Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, and pharmacodynamics of tislelizumab monotherapy and multiple tislelizumab-based immunotherapy combinations in participants with resectable non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a randomized, open-label, multicenter, phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in chinese participants with resectable stage ii to iiia non-small cell lung cancer (nsclc). the study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 * histologically confirmed stage ii-iiia nsclc (per the eighth american joint committee on cancer/union internationale contre le cancer \[nsclc\] staging system) * evaluation by an attending thoracic surgeon to confirm eligibility for an r0 resection with curative intent * adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization * provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained ffpe slides of the primary tumor for biomarker evaluation during screening exclusion criteria: * any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment) * prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4, anti-cell immunoglobulin and itim domain (tigit), anti-lymphocyte activation gene-3 (lag-3), or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways * has mixed small cell lung cancer * participants with large cell neuroendocrine carcinoma (lcnec) * the presence of locally advanced unresectable nsclc regardless of stage or metastatic disease * known egfr sensitizing mutations and/or alk rearrangement note: other protocol defined inclusion/exclusion criteria may apply.
promoting stress management and resilience among individuals with von hippel- lindau disease

Conditions: Von Hippel-Lindau Disease; Genetic Disorder

Summary: the relaxation response resiliency program (3rp) has shown efficacy in improving coping and resilience across diverse populations; however, little is known about how it helps individuals manage the challenges of living with a chronic illness. this study proposes to pilot test an adapted version of the 3rp among patients living with vhl.

the 3rp has not been carried out with vhl patients. as such, the investigators are looking to see if an adapted program, tailored to the needs of patients with vhl, is feasible, acceptable, and helpful in improving coping among individuals living with vhl. this study is a two phase trial. phase i is descriptive. it is comprised of conducting interviews with patients and caregivers to understand the challenges of living with vhl and patient's programatic needs. this information will be used to tailor the program for patients living with vhl. phase ii is a single-arm feasibility trial that will examine if the adapted program is feasible, acceptable, and helps promote stress management among vhl patients. to these means, we will test the adapted 3rp (3rp-vhl) in up to 40 patients living with vhl. participants will complete surveys at baseline and post 3rp-vhl program completion. this record will reflect the trial component (phase ii) only, as feasibility and acceptability outcomes will be collected for this phase.

Eligibility criteria:
inclusion criteria: * ages 18+ * confirmed diagnosis of vhl exclusion criteria: * is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study pi). * unwilling or unable to participate in study sessions delivered via partners telehealth videoconferencing. * participated in phase 1 qualitative interview.

Keywords: von-hippel-lindau disease vhl genetic disorder
bilateral bispectral index (bis)-monitoring in trauma surgery

Conditions: Knee Replacement Surgery

Summary: the principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (bis) monitoring during induction and maintenance of anesthesia. otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.


Eligibility criteria:
inclusion criteria: - exclusion criteria: asa iv, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-

Keywords: trauma patients
the effects of an infant formula containing probiotic cect7210 on gastrointestinal health

Conditions: Gastrointestinal Diseases

Summary: the purpose of this study is to determine whether an infant formula supplemented with a new probiotic cect7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.

this a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, bifidobacterium longum biovar infantis cect7210, on the incidence of diarrhea in healthy infants born at term. infants will be randomized to take an standard infant formula or the infant formula with the probiotic cect7210 during 12 weeks.

Eligibility criteria:
inclusion criteria: * full-term healthy newborns (\>= 37 weeks) * birth weight between \>=2.500g and \<=4.500g) * normal growth curve (between 3-97 percentiles) * 0-60 days of age on enrolment * maximum 30 days of breastfeeding * exclusively infant formula on enrolment * breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment * parents or caregivers agree to exclude any source of prebiotics or probiotics during the study * parents or caregivers agree to follow-on the study 12 weeks * informed consent signed ( parent/legal representative) exclusion criteria: * congenital illness or malformation that may affect infant feeding and /or normal growth * significant pre-natal or post-natal diseases * infant's family history of atopy * any pathology related to the immune or gastrointestinal system. * suspected or known allergy to cow's milk protein * infants receiving pre or probiotics within less than 15 days prior to enrolment * infant's family who in the investigator's assessment cannot be expected to comply with the protocol

Keywords: probiotics infant formula microbiota bifidobacterium longum biovar infantis cect7210 growth
effects of gw572016 in combination with docetaxel (taxotere)

Conditions: Neoplasms, Breast

Summary: this is a safety and tolerability study of gw572016 given with docetaxel (taxotere).


Eligibility criteria:
inclusion criteria: * advanced solid tumors. * able to swallow oral medication.

Keywords: tumor
a prospective observational study on the use of a self fixating lightweight polyester mesh in open inguinal hernia

Conditions: Hernia, Inguinal

Summary: this study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the philippine setting. it will result in a comparable recurrence rate as published for the traditional lichtenstein approach.

the specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the philippines. the primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).

Eligibility criteria:
inclusion criteria: * age 18-80 years * informed consent * primary inguinal hernia suitable for open inguinal repair * reducible hernia exclusion criteria: * incarcerated non reducible hernias * bleeding disorders * patients below 18 (lower age limit) and above 80 (upper age limit) years old * hernia defects of greater than 4 cm

Keywords: inguinal hernia self-fixating mesh progrip hernia recurrence mesh, surgical recurrence
a 6-month follow-up study of patients with severe fever with thrombocytopenia syndrome

Conditions: Severe Fever With Thrombocytopenia Syndrome

Summary: this is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. all hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.


Eligibility criteria:
inclusion criteria: * age and gender are not limited; * hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (sftsv)-specific igm antibody positive or igg antibody level increased more than 4 times; or positive for sftsv rna; or positive for sftsv nucleic acid detected by real-time fluorescent quantitative rt-pcr; or sftsv isolated from case specimens. exclusion criteria: * patients who were found to be positive for other tick-borne pathogens by pcr analysis of blood samples in the acute phase; * it is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely; * no outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch; * due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone; * currently participating in clinical trials of other drugs or medical devices; * the researchers think it is not suitable for inclusion.
sorbact tm: effect of a microbial binding dressing on wound healing after pilonidal sinus excision

Conditions: Sinus Pilonidal

Summary: sinus pilonidal concern 26/100 000 young adults. it manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (algosteril®). the objective is to show a better efficiency of sorbact tm (trademark) dressings compared to alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. the main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with algosteril tm compared to 70% of wounds healed with sorbact tm.


Eligibility criteria:
inclusion criteria: * man or woman over 18 years old * informed consent signed by the participant * affiliation to social security system * having a pilonidal sinus: * asymptomatic or discovered by the patient during a routine examination * with chronic recurrent infection and skin rupture exclusion criteria: * patients with concomitant pathology: * cancer treated by chemotherapy * hypertension uncontrolled systolic blood pressure\>180 mmhg or diastolic\> 110 mmhg * severe comorbidity with reduced life expectancy less than 12 months * acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion * patients participating in another clinical trial * known for intolerance to one of the dressings * known pregnancy * uncontrolled diabetes (fasting glucose \>2g/l)

Keywords: sorbact tm alginates dressing wound healing
diabetes em movimento® - community-based lifestyle intervention program for patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Diabetes-Related Complications

Summary: type 2 diabetes is a chronic disease that affects approximately 13% of portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. this study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. patients with diagnosed type 2 diabetes at least for six months; 2. both genders; 3. aged between 50 and 80 years old; 4. non-smokers; 5. not engaged in supervised exercise; 6. community-dwelling; 7. medical recommendation for lifestyle intervention; 8. known medical history; 9. diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy; 10. no cardiovascular, respiratory and musculoskeletal contraindications to exercise; 11. no gait and balance problems; 12. not taking insulin or sulfonylureas for less than three months; 13. volunteer participation with signed informed consent. exclusion criteria: 1. participation in another supervised exercise program during the study; 2. participation in another supervised dietary intervention during the study; 3. aggravation of a diabetes complication or another major health problem;

Keywords: community-based intervention exercise program dietary intervention program health promotion subjective well-being cardiovascular risk
use of a voice assistant to improve mental health in older people

Conditions: Depression; Loneliness; Anxiety; Quality of Life

Summary: the main objective of this study is to evaluate the effectiveness of dial (an innovative and user-friendly solution based on multiplatform voice assistive technologies) in reducing unwanted loneliness and increasing the mental health and the quality of life in individuals over 65 years old. additionally, a secondary objective is to evaluate the experience of using the system, including aspects of usability and satisfaction, and to analyze whether the functionalities provided by dial contribute to the improvement of various dimensions in the lives of the elderly. it is hypothesized that dial will reduce unwanted loneliness and improve mental health in older people. in addition, we aim to obtain positive ratings in terms of usability and satisfaction with dial, along with the verification that most of the functionalities provided by dial will be useful to older people.

the main objective of this study is to evaluate the effectiveness of dial in reducing unwanted loneliness and increasing the mental health and the quality of life of elderly people. additionally, a secondary objective is to evaluate the experience of using the system, including aspects of usability and satisfaction, and to analyze whether the functionalities provided by dial contribute to the improvement of various dimensions in the lives of the elderly. for this purposes, a randomized controlled trial with a control group and an experimental group will be conducted in valencia at the end of 2023. participants in the experimental group will use dial for four weeks. all participants will complete different measures of mental health and quality of life, as well as measures related to the experience of using dial. mixed anova tests will be used to determine if there were statistically significant differences between the different measures evaluated. an alpha of 0.05 will be taken as the confidence level. in addition, a descriptive study will be conducted on the variables related to the dial user experience. it is hypothesized that dial will reduce unwanted loneliness and improve mental health in older people. in addition, we aim to obtain positive ratings in terms of usability and satisfaction with dial, along with the verification that most of the functionalities provided by dial will be useful to older people.

Eligibility criteria:
inclusion criteria: * 1) be 65 years old or older, 2) speak spanish, 3) meet at least one criterion of vulnerability to suffering unwanted loneliness (the criteria will be taken from the european report by baarck et al. 2021. for example, being a widower, have a physical illness...), 4) ability and willingness to participate in the study. exclusion criteria: * 1) present cognitive impairment, 2) suffer from a serious mental problem (e.g. depression, schizophrenia) or 3) suffer from a serious physical problem (e.g. blindness or deafness) that makes interaction with the device difficult.
a study of cellcept (mycophenolate mofetil) in combination therapy in liver transplant patients.

Conditions: Liver Transplantation

Summary: this 2 arm study will compare the efficacy and safety of two cellcept-containing treatment regimens in de novo liver transplant patients. patients will be randomized into one of two groups, to receive either cellcept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose cellcept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * recipient of a first orthotopic liver transplant. exclusion criteria: * history of organ transplants; * patient receiving a multi-organ transplant; * calculated creatinine clearance \<=30ml/min before transplant; * leukocyte count \< 2000/mm3 at randomization; * history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer; * pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
the correlation between iodine and selenium status in pregnancy and risk of thyroid disease

Conditions: Iodine Excess in Pregnancy; Selenium Excess in Pregnancy; Iodine Deficiency in Pregnancy; Selenium Deficiency in Pregnancy

Summary: two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.

the study will recruit 290 pregnant women with gestational age less than 20 weeks. iodine and selenium condition will be evaluated through dietary recall (on base of chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). the nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. the information of thyroid function and level of anti-tpo and anti-tg will be collected. and all the complications (especially thyroid disease) in pregnancy will also be recorded. all pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.

Eligibility criteria:
inclusion criteria: * clinical confirmation of being pregnant. * being within less than 20 weeks of gestationa. exclusion criteria: * being pregnant but over 20 weeks of gestationa. * mentally or psychologically unstable.
collection of primary human

Conditions: Nasal Disease

Summary: treatment and prevention of respiratory infections are of great interest in many medical areas. create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. in this context the aim of this project is to create a collection of primary cells from the human nasal epithelium. this collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.

the treatment and prevention of respiratory infections caused by emerging viruses or antibiotic-resistant bacteria are major societal and medical challenges. inhalation allows drugs to be administered in the form of a spray or aerosol, directly into the respiratory tract (nose or lung). this is a validated approach for the non-invasive delivery of drugs to prevent and treat respiratory diseases, particularly infectious ones. primary human nasal cell cultures grown at the air-liquid interface are an excellent 'ex vivo' model for their study in a physiological and pathophysiological context, and for testing new therapies, including aerosols. in addition, this culture model also offers an alternative to animal experimentation. the aim of this project is therefore to create a collection of primary cells from the human nasal epithelium. the main objective is to obtain a minimum of 60 samples of nasal epithelial cells from patients that can be cultured in air-liquid interface. the secondary objectives are to be able to study these nasal cells under physiological and pathophysiological conditions. the cells will first be amplified to constitute a cell biobank. they will then be studied under physiological conditions (anatomical and functional characterisation). finally, they can be used to establish different models of infection or inflammation, in order to test future aerosol drugs.

Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 years) whose native language is french, or who understands french. * affiliation with a french social security system (cmu accepted). * informed consent, written and signed by the participant. * planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well) exclusion criteria: * patients under court protection, guardianship or curatorship. * pregnant or breast-feeding women (positive pregnancy test for women of childbearing age). * patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.

Keywords: nasal cells respiratory epithelium