Kornimate/medical-research-clean huggingface dataset:
comparison of intrathecal morphine with the quadratus lumborum type 2 block for post-operative analgesia following elective caesarean section (qlbvitm study)

Conditions: Cesarean Section; Pain, Acute

Summary: the investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

in australia the rate of birth via caesarean section (cs) has significantly increased over the last twenty years. improvements in the care of women undergoing cs are important locally, nationally and internationally. compared to women birthing vaginally, women undergoing cs experience more adverse events and more pain. effective pain relief following cs is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. traditional analgesic techniques following cs include opioid medications. whist effective, the use of opioids are associated with frequent and significant side effects. alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians. the quadratus lumborum block (qlb) block is an innovative regional analgesic technique. its role as an effective analgesic agent in abdominal surgery is increasing. however, it has not been studied for pain relief in australia after cesarean section. in this study, the investigator aims to compare post-operative analgesia and side effects between the qlb blocks versus adding morphine the participant's spinal anaesthetic (itm) during the elective c/s. results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.

Eligibility criteria:
inclusion criteria: * anaesthetist trained in qlb and itm techniques available * american society of anaesthesiologists ps category client i or ii * 18 years of age or older * ability to read and understand english * uncomplicated pregnancy at term (\>37 weeks completed gestation) * booked elective cs exclusion criteria: * contraindications to spinal anaesthesia * history of chronic opioid consumption / chronic pain conditions * known allergy to study drugs * weight more than 95kg or body mass index (bmi) more than 35 pre operative * placenta previa / accreta * obstructive sleep apnoea * severe asthma unable to tolerate non steroidal anti inflammatory agents

Keywords: intrathecal morphine quadratus lumborum type 2 block cesarean section pain
periodic continuous glucose monitoring in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this randomised controlled trial is to investigate the effectiveness of periodic cgm (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (smbg) in adults with type 2 diabetes on glucose control and patient reported outcomes.

this is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in sweden. periodic cgm group- intervention group: the participants in the intervention group will be provided with freestyle libre (abbott diabetes care). participants wear the sensor and check their glucose level for a period of 28 days (14 days x 2) during week 0-4 and week 10-13.patient's measurement data from the freestyle libre system 2 will be transferred to the onetwo analytics (dda) analysis tool for an automated analysis and this insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). the diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. this approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning. self-monitoring of blood glucose, smbg and usual care - control group the participants in the control group perform smbg testing as usual including fasting, pre- or post-prandial measurements. they also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.

Eligibility criteria:
inclusion criteria: * adults aged 18-80 years * type 2 diabetes with a duration of \> 6 months * hba1c 45-70 mmol/mol * have a smartphone * experience of self-monitoring of blood glucose prior to the study start exclusion criteria: * prandial insulin * pregnancy or planning pregnancy during the study * breastfeeding * renal disease with estimated glomerular filtration rate (egfr) \<45 ml/ min/1.73 m2 * active malignancy or under investigation for malignancy * severe visual impairment * severe skin allergy that inhibits the use of a continuous glucose monitoring device * glucocorticoids (systemic) * planned or currently using weight reduction medications, programs, or surgery * cognitively or psychologically unable to participate and read instructions * enrolled in other clinical trials * eating disorders

Keywords: cgm personcentered care
role of fexofenadine in diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: * this study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus. * patients will be recruited from internal medicine department, tanta university hospital, tanta, egypt. this study will be randomized, controlled, parallel, prospective clinical study. accepted patients will be randomized into 2 groups as the following * group 1 (control group): 30 patients will receive maximum tolerated dose of acei for six months * group 2 (fexofenadine group): 30 patients will receive maximum tolerated dose of acei plus fexofenadine tablets 60 mg once daily for six months the primary end point will be the change in urinary albumin to creatinine ratio (uacr) after six months of treatment


Eligibility criteria:
inclusion criteria: * males or females aged ≥ 18 years * confirmed diagnosis of type 2 diabetes mellitus at least 6 months prior to screening * stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (uacr) \>30mg/g) despite treatment with maximum tolerated dose of ace inhibitors for at least 8 weeks prior to the screening * hemoglobin a1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents exclusion criteria: * type 1 diabetes mellitus * severe renal impairment (egfr\< 30 ml/min/1.73 m2 at screening) * pregnant or lactating women * chronic heart failure * malignancy * inflammatory or autoimmune disease * history of kidney disease other than diabetic nephropathy
survey of cancer patients' perceptions of difficulties encountered when filling opioid prescriptions

Conditions: Malignant Neoplasm; Pain

Summary: this trial studies the problems that cancer patients face when filling prescriptions for opioids (medications that are used to manage pain). pain is one of the most common symptoms among cancer patients. opioid therapy is generally the treatment of choice for adequate management of cancer-related pain. knowledge of these problems may help health care providers assess the most effective treatment options for cancer patients, and inform policy makers of the adjustments that need to be made to regulations to ensure cancer patients don't lose their access to opioids.

primary objectives: i. to evaluate patients' perceptions of overall difficulties when filling their opioid prescription. secondary objectives: i. to determine cancer patients' perceptions of financial, logistical, and psychosocial difficulties when filling their opioid prescription. ii. to evaluate the association between patient characteristics and patient difficulty filling opioid prescriptions. outline: participants complete a survey over 5-10 minutes.

Eligibility criteria:
inclusion criteria: * patients must be on opioids provided by the supportive care center (scc), and must have visited the scc 2 previous times for the purpose of opioid pain management. this will ensure that 1) patients will have been told that they are being prescribed an opioid as a treatment for pain, and 2) patients will have gone to a pharmacy to fill their opioid prescription a minimum of one time. * patients must be able to understand, read, write, and speak english. * patients must sign an informed consent document. * patients must have a cancer diagnosis. exclusion criteria: * patients who have clinical evidence of cognitive impairment (memorial delirium assessment scale \[mdas\] score of \>= 13) as determined by the research staff, treating physician, or nurse. * patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff. * patients who refuse to participate in the study.
modified guarnieri-desarda technique versus lichtenstein technique in inguinal hernia repair

Conditions: Inguinal Hernia

Summary: the aim of this study is to compare the surgical outcome of both lichnichtien tension free mesh hernioplasty of inguinal hernia and the combined modified guarnieri desarda technique in terms of postoperative pain, post operative complications (seroma, hematoma, wound infection), chronic inguinodenia, early recurrence and assessment of testicular vascularity and size by application of a testicular duplex and ultrasound.


Eligibility criteria:
inclusion criteria: * adult male patients aged 18 years or older. * patients diagnosed with non-complicated inguinal hernia (both direct and indirect). * patients able to provide written informed consent to participate in the study. exclusion criteria: * patients younger than 18 years old. * patients with complicated hernias (e.g., inflamed, obstructed, or strangulated hernias). * patients with a recurrent inguinal hernia. * patients with weak or thin external oblique aponeurosis (intraoperative findings). * patients with a history of prior surgery in the inguinal region. * patients who refuse to participate in the study.

Keywords: inguinal hernia hernia repair guarnieri technique desarda technique lichtenstein hernioplasty
a study to compare the efficacy of gns561 versus standard of care in patients with sars-cov-2 (covid-19) infection

Conditions: COVID-19

Summary: this is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of gns561 in patients with covid-19.

patients will be treated either with oral gns561 plus standard of care or only standard of care. all patients in experimental arm will be treated for ten days. study drug will be provided as oral capsules containing 200 mg of gns561. patients will be followed-up during hospitalization and after discharge.

Eligibility criteria:
inclusion criteria: * documented diagnosis of covid-19 (diagnostic test performed in a certified laboratory). * clinical status: hospitalized for moderate covid-19 with news2 score between 5 and 6 exclusion criteria: * patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine). * history of qt prolongation (qtc ≥ 500 ms) or qtc ≥ 500msec at screening or bradycardia \< 50/mn * current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia \< 3.5mmol/l at screening * prior allogeneic bone marrow transplantation or solid organ transplant in the past. * pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.
shared decision making with breast cancer patients

Conditions: Shared Decision Making; Breast Neoplasms; Radiotherapy, Adjuvant

Summary: the aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

the risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (rt). on the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation. in the shared decision making (sdm) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. a patient decision aid (ptda) is instrumental in the sdm process. this study is a multicenter, national trial randomizing doctors to either use or not use sdm and a ptda when informing the patients about benefits and risks of receiving adjuvant radiotherapy. it is not expected that significantly less patients will receive radiotherapy as a consequence of sdm. the primary aim of the study is to evaluate whether patient engagement in decision making is affected by sdm and the use of an in-consultation ptda.

Eligibility criteria:
inclusion criteria: * histologically verified breast cancer or ductal carcinoma in situ breast cancer * candidate for adjuvant radiotherapy danish breast cancer group type f after breast-conserving surgery for t1-2, n0-nmi, m0 disease according to national guidelines. * signed confirmation of participation. exclusion criteria: * bilateral breast cancer or suspicion of disseminated cancer * unable to understand the information, the planned treatment or follow-up for any reason. * earlier radiotherapy towards the thoracic region.
conventional laparoscopic apr versus laparoscopic apr with transabdominal individualized levator transection

Conditions: Rectal Cancer

Summary: this study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (apr) and laparoscopic apr with transabdominal individualized levator transection (tilt).

in the field of surgical treatment for low rectal cancer, the traditional apr is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (elapr) is still hindered by its high risk of wound complications and neurovascular injuries. owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic apr with tilt procedure. during the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. this technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. this clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy. 2. patients undergoing elective, radial surgery with no distant metastasis. 3. patients with body mass index (bmi) between 18-30kg/m2. 4. patients who agree to undergo standard adjuvant treatment after surgery. 5. patients who have fully understood the aim of the trial and have signed the written informed consent. exclusion criteria: 1. patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors. 2. patients undergoing emergent surgery. 3. pregnant patients. 4. patients with tumors other than rectal tumor. 5. patients with severe comorbid diseases which preclude surgery. 6. patients in bad conditions and do not ameliorate before surgery. 7. patients undergoing other procedures to treat rectal cancer, eg. l-dixon, l-hartmann or parks surgery. 8. patients who refuse to accept standard adjuvant surgery.

Keywords: laparoscopic surgery abdominoperineal resection rectal cancer individualized surgery levator muscle
evaluation of vein of marshall ethanol infusion during left atrial linear ablation in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: in this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the aline protocol.


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 85 years * diagnosed with symptomatic af without previous mitral isthmus line ablation exclusion criteria: * previous mi line ablation * left atrial thrombus. laa thrombus can be determined by preprocedural imaging: ct, tee or mri. * la diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc. * left ventricular ejection fraction \<35%. * cardiac surgery within the previous 90 days. * expecting cardiac transplantation or other cardiac surgery within 180 days. * coronary ptca/stenting within the previous 90 days or myocardial infarction within the previous 60 days. * documented history of a thromboembolic event within the previous 90 days. * diagnosed atrial myxoma. * significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment * women who are pregnant or who plan to become pregnant during the study. * acute illness or active infection at time of index procedure * renal insufficiency * unstable angina. * history of blood clotting or bleeding abnormalities. * contraindication to anticoagulation. * life expectancy less than 1 year. * uncontrolled heart failure. * presence of a condition that precludes vascular access. * inr greater than 3.5 within 24 hours of procedure - for patients taking warfarin. * patient cannot be removed from antiarrhythmic drugs for reasons other than af. * unwilling or unable to provide informed consent.
cell samples from patients with leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. it may also help doctors find better ways to treat cancer. purpose: this research trial is studying samples from patients with leukemia.

objectives: * demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo. * confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo. * evaluate the effect of novel anticancer drugs and/or their combinations on individual samples. outline: this is a multicenter study. cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. after 1 hour of recovery at 28° c, embryos are maintained at 38° c and screened for fluorescence at the injection site. within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. proliferation of leukemia cells are monitored by live-cell microscopy. cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.

Eligibility criteria:
disease characteristics: * samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes: * chronic phase chronic myeloid leukemia (cml), to complement initial studies in the k562 cml cell line * acute promyelocytic leukemia (apl), to complement initial studies in the nb4 apl cell line * acute myeloid leukemia (aml) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric aml and is associated with good prognosis * aml expressing 5q- or monosomy 7, associated with a poor prognosis * aml expressing the fms-like tyrosine kinase 3 internal tandem duplication (flt3-itd), associated with a poor prognosis patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: chronic phase chronic myelogenous leukemia childhood acute promyelocytic leukemia (m3) childhood acute myeloid leukemia/other myeloid malignancies adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with del(5q) adult acute promyelocytic leukemia (m3)
diet and behavior in young children with autism

Conditions: Autism; Autistic Disorder

Summary: this study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

autism is a serious brain disorder that affects brain development and often causes social and educational problems. prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. this study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy. children in this study will be following a gluten free and casein free diet for 18 weeks. all subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. they also will be receiving uniform educational and behavioral services through their provider. standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. an end of study, follow-up assessment will be completed at 30 weeks after the start of the study.

Eligibility criteria:
inclusion criteria: * autism spectrum disorder or pervasive developmental disorder, adi-r and ados positive. * participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home * a score higher than 30 on the mullen early learning scale * ability to maintain a gluten- and casein-free diet during the study * in order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the rochester area

Keywords: autism applied behavioral analysis gluten casein
carboplatin periocular injection for retinoblastoma

Conditions: Retinoblastoma

Summary: this study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of retinoblastoma as compared to chemotherapy alone.

this study will be a phase ⅲ open label interventional case series. patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. patients will be followed for 24 months .

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study. * linical diagnosis of retinoblastoma, stage 0 or ⅱ base on international retinoblastoma staging system. exclusion criteria: * any previous disease in the study eye. * previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals). * history of chemical intervention for retinoblastoma in the study eye.

Keywords: retinoblastoma carboplatin