Kornimate/medical-research-clean huggingface dataset:
psychological impact of the hospitalization of a family member in intensive care for covid-19 infection

Conditions: Covid-19; Stress Disorders, Post-Traumatic; Anxiety; Depression

Summary: the hospitalization of a patient in intensive care is a traumatic experience for his family members. with the current covid-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of covid+ patients, and family are not allowed to visit. at the strasbourg university hospital, visits were prohibited from the start of the epidemic. information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time. the primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.


Eligibility criteria:
inclusion criteria: * family member of a covid-19 positive patient hospitalized in intensive care unit who gave his oral agreement following the communication of the notice of non-opposition. * a patient is considered to be covid + if the rt-pcr is positive or if characteristic images are taken with a chest scanner. * the family member included in the study is preferably the patient's support person. in the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor. exclusion criteria: * difficulties in understanding french

Keywords: covid-19 psychological impact family members
protein provision in critical illness

Conditions: Critical Illness; Intensive Care Unit Acquired Weakness

Summary: rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following icu admission. increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-icu function. the investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.

icu-acquired weakness (icu-aw) is frequent among icu survivors and negatively affects both short and long term outcomes. icu-aw is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of icu admission.therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after icu discharge are urgently needed. retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. current icu guidelines recommend dietary protein delivery at 1.3 g/kg/day (espen), or even up to 2.0 g/kg/day (aspen). however, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients. the focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. therefore, it is nowadays increasingly recognized to move primary icu trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.

Eligibility criteria:
inclusion criteria: * adult (18 years or above) patient admitted to the icu * unplanned icu admission * invasive mechanical ventilation initiated \<24 hours of icu admission * expected icu stay on ventilator support of 3 days or more exclusion criteria: * contraindication for enteral nutrition * moribund or expected withholding of treatment * kidney failure and 'no-dialysis'-code on admission * hepatic encephalopathy.(west haven grade 3 or 4) * body-mass index \< 18 kg/m2

Keywords: enteral nutrition dietary proteins respiratory failure catabolism
chronotropic incompetence during exercise in obese adolescents: clinical implications and pathophysiology

Conditions: Obesity; Adolescent Obesity

Summary: a reduction in peak heart rate (hr) and suppressed hr response during exercise is highly prevalent in obese populations. this phenomenon is also known as chronotropic incompetence (ci). in adult obese individuals, ci is independently related to elevated risk for major adverse cardiovascular events and premature death. despite the established association between ci and prognosis in adult populations, the prognostic relevance of ci in adolescents with obesity has however deserved no attention, but is important. ci during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. however, whether ci during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. in addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. in this project, we examine the prevalence of ci (during maximal cardiopulmonary exercise testing, cpet) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between ci and changes in cpet parameters, lactate, catecholamine and potassium concentrations during cpet, biochemical variables, and cardiac electrophysiology (by ecg recording). in addition, the relation between ci and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. in this regard, the diagnostic value of hr (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.


Eligibility criteria:
inclusion criteria: * aged 12-16 years * obese or lean (based on extended international (iotf) body mass index cut-offs for thinness, overweight and obesity) * parental permission exclusion criteria: - chronic cardiovascular, renal, pulmonary and orthopedic disease
clinical study to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (cteph)


Eligibility criteria:
inclusion criteria: * written informed consent * subject with cteph having completed the double-blind (db) ac-055e201/ merit-1 study as scheduled (i.e., who remained in the db study up to week 24). * females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception. exclusion criteria: * permanent discontinuation of db study treatment due to an hepatic adverse event or liver aminotransferase abnormalities. * any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Keywords: chronic thromboembolic pulmonary hypertension (cteph)
vascular endothelial inflammation and dysfunction in pediatric long-term cancer survivors

Conditions: Cancer Survivor; Pediatric Cancer

Summary: survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. the nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. we propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.


Eligibility criteria:
inclusion criteria: * 6-30 years of age * 2 years from the completion of therapy for cancer * free of active disease exclusion criteria: * \ 30 years of age * current cancer treatment or inside of 2 years post treatment * active disease/infection

Keywords: cancer survivors long-term cancer survivor
effect of bupivacaine liposomes or bupivacaine for femoral triangle or adductor block on analgesia after total knee replacement

Conditions: Knee Arthropathy; Knee Arthritis

Summary: the purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in tka ( total knee replacement ) patients.the main questions answered are: 1. is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement 2. which block method(femoral triangle block or adductor block) combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery. investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block. participants will: 1. receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. 2. undergo total knee replacement surgery under spinal anesthesia. 3. follow-up within 72 hours after surgery , opioid consumption, nrs score, pca（patient controlled analgesia，pca） data, first postoperative remedial analgesia time, quadriceps muscle strength and complications were recorded

the patients received femoral triangle block plus ipack(infiltration between popliteal artery and capsule of knee) block or adductor canal block plus ipack block during induction . the local anesthetic formulation was bupivacaine (0.75% bupivacaine hydrochloride 10ml+ normal saline 20ml) or bupivacaine liposome (0.75% bupivacaine hydrochloride 10ml+ bupivacaine liposome 20ml(266mg)).

Eligibility criteria:
inclusion criteria: 1. patients with asai-ⅲ 2. receive a unilateral initial tka 3. age 18-80 years old - exclusion criteria: 1. bilateral tka surgery 2. tka revision surgery 3. contraindications for nerve block and intraspinal anesthesia 4. allergies to local anesthetics 5. diabetic neuropathy 6. patients who are unable to cooperate with the evaluation 7. chronic use of opioid analgesics 8. bmi≥35kg/cm2 9. cases of lumbar anesthesia failure requiring general anesthesia surgery 10. cases of nerve block failure -

Keywords: knee arthropathy liposome bupivacaine femoral nerve block adductor canal block
effect of vibration exercise on upper limb strength, function, and pain

Conditions: Spinal Cord Injuries

Summary: the primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.

objectives: the primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia. experimental design: design: randomized control trial methods: twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (v-dt) group and a standard dumbbell training group (s-dt). both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. for each of the nine exercises the vibration group will hold a high-frequency (40 hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects. all participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .

Eligibility criteria:
inclusion criteria: * have a neurological impairment secondary to spinal cord injury (sci) or disease at t2 or lower * greater than 6 months post injury * use a manual wheelchair as primary means of mobility (at least 30 hrs. per week) * 18 to 65 years of age * provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program * live within 60 minutes driving time (1 hour) from the research center * able to perform a transfer independently to and from a wheelchair * have normal range of motion in the upper limbs. exclusion criteria: * history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities * upper limb pain that interferes with the ability to propel or transfer * recent hospitalization for any reason (within the past three months) * pregnant women * history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events
prospective investigation of multiple sclerosis in the three rivers region

Conditions: Multiple Sclerosis

Summary: in this longitudinal prospective natural history study of multiple sclerosis (ms), the overarching goal is to understand the factors that influence individual variation in disease trajectory and treatment response and pave the way for realizing precision medicine in ms. because ms is a chronic neurological disorder, this observational cohort study will span a 30-year time frame.

research activities: initial questionnaire, questionnaire for self-reported outcomes, biological sample collection (blood, stool, urine, cerebrospinal fluid), genetic analysis, standard quantitative assessment of function, cognitive assessment, neuroimaging, biometric sensors, social network questionnaire, connor-davidson resilience scale, neo five-factor inventory, and the covid19 response surveys.

Eligibility criteria:
inclusion criteria: * inclusion criteria for ms patients include: 1. willing and able to give consent 2. age 7 years or older 3. diagnosis of multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive mri scan or abnormal mri scans characteristic of ms but no clinical symptoms of the disease * for healthy controls: 1. age 7 years or older 2. willing and able to provide consent (for \>=18 years) or assent with permission from at least one of the child's parents (for \<18 years) 3. no known personal history of multiple sclerosis or related disorders 4. no other chronic diseases 5. family members, unrelated household controls, or controls from the general population could be eligible there is no exclusion criteria.
evaluation of optimal dosing conditions for glp-1 analogue nnc0113-0987 when administered orally in healthy male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to evaluate the optimal dosing conditions for glp-1 analogue nnc0113-0987 when administered orally in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male aged 18 between 55 years (both inclusive) at the time of signing informed consent * good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator * body mass index (bmi) between 18.5 and 29.9 kg/m\^2 (both inclusive) exclusion criteria: * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * blood pressure above 140 mmhg systolic and/or above 90 mmhg diastolic or pulse above 90 beats per minute at the screening visit * smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products) * history of significant drug abuse, or a positive drug test at the screening visit * any blood draw in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding the screening visit
femtosecond small incision lenticular extraction in comparison to femtosecond laser insitu keratomileusis regarding dry eye disease

Conditions: Dry Eye Disease

Summary: comparison of femtosecond small incision lenticule extraction (fs-smile) versus femtosecond laser insitu keratomileusis (fs-lasik) regarding dry eye disease (ded) and corneal sensitivity (cs) after those refractive surgeries.


Eligibility criteria:
inclusion criteria: * bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters exclusion criteria: * sign or symptom of dry eye disease (tear film breakup time (tbut) \>10 seconds * schirmer i test \>10 mm /5 minutes) * corneal or conjunctival staining * meibomian gland dysfunction * previous ocular and or eyelid medical or surgical treatment * pregnancy * chronic systemic disorder
aranesp and neulasta in patients with sarcoma receiving adriamycin and ifosfamide

Conditions: Sarcoma

Summary: to determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.

the use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. this trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. the once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.

Eligibility criteria:
inclusion criteria: * patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with ai is indicated * must be between 18-65 years of age * women of childbearing potential should use effective contraceptive measures * adequate hematologic, renal, and hepatic functions * karnofsky performance status above or equal to 80 exclusion criteria: * pregnant or lactating women. * patients with comorbid condition which renders patients at high risk of treatment complication * patients with metastatic disease to cns * patients with significant cardiac abnormalities * history of seizure disorder in the past 5 years * patient has received any packed red blood cell transfusion within 2 weeks before study entry * prior surgery or radiation therapy within 2 weeks of study entry * history of prior chemotherapy for sarcomas * iron deficiency * hypersensitivity to e.coli derived products

Keywords: aranesp darbepoetin alfa pegfilgrastim neulasta sarcoma adriamycin doxorubicin hydrocholoride adriamycin pfs adriamycin rdf ifosfamide
genetic evaluation of aaas gene in early-onset achalasia and alacrima patients

Conditions: Achalasia; Alacrima

Summary: the aaas gene has been known to cause achalasia, alacrima, adrenal abnormalities and a progressive neurological syndrome. a considerable proportion of achalasia patients have been known to show alacrima (decreased secretion of tears). however, the genetic mechanism between achalasia and alacrima has not been defined yet. the investigators postulated that some proportions of early-onset achalasia could be correlated with aaas gene; thus, the investigators aimed to investigate the relationship between the aaas gene and early-onset achalasia.


Eligibility criteria:
inclusion criteria: * early age onset * primary achalasia patient * less than 35 years old exclusion criteria: * secondary achalasia patients

Keywords: relationship between achalasia and aaas gene
safety and efficacy of rad001 + tace in localized unresectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this study will evaluate the role of everolimus in combination with local transcatheter arterial chemoembolization (tace) procedure in patients with localized unresectable hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation. * intermediate stage (stage b) (according to recognized guidelines) and suitable for tace therapy * at least one nodule between \> 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases. * must have 1 tumor which can be measured in 1 dimension according to specified criteria (recist and mrecist) and has not previously been treated with any type of therapy. * ecog performance status \< 2cm * cirrhotic status of child-pugh class a or early b * hbv-dna or hbsag positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug exclusion criteria: * any local and/or investigational drugs within 28 days prior to randomization * active bleeding during the last 28 days prior to screening including variceal bleeding * prior therapy with mtor inhibitors * tumor burden of \> 60% liver involvement * prior systemic or local therapy including tace except for the first tace at day 0), surgery or liver transplantation * failed first tace at day 0, cycle 1 for any reason * known history of human immunodeficiency virus (hiv) seropositivity (hiv testing is not mandatory) * alcohol intake of 80 grams per day * undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery * female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods other protocol-defined inclusion/exclusion criteria may apply

Keywords: localised unresectable chemoembolization