Kornimate/medical-research-clean huggingface dataset:
tislelizumab (anti-programmed cell death protein-1 (pd-1) antibody) in msi-h or dmmr solid tumors

Conditions: MSI-H/dMMR Solid Tumors

Summary: in this phase 2, single-arm, multi-center, open-label study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dmmr) or microsatellite instability-high (msi-h) will be treated with anti-pd-1 monoclonal antibody tislelizumab (bgb-a317).


Eligibility criteria:
key inclusion criteria: 1. having histological confirmed diagnosis of malignancy 2. having locally advanced unresectable or metastatic solid tumors with msi-h or dmmr 3. having received prior cancer therapy regimen(s) for advanced disease. 4. at least 1 measurable lesion as defined per recist version (v) 1.1 5. eastern cooperative oncology group (ecog) performance status ≤ 1 6. adequate organ function key exclusion criteria: 1. prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2 or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways 2. active leptomeningeal disease or uncontrolled brain metastasis. 3. clinically significant pleural effusion, pericardial effusion or ascites 4. active autoimmune diseases or history of autoimmune diseases that may relapse 5. any active malignancy 6. any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug 7. having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.) 8. participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management 9. having severe chronic or active infections 10. a known history of human immunodeficiency virus infection 11. child - pugh b or greater cirrhosis 12. any major surgical procedure ≤ 28 days before the first dose of study drug 13. prior allogeneic stem cell transplantation or organ transplantation note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: msi-h/dmmr solid tumors pd-1
a study to evaluate the efficacy and safety of tanfanercept (hl036) in dry eye disease

Conditions: Dry Eye

Summary: the objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of ded.

the purpose of this research study is to test the safety and effectiveness (how well the drug works) of tanfanercept ophthalmic solution 0.25% and tanfanercept ophthalmic solution 1% against vehicle (no active treatment). effectiveness will be measured by the improvement in schirmer test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). eye safety assessments will also be performed.

Eligibility criteria:
inclusion criteria: 1. are at least 18 years of age 2. provide written informed consent 3. are willing to attend all study visits and able to comply with study procedures and assessments 4. have a self-reported history of ded (ou) for at least 6 months prior to visit 1 exclusion criteria: 1. have an uncontrolled systemic disease 2. have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to visit 1, whichever is longer
biofeedback effects on nursing personal at an university hospital

Conditions: Stress (Psychology); Biofeedback, Psychology

Summary: randomized clinical trial comparing two groups: placebo group without self-monitoring of heart rate variability (hrv) and biofeedback intervention that includes self-monitoring of hrv

its main objective is to evaluate the effects of biofeedback intervention on the stress, and anxiety levels, as well as the quality of professional life, and their coping mechanisms, of a nursing staff from de hospital de clínicas de porto alegre. the research will have two phases, first to select the nursing staff sample, and then to apply and evaluate the intervention. from 2.219 individuals will be randomly drawn a sample of 272 participants. all will respond a questionnaire (vasconcelos symptoms and stress list) in order to obtain a general level of stress score greater than 1 (inclusion criteria to enter the rct). the 272 group will be randomly split in two groups (136 subjects each) to compare the intervention vs placebo.

Eligibility criteria:
inclusion criteria: * nursing staff * both sexes * working activities * admitted in the last 90 days * presenting a level stress greater then 1 exclusion criteria: * pregnant and breast feeding professionals * those away from work a long time, and or returning from vacations in the last 15 days. ----participants with any kind of cardiac pathology

Keywords: nursing staff
volumetric analysis of hepatocellular carcinoma after transarterial chemoembolization

Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage

Summary: the application of transarterial chemoembolisation (tace) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. the registry has the following objectives: to assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors to determinate interobserver variability of the methods.

the patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (tace) with drug-eluting beads are included in the study. the investigators assess the response to the treatment by standard methods (recist, mrecist) as well as by volumetric analysis. the size of tumor is evaluated on ct/mri by two investigators prior to first tace and then on all the check-ups (routinely every three months) until 31 december, 2019 or the patients' death.

Eligibility criteria:
inclusion criteria: * diagnosis of hcc by a radiologist according to the european association for the study of the liver (easl) criteria or confirmed histologically * at least one tace undergone at the university hospital brno * initial/ closing ct (brillance 64, philips, netherlands; contrast enhancement 125 ml iomeron 400, bracco, germany) or mri study (achieva, philips, netherlands, sense xl torso coil 16 1.5t; contrast enhancement 15 ml primovist, bayer, germany) * follow-up on or before december 31, 2019. exclusion criteria: * when the inclusion criteria are not met.

Keywords: transarterial chemoembolization recist mrecist volumetric analysis
effects of intranasal corticosteroid and montelukast on nasal allergen challenges*

Conditions: Allergy

Summary: this study will be a randomized, double blind, placebo-controlled, parallel group study and will include subjects with ragweed-induced seasonal allergic rhinitis.

the primary goal of this proposal is to assess the ability of an intranasal corticosteroid, fluticasone, and montelukast to affect the upper airway and systemic physiologic, biologic and clinical parameters occurring after an early and late upper airway allergic response to ragweed in ragweed allergic rhiniticsthe assessment of early allergy responses in the nose has been fairly well established in our laboratory and we will use methods detailed in previous publications (21, 23 24). one potential challenge will be to sample upper airway mediators and cytokines without affecting clinical parameters such as symptom scores and acoustic rhinometry readings. moreover, we will need to sample at time points throughout six or more hours in order to accurately determine the effects on late phase allergic responses. nasal filter paper sampling is a technique that we are currently engaged in using, and we will work with roche to elute the samples and measure multiple mediators and cytokines.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 19-60 years. * females of child bearing potential must use appropriate birth control throughout the study and urine pregnancy tests must be negative prior to dosing at each study visit. * subjects with a documented history of ragweed-induced seasonal allergic rhinitis requiring pharmacotherapy during the preceding 2 allergen seasons. * subjects with a positive skin prick test to short ragweed (amb a 1) extract, defined as \>3mm wheal larger than saline control * subjects spirometry fev1 must be \> 80% predicted prior to each allergen challenge * subjects average post diluents nasal congestion score must be \< 1 at admission for each study visit exclusion criteria: * subjects with evidence or history of clinically significant medical illnesses other than changes related to allergic rhinitis. subjects with some stable chronic medical conditions not expected to interfere with the conduct or safety of the study may be eligible to participate based on the investigator's discretion. * subjects with a history of asthma or urticaria, or a screening fev1 prior to allergen challenge of \<80% of predicted. in fev1 compared to pre-diluent fev1 baseline at either screening visit. * subjects with significant nasal deformity, recent nasal surgery nasal polyps or chronic rhinosinusitis. * subjects who have smoked in the last 6 months or have a history of \>10 pack years. * subjects who are taking or have taken restricted concomitant medications that could confound the safety or efficacy assessments including those shown below. * subjects who have history or evidence of alcohol or drug abuse. * subjects exposed to cat and have a positive skin test to cat. * subjects that have a positive skin test to dust mite (d pteronyssinus/ d farinae) requiring pharmacotherapy

Keywords: ragweed allergies acoustic rhinometry nasal allergen challenge
stem cell transplantation in cirrhotic patients

Conditions: Liver Cirrhosis

Summary: chronic liver disease end by liver cirrhosis and increases the risk of cancer development. chronic liver disease in egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection. liver transplantation is still the standard treatment for advanced decompensated liver cirrhosis. however, this treatment is quite limited in clinical practice. therefore there is a concerted effort around the world to develop regenerative and alternative therapies, so, stem cell-based therapies are emerging as new alternatives to liver transplantation for end-stage liver pathologies.

this study aimed to transplant autologous bone marrow derived mesenchymal stem cells to the patients with liver cirrhosis to assess liver tissue regeneration, efficacy and safety of stem cell therapy and finally to establish an alternative treatment modality to liver transplantation. medical treatment of liver cirrhosis (the last stage of the illness) is very difficult that leads to high morbidity and mortality rate. liver transplantation is still the most effective treatment for the patients with liver cirrhosis, however, serious problems are accompanied with liver transplantation, donor shortage, long waiting list, high cost, risk of rejection, operative complications and complications related to immunosuppressive drugs. "stem cells" are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types and can be differentiated to specialized cells in appropriate medias in the laboratory. in recent years, advances in stem cell biology, have made the prospect of tissue regeneration a potential clinical reality, and several studies have shown the great promise that stem cells hold for therapy. mesenchymal stem cell based therapy has shown as promising tool in cirrhotic conditions as this type of cells have the ability to differentiate to different cell types including hepatocytes a series of studies have been performed to assess the application of bone marrow derived mesenchymal stem cells to promote liver regeneration and to alleviate cirrhosis. some animal-based studies showed that stem cell transplantation could ameliorate liver fibrosis and improve liver functions followed by several clinical trials on human, in patients with advanced liver diseases, these studies demonstrated that stem cell transplantation could significantly reverse hepatic failure with only limited side effects. however, the effectiveness of this therapy in recent clinical trials is still conflicting and need further evaluation.

Eligibility criteria:
inclusion criteria: * decompensated liver cirrhosis child class b or c exclusion criteria: * patients with portal vein thrombosis, or * recent recurrent gastrointestinal bleeding, or * hepatocellular carcinoma (hcc), or * spontaneous bacterial peritonitis * pregnant or lactating women * vital organs failure

Keywords: mesenchymal stem cells liver cirrhosis stem cell therapy
platelet-rich-plasma treating tennis elbow

Conditions: Pain

Summary: the study is to compare the efficacy of autologous platelet concentrate injections to corticosteroid injection in patients suffering from tennis elbow with respect to pain and function.

patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. data will be collected before the procedure, 4, 8, 12, 26 weeks and 1 year after the procedure. the main outcome measures of this study are pain and function measured with questionnaires.

Eligibility criteria:
inclusion criteria: * patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon exclusion criteria:

Keywords: tennis elbow
evaluation of a quality improvement project on impacted fetal head at cesarean section

Conditions: Obstetric Labor Complications; Cesarean Section

Summary: this study is an evaluation of a quality improvement (qi) project addressing delivery of the impacted fetal head being conducted at regions hospital. this study aims to determine the morbidity of second stage cesarean deliveries before and after implementation of simulation protocols that address delivery of the impacted fetal head for ob/gyn surgeons, nursing staff, and surgical technicians at regions hospital.

cesarean deliveries performed during the second stage of labor can be difficult due to impaction of the fetal head deep in the maternal pelvis and is associated with increased risk of both maternal and perinatal complications. there is little existing data to inform management of deeply impacted fetal heads, therefore these situations can be difficult for surgeons and other healthcare staff when they arise. team simulations for obstetric emergencies have been shown to assist with provider comfort, improved clarity of thinking, and quicker action during emergency situations resulting in improved outcomes. this study aims to show that a simulation education project for the entire obstetric team can decrease morbidity of difficult fetal head extraction associated with second stage cesarean deliveries and improve provider and nursing staff confidence regarding anticipation and management of this emergency. the simulation education project is not being conducted for the purpose of research, but is a department-wide educational activity and quality improvement project.

Eligibility criteria:
inclusion criteria: patient: the patient study population includes all patients age 18-45 who underwent cesarean section during the second stage of labor (during the time period july 2016-june 2019 at regions hospital and methodist hospital) and their infants. second stage is defined as the time between complete cervical dilation and delivery of the infant. medical staff: all staff members (staff physicians, residents, nurses, surgical technicians) at regions hospital who practice in the birth center who underwent required simulation education regarding delivery of impacted fetal heads during second stage cesarean section and completed the surveys as part of the qi project. note: medical staff were not enrolled in the research study; rather, staff survey data from the qi project was a data source for the study. exclusion criteria: patient: exclusion criteria include patients who underwent cesarean section in second stage for malpresentations (i.e., breech and noncephalic presentations) and patients who underwent cesarean section prior to 37 weeks gestation. medical staff: no exclusion criteria
characterization and kinetic of chemotherapy-induced cardiovascular toxicity in breast cancer

Conditions: Breast Cancer

Summary: the combination of epirubicin-cyclophosphamide (ec) and paclitaxel (tax) is one of the main chemotherapy treatments used in breast cancer patients. these treatments, which can be combined with anti-her2 therapy using trastuzumab, are frequently associated with side effects including cardiac toxicity. however, this cardiac toxicity has only been demonstrated several months after treatment and using global indices such as ejection fraction. the assessment of myocardial dysfunction using regional deformations and the kinetic of this dysfunction during chemotherapy treatment has never been performed. in order to counteract these myocardial dysfunctions, it is essential to better describe the kinetic of the cardiac toxicity by initiating measurements since the beginning of the treatment, in order to be able to propose adapted countermeasures (e.g. exercise training) in parallel with the chemotherapy.


Eligibility criteria:
inclusion criteria: epirubicin-cyclophosphamide + paclitaxel group: * female ≥ 18 years * stage i to iii breast cancer * patient being planned for (neo)adjuvant therapy combining ec and taxol on a weekly basis * enrolled in a social security plan * able to speak, read and understand french trastuzumab group: * female ≥ 18 years of age * stage i to iii breast cancer * patient treated with trastuzumab * enrolled in a social security plan * able to speak, read and understand french exclusion criteria: for both groups: epirubicin-cyclophosphamid + paclitaxel group and trastuzumab group * implantation of a pacemaker * contraindications to exercise * protected adult * psychiatric, musculoskeletal or neurological problems * pregnant or breastfeeding woman * uncontrolled high blood pressure * body mass index \> 35 kg/m²
safety and efficacy of an immune response modifier to treat inoperable advanced melanoma skin lesions

Conditions: Melanoma

Summary: study 1501-852a is a phase 1 study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. the study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.


Eligibility criteria:
inclusion criteria: * have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * have a life expectancy of 4 months * have normal organ and bone marrow function exclusion criteria: * need for non-steroidal anti-inflammatory drugs (nsaids) during the study * have a body mass index (bmi)\> 30 kg/m2 * have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months * have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis b or c, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements * have a history of disease requiring ongoing steroid treatment * have a history of seizure disorder (other than febrile seizures in childhood) * have a history of clinically significant coagulation or bleeding disorders or abnormalities * are hiv positive. hiv positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852a and because of potential pharmacokinetic interactions associated with combination retroviral therapy.

Keywords: advanced metastatic melanoma
effect of cetylpyridinium chloride (cpc) rinse in viral upper respiratory tract infections (vurti)

Conditions: Viral Pharyngitis

Summary: this is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will receive either vitis cpc protect® mouthwash (mouthwash with cetylpyridinium chloride (cpc) as an anti-plaque antiseptic at a concentration of 0.07%) or mouthwash without cetylpyridinium chloride, as control group subjects included in the study will be followed for 90 days. symptoms associated with vurtis (viral upper respiratory tract infections) should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. symptoms and adverse effects will be recorded when the episode occurs. the assignment as vuris will be made by the investigator once the diaries have been completed, or during the symptoms if possible.

this is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will be included. allocation ratio (1:1). the trial will be offered to subjects who live in a nursing home and who can perform mouthwashes themselves or to whom healthcare professionals can apply the product. subjects included in the study will be followed for 90 days. symptoms associated with vurti should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. if such an infection exists (when three of the following symptoms are present: fever over 37º, non-productive cough, sore throat, runny nose, nasal congestion or malaise) the degree of severity will be determined and recorded. symptoms and adverse effects will be recorded when the episode occurs. the assignment as vurti will be made by the investigator once the diaries have been completed, or during the symptoms if possible. follow-up visits will be conducted fortnightly

Eligibility criteria:
inclusion criteria: * subjects admitted to nursing home * subjects who have had a washing period of 2 months since the last use with mouthwashes. * \> age 65 * subjects who are able to do mouthwashes or receive oral hygiene by caregivers * delivery of the participant information sheet (hip) and signing of the informed consent (ic) to subjects or legal guardians of the subjects who agree to participate. exclusion criteria: * subjects who are suffering from an upper or lower airway infection at the time of recruitment * subjects who are physically or psychologically unable to perform mouthwashes or receive oral hygiene with gauze or cotton soaked in antiseptic * subjects who have used oral antiseptics continuously in the past month * use of oral hygiene measures outside the study conditions * subjects who frequent residences, but are not admitted (e.g. day centre) subjects or legal guardians of subjects who do not provide their ic to participate subjects who have a registered allergy to the product or to the excipients of the product.

Keywords: cpc viral upper-respiratory infections