Kornimate/medical-research-clean huggingface dataset:
a two centre study to assess the long-term performance of the pinnacle™ cup with a metal-on-metal bearing in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to monitor the performance and determine the metal ion release of the pinnacle™ cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. a subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged between 18 and 70 years inclusive. ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) subjects undergoing revision hip replacement. iii) women who are pregnant. iv) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. v) subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) subjects who are currently involved in any injury litigation claims. additional exclusion criteria for subjects having blood analysis: 1. subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy. 2. subjects with an occupational exposure to cobalt or chromium. 3. subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months. 4. subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations. 5. subjects who are undergoing a simultaneous bilateral total hip replacement.

Keywords: hip cementless metal-on-metal
safety and efficacy of bimatoprost timolol ophthalmic solution in patients with open angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of once daily administered 0.03% bimatoprost/0.5% timolol ophthalmic solution compared with once daily administered 0.03% bimatoprost ophthalmic solution and once daily administered 0.5% timolol ophthalmic solution concurrently in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes * eye pressure lowering topical medications are not working * visual acuity is at least 0.2 in each eye exclusion criteria: * uncontrolled systemic disease * any other active eye disease other than glaucoma or ocular hypertension * significant visual field loss or evidence of progressive visual field loss within the last year * anticipated wearing of contact lenses during the study * required chronic use of other ocular medications during the study * eye surgery or laser treatment within 12 weeks prior to study enrollment
the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Summary: the goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness. the main ways of stimulation is thermal and itch. six months after inclusion in the study, patients were classified according to the glasgow outcome scale extended, (gose).


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. brain damage lasts 28 to 90 days. 3. it meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (uws/vs) or microconscious state (mcs). diagnostic criteria for uws/vs: loss of cognitive function and inability to execute commands; there is a sleep-wake cycle; inability to understand or express language; the ability to open eyes automatically or in response to stimulation; can be purposeless eye following movement; the functions of hypothalamus and brainstem were basically preserved. mcs diagnostic criteria: simple instructions can be executed; yes/no (whether correct or not) can be expressed by gesture or speech; have an understandable language; purposeful behavior (including activity or emotional response) with more than one can diagnose mcs. 4. all subjects' legal guardians sign informed consent forms. exclusion criteria: 1. spinal cord t1 and above plane injury, peripheral nerve injury and so on affect nerve conduction; 2. the impact of injury on palms and soles of feet; 3. history of developmental, psychiatric, or neurological disorders prior to brain injury. 4. deep sedation within 72 hours, including the use of general anesthesia. 5. increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours. 6. severe co-existing systemic diseases with limited life expectancy.
effects of intrauterine administration of autologous pbmc on the endometrial cells populations

Conditions: Female Infertility

Summary: the behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. each cell type has its role in the endometrial preparation for the invading embryo. alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. immune cell homeostasis is often improved by intrauterine administration of autologous pbmc. there have been numerous reports on the positive effects of the intrauterine administration of autologous pbmc on the ivf outcomes (embryo implantation and ongoing pregnancy success). however, there is little data on the direct effect of the pbmc administration on the cell composition of the endometrium. this study will focus on the changes in the endometrial cell populations by pbmc treatment that could lead to ivf outcome improvement. the aim of this project is to analyze the effect of intrauterine administration of autologous pbmc on the endometrial cell populations and on the ivf outcome parameters (implantation and ongoing pregnancy success as ivf outcome variables).


Eligibility criteria:
inclusion criteria: * participating in assisted reproduction treatment * presenting altered endometrial immune profile * having primary infertility * having regular menstrual cycles * embryo transfer of euploid embryos exclusion criteria: * uterine pathologies * endometrial bacterial infections * active endometrial inflammation * polycystic ovary syndrome * presence of auto anti-bodies such as anti-tpo, anti-tg, aca, apa, ana, and anti-dsdna * presence of mutations involving the coagulation system such as deficiency of factor xii, pro c, pro s * cancer diagnostics * positive hiv, hcv or hbv tests

Keywords: peripheral blood mononuclear cells (pbmc) female infertility endometrium endometrial cell populations
acmella oleracea in the analgesia of the digital rectal examination

Conditions: Analgesia in the Digital Rectal Examination

Summary: the aim of the study is to develop an herbal gel based on acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.

the aim of the study is to develop an herbal gel based on acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group. we are conducting a randomized, controlled, single-blind clinical trial of man undergoing to digital rectal examination, with 150 participants. will be recruit at the urologic clinic of the samuel libânio clinical hospital and urologic clinic cisamesp in pouso alegre. participants divided into three groups, a. oleracea gel group, lidocaine gel group and ultrasound gel group. the digital rectal examination always performed by the same doctor, on the same position. a visual analogue scale (vas) will be the standard method to evaluate the pain levels. the vas will be explained to all patients, 0 = no pain and 10 = the most severe pain.

Eligibility criteria:
inclusion criteria: * male patients * patients to agree to participate in the study exclusion criteria: * diabetic, chronic kidney disease, with urogenital infections, using an indwelling urinary catheter, with history of anorectal diseases or surgeries, psychiatric patients and who refused to participate in the research

Keywords: prostatic neoplasms digital rectal examination phytotherapy pain analgesia spilanthes oleracea
use of mesenchymal stem cells for alveolar bone tissue engineering for cleft lip and palate patients

Conditions: Cleft Lip and Palate

Summary: the aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (geistlich bio-oss®) through prospective qualitative and quantitative analysis of bone neoformation.

the reconstruction of the craniofacial skeleton in development between 2 and 10 years old, remains a major challenge for reconstructive plastic surgery. local autogenous bone is practically unavailable, the distant bone graft has significant morbidity and use of alloplastic materials is incompatible with the growing facial skeleton. with the advent of bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells associated with biomaterials has become a potential solution to the shortage bone-related morbidity and donor bone in the region in pediatric patients. the association of mesenchymal stem cells to biomaterials has provided new bone formation and a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients with cleft lip palate. to perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting. in order to eliminate the morbidity at the bone donor region for these patients and reduce costs of patient permanence in the operating room the aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (geistlich bio-oss®) through prospective qualitative and quantitative analysis of bone neoformation.

Eligibility criteria:
inclusion criteria: * diagnosis of unilateral cleft lip and palate ; * patient who has performed the treatment to align the dental arches in the ambulatory of odontology at hospital municipal infantil menino jesus; * patient that have goslow index 1, 2 or 3; * patiente which have 2/3 of the root of the canine tooth (cleft region) formed. exclusion criteria: * prior alveolar surgery; * canine teeth erupted before the bone graft; * presence of co-morbidities; * incomplete documentation; * patients who have not done all the multidisciplinary treatment at hospital municipal infantil menino jesus.

Keywords: cleft lip and palate deciduous dental pulp stem cells mesenchymal stem cells tissue engineering bone tissue engineering bioengineering
preliminary results for the double-dose adenovirus-mediated adjuvant therapy improving outcome of liver transplantation in patients with advanced hepatocellular carcinoma

Conditions: Liver Cancer; Hepatocellular Carcinoma

Summary: hcc patients with tumors \>5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. patients were randomized allocated in liver transplantation (lt) only group and lt plus adv-tk therapy group. all patients received orthotopic liver transplantation; in the lt plus adv-tk group, adv-tk therapy was delivered to patients twice.


Eligibility criteria:
inclusion criteria: * 18～70 years of age (male and female). * clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation * patients who had unresectable hcc \>5 cm and no metastasis in lungs and bones were eligible to participate in this study. tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion. * no prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks. * provide written informed consent exclusion criteria: * metastasis in lungs and bones * invasion in main vescular. * contraindications of liver transplantation * contraindications of operation of other organ system * hypersensitivity to adenovirus, gcv or similar drugs * accept clinical trials of other drugs * immunological deficit * active pregnancy * unable or unwilling to sign informed consents

Keywords: hepatocellular carcinoma liver transplantation adenovirus-thymidine kinase gene therapy
bone and vascular health in postmenopausal women with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the study is designed to evaluate the differences in bone mineral density (bmd) and carotid intima media thickness (cimt) between postmenopausal women with type 1 diabetes (t1d) compared to postmenopausal women without diabetes.

type 1 diabetes (t1d) is an autoimmune disease requiring lifelong insulin treatment. having t1d increases the risk of death, especially in women with t1d. heart disease and fractures due to osteoporosis (brittle bones) are the leading causes of death in women with t1d. since both diseases share certain common risk factors such as age, menopause, smoking, physical inactivity, and diabetes, this study is designed to find link between bone density and cardiovascular risk. this study has only one visit. all participants will undergone bone density testing using a dual energy x-ray absorptiometry (dexa) machine and measurement of carotid intima media thickness (a marker of carotid atherosclerosis) using carotid ultrasound.

Eligibility criteria:
inclusion criteria: * t1d as defined under cacti study or controls as defined as no current diabetes (hba1c \< 6.5% and fasting blood glucose \< 126 mg/dl, no diabetes diagnosis and no use of anti-diabetic medication), * diabetes duration of 10 years or greater, and * postmenopausal women. menopause is defined as no menstrual periods for at least 12 consecutive months or fsh greater than 40 iu/l on at least two occasions. exclusion criteria: * chronic diseases, which can affect the bmd measurement such as: * uncontrolled coeliac or thyroid disease, * addison's disease, * malabsorption syndrome, * rheumatologic disorder, * parathyroid disorders, * cancer other than skin cancer, and * chronic kidney disease with egfr less than 30. * medications that can affect bmd results such as: * oral or injectable steroid intake for more than 3 months, * immunosuppressant and osteoanabolic or antiresorptive medications for osteoporosis treatment, and * previous fractures or deformities making it difficult to perform dxa at hip and spine.

Keywords: type 1 diabetes menopause cardiovascular risk bone density
study with an autologous dermo-epidermal skin substitute for the treatment of burns in children

Conditions: Burns

Summary: this phase iib trial aims to evaluate the efficacy and safety of ehsg-kf (synonym denovoskin) in comparison to meshed stsg in children with partial deep dermal and full thickness burns.

this multicentre phase iib clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed stsg.

Eligibility criteria:
inclusion criteria: * age: \<12 years of age * deep partial thickness and/or full-thickness burns requiring surgical wound coverage * expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in the netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% tbsa burns can be taken as guideline, but tbsa is not an inclusion criterion. * signed informed consent exclusion criteria: * patients tested positive for hbv, hcv, syphilis or hiv * patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (child-pugh class b or c), severe malnutrition, or other concomitant illness which, in the opinion of the investigator, has the potential to significantly delay wound healing) * severe drug and alcohol abuse * patients with a known history of malignancy * pre-existing coagulation disorders as defined by inr outside its normal value, ptt \>uln and fibrinogen \<lln prior to the current hospital admission and / or at the investigator's discretion * patients with known allergies to amphotericin b, gentamicin, penicillin, streptomycin, or bovine collagen * previous enrolment of the patient into the current phase ii study * participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study * patients or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) * pregnant or breast feeding females * suspicion of child abuse * wounds in the head and neck area as study target area (only applicable for study patients in the netherlands) * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: burns scar skin wound healing tissue engineering dermis epidermis thermal injuries
exercise strategies to motivate and relieve stress

Conditions: Chronic Lung Disease; Cardiopulmonary Disease

Summary: the goal of this clinical trial is to evaluate exercise strategies that motivate and relive stress in adults with cardiopulomnary conditions. the goals of this study are as follows: * to explore the feasibility (how easily it can be done) of using self-selected music during exercise training for adults with cardiopulmonary conditions. * to assess patient satisfaction of self-selected music with exercise for adults with cardiopulmonary conditions. * to explore the immediate effects of self-selected music on mood and symptoms (shortness of breath and fatigue) compared with listening to a podcast during their exercise training session participants will: * select 5-7 songs and 1 podcast to listen to during their treatment session * walk on the treadmill while either listening to a podcast or music * fill out surveys about their mood, symptoms (shortness of breath and fatigue), music/podcast, and exercise

music2move aims to assess if tailored music (music choices that are set to a certain beats per minute and are self-selected by the participant) improves mood while exercising in adults with chronic lung diseases, to ultimately motivate them to engage in physical activity more frequently. this trial will be conducted during their pulmonary rehabilitation session for two consecutive sessions. researchers will flip a coin for a random order of music condition or no music condition for each participant. researchers will meet with participants before the trial to collect music selections to be played during the pulmonary rehabilitation session. mood will be assessed every 2 minutes during the trial using the feeling scale to examine the effect of tailored music selections on the participants tolerance for exercise and maximal limit exercise exertion during the session. heart rate, oxygen level, fatigue, and affect (immediate emotional response), measure of breathlessness (feelings of shortness of breath) will also be assessed before and after the trial to examine the affect that tailored music has on physical measures of exercise. the results of this study could aid in finding motivational tools to improve exercise participation and adherence in adults with chronic respiratory disease.

Eligibility criteria:
inclusion criteria: * diagnosed with a cardiopulmonary disease * speaks and understands english exclusion criteria: * require a hearing aid or have a hearing impairment that interferes with their ability to hear music or use headphones during the study. * unable to engage in physical activity due to health conditions including neurological or musculoskeletal diseases. * require ≥6 liters of supplemental oxygen during pulmonary rehabilitation sessions. * younger than 21 years old. * older than 85 years old. * have uncontrolled anginal symptoms. * unable to exercise on a treadmill.

Keywords: exercise stress lung disease music podcast