Kornimate/medical-research-clean huggingface dataset:
vegan vs aha diet on inflammation and glucometabolic profile in patients with cad

Conditions: Coronary Artery Disease; Inflammation

Summary: in this randomized study the investigators aim to determine the effects of a whole-food plant-based vegan diet on markers of inflammation and glucometabolic profile in patients with cardiovascular disease. the investigators hypothesize that a whole-food plant-based vegan diet will reduce markers of inflammation and improve glucometabolic profile compared with the american heart association (aha)- recommended diet at 2 months follow-up in patients with coronary artery disease (cad). the investigators are also evaluating endothelial function using the endopat device and stool microbiome.


Eligibility criteria:
inclusion criteria: * subjects on stable medical therapy for at least 7-10 days post-coronary angiography and found to have cad (defined as \>50% lesion in an artery with \>2mm caliber) . exclusion criteria: * failure of the treatment self-regulation questionnaire * use of steroids or non-steroidal anti-inflammatory medications other than aspirin * use of probiotics or over the counter supplements other than standard vitamins * have a history of myocardial infarction or active infection within the preceding 3 months * have a history of an eating disorder or colon cleansing or are already on a whole-food plant-based vegan diet * have a planned pci during the study period * are participating in a competing study * have any condition or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures
a study to assess change in disease state in adult participants with acute myeloid leukemia (aml) ineligible for intensive chemotherapy in switzerland and austria receiving oral venetoclax tablets

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. this study will evaluate how well venetoclax works to treat aml in adult participants who are ineligible for intensive chemotherapy in switzerland \& austria. venetoclax is a drug approved to treat acute myeloid leukemia. all study participants will receive venetoclax as prescribed by their study doctor in accordance with approved local label. adult participants with a new diagnosis of aml who are ineligible for intensive chemotherapy will be enrolled. around 120 participants will be enrolled in the study in approximately 15 sites in switzerland \& austria. participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. the duration of the study is approximately 24 months. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice and participants will be followed for 24 months.


Eligibility criteria:
inclusion criteria: * newly-diagnosed aml and eligible to receive venetoclax as per local label. * physician has decided to initiate venetoclax treatment. the decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study. exclusion criteria: - participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Keywords: acute myeloid leukemia venetoclax venclexta venclyxto abt-199 cancer
functional outcomes following limb sparing surgery for sarcoma patients

Conditions: Sarcoma

Summary: primary objectives: 1. to classify the types of wound healing complications that occur after pre-operative radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas of the extremity. 2. to evaluate the impact of each complication type on patient function and quality of life using the toronto extremity salvage score (tess).


Eligibility criteria:
inclusion criteria: 1. diagnosis of soft tissue sarcoma with histopathologic confirmation. 2. treatment protocol that includes pre-operative radiation therapy. 3. treatment protocol that includes limb-sparing surgical resection. 4. patient has received md anderson cancer center multidisciplinary care. 5. patient must be at least three years post-operative. exclusion criteria: 1. previous radiotherapy to the local site. 2. presence of regional or distant metastases. 3. major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

Keywords: soft tissue sarcoma limb sparing surgery toronto extremity salvage score radiotherapy quality of life questionnaire survey tess
clinical study for safety and immunogenicity study of influenza vaccine

Conditions: Influenza

Summary: the goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 ml dose. the aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. a total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 ml) at days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 ml) at day 1 and a standard dose (0.5 ml) at day 57; subjects of group 3 will receive a triple dose (0.5 ml) at day 1. local and systemic solicited adverse events up to day 4 after each vaccination will be documented. to assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (day 1), at the 4 subsequent monthly visits (months 1 to 4) and at month 12.

Eligibility criteria:
inclusion criteria: * healthy male and female adults * aged ≥ 18 to ≤ 50 years on the day of enrollment * written informed consent * female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * body weight below 40 kg at any visit during the study * acute febrile illness (≥ 38.0°c) * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥ 0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, hiv seropositivity) or cancer * known history of psychiatric diseases, particularly dementia * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial for the entire duration of this trial * employee at the investigational site or relative of the investigator * subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol

Keywords: influenza vaccination virosomal influenza vaccine
prospective cohort psoriasis follow-up (picasso)

Conditions: Psoriasis

Summary: the main purpose of the picasso-project is to facilitate future psoriasis-research in dermatology. this register biobank will enable us to perform research in the field of metabolomics, mrna-expression, cardiovascular impact and the microbiome. the final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

the picasso-project is a prospective register with extensive biobanking in which patients with a recent onset of psoriasis (\<3 years) can be enrolled. participants are followed for a period of 10 years, with scheduled visits every 2.5 years. the same protocol is followed for every visit. the registry captures patient demographics, medical history (personal and family), details of psoriasis treatment (previous and current), physical examination, disease activity scores and proms. some patients (substudy) will undergo ultra-sound to determine carotid intima media thickness. biobanking in this project encompasses extensive biosampling of multiple tissues. it is not within the scope of this project to administer study medication: patients receive standard of care treatment as prescribed by their physician.

Eligibility criteria:
inclusion criteria: * clinical signs of psoriasis since \>3 years * adults (70 years old or less) and children (\>12 years old) * willing and able to understand and sign the informed consent (plus legal representative in case of a minor) exclusion criteria: * unwilling or unable to understand and sign the informed consent * disease duration longer than 3 years
brachytherapy in treating patients with recurrent prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy radiation to damage tumor cells. brachytherapy uses radioactive material that is placed directly into or near the tumor. brachytherapy may kill more tumor cells. purpose: phase i/ii trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy.

objectives: i. determine the dosimetry and toxicity of interstitial colloidal phosphorus p32 (cp32) in patients with locally recurrent prostate cancer that has failed conventional therapy. ii. determine the maximum tolerated dose of interstitial cp32 when combined with interstitial macroaggregated albumin (infusional brachytherapy) in these patients. iii. determine the therapeutic response rate to acceptable single doses of cp32 in these patients. outline: this is a dose escalation study of colloidal phosphorus p32 (cp32). patients receive cp32 and macroaggregated albumin via interstitial infusion using ultrasound localization. cohorts of 3 patients receive escalating doses of cp32 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 2 of 4 patients experience dose limiting toxicities. additional patients are treated at the mtd. patients are followed at 1, 2, 4, and 6 weeks; then at 2, 4, 8, 12, 16, 20, and 24 months; and then every 6 months thereafter until death. projected accrual: a total of 20-25 patients will be accrued for phase i of the study and a total of 40 patients will be accrued for phase ii of the study.

Eligibility criteria:
disease characteristics: histologically proven locally recurrent prostate cancer that has failed conventional therapy (i.e., external beam radiotherapy, radioactive seed implants, and hormonal therapy) must be confirmed clinically with elevated psa and/or ultrasound prostates between 2-5 cm in diameter (i.e., volumes of 4-65 cm3) preferred prostates greater than 5 cm allowed, but 2 needles required for good distribution of study drug no clinical/radiographic evidence of metastatic disease no history of injury to urethra, bladder, or rectum patient characteristics: age: 21 and over performance status: not specified life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 neutrophil count at least 1,900/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9 g/dl (transfusion allowed) hepatic: not specified renal: blood urea nitrogen no greater than 25 mg/dl creatinine no greater than 1.5 mg/dl prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: see disease characteristics radiotherapy: see disease characteristics surgery: not specified

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer recurrent prostate cancer
stay-strong study of exercise training during chemotherapy

Conditions: Lymphoma, B-Cell; Lymphoma, Hodgkin; Exercise; Body Composition; Physical Functional Performance; Quality of Life; Sarcopenia; Muscle, Skeletal; Patient Reported Outcome Measures

Summary: this study evaluates the effectiveness of a supervised progressive resistance training program in patients malignant lymphomas with the primary outcome being lean body mass. the study is designed as a a single center, two-armed, parallel-group, investigator-initiated clinical randomized controlled superiority trail evaluating the effectiveness of a 4-month supervised progressive resistance training intervention compared to usual care.

new approaches of early rehabilitation are needed to maintain physical function levels in patients with malignant lymphoma patients during chemotherapy treatment. the stay strong trail has the potential to become the future model of care and rehabilitation with the prospect of reducing the complex symptom burden, supporting treatment tolerance, maintaining physical function and, by extension, improve the patient's chances of survival and quality of life. this study will be among the first to include structured and supervised progressive resistance training during the complete 1st line anthracycline-containing combination chemotherapy regime in patients treated with diffuse large b-cell lymphoma and hodgkin lymphoma. at present, there is a lack of knowledge regarding the potential effect of exercise to counteract muscle atrophy during chemotherapy in patients with malignant lymphomas. the overall aim of the present stay strong trail is to investigate whether a structured and supervised progressive resistance training program during the complete first line anthracycline-containing combination chemotherapy with support from an 'exercise ambassador' can preserve muscle function and prevent muscle dysfunction in patients newly diagnosed with diffuse large b-cell lymphoma and hodgkin lymphoma referred to first line treatment.

Eligibility criteria:
inclusion criteria: * participants must: * be newly diagnosed with diffuse large b-cell lymphoma and hodgkin lymphoma * be expected to receive treatment with an anthracycline-containing combination chemotherapy at the department of hematology, rigshospitalet * be ≥ 18 years of age at the time of signing the informed consent form. * be residing in denmark * have an eastern cooperative oncology group (ecog) performance status score ≤ 2 * be able to speak and read danish, and to provide a signed informed consent form. exclusion criteria: * patients with: * clinically significant cardiovascular disease, including, but not limited to: heart failure nyha (new york heart association) class iii-iv, uncontrolled hypertension, and symptomatic cardiac arrhythmias. * psychiatric, neurological, or geographical conditions that could influence protocol adherence. * disorders that cause an inability to perform exercise training for one hour. * any other known malignancy requiring active treatment.
efficacy of zelpultide alfa in preterm neonates at high risk of developing bronchopulmonary dysplasia (bpd)

Conditions: Bronchopulmonary Dysplasia

Summary: the goal of this randomized, double-blind, parallel-group, phase 3 multicenter study is to determine if an investigational drug, zelpultide alfa, can reduce the occurrence of bronchopulmonary dysplasia (bpd) in extremely premature babies. the main objective is to compare the efficacy of zelpultide alfa added to standard of care (soc) versus soc plus placebo (air-sham) in terms of incidence of grade 2 and grade 3 bronchopulmonary dysplasia (bpd) and death in neonates at high risk for developing bpd. participants will be randomized 1:1 to the treatment (zelpultide alfa plus standard of care) or placebo (air-sham plus standard of care) arms . treatment will be administered intratracheally. participants will receive up to 7 administrations of zelpultide alfa at 6 mg/kg or air-sham in 24 h intervals while the subjects are still intubated per standard of care.


Eligibility criteria:
inclusion criteria: 1. born between gestational age (ga) 23 0/7 to 27 6/7 weeks, inclusive. 2. received at least 1 dose of soc-indicated animal-derived pulmonary surfactant treatment after birth. 3. intubated and on invasive mechanical ventilation per soc. 4. able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met. 5. informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s). exclusion criteria: 1. birth weight \ 1,500 g. 2. major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to: * clinically relevant potter-like syndrome and any pulmonary congenital anomalies, * clinically relevant congenital diaphragmatic hernia, * omphalocele or gastroschisis, esophageal atresia, * known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc). 3. active do no resuscitate (dnr) order in place. 4. history of allergy or sensitivity to any surfactant or any component of zelpultide alfa. 5. concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of soc or participation in studies within the last 30 days (or 5 half-lives of an imp) prior to birth (for the mother) or up to week 36 pma. 6. any condition or situation that, in the investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.

Keywords: bpd zelpultide alfa at-100
unintended home injuries in under-5 children in sohag governorate

Conditions: Unintended Home Injuries in Under-5 Children

Summary: child injuries are a major public health problem . globally, unintended injury is one of the top 15 causes of death across all age groups of children aged؛ 0-19 years, in children under the age of five, the majority of injuries occur in the home. injuries is a health concern in every country around the world, affecting both developed and developing countries, causing over 5.8 million deaths per year or 15,000 deaths per day . a who surveillance study conducted in four developing countries showed that egypt had a prevalence of 32 % of childhood injuries which was the highest one . the home is the place where children spend most of their time, the home environment is the most common place for childhood injuries

there is a lack of studies related to unintended home injuries in under-5 children in sohag governorate , unintended home injuries may result in temporary or permanent disability and requires medical attention and continuous care . a limited number of child home injuries lead to hospitalization , so hospital based studies may ignore small scale injuries which couldn't be registered. unintended home injuries may influence health, education, and family economy of the affected children. unintended home injuries is one of the preventable causes of child morbidity and mortality , so we should know the prevalence and factors predisposing to it . the aim of the study is to decrease morbidities and mortalities associated with unintended home injuries in under-5 children in sohag governorate by assessing prevalence and epidemiology of unintended home injuries in under-5 children in sohag governorate ,measuring extent of morbidities and mortalities associated with unintended home injuries in under-5 children in sohag governorate , determining factors predisposing to unintended home injuries in under-5 children in sohag governorate .

Eligibility criteria:
inclusion criteria: * the study will be conducted through personal interview with caregivers of under-5 children who accept to participate in it . exclusion criteria: * caregivers who refuse to participate in the study and caregivers of children who experienced intended home injuries will be excluded from the study.
effects of cognitive intervention therapy on postoperative delirium

Conditions: Spinal Stenosis; Disc Herniation; Lung Neoplasms; Carcinoma, Hepatocellular

Summary: this study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.


Eligibility criteria:
inclusion criteria: * elderly patients aged 65 and above. * patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more. * patients scheduled for arterial catheterization. exclusion criteria: * patients with uncontrolled systemic conditions such as diabetes and hypertension. * those with visual impairment. * patients with cognitive impairment based on the mmse-ds criteria. * individuals experiencing difficulty in communication. * those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, parkinson's disease, cognitive impairment, depression, etc.). * patients diagnosed with alcohol or substance addiction.