Kornimate/medical-research-clean huggingface dataset:
a supervised prehabilitation program for patients with pancreatic cancer

Conditions: Pancreas Cancer

Summary: the purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored. study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. participants will receive a fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (baseline, post-intervention evaluation and 3-month follow up).

Eligibility criteria:
inclusion criteria: * pancreatic cancer diagnosis (any stage) * age ≥ 18 years * independent ambulation and activities of daily living (discretion of referring/ treating oncologist) * godin-shephard leisure-time physical activity questionnaire score of ≤ 23 * physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics * answers no to all questions on par-q or is cleared to participate by their treating oncologist * ability to read, write and understand english * written informed consent obtained from subject and ability for subjects to comply with the requirements of the study inclusion criteria for remote monitoring of physical activity (fitbit) and online pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study): * access to a smart device capable of fitbit syncing and accessing the online pain portal (www.painguide.com) exclusion criteria: * has undergone or plans to undergo resection surgery prior to projected completion of prehab exercise intervention * current pregnancy exclusion criteria for remote monitoring component of the study with fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study): * using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the pi deems study participation safe.

Keywords: exercise prehabilitation
effect of bariatric surgery on brain insulin sensitivity

Conditions: Obesity

Summary: adiposity is associated with prediabetes and type 2 diabetes. in very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. so far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. it is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. one special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * planned bariatric surgery (laparoscopic roux-en-y gastric bypass or laparoscopic sleeve gastrectomy) * stable medication 10 weeks before begin of the study exclusion criteria: * persons who wear non-removable metal parts in or on the body. * persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body * cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than nyha 2, previous heart attack, stroke condition * persons with hearing impairment or increased sensitivity to loud noises * people with claustrophobia * minors or non-consenting subjects are also excluded * subjects with an operation less than 3 months * neurological and psychiatric disorders * subjects with hemoglobin hb \<11 g / dl * hypersensitivity to any of the substances used
cold and heat investigation to lower levels of depression

Conditions: Depression; Mood Disorders

Summary: this study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single whole body hyperthermia (heat therapy) treatment or a whole body hyperthermia treatment followed by a cold water plunge. participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

the chill'd study aims to figure out how using heat exposure as a treatment for major depressive disorder (mdd) can work better. the researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone. the researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone. to answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge. participants in the heat exposure alone group will receive a single heat session using the clearlight sauna dome lasting up to 140 minutes. participants in the heat exposure and cold plunge group will receive a single heat session using the clearlight sauna dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

Eligibility criteria:
inclusion criteria: * meets dsm 5 criteria for major depressive disorder (mdd) with a depressive episode of ≥ 60 days duration. * montgomery-asberg depression rating scale (madrs) score ≥ 28 at screening * english or spanish speaking (able to provide informed consent and complete questionnaires in one of these languages) * able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations. exclusion criteria: * previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure * use of any medication that may impact thermoregulatory capacity. * pregnancy, active lactation, or intention to become pregnant during the study period. * endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.

Keywords: depression mood disorders mental health integrative health hyperthermia sauna cold plunge
safety and efficacy study of de-104 ophthalmic solution to treat open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to investigate the dose-response relationship of de-104 ophthalmic solution in lowering intraocular pressure (iop) in subjects with primary open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * provided signed, written informed consent. * diagnosed with primary open-angle glaucoma or ocular hypertension. * 18 years of age and older. * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * presence of any abnormality or significant illness that could be expected to interfere with the study.
drug interactions from simultaneous administration of metformin and gsk189075 to subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: gsk189075 is intended for use as a single treatment or in combination with other treatments for tye 2 diabetes mellitus (t2dm). metformin is widely used in europe and the usa for the treatment of t2dm. this study will evaluate the effect of gsk189075 on metformin levels in the blood in t2dm subjects. the rationale is to look for any safety problems that may result when the 2 drugs are given together.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus. * have a body mass index within range 22 to 35kg/m2 inclusive. * females who meet above criteria must be physiologically incapable of becoming pregnant (i.e., surgically sterilized, or post-menopausal per protocol definition). exclusion criteria: * are currently taking insulin therapy. * have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer). * have a history of stomach, liver, kidney, or other disease that with interfere with taking the study drug. * are currently using diuretics, oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or other medications that would cause you to deplete your fluid balance in your body; currently taking stable regimens for heart conditions; currently using prescription or non-prescription drugs within 7 days of starting the study that may interfere with the study drug. * would donate more than 450 ml of blood over a 2 month period. * physician does not think it is a good idea for you to participate in the trial. - had a urinary tract infection or bladder infection in the last month. - are currently drinking more than 2 beers, 1 glass of wine, or 1 glass of spirits daily. * have a positive urine drug screen test. * plan to change your smoking habits during the course of the trial. * have hepatitis c, hepatitis b, or hiv. - have a lab or ekg abnormality. - high or low blood pressure. * have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication. * are a male subject unwilling to abstain or use protection during intercourse.

Keywords: gsk189074 t2dm gsk189075 glucophage obesity diabetes metformin type 2 diabetes mellitus drug interaction
pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy

Conditions: Ischemia Reperfusion Injury

Summary: the present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.

renal ischemia reperfusion injury (iri) is an inevitable event in patients undergoing laparoscopic partial nephrectomy (lpn), which can obviously affect the post-operational renal function. pneumoperitoneum preconditioning (pp) is a promising strategy to render a protective effect on kidney, which has been already confirmed in some clinical settings. this study is designed as a randomized, prospective, double-blind and parallel controlled clinical trial to assess the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its effect on the other abdominal organs. patients with renal tunours and willing to accept elective lpn will be screened as eligible participants. the investigators aim to enroll 86 subjects. patients randomized to the treatment arm will receive pp consisted of three cycles of 5 min insufﬂation and 5 min desufﬂation before pln, while the control arm receive a sham operation.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years and older; * patients with renal tumours (whether benign or malignant) and accept laparoscopic partial nephrectomy as the surgical method; * the renal tumor must be stage t1a (assessed by mri/ct), and tumor≤4cm in diameter; * unilateral renal tumour, and another contralateral renal function reveal normal (renal function \>40% as determined by radionuclide scintigraphy); * patients volunteer for this study and provided written informed consent. exclusion criteria: * large tumour (tumor\>4cm in diameter); * severe renal insufficiency (glomerular filtration rate, gfr\<30 ml/min/1.73m2) or needing preoperative dialysis (hemodialysis or peritoneal dialysis); * patients severe cardiopulmonary dysfunction; * pregnancy women; * patients with other malignant tumours; * patients who have had a renal transplantation; * patients with a history of other abdominal viscera operations within one year (open or under laparoscope); * american society of anesthesiologists (asa)\>ⅲ.

Keywords: renal ischemia reperfusion injury pneumoperitoneum preconditioning laparoscopic partial nephrectomy
cogt psopt intervention study

Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment

Summary: (justification: this is the r33 stage of an nih funded r21/r33 study. r21 stage (irb-61727) was focused on intervention development; r33 stage will focus on pilot testing the effect of the intervention. the r21 phase was not considered a nih defined clinical trial; r33 will be considered a nih defined clinical trial) the purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. the personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. such a personalization will ensure that the participant can perform at his/her ideal training capacity. participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ecg collected to allow subject blinding.


Eligibility criteria:
inclusion criteria: 1. criteria related to defining "mild cognitive impairment": a. presence of memory complaint; b. rey auditory verbal learning test delayed recall (for memory) \< 59% of age-adjusted norm; c. montreal cognitive assessment (for global cognition) ranged 18 and 27; d. functional assessment questionnaire (for activities of daily living) \< 20. 2. intact score for san diego brief assessment of capacity to consent (ubacc). 3. if a participant is on ad medication (i.e., memantine, cholinesterase inhibitors, amyloid antibodies), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta-blocker), the dose should be stable for 3 months prior to recruitment. 4. age 60+, 5. read and understand english 6. adequate visual and hearing acuity for testing by self-report, 7. community-dwelling (including independent living). exclusion criteria: 1. current enrollment in another cognitive improvement study; 2. uncontrollable major depression; 3. major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction); 4. having an active legal guardian (indicating impaired capacity for decision making); 5. currently pregnant 6. 3t mri contraindication 7. neurological conditions: neurodegenerative disease diagnosis such as parkinson's, alzheimers, dementia, multiple sclerosis. of note, other neurological conditions/injury such as stroke, seizures, traumatic brain injury, will be evaluated for inclusion/exclusion on a case-by-case basis based on event recency, severity, and recovery.
national observational study on the use of inflectra™ an infliximab biosimilar in real life

Conditions: Crohn Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: national, prospective, multicentre observational study designed for eligible patients treated with inflectra. its objectives are to describe under real conditions of use, the profile of patients treated with inflectra and the response to treatment.


Eligibility criteria:
inclusion criteria: * adult patients treated with inflectra™ regardless of treatment phase in one of the following indications consistent with the spc: crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. * paediatric patients (children and adolescents between 6 and 17 years old) treated with inflectra™, regardless of treatment phase from the time when inflectra™ is prescribed in accordance with the indications listed in the spc crohn's disease or ulcerative colitis patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it. * patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet. exclusion criteria: * patients who refuse access to their medical file for collection of: their medical data * patients not treated with inflectra™. * patients treated with inflectra™ for psoriasis. * patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in inflectra™. * patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection . * patients with moderate to severe heart failure (nyha iii/iv)
icare 2: personalized genomic mutation informed treatment of patients with myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: this open-label, randomized, parallel group phase ii study will investigate the efficacy of computational biology-informed treatment vs. standard of care treatment for patients with relapsed or refractory myelodysplastic syndromes (mds).

it is hypothesized that personalized treatment informed by computational biology simulation technology will improve treatment outcomes for patients with relapsed or refractory mds.

Eligibility criteria:
inclusion criteria: * provide written informed consent * must be at least 18 years of age * diagnosis of mds, as defined by world health organization (who) 2008, that has relapsed after any duration of time from last best response or is refractory to induction therapy (defined as 4 cycles of treatment with a hypomethylating agent, 2 cycles of lenalidomide, 1 cycle of low intensity chemotherapy, or 1 cycle of high intensity chemotherapy) * ecog performance status of 0-2 * women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions: 1. must agree to use physician-approved contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptive, double barrier device) throughout the study and for 3 months following the last dose of study treatment; and 2. must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial * males with female partners of child-bearing potential must agree to use physician approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study treatment. exclusion criteria: * must not have acute myeloid leukemia (aml), as defined by who 2008 * pregnant and nursing subjects are excluded because the effects of study treatments on a fetus or nursing child are unknown * must not have had treatment with any anti-cancer therapy (investigational or standard) within the previous 21 days prior to the first dose of study drug or less than full recovery (no worse than ctcae v4.0 grade 1) from the clinically significant toxic effects of that treatment.

Keywords: myelodysplastic syndromes mds computational biology relapsed refractory
study of outcomes after surgery/treatment to treat bladder cancer

Conditions: Bladder Cancer

Summary: the purpose of this study is to create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. the registry will record side-effect and outcomes related to the treatment using different surveys and biological measures.

the primary purpose of this protocol is to create a registry of elderly patients with high-risk invasive bladder cancer undergoing radical cystectomy with or without preoperative chemotherapy. secondary objectives will include an exploration of the association between functional status, surgical complications, and laboratory markers with complications and survival. in addition, exploratory analyses may evaluate the association of expression of the senescence marker p16ink4a and the morbidity and mortality associated with treatment. patients will be asked to complete a geriatric assessment (ga) and fact-bl serially over the course of the study in order to evaluate their functional status and quality of life during the course of treatment. additionally, complications will be tracked in an inpatient and outpatient setting using the memorial sloan kettering cancer center (mskcc) complications grading system.

Eligibility criteria:
inclusion criteria: * patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment. * signed, irb approved written informed consent. * completion of baseline geriatric assessment exclusion criteria: * inability to read and speak english * inability to comply with study for any other reason than language * dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Keywords: elderly chemotherapy cystectomy radical cystectomy university of north carolina cancer bladder cancer bladder
study to evaluate the safety, tolerability, and pharmacokinetics of abt-957 in subjects with mild-to-moderate alzheimer's disease on stable doses of acetylcholinesterase inhibitors

Conditions: Alzheimer's Disease

Summary: this study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of abt-957 in subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * meets the national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association criteria for probable alzheimer's disease (ad); * has a mini-mental state examination total score of 16 to 26; * has a modified hachinski ischemia scale score of ≤ 4; * is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days; * has had a computerized tomography or magnetic resonance imaging. the scan must not show evidence for an alternative etiology for dementia; * with the exception of a diagnosis of mild-to-moderate ad and the presence of stable medical conditions, is in general good health. exclusion criteria: * positive screen for drugs of abuse, alcohol or cotinine; * females must not have positive results for pregnancy; * focal neurological signs on examination; * has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis; * history of any significant neurologic disease other than ad; * history of head trauma, motor vehicle accident, concussion.

Keywords: alzheimer's disease