Kornimate/medical-research-clean huggingface dataset:
analysis of treatment outcome and toxicity in non-small cell lung cancer patients wither-irradiated to a high dose for recurrent disease

Conditions: Non-small Cell Lung Cancer

Summary: as one of the few centers, maastro also aggressively re-treats patients with recurrent non-small cell lung cancer. even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation. publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in maastro are unknown at present. this study will provide knowledge on benefit and risks of such a therapeutic approach.

maastro clinic is a leader in the (individual) management of patients with lung cancer. this has resulted in major publications in the past on individualized (chemo)radiotherapy for (nsclc) \[van baardwijk 2006 and 2010\]. as one of the few centers, maastro also aggressively re-treats patients with recurrent non-small cell lung cancer. even after primary radical treatment to high doses, re-irradiation is also given in curative intent, thus again using high doses of radiation. publications on this topic are rare. most reports address the results of palliative re-irradiation of nsclc \[ebara 2007, jackson 1987, montebello 1993, tada 2005\]. the ones available on re-irradiation with curative intent used outdated techniques \[okamoto 2002, wu 2003\]. only one recent publication has analyzed the results of 37 nsclc patients of whom 9 were re-irradiated with at least 50 gy using helical tomotherapy \[kruser in press\]. the results of radical re-irradiation applying highly conformal radiation techniques within maastro are unknown. this study will provide knowledge on benefit and risks of such a therapeutic approach. furthermore, it may provide enough evidence to initiate a phase ii/iii clinical trial for re-irradiation of nsclc patients with curative intent.

Eligibility criteria:
patients with advanced stage non-small cell lung cancer treated to higher doses of irradiation (i.e. eqd2\>50gy) twice: in the primary and recurrent setting.

Keywords: non-small cell lung cancer
clinical and radiographic outcomes of distal metatarsal metaphyseal osteotomy for central primary metatarsalgia

Conditions: Metatarsalgia Bilateral

Summary: the primary propose of this prospective study is to specifically evaluate the safety and effectiveness of minimally invasive distal metatarsal metaphyseal osteotomy (dmmo) in treating patients with persistent central primary metatarsalgia, associated or not to hallux valgus and lesser toe deformities, identifying possible contraindications in relation to some demographic parameters (age, gender, bmi, and smoking). the second objective is to verify the potential of dmmo in restoring a harmonious foot morphotype according to maestro's criteria and if these radiographic parameters are correlated with clinical outcomes, maintaining the predictive value of these criteria during preoperative planning also for this percutaneous surgery.

a consecutive series of patients with metatarsalgia is consecutively enrolled and treated by dmmo. according to maestro criteria, pre-operative planning is carried out by both clinical and radiological assessment. patient demographic data, aofas scores, 17-foot functional index, manchester-oxford foot questionnaire, sf-36, vas, and complications are recorded. maestro parameters, relative morphotypes, and bone callus formation are assessed. statistical analysis is carried out (p \< 0.05).

Eligibility criteria:
inclusion criteria: * forefoot persistent pain; * presence or not of forefoot plantar hyperkeratosis lesions; * ineffective conservative and orthotic treatment performed for at least 6 months. exclusion criteria: * arthritis and stiffness of mtp joint; * congenital deformities of the foot; * hallux rigidus; * freiberg infraction; * morton's neuroma; * diagnosis of rheumatic, metabolic, neurologic, infective, or psychiatric pathologies; * previous trauma; * foot and ankle surgery, * any form of secondary or iatrogenic metatarsalgia.
arm ergometer versus stabilization exercises on trunk control and upper extremity functions in cp

Conditions: Spastic Diplegia

Summary: the purposes of the current study are to: define and compare between the efficacy of arm ergometer versus stabilization exercises on trunk control, hand grip power and upper limb quality of functions in children with diplegia.

studies have shown that the cycle ergometer exercise improves several parameters, such as muscle strength and endurance, along with torso control in sitting position. however, these results are presented only in a small sample. studies with the use of cycle ergometer in the population with cp are still few and present little information about the physiological effects .previous studies on children with cp focused on the effect of ergometer on the upper and lower extremities functions. limited literature is available regarding the effect of arm ergometer on trunk control among this population. the current study will be carried out to define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip power, upper limb function in children with diplegia.

Eligibility criteria:
inclusion criteria: 1. age ranges from six to ten years. 2. grade of spasticity 1 to 2 according to modified ashworth scale. 3. level ii and iii according to gross motor functional classification system. 4. level i-iii according to manual ability classification system. 5. able to follow verbal commands and instructions included in both test and training. exclusion criteria: 1. significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination). 2. structural or fixed soft tissue deformities of the upper extremities. 3. neurological or orthopedic surgery in the past 12 months in the upper extremities. 4. botox injection in the upper extremities in the past 6 months.

Keywords: cerebral palsy / arm ergometer
integrated hypertension and diabetes mellitus type ii treatment and care among people living with hiv/aids

Conditions: Diabetes Mellitus; Hypertension; HIV Infections

Summary: this project was a facility-based program intervention for people living with hiv (plhiv) aged 18 years and above who attended a care and treatment center (ctc) in dar es salaam, tanzania. clients received preventive, diagnostic, and treatment services for hypertension (htn) and type two diabetes mellitus (t2dm). the primary health outcomes were all-cause mortality, disease-specific morbidity, htn, and t2dm control rates. secondary outcomes included access to care, retention in care adherence, and quality of care. results obtained can be used to strengthen non-communicable diseases (ncds) care delivery in hiv/aids care in ctc in tanzania.

a cohort of patients who were diagnosed with hypertension and diabetes was created and followed up for 6 months. patients were required to attend clinics on a monthly basis. at the first visit short interview using the stepwise approach of the steps surveillance tool for ncds from the world health organization (who) was conducted. on subsequent visits, hypertension and blood sugar levels and cholesterol levels will be measured and adherence to medication were assessed. the patient registry was developed following recommendations from the hearts (healthy lifestyle, evidence-based protocols, access to essential medicines and technology, risk-based cardiovascular disease (cvd) management, team-based care guidance systems for monitoring)technical package of who with some modifications if needed. a simple surveillance system was developed for all patients diagnosed with hypertension and diabetes so that there is continuous evaluation and monitoring of all patients attending ncds care at the hiv clinic.

Eligibility criteria:
inclusion criteria: all plhiv who attended ctc 18 years and above exclusion criteria: * pregnant women living with hiv/aids * patients with mental diseases.
the effect of insulin-induced hypoglycaemia on gut-derived glucagon secretion (px-hypo)

Conditions: Diabetes After Total Pancreatectomy

Summary: the overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.

the investigators want to assess the plasma glucagon response to insulin-induced hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether hypoglycaemia affects a range of other products from endocrine cells in the gastrointestinal tract including ghrelin, gastrin, cholecystokinin (cck), glucose-dependent insulinotropic polypeptide (gip), glp-1, glucagon-like peptide-2 (glp-2), oxyntomodulin and peptide yy (pyy). furthermore the investigators will evaluate how hypoglycaemia in these patients affects other counter-regulatory mechanisms including plasma responses of the hormones adrenaline, noradrenaline, growth hormone and cortisol as well as the rate of gastric emptying rate (which under normal circumstances accelerates during hypoglycaemia) during an oral glucose tolerance test (ogtt).

Eligibility criteria:
inclusion criteria: pancreatectomised patients * caucasian above 30 years of age who have undergone total pancreatectomy * blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females non-diabetic control subjects * normal fasting plasma glucose and normal hba1c (according to the world health organization (who) criteria) * normal blood haemoglobin * caucasian above 30 years of age * bmi (body mass index) 17-30 * informed consent exclusion criteria: pancreatectomised patients * pancreatectomy within the last 3 months * ongoing chemotherapy or chemotherapy within the last 3 months * previous or ongoing treatment with glp-1 receptor agonists or dipeptidyl peptidase 4 (dpp-4) inhibitors * inflammatory bowel disease * gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy * nephropathy (egfr\<60 and/or albuminuria) * known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>3 × normal values) * severe lung disease * pregnancy and/or breastfeeding * age above 85 years * uncontrolled hypertension and/or significant cardiovascular disease * any condition that the investigator feels would interfere with trial participation non-diabetic control subjects * diabetes or prediabetes (according to who criteria) * first-degree relatives with diabetes * inflammatory bowel disease * gastrointestinal resection and/or ostomy * nephropathy (serum creatinine \>150 µmol/l and/or albuminuria) * known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alat and/or serum asat \>3 × normal values) * severe lung disease * pregnancy and/or breastfeeding * age above 85 years * uncontrolled hypertension and/or significant cardiovascular disease * any condition that the investigator feels would interfere with trial participation

Keywords: glucagon
understanding allergies and sensitizations in healthy and allergic individuals

Conditions: Allergy

Summary: the purpose of this study is to strengthen our ability to accurately diagnose allergies and understand cellular, humoral, genetic components and physiological changes in allergic disease


Eligibility criteria:
inclusion criteria: * any individual with possible allergy exclusion criteria: * patients with special risks attendant to venipuncture will be excluded
changes in gene expression and prognosis of blood immune cells after cardiopulmonary bypass surgery

Conditions: Acute Kidney Injury

Summary: the goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.the main question it aims to answer is: what specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. participants received conventional treatment.


Eligibility criteria:
inclusion criteria: * 1) age≥ 18 years old; 2) cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery. exclusion criteria: * 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) have basic immune system and blood system diseases; 3) pregnancy; 4) receiving radiotherapy and chemotherapy before surgery; 5) receiving immunosuppressive drugs within six months; 6) have participated in other interventional clinical trials within 30 days before surgery. exit criteria: 1. incomplete surgery; 2. secondary transfer in the operating room; 3. automatically request to terminate the test.

Keywords: acute kidney injury cardiopulmonary bypass gene expression
treatment of severe and critical covid-19 pneumonia with convalescent plasma

Conditions: Covid-19

Summary: open label two arms, non randomized convalescent plasma treatment to severe and critical pneumonia covid-19 hospitlaized patients compared to a historical cohort with matched controls.

we will perform an open label two arms, non randomized trial giving convalescent plasma donated from recovered covid-19 patients with positive serology to severe and clinical pneumonia covid-19 patients admitted to the abc medical center.

Eligibility criteria:
inclusion criteria: donors: 1. age: \>18 and \<60 years 2. body weight : \>60 kg 3. confirmed previous sars cov-2 infection 4. negative sars cov-2 test result 5. 21 day without symptoms from the negative sars cov2 negative test 6. written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing. 7. positive covid-19 igg antibodies 8. male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for hla antibodies 9. individuals who meet all regular voluntary donor eligibility requirements by the mexican legislation. patients/recipients: 1. age: \>18 years 2. admitted to the abc medical center facility for the treatment of covid-19 3. patients with severe or critical covid-19 4. informed consent provided by the patient or healthcare proxy exclusion criteria: patients/recipients: 1. contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. any other not controlled infection 3. disseminated intravascular coagulopathy 4. patient under dialysis 5. patient with recent hemorrhagic stroke 6. severe ischemic heart disease -

Keywords: covid-19 pneumonia pandemic convalescent plasma
dissemination strategies and implementation outcomes of adolescent character strength interventions.

Conditions: Mental Health Disorder

Summary: the present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in kenya. this intervention, derived from a previously tested intervention named shamiri, or thrive in kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. this will be a one-arm trial with participants recruited from 20 secondary schools in nairobi, kiambu and makueni counties. the investigators estimate a sample size of 3000 youth, working on an intention to treat basis. all interested participants will be admitted to the program, with no exclusion criteria applied. the investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. further, the investigators will also assess the scalability and acceptability of the program post intervention. additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.

this is a dissemination study whose objective is to explore the effectiveness, acceptability, and scalability of the shamiri intervention when implemented in a large-scale naturalistic dissemination study in kenyan secondary schools. specifically, this study has two broad goals: 1) to test the effectiveness of shamiri on mental health and psychosocial outcomes when delivered naturalistically on a large scale through either a centralized and de-centralized (train the trainers) administration, and 2) to examine and measure outcomes of these large-scale dissemination models. for goal 1, participants will receive shamiri directly through the shamiri team or through an implementation partner. the investigators will measure mental health and psychosocial outcomes to determine if these outcomes compare to those reported in prior rcts of shamiri. the investigators hypothesize that participants receiving shamiri will experience similar improvements in mental health and psychosocial outcomes as reported in previous rcts. the investigators don't have a priori hypothesis on whether the mode through which the participants receive the intervention will affect intervention outcomes. to achieve goal 2, investigators measure the following implementation related outcomes: intervention fidelity, cost, sustainment, acceptability, penetration, and cost-effectiveness. the investigators hypothesize that the shamiri intervention will achieve high ratings in all intervention outcomes.

Eligibility criteria:
inclusion criteria: * participants must be high school students in one of the selected schools. * participants must be between the ages of 12 to 21. exclusion criteria: * there will be no other exclusion criteria.

Keywords: depression anxiety
single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function

Conditions: Postoperative Pain; Postoperative Nausea and Vomit; Postoperative Vocal Function; Thyroidectomy

Summary: the purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients undergoing thyroidectomy exclusion criteria: * patients who had received antiemetic therapy within 48 hours before surgery * patients with depression * chronic pain disorder * insulin-dependent diabetes mellitus * history of severe and/or repeated ponv after previous minor surgery, that led to change from standard anesthetic protocol * pregnancy * age \< 18 years * patients who had known malignant disease or had undergone previous thyroid or neck surgery
efficacy study of herbal formula cuf2 to treat childhood asthma

Conditions: Asthma

Summary: asthma is a long-term disease process with genetic, allergic, environmental, infectious, emotional and dietary influences. the symptoms control are mainly using an inhaled drug, avoiding triggers or taking preventive medicine. although side effects are unlikely at low dose of the asthma treatment, they have become apparent at the higher dose. due to safety concern, parents often turn to complementary and alternative medicine which they believe is natural and safe and may help to reduce the conventional medication dosage. there are number of reports that treatment with traditional chinese herbs or formulas resulted in significant improvement in lung function and reduction in the airway hyper-reactivity reaction. our study drug cuf2, was based on a classical formulae and had been proven to have anti-inflammatory and immunomodulatory activities in laboratory and animal studies. with the pre-clinical evidence, this study aims to determine the effect of cuf2 on improving the clinical symptoms, biochemical markers, and requirement of steroid dosage among children with asthma.

patients are recruited from 2 major governmental hospitals in hong kong (prince of wales hospital and tuen mun hospital),aged between 7 to 15 years with mild to moderate asthma according to the global initiative for asthma guideline, on regular inhaled steroid therapy and capable to perform a lung function test. however, those patients are excluded if they could not swallow capsules or had received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in the past 4 weeks. before study start, written informed consent will be obtained from each patient and one of their parents. the eligible patients will be randomly assigned to receive cuf2 or placebo capsules for 6 months. for the dosage, children aged above 12 years old, 3 capsules twice daily and under 12 years old, 2 capsules twice daily. during the 6 months period, below measurements will be taken: * the severity of asthma symptoms was assessed using a modified disease severity score (dss) * lung function test by spirometry (spiropro jaeger toennies, hoechberg, germany) * conventional medication consumption, according to gina/nih guidelines. * blood test, edta and clotted blood samples were taken at the baseline and end of the study for eosinophil counts, ige level and cytokine assay.

Eligibility criteria:
inclusion criteria: * persistent mild to moderate asthma * aged 7 to 15 years * on regular inhaled steroid therapy * able to perform reproducible spirometry exclusion criteria: * could not swallow capsules * received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in past 4 weeks

Keywords: traditional chinese medicine asthma paediatric
primary graft dysfunction score in lung transplantation

Conditions: Lung Transplant; Complications

Summary: the validity of several functional parameters, which could be included in a new pgd scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by picco) will be tested. insights will serve to generate a hypothesis (a novel pgd score), which can then be tested in future prospective trials.


Eligibility criteria:
inclusion criteria: * double lung transplantation for primary pulmonary hypertension (pph), fibrosis, cystic fibrosis (cf), emphysema * no restrictions regarding donor lungs (marginal donors, evlp possible) * no restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations) exclusion criteria: * single-lung transplantation * heart-lung transplantation * re-transplantation * patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), pa/la novalung, ilaactive, ila) * clinical situations leading to inaccurate picco measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling * no access to the femoral artery possible * severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary