Kornimate/medical-research-clean huggingface dataset:
norwegian laparoscopic aortic surgery trial

Conditions: Aortobifemoral Bypass; Aortoiliac Occlusive Disease; TASC Type D Lesions; Laparoscopic Versus Open Bifurcation Graft

Summary: patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(abfb)through a median laparotomy. since 1993, this operation has also been performed laparoscopically. the laparoscopic abfb operation claims to be minimally invasive as compared to the open abfb. the cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence. however, no randomized control trial has yet been published to compare the two procedures. in the nlast-study, which is a multicenter randomized control trial, the patients with tasc type d atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (labfb)or an open abfb operation.

the primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc. secondary endpoints are as follows, * health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of sf36v2 questionnaire and eq5d5l. * perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes * perioperative inflammatory response * cost-utility analysis * cost differences

Eligibility criteria:
inclusion criteria: * aortoiliac occlusive disease (tasc type d lesions) exclusion criteria: * active cancer disease * acute critical limb ischemia * prior major abdominal surgery * heart failure (ejection fraction \<40%

Keywords: aortobifemoral bypass laparoscopic aortic surgery aortoiliac occlusive disease tasc type d lesions open aortic surgery
role of osteocytes in myeloma bone disease

Conditions: Multiple Myeloma

Summary: progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. the bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. treatments need to block centrally important, multifunctional pathways. the investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. increased heparanase due to fgf23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. fgf23 neutralizing antibodies have been developed for non-cancer conditions of fgf23 excess, such as chronic kidney disease (shimada \& fukamoto, 2012), and could be used in mm alone or in combination with heparanase inhibitors. complete neutralization of fgf23 has adverse effects, but neutralization of fgf23 excess may be practical, or in the future, suppression of excess fgf23 biosynthesis by osteocytes. the investigators hope to determine serum fgf23 and heparanase, dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years but ≤ 95 years at the time of consent 2. subjects must be english-speaking 3. must voluntarily sign the most current informed consent and hipaa documents prior to study participation. 4. have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers. 5. have no known liver or kidney disorders exclusion criteria: 1. pregnant females will be excluded from the study. 2. subjects allergic to xylocaine will be excluded. 3. subjects with an acute illness (ex. upper respiratory infection, viral illness) in the past seven days will be excluded. 4. history of bleeding disorders. 5. subjects deemed incompetent by treating physician 6. institutionalized, mentally disabled subjects 7. subjects who are prisoners
safety and tolerability of fingolimod in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (rrms) and generate additional data in multiple sclerosis (ms) patient population that closely resembles the clinical population seen in routine medical care.


Eligibility criteria:
inclusion criteria: * patients with relapsing remitting multiple sclerosis * patients with expanded disability status scale (edss) score of 0-6.5. exclusion criteria: * patients with ms other than relapsing remitting ms * patients with a history of chronic disease of the immune system other than ms, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. * patients who have been treated with: * systemic corticosteroids or immunoglobulins within 1 month prior to baseline; * immunosuppressive medications within 3 months prior to baseline; * monoclonal antibodies within 3 months prior to baseline; * cladribine, mitoxantrone or alemtuzumab at any time. * uncontrolled diabetes mellitus at screening * diagnosis of macular edema during screening phase * patients with active systemic bacterial, viral or fungal infections, or known to have aids, hepatitis b, hepatitis c infection or to have positive hiv antibody, hepatitis b surface antigen or hepatitis c antibody tests. * patients who have received total lymphoid irradiation or bone marrow transplantation. * patients with certain cardiovascular conditions and/or findings in the screening ecg * patients with certain liver conditions * pregnant confirmed by a positive pregnancy test t or nursing (lactating) women * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis relapsing-remitting
study of the anti-hcv drug (bms-790052) combined with peginterferon and ribavirin in patients who failed prior treatment

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to determine whether bms-790052 added to peginterferon alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with peginterferon alfa-2a and ribavirin alone.


Eligibility criteria:
inclusion criteria: * subjects chronically infected with hcv genotype 1 * non-responder to prior therapy with peginterferon alfa and ribavirin * hcv rna viral load of 100,00 iu/ml * results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic hcv infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) * ultrasound, ct scan or mri results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma * body mass index (bmi) of 18 to 35 kg/m2 exclusion criteria: * positive for hepatitis b infection (hbsag) or hiv-1/hiv-2 antibody at screening * evidence of medical condition associated with chronic liver disease other than hcv * evidence of decompensated cirrhosis based on radiologic criteria or biopsy
interest of s100b protein for patient victim of minor traumatic brain injury and treated by antiplatelet

Conditions: Minor Traumatic Brain Injury; Treatment by Antiplatelet

Summary: all the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. if they are agree, a blood sample for the dosage of s100b will be done. no other modification of the medical care, all patients will have tomodensitometria, according with recommendations. the aim of the study is to validate the negative predictive value of s100b in this population.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * minor traumatic brain injury measured by a glasgow score between 13 and 15 * antiplatelet agent therapy * free subject without tutorship or curatorship exclusion criteria: * age \< 18 years old * glasgow score \<13 * traumatic brain injury older than 6 hours * patient without any social security system * patient with renforced protection (tutorship, curatorship, ...)

Keywords: s100b protein minor traumatic brain injuries antiplatelet therapy
epidemiological study for traumatic humeral shaft fractures in adults

Conditions: Humerus Shaft Fracture

Summary: primary objective : to evaluate the incidence of radial nerve palsy for adult patients with humeral shaft fractures secondary objective : to establish management protocol for traumatic humeral shaft fractures in adults at auh

diaphyseal humeral shaft fracture is defined as an extra articular fracture of the humerus with exclusion of both 5 cm of both upper and lower ends (muller et al,1990) within the last century, many conservative and surgical techniques developed all over the world to solve this problem (welter d et al, 1991) conservative treatment was a gold standard since the full research which was published by sarmiento (sarmiento, 1977 ) within the last few decades, with the establishment of osteosynthesis and surgical fixation of long bone which had better outcome in comparison to conservative treatment, it led to a changes in the protocols of treating fractures of the humerus (muller et al,1990) within the last decade, with the revolution of biological non anatomical fixation of the humeral shaft fractures, a new era of management was established and became popular all over the highly qualified trauma centres (balam km et al, 2014) so, the rational of this work, is to document different surgical strategies of biological fixation of humeral shaft fractures in adults with its results.

Eligibility criteria:
inclusion criteria: * all patients with traumatic humeral shaft fracture more than 16 years old who are admitted in assiut university hospital exclusion criteria: * patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture
can resveratrol improve insulin sensitivity and preserve beta cell function following gestational diabetes?

Conditions: Gestational Diabetes

Summary: the purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. we hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity.

our primary aim is to perform a randomized controlled trial of resveratrol for the improvement of insulin sensitivity and the preservation of beta cell function in post-partum women following a first diagnosis of gestational diabetes. our long-term goal is to test resveratrol for the secondary prevention of gestational diabetes and type 2 diabetes. we have developed six conditions that should be satisfied by the study to justify project expansion. therefore, we will be testing hypotheses and computing estimates for the following six outcomes: (1) recruitment numbers, (2) adherence to study treatment, (3) adherence to study visits, (4) insulin sensitivity measured at 12 months post-partum, (5) beta cell function measured at 12 months post-partum, and (6) adverse events. the study is a single-site, parallel, double-blind, randomized, placebo-controlled trial. the study population consists of women recruited during pregnancy who had a confirmed first diagnosis of gestational diabetes, who do not have either diabetes or pre-diabetes when re-tested 3 months post-partum, and who have stopped breastfeeding by 9 months post-partum. they study intervention is resveratrol (or identical placebo) twice daily for a total of 12 weeks from 9 months to 12 months post-partum. our planned sample size is 112 women based on the hypothesis testing and estimation considerations for the six above-mentioned outcomes.

Eligibility criteria:
inclusion criteria: * adult women (18 years of age or older) 3 months post-partum with a recent history of first diagnosis of gestational diabetes. * willingness to provide informed consent 3 months post-partum. exclusion criteria: * abnormal glucose tolerance or type 2 diabetes recorded at 3 months post-partum. * breastfeeding beyond 9 months post-partum. * intention to consume resveratrol open label. * intention to drink red wine (more than 4 glasses per week) or eat foods high in resveratrol (grapes, grape juice, peanuts, peanut products). * unwillingness to use two approved types of contraception until one year post-partum and unwillingness to undergo pregnancy test at randomization. * twin pregnancy. * consuming medications with a risk of interaction with resveratrol. * liver disease. * unlikely to be able to comply with study follow-up as judged by social (e.g. transient, not permanent residents, etc.) or geographical considerations.

Keywords: resveratrol, gestational diabetes, beta cell function history
effect of osteosynthesis, primary hemi-arthroplasty, and non-surgical management for fractures of the proximal humerus

Conditions: Proximal Humeral Fractures

Summary: displaced four-part fractures are among the most severe injuries of the proximal humerus. the optimal treatment is disputed and published data are inadequate for evidence-based decision making. the investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns. the investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. all patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including constant disability scale, oxford shoulder score, and short form-36.


Eligibility criteria:
inclusion criteria: * displaced four-part fracture of the proximal humerus * mentally alert * physically fit for surgery and rehabilitation (asa-group 1-3) * informed written consent * operation can be conducted within 2 weeks of injury exclusion criteria: * fracture-dislocations * head-splitting fractures * previous shoulder surgery on injured side * chronic shoulder pain * abuse problems * patients unable to understand instructions in danish

Keywords: shoulder fractures proximal humeral fractures randomised clinical trial elderly displaced four-part fractures of the proximal humerus
very small embryonic-like stem cells for ovary

Conditions: Stem Cell Transplant Complications; Premature Ovarian Failure

Summary: the aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(vsels) to premature ovarian failure.

premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (fsh, \> 40 iu/l)、luteinizing hormon (lh, \> 40 iu/l)、estradiol (e2, \> 100pg/ml) and/or amenorrhea before the age of 40. vsels come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed as premature ovarian failure by professional doctor. * those have clear abnormal sex hormone levels exclusion criteria: * unmarried woman * suffering from other serious gynecological diseases or gynecological tumors * blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
ultra-long acting bronchodilator therapy in smoking asthmatics

Conditions: Asthma

Summary: single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. sufficient participants enrolled to complete 16 adults. withdrawn subjects may be replaced. this clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. this will be via a pulmonary function test called impulse oscillometry.

cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma. unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (copd). hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking. in view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke. participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between: olodaterol which is a new long-acting bronchodilator. olodaterol combined with tiotropium (dual bronchodilators). we wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.

Eligibility criteria:
inclusion criteria: * male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily) * current smoker * forced expiratory volume in 1 second (fev1) ≥ 60 % predicted * ability to give informed consent * agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being exclusion criteria: * other significant respiratory diseases, in the opinion of the investigator, such as copd or bronchiectasis. * an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required * any clinically significant medical condition that may endanger the health or safety of the participant * participation in another drug trial within 30 days before the commencement of the study * pregnancy or lactation * unable to comply with the procedures of the protocol * unable or unwilling to consent

Keywords: tiotropium olodaterol smoker cigarette bronchodilator
cardiovascular assessment in patient recovered from covid-19 and recovery of autonomic nervous system in association with the severity of the disease

Conditions: COVID-19

Summary: the goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from covid-19 and devided into three groups depend on severity of the morbidity.


Eligibility criteria:
inclusion criteria: * age over 18 * spontaneous sinus rhythm * signed informed consent exclusion criteria: * no spontaneous sinus rhythm * pregnancy
ocular changes after ivermectin - (dolf ivm/oncho)

Conditions: Onchocerciasis

Summary: the dolf ocular changes after ivermectin study will investigate the kinetics of o. volvulus microfilaria (mf) in the eye following treatment with ivermectin. the primary objective is to determine the proportion of participants with complete mf clearance from the eye at 3 and 6 months following treatment with ivermectin (ivm).

this study will examine the kinetics of mf clearance in the eye following ivermectin treatment. previous studies have been unable to fully assess clearance mf from the posterior chamber of the eye. this study will be the first to use optical coherence tomography (oct) in patients with onchocerciasis to document parasites and pathology in the anterior and posterior chambers of the eye, and assess ocular changes following standard ivermectin treatment. this will be a biomedical prospective cohort study. the cohort will be stratified based on mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group. 1. individuals with positive skin snip mf density of ≥ 1 mf/mg), but no observable mf in eyes using slit lamp and indirect ophthalmoscopy 2. individuals with positive skin snip mf density of ≥ 1 mf/mg and 1-10 mf in either eye at baseline (based on the highest number counted in either eye) 3. individuals with positive skin snip mf density of ≥ 1 mf/mg and \>10 mf in either eye at baseline. all participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. this is the standard of care for treatment with onchocerciasis. participants will be evaluated following treatment with detailed parasitological and ocular examinations 7 days, 3 months and 6 months after treatment.

Eligibility criteria:
inclusion criteria: * have at least 1 palpable subcutaneous nodule (onchocercoma) and ≥ 1 mf/mg of skin (by skin snip) exclusion criteria: * pregnancy and breastfeeding mothers within 1 month of giving birth * have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye. * prior allergic / hypersensitivity reactions or intolerance to ivermectin * treatment with ivermectin in the past 6 (six) months

Keywords: mass drug administration ophthalmology
g-csf administration in ivf in a preferable preceptive endometrium score

Conditions: Women Infertility

Summary: this is a controlled preminary trial intended to increase the implantation rate of ivf cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αvβ3 integrin, l-selectin ligand meca-79, e-cadherin and icam-1, as a determinant for intervention by g-csf, according to a score that can be done on a small sample obtained during scratching, then give g-csf for the scores less than 4 intrauterine and subcutaneously.

placebo: control patients treated with placebo (saline solution) from the day of embryo transfer through the day of beta hcg test drug\& scratching control saline infusion every day from the day of embryo transfer through the day of beta hcg test other name: saline infusion experimental: g-csf group patients treated with g-csf if the biopsy adhesive score 1-3 only 1. endometrial scratching and adhesive factor score, day 21-24 cycle prior to ivf//0rv day 3 of ivf cycle not planned before. 2. drug \&scratching : g-csf group 1- 300 µg trans cervical intrauterine of g-csf was administered at the oocyte retrieval day, 2- subcutaneous 300 micrograms g-csf on the day of embryo transfer comparative group patients not treated with g-csf after scratching if the biopsy adhesive score 4 only scratching only : patients undergoing scratching on day 21-24 of prior ivf cycle/ and on day 5 of ivf cycle with biopsy score of 4.

Eligibility criteria:
inclusion criteria: * all women aged \< 40 years who would be submitted to oocyte retrieval and embryo transfer in ivf cycle. exclusion criteria: * • contraindications for g-csf treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)

Keywords: ivf