Kornimate/medical-research-clean huggingface dataset:
football fitness after breast cancer

Conditions: Breast Neoplasm Female

Summary: late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. however only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. the 'football fitness after breast cancer' (ff abc) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for breast cancer.


Eligibility criteria:
inclusion criteria: * women surgically managed for breast cancer, local and regional advanced breast cancer. * completion of adjuvant chemotherapy and radiation therapy. * legally competent persons with ability to read and understand danish. * signed informed consent. * performance level 0-1 (who). exclusion criteria: * who performance level \> 1. * osteoporosis (t-score \< -2.5). * known metastatic breast cancer (stage iv). * women in dbcg-group i (age =\> 60 years, tumor =\< 10 mm, invasive ductal carcinoma grade i, invasive lobular carcinoma grade i / ii, estrogen receptor positive and her2 normal). * cardiovascular or pulmonary disorders (e.g., arrhythmias, ischemic heart disease, unregulated high blood pressure, chronic obstructive lung disease). * ongoing anticoagulant therapy (vitamin k antagonists; marevan, marcoumar and low molecular weight heparins; innohep, clexane, fragmin) for pulmonary embolism or deep venous thrombosis (dvt) due to increased bleeding risk of falls and clashes with other players during exercise. * current or scheduled chemotherapy and radiation therapy in the intervention period (12 months).

Keywords: breast cancer football late effects physical exercise soccer training rehabilitation bone mineralization body composition fitness aerobic capacity
broadband collaborative pulse ablation instrument treating malignant pulmonary nodules

Conditions: Lung Neoplasm Malignant; Secondary Lung Cancer

Summary: effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules

this clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.

Eligibility criteria:
inclusion criteria: 1. age: between 18 and 70 years old with no gender limitation; 2. malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors ≤3. the pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites; 3. surgery is not available or the patient refuses surgical treatment; 4. nodules' maximum diameter≤2cm; 5. ecog score≤2; 6. patients understood the trial procedure and voluntarily signed informed consent. exclusion criteria: 1. an electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body; 2. coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time \>18s, prothrombin activity \<40%, platelet \<80×109 /l); 3. patient who can not stop taking antiplatelet and anticoagulant drugs 5 days before surgery; 4. severe pulmonary fibrosis and pulmonary hypertension; 5. patients with poor control of pleural effusion; 6. patients with serious insufficiency of liver, kidney, heart, lung, and brain function; 7. patients with severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term; 8. patients with severe systemic infection, high fever (\>38.5℃); 9. pregnant and lactating women and those planning to become pregnant within one year; 10. participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment; 11. any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study.
a pilot randomized controlled trial of the effects of daily skin-to-skin contact (prcts2s)

Conditions: Premature Baby 33 to 36 Weeks; Mother-Infant Interaction; Oxidative Stress

Summary: late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (atp) degradation, which indicates cellular increased and stress. processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. skin-to-skin contact (ssc), also known as kangaroo mother care (kmc), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. ssc has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. ssc also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. however, little is known about how ssc affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life. the aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous ssc care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged ssc on stress biomarkers in preterm infants.


Eligibility criteria:
inclusion criteria: * infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age * medically stable as determined by a neonatal acute physiology- perinatal extension snappe -ii (snappe-ii) score of less than 9 * mothers able to read and write english * mothers have no medical contraindications to holding their infant in ssc for up to 2 hours exclusion criteria: * surgery in the first week of life * intraventricular hemorrhage (ivh) of grade 3 or 4 * opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin * plasma creatinine of \>1 mg/dl * severe cyanotic heart disease or severe respiratory distress * abdominal wall or intestinal anomaly or injury (nec) * facial anomaly or other known chromosomal anomaly * life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care
phase 1/2a trial of yh12852 in healthy subjects and patients with functional constipation

Conditions: Functional Constipation

Summary: a randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of yh12852 in healthy subjects and patients with functional constipation


Eligibility criteria:
inclusion criteria: 1. subjects must be willing and able to provide written informed consent. 2. bmi within the range 18 to 25 kg/m2. exclusion criteria: 1. history of positive serologic evidence for infectious disease including hbsag, anti-hcv, anti-hiv. 2. clinically significant lab/ecg abnormalities in the opinion of the investigator. 3. wocbp who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. wocbp include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause. clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence. 4. wocbp who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study. 5. wocbp who are pregnant or breastfeeding. 6. wocbp with a positive pregnancy test prior to randomization. 7. males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study. 8. presence of uncontrolled or severe medical illness. 9. presence of a disease that require surgery at any time during the study.
monkeypox asymptomatic shedding: evaluation by self-sampling mpx-assess

Conditions: Monkey Pox

Summary: monkeypox (mpx) is a viral zoonosis, caused by the monkeypox virus (mpxv), a dna virus that belongs to the orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox. until recently the spread of mpx was mainly confined to the central african rainforest and to parts of west africa. however, in may 2022, several cases of mpx were detected throughout europe and northern america, albeit with a different presentation than previously seen. many questions remain on this new presentation of the disease: what the exact mode of transmission is, how contagious the virus really is and whether asymptomatic carriers exist. with this study the researchers aim to perform a close follow-up study of close contacts of mpx confirmed cases. participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the itm for diagnosis (index). contacts that are asymptomatic (for symptoms compatible with mpxv infection according to national case definitions) at the time of recruitment will be enrolled. contacts of the index case that are symptomatic at recruitment or become symptomatic during follow-up will be invited for sample collection at different timepoints until 21 days after contact as suspect cases.


Eligibility criteria:
inclusion criteria: 1. be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with: * very high-risk contact: * sexual partner(s) * prolonged skin-to-skin contact while the patient had skin lesions * high risk contact * living in the same household or similar environment (e.g. camping, spending the night, etc.); * shared clothing, bedding, utensils, etc., while the patient had skin lesions * healthcare workers with unprotected contact (inadequate or no ppe) 2. last exposure to the monkeypox index case of less than 21 days ago 3. adult participants (≥ 18 years old) of any gender 4. written informed consent is obtained from the participant exclusion criteria: 1. presenting with symptoms compatible with mpx: * an unexplained rash on any part of the body and * one or more of the following symptoms: fever, headache, back pain, fatigue, lymphadenopathy (localised or generalised) 2. inability or unwillingness to comply with the proposed follow-up schedule
eurbio-alport (radico cohort) (radico eurbio-alport)

Conditions: Alport Syndrome

Summary: alport syndrome is a rare, inherited condition characterized by a combination of glomerular nephropathy progressing to kidney failure, deafness, and eye involvement. this disease is associated with mutations in the genes encoding one of the three iv collagen chains expressed in the glomerular basement membrane. significant progress has been made in understanding the molecular mechanisms responsible for the disease, but relatively little in understanding the progression of renal failure and in the area of therapeutics. we have shown in a retrospective european study that blockers of the renin angiotensin system may slow disease progression, but no controlled studies have been performed. finally, innovative therapies (anti-micro-rna, stem cells) have recently shown their effectiveness in animal models of the disease, and industrials are planning to quickly carry out phase 1 trials to test molecules. carrying out therapeutic trials in humans will require full knowledge of the natural history of the disease (isolated hematuria, microalbuminuria, macroalbuminuria, renal failure and its progression) and gathering a sufficient number of patients, especially in the early stages. these trials and the indications for treatments would be greatly facilitated by the discovery of biomarkers that make it possible to predict the progression to renal failure earlier than the onset of proteinuria. the study aims to: * establish a european database on alport syndrome to assess the natural history of the disease. * to investigate the impact of the disease on the educational and professional life of patients and their families, and on the adherence and tolerance to renin-angiotensin system blockers prescribed to proteinuric patients. * investigate access to molecular diagnostics and genetic counseling, as well as identify biomarkers that can predict progression of kidney disease. this project will be carried out at a french level with the support and participation of the very active renal rare disease sector, in collaboration with various countries wishing to participate.


Eligibility criteria:
inclusion criteria: * diagnosis of as based on electron microscopic examination of the renal biopsy and/or molecular studies and/or abnormal expression of type iv collagen chains on skin and/or glomerular basement membranes. * signed informed consent exclusion criteria: - no exclusion criteria

Keywords: alport syndrome rare disease european database quality of life kidney disease molecular diagnostics predictive biomarkers
investigating the metabolic pathways in hormone receptor positive/her2 negative breast cancer

Conditions: Breast Cancer

Summary: to analyze the metabolic activity of hormone receptor positive (hr+)/her 2 negative (her2-) breast cancer.

participants will be asked to receive a glucose infusion (u-13c- glucose intravenous) during routine breast cancer surgery at which time, tumor biopsy samples and blood samples will be collected to be used in research experiments to help provide insight into the metabolic activity of the tumor. the length of time on study for each patient will be three - four weeks including two to three hours for glucose infusion and breast cancer biopsy.

Eligibility criteria:
inclusion criteria: * have hormone receptor (hr) positive \[estrogen receptor( er)+/progesterone receptor (pr)+, er+/pr- or er-/pr+)/her2 negative breast cancer previously diagnosed by biopsy. * have early stage, clinical or anatomic stage i, ii or iii breast cancer (ct1cn0, ct1cn1, ct2n0, ct2n1, ct3n0) * candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy). * willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection. exclusion criteria: * is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. * has triple negative (er-/pr-/her2-) or her2+ breast cancer. * concomitant active malignancy * is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)

Keywords: hormone receptor positive metabolic activity breast cancer surgery 13c isotope glucose metabolomics
fluorescence imaging of the parathyroid glands of children

Conditions: Childhood Thyroid Gland Carcinoma; Thyroid Diseases

Summary: the aim of this study is to develop a standardized and user-independent imaging workflow model for autofluorescence and quantified fluorescence angiography with indocyanine green (icg) of the parathyroid glands of children. for this purpose, all pediatric patients will undergo thyroid surgery with the use of autofluorescence and quantified icg-fluorescence. this study could be the first step in reducing the rate of postoperative hypocalcemia in children, by using fluorescence angiography during pediatric thyroid surgery.

background: children with thyroid cancer have excellent survival rates. however, postoperative hypocalcemia, due to inadvertent excision of the parathyroid glands or damage to their vasculature during thyroid surgery, is a severe complication which occurs in 24% - 67% of the children with thyroid cancer and causes lifelong reduced quality of life and increased morbidity rates. in adults, intraoperative identification of the parathyroid glands with autofluorescence and assessment of their perfusion using quantified icg-fluorescence angiography has shown to reduce postoperative hypocalcemia. however, in children no studies regarding quantified fluorescence of the parathyroid glands have been conducted. there is a clear need for surgical techniques to identify and preserve the parathyroid glands during thyroid surgery in children. therefore, the aim of this study is to develop a standardized imaging workflow model for autofluorescence and quantified icg-angiography of the parathyroid glands in children. this workflow model can be the first step in reducing the rate of postoperative hypocalcemia in children. study design: this will be a prospective, observational, multicenter, feasibility study. the aim is to generate the patterns of intraoperative autofluorescence and quantified icg-fluorescence angiography of the parathyroid glands in children, resulting in a user-independent, standardized imaging workflow model for autofluorescence and quantified icg-angiography of the parathyroid glands of children.

Eligibility criteria:
inclusion criteria: 1. patients \<18 years 2. patients undergoing total thyroidectomy (for any indication) 3. patients undergoing lobectomy for the suspicion of a malignancy, with a subsequent completion thyroidectomy 4. written informed consent (from parents/caregivers, patients or both, see chapter 6.0) exclusion criteria: 1. patients with preoperative hypo - or hypercalcemia, treated for hypo- or hypercalcemia, (chronic) renal disease, kidney transplantation or any disorder that requires calcium supplementation (other than standard preoperative calcium supplementation for a total thyroidectomy). 2. patients with known allergy to icg or iodinated contrast 3. pregnancy or breastfeeding 4. patients with severe liver dysfunction 5. preterm neonates 6. newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia

Keywords: indocyanine green icg-fluorescence angiography autofluorescence children
progesterone for the prevention of miscarriage and preterm birth in women with first trimester bleeding: preempt trial

Conditions: Miscarriage; Preterm Birth

Summary: miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. one of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. the purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. we will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.


Eligibility criteria:
inclusion criteria: * live intrauterine singleton pregnancy of \<14 weeks by crown-rump length on ultrasound with documented fetal cardiac activity * presence of a perigestational (subchorionic) hemorrhage on ultrasound exclusion criteria: * contraindication to progesterone * any indication for progesterone
patient's anastrozole compliance to therapy programme

Conditions: Breast Cancer

Summary: approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (nis). the clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. a breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). it is planned to enroll approximately 4674 patients in this nis (2337 patients per arm). the patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.


Eligibility criteria:
inclusion criteria: * histological/cytological confirmed primary diagnosis of early breast cancer * postmenopausal * hormone receptor positive exclusion criteria: * patients with severe renal function disorders * patients with moderate or severe disorders of hepatic function * concomitant treatment with drugs known to affect sex hormonal status and tamoxifen

Keywords: hormone-receptor positive primary breast cancer compliance postmenopausal women
the cardiac imaging registry study

Conditions: Coronary Artery Disease (CAD)

Summary: in this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-ct for clinical reasons, to evaluate the role of cardio-ct terms of its diagnostic and prognostic value, as well as risk-benefit ratio. particular aims include: 1. to determine the prevalence of cad for age, gender, ethnicity relative to established risk models 2. to determine associations between cad severity and plaque type and: 1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) 2. blood markers of increased cardiovascular risk 3. to determine predictive associations of between cad with outcome (endpoint definitions in appendix) 4. to determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

particular aims include: 1. to determine the prevalence of cad for age, gender, ethnicity relative to established risk models 2. to determine associations between cad severity and plaque type and: 1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) 2. blood markers of increased cardiovascular risk 3. to determine predictive associations of between cad with outcome (endpoint definitions in appendix) 4. to determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Eligibility criteria:
inclusion criteria: 1. adults (=/\>18 years of age) 2. able to provide informed consent 3. clinical indication for cardio-ct in line with the latest clinical guidelines exclusion criteria: 1. standard contraindications to ct (in line with local roles and guidelines - please see appendix) 2. known allergy to iodinated contrast agent 3. suspected acute kidney injury 4. unstable hemodynamic status or arrhythmias 5. suspected acute coronary syndrome 6. manifest thyrotoxicosis