Kornimate/medical-research-clean huggingface dataset:
stoma hernia intraperitoneal full-thickness skin

Conditions: Parastomal Hernia

Summary: this is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

parastomal hernia is a common complication to a stoma which can cause considerable suffering for the patient. the conventional methods of repair available today have disappointing results with high recurrence rates and serious complications. some of the complications can be related to the introduction of foreign material into the abdominal wall. the investigators hypothesis is that the use of autologous full-thickness skin graft as reinforcement material can offer an alternative with fewer complications and recurrences. patients with symptomatic parastomal hernia will be included in a prospective randomized multicenter study comparing reinforcement with conventional synthetic mesh (with the best available technique today), to full thickness skin grafts placed in an intraperitoneal position. the intervention will be blinded to the participants, nursing staff and the follow-up staff. the participants will be followed up at 3, 12 and 36 months monitoring complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and calculations will be done on the health economics.

Eligibility criteria:
inclusion criteria: * colo-, ileo- or urostomy * parastomal hernia diagnosed with intrastomal ultrasound and/or ct * symptoms from the parastomal hernia requiring surgical intervention * informed consent * \>18 years of age * sufficient knowledge in the swedish language so that questionnaires can be answered exclusion criteria: * cognitive impairment unabling compliance to post-operative prescriptions and/or answering questionnaires * insufficient amount of good quality skin suitable for transplantation * expected high donor-site morbidity * fistula/e adjacent to stoma * mb crohn
phase i and pharmacokinetic trial of paclitaxel (taxol) given as a 3-hour infusion in pediatric patients with refractory malignancy

Conditions: Neoplasms

Summary: the objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.

paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies. the optimal dose and schedule has not yet been determined in either adults or children. the objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy. in addition, the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined.

Eligibility criteria:
disease characteristics: histologically confirmed cancer (including leukemia) that is: refractory to standard therapy (objective disease progression required) or for which no standard therapy exists and patient is ineligible for potentially curative surgery. prior/concurrent therapy: recovery from the toxic effects of prior therapy required. biologic therapy: not specified. chemotherapy: no prior taxanes. at least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea). endocrine therapy: not specified. radiotherapy: prior extensive craniospinal or pelvic irradiation allowed. surgery: ineligible for potential curative surgery. other: prior bone marrow transplant allowed. patient characteristics: age: over 1 to 21; performance status: ecog 0-2; life expectancy: at least 8 weeks. hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy). absolute granulocyte count at least 1,500/mm(3); platelet count at least 100,000/mm(3); hemoglobin at least 8.0 g/dl. hepatic: bilirubin no greater than 1.5 mg/dl; ast less than 2 times normal. renal: creatinine no greater than 1.5 mg/dl or; creatinine clearance at least 60 ml/min per square meter. other: no concurrent anticonvulsant therapy. no grade 2 or worse neuropathy. no significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity. not pregnant or nursing.

Keywords: paclitaxel pediatric pharmacokinetics phase i toxicity
the acute effects of food structure on post prandial glucose and subsequent metabolic responses

Conditions: Obesity

Summary: aims: to investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,gip, glp-1 design: a randomised, controlled, clinical trial.

rationale: there is very little evidence at the present time in the role of food structure in glucose homeostasis. there is circumstantial evidence that foods consumed intact have great effects on suppressing appetite. to test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. each participant will receive the following meals: solid meal group. milled (intact-cell) meal group. milled (destroyed-cell) meal group. all of which will contain the same macro and micro nutrients from the same food sources

Eligibility criteria:
inclusion criteria: * gender: male and female * age ≥ 18 years ≤ 65 years * normal weight as classified by bmi 20-29.9 kg/m2 * healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening. * willingness and ability to understand, participate and to comply with the study requirements * willingness and ability to give written informed consent exclusion criteria: * has thyroid defects * under hormone or steroids therapy * is pregnant or lactating (female) * had given birth within the past year (female) * is taking drugs that could affect appetite or plasma glucose levels. * is taking natural remedies that modulate appetite or plasma glucose levels. * has excessive alcohol intake * had blood donation within 12wks prior to start date * psychiatric illness * smokers * history of any disease with unknown outcome * has diabetes * has nut allergy
evaluating the effectiveness of an act-based bibliotherapy intervention among adults living with chronic pain

Conditions: Chronic Pain

Summary: chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. it is now recognized that acceptance and commitment therapy (act) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility. the current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on act, in the management of chronic pain. this study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

the purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on acceptance and commitment therapy with minimal therapeutic support in the management of chronic pain. this study was based on the following hypotheses. in comparison to the control group, from pre to post, the self-help program will: 1. significantly reduce pain-related disability (primary variable); 2. improve depressive symptoms related to cp (secondary variable); 3. increase the level of pain acceptance; 4. reduce psychological inflexibility linked to painful symptoms (process variables). it was also expected that: 5. the improvements would be maintained at three-month follow-up; 6. participants would have an overall impression of a positive change following the intervention.

Eligibility criteria:
inclusion criteria: * being 18 years of age or older * having suffered from daily pain for more than three months * having reading and writing abilities in french equivalent or superior to grade 8 * having access to internet at home and having a valid e-mail address * not having previously completed an act-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on act for pain * having stable medication for at least one month, if applicable. exclusion criteria: -

Keywords: chronic pain acceptance or commitment therapy (act) self-help pain-related disability psychological inflexibility depression pain acceptance bibliotherapy
effectiveness of a femoral block following total knee arthroplasty (tka)

Conditions: Total Knee Arthroplasty

Summary: hospital stays after total joint replacement surgery have been getting shorter over the past 10 years. this is mostly due to new ways to manage pain and early rehabilitation. to be able to go home safely soon after surgery, patients need to: * 1) have adequate pain control * 2) be able to move through activities of daily living on their own (using aids) femoral nerve block, in combination with pain medications, is one of the new treatment strategies that are currently being used at other hospitals in canada, the united states and the united kingdom. nerve blocks involve a needle filled with local anesthetic into the nerve that allows the feeling of pain around the knee. with good pain management, patients will be able to more quickly bend their knee and regain the ability to walk with aids and move from sitting and lying positions to standing and walking. once they can do these activities with adequate pain control, they can be discharged from hospital to continue recovery at home. the purpose of this study is to examine a new way of managing postoperative pain and encourage early knee flexion and mobility, while maintaining pain control for patients after total knee replacement. we believe that patients who receive the nerve block in addition to the regular pain medication will have more knee flexion at discharge and experience less pain than patients who only receive usual pain medications.


Eligibility criteria:
inclusion criteria: * undergoing primary total knee arthroplasty * english-speaking * preoperative knee rom \> 90 degrees * body mass index \< 40 exclusion criteria: * regular preoperative opioid use * hepatic insufficiency * any contra-indications to receiving a femoral block

Keywords: total knee range of motion pain
"investigation of the relationship between new coronary virus disease (covid-19) and anxiety and depressive symptoms in pregnant women"

Conditions: COVID; Anxiety; Depression, Postpartum

Summary: in our study; anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelswi̇th beck depression and anxiety score after the disease regressed are planned. (beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. high score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms

the sociodemographic data form prepared by the researchers will be filled out by interviewing the patients who are willing to participate in the study. in addition, beck depression scale, beck anxiety scale, state and trait anxiety scale will be given by the participants themselves. when the patients come to their first control after discharge, the scales specified will be repeated.

Eligibility criteria:
inclusion criteria: * covid -19 pcr positive pregnant women * no psychiatric diagnosis no use of psychiatric medicine exclusion criteria: non-pregnant patients, a psychiatric diagnosis use of psychiatric medicine
effects of appropriate technology for home-based rehabilitation in patients with post-stroke physical dysfunction

Conditions: Stroke

Summary: the goal of this clinical trial is to assess the effect of s-hrat to improve patients' motor function and activities of daily living.

limb dysfunction is the primary disability factor among stroke patients. however, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. home-based rehabilitation appropriate technology (s-hrat） training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. this study aims to assess the effect of a nursing intervention based on cox's interaction model of client health behavior (imchb) with the application of s-hrat to improve patients' motor function and activities of daily living. in this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. the control group(n=18) will receive the usual care provided by the hospital. the experimental group(n=18) will receive usual care and an 8-week s-hrat training program. this nursing interventions use cox's imchb as a theoretical framework that consists of rehabilitation exercises and the provision of health information. baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. the primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction. this study is the first of its kind conducted in china to use cox's imchb as a framework to guide the development of the s-hrat training program. our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge.

Eligibility criteria:
inclusion criteria: * age≥18; * patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial ct or mri and meet the diagnostic criteria; * patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease; * patients with limb dysfunction. exclusion criteria: * return to a hospital or rehabilitation facility after discharge; * the patient has a history of mental illness and dyslexia; * patients have a combination of serious, life-threatening conditions.

Keywords: home-based rehabilitation appropriate technology
remineralization potential of curodont repair flouride plus versus cpp-acp in management of white spot lesions: randomized clinical trial

Conditions: White Spot Lesion

Summary: the goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. white spot lesions should be managed using a multifactorial approach. the most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions . self-assembling peptide (p11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (takahashi fet al in 2015) this peptide forms a 3d matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. the peptide has shown encouraging results as a scaffold for enamel regeneration


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 35 years of age female and males * had received conventional periodontal therapy * active carious white spot lesions * no systemic diseases or concomitant medication affecting salivary flow exclusion criteria: * - participant in another trial * non carious lesion (enamel hypoplasia and dental flourosis) * presence of abnormal oral, medical, or mental condition. * participants who had evidence of reduced salivary flow or significant tooth wear. * allergy to mi paste
from great surgeons to brilliant observators, evolution of penetrating neck trauma in a single center reference in spain

Conditions: Penetrating Neck Trauma

Summary: penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons. the aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified protocol.

penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons. traditionally, the management was followed by surgical treatment, but the non-therapeutic cervicotomies were ascendent to the 89%, the zone approach was established, following the monson anatomy zones, with different indications for surgery in every zone, and finally, after the year 2000, started to publish articles on where the injury was not correlated with the zone in about a 23% of the patients. the aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified no zone approach protocol.

Eligibility criteria:
inclusion criteria: * all penetrating trauma patients admitted in the emergency department. exclusion criteria: * all patients with any other diagnostic different from penetrating trauma * blunt trauma patients admitted in the emergency department

Keywords: penetrating trauma trauma surgery no zone approach non-surgical treatment polytrauma
prom project urology

Conditions: Surgery; Urologic Diseases; Urologic Cancer

Summary: all patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. in combination with the clinical data, the prom data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.


Eligibility criteria:
inclusion criteria: 1. patients treated at the department of urology 2. ≥18 years of age 3. active mail-account, use of smartphone/tablet/pc 4. written informed consent exclusion criteria: - patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)
a perspective, self-control study on the progression of carotid plaques in anti-pd-1 mab treated tumor patients by artery ultrasound follow-up

Conditions: Plaque, Atherosclerotic; Immune Checkpoint Inhibitors; Programmed Cell Death Protein 1 Inhibitor; Carotid Artery Plaque; Intimal Medial Thickness of Internal Carotid Artery

Summary: a perspective, self-control study on the progression of carotid plaques in anti-pd-1 mab treated tumor patients by artery ultrasound follow-up

this is a perspective, self-controlled cohort study. this study aims to evaluate the effectiveness of anti-pd-1 mabs (pd-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-pd-1 mabs treated patients. the method for quantification and evaluation of atherosclerotic plaques are based on the: ① the mean intima-media thickness of the common carotid artery (mean cca thickness); ② the maximum intima-media thickness of the internal carotid artery (maximum ica thickness); ③ carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. by comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-pd-1 mabs therapy and 3 months post anti-pd-1 mabs therapy. it is designed to assess the effectiveness of anti-pd-1 mabs on the progression of carotid plaques.

Eligibility criteria:
inclusion criteria: 1. the age of subjects are between 18-90 years old (including 18 and 90 years old); 2. all kinds of tumor diseases of subjects are acceptable; 3. all kinds of pd-1 immune checkpoint blockades or dosages are acceptable; 4. the subjects knew about the experiment and signed the informed consent voluntarily; 5. the subjects plan to receive pd-1 immune checkpoint blockades and potentially to be treated for over 3 months; 6. the subjects complicated with atherosclerotic carotid plaques. exclusion criteria: 1. subjects stop receiving or changing the pd-1 immune checkpoint blockades during follow-up; 2. subjects are reluctant to continue to be involved in this study; 3. known pregnant and lactating women; 4. the parameters (e.g., cca intima-media, ica intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image; 5. other situations that the researchers judged were not suitable for inclusion.
a multiple ascending dose study of htd1801 in adults with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (mad) study to evaluate the safety and tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) profiles of htd1801 in overweight to obese adults with hypercholesterolemia. there were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either htd1801 or placebo.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. males or females aged 18 to 70 years old at the time of first dosing 3. have a body mass index (bmi) of \>25.0 and ≤ 45.0 kg/m2 at screening 4. have a documented history of hypercholesterolemia, defined as ldl-c ≥ 2.59 mmol/l exclusion criteria: 1. the use of any anti-dyslipidemia agent within 28 days prior to dosing 2. history of a total cholesterol ≥ 10.35 mmol/l or triglyceride ≥ 11.3 mmol/l 3. history of a clinically significant cardiac arrhythmia or clinically significant abnormal ecg results at screening 4. significant peripheral or coronary vascular disease 5. clinically significant abnormal blood pressure at screening or baseline, defined as supine blood pressure ≥160/100 mmhg, or ≤ 90/60 mmhg 6. primary hypothyroidism (thyroid stimulating hormone \[tsh\] \> upper limit or normal \[uln\] and free t4 \ uln and free t4 within normal limits \[wnl\]), or secondary hypothyroidism (screening tsh \< lln and free t4\< lln) at screening 7. glucose-6-phosphate dehydrogenase (g6pd) deficiency