Kornimate/medical-research-clean huggingface dataset:
bacterial intestinal gut modification around cancer surgery (big macs) diet

Conditions: Dysbiosis; Sarcopenia; Colon Cancer

Summary: the long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. this pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. the study hypothesizes that the bacterial intestinal gut modification around cancer surgery (big macs) diet will provide participants with increased microbiota accessible carbohydrates (macs) to support the microbiome and improve outcomes.


Eligibility criteria:
inclusion criteria: * age 25-70 years * primary diagnosis of colon cancer, stages 1-3. * able and willing to provide informed consent. * english-speaking. * willingness to return to the study site for specified study visits at d7 and d30. * able to comply with study measures. exclusion criteria: * age ≤ 25 years or ≥70 years * if surgery is being performed for any reason other than resection of colon cancer. neoadjuvant therapy, or if surgery is not the initial approach for the patient's colon cancer treatment * significant anemia (hemoglobin 1.0 g/dl or more below normal range) or history of coagulopathy: any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000. * serum creatinine greater than 1.5 mg/dl. * serum total bilirubin greater than the upper limit of normal in the absence of gilbert's syndrome or alkaline phosphatase or alt or ast greater than 2.5 times the upper limit of normal. elevated inr (1.5 or above). * alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men. * history of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery, or splenectomy, or gastric bypass. * history of intra-abdominal sepsis. * previous organ transplantation. * self-reported hiv-positive status, active tuberculosis, active malaria, chronic hepatitis b or c, cirrhosis, or inflammatory bowel disease. * currently pregnant or nursing. * history of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years. * active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. * depression: a ces-d score more than 16 and a psychologist determining that the patient is not a good fit for surgery. * body mass index (bmi) \&lt;20 or \&gt; 40 kilograms per meter squared: obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. inferences may be made by matching participants with less severe obesity (bmi \&lt;40). * presence of any type of non-mri compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware * self-reported history of claustrophobia. * incarceration * inability to adhere to the study protocol, procedures, and diet * exclusions may also be made at the discretion of the attending physician.
radiofrequency ablation after total knee arthroplasty

Conditions: Chronic Knee Pain

Summary: the purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. eligible individuals over 18 years of age in general good health apart from their chronic knee pain 2. at least one year post-tka 3. report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months" 4. in an unacceptable symptom state classified using a validated question: "think about all consequences of your arthroplasty in the last week. if you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?" 5. willingness to complete all the study procedures, including a daily pain nrs, ae, and medication usage questions via daily notification 6. subjects must have read and understood the informed consent form (icf), and must have signed and dated it prior to any study-related procedure being performed exclusion criteria: 1. pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) 2. women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in section 5.3.1 during the study period 3. significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon 4. individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated knee pain map 5. individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice 6. participation in a clinical research trial that included the receipt of an investigational product (ip) or any experimental therapeutic procedure within 30 days prior to the screening visit, or planned participation in any such trial 7. use of anticoagulants and inability to withhold for three days prior to the study rfa procedure with clearance by the prescribing physician 8. other conditions that, in the opinion of the investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
a retrospective observational study comparing two different treatment options in thyroid cancer patients with t4 tumours

Conditions: Thyroid Cancer

Summary: the study is to demonstrate non-inferior thyroid remnant first ablation success of thyrogen and 131i compared to thyroid hormone withdrawal (thw) and 131i in patients with t4 tumour based on historical diagnostic whole body scan (dxwbs) records.


Eligibility criteria:
inclusion criteria: historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation: 1. male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer. 2. diagnosed with a well-differentiated t4 tumour (defined as a primary tumour of any size that extends beyond the thyroid capsule \[this may be referred to as tnm classification t4, n0-1, m0-1\]). this excludes unusual histological types such as oncocytic (hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid cancers. 3. undergone a near-total or total thyroidectomy on or after 01 january 2000 4. undergone first ablation of thyroid remnants with high activity 131i (≥28 mci or ≥ 1.036 gbq). 5. undergone first 131i ablation for the t4 tumour using either thyrogen (0.9 mg im on 2 consecutive days) or thw stimulation. this excludes use of non-standard thyrogen regimens (i.e., had a regimen of thyrogen other than the standard 0.9 mg im on 2 consecutive days or received thyrogen in combination with thw). 6. historical records are available confirming ablation results by: * dxwbs using small activity (≥2 mci or 74 mbq) of iodine 131i (or 123i) performed at least 6 months after administration of the first ablation activity of 131i and/or * stimulated tg measured at least 6 months after administration of the first ablation activity of 131i. exclusion criteria: historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation: 1. received propylthiouracil, methimazole, vitamins or supplements containing kelp or iodine (taking a multivitamin that does not contain iodine or kelp is acceptable), medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium in the 45 days before administration of first ablative activity of 131i. 2. received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131i administered. 3. used amiodarone within the 2 years prior to first ablative activity of 131i administered.
fraction dose escalation of hypo-fractionated radiotherapy in lansclc

Conditions: Locally Advanced Lung Carcinoma

Summary: this phase 1 trial aimed to determine the maximum tolerated fraction dose (mtd) of hypofractionated radiotherapy (hypo-rt) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cici) for patients with locally advanced non-small cell lung cancer (la-nsclc).


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer confirmed by histology. * tumor size is measured according to recist standard. * unresectable stage iiia (n2) and iiib/iiic, confirmed by pet-ct/or chest and abdomen ct, brain mri, and whole body bone scan. * 18-75 years old, regardless of gender. * the ecog score is 0-1. * newly treated or underwent neoadjuvant chemotherapy and/or immunotherapy. * have not received chest radiotherapy in the past. * serum hemoglobin ≥10 mg/dl, platelets ≥100000/μl, absolute neutrophil count ≥1500/μl. * serum creatinine ≤1.25 times unl or creatinine clearance ≥60 ml/min. * serum bilirubin ≤1.5 times unl, ast (sgot) and alt (sgpt) ≤2.5 times unl, alkaline phosphatase≤ 5 times unl. * fev1\>1 l. * cb6 normal range. * the patient and his family members agree and sign an informed consent form. exclusion criteria: * other malignant tumors in the past or during treatment, except for non-melanoma of the skin or carcinoma in situ of the cervix. * any other diseases or conditions are contraindications to chemotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). * pregnant or breastfeeding women, women who have not undergone a pregnancy test (within 14 days before the first dose), and pregnant women. * those who are pregnant, breastfeeding or have fertility but have not taken contraceptive measures. * people with bleeding tendency. * those who participated in other clinical trials within 30 days before participating in this experiment. * drug addiction, long-term alcoholism, and aids patients. * people with uncontrollable seizures or loss of self-control due to mental illness. * people with a history of severe allergies or specific physique. * the researcher believes that the patient is inappropriate to participate in this trial. exit criteria * the treatment cannot be carried out in accordance with the requirements of the research protocol; * the patient has an allergic reaction ≥ grade 4 or a serious adverse reaction to the study drug; * the patient is pregnant or has not used adequate contraceptive measures; * the researcher judges that the patient should not continue to participate the clinical trial; * the subject asked to withdraw.

Keywords: locally advanced non-small cell lung cancer definitive hypofractionated chemoradiotherapy fraction dose escalation consolidation immunotherapy
evaluation of a smartphone based optical diagnostic tool for neonatal jaundice

Conditions: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Summary: neonatal jaundice is a common and most often harmless condition. however, when unrecognized it can be fatal or cause serious brain injury. three quarters of these deaths are estimated to occur in the poorest regions of the world. the treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. the crucial point in reducing the burden of disease is therefore to identify then children at risk. this results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice. based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. this prototype will be evaluated in a clinical trial in two hospitals in norway. a smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. the results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.


Eligibility criteria:
inclusion criteria: * born in st.olavs hospital, trondheim or in akershus hospital, oslo, norway * born at term * normal birth weight exclusion criteria: * in need of advanced medical treatment

Keywords: diagnosis cell phones infant, newborn
study of ravulizumab in pediatric participants with primary igan

Conditions: IgAN; IgAVN; Immunoglobulin A Nephropathy; Immunoglobulin A Vasculitis Associated Nephritis; Henoch-schonlein Purpura Nephritis; IgA Vasculitis

Summary: the primary objective of this study is to characterize the pharmacokinetics (pk) and pharmacodynamics (pd) of treatment with ravulizumab iv in pediatric participants to support the extrapolation of efficacy from the adult population.


Eligibility criteria:
inclusion criteria: * participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent. * stable and maximum allowed or tolerated rasi (acei and/or arb) dose for ≥ 3 months prior to screening with no planned change during screening through week 106. * upcr ≥ 0.5 g/g from the mean of 3 first morning voids (fmv) collected within 1 week during the screening period * estimated gfr ≥ 30 ml/min/1.73 m2 during screening * meningococcal infection vaccine * haemophilus influenzae type b and streptococcus pneumoniae vaccine exclusion criteria: * diagnosis of rapidly progressive glomerulonephritis * secondary forms of igan not in the context of primary igan or igav * concomitant clinically significant renal disease other than igan or igavn * uncontrolled diabetes mellitus with hba1c \> 8.5% * history of kidney transplant or planned kidney transplant during the primary evaluation period. * history of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant * splenectomy or functional asplenia * participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to screening. * hemolytic uremic syndrome diagnosed any time prior to screening. * planned urological surgery expected to influence kidney function within the study time frame. * congenital immunodeficiency * active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment * received biologics for the treatment of igan or igavn ≤ 6 months prior to screening

Keywords: ravulizumab igan igavn pediatric proteinuria glomerulonephropathy immunoglobulin a nephropathy immunoglobulin a vasculitis associated nephritis
using multifamily groups to improve self-management of type 2 diabetes

Conditions: Type2 Diabetes

Summary: the overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for mexican americans with type 2 diabetes. the project incorporates four evidence-based, culturally tailored treatments using a sequential, multiple assignment randomized trial to help determine what sequence of intervention strategies work most efficiently and for whom.

the project evaluates four culturally adapted, family-based treatments designed to improve health status, self-management behaviors and self-efficacy among mexican-americans with type 2 diabetes using a sequential, multiple assignment randomized trial in a public health setting. in the first phase of the study, subjects will be randomly assigned to six 2.5 hour sessions (three months) of either: 1) tomando control de su diabetes (tc), a culturally tailored, community-based, diabetes self-management program delivered in a group format by community health workers (promotoras) working with individual patients and families; or 2) tc delivered by health professionals (licensed nurses). evaluations will be made at baseline, three months, six months and 12 months. after six weeks of treatment (at the midway point of the intervention), subjects will be assessed for improvement in diabetes self-management behaviors (the primary outcome). in the second phase of the study, those subjects who have improved their diabetes self-management behaviors by 50% over baseline will be continued in their assigned treatment for the duration of three months. those subjects who do not meet this target will be re-randomized to receive either: 1) an augmented version of tc that has a specific focus on engaging family members; or 2) a multifamily group treatment led by nurses specially trained in teaching diabetes self-management skills for an additional three months.

Eligibility criteria:
inclusion criteria: 1. mexican origin and speaks spanish fluently 2. age 18 years or older 3. medical chart diagnosis of type 2 diabetes 4. living with at least one adult family member who is willing to participate. exclusion criteria: 1. diagnosis of type 1 diabetes 2. participation in another diabetes self-management education program within the past 12 months 3. pregnancy 4. significant cognitive impairment.
optimizing patient usability experience for chronic care

Conditions: Chronic Disease

Summary: the study aims to develop a module of an ehealth platform, do a feasibility study through a pilot cluster randomized control trial and assess the scalability of the solution.

multimorbidity increases care needs and primary care use among people with chronic diseases (1). the concerto health program (chp) has been developed to optimize chronic disease management in primary care services. however, in its current version, the chp primarily targets clinicians and does not aim to respond directly to the needs of patients and their informal caregivers for chronic disease management . this project aims to develop, implement and evaluate a user-centered, multifunctional and personalized ehealth platform (concerto+) to promote a more active patient role in chronic disease management and decision-making through three phases. for phase1: a first prototype will be developed by the design and technology teams, in close collaboration with researchers, health professionals and patient representatives who will identify the functionalities to include in the concerto+ solution. the phase 2 of the project will consist in a feasibility study based on a pilot cluster randomized clinical trial (c-rct) where patients with chronic diseases from a primary healthcare practice will receive concerto+ and be compared to patients from a control practice receiving usual care. for phase 3, the analysis of concerto+ potential for scaling-up will be done by documenting factors and conditions associated with the sustainability and scaling-up of the solution. to do so, the investigators will conduct: 1) two focus groups with patients and informal caregivers who participated in the study (one with the experimental group and one with the control group, each group gathering between eight and twelve participants); 2) semi-structured individual interviews with health professionals at the two study sites, as well as with health care managers, information officers, and representatives of the ministry of health and social services.

Eligibility criteria:
inclusion criteria: * having one or more targeted chronic diseases (diabetes, hypertension, dyslipidemia) * had 3 or more visits in the last 12 months * having an interest in health and technologies, * be able to read and speak in french exclusion criteria: * majors whose incapacity has been recognised judically

Keywords: diabetes hypertension dyslipidemia
bacterial pathogens associated with community-acquired pneumonia in children

Conditions: Children Chest Infection

Summary: pediatric community acquired pneumonia (cap) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features. this study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in dakahlia governorate.


Eligibility criteria:
- inclusion criteria: * infants and children aged 28 days to ten years (male and female sexes). * patients diagnosed with community-acquired pneumonia. * pneumonia was diagnosed if the patient fulfilled has fever (temperature ≥38.3° c), fast breathing (40 breaths per minute if the child is 1 year up to 10 years old), respiratory distress (tachypnea, retractions) and chest indrawing and cyanosis with compatible chest x-ray findings. exclusion criteria: * neonates * children more than 10 years * hospital acquired pneumonia * chronic lung disease, immunodeficiency and other congenital anomalies
candesartan versus propranolol for migraine prevention

Conditions: Migraine Without Aura; Migraine With Aura; Chronic Migraine

Summary: the main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.

candesartan was shown to be effective for migraine prophylaxis in a randomized double blind cross-over study published in 2003. the drug is now widely used for this purpose in many countries, although no confirmatory study has been published. the aims of the present study are: 1) to see if the results in the first candesartan study can be replicated in a new patient population, including patients with chronic migraine, and, 2) to perform a head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160 mg slow release. we also intend to study whether responsiveness to these drugs may be related to heart rate variability and baroreceptor sensitivity.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * retrospectively have ≥ 2 migraine attacks per month during the last 3 months * during the baseline period have ≥ 2 migraine attacks * debut of migraine at least one year prior to inclusion * start of migraine before age 50 years. exclusion criteria: * interval headache not distinguishable from migraine * chronic tension-type headache or other headache occurring on ≥ 15 days/month * pregnancy, nursing or inability to use contraceptives * heart conduction block on ecg or significant ecg abnormality on inclusion * heart rate \< 54 after 3 minutes rest * previous or present asthma, diabetes; decreased hepatic or renal function * hypersensitivity to active substance * history of angioneurotic edema * significant psychiatric illness * use of daily migraine prophylactics less than 4 weeks prior to start of study * having tried ≥ 3 prophylactic drugs against migraine during the last 10 years * previous use of propranolol or candesartan in adequate doses * previous discontinuation of either atacand or inderal retard (or another beta blocker) due to side effects * current use of antihypertensive medication * require use of rizatriptan (maxalt) 10 mg tabl. * subjects requiring detoxification from acute medication (ergotamines, opioids) * patients who consistently fail to respond to any acute migraine medication * patients with alcohol or illicit drug dependence