Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy for locally advanced squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma; Carcinoma of Head/Neck

Summary: the purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.

* patients will be admitted to hospital and receive a one hour infusion of taxotere. approximately 2 hours after taxotere is finished they will receive cisplatin, 5-fluorouracil, and leucovorin continuously over a 4 day period. * approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's anc level is greater than 10,000. * infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days). * during each cycle patients will have blood tests performed weekly and may be asked to return to the head and neck clinic for examination around the middle of each cycle. * at the end of each cycle the impact of the chemotherapy will be assessed. if after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. however, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed. * during the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy. * within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.

Eligibility criteria:
inclusion criteria: * histologic confirmation of squamous cell carcinoma of head and neck. * all patients with previously untreated stage iii or iv. * measurable disease * complete recovery from previous diagnostic or therapeutic procedures. * life expectancy greater than 3 months * creatinine less than or equal to 1.5 * sgot less than 1.5 x uln * alkaline phosphatase less than 2.5 x uln * wbc greater than or equal to 4,000/mm * platelet count greater than to equal to 100,000/mm * hemoglobin greater than or equal to 10gm/dl * patients of childbearing age must use effective contraception methods. exclusion criteria: * patients with previous head and neck cancer except those treated with surgery only. * patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * peripheral neuropathy exceeding grade 1. * cardiovascular or pulmonary disease * pregnant or breastfeeding women

Keywords: squamous cell carcinoma of head and neck compressed tpfl taxotere growth factor support
safety and efficacy of pegintron plus rebetol in patients with chronic hepatitis c in japan, excluding (1) subjects with hcv genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load (study p04841)(completed)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to evaluate the safety and efficacy of pegintron plus rebetol combination therapy administered to patients with chronic hepatitis c. the study will exclude (1) subjects with hcv genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. it is being conducted as a post-approval commitment, in accordance with the ministry of health, labour and welfare's guideline on good post-marketing study practice. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic hepatitis c * among interferon-naïve patients, only patients with high viral load and hcv genotype other than 1 * among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and hcv genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1) exclusion criteria: * patients infected with hcv genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers * interferon-naïve patients with low viral load * patients with a history of hypersensitivity to test drugs or other interferon preparations * patients with a history of hypersensitivity to biological products, such as vaccines * patients being treated with shosaikoto * patients with autoimmune hepatitis * pregnant women, women who may be pregnant, and nursing mothers * patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.) * patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia) * patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia) * patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 ml/min * patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt * patients with serious hepatic dysfunction * patients with autoimmune hepatitis
the impact of app-based cognitive training on post-stroke upper extremity rehabilitation

Conditions: Stroke

Summary: to find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke.


Eligibility criteria:
inclusion criteria: * patients aged 45-70 years. * both male and female gender. * patients of sub-acute stroke patients with impaired upper extremity function * stroke patients suffering from mild to moderate cognitive impairment. * patients with the ability to fulfill and comprehend commands exclusion criteria: * patients of neurodegenerative diseases like parkinson's, multiple sclerosis etc. * patients suffering from any severe psychological disorder. * patients with severe contracture due to orthopedic disease of the shoulder, elbow, and wrist joints

Keywords: stroke, sub-acute stroke, cognitive impairment
a clinical study of the paradise™ renal denervation system in patients with hypertension (radiance-htn duo)

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: to compare the antihypertensive effect of renal denervation with the paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.


Eligibility criteria:
inclusion criteria : * patients who have received antihypertensive treatment with two antihypertensive drugs (arb/ace inhibitor and ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage. * patients with a mean seated office blood pressure of between 140 mmhg and 180 mmhg systolic and between 90 mmhg and 110 mmhg diastolic at screening visit. * patients with a mean 24-hour abpm (ambulatory blood pressure measurement) of between 130 mmhg and 170 mmhg systolic and between 80 mmhg and 105 mmhg diastolic at baseline visit exclusion criteria * lacks appropriate renal artery anatomy for renal denervation * secondary hypertension other than sleep apnea * type 1 diabetes mellitus or uncontrolled type 2 diabetes * any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent * repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent * patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health * patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period * patients with a history of persistent or permanent atrial tachyarrhythmia * patients with active implantable medical devices * primary pulmonary hypertension * patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media * night shift workers * pregnant, nursing or planning to become pregnant * patients with any of the following central laboratory tests at screening * plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml * hba1c greater than or equal to 8.0% * egfr less than 40 ml/min/1.73m2

Keywords: denervation hypertension
a study evaluating the integrative medicine at home (im@home) program in people with cancer

Conditions: Head and Neck Cancer; Head and Neck Tumor; Thoracic Tumor; Thoracic Cancer; Gynecologic Cancer; Gynecologic Tumor; Melanoma; Ovarian Cancer

Summary: the overarching long-term goal of the integrative medicine for patient-reported outcomes values and experience (improve) research program is to evaluate whether integrating a virtual mind-body programming, integrative medicine at home (im@home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or older * karnofsky score 60 or greater * life expectancy greater than six months * english speaking additional inclusion criteria for head and neck, thoracic, gynecologic, melanoma and breast baskets * patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or gynecologic cancer * actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion or primary cytoreductive surgery * worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) additional inclusion criteria for first remission gynecologic cancer basket * patients with a diagnosis or clinical suspicion of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed) additional inclusion criteria for the advanced cancer basket: * patients with a diagnosis of stage iii or iv lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage iv gastrointestinal cancer; stage iii or iv ovarian or fallopian tube cancers or other stage iv gynecologic cancer; stage iv breast cancer; stage iii testicular cancer or any stage iv genitourinary cancer; stage iv sarcoma; stage iv melanoma; stage iv endocrine cancer; lymphoma, myeloma, or leukemia * actively receiving oncological treatment, radiotherapy or active surveillance additional inclusion criteria for the cancer survivor basket: * completed active cancer treatment (e.g., surgery, radiation, chemotherapy) (maintenance hormonal or targeted therapies are allowed). * worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) exclusion criteria: * cognitive impairment that would preclude response to study assessments or require the use of legally authorized representatives * unwilling to accept random assignment * concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome. note, however, patient will be allowed to enroll on other therapeutic protocols

Keywords: head and neck cancer head and neck tumor thoracic tumors gynecological tumors melanoma 21-369 memorial sloan kettering cancer center ovarian cancer
the microbiota in kidney donation and transplantation

Conditions: Kidney Diseases; Kidney Transplant Failure and Rejection; Urinary Tract Infections

Summary: the human gastrointestinal tract harbours \~40 trillion microbial cells, far outnumbering the cell number, and therefore the genetic content of its host. how this genetically diverse bacterial (collectively referred as 'microbiota') co-resident modulates host homeostasis is largely unknown. we are increasing gaining a better understanding how the microbes modulate mucosal and systemic metabolic/immune and organ systems including the kidney, heart and the brain. therapeutic targeting of the gastrointestinal (gi) microbiota may help improve clinical outcomes in conditions as diverse as arthritis, cardiovascular disease, and cancer. in contrast to other organ systems, studies investigating the role of the microbiota in modulating clinical outcomes in renal transplantation lags behind. the aim of the study is to examine (a) how alterations in the urinary and gi microbiota and associated metabolites impact on host immunity after renal transplantation, and (b) whether such changes are correlated with post-transplant complications, such as rejection, development of de novo donor specific antibodies, metabolic complications (e.g post-transplant diabetes) and infections. participants will be followed before and up to twelve months post-transplantation, and, longitudinal microbial data will be correlated with in-depth immune phenotyping and clinical end-points to define the impact that changes in urinary and gi microbial ecology have on kidney transplant outcomes.


Eligibility criteria:
inclusion criteria: * all adult (≥18 years old) undergoing living donor nephrectomy or kidney transplantation. patients willing to provide samples including urine, blood, faecal samples. 1. participant able to give informed consent 2. all patients will be at least 18 years old 3. patients will either be a live renal transplant donor or a renal transplant recipient on the waiting list to have or will have had an abo-blood group compatible renal transplant. 4. patients attending hospital clinics at participating centre for routine clinical follow -up. 5. patients willing to comply with study procedures and willing to provide blood, faecal and urine samples. exclusion criteria: 1. patients under the age of 18 years 2. patients unable to give informed consent 3. patients not able to comply with study procedures or follow-up visits 4. patients that are not a live renal donor or that are not on the waiting list to have or have not had an abo blood group compatible renal transplant and are not attending hospital outpatient clinics at participating study centres for routine clinical follow-up.
ripasudil 0.4% eye drops in fuchs endothelial corneal dystrophy

Conditions: Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Corneal Endothelial Dystrophy; Corneal Endothelial Cell Loss; Cornea Guttata

Summary: the cornea forms our "window to the world". hence, its transparency is of utmost importance for vision. corneal endothelium plays a central role in the maintenance of a transparent corneal stroma. it limits stromal fluid uptake from the anterior chamber of the eye through the formation of tight junctions. simultaneously, fluid is actively transported from corneal stroma into the anterior chamber. this maintains the corneal stroma in a state of relative dehydration, thereby ensuring a constant distance of stromal collagen lamellae to each other, which in turn forms the basis for transparency of this tissue. if however corneal endothelial function is impaired, stromal swelling leads to corneal clouding and loss of vision. fuchs endothelial corneal dystrophy represents the most common form of corneal dystrophy. it occurs sporadically, however in some cases autosomal dominant inheritance has been described. this condition leads to progressive loss of corneal endothelium (typically around the age of 50-60 years), causing visual impairment due to swelling and opacification of corneal stroma. cell culture experiments have been able to show that chemical inhibitors of rho-kinase promote corneal endothelial cell proliferation and reduce apoptosis, while topical application in an animal model promoted corneal endothelial wound healing. this has prompted the notion of using topical rho-kinase-inhibitor treatment to support endothelial cell regeneration in fuchs endothelial corneal dystrophy. since september 2014, rho-kinase-inhibitor eye drops (ripasudil) are clinically available in japan for reduction of intraocular pressure in glaucoma patients. ripasudil eye drops therefore represent a strong candidate for safe and effective adjunctive treatment in patients with fuchs corneal endothelial cell dystrophy.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from the subject 2. understanding of study procedures and willingness to abide by all procedures during the course of the study. 3. age range: 18-70 years 4. diagnosis of moderate to advanced fecd with central guttae and clinical relevant corneal endothelial cell loss of \<1,000 cells/mm2 and clinical indication of surgical intervention (descemetorhexis) with or without accompanying cataract operation 5. reduced visual acuity, defined as bcva \<20/30 6. woman of childbearing potential must be using a highly effective method of birth control.
attain starfix™ model 4195 left ventricular lead

Conditions: Heart Failure

Summary: people who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (crt) device. a crt device is implanted surgically just under the skin in the upper chest area. this device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. the device may also be able to stop the heart from beating too fast. three leads are implanted into the chambers of your heart. two of the leads will be placed on the right side of your heart. the third lead is placed on the left side of your heart and is the lead being studied. the purpose of this study is to evaluate the safety and efficacy of the attain starfixtm model 4195 left ventricular (lv) lead. this particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. it is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.


Eligibility criteria:
inclusion criteria: * qrs \> 130 ms (the qrs interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. a wide qrs (more than 120) suggests that there is a conduction problem, or block, in the ventricles.) * left ventricular ejection fraction (ef) \< 35% (ejection fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. the higher the ef the more blood the ventricle is pumping.) * subject has moderate to severe heart failure despite medications exclusion criteria: * subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt * subjects with chest pain or who have had a heart attack within the past month before enrollment in the study * subjects that have had certain surgeries on their heart within the past three months * subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Keywords: cardiac resynchronization therapy, left ventricular lead, heart failure
arginine replacement therapy in covid-19

Conditions: COVID-19

Summary: this study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with covid-19. the study will be performed at the children's healthcare of atlanta, arthur m. blank hospital. patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.

in the early stages of covid-19, it was believed that children were immune or had very mild disease. given the unfolding pandemic, children's cases are exhibiting an increasing global trend and are associated with some serious complications in addition to more long-term complications such as multisystem inflammatory syndrome in children (mis-c) and "long covid". a significant number of hospitalized and critically ill pediatric patients have now been documented, in addition to a high number of emergency department (ed) visits despite previous reports suggesting rare or mild disease in children. the research team and others have shown that severe covid-19 and mis-c are associated with acute arginine deficiency in both adults and children. there has been increased evidence of the role of the endothelium associated with severe inflammation in covid-19. low plasma arginine bioavailability has been implicated in endothelial dysfunction, immune regulation, and hypercoagulation. the research team also identified high spla2 levels in covid-19 and mis-c, an observation previously made in children with kawasaki's disease. subsequent studies have shown that spla2 is associated with the pathobiology leading to covid-19 mortality, with enzyme levels 10-fold higher in people who died vs. mild disease, and is also associated with mito dysfunction. not only could spla2 represent a prognostic indicator of disease severity, but it also represents a mechanism with potential therapeutic targets. information learned from the mito activity in covid-19 can contribute to further understanding of severe acute respiratory syndrome by coronavirus (sars-cov-2) infection. this data may help guide future treatment targets and strategies.

Eligibility criteria:
inclusion criteria: * established diagnosis of covid-19 requiring admission to the hospital for treatment of covid-19 infection * age 3 years - 21 years of age exclusion criteria: * severe hepatic dysfunction: alt\> 6 x upper limit of normal * renal dysfunction: creatinine \> 1.5 x upper limit of normal or on dialysis * acute stroke * pregnancy * allergy to arginine * past history of severe cardiac disease or significant cardiac surgery \[minor procedures like ventricular septal defect (vsd) repair are not an exclusion\] * history of significant pulmonary disease \[cystic fibrosis, sickle cell disease (scd)\] * history of organ transplant * history of metabolic or mitochondrial disease (including diabetes) * history of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury) * history of ventriculoperitoneal (vp) shunt or hydrocephalus * pi discretion that the patient is not an ideal candidate for the study * history of hiv of immune compromise