Kornimate/medical-research-clean huggingface dataset:
psychoneurological symptom cluster in oncology

Conditions: Cancer; Breast Cancer; Digestive Cancer

Summary: a psychoneurological symptom cluster is increasingly documented in oncology. it is composed of cancer-related fatigue, sleep difficulties, pain, emotional distress, and cognitive difficulties. these symptoms are linked by strong but complex relationships, and reinforce each other, negatively impacting patients' quality of life and survival. the configuration of this cluster (i.e., the relationships between the symptoms) seems different according to the cancer diagnosis or moment in the cancer journey. it has however been very little studied. network analysis is an innovative method that allows a deeper understanding of the interactions between these symptoms. it also allows to compare patterns of clustering between distinct populations or measurement times. finally, it allows to determine one core symptom in a cluster (i.e., the one with the strongest associations with the other symptoms), which could represent a target of choice for interventions aiming to improve the whole symptom cluster. this innovative project has then two main goals. first, the investigators will assess the evolution of the psychoneurological symptom cluster in two populations of patients with cancer: women with breast cancer, and patients with digestive cancer, over two years. second, the investigators will test the feasibility and preliminary benefits of a new mind-body group intervention specifically designed to address the core symptom of the cluster, determined with network analysis in each population. as suggested by many authors, the proposed intervention will be based on the common-sense model of self-regulation developed by leventhal and focus on cognitive-behavioral, self-care and mind-body (i.e., hypnosis) empowering strategies. the aim is to assess the satisfaction of the participants regarding the intervention, as well as its impact on the symptoms involved in the cluster.


Eligibility criteria:
inclusion critera for wp1: * diagnosis of non-metastatic breast cancer, or digestive cancer (i.e., anal, colorectal, gastric, esophageal, liver, pancreatic cancers). * ≥ 18 years old. * no history of cancer, and not currently in relapse. * having completed the active treatments (i.e., surgery, chemotherapy, radiotherapy) for 5 years maximum, based on the methodology and recommendations of studies on symptom clusters in oncology additional inclusion criteria for wp2: * no history of severe psychiatric disorders (e.g., schizophrenia, dissociative episodes) or substance abuse (to avoid severe dissociation during hypnosis). * score ≥ 4 for the core symptom selected to design the intervention, as suggest by previous interventional studies, and measured on a visual analogue scale from 0 to 10.

Keywords: cancer oncology symptoms quality of life hypnosis self-care
master mind program evaluation study

Conditions: Substance Abuse; Mindfulness

Summary: the purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of the master mind program, a mindfulness education substance abuse prevention program. the program has the goal of enhancing coping strategies and decision-making skills and preventing substance abuse in late elementary school students.


Eligibility criteria:
inclusion criteria: * english fluency exclusion criteria: -
international study of inflammation in covid-19

Conditions: Covid19; Outcome, Fatal; Respiratory Failure; Acute Kidney Injury; Inflammation

Summary: this is a prospective multi-center observational study which purpose is to evaluate the ability of blood-based inflammatory markers to risk-stratify patients hospitalized for covid-19. blood-based biomarkers examined include: soluble urokinase plasminogen activator receptor (supar), c-reactive protein (crp), procalcitonin, d-dimer, ferritin, lactate dehydrogenase and interleukin-6.

all consecutive patients hospitalized specifically for covid-19 at the university of michigan in ann arbor from february 1st, 2020 to date are included. other participating centers will enroll patients depending on their variable capacity. patients with a positive test for sars-cov-2 but hospitalized for non-covid-19 reasons were excluded. blood-based biomarkers including soluble urokinase plasminogen activator receptor (supar), c-reactive protein (crp), procalcitonin, d-dimer, ferritin, lactate dehydrogenase and interleukin-6 are measured in samples collected within 48 hours of presentation. the primary outcome of the study is the composite endpoint of in-hospital mortality, need for mechanical ventilation and need for renal replacement therapy.

Eligibility criteria:
inclusion criteria: * positive sars-cov-2 test result * covid-19 as the primary reason for hospitalization exclusion criteria: * hospitalized primarily for non-covid-19 reasons

Keywords: supar crp d-dimer ferritin interleukin-6 procalcitonin lactate dehydrogenase biomarkers
repair of proximal restoration resin bulk fill. clinical trial

Conditions: Dental Diseases

Summary: bulk fill" (rbf) composite resins (rc) has been on the market, with the main advantage of being applied in a single layer, faster and easier than a conventional rc. repair of rc restorations is a validated treatment option in dentistry, which has been shown to increase the longevity of restorations by minimizing tooth damage such as complete replacement. currently there are no clinical studies that support the actual performance of rbf repair

main objective: compare the clinical performance with fdi of repairs proximal rc restorations between a conventional resin and a rbf in a period of 24 months. hypothesis: there is not different clinical performance of proximal rc repairs done with rbf when compared to conventional rc repairs. material and method: 80 volunteer patients will be randomly recruited to attend the clinic of the faculty of dentistry of the university of chile who have two proximal rc restorations with indication of repair according to the fdi system (n per group = 80). each patient must accept and sign an informed consent. the repairs will be randomly divided into two groups on the same patient. control group: conventional rc repair (z350 xt). experimental group: rbf (tetric evoceram bulk fill) repair. for the restorative technique, a three-step adhesive with acid-etched enamel-dentin will be used. it will be evaluated at 2 weeks (baseline), at 6, 12, 18, 24 months by two blind and calibrated evaluators (cohen kappa\> 0.8). the data will be analyzed with the ssps 21.0 software and the friedman, wilcoxon and mann whitney tests will be applied with a significance level of 95%.

Eligibility criteria:
inclusion criteria: * \> 18 years, * healthy * high cariogenic risk, * vital molars and premolars, * natural antagonist and proximal * indication of repair in the proximal with depth\> 2mm. exclusion criteria: * patients has xerostomia either by taking medications known to produce xerostomia or those with radiation induced or sjogren's syndrome patients -inability to perform hygiene * pregnant women * severe bruxism * prosthesis * not absolute isolation * tooth fracture and / or restoration.

Keywords: composite dental resin
impact of a history of tonsillectomy or adenoidectomy on the severity of covid-19 : amyvid study

Conditions: Tonsillectomy; COVID-19; Adenoidectomy

Summary: little is known about the impact of tonsillectomy and/or adenoidectomy on the severity and presentation of respiratory infections, let alone covid-19. current knowledge of the role of nalt suggests that its absence may be associated with an increased risk of severe disease. assessing the impact of tonsillectomy and adenoidectomy on the risk of adverse evolution in covid-19 would help to better identify patients at risk of adverse evolution, so that they can be rapidly offered appropriate treatment. it would also provide a better understanding of the pathophysiology of this infection. primary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe covid-19. primary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe covid-19. the results of this study will be compared with a data-driven study of covid patients without severe disease.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 80 * hospitalized in smit at chu d'angers between 01/03/2020 and 30/11/2021 for severe covid-19 infection (at least 1 severity criterion) exclusion criteria: long-term home oxygen therapy prior to covid-19 infection * vaccination against covid-19 with at least one dose of vaccine received prior to covid-19 infection confidential page 11 of 15 * inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy * person objecting to participation in research
safety, tolerability and pharmacokinetics study of ck-3773274

Conditions: Obstructive Hypertrophic Cardiomyopathy; Healthy Adult Subjects

Summary: the purposes of this study are to: 1. learn about the safety of ck-3773274 after a single dose and multiple doses in chinese healthy adult subjects. 2. learn how healthy subjects tolerate ck-3773274 after a single dose and multiple doses. 3. find out how much ck-3773274 is in the blood after a single dose and multiple doses. 4. determine the effect of doses of ck-3773274 on the pumping function of the heart. 5. evaluate the effect cyp2d6 genetic polymorphisms on how the body metabolizes ck-3773274.


Eligibility criteria:
inclusion criteria: 1. healthy chinese males and females between 18 and 45 years of age, inclusive 2. body weight ≥50kg and body mass index (bmi) within 18 to 26 kg/m2, inclusive 3. acoustic windows adequate for accurate transthoracic echocardiograms 4. normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist 5. lvef ≥65 percent at screening, and lvef ≥60 percent at day-1 6. normal ecg exclusion criteria: 1. history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs 2. subjects with breast implants that may impede echocardiography 3. a clinically significant illness within 4 weeks prior to admission to the cru 4. inability to swallow tablets 5. use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the cru 6. poor peripheral venous access 7. any blood donation within 60 days prior to admission to the cru, or any plasma donation within 30 days prior to admission to the cru, or receipt of blood products within 2 months prior to admission to the cru

Keywords: ck-274 obstructive hypertrophic cardiomyopathy ck-3773274 ohcm aficamten
adipokines as predictors of the metabolic syndrome in all survivors

Conditions: Leukemia; Metabolic Syndrome X

Summary: background: acute lymphoblastic leukemia (all) is the most common malignancy in children. it accounts for 25% of all childhood cancers. peak incidence occurs between 2 to 5 years of age. modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to current overall survival rates of approximately 80%.the high survival rates have introduced us to novel medical problems as a consequences of the different treatment regimens. no single treatment modality exists today but rather several treatment protocols are accepted worldwide. as such, the population of the childhood all survivors differ in their toxic exposure: cranial \& spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone marrow transplantation .as the survival rates grow, there are more young adult all survivors worldwide susceptible to these late effects of treatment. numerous reports have pointed out that this particular group is at increased risk to develop cardiovascular disease (cvd) and diabetes (ms). the metabolic syndrome, i.e hypertension, dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the general population. adipocytokines, mediators secreted by adipose tissue, play an important role in the regulation of carbohydrates and lipid metabolism.changes in serum adipokine levels precede the clinical symptoms. we aim to identify and assess prevalence of the ms in all survivors. we aim to characterize the population at risk to develop dm and cvd prior to overt clinical disease. characterization will be done by measuring serum adipocytokines and inflammatory cytokine profiles .biochemical characterization of the group at risk will enable us to intervene in the preventive stage in the future.


Eligibility criteria:
inclusion criteria: * all diagnosis * five years after completion of treatment * leukemia free during research exclusion criteria: * ongoing chemotherapy and radiotherapy

Keywords: adipocytokines inflammatory markers cardiovascular disease diabetes mellitus leptin
oral thiamine for the treatment of painful diabetic peripheral neuropathy

Conditions: Peripheral Neuropathy; Diabetes Mellitus; Diabetes Complications

Summary: this study will examine the effect of oral thiamine (vitamin b1) supplementation on pain in patients with diabetic peripheral neuropathy.

it is estimated that more then 5 million people in the united states suffer from diabetes mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. multiple medications have been tried for the treatment of painful diabetic neuropathy. these medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy. basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. a study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination. a screening study of patients with type ii diabetes found that 76% of patients tested had a low serum thiamine level. our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. in addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels

Eligibility criteria:
inclusion criteria: diagnosis of diabetes mellitus painful diabetic neuropathy for \> six months with a score of \>40mm on a visual pain analog scale age \>18 years hemoglobin a1c obtained within the last 3 months. willingness and ability to comply with the study requirements and give informed consent. exclusion criteria: known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or hiv. hgb a1c\>11

Keywords: diabetic peripheral neuropathy peripheral neuropathy diabetes mellitus
trial investigating the absorption, metabolism and excretion after a single subcutaneous dose of [3h]-semaglutide in healthy male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of \[3h\]-semaglutide in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects, based on an assessment of medical history, physical examination, ecg (electrocardiogram) and vital signs, as determined by the investigator * age between 45-64 years (both inclusive) at the time of signing inform consent * body mass index (bmi) between 20 and 30 kg/m\^2 (both inclusive) exclusion criteria: * donation of any blood or plasma in the past month or in excess of 100 ml within the 3 months preceding screening, or surgery or trauma with more than 100 ml blood loss within the 3 months preceding screening * use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, day 1 * history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test * history of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 ml of beer or lager, one glass (120 ml) of wine, or 20 ml spirits) * smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test
clinical outcomes of patients implanted with the rxsight light adjustable lens (lal)

Conditions: Cataract; Pseudophakia

Summary: the objective of this investigator initiated study (iit-002) is to collect data on commercial patients implanted with the rxsight light adjustable lens (lal).


Eligibility criteria:
inclusion criteria: * sign a written informed consent document * implanted commercially with the lal and completed ldd light treatments exclusion criteria: * previous corneal or intraocular surgery other than removal of cataract and implantation of the lal
global trial in apg2575 for patients with cll/sll

Conditions: CLL/SLL

Summary: this is a global multicenter, open label, randomized, registrational phase iii study to investigate the efficacy and safety of lisaftoclax in combination with btk inhibitors in cll/sll patients who previously treated with btk inhibitors

approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a btk inhibitor) or the control arm (btk inhibitor alone). these patients with cll/sll have been on btki monotherapy and meet all other protocol required eligibility criteria.

Eligibility criteria:
inclusion criteria: 1. - age ≥ 18 years. 2. . patients that have documented cll/sll who meet iwcll 2018 criteria for cll treatment guidelines are eligible for treatment and must be receiving btki monotherapy for at least 12 months 3. ecog performance status grade 0-2 4. adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows: * absolute neutrophil count ≥ 1.0 × 109/l * platelet counts ≥ 75 × 109/l; in cases of thrombocytopenia * total hemoglobin ≥ 9 g/dl, 5. adequate renal function * creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of cockcroft and gault (for men: gfr ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method. * for patients with creatinine values within the normal range, the calculation of clearance is not necessary. dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min. 6. adequate liver function as indicated by: * total bilirubin ≤ 1.5 x uln, except patients with known gilbert's syndrome * aspartate aminotransferase (ast) ≤ 2.5 x the institutional uln value * alanine aminotransferase (alt) ≤ 2.5 x the institutional uln value, * international normalized ratio (inr), prothrombin time (pt) or activated partial thromboplastin time (aptt) ≤ 1.5×uln. 7. ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
recurrence in buccinator muscle excision with the skin versus without the skin in buccal squamous cell carcinoma

Conditions: Squamous Cell Carcinoma of the Oral Cavity

Summary: evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: a randomized clinical trial.

preoperative multi slice ct scan or mri carried out for evaluation the lymph node of the neck. also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (the invasion in the buccinator muscle). * under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. this will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour. * a neck dissection will be done in all cases of negative or positive neck lymph node. * reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.

Eligibility criteria:
inclusion criteria: * patients suffering from buccal squamous cell carcinoma. * patients should be free from any systemic disease that may affect normal healing, and predictable outcome. * both sexes and all ages will be included in the study. * cooperative patients, who accept the procedure and return for follow up , examination and evaluation. exclusion criteria: * patients with any systemic disease that may affect normal healing.9,10 * patients who physically and psychologically not able to tolerate the procedures. * patients may discontinue the follow up.

Keywords: buccal squamous cell carcinoma
the effect of priming intravenous rocuronium on fentanyl-induced coughing

Conditions: Fentanyl-induced Coughing

Summary: an intravenous bolus of fentanyl often induces a cough reflex. this study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.

fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics. the cause of fic is unclear. one hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. muscle relaxants are commonly used to treat this condition. this study hypothesizes that priming muscle relaxants could prevent or suppress fic. this study investigates whether the muscle relaxant rocuronium attenuates fic effectively.

Eligibility criteria:
inclusion criteria: * 260 asa i-ii patients, * aged between 18 and 80 years, and undergoing various elective surgeries at taichung armed forces general hospital. exclusion criteria: * a history of asthma, * chronic cough, * smoking, * upper respiratory tract infection in the previous 2 weeks, and * medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.

Keywords: fentanyl-induced coughing, rocuronium