Kornimate/medical-research-clean huggingface dataset:
pro1160 for advanced solid and liquid tumors (pro1160-001)

Conditions: Renal Cell Carcinoma; Nasopharyngeal Carcinoma; Non Hodgkin Lymphoma

Summary: brief summary: this study will test the safety, including side effects, and determine the characteristics of a drug called pro1160 in participants with solid tumors. participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). this phase 1/2 study will have two parts. part a of the study will find out how much and how frequently pro1160 should be given to participants. part b will use the dose and schedule found in part a to find out how safe pro1160 is and if it works to treat the diseases under study. the diseases under study will be renal cell carcinoma (rcc),nasopharyngeal carcinoma (npc) and non-hodgkin lymphoma (nhl).

this is a phase 1/2 study of pro1160, a cd70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, pk, and antitumor activity of pro1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. this study consists of 2 parts, part a: dose escalation and part b: dose expansion. part a may evaluate up to 7 dose levels of pro1160 on day 1 of a 21 day cycle by iv infusion. part b will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical pk, pd and activity data from part a in up to 4 different cohorts of up to 20 patients per cohort. patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death.

Eligibility criteria:
inclusion criteria: * pathologically confirmed metastatic or unresectable solid malignancy including renal cell carcinoma, nasopharyngeal carcinoma or stage iii or iv non hodgkin lymphoma * relapsed or refractory disease following prior systemic therapies known to confer medical benefit * willing to provide a tumor sample (archive tissue or fresh biopsy) * ecog performance status 0 or 1 * measurable disease per recist v1.1 for rcc and npc and per lugano for nhl exclusion criteria: * prior treatment with anti-cd70 directed therapy * other malignancy within 3 years * active cns metastases (treated, stable cns metastases are allowed) * uncontrolled grade 3 or greater infection within 2 weeks * positive for hbv, hcv or hiv * use of a strong p450 cyp3a inhibitor within 14 days (dose escalation only) * additional protocol defined inclusion/exclusion criteria may apply
pas for post-sci neuropathic pain

Conditions: Spinal Cord Injury Cervical; Neuropathic Pain

Summary: the investigators have shown in incomplete sci patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. in this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level sci and sci- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.


Eligibility criteria:
inclusion criteria: * incomplete cervical spinal cord injury * time from injury at least 1.5 years * chronic sci- induced neuropathic pain in the upper limb exclusion criteria: * diagnosed brain damage, visible in mri or ct. * no activity in hands/fingers and no meps recorded from distal hand muscles. * epilepsy * metal inclusion in the head area * high intracranial pressure * pacemaker * implanted hearing device * progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases). * previous head or spinal cord injury affecting the motor performance of upper extremities. * congenital anomaly in the anatomical structure of spinal canal/cord or dura. * significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures. * acute severe infection. * contraindications for mri. * current severe psychiatric diseases. * current chronic drug and/or alcohol abuse. * pregnancy. * pressure ulcer affecting the subject's capability to undergo the procedure safely
exploring the safety and efficacy of low-dose ketamine infusions for pain control in acute burn injury

Conditions: Pain

Summary: the purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.

this aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. while the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.

Eligibility criteria:
inclusion criteria: * acute burn injury comprising 10-30% of total body surface. burns severity may include second or third degree burns * burn injury must have occurred within 72 hours of enrollment and randomization * subjects may be opioid-naïve or opioid non-naïve * anticipated stay in the burn unit is greater than 4 days, which is typically the minimum length of stay for patients with this level of burn injury exclusion criteria: * burn injury older than 72 hours * acute burn injury comprising \>30% total body surface * patients who are intubated * patients who have contraindication to ketamine administration
image guided adaptive radiotherapy in the head-and-neck region

Conditions: Head and Neck Neoplasms

Summary: aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy concept. this involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat ct scans. it is investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "redeform" can be implemented in clinical routine.

aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy (art) concept. this involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat ct scans. it is prospectively investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "redeform" can be implemented in clinical routine. for that purpose 2 repeat ct scans are acquired during the radiotherapy course (week 3 and week 5 of radiotherapy). the initial ct scan is "matched" to the follow-up ct-scan by means of deformable image registration.

Eligibility criteria:
inclusion criteria: * patients with histo-pathologically verified malignancies in the head-and-neck without clinical signs of dissemination, who consented in radiotherapy or radio-chemotherapy. exclusion criteria: * previous radiation therapy for head-and-neck
intravitreal injections-related anxiety

Conditions: Age-related Macular Degeneration

Summary: intravitreal injection of ranibizumab (lucentis, genentech) is clinically indicated for patients with wet age-related macular degeneration (amd) an disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". in addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (vegf) agents. the purpose of our study is to determine whether visual education on amd and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.

the use of intravitreal injections of ranibizumab (lucentis, genentech) is becoming increasing common for the management of age-related macular degeneration (amd). it is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". in addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. the use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. the purpose of our study is to determine whether visual education on amd and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis. although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.

Eligibility criteria:
inclusion criteria: * 18 years and older * amd patients requiring intravitreal injections exclusion criteria: * unable to read or comprehend english * any contraindications to intravitreal injections, such as iop elevations
time to hip fracture surgery

Conditions: Hip Fractures; Mortality; Surgery

Summary: the purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, american society of anesthesiologists (asa) physical status classification, type of surgery and time from admission to surgery along with data on mortality.


Eligibility criteria:
inclusion criteria: undergoing * hip fracture surgery between 2007-2016. * over 60 years of age. exclusion criteria: * pathological fracture. * in-hospital falls. * diagnostic delay.
surgeon compared to nuclear radiology readers for tc-99m sestamibi scans for parathyroid disease

Conditions: Parathyroid Disease

Summary: the purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear radiologists of 61 individual thyroid scans. the goal is to determine if surgeons are more prone to making a definitive diagnosis based on a given scan than a nuclear radiologist. accuracy of localization of the two groups will be analyzed. a secure website has been designed to which the physician will be able to login and view and rate the quality of each image and make a localizing diagnosis. once they are finished, they will not be able to make any more changes, and their responses will be compared to the responses of their colleagues. the results will be analyzed to find if there is a significant variation in the ratings between the surgeons and the nuclear radiologists as to the quality, location, and number of parathyroid glands, if any, on the scans.


Eligibility criteria:
inclusion criteria: * must be a surgeon or nuclear radiologist to be eligible read scans for this study. exclusion criteria: * none
mri and biomarkers in prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer has been the most common neoplastic disease in men in finland over the last ten years. prostate-specific antigen (psa) plays an important role in screening of prostate cancer. however, psa has a limited sensitivity and specificity for prostate cancer detection. commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (trus) guided biopsy. because of the low accuracy of trus a systematic biopsy is usually performed instead of targeted trus biopsy. as biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. this prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of psa than 2.5 ng/ml and/or abnormal digital rectal examination. anatomical magnetic resonance imaging (mri) and diffusion weighted imaging (dwi) at 1.5/3 tesla (t) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. targeted trus guided biopsy based on mri findings will be performed in addition to routine twelve core trus biopsy. moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.


Eligibility criteria:
inclusion criteria: * age: 18 to 85 years * clinical suspicion of prostate cancer, based on: serum level of psa from 2,5 ng/ml to 20 ng/ml in two following measurements and/or abnormal digital rectal examination * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethics committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * previous prostate biopsies within 6 months * previous diagnosis of prostate carcinoma * previous prostate surgeries, e.g. turp (transurethral prostatic resection) * symptomatic of acute prostatitis * contraindications for mri (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia * hip replacement surgery or other metal implants in the pelvic area

Keywords: prostate cancer psa mri biopsy biomarker
immune response to sars-cov-2 (covid-19) vaccines in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) vaccines in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). cll and sll are types of blood cancer that begin in cells of the immune system. cll/sll and the medications used to treat these conditions may change the way vaccines work in a patient's body. the purpose of this study is to find out if patients with cll/sll make antibodies, or have an immune response, to the sars-cov-2 vaccines. information gained from this study may help researchers better understand how effective the vaccines work in preventing covid-19 (coronavirus disease 2019) in patients with cll and sll.

outline: for patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. patients' medical records are also reviewed. for patients enrolled after vaccination, they will undergo collection of blood samples at 1-4, 6, and 12 months after completing the vaccination series. patients who receive booster dose also undergo collection of blood samples at 1, 6, and 12 months post final booster dose. after completion of study, patients are followed up every 6 months for 2 years.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * a diagnosis of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) * willing and able to participate in all required evaluations and procedures in this study exclusion criteria: * any evidence of prior sars-cov-2/covid19 infection
the predictability of intraoperative rotational thromboelastometry on postoperative bleeding and transfusion requirements

Conditions: Surgery for Congenital Heart Disease; Pediatric Patients

Summary: viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. however, the role of rotational thromboelastometry (rotem) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. the investigators also attempt to evaluate the correlation between rotem parameters, platelet count, and results of conventional coagulation test results.

viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. however, the role of rotational thromboelastometry (rotem) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. the investigators also attempt to evaluate the correlation between rotem parameters, platelet count, and results of conventional coagulation test results.

Eligibility criteria:
inclusion criteria: * pediatric patients (\< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at samsung medical center exclusion criteria: * incomplete data about blood loss count or transfusion requirements during seven days after surgery

Keywords: congenital heart disease rotational thromboelastometry blood loss transfusion requirements
markers for chronic obstructive pulmonary disease (copd)

Conditions: Healthy Non-smokers; Current Smokers; COPD Patients

Summary: the primary aim of this study is to exploit a difference between copd patients, chronic smokers without copd and healthy non-smoking subjects. this will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (ct).


Eligibility criteria:
inclusion criteria: healthy non-smokers * fev1 \>80% predicted * fev1 reversibility of \<10% after inhaled (beta2-agonists current smokers * fev1 no less than 80% predicted * fev1 reversibility of \<10% after inhaled (beta2-agonists * smoking history of \> 10 pack-years moderate copd * fev1 40-59% predicted * fev1 reversibility of \<10% after inhaled (beta2-agonists * smoking history of \> 10 pack-years\*\* severe copd * fev1 \<40% predicted * fev1 reversibility of \<10% after inhaled (beta2-agonists * smoking history of \> 10 pack-years exclusion criteria: * fev1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists * asthma * unstable disease (fev1 \<35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.
study the role of stem cell in curing drug induced liver injury in metastatic breast cancer (mbc)

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the investigators want to know the role of peripheral hematopoietic stem cell infusion in avoiding drug induced liver injury,and also try to research snps genotyping associated with drug induced liver injury.

1. the researcher investigate the incidence and the cause of drug induced liver injury in mbc. 2. patients having a complete clinical history and physical examination, receive routine chemotherapy. 3. venous blood sample(4 ml)is collected before and after each cycle according to the planning time. 4. genomic dna,rna and upper serum is isolated. elisa、rt-pcr or pcr-direct sequencing is used to detect the protein or gene expression associated with liver function.

Eligibility criteria:
inclusion criteria: * patients should be histologically confirmed with metastatic breast cancer; * an eastern cooperative oncology group (ecog) performance status of 0-2; * normal cardiac, hepatic, renal and bone marrow functions; * life expectancy ≥3 months; exclusion criteria: * previous history of other malignancies; * central nervous system metastases; * serious or uncontrolled concurrent medical illness.

Keywords: breast neoplasm neoplasm metastasis stem cells drug-induced liver injury
effect of xylitol-containing chewing gum with/without bicarbonate versus paraffin pellet on salivary ph

Conditions: Dental Caries

Summary: 36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (a), where (a1) represents participants exposed to xylitol chewing gum, (a2) represents participants exposed to bicarbonate and xylitol chewing gum and (a3) represents control group where participants are exposed to paraffin pellet chewing. the ph of saliva will be evaluated according to time in relation to the gum chewing (t) where (t0) represent the ph before chewing, (t1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am). direct benefit of the research to the human volunteer: it is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost. scientific value and social benefits: this study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods. expected risk to the human subjects: allergic reactions due to any of the components of the materials used which is rare to occur.


Eligibility criteria:
inclusion criteria: * patients eligible for the trial must comply with all of the following at randomization. 1. age range from 20-50 years 2. high caries risk patients defined according to american dental association (ada) 3. acidic baseline saliva ph 4. systematically healthy 5. not taking any medication interfering with saliva secretion 6. subjects who signed informed consent exclusion criteria: * (1) subjects who wore orthodontic appliances or removable prosthesis (2) subjects suffering from any medical or systematic disease (3) smokers (4) pregnant females (5) allergy to any of chewing gum ingredients
upper extremity-based exercises and elbow-focused exercises in let

Conditions: Lateral Epicondylitis; Elbow Tendinopathy

Summary: the aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program.


Eligibility criteria:
inclusion criteria: * cases are between the ages of 18-65 * getting a diagnosis of unilateral lateral elbow tendinopathy * at least two positive thomsen, maudsley's mill's and cozen tests on clinical examination * continuing symptoms for at least 3 months * the absence of any chronic disease that would prevent participation in the treatment program exclusion criteria: * history of trauma or surgery in the involved elbow joint * having orthopedic problems in the cervical spine, shoulder joint or wrist * to have participated in the rehabilitation program in the last 3 months * corticosteroid injection application in the last 3 months * systemic arthritis

Keywords: tendinopathy elbow
clinical evaluation of nir (non-invasive infrared) thermometer performance

Conditions: Elevated Temperature

Summary: the study is conducted in order to evaluate the performance of the nit thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.


Eligibility criteria:
inclusion criteria: * children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in schneider medical center. * an informed consent was signed by the patient or his guardian. exclusion criteria: * the medical stuff decides that the patient can't participate.