Kornimate/medical-research-clean huggingface dataset:
tcr-t cell immunotherapy of lung cancer and other solid tumors

Conditions: Nonsmall Cell Lung Cancer; Solid Tumor, Adult

Summary: tumor organoids and tils (and/or peripheral t cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. coculture will be utilized to screen tumor-responsive t cells which are further selected for monoclonal expansion and tcr cloning for engineered reconstitution of tcr-t cells. after verification by multiple in vitro and in vivo studies, a large number of tcr-t cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. in this phase i study, the safety, tolerance and preliminary efficacy of the tcr-t cell immunotherapy on human will firstly be assessed.

1. choose appropriate patients with kk-lc-1 expression in advanced lung cancer or other solid tumors and matched mhc-a11 typing, with written consent for this study; for cancer without expression of kk-lc-1, fresh tumor tissue should be obtained for rna/dna sequencing to computationally identify neoantigen peptides that can be captured by specifically personizedly synthesized poly-mhci which can be further used to fish appropriate t cells from the patient. 2. perform biopsy to obtain tissue from tumor/lymph node for organoids, tils, dc and t cells culture, coculture to screening anti-tumor t cells, establish and select monoclonal t cells for tcr cloning; 3. clone tcr sequence that targets kk-lc-1 or neoantigens; collect pbmcs from the blood of the patients, isolate and activate the t cells and generate the tcr-t cells; 4. test the quality and killing activity of the tcr-t cells in vitro and then transplant back the patients via systemic (vein and/or artery) or local injections, and follow up closely to collect related clinical data as needed; 5. evaluate the clinical results as needed.

Eligibility criteria:
inclusion criteria: 1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable 2. life expectancy \>12 weeks 3. child-pugh-turcotte score \<7 4. adequate heart,lung,liver,kidney function 5. available autologous transduced t cells with greater than or equal to 20% expression of targeted tcr sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay 6. informed consent explained to, understood by and signed by patient/ guardian. patient/guardian given copy of informed consent. - exclusion criteria: 1. had accepted gene therapy before; 2. tumor size more than 25cm; 3. severe virus infection such as hbv, hcv, hiv, et al 4. known hiv positivity 5. history of lung transplantation 6. active infectious disease related to bacteria, virus,fungi,et al 7. other severe diseases that the investigators consider not appropriate; 8. pregnant or lactating women 9. systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. other conditions that the investigators consider not appropriate.

Keywords: lung cancer; solid tumor immunotherapy tcr-t cell therapy
a pilot study to determine the safety of campath-1h (anti-cd52 antibody) therapy in newly diagnosed subjects with type 1 diabetes mellitus

Conditions: New Onset Type 1 Diabetes Mellitus

Summary: the rationale for the study is to determine if campath-1h can be used in patients recently diagnosed with type i dm, to induce a state of immunological unresponsiveness such that subjects can safely preserve beta cell mass and eliminate or lower insulin requirements, preserving excellent metabolic control.


Eligibility criteria:
inclusion criteria: * adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to gad, ia2, iaa or islet cell cytoplasmic antibody (ica) within 2 weeks of diabetes diagnosis. exclusion criteria: * subjects under 18 years of age or over 35 years of age. * subjects who have previously received an organ transplant. * subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated. * subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., cushing's disease, acromegaly). * subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (a history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.) * patients with a history of hepatitis b, hepatitis c, or hiv. * ppd positive at the time of evaluation. * thrombocytopenia or neutropenia. individuals will be considered to have thrombocytopenia if they have a platelet count \<100,000 platelets/mm2 or \<3,000 wbc/ml. * subjects with a history of renal, pulmonary, or cardiac failure * subjects with severe systemic infections. only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
safety and efficacy of sofosbuvir plus ribavirin in treatment-naive adults with chronic genotype 1 or 3 hcv infection

Conditions: Chronic HCV Infection

Summary: this study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (sof) + ribavirin (rbv) in treatment-naive adults with chronic genotype 1 or 3 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * hcv rna ≥10\^4 iu/ml at screening * confirmed chronic hcv genotype 1 or 3 infection * hcv treatment naive * approximately 30% of individuals may have compensated cirrhosis at screening exclusion criteria: * any other chronic liver disease * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * current or prior history of clinical hepatic de-compensation * contraindication to rbv therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia). * chronic use of systemically administered immunosuppressive agents * history of solid organ transplantation
virtual reality exposure therapy for public speaking anxiety

Conditions: Public Speaking; Social Anxiety; Social Anxiety Disorder, Performance Only

Summary: virtual reality exposure therapy (vret) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. this is arguably due to the limitations of the past generation of vr technology, which was expensive, inaccessible, cumbersome and hard to use. with the advent of consumer vr technology, vret is now ready for implementation in regular care. this multiple-baseline trial will examine the effectiveness of vret for public speaking anxiety (psa) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief vret training. participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. self-rated psa will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.


Eligibility criteria:
inclusion criteria: * have substantial public speaking anxiety (psas \>= 60) * can travel to pbm clinic on one occasion and pay stipulated patient fee * can speak and understand sufficient swedish * have stable access to the internet exclusion criteria: * deficits in sight or balance impacting the vr-experience * a severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar * active psychopharmacological treatment, unless stable for last 3 months * other ongoing psychological treatment
national survey of people with haemophilia in portugal

Conditions: Haemophilia

Summary: the purpose of this study is to implement a national survey to collect information regarding portuguese people with haemophilia (pwh) on socio-demographic, clinical and psychosocial factors.

this is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of portuguese people with haemophilia (pwh). all pwh, registered in the portuguese hemophilia association (aph) will be identified in aph registries and contacted through mail, in order to be invited to participate in the first portuguese survey on haemophilia. in case of acceptance, patients must sign the informed consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system. pwh of all ages are invited to participate in this survey. adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. parents of small children (0 to 9) will fill in the proxy versions. all questionnaires are adapted for the specific age groups. this study will comply with ethic guidelines and was approved by the life sciences and health ethics subcommittee (university of minho) and is registered on the portuguese authority for data collection (cnpd).

Eligibility criteria:
inclusion criteria: * haemophilia a or b * portuguese nationality exclusion criteria: * acquired haemophilia * psychiatric or neurological deficit

Keywords: haemophilia quality of life distress hemarthrosis pain
referral patterns for hospital acquired acute kidney injury and relevance to renal outcomes

Conditions: Renal Replacement Therapy; Mortality

Summary: few studies analyzed the referral time to nephrologists and its impact on the patient outcome in a large cohort. the investigators described the incidence and determined the outcome with respect to renal function recovery, renal replacement therapy (rrt) requirement and in-hospital mortality of hospital acquired acute kidney injury (ha-aki) without nephrology referral (nrha-aki) and late referred ha-aki patients to nephrologists (lrha-aki) compared with early referral patients (erha-aki). the patients included were admitted to the tertiary care academic center of lausanne (switzerland) between 2004 and 2008, in the medical and surgical services and in the intensive care unit (icu).


Eligibility criteria:
inclusion criteria: * adult patients. * hospitalization in the medicine and surgery wards and in the intensive care unit. * hospitalized patients with acquired acute kidney injury according to the * acute kidney injury network (akin)criteria. * ha-aki patients with no referral to the nephrologist (nrha-aki). * ha-aki patients referred late (more than five days \[\> 5 days\]) to the nephrologist (lrha-aki). * ha-aki patients early referred (within five days after scr increase) to the nephrologist (erha-aki). exclusion criteria: * patients with aki at the time of the hospital admission and during the first * 48 hours after admission. * patients hospitalized in other wards. * children under 18.

Keywords: no referral late referral acute kidney injury intensive care unit in-hospital mortality renal outcome requirement for renal replacement therapy length of hospital stay impact incidence
rfa of benign thyroid nodules: clinical outcomes and quality of life study

Conditions: Thyroid Nodules

Summary: the purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (mng) patients. this is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

benign multinodular goiter (mng) refers to an enlarged thyroid gland with nodules within it, frequently owing to iodine deficiency. it is the most common endocrine disorder worldwide. significant growths of nodules can cause symptomatic compressive symptoms such as dysphagia, dyspnea, or vascular compression of the neck vessels. on occasion, these nodules can develop autonomy and secrete excess thyroid hormone (toxic multinodular goiter). surgical resection has been the preferred treatment option for symptomatic multinodular goiters and addresses both compressive symptoms as well as hyperthyroidism, but is associated with small, but not negligible risk of nerve injury, hypoparathyroidism, and may confer a risk of hypothyroidism and dependence on thyroid hormone supplementation. thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for mng. monopolar radiofrequency ablation (rfa) is presently the best documented thermoablative technique. although rfa of thyroid nodules specifically, is still considered investigational in the united states, rfa of thyroid nodules has been used by several centers globally (mainly in south korea, italy, china, and austria) since 2006 with excellent clinical outcomes. in addition, rfa of other solid tumors is a commonly performed procedure in the united states and all rfa devices, including the device that we will use for the clinical care of these patients, are cleared by the fda (new devices/technology to the market are approved, but devices that have a predicate device/technology that are already on the market only need to be cleared). in response to its increasing popularity, the korean society of thyroid radiology commissioned a task force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012, and these recommendations were recently revised in 2017 and the american association of clinical endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules.

Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years old with benign thyroid nodules exclusion criteria: * cardiac arrhythmia * pregnancy

Keywords: radiofrequency ablation
standard operating procedures for anti-hpv (human papillomavirus) antibody detection in first-void urine (ab-sop study)

Conditions: Human Papilloma Virus Infection

Summary: the aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against hpv (human papillomavirus).

in total 57 women will be included in this trial: 38 vaccinated with an prophylactic hpv vaccine and 19 not vaccinated with a prophylactic hpv vaccine. these women are asked to collect a first-void urine sample with the colli-peetm device (novosanis). hereafter, a blood sample of 5-10 cc is collected. the collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.

Eligibility criteria:
inclusion criteria: * female * 18-26 year * cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (cervarix®) or quadrivalent (gardasil®) hpv vaccine (according to the kce (belgian knowledge centre for health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine). * cases should be able to prove their vaccination (brand and schedule) with an official document. * control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic hpv vaccine available (gardasil®, cervarix®, gardasil-9®) * signing informed consent form (icf). * giving consent to the research team (cev) to contact his/her general practioner and/or gynaecologist to access details of the participants hpv vaccination (schedule) and results of cervical smears/cytology, hpv tests, colposcopy, and biopsy (included in icf). exclusion criteria: * participating in another clinical study at the same time of participating in this study. * not able to understand the information brochure/what the study is about * anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Keywords: antibodies vaccination self-sampling first-void urine serum
study evaluating pneumococcal meningitis in the paediatric population in spain four years after the marketing of prevenar.

Conditions: Pneumococcal Meningitis

Summary: the aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in spain four years after the marketing of prevenar. also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.


Eligibility criteria:
inclusion criteria: * all children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.
the effect of kangaroo father care transport on preterm infants

Conditions: Nurse's Role; Preterm Birth; Fathers

Summary: this study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

this study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

Eligibility criteria:
inclusion criteria:neonatal related; * born by caesarean section, * born at 34-36+6 weeks gestation, * apgar score of 7 and above at 1 and 5 minutes, * stable and healthy, * infants with a body weight of 1500 g and above were included. it's about the father; * who volunteered to participate in the study, * no mental and psychological problems, * no communication problems (speech, hearing and severe visual impairment), * fathers who did not carry contact-transmitted diseases (covid-19, herpes simplex, scabies, etc.) were included. exclusion criteria:- congenital anomalies, * abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis, * receiving invasive and noninvasive respiratory support, * with chest tube and umbilical catheter, * foreign babies and their fathers were ostracized.

Keywords: father early kangaroo care preterm infant nurse transport
hypoxia-specific imaging to predict outcomes of chimeric antigen receptor t-cell therapy

Conditions: Recurrent Aggressive Non-Hodgkin Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent High Grade B-Cell Lymphoma; Recurrent Malignant Neoplasm; Recurrent Plasma Cell Myeloma; Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma; Refractory Aggressive Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory High Grade B-Cell Lymphoma; Refractory Malignant Neoplasm; Refractory Plasma Cell Myeloma; Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma

Summary: this study evaluates whether tumors present in patients with cancer who are planned to get car t-cells have low amounts of oxygen (hypoxia). pet scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called faza that specifically looks for areas of low oxygen. this study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well car t-cells kill cancer cells.

primary objective: i. to evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (r/r) malignancies before treatment with chimeric antigen receptor (car) t-cell therapy. secondary objective: i. to evaluate the association between intratumoral hypoxia and clinical responses to car t-cell therapy. exploratory objectives: i. to correlate intratumoral hypoxia with markers of car t-cell activity and toxicity. 2. to correlate pre-therapy fluorine f 18-fluoroazomycin arabinoside (18f-faza) uptake with pre-therapy 18ffluorodeoxyglucose (fdg) positron emission tomography (pet) uptake (if available). outline: prior to car t-cell therapy, patients receive 18f-faza intravenously (iv). beginning 2 hours after injection, patients undergo a single pet scan. patients are followed for up to 6 months after car t-cell therapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of: * aggressive lymphoma, including: diffuse large b-cell lymphoma (dlbcl) (including transformed disease), high-grade b-cell lymphoma, or primary mediastinal b-cell lymphoma * multiple myeloma (mm), with imaging within 6 months of enrollment demonstrating \>= 1 plasmacytoma measuring \>= 5 cm along any axis * other malignancy with radiographically measurable disease * r/r disease with planned receipt of car t-cell therapy at university of california, san francisco (ucsf), either through an food and drug administration-approved car construct or through a separate interventional clinical trial * ability to provide informed consent prior to study entry exclusion criteria: * any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures * pregnancy or active lactation
efficacy and safety study of darolutamide (odm-201) in men with high-risk non-metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer Non-Metastatic; Castration-Resistant

Summary: the purpose of this study is to assess the safety and efficacy of bay1841788 (odm-201) in patients with non-metastatic castration-resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features. * castration-resistant prostate cancer (crpc) with castrate level of serum testosterone. * prostate-specific antigen (psa) doubling time of ≤ 10 months and psa \> 2ng/ml. * eastern cooperative oncology group (ecog) performance status of 0-1. * blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl. * screening values of serum alanine aminotransferase (alt) and/or aspartate transaminase (ast) ≤ 2.5 x upper limit of normal (uln), total bilirubin ≤ 1.5 x uln, creatinine ≤ 2.0 x uln. * sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment. exclusion criteria: * history of metastatic disease at any time or presence of detectable metastases. * acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation. * prior treatment with: second generation androgen receptor (ar) inhibitors, other investigational ar inhibitors, or cyp17 enzyme inhibitor. * use of estrogens or 5-α reductase inhibitors or ar inhibitors. * prior chemotherapy or immunotherapy for prostate cancer. * use of systemic corticosteroid. * radiation therapy within 12 weeks before randomisation. * severe or uncontrolled concurrent disease, infection or co-morbidity. * treatment with bisphosphonate or denosumab within 12 weeks before randomisation. * known hypersensitivity to the study treatment or any of its ingredients. * major surgery within 28 days before randomisation. * any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure new york heart association (nyha) class iii or iv. * uncontrolled hypertension. * prior malignancy. * gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment. * active viral hepatitis, active human immunodeficiency virus (hiv) or chronic liver disease. * treatment with any investigational drug within 28 days before randomisation. * any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.