Kornimate/medical-research-clean huggingface dataset:
a trial to assess the efficacy and safety of morinidazole in patients with appendicitis

Conditions: Appendicitis

Summary: to assess the efficacy, safety, tissue distribution of target organ and population pharmacokinetic (ppk) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis

acute appendicitis is among the most common cause of acute abdominal pain. in patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. the sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. morinidazole, a national class i antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole. morinidazole and sodium chloride injection used in pelvic inflammatory disease or appendicitis cases had been approved by cfda in 2014. this phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and population pharmacokinetic (ppk) of morinidazole in patients with suppurative or gangrenous appendicitis.

Eligibility criteria:
inclusion criteria: * 18 and 65 years old * a diagnosis of suppurative or gangrenous appendicitis based on: 1. metastatic right lower abdominal pain 2. lower abdominal tenderness and/or rebound tenderness 3. pyrexia (axillary temperature ≥ 37.5 °c), a wbc \> 10\*109/l on routine blood examination 4. voluntary signing of written informed consent exclusion criteria: * patients with an allergy to nitroimidazole * patients with a history of antibiotic therapy within the last 48 hours * patients with any condition likely to require broad spectrum antibiotics * patients who can not evaluate the efficacy or difficult to complete the desired course of treatment * alt and / or ast ≥ 1.5 times the uln, and / or serum creatinine ≥ the uln * patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy) * patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug * patients who participated other clinical trials within 6 months before the start of the trial * pregnant women, breastfeeding women, women of childbearing age without effective contraceptive
a pilot study to assess the glucose lowering effect of metformin and sitagliptin in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with type 1 diabetes.

* the study will include a total of 4 visits. the time period between the very first visit and the very last visit will be between 10 and 15 weeks. each participant will be randomized to one of the 3 groups in the study. the groups are as follows: * group 1: insulin and sitagliptin * group 2: insulin and metformin * group 3: insulin and combination of sitagliptin and metformin * the study is a randomized open label design. all subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. at the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). the total duration on study medication will be 6 weeks. all subjects will undergo a baseline mixed meal tolerance test (mmtt) in their standard or usual insulin each subject will undergo a total of two studies. blood draws will be necessary.

Eligibility criteria:
inclusion criteria: * age of 13 to 18 years * hba1c \>7.5% but \<10% * subjects must be on intensive insulin management * tanner stage greater than or equal to 4 * must have t1dm for at least one year , t1dm defined by ada criteria and having at least one of the following antibodies: anti-gad, anti-islet, anti-insulin * c-peptide \> 0.6 ng/ml exclusion criteria: * type 2 diabetes * history of any other chronic condition (except hypothyroidism stable on medications) * actively taking medications that may affect glucose excursions (steroids or oral contraceptives) * evidence of anemia, clinically significant elevation of the liver enzymes (3 x normal), amylase or lipase (2 x normal), abnormal triclycerides (3 x normal), abnormal renal function test * an unsupportive family environment and pregnant or lactating females

Keywords: adolescents
transcutaneous magnetic spinal cord stimulation for freezing of gait in parkinson's disease

Conditions: Gait Disorders, Neurologic

Summary: dopaminergic drugs partially alleviate gait problems in parkinson's disease, but the effects are not sustained in the long-term. particularly, the freezing of gait, balance problems and other gait issues directly impacts patients' quality of life. experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among pd patients, but the effects of non invasive stimulation have never been explored.

the present study is a randomized, double-blind, placebo-controlled, parallel, phase ii clinical trial that will assess the efficacy and safety of transcutaneous magnetic spinal cord stimulation in pd patients who have gait and balance changes refractory to dopaminergic therapy.

Eligibility criteria:
inclusion criteria: 1. men and women (not pregnant) aged between 21 and 80 years old; 2. participants with idiopathic parkinson's disease in hoehn yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the msd scale -updrs \["gait and balance"\]). the participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the msd-updrs scale - "freezing"). patients should experience the above symptoms even though they are optimized from the medication point of view. the criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. the presence of freezing will be confirmed through a specific scale (fog score). 3. mini-examination of mental status greater than or equal to 24 points; 4. able to give informed consent in accordance with institutional policies; 5. able to meet all testing and monitoring requirements, as defined by the study protocol; exclusion criteria: 1. patients with unstabilized psychiatric comorbidities 2. impossibility to consent to your participation in the study. 3. patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease). 4. concomitant treatment with other experimental drugs. 5. pregnant or breastfeeding women. 6. presence of chronic pain in the lower limbs. 7. patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for parkinson's disease (off-medication).
spectroscopic evaluation of middle ear infection

Conditions: Middle Ear Infection

Summary: otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. researchers can use led-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

the research can use low energy led signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. these measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Eligibility criteria:
inclusion criteria: 1. male/ female at all age- newborn to adult. 2. non- pregnant woman. 3. diagnose of middle ear infection and plan for surgery procedure. exclusion criteria: 1. pregnant woman 2. incompetent adults (i.e. individuals with cognitive impairment) 3. no diagnose of middle ear infection and no plan for surgery procedure. 4. adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Keywords: middle ear infection
effects of inhaled corticosteroids on sputum bacterial load in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: exacerbations are important events in the natural history of chronic obstructive pulmonary disease (copd). beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing. either alone or in combination with viruses, airway bacterial load in stable copd correlates with both the frequency of exacerbations and the decline in lung function. a long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ics) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute copd exacerbations in copd. in a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable copd. in this study, virtually all patients (93%) were treated with ics. this study is designed to evaluate whether long-term (1 year) ics treatment increases viral and/or bacterial load in the sputum of copd patients.


Eligibility criteria:
inclusion criteria: * sixty stable moderate copd patients (global initiative for chronic obstructive lung disease (gold) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines. * gold stage 2 copd patients will be enrolled providing they were steroid-free for the last 4 months exclusion criteria: * atopy * asthma * concomitant lung diseases (e.g. lung cancer) * acute infections of the respiratory tree in the previous 3 months including copd exacerbation.

Keywords: copd bacteria virus inhaled corticosteroids
ican symptoms duke-nus

Conditions: Breast Cancer

Summary: the purpose of this study is to conduct a pilot randomized controlled trial (rct) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (cbt) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with advanced stage breast cancer in singapore and the us.

up to two-thirds of women with advanced breast cancer experience significant symptom burden (e.g., distress, pain, fatigue), yet these symptoms are not adequately addressed. cognitive behavioral therapy (cbt) protocols designed to teach patients strategies to improve their symptom management may be helpful in alleviating multiple symptoms. the efficacy of cbt protocols for reducing distinct symptoms in early-stage breast cancer has been shown in western countries; however, the role of cbt protocols for multiple symptoms in late-stage cancer is less clear. this study aims to investigate the feasibility and acceptability and obtain estimates of efficacy of a novel, cross-cultural multi-symptom (i.e., anxiety and depression, pain, fatigue) cbt protocol in advanced breast cancer patients. a randomized controlled design will compare patients receiving the cbt protocol to a waitlist control condition in both singapore and united states patients. the goal of this collaborative effort is to determine the scalability of the cross- cultural intervention. this irb protocol only represents the duke us portion of the project; duke-nus will obtain their own irb approvals.

Eligibility criteria:
inclusion criteria: * being at least 21 years of age * a diagnosis of stage iv breast cancer * being able and willing to attend study appointments * being able to speak/read english * estimated survival of at least 3 months. exclusion criteria: * they have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records * if visual, hearing, or cognitive impairment will interfere with intervention.
maternal problem-solving in childhood cancer

Conditions: Stress; Cancer

Summary: the purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

the purpose of this study is: 1. to develop a time-and-attention control condition to better assess the direct and mediational effect of psst independent of social support (placebo); 2. to develop a personal digital assistant hand-held supplement to standard psst to provide real-time training, reinforcement, and on-the-spot documentation of psst usage; 3. to develop independent measures of the application of problem-solving strategies in everyday life; and 4. to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of psst.

Eligibility criteria:
inclusion criteria: * mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact. exclusion criteria: * mothers of children with cancer if they do not read or speak english or spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.

Keywords: childhood cancer intervention maternal coping problem solving skills anxiety cope problem solving
the effect of education on vaginal effects of menopausal women

Conditions: Menopause; Aging; Failure of Genital Response

Summary: the aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress. it is a pretest-posttest randomized controlled experimental study. the universe of the research; it consisted of menopausal women over the age of 45 who attended courses at özgecan cultural center and binevler social facility in gaziantep. the sample of the research consisted of 102 people determined by the gpower method and determined by simple random method among all women who volunteered to participate in the study. introductory information form, daily effect of vaginal aging scale, sexuality avoidance decision balance scale and sexuality avoidance self-efficacy scale, female sexual distress scale were used to collect the research data. . the data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.

menopause is an inevitable event in every woman's life. this is a period in which women adapt to physical, emotional, mental and hormonal changes in their lives. during this process, the woman's menstrual cycle is permanently interrupted. the aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress. it is a pretest-posttest randomized controlled experimental study. this research was conducted between october 2023 and december 2023 with menopausal women over the age of 45 who attended courses at özgecan cultural center and binevler social facility in gaziantep. the universe of the research; it consisted of menopausal women over the age of 45 who attended courses at özgecan cultural center and binevler social facility in gaziantep. the sample of the research consisted of 102 people determined by the gpower method and determined by simple random method among all women who volunteered to participate in the study. introductory information form, daily effect of vaginal aging scale, sexuality avoidance decision balance scale and sexual avoidance self-efficacy scale, female sexual distress scale were used to collect the research data. . the data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.

Eligibility criteria:
inclusion criteria: * being able to understand what you read * being in menopause * continue throughout education * being 45 years or older exclusion criteria: * being under 45 * having a mental problem * not being in menopause * not attending one of the training sessions
effect of prehabilitation protocol on quality of life after thoracoscopic surgery

Conditions: Thoracoscopy; Prehabilitation

Summary: video-assisted thoracic surgery (vats) is a new approach used in cardio thoracic surgery department instead of thoracotomy to treat several diseases.patients underwent thoracoscopic surgery without organized educational protocol either before or after the procedure. therefore, this study will be the first clinical research which will increase patients' knowledge about thoracoscopy and decrease its complications.

the role of thoracic nursing specialty is to support and educate patients, who are suffering from thoracic diseases, to achieve the best outcome in terms of physical, psychological, social and spiritual well beings. the care provided not only focuses on in-hospital treatments that patient received, but also encompasses the whole patient journey including lifestyle modification, health concept promotion, self-empowerment and secondary prevention. preoperative prophylactic physiotherapy has been shown to be an important and effective approach in preventing or reducing postoperative complications, in addition to optimizing treatment by familiarizing the patient with the physiotherapeutic procedures. quasi experimental research design was utilized to conduct this study.sixty adult patients undergoing thoracoscopic surgery included and had the following criteria, the age ranged from 18-65 years old, both male and female. the patients divided into two equal groups (study and control groups), 30 patients for each. the study group received educational nursing protocol while the control group received the routine hospital care.

Eligibility criteria:
inclusion criteria: * patients who undergoing thoracoscopic surgery * age 18-65 year * patients who agree to participate in the study exclusion criteria: * converting to thoracotomy * patients refuse to participate

Keywords: thoracoscopy educational nursing protocol quality of life
the effect in renal function on patients with type 1 cardiorenal syndrome treated with two strategies of furosemide.

Conditions: Cardiorenal Syndrome

Summary: in double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.

in a patient with type 1 cardiorenal syndrome, we tried to compare two furosemide strategies: both with a morning bolus, and randomized in two groups: group a: furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * day 1 furosemide 100mg / day infused with 100cc of hartmann solution * day 2 furosemide 200mg / day infused with 100cc of hartmann solution * day 3 furosemide 300mg / day infused with 100cc of hartmann solution * day 4 furosemide 400mg / day infused with 100cc of hartmann solution group b: furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * day 1 furosemide 100mg / day infused with 100cc of hartmann solution + chlortalidone 50mg vo every 24 hours + spironolactone 50mg vo every 24 hrs. * day 2 furosemide 100mg / day infused with 100cc of hartmann solution + chlortalidone 50mg vo every 24 hours + spironolactone 50mg vo every 24 hrs. * day 3 furosemide 100mg / day infused with 100cc of hartmann solution + chlortalidone 50mg vo every 24 hours + spironolactone 50mg vo every 24 hrs. * day 4 furosemide 100mg / day infused with 100cc of hartmann solution + chlortalidone 50mg vo every 24 hours + spironolactone 50mg vo every 24 hrs. ution + chlortalidone 50mg vo every 24 hours + spironolactone 25mg vo every 24 hrs. with the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations.

Eligibility criteria:
inclusion criteria: * comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the kidney disease improving global outcomes (kdigo) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge. * have agreed and signed informed consent exclusion criteria: * patient in chronic dialysis either peritoneal dialysis or hemodialysis. * history of being a renal transplant recipient * history of acute kidney injury according to the kdigo 2012 guidelines and / or renal replacement therapy in the last 3 months * pregnancy * impossibility to administer medication by the oral route
registry for hypoparathyroidism wuerzburg

Conditions: Comorbidities and Coexisting Conditions; Morality; Hypocalcemia; Hypercalcemia; Quality of Life

Summary: long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. to further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a standardized interview as well as blood sampling and examinations such as echocardiography and renal ultrasound are performed.

design: in a longitudinal prospective trial the comorbidities, mortality, hypocalcemic and hypercalcemic events and quality of life in patients with chronic hypoparathyroidism will be evaluated by a standardized interview, blood sampling and further examinations such as echocardiography and renal ultrasound. patients: patients will be recruited out of the patient population of the university hospital wuerzburg. statistical analysis: documentation and analysis will be performed at the department of medicine i, endocrine and diabetes unit, university of würzburg, germany. data will be documented after pseudonymisation in a data base. for further analysis data will be compared to sex- and age-matched controls.

Eligibility criteria:
inclusion criteria: * age of 18 * chronic hypoparathyroidism (\>12 months) under established therapy or chronic pseudohypoparathyroidism (\>12 months) under established therapy * written informed consent exclusion criteria: * age \<18 years * no detailed documentation of hypo- or pseudohypoparathyroidism
primary vs. secondary anastomosis for hinchey stage iii-iv diverticulitis a prospective randomized trial

Conditions: Peritonitis

Summary: this study compares primary resection with anastomosis and hartmann's procedure in an adult population with acute perforated colonic diverticulitis (hinchey stage iii and iv) methods: the primary end point was postoperative mortality. secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

inclusion criteria: hinchey iii and iv diverticulitis

Eligibility criteria:
inclusion criteria: * patient with peritonitis du to sigmoid diverticulum complication * surgeon - anesthetist confirming the 2 surgeries can be performed exclusion criteria: * physical state which can not permit patient to participate * contraindication to surgery * non-diverticulum peritonitis