Kornimate/medical-research-clean huggingface dataset:
low dose radiation to improve t-cell infiltration in pancreatic cancer

Conditions: Primarily Resectable Pancreatic Cancer

Summary: principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating t-cells.


Eligibility criteria:
inclusion criteria: * radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. potentially resectable is defined as no extrapancreatic disease, no evidence (on ct) of involvement of the celiac axis or superior mesenteric artery, no evidence (on ct or mri) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence. * no evidence of metastatic disease as determined by chest ct scan, abdominal ct scan (or mri) * 18 years of age or older * american society of anesthesiologists (asa)- performance status of 1 to 3 * women of child bearing potential must practice adequate contraception and refrain from breast feeding. female patients must have a negative pregnancy test within 7 days of treatment * informed consent exclusion criteria: * locally irresectable pancreatic cancer * distant metastases * medically unfit for surgery * pregnant or lactating women * prior chemotherapy or radiation treatment * other serious uncontrolled medical conditions that the investigator feels might compromise study participation * unwillingness to participate or inability to comply with the protocol for the duration of the study * major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery * participation in other interventional trials

Keywords: low dose radiation pancreatic cancer immunostimulation
trial to evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (ldl-c) in subjects with heterozygous familial hypercholesterolemia (hefh)

Conditions: Heterozygous Familial Hypercholesterolemia; Elevated Cholesterol

Summary: this is a phase iii, placebo-controlled, double-blind, randomized study in participants with hefh and elevated ldl-c to evaluate the efficacy, safety, and tolerability of subcutaneous (sc) injection(s) of inclisiran. the study will be multicenter and international.


Eligibility criteria:
inclusion criteria: participants may be included if they meet all of the following inclusion criteria prior to randomization: 1. male or female participants ≥18 years of age. 2. history of hefh with a diagnosis of hefh by genetic testing; and/or a documented history of untreated ldl-c of \>190 mg/dl, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia. 3. serum ldl-c ≥2.6 millimoles (mmol)/liter (l) (≥100 mg/dl) at screening. 4. fasting triglyceride \<4.52 mmol/l (\<400 mg/dl) at screening. 5. participants on statins should be receiving a maximally tolerated dose. 6. participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 7. participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation. exclusion criteria: participants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization: 1. new york heart association (nyha) class iv heart failure. 2. uncontrolled cardiac arrhythmia 3. uncontrolled severe hypertension 4. active liver disease 5. females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. exemptions from this criterion: 1. women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. 2. postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. 3. women who are surgically sterilized at least 3 months prior to enrollment. 6. males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide). 7. treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 8. treatment (within 90 days of screening) with monoclonal antibodies directed towards pcsk9. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: hefh ldl-c inclisiran
interest of daily physical activity after cancer treatment

Conditions: Cancer; Tiredness

Summary: many studies have demonstrated the beneficial effects of adapted physical activity (apa) in different cancer types. it therefore seems necessary to assess spontaneous physical activity in order to integrate it to the overall calculation of physical activity in clinical practice. to assess the ap, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry . subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity. objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive. in this study the investigators will measure the spontaneous daily physical activity by both methods andd evaluate the correclation.


Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years) * having been informed of the study orally and in writing and have not expressed opposition to his participation * performance status \<2 * invasive breast adenocarcinoma, histologically documented. * patients with a breast cancer and are completing treatment * exclusion criteria: * patient with metastatic cancer. * patient for which monitoring required by the protocol is impossible.

Keywords: physical activity cancer
complementary self-help strategies for patients with post-covid-19 syndrome

Conditions: Post-COVID-19 Syndrome

Summary: individuals affected by sars-cov-2 infection may subsequently be affected by the so-called post-covid syndrome. the aim of the present study is to investigate the effects of a multimodal 10-week group program consisting of self-help strategies based on complementary medicine approaches of tem (traditional european medicine), tcm (traditional chinese medicine), and tim (traditional indian medicine) in addition to treatment as usual versus treatment as usual alone (no active study intervention/waiting list). endpoints of the study include subjective quantitative and qualitative as well as objective (physician-reported) variables.


Eligibility criteria:
inclusion criteria: * age of 18 years and older * confirmed covid-19 diagnosis by: 1. polymerase chain reaction (pcr) test or 2. physician's letter/medical certificate/quarantine order due to icd-10-gm u07.1 g or icd-10-gm u09.9 g * sequelae symptoms, new symptoms/disabilities, or worsening of a pre-existing medical condition that occurred in the first 3 months after confirmed sars-cov-2 infection and persisted for more than 2 months * at least 8 points (moderate symptom burden) out of a possible 32 points on the somatic symptom scale-8 (sss-8) exclusion criteria: * patients who were treated with invasive ventilation during active sars-cov-2 infection * severe comorbid mental illness (e.g. addiction diagnosis, major depression) or other severe comorbid somatic illness (e.g. cancer without remission, severe pre-existing cardiovascular disease, insufficiency of other organs such as kidney or liver, acute febrile infection, other severe neurologic disease) * pregnancy or lactation * current pension application * simultaneous participation in other clinical/interventional trials

Keywords: complementary medicine covid-19 post-covid-19 syndrome randomized controlled trial self-help
management of lower limb apophysitis: a cross-sectional study on long-term impact on health status

Conditions: Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)

Summary: lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. we are therefore conducting a national cross-sectional study based on data from the danish national patient registry. in this protocol we describe, as detailed as possible, the planned methods.


Eligibility criteria:
inclusion criteria: * all patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (severs, sinding-larsen johansson, osgood schlatter) in the years 1977-2020 in denmark will be eligible to participate. exclusion criteria: * diseased participants will be censored
use of hyperbaric oxygen therapy for the treatment of crush injuries

Conditions: Crush Injury

Summary: the purpose of this study is to determine whether using hyperbaric oxygen (hbo) improves wound healing for patients who have a crush injury. the comparison of the prospective intervention group to the retrospective matched cohort aims to show that hbo can improve wound healing and decrease poor outcomes for patients with crush injuries. the information gained from this small study will serve as a basis for a follow-up prospective, randomized control trial to further delineate the role of hbo in a larger patient population.


Eligibility criteria:
inclusion criteria: * presenting to nyu winthrop hospital with a crush injury of the extremity, including appendages, up to 14 days post injury. * no contraindication to hyperbaric oxygen therapy. * able and willing to sign informed consent. exclusion criteria: * critically-ill patient requiring intubation or pressor support. * crush injury isolated to the distal phalanx (tuft fracture). * absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician. * unable or unwilling to sign informed consent.
risk factors related to postoperative acute kidney injury in elderly patients undergoing joint replacement

Conditions: Acute Kidney Injury

Summary: total hip arthroplasty refers to the replacement of the femoral head and acetabulum damaged by disease or trauma with an artificial hip joint, thereby restoring joint activity and original function. acute kidney injury is a common complication after total hip arthroplasty. previous studies have shown that the incidence of acute kidney injury after hip replacement is as high as 21.9%. acute kidney injury has become a global safety issue, and the occurrence of acute kidney injury can lead to an increase in hospital stay, medical costs and increased risk of death.there is currently no global survey of the incidence of aki, and only a number of studies have been conducted on specific patient groups (eg, inpatients, intensive care units \[icu\] patients or children) due to differences in study design and definition of acute kidney injury.

the incidence and prevalence of different studies vary widely, ranging from 0.32% to 44.30%. there are few studies on the risk factors associated with acute kidney injury after total hip arthroplasty, and early acute kidney injury is often overlooked due to the limitations of the current kdigo-based diagnostic method. therefore, it is particularly important for clinicians to understand the risk factors for postoperative acute kidney injury .

Eligibility criteria:
inclusion criteria: * patients age 65 or older * one-sided joint replacement; * asa score grade i-iii exclusion criteria: * emergency surgery patients; * patients with severe liver and kidney dysfunction; * missing related data; * serious systemic diseases before surgery;
ptg-100 for patients with celiac disease

Conditions: Celiac Disease

Summary: the goal of this study is to learn whether or not the drug ptg-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. this is a clinical research study to determine the safety and efficacy of ptg-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or ptg-100 (real drug) in capsule form twice daily for 42 days. they will also receive a gluten challenge twice daily in the form of a cookie or equivalent. an upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (csi) survey.


Eligibility criteria:
inclusion criteria: * diagnosis of celiac disease exclusion criteria: * active gi disease or history of clinically significant diseases * diagnosis of crohn's disease or ulcerative colitis.
optimizing the use of entonox® during screening colonoscopy

Conditions: Bowel Cancer Screening; Analgesia; Entonox; Colonoscopy

Summary: this study will randomise patients undergoing screening colonoscopy to receive entonox either continuously or as required. both these methods are used in the published studies of entonox and in clinical practice. null hypothesis there will be no difference in pain levels between these two methods of entonox administration


Eligibility criteria:
inclusion criteria: * having a bowel cancer screening programme colonoscopy exclusion criteria: * contraindications to entonox * previous bowel resections

Keywords: bowel cancer screening analgesia entonox pain side effects colonoscopy
post-stroke haptic feedback use deficit: a comparative and reliability study

Conditions: Stroke; Upper Extremity Paresis; Manual Dexterity; Sensory Integration Dysfunction; Vibration; Disorder

Summary: the aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. the investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. if they so wish, participants will be able to take part in a transcranial magnetic stimulation (tms) study to assess the facilitation of cortical excitability due to the haptic effect.

firstly, the investigators would like to carry out a study into the validity of measuring haptic deficits using vibro-tactile sensors positioned on the hands of chronic stroke patients and young and elderly healthy subjects. they believe that identifying the haptic deficit using a simple and rapid method, in combination with motor training, could make it possible to improve the prediction of recovery and personalise the rehabilitation of manual dexterity deficits after stroke. they will also compare the effect of tactile feedback with that of auditory feedback in order to study the specificity of the effect of this feedback on manual dexterity. in the second part, to better understand this and to study the cortical mechanisms involved in sensory-motor integration, the investigators propose to measure the haptic effect on cortical excitability in stroke patients and healthy subjects using transcranial magnetic stimulation (tms).

Eligibility criteria:
inclusion criteria for healthy controls: * between 18 and 40 years old * or age and sex match with chronic stroke patients * ability to perform motor, cognitive (moca score ≥26/30) and sensory assessment inclusion criteria for chronic stroke patients: * more than 18 years old * ability to perform motor, cognitive (moca score ≥26/30) and sensory assessment * first symptomatic stroke more than 6 months ago * upper limb paresis (≤4/5 on the mrc scale) * feel ≥3/6 touch on the index and thumb fingers * box and blocks test score between 1 and 54 blocks / min exclusion criteria: * contraindication to tms (epilepsy, metal implants)
28-day study of sage-718 on functioning capacity in participants with huntington's disease

Conditions: Huntington Disease

Summary: the primary purpose of this study is to assess the magnitude of the baseline difference between participants with early huntington's disease (hd) and healthy participants (hp) with respect to measures of cognitive performance.


Eligibility criteria:
inclusion criteria: for all 1. agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit. additional criteria for participants with hd only: 2. be ambulatory, able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study. 3. have: 1. genetically confirmed disease with cytosine, adenine, and guanine (cag) expansion ≥36. 2. at screening, unified huntington's disease rating scale (uhdrs) total functional capacity (tfc) \>6 and \<13, suggesting no more than a moderate level of functional impairment. 3. no features of juvenile hd. 4. cag-age-product (cap) score \>70, as calculated using the cap formula: age × (cag - 30) / 6.49. 5. score of 15 to 25 (inclusive) on the montreal cognitive assessment (moca) at screening, indicating the presence of cognitive impairment. additional criteria for hp only: 1. score ≥26 on the moca at screening. 2. have no known family history of hd; or, have known family history of hd but have genetic test results available that show a normal cag repeat length for both huntingtin (htt) alleles (\<36). exclusion criteria: for all 1. receive any prohibited medications within 30 days of screening and during participation in the study 2. have participated in a previous clinical study of sage-718, have previous exposure to gene therapy; or have participated in any hd investigational drug, biologic, or device trial within 180 days, or a non-hd drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer). (note: participants with confirmation of enrolment in the placebo arm of these trials would not be excluded.) 3. is known to be allergic to any of sage-718 excipients, including soy lecithin. additional criteria for participants with hd only: 1. had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit. 2. receive any prohibited medications within 30 days of screening and during participation in the study.
neoadjuvant sitravatinib in combination with nivolumab in patients with clear cell renal cell carcinoma

Conditions: Clear Cell Renal Cell Carcinoma

Summary: the study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccrcc) in the neoadjuvant setting prior to nephrectomy.

sitravatinib is a receptor tyrosine kinase inhibitor (tki) that targets multiple closely related receptor tyrosine kinase pathways including vegfr, pdgfr, c-kit, met, and the tam family of receptors (tyro3, axl, and mer). nivolumab is a monoclonal antibody directed against pd-1 and blocks the interaction between pd-1 and its ligands, thereby releasing pd-1-mediated inhibition of t-cell proliferation (including cytotoxic cd8+ t-cells) and cytokine production. together, sitravatinib and nivolumab may cooperate to elicit greater anti-tumor activity than either agent alone, as sitravatinib is predicted to enhance several steps in the cancer immunity cycle that may augment the efficacy of nivolumab.

Eligibility criteria:
inclusion criteria: 1. imaging results consistent with locally-advanced rcc 2. candidate for partial or complete nephrectomy as part of treatment plan. 3. measurable disease per recist version 1.1. 4. ecog performance status 0 or 1. 5. adequate bone marrow and organ function. exclusion criteria: 1. prior systemic anti-tumor treatment for rcc. 2. patients who are receiving any other investigational agents. 3. clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon. 4. inability to undergo baseline tumor biopsy. 5. active or prior documented autoimmune or immunocompromising conditions. 6. uncontrolled hypertension.

Keywords: ccrcc mgcd516 antineoplastic agents immunologic factors nivolumab tyrosine kinase inhibitor vegfr tam rtks pd-1 pd-l1
bioequivalency study of exemestane 25 mg tablet under fasted conditions

Conditions: Breast Cancer

Summary: the objective of this study was to prove the bioequivalence of exemestane 25 mg tablet under fasted conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to exemestane or any comparable or similar product.