Kornimate/medical-research-clean huggingface dataset:
early supplementation for cow's milk allergy prevention

Conditions: Food Allergy; Cow's Milk Allergy

Summary: cow's milk allergy (cma) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. it also represents a financial burden for families and healthcare resources. there is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing cma later in life. current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. this knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of cma, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families. this trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula \[cmf\], amino acids formula \[aaf\], donor human milk \[dhm\], or high-pressure processed "pascalized" donor human milk \[dhm-p\]) could serve as an effective strategy for the primary prevention of cma in breastfed neonates. this study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.


Eligibility criteria:
inclusion criteria: 1. healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life 2. full-term infants (defined as gestational age of at least 37 weeks) 3. infant birth weight at least 2500 g and ≤ 4500 g 4. age at enrolment \<24 h of life 5. regardless of any atopic condition in parents 6. written informed consent of the caregiver exclusion criteria: 1. infants of parents who intend to partially or fully formula feed 2. serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth 3. contradictions to exclusive breastfeeding 4. multiple pregnancy
dry needling and muscle stiffness

Conditions: Muscle Tightness

Summary: the goal of this study is to investigate the effect of intramuscular dry needling (imdn) on muscle stiffness and pain. research has suggested that imdn can reduce muscle stiffness in needled areas. as well, imdn may reduce mechanical pain sensitivity experienced by individuals. imdn will be performed at several anatomical locations. muscle stiffness will be measured with a handheld probe, which measures contact force and displacement of soft tissue. pressure-pain thresholds (ppt) will be discovered at each region of interest. stiffness and pressure-pain thresholds will be collected before and after imdn. the data collected from this research is important to understand the mechanism of imdn and its relationship to pain.


Eligibility criteria:
inclusion criteria: * over the age of 18 * pain-free in your lower back and lower legs exclusion criteria: * unable to communicate in english * surgery of any kind in the lumbar spine or lower legs. * participants with a skin condition that does not allow for hypoallergenic tape to be attached to their skin. * have a bmi\>25 * unable to hold your breath for 20 seconds * contraindications to dry needling, i.e. pregnancy; fever or infection that is in your bloodstream; unstable compromised immune system; unstable bleeding disorders; presence at the site of dn of infection, an open wound , a burn, cellulitis, or an undiagnosed lump; post- mastectomy/lymph node removal in the affected limb; post-major surgery (3-6 month time period); presence of metal or plastic implant; absent sensation in area of planned dn; post-bacterial endocarditis or heart valve conditions/replacement without medical clearance for dn from medical doctor.
increasing colorectal and breast cancer screening in women

Conditions: Breast Cancer Female; Colorectal Cancer

Summary: this study compares the efficacy (adherence and stage) of four interventions to promote colorectal (crc) and breast cancer (bc) screenings among women ages 50 to 75. they are: 1. usual care; 2. a tiweb (tailored intervention website) 3. a csc (cancer screening call) and 4. tiweb + a csc. this study also compares the cost-effectiveness of the 4 interventions to promote crc and bc screening among women ages 50 to 75.

this study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the united states.the cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (crc) and breast cancer (bc) in all eligible women. this research tests intervention to simultaneously increase both crc and bc screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. two groups of women, group a (adherent to bc screening guidelines, but not to crc screening guidelines) and group b (non-adherent to bc \& crc guidelines) are randomized to 1. usual care, 2. tiweb, 3. csc and 4. tiweb +csc.

Eligibility criteria:
inclusion criteria: * a patient of any of the participating physicians * not having had a fecal occult blood test (fobt) in the last 12 months * not having had a fecal immunochemical test (fit) in the past 15 months * not having had sigmoidoscopy more than 5 years ago * not having had a colonoscopy more than 10 years ago * have high-speed internet access exclusion criteria * a personal history of colorectal cancer * a personal history of breast cancer * a personal history of colorectal polyps * a personal history of inflammatory bowel disease * having any medical conditions that would prohibit a mammogram or crc screening * have already had crc screening

Keywords: breast cancer screening colorectal cancer screening cervical cancer screening cancer screening beliefs cost-effectiveness demographics tailored intervention
one heart to care for

Conditions: Heart Failure

Summary: this is an open randomized clinical trial with two study arms. one group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. when leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient. the telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. during the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.


Eligibility criteria:
inclusion criteria: * - age ≥ 50 * patient has to be followed in ziekenhuis oost-limburg or jessa ziekenhuis hasselt * the patient has to be able to live independently or in a service flat * the diagnosis of heart failure or severe myocardial infarction has to be done after september 1, 2013 according to: * left ventricular ejection fraction (lvef) \<40% * egfr\>30ml/min/kg * treatment minimally with ace-i and bb * the general practitioner had to give his approval for the installation of telemonitoring on the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil to join the study. the patient also needs to speak sufficient dutch to be communicative about his/her medical condition. exclusion criteria: * reversible form of heart failure * heart failure due to severe aortic stenosis * egfr less than 30ml/min/kg * presence of a cardiac resynchronization therapy (crt) device * palliative status following the riziv guidelines or according to the assessment of the cardiologist (\<1 year) * patients staying in a nursing or retirement home * active treatment with either ace-i/arb or bb

Keywords: heart failure telemonitoring medication up titration automatic blood pressure device medication dispenser
mapping functional networks of brain activity (brain network activation, bna) based on analysis of evoked response potential (erp) signals for healthy controls evoked response potential (erp) signals for healthy controls and patients with parkinson disease

Conditions: Parkinson Disease

Summary: a cornerstone in pd research is the investigation of neurophysiological changes as potential biomarkers that could help in tracking disease progression and response to therapies. electroencephalography (eeg) could provide a non-invasive and relatively cheap tool for identification of such biomarkers. in this study we will use high-density electroencephalograph (eeg) recording, in order to develop a platform of biomarkers that could be more sensitive and reliable to disease progression and response to therapeutic intervention than standard clinical measures.


Eligibility criteria:
inclusion criteria: 1. idiopathic pd patients (according to the uk pd society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of pd, no atypical features or secondary cause) and hc aged 40-80 years 2. pd patients hoehn and yahr stages i to ivstable pd therapy exclusion criteria: * in the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements. * patients or hc with significant psychiatric symptoms or history * bdi score \<14 * mmse \<25 * treatment with neuroleptics. * for pd patients: hoehn and yahr stage 5 * pd patients with severe dyskinesia or tremor * pd patients with atypical parkinsonism or secondary parkinsonism * history or evidence of neurological problems: cerebrovascular disease, previous head injury or neurosurgical interventions. * currently with lice or open wounds on scalp. * significant sensory deficits, e.g., deafness or blindness * current drug abuse or alcoholism. * pregnancy or not using a reliable method of birth control. * participation in current clinical study or clinical study within 30 days prior to this study.

Keywords: parkinson eeg bna
body composition analysis in patients undergoing chemoembolization

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis. chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized. bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass. bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. it can be used as a control for the interpretation of the bioelectrical impedance.


Eligibility criteria:
inclusion criteria: * patients with hepato-renal disease * patients with hepatocellular carcinoma that are put down to radiofrequency ablation * patients with depression or any psiquiatric disease. * patients that don't agree to participate in the project. exclusion criteria: * patients with hepatocellular carcinoma that are put down to radiofrequency ablation * patients with depression or any psiquiatric disease. * patients that don't agree to participate in the project.

Keywords: body composition hepatocellular carcinoma chemoembolization
use of the avulux® lenses as an aid in reducing the impact of migraine headaches

Conditions: Migraine

Summary: the purpose of this research is to assess how well the avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.

avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. in this study, the investigative avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. the optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines. the control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the avulux® device.

Eligibility criteria:
inclusion criteria: * subject is 18 years or older * subject is willing and able to provide written informed consent * diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics: * headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) * headache has at least two of the following characteristics: * unilateral location * pulsating quality * moderate or severe pain intensity * aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) * headache occurs with at least one of the following symptoms: * nausea and/or vomiting * photophobia and phonophobia * subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications * migraines are not attributed to another disorder exclusion criteria: * subjects participating in another prospective, interventional clinical study * subjects with other light sensitive conditions, such as iritis * subjects who have less than 4 headache days per month with the above characteristics * chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month) * subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months) * subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment * subjects whose family members are currently participating in this study, or are employees of the study site, avulux, or the coordinating cro
detection of plasma dna in non small cell and small cell lung cancer patients

Conditions: Non-Small Cell Lung Carcinoma; Small Cell Lung Cancer

Summary: the majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma dna that could be exploited as a diagnostic tool. the aim of this study is to evaluate if plasma dna can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.


Eligibility criteria:
inclusion criteria: * presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis. * no lung instability. * individuals give all informed consent

Keywords: lung cancer plasma dna allelotyping follow-up prospective study non-small cell lung cancer small cell lung cancer
nintedanib plus docetaxel in japanese patients with adenocarcinoma subtype non-small cell lung cancer after failure of first line chemotherapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in japanese patients with body surface area (bsa) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (nsclc) after failure of first line platinum- based chemotherapy


Eligibility criteria:
inclusion criteria: 1. patients aged 20 years or older at the date of informed consent 2. patients with body surface area (bsa)\<1.5 m2 at screening 3. patients with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (nsclc) after failure of first line platinum-based chemotherapy (patients with non-target lesion only are eligible) first line chemotherapy may include continuation or switch maintenance therapy. one prior adjuvant and/or neoadjuvant chemotherapy is accepted. 4. patients who have life expectancy of at least 3 months 5. patients who are eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 at screening 6. patients obtained written informed consent in accordance with international conference on harmonisation-good clinical practice (ich-gcp)and japanese gcp exclusion criteria: 1. patients who have received more than one prior line of chemotherapy (i.e., second or third line chemotherapy) for advanced or metastatic nsclc (prior monotherapies with an epidermal growth factor receptor tyrosine kinase inhibitors \[egfr-tki\]) or anaplastic lymphoma kinase (alk) inhibitor can be allowed) 2. patients who have received previous therapy with other vascular endothelial growth factor (vegf) or vascular endothelial growth factor receptor (vegfr) inhibitors (other than bevacizumab) for the treatment of nsclc at any time 3. patients who have received following treatments within 4 weeks prior to start of study therapy 1) other investigational drugs 2) chemo-, hormone-, immunotherapy, or monoclonal antibody. 4. patients who have received molecular target therapy including egfr tkis and alk inhibitors within 2 weeks prior to start of study therapy 5. patents who have received radiotherapy within the past 3 months (in the case of limited -field \[e.g. brain or bone metastasis\] radiotherapy with palliative intent), within 2 weeks) prior to start of study therapy 6. patients who not recovered clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy (=ctcae grade 2 adverse event from previous treatment) at screening further exclusion criteria may be applied
steroids in eosinophil negative asthma

Conditions: Asthma

Summary: because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.

siena is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ics) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (lma).

Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma for at least previous 12 months. * able to perform reproducible spirometry. * baseline fev1≥70% of predicted. * asthma confirmed either by: * beta-agonist reversibility to 4 puffs albuterol ≥ 12% or * methacholine pc20 ≤ 16 mg/ml * at least 1 of the following indications for chronic controller therapy: * asthma symptoms \> 2 days/week or * nocturnal asthma symptoms \> 2 nights/month or * short-acting beta-agonist use for symptom control \> 2 days/week * for participants ≥18 years of age: ability to provide informed consent. for participants under 18 years of age: ability to provide verbal or written assent and ability of parent to provide informed consent. * willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception. exclusion criteria: * chronic inhaled or oral corticosteroid therapy. * use of inhaled or oral corticosteroid therapy within 6 weeks. * new allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen. * use of omalizumab within 3 months. * history of: * bladder-neck obstruction, urinary retention or benign prostatic hyperplasia * narrow angle glaucoma * significant cardiovascular disorders and arrhythmias * life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years * respiratory tract infection within past 6 weeks. * history of smoking within the past 1 year, or \> 10 pack-years total if ≥ 18 years of age, or \> 5 pack-years total if \< 18 years of age. * chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.

Keywords: asthma mometasone tiotropium
a study of rapcabtagene autoleucel in systemic lupus erythematosus (sle) patients with active, refractory lupus nephritis (ln)

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Summary: the purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus standard of care (soc) in patients with systemic lupus erythematosus (sle) with active, refractory lupus nephritis (ln).

this is a phase 2, adaptive, five-year, randomized, assessor-blinded, active controlled study: * part a: participants suffering from systemic lupus erythematosus (sle) with active, refractory ln will be randomized to regimen 1, regimen 2, or soc. * part b: participants suffering from sle with active, refractory ln will be randomized to the selected regimen from part a or soc. the study will consist of two periods: * a screening period lasting up to 6 weeks, and * a randomized treatment period and primary follow-up period lasting up to 5 years. participants in the soc arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible.

Eligibility criteria:
key inclusion criteria: * men and women with sle, aged \>= 18 years and =\< 65 years at screening, fulfilling the 2019 european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria for sle at screening. * participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ana) at a titer of \>= 1:80 (on hep-2 cells or an equivalent positive test), or anti-dsdna (above the uln); or anti-sm (above the uln) as determined by a central laboratory. * active lupus nephritis without signs of significant chronicity * sledai-2k criteria at screening: sledai-2k score \>= 6 points (gladman et al 2002, touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome". * inadequate response at screening to at least two ln treatment regimens key exclusion criteria: * any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse gcs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for cd19 car-t therapy * inadequate organ function during screening and prior to randomization * history or current diagnosis of ecg or cardiac abnormalities indicating significant risk of safety for participants prior to randomization * human immunodeficiency virus (hiv) positivity at screening. * acute or chronic infection with hepatitis b (hbv) or hepatitis c (hcv) at screening. * evidence of active or latent tuberculosis. * grade 2 or higher thromboembolic event in the past 4 weeks prior to screening. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chimeric antigen receptor-t (car-t) rapcabtagene autoleucel lupus nephritis (ln) systemic lupus erythematosus (sle)