Kornimate/medical-research-clean huggingface dataset:
protective analgesia for postoperative pain relief following day case oral surgery

Conditions: Postoperative Pain; Wisdom Tooth

Summary: the purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.

the aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia. the primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia. the secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.

Eligibility criteria:
inclusion criteria: * healthy male and female patients aged 18 years and over * patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal exclusion criteria: * history of allergy to nsaids * pregnant * history of gi disease * history of bleeding disorders * alcohol dependancy * drug abuse

Keywords: third molar
relationship and pathophysiology of gastroesophageal reflux and dental/periodontal disease

Conditions: Gastroesophageal Reflux; Dental Erosion

Summary: this study investigates the prevalence and pathophysiology of dental and periodontal involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux (ger) or gastroesophageal reflux disease (gerd). primary objectives are to compare the prevalence of oral disease in children with and without a diagnosis or symptoms/signs of gerd in a cross-sectional study. secondary objectives are to examine factors that might lead to the pathogenesis of the dental and periodontal lesions observed in this group of subjects. the primary hypothesis is to prove that children aged 10-18 years diagnosed with or having symptoms or signs of gerd have a significantly higher amount of dental erosions in comparison to a matched control group. secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of ger have higher dmfs (decayed, missing, filled permanent tooth surfaces) rates, higher sbi (sulcus bleeding index) rates, worse periodontal status, and lower saliva buffering capacity.


Eligibility criteria:
inclusion criteria: * ages 9.0 to 18.0 years, of either gender * able to give verbal / written assent / consent themselves and/or informed consent from a parent/guardian * willing to comply with all study procedures and protocols, * willing to get dental photographs and impressions taken * willing to sign the "authorization for release of personal health information and use of personally unidentified study data for research" form exclusion criteria: * subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, hiv, heart conditions that require antibiotic prophylaxis) * other conditions that may decrease the likelihood of adhering to study protocol, * subjects who will leave the area and are unable to complete the study.
evaluation of the impact of a multidimensional ict intervention on the quality of life of breast cancer survivors

Conditions: Breast Cancer; Breast Neoplasms; Quality of Life; Survivorship

Summary: macma is a pilot study that is developed for breast cancer survivors of the hospital clinic of barcelona. the objective of this study is to evaluate the progress in quality of life through the introduction of a mobile phone app that allows for symptom tracking, physical activity tracking and a calendar of patient-oriented events organized by patient organizations. this study is a two-arm randomized clinical trial. this project has received funding from the european union's horizon 2020 research and innovation program under grant agreement no 875351.


Eligibility criteria:
inclusion criteria: * previous diagnostic of breast cancer * free of disease at the time of randomization * signed consent form * possession of a smartphone and ability to use smartphone applications * patients belonging to the acma group o being treated at hospital clínic * without diagnosis of neurodegenerative disorders that prevent participation in the study exclusion criteria: * acute process of cancer at the moment of recruitment * active treatment for cancer (chemotherapy, radiotherapy) * comorbidities such as heart failure nyha class 4, copd,... * inability to give informed consent

Keywords: digital health mhealth quality of life patient support ehealth
study of gamma interfereon in metastatic colorectal carcinoma

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (gfl) with or without bevacizumab.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer, histologically or cytologically confirmed * age 18 or greater * adequate hematologic function (anc \> 1500, hemoglobin \> 10 g/dl, platelet count \> 100,000) * adequate hepatic parameters (bilirubin \< 2.0, alk. phos \< 5 times normal, alt \< 5 times normal) * adequate renal function (creatinine \< 2.0) * performance status ecog 0-2 * 0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. prior 5-fu/lv or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both. * absence of other serious concurrent medical illnesses * evaluable or measurable disease for phase i; measurable disease only for phase ii exclusion criteria: * histologies other than adenocarcinoma * previous grade 4 toxicity to 5-fu +/- lv or capecitabine * uncontrolled brain metastases * chronic diarrhea (greater than five bowel movements per day) * previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with mitomycin or nitrosoureas) * major surgery within 2 weeks before study entry * known allergic sensitivity to leucovorin * prior exposure to ifn-γ * previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1) * pregnancy or breast feeding. women of child-bearing potential must have a negative pregnancy test before the first dose. * other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ * inability to provide written and informed consent * uncontrolled hypertension * history of deep venous thrombosis or cva * prior exposure to bevacizumab * proteinuria \> 500 mg/24 hr

Keywords: gamma interferon 5-fu lv
wedges: coronary lesion preparation with enhanced dilatation for good expansion of stent: assessment of a new scoring balloon by quantitative stent enhanced visualization

Conditions: Coronary Artery Disease

Summary: stent under-expansion during percutaneous coronary intervention (pci) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. in order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase. for this, different devices are used in everyday practices, including non-compliant balloon (nc), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. the purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion


Eligibility criteria:
inclusion criteria: * patient written consent is given a de novo lesion * mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power exclusion criteria: * exclusion criteria patient-related: 1. patient \<18 years old 2. pregnant female 3. contraindication to dual antiplatelet therapy 4. thrombocytopenia \<100 000 5. major surgical intervention planned exclusion criteria lesion-related: 1. significant left main lesion 2. bifurcating lesion with a significant side branch to be treated 3. lesion length \> 25 mm 4. chronic total occlusion 5. lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned 6. lesion in a graft 7. in-stent restenosis lesion 8. lesion responsible of a stemi
effect of vitamin d supplementation on in-vitro fertilization (ivf) outcomes

Conditions: Infertility; Vitamin D Deficiency

Summary: historically, vitamin d has been considered to play a role solely in bone and calcium metabolism. numerous studies have suggested a link between vitamin d deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. in the obstetrics literature, vitamin d deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. recent data from retrospective chart reviews have demonstrated a possible role of vitamin d in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. patients found to be deficient in vitamin d were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin d levels. currently, there are no prospective clinical trials investigating the effects of vitamin d supplementation on ivf outcomes such as clinical pregnancy rate and implantation rates. the investigators hypothesize that the vitamin d supplementation in patients found to be either deficient or insufficient in vitamin d will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

the trial will not pay for or subsidize for ivf treatment. participants will receive blood vitamin d screening test and any necessary supplements free of charge.

Eligibility criteria:
inclusion criteria: * infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles exclusion criteria: * infertile women aged \> 38 undergoing fresh invitro fertilization cycles * patients undergoing frozen embryo transfers * patients undergoing donor-egg cycles * patients who have a contraindication to receiving vitamin d (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)

Keywords: vitamin d deficiency supplementation infertility clinical pregnancy rates
(anti-ribosomal p protein,anti-u1 rnp, anti-nucleosome and anti-ds dna antibodies) and relation to depression and anxiety in sle

Conditions: Systemic Lupus Erythematosus

Summary: the study determine the relation between the degree of (depression and anxiety) in systemic lupus erythematosus patients by zung self rating depression scale and zung self rating anxiety scale and (anti-ribosomal p protein,anti-u1 rnp, anti-nucleosome and anti-double strad dna antibodies).


Eligibility criteria:
inclusion criteria: 1. patients who fulfill the 2012 systemic lupus international collaborating clinics (slicc) criteria or 2019 american college of rheumatology/european league against rheumatism classification criteria of systemic lupus erythematosus. 2. patients who is able to give informed consent to join the study. exclusion criteria: * - any patient with any autoimmune disease other than systemic lupus erythematosus.

Keywords: depression -anxiety-anti-ribosomal p protein antibody - anti-u1 antibody - anti-nucleosome antibody - anti-double strad dna antibody
effects of buprenorphine/naloxone in treating opioid dependent individuals who are maintained on methadone

Conditions: Opioid-Related Disorders

Summary: buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. the purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. a person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. the purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. the study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Eligibility criteria:
inclusion criteria: * meets criteria for opioid dependence exclusion criteria: * significant medical or psychiatric illness

Keywords: opioid dependence
embozene® microspheres for prostatic arterial embolization in patients with symptomatic benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this observational study is to evaluate the prostatic arterial embolization (pae) with embozene® microspheres (boston scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (bph).

emboprostate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm embozene ® microspheres (boston scientific). the study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. if eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. the injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by bph. within one week after pae as well as after one, three and six months post-procedure an mri examination ill occur. a follow-up visit using a questionnaire is due after 6 months.

Eligibility criteria:
inclusion criteria: * male * adults \> 40 years old * severe symptomatic bph with ipss \> 18 and/or qol \> 3 or maximum urinary flow rate (qmax) ≤ 15 ml/sec or transurethral catheter for retention * no improvement after or intolerance of medical treatment for at least six months * prostatic volume \> 30 cm³ exclusion criteria: * female * less than 40 years old * egfr \< 45 ml/min \* m² * suspicion of prostatic malignancy * prostatic malignancy * acute prostatitis or cystitis * hydronephrosis * bladder stone or bladder diverticulum * urethral stenosis * major surgery within 4 weeks prior to the screening visit * active clinically serious infection * progressive arteriosclerosis * contraindications against angiography

Keywords: benign prostatic hyperplasia bph
tympanoplasty using conchal cavum approach and conchal pericondrium

Conditions: Perforation of Eardrum.

Summary: tympanoplasty -- conchal cavum approach is a modification of heermann endural approach to repair broken eardrums. the heermann approach is a well recognized procedure, in common clinical practise for years. the new approach has been used in patients after informed consent was obtained from each patient.

from 2010 to 2013, a total of 96 patients had the procedure. the data are entered, and analyzed. all identifiable information would be hidden. this application is to obtain patients' consent for release and publication of the data. patients would be assured their identities are protected.

Eligibility criteria:
inclusion criteria: * all patients with informed consent exclusion criteria: * patients without consent

Keywords: perforation tympanoplasty conchal cavum approach perichondrium/ cartilage scar
safety and efficacy of venetoclax, cytarabine and metformin (vencm) for relapsed-refractory and induction-ineligible acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

subjects will be included voluntarily after informed consent. diagnosis of aml in accordance with the who classification and determination of inegibility to induction therapy or refractory or relapsed disease after initial treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of aml in accordance with the world health organization criteria. * ineligibility for induction chemotherapy due to age (≥ 70 years) or, for patients 18 to 74 years of age, ecog-ps 2 or 3, creatinine clearance below 60 ml/min/1,73m², left ventricular ejection fraction ≤ 50%. * projected life expectancy of at least 12 weeks. * not requiring supplemental oxygen or substitutive renal therapy. * female participants must be either postmenopausal, surgically sterile or practicing at least one protocol specified method of birth control starting at study day 1 through at least 180 days after the last dose of study drug. * male participants must agree, from study day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception and to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug. * participant must voluntarily sign and date an informed consent form, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures. exclusion criteria: * diagnosis of acute promyelocytic leukemia (apl). * known central nervous system (cns) involvement with aml. * known human immunodeficiency virus (hiv) infection, hepatitis b virus (hbv), or hepatitis c virus (hcv) infection, or other active viral, bacterial or fungal infection requiring treatment. * history of other malignancies prior to study entry, with the exception of non-melanoma skin cancer. * chronic liver disease and cirrhosis with a class b or c child-pugh score.
shoulder, or elbow, or wrist: what should we train first after a stroke?

Conditions: Stroke

Summary: we will test on persons with chronic impairment due to stroke: 1. whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow). 2. whether we should train the shoulder, elbow, and wrist at the same time or on different days.

the effect of proximal and distal training on stroke recovery: specific aim 1. test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke. specific aim 2. test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow). specific aim 3. test whether there is generalization across different joints (shoulder \& elbow vs wrist). specific aim 4: test whether there is any interference between training across different joints among persons with chronic impairment after stroke. briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. a third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. outcomes will be measured using standard instruments as well as robot-based measures. we expect that results from this study will provide an objective basis for maximizing this kind of therapy.

Eligibility criteria:
inclusion criteria: patients will be included in the study if they meet the following criteria: 1. naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients; 2. first single focal unilateral lesion with diagnosis verified by brain imaging (mri or ct scans) that has occurred at least 6 months prior; 3. cognitive function sufficient to understand the experiments and follow instructions (mini-mental status score of 22 and higher or interview for aphasic subjects); 4. average motor power score \>= 1/5 or \<= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist); 5. informed written consent to participate in the study. exclusion criteria: patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.

Keywords: stroke movement therapy robotics rehabilitation robotics shoulder, elbow, wrist
t2 heart mapping in ami population for the prediction of short term major adverse cardiovascular events

Conditions: Myocardial Infarction, Acute

Summary: a novel cardiac mri sequence, developed by dr. maria altbach (double inversion radial fast spin echo t2 mapping), has been tested clinically. it demonstrated a high sensitivity to the heart muscle swelling ("edema") in different types of heart injury, including heart attacks. the investigators propose to use t2-map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients. if successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

in the initial feasibility project, a novel cardiac mri sequence (double inversion radial fast spin echo t2 mapping)developed by dr. maria altbach at the university of arizona, has been tested clinically. it demonstrated a high sensitivity to the heart muscle swelling ("edema") in different types of heart injury, including heart attacks. the investigators have successfully tested the reproducibility of the new method in a series of healthy volunteers. the phase i study revealed a robust clinical performance of the t2-map sequence in multiple cardiac disorders. based on these promising results, presented on several international cardiac imaging meetings, the investigators propose to use t2-map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients. if successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

Eligibility criteria:
inclusion criteria: * between 18 to 89 years old * diagnosis of acute mi * clinically exclusion criteria: * contraindications for contrast enhanced cmr * acute congestive heart failure * ventricular or atrial arrhythmias * ongoing chest pain/unstable angina * ecg changes suggestive of acute/ongoing ischemia * hypotension with systolic blood pressure \<100 mmhg * severe hypertension despite therapy, with systolic bp\>180 mmhg, * patients without a telephone number and/or address for follow up * patients with severe claustrophobia. * vulnerable populations, such as minors, pregnant women, prisoners, or cognitively impaired patients

Keywords: mri double inversion radial fast spin echo t2 mapping heart failure risk stratification 30 day post hospitalization outcome