Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of abh001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing

Conditions: Epidermolysis Bullosa

Summary: the purpose of this study is to evaluate the efficacy and safety of abh001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. it is hypothesized that abh001 may initiate and continue wound healing in patients with epidermolysis bullosa.


Eligibility criteria:
inclusion criteria: 1. the subject or legal guardian must have read, understood and signed an institutional review board/ethics committee (irb/ec) approved informed consent or assent form and must be able to and willing to follow study procedures and instructions 2. male and female subjects. 3. stable nutritional status. 4. subjects with a confirmed diagnosis of generalized epidermolysis bullosa (eb) 5. cutaneous wounds meeting the following criteria: 1. anatomical location: arms, legs, thorax, or back above the waistline and below the neck. 2. documented age (duration) of the wound(s). 3. one or more wounds capable of potentially meeting the following wound selection criteria at the end of the observation period: i. two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period. ii. two matched wounds. 6. negative urine pregnancy test for women of child-bearing potential. 7. female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception. exclusion criteria: 1. pregnant or nursing women. 2. diagnosis of non-genetic generalized eb. 3. localized, active clinical infection of study wounds. 4. diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures. 5. known allergy to bovine products. 6. known allergy to silver products. 7. systemic infection at the time of enrolment in the study. 8. currently receiving or have received oral steroid therapy within the previous 4 weeks. 9. taking, or have participated in other clinical studies involving gene therapy, stem cell therapy, recombinant dna/protein therapy. 10. received abh001, or other biologic or cell therapy for the treatment of eb in the study wound sites within the previous 3 months. 11. hypersensitivity to any of the therapeutic agents. 12. history of malignant skin disease.

Keywords: epidermolysis bullosa, chronic wound, wound healing, dermal repair, fibroblasts, dermagraft
auricular acupuncture in substance abuse: effects on anxiety, sleep, drug use.

Conditions: Substance Abuse; Anxiety; Sleep

Summary: background. a common alternative treatment for substance abuse is ear acupuncture. the aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. method. adults with substance abuse and psychiatric comorbidity were randomly assigned to either of two variants of auricular acupuncture - the national acupuncture detoxification association protocol (nada) or a local protocol (lp) - or relaxation training (controls). primary outcomes were measured using the beck anxiety inventory (bai) and insomnia severity index (isi) with assessment before treatment and follow-ups after five weeks and three months. secondary outcomes were drug use and addiction service utilization.


Eligibility criteria:
inclusion criteria: * ongoing patients status at the clinic. exclusion criteria: * nickel-allergy * ear infection * heart disease
escalating, constant and reduction energy output in swl for renal stones

Conditions: Renal Stones

Summary: research problem: shock wave lithotripsy (swl) dramatically changed the management of renal and ureteral calculus disease. in vitro studies suggest that progressive increase in lithotripter energy output voltage could produce the best overall stone comminution in comparison with constant or deescalating energy output. however, it is possible that the beneficial impact of slow rate swl on comminution of stones and stone free rates has masked any marginal benefits for energy output escalation. the escalating sw method adds the benefit of less renal tissue injury. research significance:the present study will signifies and evaluates the stone free rates of three groups of patients with renal stones treated with different swl energy outputs (escalating, constant and reduction energy output). research objectives: the aim of this research project is to study the effect of dose adjustment strategies on success rate of shock wave lithotripsy in the clinical setting and to optimize the conditions for successful shock wave lithotripsy. research methodology: this clinical trial will be conducted at a tertiary care university hospital. 150 patients referred to the shock wave lithotripsy unit will be evaluated for eligibility to be randomized into three groups (dose escalation, dose reduction and constant dose). parameter of the three groups will be compared to detect the treatment difference.

escalating sw amplitude treatment protocols have been shown to be safe on long-term with less harm to kidney tissue. this clinical trial will be conducted at a tertiary care university hospital. all patients referred to the swl unit will be evaluated for eligibility to be randomized. randomization process "complete" or "unrestricted" randomization was used to allocate patients to the three arms of the clinical trial where one patient was randomly assigned to one of the three arms blindly.

Eligibility criteria:
inclusion criteria: * single stone * radio opaque * less than 2cm in size * renal stone exclusion criteria: * bleeding disorder, * urinary tract infection (uti) * distal ureteric obstruction

Keywords: renal stones swl
ultrasound for postop lung issues in low-flow anesthesia

Conditions: Atelectasis, Postoperative; Cholecystitis; Gallstone; Pulmonary Atelectasis

Summary: detecting possible atelectasis and other respiratory problems that may develop immediately after extubation via lung ultrasonography can reduce pulmonary complications by performing necessary interventions such as oxygen support, respiratory exercises, mobilization, and non-invasive mechanical ventilation applications at an early stage. in addition, although low-flow anesthesia is frequently used in daily anesthesia practice, publications showing the effects of its use in laparoscopic cholecystectomy operations on pulmonary complications are limited. on this occasion, this study can be presented as a contribution to the literature.

postoperative atelectasis is a common complication that can develop in all patients receiving general anesthesia. the frequency of atelectasis increases due to increased intraabdominal pressure, especially in laparoscopic surgeries performed with pneumoperitoneum. for this reason, in order to prevent postoperative complications related to the lungs, it is extremely important to recognize atelectasis at an early stage, as well as to recognize the mechanisms that will cause atelectasis and avoid them. lung ultrasonography (lung usg) draws attention for the rapid, cheap, safe and reliable detection of postoperative atelectasis. the fact that it can be applied at the bedside and can be easily repeated makes this method valuable. in the literature and in daily practice, it is seen that anesthesiologists commonly apply inhalation anesthesia with different fresh gas flow (fgf) rates during general anesthesia. as defined by baker and simionescu, in low-flow anesthesia, fgf varies between 0.5 and 1 liter per minute. it has been shown that all types of flow are safe with modern anesthesia machines. this study aims to demonstrate the effect of low-flow anesthesia (lfa) on pulmonary complications and, in particular, atelectasis that may develop after laparoscopic cholecystectomy operations, using a non-invasive, rapidly applicable, and proven method such as lung usg.

Eligibility criteria:
inclusion criteria: * patients with informed consent * patients scheduled for laparoscopic cholecystectomy * patients with a body mass index between 18-35 kg/m² * patients in the american society of anesthesiologist (asa) 1-2-3 category exclusion criteria: * patients with emergency surgery planned * patients with asa 4 and above * patients with lung disease * patients who have undergone thoracic surgery * pregnancy * patients with a preoperative lung ultrasound score of 2 or 3 in any lung region

Keywords: lung ultrasound low flow anesthesia laparoscopic cholecystectomy
receptive music therapy on anxiety and vital parameters in hospitalized covid-19 patients.

Conditions: SARS-CoV2 Infection

Summary: hospitalized patients for covid-19 are extremely isolated from their families for a long and uncertain period of time .this traumatic separation makes patients vulnerable to different degrees of stress disorders as well as depression and anxiety , fear of the unknown and dying, sleeplessness, agitation, discomfort, pain, immobility, frustration and inability to relax . musicttherapy has been shown to play a valuable role in the care of patients with serious illness, helping to address physical symptoms and psychological distress . the aim of this study was to evaluate the feasibility of introducing music therapy (mt) on site with covid-19 patients as a supporting complementary/non-pharmacological intervention, to investigate the immediate effects a single mt session has on anxiety, heart rate (hr), oxygen saturation (o2sat) and satisfaction compared to standard care. in order to verify the hypotheses of the study, an rct (mixed-methods approach pre -post design) will be carried out on patients diagnosed with sars-cov2 admitted to covid hospital bari, randomized into two groups: control group (b) and treatment group (a). . the study starts on 15th april 2021 and it is expected to run for 1 mounth (15th may 2021). the study is funding by university of bari.


Eligibility criteria:
inclusion criteria: * age over 18 years * not severe neurological or psychiatric conditions * not hearing impairment * not intubated exclusion criteria: * age under 18 years * severe neurological or psychiatric conditions * hearing impairment * intubated

Keywords: music therapy anxiety stress quality of life vital parameters
balance, trunk impairment and fear of falling in multiple sclerosis patients with incontinence

Conditions: Multiple Sclerosis; Physical Therapy; Incontinence

Summary: the aim of the present study was to examine balance, trunk impairment, and fear of falling in ms patients with incontinence. clinical symptoms of the ms patients are heterogenous, and they vary according to the lesion levels and the duration and the type of the disease. in the neurologic group,especially in ms patients, incontinence is observed even at early stages. pelvic floor muscles contribute to continence by stabilizing the bladder neck and increasing the intraurethral pressure. furthermore, they mechanically support the spine and the pelvis.this mechanical support is attained through an increase in sacroiliac joint stiffness and intra-abdominal pressure changes, which are important for spinal control. along with incontinence, this mechanical support deteriorates resulting in some problems. by this way, postural function of pelvic floor muscles may alter in individuals with incontinence, and thus, lumbopelvic stabilization may be negatively affected. in addition, the activity of trunk muscles changes in individuals with incontinence, which may result in spinal movement and affect the posture. therefore, balance disorders may develop. postural sways caused by balance disorders and the decrease in postural corrections have been listed among risk the factors associated with falling. when literature is examined, there exists no study examining the effects of incontinence on balance, trunk impairment, and fear of falling in ms patients. for all these reasons, investigators think that incontinence in ms patients has an effect on balance, trunk impairment, and fear of fall.

this study was aimed to investigate balance, trunk impairment, and fear of falling in ms patients with and without incontinence. the study was conducted in 35 ms patients with an age range of 24-58 years. the patients were divided into two groups based on the occurrence of incontinence. a neurologic examination was performed using the edss by a neurologist. incontinence was measured with the incontinence severity index (isi), balance was measured with a technobody® stabilometric platform, and fear of falling was measured with the falls efficacy scale (fes).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis disease * the level of disability should be between 0.5-4 according to edss * having a score of 24 or more in the mini mental status test exclusion criteria: * patients with acute attacks (six months prior to the study) * mini-mental state examination (mmse) score of less tahn 25 points * history of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants

Keywords: multiple sclerosis balance trunk impairment fear of falling incontinence
safety and effect of elbasvir/grazoprevir combination therapy in hemodialysis patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the number of hemodialysis patients with chronic renal failure in japan exceeds 0.3 million and is showing an increasing trend. the rate of infection with hepatitis c virus (hcv) is high in hemodialysis patients, and it has been revealed that the prognosis is poorer in hcv-infected hemodialysis patients compared to uninfected patients; therefore, aggressive therapeutic intervention is required.investigator previously reported the efficacy and safety of a ns5a inhibitor; daclatasvir and a hcv protease inhibitor; asunaprevir combination therapy for japanese dialysis patients with genotype 1 hcv infection. however, the duration of the treatment is 24 week, which is quite longer than current standard 12 week therapy . elbasvir/grazoprevir combination therapy is oral anti-hcv 12 week therapy without the use of ifn/ribavirin, and a good therapeutic effect has been reported in japanese phase ii studies . of note is that these drugs are metabolized mainly in the liver and thus they can be used in patients with chronic renal failure. recently, david roth et al reported that the efficacy and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis c virus genotype 1 infection and stage 4-5 chronic kidney disease. in this report, they revealed that elbasvir/grazoprevir combination therapy could achieve svr rate of 99% in the modified full analysis set. however, no adequate clinical investigation has been performed in japan, thus far concerning the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in japanese hemodialysis patients.


Eligibility criteria:
inclusion criteria * patients aged 20 years or older at the time of consent * patients who received an adequate explanation prior to the study and provided written consent for participation in the study * hemodialysis patients complicated by chronic hepatitis c who have hcv genotype 1b infection and do not meet the exclusion criteria listed in the following section exclusion criteria * patients with a past history of hypersensitivity to hcv protease inhibitors and ns5a inhibitors * patients with serious liver dysfunction (child-pugh class b or c) * patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) * patients who have malignant tumors, including hepatoma, at the start of treatment * patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (hiv) protease inhibitors) * patients with albumin \<3.0 g/dl and platelets \<75,000 /μl * other patients judged to be inappropriate to participate in the study by the primary physician * other patients judged to be inappropriate as study subjects by the study manager
patient specific talus spacer post approval study

Conditions: Avascular Necrosis of the Talus

Summary: humanitarian device exemption approved patient specific talus spacer post approval study.

this is a humanitarian device exemption (hde) approved device called the patient specific talus spacer. this is a post approval study to determine the safety and probable benefit of the patient specific talus spacer in commercial use. the patient specific talus spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.

Eligibility criteria:
inclusion criteria: 1. subject plans to undergo implantation of the patient specific talus spacer for avascular necrosis of the ankle joint independent of this research protocol; 2. avascular necrosis of the ankle joint; 3. age 21 years old or older; 4. subject has good general health; and 5. subject signs a written informed consent form (icf) prior to the surgical procedure. exclusion criteria: 1. presence of any contraindication identified in the device instructions for use; 2. surgeon determines that the patient is not appropriate for the talus spacer procedure based on the device ifu (including the enumerated warnings and precautions); 3. based on the medical opinion of the surgeon, the patient is not appropriate for the talus spacer procedure; 4. for female subjects, pregnancy; 5. active systemic disease, such as aids, hiv, or active infection; 6. active infection or the skin is compromised at the surgical site; and 7. systemic disease that would affect the subject's welfare; 8. is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results; 9. is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up. 10. if the sponsor has notified the site that 30 subjects have been enrolled in the study with a cobalt chromium patient specific talus spacer, and the surgeon believes that a cobalt chromium patient specific talus spacer is the best option for the patient. 11. if the sponsor has notified the site that 30 subjects have been enrolled in the study with a titanium (ti6al4v) with titanium nitride (tin) coating patient specific talus spacer, and the surgeon believes that a titanium (ti6al4v) with titanium nitride (tin) coating patient specific talus spacer is the best option for the patient.

Keywords: avascular necrosis talus ankle
safety and feasibility of the elios system in poag patients

Conditions: Glaucoma, Primary Open Angle

Summary: evaluation of the safety and effectiveness of the elios system procedure to reduce intraocular pressure (iop) in adult subjects with mild to moderate primary open-angle glaucoma (poag)


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate poag * medicated iop of \<=24 mmhg * shaffer angle grade of iii or iv * cd ratio \<=0.8 * at least 45 years old exclusion criteria: * closed-angle and secondary glaucomas * prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * cannot undergo medication washout in the study eye * diagnosis of degenerative visual disorders non-study eye with bcva worse than 20/80 known corticosteroid responder pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
transcultural validation of the french version of the " patients' endorsement of a biopsychosocial model of chronic pain " scale

Conditions: Pain, Chronic

Summary: we will validate the french version of the "patients' endorsement of a biopsychosocial model of chronic pain (peb) scale" by comparing it to the "pain self-efficacy" questionnaire

the primary objective is to validate the french version of the peb scale, called "echelle d'adhésion du modèle bio-psycho-social par des patients avec douleur chronique abdc". the hypothesis is that the abdc scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain. consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (bpi, gad-7, phq-9). patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.

Eligibility criteria:
inclusion criteria: * - patients with chronic pain (defined by icd-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the hug * french-speaking and able to understand the study information * ≥18 years of age exclusion criteria: * - inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant * enrolment of the investigator, his/her family members, employees and other de-pendent persons

Keywords: pain, chronic patient education self efficacy bio-psycho-social model
link between biochemical, anthropometric variables and cd36 in metabolic syndrome after a low-calorie diet

Conditions: Metabolic Syndrome; Weight Loss

Summary: this study evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (cd36) levels in 65 patients newly diagnosed with metabolic syndrome (mets). participants followed an 8-week medical nutrition therapy (mnt) designed to achieve at least 5% weight loss. significant changes were observed in some biochemical parameters and blood pressure among those who adhered to the diet. cd36 levels showed correlations with various metabolic and body composition parameters.

this research aimed to assess the impact of a weight loss diet on biochemical and anthropometric variables, as well as cd36 levels, in 80 patients newly diagnosed with metabolic syndrome (mets) who began a weight loss program. the study was completed all of whom were diagnosed with mets and had applied to the internal medicine outpatient clinic at ordu university training and research hospital. at the start of the study, participants were provided with medical nutrition therapy (mnt) tailored to their energy and nutritional needs, as well as their lifestyle, with the goal of achieving at least a 5% weight loss within 8 weeks. patients were monitored regularly throughout the process. before initiating mnt, participants' general characteristics and dietary habits were collected through face-to-face interviews. additionally, 24-hour dietary recalls and anthropometric measurements were taken both before and at the end of the 8th week. biochemical data were retrieved from patient records, blood pressure was measured by a physician, and fasting blood samples were collected for cd36 analysis, which were then stored at -80°c until further examination. by the end of the study, some individuals adhered strictly to the mnt. statistical differences were observed in some biochemical parameters and blood pressure between those who complied with mnt and those who did not. correlations were observed between cd36 levels and some variables.

Eligibility criteria:
inclusion criteria: * being between the ages of 19-64 * being diagnosed with mets by a physician according to the international diabetes federation (idf)-2005 metabolic syndrome diagnostic criteria * being a volunteer to participate in the study exclusion criteria: * being pregnant and breastfeeding * smoking and drinking alcohol * having any chronic disease other than metabolic syndrome * taking regular medication * taking regular nutritional supplements * having a change in weight within the last 3 months

Keywords: metabolic syndrome weight loss cd36 fatty acids fatty acid receptor