Kornimate/medical-research-clean huggingface dataset:
a study to assess the effect of oral temanogrel on digital blood flow in adult participants with raynaud's phenomenon secondary to systemic sclerosis

Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis

Summary: the purpose of this study is to determine whether oral temanogrel improves digital blood flow in participants with raynaud's phenomenon secondary to systemic sclerosis (ssc-rp) as a potential safe and effective treatment for symptoms associated with ssc-rp.

the study will be conducted in 2 stages: stage a and stage b. in both stages, participants will be equally randomized in a double-blind manner to a 3-period crossover treatment sequence. separate cohorts of participants will participate in each stage. in stage a, participants will be treated with two dose levels of temanogrel and placebo. doses in stage b will be determined based on the results of stage a.

Eligibility criteria:
inclusion criteria: * raynaud's phenomenon (defined as a history of digital cold sensitivity associated with color changes of cyanosis and pallor, with on average at least 5 attacks per week during the winter period) secondary to systemic sclerosis (ssc) * both men and women participants agree to use a highly effective method of birth control if the possibility of conception exists * body mass index 18.0 to 40.0 kilograms per square meter (kg/m\^2), inclusive exclusion criteria: * active digital ulcer(s), recent history (within 3 months of screening) of digital ulcers, or history of recurrent digital ulcerations that in the opinion of the investigator increase the likelihood of developing a digital ulcer during the course of the study. any history of gangrene, amputations, or other critical digital ischemic event * raynaud's phenomenon due to any cause other than ssc * severe gastrointestinal complications related to ssc that in the opinion of the investigator could significantly affect study drug absorption * history of gastrointestinal bleeding or active gastric or duodenal ulcers

Keywords: raynaud's phenomenon ssc-rp systemic sclerosis ssc digital cold sensitivity digital blood flow apd791 temanogrel
impact of hypnosis during invasive procedure in intensive care unit

Conditions: Pain

Summary: pain during icu stay remains one of the major complaints for patients. beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. the aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated icu patients.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and older * icu hospitalisation * non-sedated patients who need an invasive procedure (invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration) * physician experienced in hypnosis available * written informed consent * health insurance exclusion criteria: * sedation and intubation, delirium, end-of-life decision, * deaf patient, * patient who does not understand french language, * pregnancy * patient under guardianship or curatorship * lack of health insurance

Keywords: invasive procedure pain distress hypnosis
the comparative study about the effect of vertebral body decompression procedure

Conditions: Osteoporotic Vertebral Compression Fracture

Summary: the purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design


Eligibility criteria:
inclusion criteria: * osteoporotic vertebral compression fracture exclusion criteria: * malignancy or inflammatory disease * severe pain in other joints * coagulopathy * an inappropriate person considered by investigator

Keywords: vertebroplasty core decompression osteoporosis
the impact of plant-based protein-rich food products with varying degree of processing on the human gut microbiome composition and human metabolome

Conditions: Metabolism; Gut Microbiota; Inflammation

Summary: it is observed that replacing meat with protein-rich plant-based food products are associated with lower mortality and obesity prevention. sources of plant proteins typically undergo several processing and refinement procedures to improve the taste and digestibility of plant-based food products. these procedures alter the chemical composition, which can impact the nutritional quality of the processed food. it is not known what is the impact of processed products on human metabolism and intestinal microbiota. therefore, the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention

plant-based diets are known to have beneficial effects on both the environment and human health. replacing animal protein with plant protein reduces overall mortality risk, and replacing meat with legumes and other sources of plant protein can lower the risk of chronic diseases such as type 2 diabetes and cardiovascular disease. however, the benefits of plant protein products is not evident. in order to make plant protein products more palatable and digestible, plant raw materials may go through several processing and refinement procedures. typically, during these phases, carbohydrate fractions (e.g. dietary fiber) are removed from the plant material, which results in the loss of micronutrients as well as secondary plant metabolites with potentially health effects (e.g. polyphenolic compounds). salt and various fats are added to some products, which can reduce the nutritional quality of the product. subsequently, not all plant-based protein-rich foods are automatically healthy as there may be significant differences in the nutritional quality of the processed products, depending on the food processing utilized. only little research information is available on the effects of processed plant protein products on human metabolism and intestinal microbiota. therefore, this cross-over clinical intervention will be conducted with 38 healthy participants to investigate the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention.

Eligibility criteria:
inclusion criteria: * willingness to participate * 18-65-years olf * bmi 18.5-27 kg/m2 exclusion criteria: * chronic disease with continuous medication * antibiotic use in the past 6 months * active smoker * gluten-free or vegan diet * pregnancy, lactation * abnormal thyroid, liver, or kidney function * low hemoglobin
post-hospitalisation nutritional support and gait speed in copd

Conditions: Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Lung Diseases, Obstructive; Bronchitis, Chronic; Pulmonary Emphysema

Summary: to determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (copd) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of copd.


Eligibility criteria:
inclusion criteria: * ability to consent * patients at moderate or severe risk of malnutrition * adults over the age of 40 * hospitalised with an aecopd exclusion criteria: * receiving long term parental or enteral nutrition * inability to swallow or difficulty liquids * lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance * co-existing active cancer, progressive neurological condition or active gi disorder. * receiving palliative care with expectation of death within 3 months * cognitive dysfunction or unable to consent
analysis of functional performance in subjects with obesity during motor tasks.

Conditions: Obesity

Summary: background. individuals with obesity can present several functional limitations that can significantly impact on their quality of life. furthermore, even during the execution of specific motor tasks, subjects with obesity can experience excessive biomechanical overload. it is therefore necessary to develop appropriate assessment protocols that are able to provide support for risk assessment, in consideration of different types of motor tasks, including movements that can reflect the main daily and / or work activities. in this perspective, it is essential to define a protocol that includes an integrated evaluation process based on objective and quantitative metrics, i.e., functional scales, clinical scores, etc. in this context, the quantitative analysis of movement is widely used in clinical practice and in research to investigate in an objective and comprehensive way on movement disorders in various pathological conditions, including obesity. conventionally, kinematic and kinetic parameters of movement are measured in motion analysis laboratories, using optoelectronic systems based on passive markers, force platforms and electromyographic systems, which represent the gold standard. although motion analysis is considered accurate, the availability of specific laboratories, high costs and dependence on trained users sometimes limit its use in clinical practice. a variety of wearable sensors available today has enabled researchers and clinicians to pursue applications where individuals are monitored in home and outpatient settings. hypothesis and significance. the hypothesis is that wearables could reveal a good agreement, accuracy, and correlation between the parameters measured by means of optoelectronic system and those measured by wearables in individuals with obesity. specific aims. the main objective is the implementation of an integrated protocol for the clinical evaluation of subjects with obesity through the analysis of the execution of different motor tasks typical of daily life and work. appropriately identified clinical scores and scales will also be supported by quantitative evaluations carried out with human movement analysis systems (optoelectronic systems based on markers and inertial measurement units).


Eligibility criteria:
inclusion criteria: * bmi \>= 30/35 kg/m2; * no impediments to physical activity; exclusion criteria: * pathologies of the locomotor system, * neurological pathologies affecting movement; * internal pathologies contraindicating physical activity; * pregnant or breastfeeding women; * individuals with genetic obesity (down's or prader-willi syndrome).
new models for the evaluation of preclinical treatment for urothelial carcinomas of the upper excretory tract.

Conditions: Upper Urinary Tract Urothelial Carcinoma; Nephroureterectomy; Tumor; Xenograft Model

Summary: upper urinary tract urothelial carcinomas are rare, aggressive tumors, accounting for 5 to 10% of all urothelial tumors. these include tumors which develop in the renal cavities (renal pelvis, calices) and ureteral tumors. nephro-ureterectomy is the standard treatment but 80% of patients will have a relapse within 2 years. only one trial has (birtle et al. 2020), has shown the interest of postoperative chemotherapy. neoadjuvant systemic treatment seems particularly interesting for a population which is going to undergo a nephronic loss and therefore reduction in kidney function which is likely to make patients ineligible for cisplatin. in favor of additional immunotherapy, it has been described that upper excretory tract tumors have a high immunogenic potential with a high rate of microsatellite instability. from surgical samples of patient tumors obtained after nephroureterectomy or biopsy material collected before treatment, we are going to generate patient-derived cell lines and xenograft models in the mouse. a recent publication has demonstrated the feasibility of this approach by specifying that the capture rate of tumor cells is 50% for patient-derived xenografts and 25% for patient-derived cells (coleman et al. 2020). as tumors harvested from biopsies do not grow in patient-derived xenografts,we plan to graft the biopsies onto chorioallantoic chicken embryo membranes, a model which has never been used for this indication and which is one of the original features of our approach. these three concomitant approaches will allow us to increase our chances of obtaining stable upper urinary tract urothelial carcinoma lines to be used for the screening and identification of new treatments or new combinations of molecules that would benefit patients with upper urinary tract urothelial carcinomas, knowing that very few studies dedicated to this type of cancer have been conducted or published due to the rarity of the disease and the lack of existing models published on the subject of these particular tumors. .


Eligibility criteria:
inclusion criteria: * patients treated consecutively at the urology andrology department of nîmes university hospital for high grade carcinoma of the pelvis or renal ureter with an indication for total nephroureterectomy decided during a multidisciplinary meeting. * patient with a diagnosis of high-grade urothelial carcinoma of the pelvis or renal ureter confirmed by histology (biopsy, biopsy of the ureteroscopic) or by cytology with the presence of : * high-grade disease on ureteroscopic biopsy or ; * high grade disease on urinary cytology and infiltrating appearance of the renal pelvic wall / ureter on the scanner (the presence of hydronephrosis will be considered as pervasive by definition) with a negative cytoscopy. exclusion criteria: * any patient who has undergone previous systemic treatment.
a 5 day course of fludarabine and cytarabine followed by full intensity allogeneic stem cell transplantation (fa5-bucy) in treating patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Summary: a 5 day course of fludarabine and cytarabine (fa) will be administered followed by full intensity conditioning regimen (bucy) in the setting of allogeneic stem cell transplantation (sct). the purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of fa as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged between 0-65 years * patients suffering from either refractory de novo aml/all or relapsed aml/all or patients with very high risk aml/all in cr1 * patients with advanced mds * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females * current participation in another clinical trial * contra-indication to one of the drug of the regimen * any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
effects of muscle trainins inspiratory linked to cardiac rehabilitation post-operative of cabg surgery

Conditions: Cardiovascular Diseases

Summary: heart surgery procedures are still widely used worldwide for the treatment of patients with heart problems, and rates of complications in the postoperative period related to them remain high. in these patients, physical conditioning programs result in improved functional capacity, and reducing the heart rate and systolic blood pressure. the inspiratory muscle training is also emerging as a valuable strategy in the treatment of cardiac patients. the study of the interaction between cardiac rehabilitation and high intensity imt about these changes is not yet understood in this population. the aim of this study is to assess the effects of inspiratory muscle training high intensity associated with cardiac rehabilitation exercise performance of patients in the postoperative period of cabg surgery.

it is a controlled, randomized clinical trial in which patients were randomly assigned randomly after referral to cardiac rehabilitation: group 1 imt-hi, group 2 - imt-hi control. the evaluator of outcomes is blinded as to groups. the study protocol lasts 36 sessions for both groups. the group 1 patients performs cardiac rehabilitation protocol for 40 minutes with cardio and stretching and also inspiratory muscle training protocol of high intensity with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of mip in third and fourth week, 70% of mip in the fifth and sixth week and 80% mip in the seventh and eighth week. the group 2 patients only perform the cardiac rehabilitation protocol for 40 minutes with aerobic exercise and stretching.

Eligibility criteria:
inclusion criteria: * patients in the postoperative period of elective cabg * between the fourteenth and the thirtieth day after surgery * between 30 and 70 years old exclusion criteria: * decompensated heart failure * unstable angina * moderate respiratory disease severe * active infectious disease or fever * disabling peripheral vascular disease * unstable ventricular arrhythmias * use of cardiac pacemaker.
esp block on patient outcomes in patients with liver tumor undergoing radiofrequency ablation

Conditions: Hepatic Carcinoma

Summary: to evaluate the ability of erector spina plane block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous radiofrequency ablation of hepatocellular carcinomas.

erector spina plane block is performed with guided ultrasound at t8 transverse process level lead to adequate intraprocedural and postoperative analgesia, in percutaneous radiofrequency ablation of hepatocellular carcinomas.

Eligibility criteria:
inclusion criteria: * asa i-ii patients exclusion criteria: * history of allergy to the study medication * refused to participate

Keywords: erector spinae block radiofrequency ablation hepatocellular carcinomas ultrasound
effects of berries on post-meal blood sugar

Conditions: Blood Glucose, Postprandial; Blood Insulin, Postprandial; Hyperglycemia

Summary: the purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.

berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. in vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. however, current evidence on the effects of berries on postprandial glycemic responses in humans is limited. the purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. it consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in finland and a reference meal without berries. the following combinations of carbohydrates and berries are studied: * studies 1-2: white wheat bread (starch) is consumed with several berry species * study 3: white wheat bread or rye bread is consumed with a mixture of berries * study 4: sugar (sucrose) is consumed with berries and berry nectars * study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.

Eligibility criteria:
inclusion criteria: * bmi 20-28 kg/m2 * normal fasting plasma glucose exclusion criteria: * smoking * diabetes or other chronic disease * antibiotic medication within the past 3 months * blood donation within the past month

Keywords: berries starch sucrose glucose insulin postprandial
carvedilol effect in preventing chemotherapy - induced cardiotoxicity

Conditions: Breast Cancer; Heart Failure; Cardiotoxicity

Summary: the purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies. initial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. this study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.these patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.

Eligibility criteria:
inclusion criteria: patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline. exclusion criteria: failure analysis of ventricular function; history of chemotherapy or radiotherapy; previous symptoms of heart failure; presence of cardiomyopathy; presence of coronary artery disease; aortic valve disease or moderate to severe mitral regurgitation; contraindication to the use of β-blocker; use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers. patients with her 2 expression

Keywords: breast cancer heart failure cardiotoxicity biomarkers
nutritional status in subacute stroke patients under rehabilitation 2.0

Conditions: Stroke

Summary: the nutristroke study's findings revealed a malnutrition scenario in post-stroke patients undergoing rehabilitation. this has highlighted the significance of a correct nutritional status assessment upon admission to a rehabilitation unit. the aim of nutristroke2, therefore, is the assessment of nutritional status, dietary intake, dysphagia, the presence of stroke-related sarcopenia, and systemic oxidative status in patients with subacute stroke outcomes before and after rehabilitation treatment. a secondary aim is to assess whether there is any correlation between nutritional status, dietary intake, dysphagia, sarcopenia, and systemic oxidative status with rehabilitation outcomes.


Eligibility criteria:
inclusion criteria: * stroke patients (hemorrhagic or ischemic) documented through magnetic resonance -imaging (mri) or computed tomography (ct); * time since stroke event within 6 months * sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent exclusion criteria: * presence of a previous stroke based on the medical history; * behavioral and cognitive disorders that may interfere with the therapeutic activity; * other orthopedic or neurological complications that may interfere with the rehabilitation protocol; * inability to understand and sign informed consent; * the presence of pacemakers (for interference with bioimpedance measures).