Kornimate/medical-research-clean huggingface dataset:
open label, multi-center study to assess the safety, tolerability and pharmacokinetics of cudc-907 in subjects with advanced/relapsed solid tumors

Conditions: Triple-Negative Breast Cancer; High-grade Serous Ovarian Cancer; Solid Tumors; NUT Midline Carcinoma

Summary: this is a phase i, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of cudc-907 administered orally to subjects with advanced/relapsed solid tumors.

this is a phase i, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of cudc-907 administered orally to subjects with advanced/relapsed solid tumors. the following dosing schedule, consisting of 21-day treatment cycles, is being examined: five days on/two days off on days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Eligibility criteria:
inclusion criteria: 1. subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with nut rearrangement. subjects may be ≥16 years of age. 2. histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with nut rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. for enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required. 3. measurable or evaluable disease. 4. eastern cooperative oncology group (ecog) performance status of 0 to 2. 5. recovery to grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia). exclusion criteria: 1. systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin c within six weeks. 2. radiotherapy within one week prior to starting study treatment. 3. other investigational agent(s) within 21 days prior starting to study treatment. 4. symptomatic central nervous system (cns) involvement or lymphangitic metastasis. stable or improving cns disease that is not under active treatment after receipt of adequate therapy is allowed. 5. uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, new york heart association (nyha) class ii or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.

Keywords: tnbc hgsoc nmc
high rate spinal cord stimulation (scs) for chronic pain

Conditions: Chronic Pain

Summary: to determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

this study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Eligibility criteria:
inclusion criteria: * chronic intractable pain of the trunk and/or limbs * documented history of trunk and/or limb pain of at least 180 days * average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the screening visit * pass study site's routine psychological/psychiatric evaluation within 180 days of the trial lead insertion visit * if taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the trial lead insertion visit and agree to continue on the same prescription throughout study participation * subject is willing and able to comply with all protocol-required procedures and assessments/evaluations * subject is able to independently read and complete all questionnaires and/or assessments provided in english * 18 years of age or older when written informed consent is obtained * subject signs a valid, institutional review board (irb)-approved informed consent form (icf) provided in english exclusion criteria: * unable to operate the precision plus system * primary source of pain is cancer-related, pelvic, visceral, angina, or migraine * is a high surgical risk * is diabetic * is immunocompromised * currently on any anticoagulant medications that cannot be discontinued during perioperative period * untreated major depression or untreated generalized anxiety disorder * diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder * diagnosed with any major psychiatric disorder not specifically listed in ce7 or ce8 * currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care * current abuse of alcohol or illicit drugs * subject requires magnetic resonance imaging (mri) while implanted with lead(s). * subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study * subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (implantable pulse generators (ipgs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator * patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the trial lead insertion visit in women of child-bearing potential and the test result documented)
intralesional treatment of keloids

Conditions: Scar, Hypertrophic

Summary: intralesional injection in treatment of keloid

our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope

Eligibility criteria:
inclusion criteria: both sex aged 18-60 having keloid - exclusion criteria: * pregnancy , lactation skin disease

Keywords: keloids , vitamin d
contribution of real time analyses of cardio-respiratory signals to the diagnosis of infection in preterm infants

Conditions: Bacterial Infection

Summary: hospital-acquired infections are common complications in preterm infants. the diagnosis has to be fast and accurate. indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance. the aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.

hospital-acquired infections increase morbidity and mortality in the preterm infants. early diagnosis of infection is difficult mainly due to the poor performance of clinical signs and to the need for invasive procedure to get blood tests. however, early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. many clinical features have been described, associated with an ongoing infection but they are inconsistent, variable and nonspecific. similarly, many invasive laboratory tests have been proposed for the diagnosis of infection in the newborn but they all need blood sampling and none has a good predictive value. the combined analysis of the heart rate and respiratory characteristics appears to be a promising tool for the diagnosis of infection in the preterm infants. these signals are non-invasively recorded and their computerized real time analyses would allow for a continuous assessment of the risk of infection. the main objective is to test the hypothesis that the analyses of the variability of the cardiac cycle duration, the variability of the respiratory cycle amplitude and duration, and their relationships, can significantly improve the performance of the diagnosis of late onset infection in the preterm infant at the bedside in neonatal units.

Eligibility criteria:
inclusion criteria: * preterm birth before \ 24wks * birth weight \> 500g * postnatal age\> 3 days * postconceptional age \< 34wks * parents information and collection of non-opposition exclusion criteria: * malformative syndrome * severe neurological injury (ivh grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)

Keywords: preterm infant bacterial infection diagnosis of proven or suspected bacterial infection
hip fracture rehabilitation programme for elderly with hip fractures

Conditions: Hip Fractures

Summary: objectives: to evaluate the feasibility of a hip fracture rehabilitation programme (hip-rep).this study will investigate adherence, satisfaction, technical and practical circumstances regarding implementation and taking this into account when evaluating the feasibility of the hip-rep program. hypothesis: by testing the feasibility of a hip-rep for the participants and the usefulness of the selected measurement tools, the investigators will be able to evaluate and adjust the hip-rep before evaluating this in a larger randomized controlled trial (rct).

little is known about the feasibility and effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in activities of daily living (adl) ability for elderly with hip fractures. despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and adl ability. after hip fracture, the loss of independence, and further decrease in adl ability often persists beyond three months after surgery. this increases the risk of social isolation, depression and thus a decrease in quality of life (qol). therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is feasible and influences this fragile group of patients. the investigators hope to increase the ability to safely and independently perform adl in elderly with hip fractures, and thereby enhance their health-related qol.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * recent proximal hip fracture (s 72.0 medial femur fracture, s 72.1, pertrochanteric femur fracture, s 72.2 subtrochanteric femur fracture) * living at home prior to hip fracture in herlev, gentofte or lyngby-taarbæk municipalities * ability to give informed consent * discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset exclusion criteria: * not expected to be discharged to home or rehabilitation centers in the municipality * not able to speak and/or understand danish * have prior severe physical and /or mental disabilities
perinatal diagnosis of git anomalies

Conditions: Fetal Anomalies

Summary: fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester

prenatal diagnosis of these anomalies allows for early postnatal interventions and implementation of treatment options

Eligibility criteria:
inclusion criteria: * pregnant women either primi or multigravida * pregnant in 18- 24 weeks exclusion criteria: * first trimester pregnant ladies
the effect of the dash diet containing meat on muscle and metabolic health in older adults

Conditions: Obesity; Sarcopenia; Aging

Summary: age-related changes in body composition, muscular fitness, and metabolic health resulting in the onset of obesity, sarcopenia, and chronic diseases are profound public health issues that are in need of immediate attention. effective and feasible methods, such as dietary therapies, are needed to improve health in older adults that in turn lead to independence, enhanced quality of life and reduced hospitalizations. diet quality and dietary protein intake are vital for maintaining body composition, muscle mass and improved physical performance. malnutrition in dietary protein intake is a major cause of reduced muscle mass, strength, and function in older adults. the dietary approaches to stop hypertension (dash) dietary pattern is a high-quality therapeutic diet known to improve health status in various diverse and at-risk populations resulting in improved heart health, maintained cognitive function and reductions in metabolic diseases such as diabetes, metabolic syndrome, and nonalcoholic fatty liver disease. the primary protein recommendations of the dash diet are poultry and fish and it is recommended to decrease or exclude red meats from the diet. however, studies have demonstrated that lean red meat incorporated into a dash-like diet doesn't exacerbate cardiovascular health indices in adults, indicating that lean red meat can be included in the dash diet without negative effects on heart health. although studies have reported on the dash diet in older adults, no studies have investigated the effect of the dash diet containing lean red meat on measures of body composition, muscle mass or metabolic health under controlled-feeding conditions. the purpose of this study was to determine the effect of the dash diet containing daily intakes of lean red meat on indicators of body composition, muscular fitness and biomarkers of metabolic health in adults 65 and older using controlled-feeding and systems biology approaches.


Eligibility criteria:
inclusion criteria: * 65 and older * upward mobile ability exclusion criteria: * under the age of 65 * immobility
spirogym app-aided cough rehabilitation

Conditions: Parkinson Disease; Voluntary Peak Cough Strength; mHealth

Summary: the pilot study by srp et al. (2021) proved that the spirogym app was feasible for supporting expiratory muscle strength training (emst) in parkinson's disease (pd) patients. two weeks of intensive emst coupled with spirogym were sufficient to significantly improve the participants' voluntary peak cough flow (pcf). the improvement was quantitatively comparable to the results of other intensive emst studies with longer durations. when interpreting such rapid improvement, the impact of spirogym's visual feedback was considered. it was assumed that visual feedback increased training effort compared to regular training without immediate control. however, comparative studies were required to verify the possible additional effects of visual feedback on voluntary pcf compared to emst without feedback.

goal: to explore the visual feedback effect of the spirogym app in emst on voluntary peak cough hypothesis 1: change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of emst. study design: a double-blind, randomized controlled trial

Eligibility criteria:
inclusion criteria: * diagnosis of parkinsons disease * stable dopaminergic medication (stable dose for at least 1 month) exclusion criteria: * other neurological disorders * difficulty complying due to neuropsychological dysfunction (dementia with a score of less - - than 19 on the montreal cognitive assessment) * breathing disorders or diseases * smoking in the past 5 years * uncontrolled hypertension
bremiss : brain resilience minor stroke study

Conditions: Stroke Ischemic

Summary: all patients eligible recorded in the brest stroke registry (bsr) will be proposed to have either a telephone interview or a face-to-face interview. in the case of telephone interview, they will be proposed to have a saliva kit for dna analysis send to their home at the time as the self-questionnaires that will need to be send back to the hospital. in the case of face-to-face interview, they will be proposed to have on the spot a saliva sample for dna and a cerebral mri. around 1000 patients can be included.

the study is a retrospective study for pairing the population-based stroke registry and hospital medical record data and prospective study for calling back patient more than 4 years for new clinical, cognitive, thymic and quality of life evaluations and for dna sample and cerebral mri realization duration of recruitment is anticipated to last between 2 years and 2 years and half. the principal objective is to develop a predictive model of quality of life more than 4 years after stroke onset in patients with minor stroke based on initial (first days after stroke onset) patients characteristics based on the assumption that more than 4 years after a stroke the related sequelae are going to be stable.

Eligibility criteria:
inclusion criteria: * cases of stroke in the brest stroke registry (bsr) * ability to sign informed consent * patients followed-up \> 4 years during the study period * nihss score ≤ 5 on admission * first stroke above 18 and before 75-year old * rankin before stroke \< 1 * possibility to draw saliva samples for genomic study * possibility to perform cerebral mri exclusion criteria: * patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded. * not affiliated to social security * patient under legal protection or deprived of liberty by a judicial or administrative decision * patient unable to sign informed consent * patient whose follow-up will be impossible

Keywords: stroke predictive model
exploratory study of clonal evolution in cancer for patients undergoing transoral robotic surgery for radiation exposed residual/recurrent tumours of the upper aerodigestive tract

Conditions: Head and Neck Cancer

Summary: radical radiotherapy for head and neck squamous cell cancer (hnscc) can be administered to primary disease with curative intent. residual disease, recurrence or further tumours may subsequently occur in this irradiated field. it is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment. understanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields. recut+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on hnscc. participants will be recruited from the royal marsden hospital (rmh), chelsea, a tertiary referral h\&n cancer unit in london, uk, specialising in transoral robotic surgery. retrospective participants will be identified from previous head and neck mdt lists at rmh. prospective participants will be screened for by the recut+ team during the weekly h\&n mdt meetings at the royal marsden hospital (rmh). blood/saliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour dna analysis. biopsy samples from the original cancer and resected specimens from the post radiotherapy residual/recurrent/new primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.


Eligibility criteria:
inclusion criteria * aged over 18 * previous h\&n cancer treated with radiotherapy. * undergoing tors as part of their management for residual, recurrent or new primary h\&n cancer. exclusion criteria * where tors is used in a diagnostic setting only * nasopharyngeal and thyroid head and neck cancers * where no tissue specimens are available from the recurrent/residual/secondary tumour for the retrospective cohort
an open-label multicentre long-term extension study of etanercept for ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study is an extension trial of 0881a3-312-eu and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.


Eligibility criteria:
inclusion criteria: * completed study 0881a3-312-eu * agreeable to utilize medically acceptable form of contraception * able to reconstitute and self-inject or have a designee exclusion criteria: * withdrawn from study 0881a3-312-eu * abnormal hematology or chemistry profiles * clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection
safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer

Conditions: Breast Cancer

Summary: to compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.


Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years, premenopausal 2. histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(er)/progesterone receptor(pr) positive 3. patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy. 4. leukocyte ≥ 3\*109/l; platelets ≥ 75\*109/l; serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) \<2.5 times of upper limit of normal (unl) range serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range; written informed consent according to the local ethics committee requirements. 5. has eastern cooperative oncology group(ecog) performance score 0-2; exclusion criteria: 1. histologically confirmed hormonal receptor negative. 2. have received neoadjuvant/adjuvant endocrine therapy. 3. with metastatic tumor. 4. family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor. 5. have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound. 6. with any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc. 7. with any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc. 8. ovarian ablation or suppression 9. with severe non-malignant co-morbidity that will influence long-term follow up. 10. with severe hepatic dysfunction, child-pugh c. 11. with severe cardiac dysfunction, new york heart association (nyha) grading iii or worse. 12. known severe hypersensitivity to any drugs in this study;

Keywords: operable premenopausal endocrine therapy safety tamoxifen toremifene