Kornimate/medical-research-clean huggingface dataset:
bone marrow derived stem cell transplantation in t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to improve the blood glucose level in type 2 diabetic patients.

we hypothesize that autologous bone marrow derived stem cells which would be expanded into culture and their subsequent transplant into the pancreas of patients with t2dm, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(\>0.4 u/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. it is assumed that stem cell in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and vascular endothelial growth factor(vegf) and creates a micro-environment which supports beta cell/resident stem cell activation and survival.

Eligibility criteria:
inclusion criteria: patients with type 2 diabetes mellitus between 30 and 70 years of age. * failure to triple oral hypoglycemic agent and on stable doses of insulin for at least 3 months. * on vildagliptin,pioglitazone and metformin for at least 3 months along with insulin to maintain euglycemia. * hba1c \< 7.5%. * insulin requirement ≥0.4 iu/kg/d. * gad antibody negative status. exclusion criteria: * patients with type 1 diabetes mellitus or secondary diabetes. * patients with serum creatinine \> 1.5 mg/dl. * abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory). * history of cholecystitis/ cholelithiasis/ cholecystectomy * seropositivity for hiv, hbsag and hepatitis c virus (hcv). * history of myocardial infarction or unstable angina in the previous 3 months. * history of malignancy * patients with active infections.
effect of hiv and/or active tuberculosis on the immune responses to trivalent influenza vaccine (tiv) in adults

Conditions: Influenza; HIV; Tuberculosis

Summary: prospective, open-labelled study which will enrol 360 participants in four groups of 80 participants including: hiv-uninfected adults without evidence of tb; hiv-infected adults without any evidence of tb; hiv-uninfected adults with concurrent microbiologic confirmed tb, hiv-infected adults with concurrent microbiologic confirmed tb. participants will receive the recommended seasonal 2013 un-adjuvanted trivalent influenza vaccine (tiv). at 3 visits, blood will be collected for determination of immune responses. objective: • to determine the effect of hiv-infection, tuberculosis (tb) and hiv-tb co-infection on immune responses


Eligibility criteria:
inclusion criteria: * for hiv-infected subjects: a cluster of differntiation4 (cd4+) cell count of \>100/ul within the previous 3 months; * able to attend the clinic for immunogenicity and illness visits; * for subjects with tb: having a microbiologic confirmed diagnosis of tb (defined as the presence of acid-fast-bacilli (afb) on a sputum smear or other specimen and/or a positive culture for m. tuberculosis) within the past 120 days; * aged 18 to 55 years. exclusion criteria: * any contraindication to influenza vaccine; * any contraindication to intramuscular injections; * any existing grade 3 or grade 4 laboratory or clinical toxicity as per division of acquired immune deficiency syndrome (daids) toxicity tables; * systemic steroid treatment for \>21 days within the past 30 days. * pregnancy (a urine human chorionic gonadotropin (βhcg) will be performed on all women of childbearing age to exclude pregnancy)

Keywords: tuberculosis hiv infection immune responses to influenza vaccination
impact of a multidisciplinary approach in the perioperative geriatrics unit on functional status of patients aged 70 and over operated on for colorectal cancer

Conditions: Colorectal Cancer; Surgery

Summary: health establishments encourage the development of specific care pathways for the elderly by supporting geriatric peri-operative units (gpou). indeed, this shared care model has shown a clear reduction in mortality and the number of re-hospitalizations in patients 6 months after their care. the multidisciplinary approach of global management of the patient in the perioperative period aims to reduce surgical stress as well as the rapid restoration of previous physical and psychic abilities. colorectal surgery, the main treatment for stage i to iii colon cancer, is a morbid surgery. despite numerous efficacy data on improved rehabilitation after colorectal surgery, care programs are not specific to the geriatric population and geriatric assessment criteria to describe the functional status of patients are not commonly used. the study investigators wish to evaluate the impact of gpou treatment following colorectal surgery, on the evolution of several clinical parameters such as: functional status, morbidity mortality, quality of life, and lifestyle. the study investigators hypothesize that management in the gpou for colorectal cancer surgery in patients aged 70 and over will improve functional status at 3 months, in comparison with traditional management. the proposed intervention should also lead to an improvement in patient satisfaction with care, complications and re-hospitalizations, nutritional status, lifestyle and patient survival.


Eligibility criteria:
inclusion criteria: * the patient or their representative must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * diagnosis of proven colorectal cancer. * patient to benefit from scheduled colorectal surgery at the university hospital of nîmes validated in digestive surgery spc after oncogeriatric evaluation. * surgical act: resection with anastomosis in one step. exclusion criteria: * interventional riph patient defined as category 1 if there is interference with the primary endpoint * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship

Keywords: elderly geriatric unit postoperative
covid-19 booster study in healthy adults in australia

Conditions: COVID-19

Summary: this is a double-blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a bivalent mrna moderna covid-19 vaccine or a protein-based novavax covid-19 vaccine given as a fourth dose in healthy adults in australia.

this is a blinded, two-arm randomised study to determine the safety, reactogenicity and immunogenicity of a fourth dose of sars-cov-2 vaccines in australia in adults 18 years or older who have received their third dose of covid-19 vaccine at least six months previously. participants will be randomised to receive either bivalent moderna (mrna-1273.214) or novavax. a separate non-randomised control arm (no vaccine given), frequency matched by age to the vaccine groups will also be enrolled for comparison. a total of 200 participants per group will be recruited.

Eligibility criteria:
inclusion criteria: 1. have received three doses of covid-19 vaccines at least 6 months earlier. 2. no confirmed sars-cov-2 infection on pcr or rat within the last 3 months. 3. willing and able to give written informed consent. 4. aged 18 years or above. 5. willing to complete the follow-up requirements of the study. exclusion criteria: 1. currently receiving immunosuppressive medication or anti-cancer chemotherapy. 2. known hiv infection. 3. congenital immune deficiency syndrome. 4. received immunoglobulin or other blood products in the three months prior to potential study booster vaccination. 5. study staff and their relatives. 6. have a history of a severe allergic reaction to any covid-19 vaccines or have a medical exemption to receiving further covid-19 vaccines. 7. cannot read or understand english.

Keywords: booster dose moderna and novavax control group monovalent, bivalent
intraoperative different concentrations oxygen and oxidatıve stress markers

Conditions: Stress; Hyperoxia

Summary: the aim of the study was to assess the effect of intraoperative oxygen (o2), which was applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on total oxidant status (tos), total antioxidant status (tas), and oxidative stress index (osi).


Eligibility criteria:
inclusion criteria: * patients aged between 18-60 years, * asa i-ii risk class with a minimum operative time of 1.5 hour(s) for whom septoplasty operation under elective conditions exclusion criteria: * metabolic, endocrine, hepatic, cardiac, or renal diseases, * malignancies and who used a drug with antioxidant properties such as vitamin e-c * acetylcysteine in the last 48 hours, * patients requiring intraoperative 100% o2 inhalation

Keywords: oxidative stress markers general anesthesia
the effect of integrated cam treatment in hospitalized patients

Conditions: Low Back Pain; Neck Pain; Knee Pain; Shoulder Pain; Intervertebral Disc Herniation; Spinal Stenosis

Summary: this study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (cam) and conventional medicine treatment.

this study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (cam) and conventional medicine treatment. inpatients received treatment according to a cam treatment protocol (herbal medicine, acupuncture, bee venom pharmacopuncture, and chuna manipulation) and conventional medicine treatment as needed. the main outcome measures were the duration of pain, nrs of back pain, radiating leg pain, neck pain, radiating arm pain, knee pain, shoulder pain, previous surgery, previous interventions (injections), oswestry disability index (odi), vernon-mior neck disability index, the korean western ontario mcmaster index, shoulder pain and disability index, range of motion (rom), straight leg raise test (slr), alcohol use, smoking at admission, 2 weeks, and discharge.

Eligibility criteria:
inclusion criteria: * patients hospitalized due to spine or joint diseases exclusion criteria: * main complaint other than back pain, radiating leg pain, neck pain, radiating arm pain, knee pain or shoulder pain * cause of pain non-related to spine, joint or soft tissue; for example, spinal tumors, pregnancy, urolithiasis, etc. * refusal to provide the information needed for clinical research

Keywords: inpatient care complementary and alternative medicine integrated medicine
sildenafil citrate before surgery in improving kidney function in patients with kidney cancer

Conditions: Kidney Tumor

Summary: this randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.

primary objectives: i. to assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (rpn) for a suspected renal malignancy. secondary objectives: i. to evaluate individual alterations in glomerular filtration rate (gfr) at 24 hours, 48 hours and one month following rpn and compare these to the placebo group. ii. to evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following rpn and compare these to the placebo group. iii. to measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following rpn. iv. to describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit. v. to describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure. vi. to compare overall complication rates (within 90 days postoperatively) between groups. vii. to obtain a preliminary effect size of sildenafil on change in gfr at three months following rpn. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive sildenafil citrate orally (po) before the initiation of standard robotic partial nephrectomy. arm ii: patients receive placebo po before the initiation of standard robotic partial nephrectomy. after completion of study treatment, patients are followed up at 1 and 3 months.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing * history of adverse reactions to any phosphodiesterase (pde) inhibitor (pde type 5 inhibitor \[pde5i\]) * any patient currently taking a pde5i will be asked to refrain from use for one week prior to their surgery; patients who have used a pde5i within 72 hours of surgery will be excluded * pregnant women are excluded from this study * patients with only one kidney
association between uric acid and acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the aim of the study is to acess the association between admission serum uric acid level and in_hospital outcomes in patients with acute coronary syndromes

prospective study 1. to acess patients with acute coronary syndrome including one of (typical chest pain _ecgchanges _elevated cardic enzyme) 2. the complication occur in patients with hyperurecemia and those with normal uric acid

Eligibility criteria:
inclusion criteria: all patients with acute coronary syndrome with one of the following * typical chest pain * ecg changes * elevated cardiac enzyme exclusion criteria: * patients aged less than 18 years * patients with gout * patients with treated with diuretics * patient with ckd * patient with chronic haemolytic anemia
taxotere (docetaxel) in 1st line treatment of recurrent/metastatic head and neck squamous cell carcinoma

Conditions: Head and Neck Neoplasms; Neoplasm Recurrence, Local; Neoplasm Metastasis

Summary: the purpose of the study is to compare time to progression and overall survival after treatment with taxotere plus cisplatin versus cisplatin plus 5-fu (pf treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (scchn) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
efficacy study on dimethyl fumarate to treat moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this multicenter, randomised, double-dummy, fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of fp187 (250 mg twice daily) compared to 720 mg fumaderm® (240 mg three times daily) over 20 weeks of treatment. after an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated study treatment up-titrated to the relevant dose level (i.e., 500 mg daily fp187, 720 mg daily fumaderm®, or placebo). the up-titration to full dose will last 4 weeks for fp187 and 9 weeks for fumaderm®. after 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months; * clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the pasi scale and on the spga score at least as moderate; * besides psoriasis, patient is in good general health * patients with a dlqi score of at least 10 exclusion criteria: * pustular forms of psoriasis, erythrodermic or guttate psoriasis; * known immunosuppressive diseases; * presence of another serious or progressive disease including skin malignancies; * active skin disease; * use of topical medical treatment or uvb treatment during the 2 weeks preceding randomization; * use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or puva (psoralen + uva treatment) treatment within 4 weeks; biological treatment within 12 weeks; stelara within 20 weeks; acitretin within 6 months; * treatment with fumaderm® or other dimethyl fumarate containing products within 12 weeks prior randomization; * treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization; * treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization; * on-going stomach or intestinal problems; * aspartate transaminase (ast), alanine transaminase (alt) \> 2 x upper normal limit (uln), or gamma-glutamyltransferase (γ-gt) \> 2.5 x uln; * creatinine clearance \< 60 ml/min; * leucopenia, eosinophilia or lymphopenia; * protein in the urine test;

Keywords: psoriasis dimethyl fumarate fumaderm®
prone position and respiratory outcomes in non-intubated covid-19 patients the "prone" study

Conditions: Covid19; Pneumonia, Viral

Summary: the overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (covid-19) pneumonia.

as the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and the disease it causes, coronavirus disease 2019 (covid-19) has spread beyond wuhan, china it has become a pandemic affecting over 178 countries. of patients admitted to the icu, upwards of 85% developed the acute respiratory distress syndrome (ards) and most if not all required mechanical ventilation. the beneficial effects of prone positioning for ards have been well described. coupling the reported benefits of prone positioning in covid-19 associated ards patients with the known beneficial effects of early prone-positioning in the treatment of ards, it is not surprising that many hospital systems are advocating prone positioning for treatment of ards in patients with covid-19. however, as the pandemic continues to progress in the united states and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. therefore, therapies that prevent the need for mechanical ventilation are desperately needed. given the distinct benefit that patients with covid-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * covid-19 positive by nasopharyngeal swab or serostatus * use of supplemental oxygen or respiratory rate ≥ 20 exclusion criteria: * bmi ≥ 45 kg/m2 * pregnancy * chest tube placement * hemodynamic instability with mean arterial pressure \< 60 mmhg * thoracic or abdominal wounds * chest wall deformities * vertebral column deformities that would preclude prone positioning * facial trauma or surgery in the last 30 days * established diagnosis of interstitial lung disease * prior single or double lung transplant * surgery for spine, femur, or pelvis in the last 3 months * thoracic or cardiac surgery in the last 30 days * pacemaker placement last 7 days

Keywords: covid19 pneumonia prone positioning covid
vaginal estradiol tablets (vagifem®) and endometrial cancer risk in the treatment of postmenopausal vaginal atrophy

Conditions: Postmenopausal Vaginal Atrophy

Summary: the study will include data from a nationwide danish cohort of postmenopausal women and the united states of america (us) cohort of postmenopausal women. the danish nationwide cohort will be established through linkage of danish national patient registries. the us cohort will be established based on data from us claims database, truven. the aim of this study is to evaluate whether exposure to vagifem® increases the rate of endometrial cancer in postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. female 2. age 50-75 years at entry exclusion criteria: 1. endometrial cancer prior to entry 2. any use of vaginal estrogen products prior to entry 3. hysterectomy prior to entry
an evaluation of potential next-day residual effects of eszopiclone in healthy volunteers.

Conditions: Healthy Subjects; Sleep Initiation and Maintenance Disorders

Summary: this study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects providing written informed consent. exclusion criteria: * significant medical disorders; * sleeping difficulties; alcohol and/or substance abuse; * recent use of psychotropic medications, or need to use them during study; * very high bmi or very low bmi or bodyweight; * known hypersensitivity to the study medications or their excipients; * unwilling or unable to meet certain lifestyle or dietary restrictions during the study.

Keywords: zopiclone hypnotic residual effects eszopiclone