Kornimate/medical-research-clean huggingface dataset:
a phase 2 trial of iw-1973, a stimulator of soluble guanylate cyclase (sgc), in patients with stable type 2 diabetes and hypertension

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: to evaluate the impact of escalating doses of iw-1973 on endothelial function \[using endopat to measure fingertip small vessel pulse volume\], blood pressure (bp), and heart rate.


Eligibility criteria:
inclusion criteria: * patient is ambulatory male or female * patient's body mass index score is \>20 and \<40 kg/m2 at the screening visit * women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study * patient's health is stable with no clinically significant findings on a physical examination * patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner \> 6 months before the screening visit, and an entry hba1c that does not mandate prompt intervention for improved control * patient has hypertension diagnosed by a physician or nurse practitioner \> 6 months before the screening visit and bp within the protocol's acceptable range * patients must be on a stable regimen for glycemic control, and a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) * patient has abnormal endothelial function measured by the endopat * other inclusion criteria per protocol exclusion criteria: * patient has a clinically significant active or unstable medical condition that, in the opinion of the investigator, would preclude trial participation * patient is on medication(s) that when co-administered with a soluble guanylate cyclase (sgc) stimulator, could increase the risk of hypotension * patient has evidence of severe or active end-organ damage attributable to diabetes * patient has severe renal insufficiency, has undergone renal transplantation, or has planned renal transplantation * other exclusion criteria per protocol
a study of the glaukos trabecular micro-bypass stent in open angle glaucoma subjects 1 stent versus 2

Conditions: Open-Angle Glaucoma

Summary: the purpose of this study is to evaluate the safety and efficacy of the istent trabecular micro-bypass stent in reducing intraocular pressure (iop) in subjects with open-angle glaucoma.

the study compares 1 stent versus 2 stents.

Eligibility criteria:
inclusion criteria: * diagnosed with open-angle glaucoma (oag) * subject on at least one glaucoma medication * signed informed consent exclusion criteria: * angle closure glaucoma * secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma * prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, alt, slt, shunt implant, collagen implant, cyclo destructive procedures etc) * fellow eye already enrolled

Keywords: open angle glaucoma surgery
autologous heterotopic fresh ovarian graft in woman with lacc eligible for pelvic radiotherapy treatment.

Conditions: Locally Advanced Cervical Carcinoma; Premature Ovarian Failure

Summary: pelvic chemoradiotherapy (crt) is an effective treatment for locally advanced cervical cancer (lacc). however, crt induces premature ovarian failure ceasing the production of ovarian hormones. this may lead to severe consequences to the patient's life quality, sexuality and overall healthy. an acceptable treatment to minimize the adverse effects caused by the lack of ovarian hormones is hormonal replacement but less than 40% of the patients younger than 50 years have access to this treatment. a second alternative treatment is ovarian transposing which is a surgical technique with variable success rate depending on how far the ovaries are from the radiotherapy field. a third, more promising, alternative is involves using autologous ovarian tissue as a graft in tissues far from the radiotherapy field. this treatment has the potential of maintaining the natural ovarian hormones production at a lower-cost and requiring a simpler procedure. the primary objective of this randomized phase 1-2 clinical trial is to validate the feasibility of ovarian tissue engraft into fatty tissue and its endocrine functionality.


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix. * figo 2018 staging ib3 to iva. * absence of ovarian involvement. * age ≤35 years. * absence of metastatic disease. * written consent. exclusion criteria: * previous treatment for cervical cancer or other malignant diseases. * rare histology tumors. * absence of one or both ovaries.
evaluation of the antinociceptive and analgesic effects of milnacipran

Conditions: Fibromyalgia Syndrome

Summary: evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients


Eligibility criteria:
inclusion criteria: * patient with fms according to the 1990 acr criteria * patient willing to withdraw from cns-active therapies commonly used for fms, including anti-depressants, anti-convulsivants, opiates * patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics exclusion criteria: * severe psychiatric illness * current major depressive episode (mde) * significant risk of suicide * history of substance abuse * epilepsy * myocardial infarction in the past 24 months * active cardiac disease * congestive heart failure * prosthetic heart valve * haemodynamically significant valvular heart disease * known cardiac rhythm anomalies or conduction abnormalities * unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmhg * pulmonary dysfunction * active liver disease * renal impairment * documented autoimmune disease * current systemic infection * active cancer, except basal cell carcinoma or current cancer therapy * severe sleep apnoea * active peptic ulcer or inflammatory bowel disease (except ibs) * unstable endocrine disease * pregnancy or breastfeeding * concomitant use of non selective mao inhibitors, mao-a or -b inhibitors, tricyclics, tetracyclics, ssris, naris, snris, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines * concomitant use of oral anticoagulants, anticonvulsants, type ic antiarrythmics, lithium * concomitant use of hypericum and same * concomitant use of digitalis preparations * regular use of centrally-acting muscle relaxants * concomitant use of strong analgesics, including tramadol, codeine or opiates * any factor known to affect the hpa axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)
prediction model for minimizing the risk of median nerve puncture

Conditions: Pronator Teres Nerve Syndrome

Summary: the main aim of this study was to correlate anthropometric measures of the forearm in healthy subjects with the ultrasound pronator teres depth to determine the needle length in order to avoid injury of the median nerve during pronator teres dry needle approach. a cross-sectional study, was carried out in order to perform a predictive model for the median nerve depth into the pronator teres muscle using a decision tree analysis algorithm.


Eligibility criteria:
inclusion criteria: * asinthomatic subjets exclusion criteria: * pain in the 3 moths before in the forearm

Keywords: dry needling median nerve pronator teres
lymph drainage mapping for tailoring elective nodal irradiation in head and neck cancer

Conditions: Head and Neck Cancer

Summary: this study aims to explore the safety and outcome of lymph drainage mapping(ldm) to individually tailor the elective nodal irradiation (eni) to the ipsilateral neck only. the goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. in case contralateral lymph drainage is found on spect/ct, a contralateral sentinel node procedure (snp) is performed to remove the draining node. the patient will only receive contralateral eni if (micro/macro)metastasis are found in this contralateral sentinel node.

the suspect2 study is a modified concept from the first suspect study (n14sus). the first study investigated whether lymph drainage mapping (ldm) using spect/ct was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral eni field to the level containing the tracer accumulation. in this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities. firstly, the suspect2 study aims to expand the inclusion criteria of the original suspect study. secondly, it aims to further reduce the proportion of patients that undergoes bilateral eni, by performing a contralateral sentinel node procedure (snp) in case of contralateral lymph drainage. the patient will only receive contralateral eni if (micro/macro)metastasis are found in this contralateral sentinel node.

Eligibility criteria:
inclusion criteria: * newly diagnosed and histopathologically proven primary hnscc * t1-4n0-2b * tumor does not cross midline * who performance status 0 or 1 * signed written informed consent exclusion criteria: * distant metastatic spread at the time of inclusion * chemotherapy or surgery (for the present tumor), prior to inclusion * previous radiation treatment in the head and neck region, for any reason * previous neck dissection * recurrent or second primary tumor in the head and neck region * head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus * pregnancy or no active contraception for pre-menopausal women * known hypersensitivity to iodine or nanocolloid injection * having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules

Keywords: head and neck cancer lymph drainage mapping sentinel node procedure radiotherapy unilateral elective neck irradiation
plasma myeloperoxidase levels in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the investigators sought to assess whether plasma myeloperoxidase (mpo) levels differ among patients with stable and unstable cad patients and control subjects, and correlate with inflammatory and clinical risk factors such as ox-ldl, no,leptin, adiponectin, spla2, lp-pla2, homocysteine and 3-nitrotyrosine in the patients.

elevation of the leukocyte enzyme myeloperoxidase (mpo) in stable coronary artery disease (cad) patients in contrast to unstable cad patients is controversial and its relationship with some inflammatory and noninflammatory markers such as oxidized ldl (ox-ldl) and nitric oxide (no) in the cad patients has not been evaluated yet. evaluation of these relationships is the aim of the study.also the relationships between mpo and some other inflammatory biomarker such as leptin, adiponectin, spla2, lp-pla2, homocysteine and 3-nitrotyrosine are examined. this study includes 50 stable cad, 50 unstable cad patients and 50 controls. plasma mpo, ox-ldl, leptin, adiponectin, spla2 levels are determined using enzyme immunoassay.homocysteine and 3-nitrotyrosine are measured using hplc-fluorescence method. plasma total no and other risk factors such as lipid profile, hypertension, smoking, diabetes mellitus and familial history of cad are also determined in the patients. results are statistically analysed and the association between all markers are assessed.

Eligibility criteria:
inclusion criteria: * stable and unstable patients with angiographically documented coronary artery disease. * control subjects without angiographically documented coronary artery disease. all subjects exclusion criteria: * patients with recent (with in 6 month) myocardial infarction or cardiovascular events, * surgery (with in 3 month), * cancer and * infective or inflammatory diseases were not included in the study.

Keywords: coronary artery disease
response evaluation of cancer therapeutics in metastatic castration-resistant prostate cancer to the bone

Conditions: Castration-resistant Prostate Cancer

Summary: this study is aimed to compare whole body mri (wb-mri) with bone scintigraphy (bs) and computerized tomography (ct) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone. this is a monocentric, prospective observational study.

this is an observational study and will not influence the choice of treatment. the treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. this may include hormonal therapy or chemotherapy or therapy with radium-223. in addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. the duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician. the use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. all other supportive or palliative treatments are permitted. all patients will undergo imaging assessments as follows: * at baseline, ct, bs (99mtc-mdp) and whole body-magnetic resonance imaging (wb-mri) will be performed. * follow-up imaging will be ct, bs and wb-mri performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192. additional patient assessments to be performed include: * questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities. * clinical and physical examinations according to routine clinical practice. the radiologist reporting the wb-mri will be blinded to the results of the ct and bs. the radiologist reporting the ct and the nuclear medicine physician reporting the bs will likewise be blinded to the results of the wb-mri. neither treating clinicians nor patients will be blinded at any point.

Eligibility criteria:
inclusion criteria: * histological diagnosis of castration-resistant prostate cancer, * single or multiple bone metastases, * life expectancy of over 6 months, * no current active malignancy other than prostate cancer, * provision of written informed consent. exclusion criteria: * absolute contraindication to wb-mri, ct or bs, * radical treatment of sole site of metastatic disease (e.g. cyberknife to solitary metastatic lesion), * psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.

Keywords: castration-resistant prostate cancer whole body magnetic resonance imaging
peri-operative expression analysis of pancreatic stone protein in a surgical study population

Conditions: Patients Undergoing Major Abdominal Surgery

Summary: the purpose of this study is to analyze the peri-operative expression of pancreatic stone protein and pancreatitis-associated protein in surgical patients following major abdominal surgery by blood samples.


Eligibility criteria:
inclusion criteria: - \>= 18 years * abdominal major surgery * need for post-operative icu care exclusion criteria: - \<18 years - patients who do not agree the written informed consent
congenital naevi of lower limb in the child

Conditions: Congenital Melanocytar Nevi in the Lower Limb

Summary: depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result. this study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

retrospective study using medical file data only. no intervention nor phone call etc.. to the patients or their parents.

Eligibility criteria:
inclusion criteria: - child + congenital nevi in the lower limb + had removal surgery exclusion criteria: - more than one congenital nevi in the lower limb.

Keywords: congenital nevi naevus congenital skin neoplasm reconstructive surgical procedures
protecting maternal brains from injury and stroke

Conditions: Preeclampsia; Maternal Hypertension

Summary: the purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. there will be two groups of patients in this early stage single center trial. both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (nirs) monitoring for 24 hours. the interventional group will have personalized blood pressure targets according to results of nirs monitoring which will be updated in real time.

maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (smm/mm). the lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological smm/mm. impaired cerebral autoregulation may be such a biomarker. preliminary results using transcranial doppler (tcd) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. however, tcd is operator dependent, and cannot be used for extended monitoring due to discomfort. in contrast, near-infrared spectroscopy (nirs) is fully automated and can be continued for hours at the bedside. identifying personalized blood pressure (bp) targets using nirs has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. however, this method has not been applied in postpartum women. the investigators are applying this novel approach to the management of postpartum preeclampsia (pec) in a single-center, phase ii clinical trial, promis (protecting maternal brains from injury and stroke).

Eligibility criteria:
inclusion criteria: * aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks. * admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features: 1. measured systolic bp ≥160 mmhg and/or diastolic bp ≥110 mmhg on two or more occasions, 15 minutes apart or 2. severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen) exclusion criteria: * acute ischemic stroke * acute intracerebral or subarachnoid hemorrhage · * eclamptic seizures * any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit * prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease * history of reynaud's syndrome (contraindication to finger plethysmography) * inability to understand and consent to the study

Keywords: pregnancy near-infrared spectroscopy (nirs) preeclampsia maternal health
comparison of endoscopic variceal ligation (evl) with propranolol in non cirrhotic portal hypertension (ncph)

Conditions: Non Cirrhotic Portal Hypertension

Summary: background: variceal bleeding is a major cause of morbidity and mortality in patients with non cirrhotic portal hypertension (ncph). beta blockers (bb) and endoscopic variceal ligation (evl) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. endotherapy in the form of est has been well studied in preventing rebleed in patients with ncph. initial studies showed that est significantly reduced the rebleeding rate in patients of ncph. data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years. beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. in contrast to liver cirrhosis, published data on the effect of beta blocker therapy on ncph are scanty. animal data and human data suggests that beta blockers reduce portal pressure in patients with ncph. in two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. however, no comparisons hae been made with evl till date. hypothesis: the investigators hypothesis that in patients with ncph, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding aim of the study: aim: to compare the efficacy and safety of propranolol and evl in the prevention of variceal rebleeding in patients with ncph.


Eligibility criteria:
inclusion criteria: * patients with non cirrhotic portal hypertension (ncph) presenting to our liver diseases follow-up clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper gi endoscopy exclusion criteria: * a history of surgery for portal hypertension * patients already on a est, evl, or glue injection program before presenting to our hospital * patients already on beta blockers for primary prophylaxis of variceal bleed * severe cardiopulmonary or renal disease * bradycardia (basal heart rate, \<50 beats per minute \[bpm\]) or complete heart block * a history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure \<90 mm hg) * refusal to give informed written consent to participate in the trial * patients bleeding from gastric varices or portal hypertensive gastropathy (phg). * patients who had a failure of primary hemostasis during acute bleed were also excluded.

Keywords: non cirrhotic portal hypertension, secondary prophylaxis