity soft tissue sarcoma.

to investigate the safety and efficacy of preoperative moderately fractionated imrt and concurrent fluzoparib hydrochloride for primary truncal or extremity soft tissue sarcoma; to investigate the quality of life and extremity function post-combination treatment; to study the mechanism of radio-sensitizing effects of fluzoparib hydrochloride for primary truncal or extremity soft tissue sarcoma; to assess the relationship between the mri imaging, pathological findings and local control.

Eligibility criteria:
inclusion criteria: * age older than 18 years. * histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion. * ecog 0-3 * histology reviewed by reference pathologist * lesion can be assessed * can tolerate radiotherapy and fluzoparib (fluzoparib group) * agree contraception. * informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed exclusion criteria: * no gross tumor post-resection in other center. * contraindications to fluzoparib, including allergic to fluzoparib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, grade 3 to 4 cardiac insufficiency (per nyha criteria), and severe hepatic or renal insufficiency (grade 4), etc. * dermatofibrosarcoma protuberans(dfsp), desmoids, etc. * benign histology * secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) * sts can be cured by extensive operation alone. * previous irradiation to the same area * radiological evidence of distant metastases * other contraindications, can't tolerate operation or other treatment needed in this study.

Keywords: soft tissue sarcoma preoperative radiotherapy moderately fractionated rt complications parp inhibitor
is decreased ovarian reserve related to an increased number of previous early miscarriages?

Conditions: Infertility, Female; Miscarriage; Miscarriage, Recurrent; IVF

Summary: this study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

by investigating the prevalence of low ovarian reserve (lor) in populations with specific reproductive histories (such as recurrent pregnancy loss, g0, and ectopic pregnancy), as well as the aneuploidy rates of embryos produced with preimplantation genetic testing for aneuploidies (pgt-a), investigators can better understand how lor impacts fertility outcomes in these populations. this information can be used to inform clinical decision-making, such as whether participants with lor should consider alternative or whether they would benefit from additional interventions to improve ovarian function. ultimately, by improving our understanding of how lor impacts fertility outcomes in specific populations, investigators can help to improve the overall success rates of infertility treatment, reduce anxiety, and distress, and help participants achieve goals of becoming parents.

Eligibility criteria:
inclusion criteria: 1. all participants with at least 1 previous pregnancy, who are assessed in one of our clinics (art fertility clinics abu dhabi, al ain, dubai) exclusion criteria: 1. severe male factor (azoospermia, cryptozoospermia, severe oligoasthenoteratozoospermia (oat)) 2. severe endometriosis and adenomyosis based on positive anamnesis or ultrasound performed in our center during the first consultation 3. uterine abnormalities (e.g. fibroids, different degrees of uterine septum), diagnosed by ultrasound 4. history of ovarian surgery, chemotherapy, or radiation therapy 5. known genetic disorder or chromosomal abnormality 6. bmi \>40kg/m2 7. currently using hormonal contraception or hormone replacement therapy

Keywords: miscarriage infertility ivf
to assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline. - 1

Conditions: Amphetamine-Related Disorders

Summary: to assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

the primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.

Eligibility criteria:
inclusion criteria: * healthy individuals with a body mass index between 18 and 30. * willing and able to give written consent. * must have a negative drug test * females must have a negative pregnancy test prior to study drug administration * must have no medical contraindications as determined by routine testing exclusion criteria: * please contact the site for more information
prospective characterization of the heart, aorta and blood pressure in turner syndrome. association with aortic dissection.

Conditions: Turner Syndrome; Aortic Aneurysm; Ischemic Heart Disease; Hypertension; Congenital Heart Defect

Summary: turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. the syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and autoimmune diseases in general. our study aim is: * using mri to further characterize and find risk factors leading to aortic dilation. * using mri to assess the degree of aortic distensibility. * using computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies. * using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as pulse wave velocity, augmentation index and central pulse pressure.

turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. the syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, congenital heart defects, hypertension, stroke, ovarian failure, infertility, decreased final height and autoimmune diseases in general our study aim is: * using mri to further characterize and find risk factors leading to aortic dilation. * using mri to describe aortic dimensions * using mri to assess the degree of aortic distensibility. * using computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies. * using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as pulse wave velocity, augmentation index and central pulse pressure.

Eligibility criteria:
inclusion criteria with respect to individuals acting as controls: * healthy age matched females exclusion criteria: * contraindications for mri * contraindications for ct * severe obesity * acute og chronic disease with known or presumed significance with concern to outcomes of the study * previous or present malignant disease * clinically significant liver disease * mechanic or biological heart valves

Keywords: turner syndrome aortic aneurysm ischemic heart disease hypertension congenital heart defect pulse wave velocity augmentation index central blood pressure agatston score segment involvement score
bcx9930 for the treatment of paroxysmal nocturnal hemoglobinuria (pnh) in participants with inadequate response to c5 inhibitor therapy

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of this study was to determine the efficacy and safety of bcx9930 monotherapy for the treatment of pnh compared to continued c5 inhibitor therapy in adult pnh participants with residual anemia despite treatment with a c5 inhibitor.

this was a randomized, active comparator-controlled, open-label, parallel-group, 2-part study. parts 1 and 2 were conducted in the same participants. part 1 of the study was designed to evaluate the efficacy, safety, and tolerability of oral bcx9930 monotherapy for 24 weeks versus continuing c5 inhibitor therapy in participants with pnh with inadequate response to their current c5 inhibitor therapy. participants were randomized to either discontinue c5 inhibitor therapy and start bcx9930 monotherapy or to continue c5 inhibitor therapy for the 24-week randomized treatment period. the primary efficacy and safety analyses were based on part 1. part 2 of the study was designed to evaluate the long-term safety, tolerability, and effectiveness of bcx9930 monotherapy when administered through week 52. all participants in part 2 received bcx9930. participants who were randomized to bcx9930 monotherapy in part 1 continued to receive bcx9930 in part 2. participants who were randomized to c5 inhibitor therapy in part 1 discontinued that therapy at the week 24 visit and received bcx9930 in part 2.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years old * body weight ≥ 40 kg * documented diagnosis of pnh * currently being treated with a stable c5 inhibitor regimen * documentation of current vaccinations against neisseria meningitidis and streptococcus pneumoniae or willing to start vaccination series * at screening: pnh clone size of ≥ 10% and hemoglobin ≤ 10.5 g/dl exclusion criteria: * known history of or existing diagnosis of hereditary complement deficiency * history of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation * myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition * history of malignancy within 5 years prior to the screening visit * active bacterial, viral, or fungal infection or any other serious infection within 14 days prior to screening * treatment with anti-thymocyte globulin within 180 days prior to screening * initiation of treatment with an erythrocyte or platelet growth factor, or danazol within 28 days prior to screening * receiving iron supplementation with an unstable dose in the 28 days prior to screening

Keywords: bcx9930 factor d inhibitor proximal complement inhibitor oral therapy paroxysmal nocturnal hemoglobinuria inadequate response to c5 inhibitor c5 inhibitor eculizumab ravulizumab
study evaluating thesafety and efficacy of pf-05212377 or placebo in subjects with alzheimer's disease with existing neuropsychiatric symptoms on donepezil

Conditions: Alzheimer's Disease

Summary: this study will evaluate safety and efficacy of pf-05212377 in subjects with mild-to-moderate alzheimer's disease with existing neuropsychiatric symptoms on a stable dose of donepezil. the 4-week run-in will minimize placebo effect. the 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect pf-05212377 on cognition and and neuropsychiatric symptoms in this population. the 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable ad with supportive brain imaging documentation * have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the npi at screening, arising from item scores equal or greater than 2 (frequency x severity) on at least 2 domains. * has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study. exclusion criteria: * demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the adas-cog assessment at screening. * have major structural brain disease other than alzheimer's disease * other severe acute or chronical medical or psychiatric condition or laboratory abnormality

Keywords: randomized double blind safety and efficacy
safety and pk study of bibf 1120 in japanese patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: to investigate safety of bibf 1120 in japanese patients with idiopathic pulmonary fibrosis (ipf), with and without pirfenidone background treatment. to assess pharmacokinetics of bibf 1120 in japanese patients, with and without pirfenidone background treatment. to assess pharmacokinetics of pirfenidone in japanese patients, alone and in combination with bibf 1120 treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic pulmonary fibrosis (ipf) according to american thoracic society (ats) /european respiratory society (ers) guideline 2. forced vital capacity (fvc) 50-90% 3. diffusing capacity for carbon monoxide (dlco) 30-79% 4. for patients on pirfenidone, have been on a steady dose for at least 3 months exclusion criteria: 1. aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 1.5 x upper limit of normal range (uln) at screening. 2. bilirubin \> 1.5 x uln at screening. 3. relevant airways obstruction (i.e. pre-bronchodilator fev1/fvc \<0.7) at screening. 4. continuous oxygen supplementation. 5. active infection at screening or randomisation. 6. being treated with any of the following concomitant medications. * oral corticosteroid medication at unstable dose * ketoconazole or atazanavir 7. patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening
antiproteinuric effect of valsartan and lisinopril

Conditions: Hypertension; Diabetic Nephropathy

Summary: title: antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up. objective: to evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients. hypothesis: combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies. design: multicentric, randomized, double blind, parallel group, active controlled. dose / regimen valsartan 320 vs lisinopril 40 vs valsartan/lisinopril 160/20


Eligibility criteria:
inclusion criteria: 1. male or female outpatients aged 18-70 years, 2. chronic nephropathy, as defined by a serum creatinine concentration of \> 3 mg/dl or calculated glomerular filtration rate of \> 30 ml/min/1.73 m2. 3. persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ). 4. normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: \<125/75 mmhg). 5. written informed consent to participate in the study prior to any study procedures. exclusion criteria * immediate need for renal replacement therapy. * treatment resistant oedema. * need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs. * proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/l. * renovascular hypertension * malignant hypertension * mi, cerebrovascular accident within last year, severe peripheral vascular disease, chf, chronic hepatic disease. * angiotensin converting enzyme inhibitors and angiotensin ii receptors blockers within one month prior to randomization. * a serum creatinine concentration \>265 ümol/l other protocol-defined exclusion criteria may apply.

Keywords: valsartan lisinopril antiproteinuric diabetic nephropathy
quality of life in cutaneous lymphoma patients using the skindex29

Conditions: Cutaneous Lymphoma

Summary: this study assesses the quality of life in patients with cutaneous lymphoma diagnosis as it relates to their personal, clinical, and therapeutic information using the skindex29 questionnaire and also assesses patients' understanding of their diagnosis and need for resources related to their care. cutaneous lymphomas are a rare type of blood cancers (non-hodgkin lymphoma) that present in the skin. the information gained from this study, may help researchers improve quality of life in cutaneous lymphoma patients.

primary objectives: i. to prospectively assess quality of life (qol) in adult patients with cutaneous lymphoma (cl) via use of a validated questionnaire (skindex-29) and identify the psychosocial needs of our patient population. ii. to prospectively evaluate the burden of pruritus in patients with cl via use of 10-point pruritus scale and compare to qol. iii. to evaluate qol for any correlation with demographic and clinical information, specifically, age, gender, race/ethnicity, type of cl, stage of mycosis fungoides (mf)/sezary syndrome (ss), treatment regimen, and social work involvement. iv. to track changes in qol and burden of pruritus as they relate to therapeutic strategies used to manage disease, including social work involvement. v. to prospectively assess patients' knowledge and understanding of their cancer diagnosis, prognosis, and overall survival; and to track changes in their knowledge and understanding, and assess for any correlation to qol. vi. to prospectively evaluate our patients' need for resources, and our ability to meet those needs; and to assess for any correlation to demographic or clinical category, or qol. outline: patients complete quality of life questionnaires over 10-20 minutes about symptoms, emotions, and functioning related to diagnosis of cutaneous lymphoma.

Eligibility criteria:
inclusion criteria: * agreement to participate in the research study * presumed or confirmed diagnosis of cl
gabapentin as preanesthetic medication to fast procedures in pediatric´s oncology

Conditions: Pain, Postoperative; Agitation States as Acute Reaction to Exceptional Stress; Anesthesia; Vomiting

Summary: this study is a clinical trial, prospective, randomized and double-blinded. placebo, gabapentin syrup at 15 mg/kg, and gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.

gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6 years. three groups were compared: the control group received placebo, the other two groups received gabapentin at 15mg/kg or at 30mg/kg. all patients received the same protocols (anesthesia and analgesia). anesthesia protocol used was induction with sevoflurane 8% plus n2o 50% and oxygen, maintenance with sevoflurane 4%. we provided local analgesia with 5% lidocaine creme before the procedure. if it was required, dipyrone 10mg/kg every 6 hours was given as rescue analgesia. to prevent post-operative vomit, ondasentron 0,1mg/kg was administered when intrathecal chemotherapy. the mypas scale was used to evaluate preoperative anxiety at several moments: at basal, at after 1-hour administration, at separation from parents, and at induction. the paed scale was applied after 30 minutes of procedure to evaluate postoperative agitation. the chipps scale was used to assess postoperative pain. the frequency of vomits was recorded for 8 hours after the procedure finished.

Eligibility criteria:
inclusion criteria: * cancer or under investigation for cancer. * children between 1 and 6 years. * previously submitted to oncologic procedures, e.g. myelogram or puncture lumbar. exclusion criteria: * cardiac disease. * pulmonary disease. * renal disease. * neurological disease. * any allergies. * refusal of parents, caregivers or patients to participate in the study.

Keywords: pediatric gabapentin agitation induction
effects of ticagrelor on no-reflow in patients with acute st-segment elevation myocardial infarction

Conditions: Cardiovascular Diseases

Summary: the 'no-reflow' phenomenon after a percutaneous coronary intervention (pci) in patients with acute st-segment elevation myocardial infarction (stemi) is a strong predictor of both short- and long-term mortality. faster antiplatelet activity and increased levels of adenosine provide a theoretical basis for ticagrelor to effectively prevent no-reflow after pci. we planned to evaluate the effects of ticagrelor on myocardial no-reflow after pci for stemi.

investigators enrolled 240 patients with stemi who were admitted to the chinese pla general hospital between september 2013 and march 2015. stemi was defined as typical chest pain lasting n30 min within the previous 12 h, a clear st-segment elevation of n0.1 mv in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin t. we screen high-risk patients through no-reflow risk prediction model， patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. we randomly assigned eligible patients in a 1:1 ratio to receive either ticagrelor 180 mg or clopidogrel 600 mg 30 min before pci. the primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure. secondary efficacy variables were troponin t (tnt), high sensitivity c-reactive protein (hscrp), interleukin-6 (il-6), superoxide dismutase (sod), malondialdehyde (mda), endothelin-1 (et-1), and nitric oxide (no) level

Eligibility criteria:
inclusion criteria: * patients with stemi who were admitted to the chinese pla general hospital exclusion criteria: * 1.unconscious at presentation; 2.had cardiogenic shock, 3.hypoglycemia, 4.diabetic ketoacidosis; 5.had a history of myocardial infarction, stent thrombosis, or renal insufficiency; 6.had previously undergone coronary artery bypass surgery.

Keywords: ticagrelor no-reflow acute st-segment elevation myocardial reperfusion injury percutaneous coronary intervention
astigmatic changes secondary to eyelid surgeries

Conditions: Blepharoptosis

Summary: eyelid surgeries change the lid position over the cornea. previous surgeries evaluated astigmatic corneal changes in children undergoing ptosis repair. only several studies evaluated astigmatic changes following eyelid surgeries in elderly patients. the investigators aim is to estimate this change, implications on corneal astigmatism may have great effect to future cataract surgeries for this group of patients.

patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.

Eligibility criteria:
inclusion criteria: upper lid blepharochalasis exclusion criteria: prior eyelid trauma mental retardation or other causes preventing from signing an agreement form

Keywords: astigmatism lid surgery older than 40 years can sign an acceptance form uper lid surgery