Kornimate/medical-research-clean huggingface dataset:
trial of vitamin d supplementation in asthma

Conditions: Asthma

Summary: the study null hypothesis is that vitamin d supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Eligibility criteria:
principal inclusion criteria: * medical record diagnosis of asthma * age ≥ 16 years and ≤ 80 years on day of first dose of imp * if a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study * able to give written informed consent to participate in the study principal exclusion criteria: * diagnosis of copd * known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin d intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years * any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study * taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone * taking dietary supplement containing vitamin d up to 2 months before first dose of imp * treatment with any investigational medical product or device up to 4 months before first dose of imp * breastfeeding, pregnant or planning a pregnancy * baseline corrected serum calcium \> 2.65 mmol/l * baseline serum creatinine \> 125 micromol/l * smoking history \>15 pack-years
multicentre study on diabetic foot treatment

Conditions: Diabetic Foot

Summary: with a rapidly growing incidence rate and a high disability rate,the diabetic foot has long been difficult to treatment, which has caused a huge burden to patients and society. the blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. however, the difference in efficacy between the two has not been reported. in this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.

in this study, investigators compared the therapeutic effects of tibial transportation combined with autologous mesenchymal stem cells local infusion on the healing of diabetes foot ulcers through a controlled clinical study.

Eligibility criteria:
inclusion criteria: * symptoms: wagner stage 2 or above foot ulcer (deep ulcer, abscess or osteomyelitis; localized gangrene, characterized by ischemic gangrene, usually with neuropathy; gangrene of the whole foot), may be accompanied by chronic limb pain, intermittent claudication, cold sensation, abnormal skin sensation and other symptoms * have not taken reserpine in the past week or can change to other antihypertensive drugs * voluntary participation and signing of informed consent exclusion criteria: * patients with organ failure diagnosed by doctors in the past: such as heart failure, liver and kidney failure * patients with myocardial infarction diagnosed by doctors in the past * with congenital or acquired organic heart disease * with basic disease is in the active stage, such as newly diagnosed leukemia patients, or leukemia patients with relapse and refractory * active infection: pulmonary infection, intestinal infection and other existing infections * severe anemia * severe osteoporosis * have undergone amputation of both lower limbs * the investigator judged that it was not suitable to participate in this study, including the existence of abnormal laboratory test results or clinical abnormal symptoms/signs * there are any of the following conditions that may limit the patient's compliance or hinder data collection: dementia; serious mental disorder, unable to express will; unable to complete the research evaluation as required * other contraindications of anesthesia or surgery

Keywords: diabetic foot tibial transportation autologous mesenchymal stem cells local infusion
imaging of t-cell activation with [18f]f-arag in advanced non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a pilot study using \[18f\]f arag pet imaging to evaluate the immunological response to checkpoint inhibitor therapy (ckit) in patients with advanced nsclc tumors at multiple study sites. the main objectives of the study are to quantify the change in \[18f\]f arag pet signal before and after ckit therapy, and to correlate this change in \[18f\]f arag pet signal with a radiographic response.

approximately 50 patients will undergo two research pet/ct scans with \[18f\]f arag at two time points. each patient will receive two 5 (+/-10%) mci doses of \[18f\]f arag, one for each imaging time point. eligible subjects will undergo a pre-treatment \[18f\]f arag pet/ct scan within 7 days prior to treatment, followed by treatment, and an on-treatment \[18f\]f arag pet/ct within 7-14 days of treatment. objectives: * quantify \[18f\]f-arag uptake in advanced nsclc tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-pd-1/pd-l1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy). * correlate change in \[18f\]f arag uptake in tumor lesions with radiographic response.

Eligibility criteria:
inclusion criteria: 1. patients with a histologically confirmed nsclc and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease. 2. recist measurable disease. 3. ecog performance status of 0, 1 or 2. 4. life expectancy \>/= 6 months at enrollment. exclusion criteria: 1. serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. 2. pregnant women or nursing mothers. 3. patients with severe claustrophobia.
transfer of bone marrow derived stem cells for the treatment of spinal cord injury

Conditions: Spinal Cord Injury

Summary: this study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord injuries. bone marrow (bm) contains several types of stem cells that can produce functional cells. this includes cells that could help the healing process of damaged neurologic tissue. the primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. a secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.

a phase i, single-center trial to assess the safety and tolerability of an intrathecal infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal stem cells in a well-defined population of spinal cord injury patients. safety will be evaluated by neurological and non-neurological tests performed after short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after cell infusion.

Eligibility criteria:
inclusion criteria: * age 18 to 65 * american spinal injury association impairment scale a * clinical evidence of lesions located below c-spine 5 (c-5) * confirmation by mri of injury level * time between injury and enrollment greater than 2 weeks * ability to provide informed consent * platelet count greater than 100 thousand/ul at screening * inr equal to or less than 1.5 * hematocrit less than 30% prior to bone marrow aspiration * spinal cord injury within 60 months of screening exclusion criteria: * anoxic brain injury * inability to provide consent * sepsis * neurological deficits attributed to lesions above c-5 * cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased * multiple sclerosis * amyotrophic lateral sclerosis * cerebral palsy * evidence of cancer over the last 3 years prior to enrollment * immunosuppressive diseases * platelet count lower than 100,000 * white blood count greater than 15,000 unless the patient is on steroids * bleeding disorders * clinical or laboratory evidence of meningitis * skin infection at the infusion site * pregnant or planning to become pregnant

Keywords: spinal cord injury
study to estimate the time course of pf-04764793 in the blood following dosing by oral inhalation from dry powder inhalers

Conditions: Healthy

Summary: the purpose of this study is to investigate the time course of pf-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * a positive urine drug screen. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. * pregnant or nursing females.
human photoallergy test

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive * be lightly pigmented (fitzpatrick skin type i, ii, iii) * have read and signed the written informed consent form and have completed a health insurance portability and accountability (hipaa) authorization form in conformance with 45cfr parts 160 and 164 * be in general good health as determined by the subject's medical history and in the discretion of the investigator exclusion criteria: * have a visible sunburn * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products * subjects who are employees of the contract research organization (cro) and/or bayer or is a household member of an employee
the vepro trial: a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia

Conditions: Presbyopia

Summary: the vepro trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia. the aim of the study is to compare the effectiveness of two corrective lenses: an old generation (varilux comfort orma crizal) and a new generation (varilux panamic orma crizal) of corrective lenses prescribed in presbyopia.


Eligibility criteria:
inclusion criteria: * age 43 to 60 years old * outpatients wearing corrective lenses for presbyopia, referred to an optician within the last 6 months for a change in their optical correction * associated hyperopia or astigmatism, the required correction had to be ≤ 3 dioptres in that case * understanding, speaking french and able to answer a questionnaire exclusion criteria: * first prescription of corrective lenses for presbyopia * associated strabism * associated amblyopia * orthoptics therapy * associated anisometropia \> 1.5 dioptres * patients treated for diabetes
epcam and p53 expressions in infiltrating duct carcinoma of the breast

Conditions: Invasive Breast Cancer

Summary: breast cancer represents the most frequently diagnosed cancer in women. it represents the 5th leading cause of cancer mortality all over the world. in egypt, breast cancer represents the 2nd most diagnosed cancer among all population. but among egyptian females it represents the 1st diagnosed cancer representing 32.4%. the main cause of death in breast cancer patients is tumor metastasis. although only 5-10% of recently diagnosed breast cancer cases show metastasis to distant sites, but still there is a high risk for metastasis in patients with localized primary tumor following successful surgical management. epithelial cell adhesion molecule (epcam) is a cell adhesion molecule. it modifies cadherin mediated cell adhesion and it induces epithelial cell migration and proliferation. some authors elucidate that epcam is involved in metastasis. p53 is a known tumor suppressor gene involved in the control of cell cycle, dna repair and apoptosis. it's one of the most mutated genes in cancer including breast cancer. mutant p53 has a big role in tumor progression.


Eligibility criteria:
inclusion criteria: - both incisional and excisional biopsy specimens. 2. all the studied cases include sufficient materials for the immunohistochemical study. 3. complete clinical data. exclusion criteria: 1. patients with recurrence of the primary tumor. 2. patients with a history of preoperative chemotherapy and/or radiotherapy. 3. insufficient or tiny tissue biopsies

Keywords: epcam, p53 , idc
use of erbium laser for extraction of the third molars

Conditions: Third Molar Extraction; Impacted Third Molar Tooth

Summary: a comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.

a single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. the lower third molars will be extracted in 60 patients. there will be 2 groups. the number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. in the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (erbium laser smart 2940d plus with the wavelength 2,94 µm, company- deka, italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. the epithelization will be assessed after 7, 10, 14 days. the bone regeneration will be assessed by cone beam computed tomography (kavo, orthopantomograph ор 3d, type: рсх-1; registration № рзн 2020/10586) after 1, 3, 6 months. the radiation exposure will not exceed the permissible limits. biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. the shapiro-wilk test will be applied to check the normality of variable distribu- tion. qualitative variables will be analyzed by pearson's chi-squared test. quantitative variables (normal distribution of variable) will be analyzed by students t-test, non-normal distribution of variables will be analyzed by mann-whitney u test.

Eligibility criteria:
inclusion criteria: 1. signing of written informed consent of the patient to participate in a study 2. age from 25 to 50 years old 3. indications for impacted third molar extraction 4. patients who are medically stable 5. therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity) exclusion criteria: 1. refusal of the patient from further participation in the study 2. pregnancy diagnosed after the inclusion into the trial 3. non-compliance by the patient with postoperative recommendations 4. absence of a lower second molar

Keywords: impacted third molars erbium laser atraumatic extraction
sentinel lymph node biopsy in ocular surface and adnexal cancers

Conditions: Ocular Sebaceous Carcinoma; Ocular Basal Cell Carcinoma; Ocular Surface Squamous Neoplasia; Merkel Cell Carcinoma, Unspecified; Porocarcinoma; Conjunctival Melanoma

Summary: the study involves enrollment of patients with sebaceous carcinoma, merkel's carcinoma, porocarcinoma, melanoma, and squamous cell ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the fondazione policlinico universitario a. gemelli, irccs. the study will last 9 years: 1 year will be devoted to the first phase of the study. patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. a preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate os and pfs at the 3 time-points indicated are planned.

patients will undergo: * evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography * staging according to tnm ajcc 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (mri with mdc orbits, massif and neck + tc/pet total body) * injection of 99mtc-labeled nanocolloids * preoperative lymphoscintigraphy * intraoperative search by gamma probe of the sentinel lymph node * sentinel lymph node biopsy * excisional biopsy of the neoformation in cases not undergoing excision before sln biopsy. * in case of sln histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy. * clinical-instrumental follow-up to be performed in current clinical practice (clinical examination, cranial orbit and neck mri, total body ct scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the tumor board.

Eligibility criteria:
inclusion criteria: * all patients with porocarcinoma, ca of merkel, ca sebaceous * patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, clark's level ≥3, \>1 mitotic figure per high-power field. * patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia. * patients with squamous cell ca of adnexa with staging ≥3, locally recurrent or with perineural invasion * patients with squamous cell ca of the surface with staging ≥3 and/or multicenter * signature of informed consent to participate in the study * cno exclusion criteria: * age less than 18 years * patients with metastatic disease at diagnosis * all patients who do not fit the inclusion criteria * failure to obtain informed consent

Keywords: sentinel lymph node biopsy malignant ocular surface tumors malignant eyelids tumors
assessment of blood pressure control and target organ damage in patients with chronic kidney disease and hypertension -ii

Conditions: Chronic Kidney Disease; Hypertension

Summary: the purpose of this study is to find the change of blood pressure (bp) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (ckd) over 3 years. and other objective is the relationship between the bp control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (lvh), and so on. in addition, we will find clinical factors related to the bp control pattern.


Eligibility criteria:
inclusion criteria: 1. with informed consent 2. 20 \<= age \< 75 years 3. diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months 4. all-cause chronic kidney disease patients with 15 \<= estimated gfr \< 90 5. no change of anti-hypertensive drugs within 2 weeks and good compliance exclusion criteria: 1. changed prescription according to ambulatory blood pressure monitoring (abpm) regularly 2. had acute kidney injury/hospitalization 3. had a proteinuria of \> 6 g/day (spot urine protein to creatinine ratio \> 6.0 g/g cr) 4. had end stage renal disease (esrd) with dialysis and/or were a kidney recipient 5. had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus 6. were pregnant/lactating women 7. were night shift workers.
desflurane versus propofol anesthesia for off-pump cabg

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (op-cabg) surgery as measured by following parameters: 1. hemodynamic parameters during and after the operation, 2. pulmonary gas exchange, need for mechanical ventilation and for icu and intrahospital stay, 3. release of heart muscle injury markers in response to surgery and intraoperative ischaemia, 4. inflammatory response to the operation. we suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.

general anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium. after induction of anesthesia a swan-ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. a transesophageal echocardiography probe will be placed additionally for the tei-index measurement. hemodynamic parameters will be recorded at the following time points: * before induction * after induction * during trachea intubation * before skin incision * 3 min. after skin incision * after sternotomy * before heart positioning for graft placing * before finishing placing each distal anastomoses * 10, 20, 30, 40 min after placing the last anastomoses * 10 min. after admission to icu, 6, 12, 18 and 24 hours after surgery. * tee measurements will be obtained after sternotomy and 20 min after placing the last distal anastomoses. the results will be compared while using the parametric anova test for normally distributed continuous data or the nonparametric kruskal-wallis/wilcoxon-u test for categoric or inhomogeneous distributed continuous data.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease qualified for cabg off-pump surgery * elective surgery * signed informed consent exclusion criteria: * left ventricle ejection fraction \< 30% * serum creatinine \> 2 mg/dl * emergency surgery * denied consent

Keywords: anesthesia intravenous propofol anesthesia inhalation desflurane heart surgery coronary artery by-pass off-pump hemodynamic processes anesthesia