Kornimate/medical-research-clean huggingface dataset:
allogeneic abcb5-positive dermal mesenchymal stromal cells for treatment of epidermolysis bullosa (phase iii)

Conditions: Epidermolysis Bullosa

Summary: the aim of this clinical trial is to investigate the safety and efficacy of allo-apz2-ots administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (rdeb) compared to placebo.


Eligibility criteria:
inclusion criteria: 1. male or female subjects from 6 months of age with a diagnosis of rdeb confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping 2. subject is eligible to participate in this clinical trial based on general health condition; 3. subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and \< 9 months, no signs of acute infection; 4. patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure; 5. women of childbearing potential must have a negative urine pregnancy test at visit 1. women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial. exclusion criteria: 1. any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma; 2. any known allergies to components of the ip or premedication; 3. patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol; 4. pregnant or lactating women; 5. current or previous (within 30 days of screening) treatment with another ip, or participation and/or under follow-up in another interventional clinical trial; 6. previous participation in this clinical trial (except for screening failures); 7. clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; confidential 8. employees of the sponsor, or employees or relatives of the investigator.
phase 1 study of bpn14770 in participants with hepatic impairment and healthy controls

Conditions: Hepatic Impairment

Summary: the primary purpose of this study is to assess the pharmacokinetics (pk) of bpn14770 after a single oral administration of bpn14770 in participants with mild, moderate, and severe liver impairment compared with control participants with normal hepatic function.


Eligibility criteria:
key inclusion criteria: * considered to be healthy (for healthy participants) or medically stable (for participants with hepatic impairment), as determined by medical evaluation. * body weight ≥ 50 kilograms (kg) and body mass index (bmi) within the range ≥ 18.5 to \< 40.0 kilograms per square meter (kg/m\^2). * a diagnosis of clinically stable hepatic disease for at least 1 month prior to the screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique. * mild, moderate, and severe hepatic impairment based on the child-pugh classification score at the screening visit and day ˗1 to determine eligibility: * mild (class a) hepatic impairment (child-pugh classification score 5 to 6) * moderate (class b) hepatic impairment (child-pugh classification score 7 to 9) * severe (class c) hepatic impairment (child-pugh classification score 10 to 15) * healthy participants matched to each participant with moderate hepatic impairment with respect to sex, age (± 10 years), and bmi (± 10%) key exclusion criteria: * history or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data, in the judgment of the investigator. * blood loss or blood donation that exceeds 500 milliliters (ml) within 56 days prior to or at the screening visit or donation of any amount of blood from the screening visit until admission to the clinical research unit (cru). * healthy participants: * clinical laboratory values outside the reference range during the screening period or on day ˗1 and considered clinically significant by the investigator * alanine aminotransferase or aspartate aminotransferase \> 1.5 \* the upper limit of normal (uln) or bilirubin ≥ 1.0 \* the uln. * participants with hepatic impairment: * participant with clinically significant laboratory values in the opinion of the investigator or outside the acceptable ranges or limits during the screening period. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: mild hepatic impairment (hi) moderate hi severe hi
biochemical urine analysis of adherence to statins and associated factors in coronary artery disease

Conditions: Coronary Heart Disease

Summary: feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease

background: statin therapy is known to improve clinical outcomes in patients with coronary artery disease (cad), while being highly cost-effective. however, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary cad disease prevention. previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. however, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. urine analysis with liquid chromatography/mass spectrometry (lc-ms) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in cad patients in germany. objectives: in this pilot study (i) a feasibility testing of objective (lc-ms urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients. methods: outpatients with cad treated in university hospital düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. based on sample size calculation about 130 patients will be recruited. a biochemical method of objective urine measurement of statin intake by lc-ms will be combined with a preselected set of questionnaires on adherence behavior and associated factors. clinical characteristics will be obtained from patient records. a sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey. outlook: based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. the results will be used for the development of a complex tailored intervention for non-adherent patients in germany.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease * prescription of atorvastatin or rosuvastatin exclusion criteria: * \< 18 years * impairment (e.g. dementia) * language barrier (german) * end-stage kidney disease with hemodialysis

Keywords: coronary artery disease statin atorvastatin rosuvastatin adherence biochemical urine testing of adherebnce
transversus abdominus plane catheters for open inguinal hernia repair

Conditions: Post-Operative Pain

Summary: this study is designed to evaluate pain control of continuous transversus abdominis plane (tap) blocks placed for open inguinal hernia repair. the investigators hypothesize that there will be improved pain control when compared with sham blocks.

this study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (tap) block versus sham block has a substantial impact on pain following open inguinal hernia repair. our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery. secondary outcomes will include: pain scores and activity assessment score.

Eligibility criteria:
inclusion criteria: * unilateral open inguinal hernia repair * asa physical status i-iii * \>18 years old * consent to participate in the study exclusion criteria: * refusal to participate in the study * \<18 years old * chronic opioid use * localized infection * pregnancy or lactating * pre-existing coagulopathy or active anticoagulant use * allergy to ultrasound gel or local anesthetics
corneal and tear film changes in chinese patients with type 2 diabetes

Conditions: Dry Eye Disease; Tear Film; Corneal Nerve

Summary: diabetes mellitus has been associated with ocular surface damage and exacerbates dry eye disease (ded) pathology. to investigate clinical and inflammatory changes in the ocular surface of insulin-independent type ii diabetic patients. this cross-sectional control study will recruit 200 type 2 diabetic patients and 200 age- and sex-matched subjects without dm.

diabetes mellitus (dm) is a developing global health challenge due to the multiple complications associated with long-term hyperglycemia. although diabetic retinopathy is the most prevalent and well-known ophthalmic consequence, diabetes also causes clinically significant effects on the ocular surface. among the ocular surface diseases, dry eye disease (ded) is the most common. multiple mechanisms, such as ocular surface and lacrimal gland inflammation, neurotrophic deficiency, and meibomian gland dysfunction (mgd), play significant roles. a loss of tear film homeostasis characterizes ded. dm is one of the risk factors for ded; 47% of dm patients suffer from ocular surface damage due to negative alterations to the tear film, corneal thickness, corneal epithelium, corneal nerve, and corneal endothelium. it has been suggested that one or more of the following initial events may lead to alterations described in the tear film and ocular surface of patients with dm: a) chronic hyperglycemia, b) corneal nerve damage, and c) impairment on insulin action. previous studies have explored the association between dm and ocular surface dysfunction. however, ocular surface and tear film parameters in diabetic patients are lacking in the chinese population. moreover, corneal nerve damage and ocular surface inflammation have not been systematically evaluated. our study aimed to investigate clinical and inflammatory changes in the ocular surface of insulin-independent type ii diabetic patients in a chinese population.

Eligibility criteria:
inclusion criteria: * participants are diagnosed with dry eye according to the tfos dews ii diagnostic criteria: (a) osdi questionnaire ≥13, (b) non-invasive tear breakup time (nitbut) \ 5 corneal spots, greater than nine conjunctival spots (the presence of two or more criteria was used to establish a positive de diagnosis). * age ≥ 18 exclusion criteria: * active ocular infection, such as infectious, viral, chlamydial, or immunologic conjunctivitis * a history of ocular surgery that might affect the corneal or tear film, such as corneal refractive surgery, keratoplasty, cataract surgery, or ocular laser surgery * long-term contact lens wear * other ocular diseases being treated might affect the corneal or tear film: such as glaucoma, dacryocystitis, uveitis, and pterygium.

Keywords: dry eye tear film
self-management program for persons with limb loss

Conditions: Amputation; Depression; Pain; Anxiety

Summary: the specific aims of this study are: 1. to develop and pilot a self-management (sm) intervention for persons with limb loss in a group setting using a participatory action research (par) strategy. 2. to evaluate the feasiablity and effectiveness of a sm intervention within the context of the existng network of limb loss peer support groups hypothesis #2a: the sm intervention groups will be more effective than standard support group activities in reducing pain, depression and anxiety, and increasing positive mood and improving function and overall quality of life. hypothesis #2b: improvements in pain, depression, anxiety, function and quality of life will correlate strongly with improvements in self-efficacy, catastrophizing, and satisfaction with the prosthesis and prosthetic services. hypothesis #2c: gains in outcome will be maintained for one year. hypothesis #2d: characteristics of study participants and their environment (i.e. sociodemographics, co-morbidities, economic and educational resources, hope, and social support) will correlate with outcome and mediate the effect of the intervention. 3. to determine the costs of the intervention and examine the relationship between costs and effectiveness. hypothesis #3a: when compared to the control support group, the sm intervention will be cost-effective in terms of gains in quality adjusted years of life.

approximately 1.2 million americans are living with limb loss. pain, psychological distress, reduced function and disability are common conditions following limb loss and are related to reduced quality of life. our own work has identified depression, anxiety, and pain as significant problems for community dwelling persons with limb loss. traditionally, interventions for disabling impairments and related secondary conditions focus on standard medical treatments such as medication, surgery or rehabilitative therapies. self-management (sm) interventions, on the other hand, have been found to be effective in reducing secondary conditions and disability associated with some chronic conditions using individual and group-based delivery methods. to date, no sm intervention has been developed for, and evaluated in, persons with limb loss. the goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and anxiety and improving positive mood, self-efficacy and function in persons with limb loss. the intervention will build on the already exisitng national network of community-based peer support groups developed by the amputee coalition of america (aca). establishing the efficacy of commmunity-based sm interventions for persons with limb loss has the potential to improve the health and quality of life for this population

Eligibility criteria:
inclusion criteria: * persons with acquired or congenital limb loss exclusion criteria: * non-english speakers

Keywords: amputation depression pain anxiety self-management secondary conditions
quality of life in patients with clinically localized prostate cancer treated with radiosurgery

Conditions: Prostate Cancer; Localized Malignant Neoplasm

Summary: quality of life data following sbrt for prostate cancer has been obtained in only a small numbers of patients. a prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with sbrt. our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of sbrt treatment with regards to quality of life assessment and outcomes.

study design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures): the main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving sbrt treatment for clinically localized prostate cancer. validated quality of life questionnaires will be administered in a deidentified, prospective fashion. eligible subjects will be patients undergoing sbrt treatment for prostate cancer. hypothesis: patients undergoing sbrt will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities. primary objective: to evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with sbrt. secondary objectives: prospective data on cancer control and toxicity following sbrt for clinically localized prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of prostate * signed study-specific consent * prostate specific antigen (psa) within 60 days of registration exclusion criteria: * prior pelvic radiotherapy * prior radical prostate surgery * medical or psychiatric illness that would interfere with treatment or follow up * implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

Keywords: prostate cancer cyberknife
strong heart water study

Conditions: Arsenic Poisoning

Summary: develop and evaluate the effectiveness of multi-level participatory interventions in reducing arsenic exposure among american indian (ai) communities from north and south dakota who participated in the strong heart study (shs).

design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in adults and children in cheyenne river, oglala, and spirit lake communities in north/south dakota by: 1) building local capacity at the tribal and community levels to ensure the long-term sustainability of the interventions. 2) conduct a 2-arm cluster-randomized controlled trial comparing arsenic removal device only to removal device and intensive education and promotion among 300 households, 600 participants.

Eligibility criteria:
inclusion criteria: * arsenic levels in household drinking water must be ≥10 µg/l * households must have ≥1 adult ≥18 years of age eligible and willing to participate. * household must have an active well on the property that is used for drinking water. * household must have indoor plumbing and a permanent heat source. * participant must plan to reside in the household for the next year, must reside in the residence for ≥4 days/week, and year round (i.e. all seasons). * ≥1 household members must identify as american indian. * household must be willing to grant study members access to the interior of their household for screening and data collection. exclusion criteria: * arsenic levels in household drinking water \<10 µg/l * households with no adult ≥18 years of age eligible and willing to participate. * households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply). * households without indoor plumbing and/or a permanent heat source. * participant planning to reside in the household \<1 year, residing in the residence for \<4 days/week, or not year round (i.e. not during all seasons). * no household member identifies as american indian. * household unwilling to grant study members access to the interior of their household for screening and data collection.

Keywords: arsenic drinking water
effect of a combination oral formulation of hyaluronic acid, chondroitin sulphate and magnesium trisilicate in patients with gastro-esophageal reflux disease not fully satisfied with their treatment

Conditions: Gastro Esophageal Reflux

Summary: this is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with gerdoff plus added on top of the current ppi treatment in patients with gerd. the aim of the study is to evaluate the performance of gerdoff plus, a class iii medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the ppis, in patients with gerd not fully satisfied with their current treatment with ppis. patients will receive either gerdoff plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. after the wash-out period, the patients will receive either placebo or gerdoff plus respectively


Eligibility criteria:
inclusion criteria: * signed and dated informed consent (icf): a written informed consent must be obtained prior to any study related procedure being performed * male and female out-patients aged 18 to 80 years * gerd diagnosis confirmed through a validated questionnaire (gerdq score ≥ 8). * egd endoscopy performed within 1 year before screening * patients in continuous or intermittent treatment with ppi for at least 1 year and continuously for at least 4 weeks prior to study entry * patients not fully satisfied with current ppi treatment (1-3 score on 5-points likert scale) exclusion criteria: * dyspeptic patients or patients with overlapping symptoms with gi diseases other than gerd * histological evidence of barrett's oesophagus \> 1 cm in egd endoscopy * peptic stricture in egd endoscopy * concurrent findings in the egd endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator * known impaired kidney or liver function at screening * presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study * medication use (including h2 antagonists, alginates, baclofen, nsaids, prokinetics, antidepressants) that may interfere with gerd symptom assessment within 2 weeks before the start of the study or during the study * pregnancy or breast-feeding * females of childbearing potential not employing adequate contraceptive methods * active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable) * history of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent * history of alcohol or drug abuse that would interfere with ability to comply with protocol requirements * treatment with any investigational drug within the previous 30 days
icp threshold after decompressive craniectomy

Conditions: Traumatic Brain Injury

Summary: severe traumatic brain injury (stbi) is a critical disease of public health importance. increased intracranial play a significant role in the secondary injury of tbi. reducing the icp is helpful in reducing the mortality of stbi. the threshold of icp for stbi has been suggested. the threshold of icp for stbi after decompressive craniectomy is not clear.

240 stbi patients who meet the inclusion criteria will be enrolled in the present study. all stbi patients will be screened. if meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review. after obtaining written consent from the family, the icp and blood pressure will be monitored continuously until retraction of icp sensor. a mean icp of each patient will be calculated. the neurological outcome will be assessed at 180 days after injury. a threshold for icp after decompressive craniectomy will be derived by analyzing the association between mean icp and neurological outcome.

Eligibility criteria:
inclusion criteria: * history of traumatic brain injury age: 18-80 years admission gcs score≤8 admitting to hospital with 24 hours after injury received decompressive craniectomy received invasive icp monitoring exclusion criteria: * refuse follow-up received operation before admitting to hospital received cardio-pulmonary resuscitation after injury disturbance of consciousness caused by non-traumatic reasons prior history of traumatic brain injury or stroke expected lifetime less than 180 days admitting to other ongoing study systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence