Kornimate/medical-research-clean huggingface dataset:
vr for surgical prehabilitation and rehabilitation

Conditions: Breast Cancer; Frailty; Surgery

Summary: this randomized controlled trial aims to determine feasibility and acceptability of of vr-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.


Eligibility criteria:
inclusion criteria: * 18+ years of age * english speaking * will undergo breast or axilla surgery at stanford * have access to internet and stable wifi at home * have access to a space with stable chair at home * ability to sit-to-stand without significant balance issues * absence of chronic vertigo or nausea/vomiting * agreeable to up to 4 weeks of prehab prior to surgery and up to 8 weeks of post-operative rehab exclusion criteria: * inability to engage in pt due to physical limitations identified by the participant and/or care team * inability to complete a brief online survey at three time points during the duration of the study * inability to consent

Keywords: prehabilitation rehabilitation virtual reality physical therapy breast surgery breast cancer breast reconstruction axillary surgery
studying the effect of methotrexate alone versus methotrexate and vitamin d on the cardiovascular risk of psoriatic patients

Conditions: Psoriasis

Summary: the prevalence of cardiovascular risk in psoriasis has been reported in previous studies.various studies have also shown that systemic treatments for psoriasis, including methotrexate, may significantly decrease this cardiovascular risk. we proposed that the addition of vitamin d may not only improve the therapeutic effect of various treatment modalities but also increase its effect on decreasing the cardiovascular risk in psoriasis. so our aim of work is to assess the clinical improvement and cardiovascular risks in psoriatic patients after treatment with methotrexate alone with the dose of 0.2-0.5 mg/kg/week for three months in comparison to combined methotrexate with the same dose and vitamin d injection with the dose of 200,000 iu per month for 3 months. each patient will do the following before starting treatment\& after 3 months: 1. fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin 2. liver and kidney function tests. 3. cardiovascular risk assessment by measuring the intima media thickness of carotid arteries using carotid duplex and high sensitive c reactive protein measuring by particle-enhanced immunonephelometry on autoanalyzer. 4. lipid profile (hdl, ldl, cholesterol and triglycerides). 5. calculate body mass index and measure blood pressure 6. albumin /creatinine ratio 7. serum vitamin d level. clinical response will be evaluated by psoriasis area and severity index (pasi) \& psoriasis disability index (pdi) scores before and after 3 months of treatment


Eligibility criteria:
inclusion criteria: * psoriasis patient not on systemic treatment at least for 3 months before inclusion in the study * pasi \>10 exclusion criteria: * patients with autoimmune diseases. * patients with liver disease or kidney diseases * patients with diabetes mellitus * females in child bearing period not using methods of contraception * any associated dermatological disease * evidence of infection * pregnancy and lactation * patients taking vitamin d

Keywords: psoriasis cardiovascular risk methotrexate vitamin d
pre-operative forearm exercise on arteriovenous fistula mauration

Conditions: Arteriovenous Fistula

Summary: to investigate the effect of pre-operative exercise on 1. hemodynamics in the fistula artery and vein, pre and post av fistula formation 2. suitability of cannulation of av fistula at 8weeks

aim: to investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, pre and post av fistula formation as well as the suitability of cannulation of av fistula at 8weeks post sugery methodology: this is a randomised control study with 20 patients each in the exercise arm and the control arm. the subjects will be randomised 1:1 into one of the two groups. chronic kidney failure patients with egfr less than 20mls/min and have chosen haemodialysis as their modality of renal replacement therapy will be included the study. all the subjects will have an ultrasound doppler vein mapping done prior to entering the study. the exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks. all patients will have a follow up ultrasound doppler of the av fistula at 8 weeks and 16 weeks post-surgery, looking at the av fistula vein diameter, arterial diameter and blood flow rate. all the subjects will also be seen by a single vascular surgeon following the scan, to assess the suitability for avf cannulation. significance of the proposed study and benefits: a well functioning arterio-venous fistula is the gold standard vascular access for hemodialysis patients due to its low rates of complications. the primary failure rate of the avfs remain high at around 20 -25%, contributed by several factors including the diameter of the vessels. if pre-operative exercise improves the hemodynamics of the av fistula and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of av fistulas.

Eligibility criteria:
inclusion criteria: 1. chronic kidney failure patients with egfr less than 20mls/min 2. chosen hemodailysis as their modality of renal replacement therapy exclusion criteria: 1. potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping 2. known left ventricular ejection fraction of less than 20% on echocardiogram 3. previous stroke effecting the av fistula arm 4. calcified brachial or radial arteries and/or duplex evidence of stenosis of \>50%

Keywords: arteriovenous fistula pre-operative exercise fistula maturation
an std prevention intervention for men newly released from jail

Conditions: Sexually Transmitted Diseases; Risk Behavior

Summary: study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat std infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group

the misters study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. men 45 days or less post release with self reported hiv negative and substance use histories were randomized into either a 5-session intervention or control group. study participation included four time-sensitive interviews and std testing at three time periods. the interview questions included demographics, std history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.

Eligibility criteria:
inclusion criteria: * ages 18 to 60, english speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported hiv negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination exclusion criteria: * opposite of the above

Keywords: sexually transmitted diseases risk behavior
anterior cruciate ligament reconstruction with and without lateral extra-articular tenodesis among high demand patients

Conditions: Anterior Cruciate Ligament Tear

Summary: anterior cruciate ligament reconstruction with and without lateral extra-articular tenodesis between high demand patients

it is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (ikdc and lysholm)

Eligibility criteria:
inclusion criteria: * high demand patients (manual workers, athletes,...etc.). * normal average body mass index ( 18.5 - 24.9 ). * age \<40 years old. * patients will be diagnosed as acl tear by the following: 1. history of knee traumatic event. 2. clinical examination ( positive lachman test and pivot shift test). 3. radiological evidence of acl tear by mri. * patient with high pivot shift test. exclusion criteria: * generalized ligamentous laxity. * other intra or extra articular knee injuries. * previous acl surgery on the affected knee. * bilateral acl injuries. * significant articular surface injury. * medical comorbidities * patients with malalignment ( genu varum, genu valgum or genu recurvatum ) * neuromuscular disorders * knee arthritic changes.

Keywords: anterior cruciate ligament tear anterolateral instability retear extra articular tenodesis
mesenchymal stem cell transplantation for osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (bmscs) plus autologous platelet rich plasma (prp) in the treatment of severe knee osteoarthritis.

this is a single centered, randomized, single blind phase ii clinical study. patients will be divided into two groups of case and control. patients of case group will receive intra-articular injection of autologous bmscs suspended in 3 ml autologous prp for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous prp for 3 times. the investigators designed this clinical study to evaluate therapeutic effects of bm-mscs in patients with severe knee osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. subject has kellgren and lawrence grade ii-iv primary osteoarthritis as determined by x-ray. 2. subject's pain score is 8-13 points (lequesne's index). 3. ages between 40-70 years. 4. signed informed consent from the subject.- exclusion criteria: 1. subject infected with hepatitis b, hepatitis c, hiv, syphilis or htlv 2. subject not suitable for bone marrow suction surgery. 3. subject with hypersensitivity/allergy to anesthetic. 4. subject's creatinine values higher than 1.6mg/dl. 5. subject with body mass index, bmi over 30. 6. subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. 7. subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. 8. subject enrolled in any other cell therapy studies within the past 30 days. 9. subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. 10. subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. 11. subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.-
pharmacokinetics and safety of vilaprisan in renal impairment

Conditions: Uterine Fibroids; Endometriosis

Summary: the purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.

this is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. pk blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations.

Eligibility criteria:
inclusion criteria: * bmi: 18 to 40 kg/m\*2 (inclusive) * decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the chronic kidney disease epidemiology collaboration (ckd-epi) formula, either: moderately impaired renal function: egfr: 30 to 59 ml/min/1.73 m\*2; or severely impaired renal function: egfr \<30 ml/min/1.73 m\*2 but not on dialysis - normal renal function, as assessed at screening and based on serum creatinine according to the ckd-epi formula: egfr ≥90 ml/min/1.73 m\*2 exclusion criteria: * any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment. * severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of grade iii or iv according to new york heart association, or arrhythmia requiring antiarrhythmic treatment. * malignancy diagnosed or treated within the past 5 years. this does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin. * acute renal failure or acute nephritis within the past 2 years. * pregnancy or lactation. * use of cyp3a4 inducers from 2 weeks before study drug administration until last day of blood sampling for pk after study drug administration, including grapefruits. * insufficiently controlled diabetes mellitus with fasting blood glucose \>220 mg/dl or hba1c \>10%.

Keywords: pharmacokinetics
effect of zinc on barrett's metaplasia

Conditions: Barrett's Metaplasia

Summary: using orally administered zinc to patients already diagnosed with the pre-cancerous condition, barrett's esophagus, this study is asking two questions: 1. can this zinc administration cause molecular-level changes in the barrett's tissue? 2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

14 days prior to already-scheduled upper endoscopy (egd) procedures for routine surveillance of barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc bid) or a placebo (molar equivalent of sodium gluconate bid) for 14 days. at the time of endoscopy, 4 biopsies are taken (and pooled) from the barrett's tissue and 4 from proximal normal esophageal tissue. biopsies are flash frozen for later analyses by atomic absorption spectroscopy, page and western immunoblot or rna microarray.

Eligibility criteria:
inclusion criteria:ages 18-80; prior diagnosis of barrett's esophagus - exclusion criteria:unable to provide written, informed consent; prior history of barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin) -

Keywords: barrett's esophagus esophagus adenocarcinoma
study of avelumab in combination with lenvatinib for children with primary cns tumors

Conditions: Central Nervous System Tumors

Summary: this study consists of 2 parts: dose escalation part 1 and dose expansion part 2. the dose escalation part 1 will evaluate the safety and tolerability of avelumab in combination with lenvatinib and determine the recommended avelumab and lenvatinib dose for expansion. dose expansion part 2 will assess the efficacy of avelumab in combination with lenvatinib by progression-free survival in participants with pre-defined primary central nervous system (cns) tumors.


Eligibility criteria:
inclusion criteria: * participants with histologically confirmed diagnosis of primary cns malignancy as follows: a) primary cns tumors: the tumor should be considered high-grade histologically; prior radiotherapy is allowed; participants must have progressed after at least 1 prior systemic therapy, except for those with diffuse midline glioma with or without the h3 k27m mutation. b) specific for participants with diffuse midline glioma with or without the h3 k27m mutation: prior radiotherapy is allowed; no more than 1 prior systemic therapy is allowed; participants with diffuse midline glioma with or without the h3 k27m mutation who have not received prior systemic therapy but have prior radiotherapy only are allowed to enroll * on screening scans, measurable disease by rano criteria * participants must have a lansky performance status \>= 50 for age \ = 50 for age \> 16 years at screening * other protocol defined inclusion criteria could apply exclusion criteria: * participants with low-grade gliomas, for example but not limited to, subependymal giant cell astrocytoma, pilocytic astrocytoma and world health organization (who) grade 1 tumors * participants demonstrating evidence of worsening of neurologic deficit within 1 week prior to initiation of study interventions * participants with bulky tumor, defined as: a) tumor with any evidence of uncal herniation or midline shift; b) tumor with a diameter of \> 4 centimeters (cm) in 1 dimension on t2/ fluid-attenuated inversion recovery (flair) images; c) tumor that in the opinion of the investigator shows significant mass effect * participants are not eligible if they experience uncontrolled seizures, defined as: a) seizures requiring regular use of rescue medications. b) seizures requiring increasing doses of antiepileptic medications. c) seizures that in the opinion of the investigator compromise the ability of the participant to tolerate study intervention or interfere with study procedures * participants who have received major surgery (including but not limited to neurosurgical resection, brain biopsy, or radiation to the primary brain tumor) within 28 days prior to the first dose of study interventions * participants with history of intracranial hemorrhage/spinal cord hemorrhage within 28 days prior to the first dose of study interventions * other protocol defined exclusion criteria could apply

Keywords: avelumab lenvatinib tumors pediatric cns tumors
academic performance and refractive error

Conditions: Refractive Errors

Summary: refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in chinese schoolchildren base on a multicohort observational design.


Eligibility criteria:
inclusion criteria: * schoolchildren in the 1st to 9th grades exclusion criteria: * schoolchildren unwilling to participate * had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes * with unreliable auto-refraction values
ivn-cat-001a performance of cast with different allergens in patients with cat dander allergy

Conditions: Allergy to Cats

Summary: primary objective of the trial: to determine at which concentration the fusion protein mat fel d1 degranulates basophils of cat dander allergic patients, in comparison to a cat dander extract and to fel d1 alone


Eligibility criteria:
inclusion criteria: 1. patient with cat dander allergy evidenced by positive history 2. age: 18 to 75 years exclusion criteria: 1. use of oral corticosteroids, chromoglycin, ketotifen, or any immunosuppressive drugs within the last 2 months 2. psychiatric disorder resulting in malcompliance 3. neg. ige to cat dander
biological markers of frailty in elderly subjects

Conditions: Elderly Persons

Summary: epidemiological data from europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. screening and treating frailty seem to be a good start towards preventing dependency. on the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (ptmdp) represents an innovative evaluation method. these include advanced glycation end-products (age), and carbamylation-derived products (homocitrulline). indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. this would make it possible to adapt treatment accordingly in elderly subjects.


Eligibility criteria:
inclusion criteria: * with social security coverage * accept to participate in the study and sign informed consent for the study and for the collection of biological samples exclusion criteria: - \< 65 yo
an investigational immuno-therapy safety and efficacy study of multiple administration regimens for nivolumab plus ipilimumab in subjects with renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * advanced renal cell carcinoma * must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work * must have at least 1 lesion with measurable disease exclusion criteria: * subjects with active central nervous system metastases * subjects who received prior therapy with checkpoint inhibitor * subjects with active, known or suspected autoimmune disease other protocol defined inclusion/exclusion criteria could apply
efficacy and safety of tors for scca

Conditions: Oropharyngeal Squamous Cell Carcinoma; Supraglottic Squamous Cell Carcinoma

Summary: the purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (tors). tors is a relatively new option involving the use of the da vinci surgical robot to remove these cancers through the mouth.


Eligibility criteria:
inclusion criteria: * adult male or female * diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma exclusion criteria: * metastatic disease

Keywords: surgery robotic carcinoma squamous cell of head and neck