Kornimate/medical-research-clean huggingface dataset:
multi-center observation of the natural course of inherited retinal dystrophies

Conditions: Inherited Retinal Dystrophies

Summary: based on a clinical multi-center study of the natural course of inherited retinal dystrophies in chinese population, screening fundus imaging indicators for patients with chinese inherited retinal dystrophies, describing the clinical features of chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in china. the research will further improve and enrich the genotype, phenotypic characteristics and natural course of chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. it is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.


Eligibility criteria:
inclusion criteria: 1. patients with irds whose mutations have been identified 2. 4\~70 years old 3. complete 4 basic examinations of the eye: corrective vision; fundus photography; oct; erg exclusion criteria: 1. has participated in other interventional treatment studies; 2. patients with severe systemic diseases, mental dysplasia, mental illness; 3. unable to accept eye examination patients; 4. traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis 5. at the initial visit, the patient's binocular vision is displayed as no light. 6. both eyes have a history of internal eye surgery

Keywords: inherited retinal dystrophies, gene screen
the accuracy of home monitoring for acute macular degeneration (amd) disease activity

Conditions: Acute Macular Degeneration

Summary: currently the best treatment for "wet" macular degeneration involves regular injections of ranibizumab (lucentis). in the initial clinical trials, the drug was injected into the eye every month. since then a number of studies have found similar benefits when the drug is given with a fixed number of injections initially and then with further injections only when needed. this approach has been adopted in the uk, following recommendation by the national institute for clinical excellence (nice). although this approach reduces the expense and risk of un-necessary treatment, it does require regular hospital assessment of disease activity to determine if a repeat injection is required or can be deferred. the hospital assessment is time-consuming, inconvenient and the large number of assessments can cause delays in hospital follow-up. using three different assessment criteria to monitor disease activity at home, the investigators plan to see if home monitoring is as good as hospital assessment. the investigators have already identified that many patients dislike the lengthy hospital assessment visit and would welcome the opportunity to do some of the monitoring of disease activity at home. the investigators have also shown that they understand and can complete each of the home assessment tests. in this pilot project, the investigators aim to get an idea of how reliable home monitoring can be in a small sample of just over 30 patients. the data that the pilot project generates will be used to influence and to help plan a subsequent, larger, national study to be submitted for funding to the national institute for health research.


Eligibility criteria:
inclusion criteria: * patients over 60 years with a clinical diagnosis of neovascular age-related macular degeneration (armd), receiving treatment with intra-vitreal ranibizumab in accordance with current uk practice * at least 6 months of prior treatment beyond the loading phase of three fixed injections * at least 2 injections during the prior 6 months of the maintenance phase of treatment * early treatment for diabetic retinopathy study (etdrs) chart letter score at 2m of between 30 and 70 letters at the start of the study exclusion criteria: * patients with chronic intra-retinal cycts or sub-retinal fluid in the study eye on optical coherence tomography (oct) examination despite prior treatment and judged to be stable without the need for further treatment * significant hearing impairment, felt likely to interfere with training and the telephone calls prior to the home monitoring * lack of informed consent
validation of a dermatology-specific treatment satisfaction instrument

Conditions: Psoriasis

Summary: the primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) * psoriasis patients undergoing some form of treatment
extension study of intrathecal enzyme replacement therapy for mps i

Conditions: Spinal Cord Compression; Mucopolysaccharidosis I; Hurler-Scheie Syndrome; Scheie Syndrome; Lysosomal Storage Disease

Summary: this is a one-year extension study of the use of laronidase into the spinal fluid to treat spinal cord compression in mucopolysaccharidosis i. mucopolysaccharidosis i is a rare genetic condition due to deficiency of the enzyme alpha-l-iduronidase. spinal cord compression occurs in this condition due to accumulation of material called glycosaminoglycans (gag). laronidase is the manufactured form of the enzyme alpha-l-iduronidase that is deficient in mucopolysaccharidosis i patients. the aim of this study is to determine whether laronidase is safe and effective when given into the spinal fluid as a potential non-surgical treatment for spinal cord compression due to mucopolysaccharidosis i disease. funding source -- fda oopd

enzyme replacement therapy (ert) has been developed for mucopolysaccharidosis i (mps i), a lysosomal storage disorder. ert helps many physical ailments due to the disease, but does not treat the central nervous system, due to inability to cross the blood brain barrier. our purpose is to test delivery of ert to the spinal fluid via intrathecal injection in patients with mps i. in this pilot study, we will use recombinant human α-l-iduronidase administered intrathecally once per month for four months to individuals with the hurler-scheie and scheie forms of mps i and spinal cord compression. if successful, intrathecal delivery could represent a practical, straightforward method of treating central nervous system disease due to lysosomal storage.

Eligibility criteria:
inclusion criteria: * hurler-scheie, scheie form of mps i, or hurler 2 years after hematopoietic stem cell transplantation * spinal cord compression * has received intrathecal laronidase previously with good response and no significant safety concerns * age greater than 8 years * able to provide legal informed consent * aware of clinical treatment option of observation without treatment or surgical decompression * negative urine pregnancy test at screening (nonsterile females of child-bearing potential who are sexually active only) exclusion criteria: * severe (hurler) form of mps i * desires surgical or medical treatment of spinal cord compression * spinal cord compression that warrants immediate surgical intervention * pregnancy or lactation * hematopoietic stem cell transplantation within 2 years of study enrollment * receipt of an investigational drug within 30 days of enrollment * infusion reactions to laronidase that required medical intervention, prophylaxis, or altered enzyme administration * significant anti-iduronidase antibody titer * recent initiation of intravenous laronidase (within past 6 months) * presence of cervical subluxation or similar external pathology as the major cause of cord compression symptoms for which surgical intervention should be immediately undertaken

Keywords: mucopolysaccharidosis hurler-scheie scheie laronidase spinal cord compression central nervous system enzyme replacement therapy intrathecal
therapeutic efficacy and safety of palonosetron in treatment of postoperative nausea and vomiting

Conditions: Laparoscopic Gynecologic, Abdominal, Other Surgery; General Anesthesia

Summary: this study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

postoperative nausea and vomiting (ponv) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. this study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. as the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (ponv), there was no evidence-based guideline of palonosetron for treatment of ponv. the aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Eligibility criteria:
inclusion criteria: * 19 years and older, younger than 70 years old * american society of anesthesiologists physical status classification i to iii * those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia * surgery for which anesthesia is expected to last at least 30 minutes * if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected qt interval, he/she may be enrolled at the discretion of the investigator. exclusion criteria: * known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient * inability to understand or cooperate with the study procedures as determined by the investigator * women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1. * has received any investigational drug within 30 days before study entry * having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures. * any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia * known or suspected current history of alcohol abuse or drug abuse. * any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study

Keywords: palonosetron postoperative nausea and vomiting
reduction of bacteria in mrsa positive ulcers

Conditions: Leg Ulcer; Pressure Ulcer

Summary: the purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in mrsa positive ulcers


Eligibility criteria:
inclusion criteria: * must have given written informed consent * must be 19 years of age or over * must have an ulcer or lesion in which the presence of mrsa has been positively identified but which is not clinically infected. * must have an ulcer / lesion size not to extend beyond the inner borders of the wound cover exclusion criteria: * is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence) * is \< 19 years of age * has a clinically infected ulcer * has an ulcer / lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment. * has been using systemic antibiotics during 7 days prior to enrolment into this study. * has an ulcer / lesion which is identified as malignant in origin (e.g., marjolin's ulcer) * has an ulcer / lesion size beyond the inner borders of the wound cover * is septic or has other signs of an invasive infection * has used any other investigational product within 30 days preceding study participation. * suffers from a condition, which, in the opinion of the investigator,would compromise his or her safety. * suffers from a condition which, in the opinion of the investigator, would compromise the quality of the data. * has a known allergy to any of the products that are part of this protocol * suffers from a condition which, in the opinion of the investigator, would seriously interfere negatively with the normal parameters of immune response to an infection. * is using any of the prohibited concomitant medications or treatments
does islet transplantation eliminate hypoglycemia?

Conditions: Diabetes Mellitus

Summary: low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. we wish to determine if it will also eliminate low blood sugar. to do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.


Eligibility criteria:
inclusion criteria: * clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
a dose-image optimization trial evaluating mannitol and voluven as adjuncts for indocyanine green

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: the goal of this clinical trial is to exploring the use of mannitol 20% as a solvent to prepare icg solution, combining with voluven, forming a hybrid small-large molecular weight solvent for protecting icg in monomer form and stimulating lymphatic uptake simultaneously in early breast cancer patients who is indicated to undergo sentinel lymph node biopsy. the main question it aims to answer is: * will adding mannitol with voluven as icg solvent improve the fluorescence signal of the lymph nodes, comparing with using pure voluven? * which proportion of mannitol-voluven delivers the best image quality when used as solvent of icg? researchers will compare the following arms with different solvent (all arms' final icg concentration are 0.25mg/ml): * pure voluven * mannitol:voluven = 1:10 * mannitol:voluven = 1:8 * mannitol:voluven = 1:6 * mannitol:voluven = 1:4 to see if increased mannitol:voluven ratio as icg solvent translates to better fluorescence image quality. participants will be invited in a group of 3, and be blindly assigned to each concentration group sequentially. participants will undergo icg fluorescence guided sentinel lymph node biopsy with the assigned solution formula. the endpoints included number of lymph nodes obtained, fluorescence signal-to-background ratio of the lymph nodes, lymphatic uptake rate, lymphatic drainage speed, detection method, lymph node pathology, and any intra- or post-operative complications.


Eligibility criteria:
inclusion criteria: * adult females aged 20 to 70 years old. * pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy. exclusion criteria: * history of allergy to iodine, icg, blue dye, voluven, or mannitol. * history of hyperthyroidism, thyroid cancer, etc. * current pregnancy, lactation, or breast infection. * individuals with impaired mental capacity or belonging to vulnerable populations. * patients who have undergone neoadjuvant chemotherapy prior to surgery.

Keywords: indocyanine green sentinel lymph node biopsy near-infrared fluorescence 6-hydroxyethyl starch mannitol breast cancer fluorescence-guided surgery
transcranial vibrating system for improving vestibular physical therapy

Conditions: Vertigo; Dizziness; Nausea; Balance

Summary: this research study aims to determine whether low-frequency transcranial vibrations can act as a possible treatment for the dizziness and nausea often associated with vestibular physical therapy.

the purpose of this study is to determine the effectiveness of a transcranial vibration system (tcvs) at reducing the increased nausea and discomfort sometimes associated with vestibular physical therapy. the tcvs is a small device attached to an elastic band. it is worn around the head and produces vibrations. there is no implant or surgical procedure. the fda has made a pre-determination that this is a low-risk device (a "class 2 device" in fda terminology). the tcvs has previously been tested in healthy volunteers and has been found to safely and effectively decrease dizziness and nausea associated with vestibular discomfort. this study will expand that research to vestibular disorder patients who are undergoing physical therapy. the study compares the outcomes to not wearing a device, or to a control (inneffective) device.

Eligibility criteria:
inclusion criteria: * reluctant or unable to perform a full session of vestibular physical therapy exclusion criteria: * history of head injury within the last six months or currently suffering the effects of a head injury (i.e. concussion or traumatic brain injury) * presence of severe aphasia. * history of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia). * documented neurodegenerative disorders. * pregnancy female candidates will be asked to take a pregnancy test first and will have to make a informed decision to participate based on the results of the pregnancy test. * history of cerebrovascular disorders. * history of ear operation other than myringotomy and tube placement in the past. * systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis.

Keywords: vestibular physical therapy positional vertigo ménière's disease
iron deposits in the pancreas by mri method of dialysis patients with hemosiderosis iatrogenic (erdfp)

Conditions: Iron Deposition; Dialysis; Iatrogenic Hemosiderosis

Summary: recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in mri), pancreatic or cardiac ferric deposits. in this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by t2\* mri in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.


Eligibility criteria:
inclusion criteria: * male, female, over 18 years old * patient on hemodialysis or peritoneal dialysis at the claude galien private hospital * patient on dialysis who has undergone one (or more) abdominal mri for iron quantification * patient who has signed a non-objection form for the retrospective use of their mri, medical and biological data for the purpose of scientific study exclusion criteria: * patient who has signed a form to object to the use of their health data * pregnant woman * poor adherence to the dialytic technique * severe cognitive impairment * hepatic cirrhosis * frank inflammatory syndrome or an active infectious disease * genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases * recent major bleeding (\< 3 months) * recent major surgery (\< 3 months) * transfusion dependence * progressive malignant disease * pacemakers incompatible with an mri and metal heart valves
assessing the effects of elo water on diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic

Summary: this pilot study examined the effects of elo water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.

as hyperbaric chamber and topical oxygen therapies have demonstrated efficacy in improving dfu healing, the aim of this study was to evaluate elo water, which has been shown to increase arterial oxygen levels, as a novel means of increasing oxygen delivery to poorly-healing dfus as an adjunct to standard care. this proof-of-concept pilot study of drinking oxygen-enriched elo water to treat diabetic foot ulcers (dfus) was conducted on 16 adults with non-healing (for at least 30 days prior to the study) dfus in changi general hospital in singapore. elo water was delivered to participants' homes and their water consumption recorded in diaries, which was checked by the research co-ordinator at 2-weekly visits for 12 weeks. minimum compliance was defined to be at least 85% of the water (12/14 bottles/fortnight), equivalent to 9 litres/week. no changes in diabetic therapy, diet or exercise were made during the study period. all participants were seen by podiatrist for standard of care dfu treatment weekly. the ulcer size was captured following wound debridement each week using a standardized digital photographic protocol and the photos were encrypted and anonymized for confidentiality and data protection. all the images were assessed independently. wound dressing was carried out twice per week in between visits at primary care clinics or at home.

Eligibility criteria:
inclusion criteria: * type 2 diabetes and haemoglobin a1c (hba1c) at screening of 7.0-10.0% on oral glucose-lowering medication and/or insulin at a stable dose for the last three months exclusion criteria: * pregnant or lactating * conditions which would independently worsen ulcer healing such as severe peripheral vascular disease or varicose veins * immunosuppressive therapy * comorbidities necessitating fluid restriction such as renal, liver or cardiac failure.
monitoring arrhythmia patients (impact)

Conditions: Arrhythmias

Summary: prospective, multicenter, non-randomized study to determine the performance of nuvant mobile cardiac telemetry system in arrhythmia detection.

arrhythmia patients will be externally monitored. the collected information will be used to evaluate the nuvant mct system.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients undergoing remote ambulatory electrocardiographic monitoring exclusion criteria: * is participating in another clinical study that may confound the results of this study
the influence of menopausal status on myocardial stiffness and exercise capacity among female masters endurance athletes.

Conditions: Myocardial Stiffness

Summary: the purpose of this research is to study postmenopausal female masters athletes to see if they will show greater myocardial stiffness and reduced exercise capacity than premenopausal females and similarly aged male masters athletes.


Eligibility criteria:
inclusion criteria: * longstanding history of competitive endurance athletic performance defined as \>15 years of continuous athletic training for at least 7 hours per week and ongoing engagement in competitive events. exclusion criteria: * a current or prior diagnosis of cardiovascular disease as defined by the presence of structural heart disease, heart failure, symptomatic coronary artery disease, more than moderate valve disease or prior valve surgery, * current or recent pregnancy within 1 year * positive pregnancy test (study visit 1) * concurrent or use within 1 year of oral contraceptives or hormone replacement therapy, * unable to undergo a cmri (please refer standard clinical contraindications for mri)
indonesian registry on atrial fibrillation

Conditions: Atrial Fibrillation

Summary: our rationale of creation of this registry stems from the fact that the use of vka in patients with af is a double-edged sword, physicians face tremendous burden in assigning patients with vka, due to risk of bleeding complications despite its potential benefit. we intend to seek a safe and beneficial range of inr on indonesian patients.


Eligibility criteria:
inclusion criteria: * age \>18 years old * diagnosis of valvular or nonvalvular af exclusion criteria: * reversible af * patients who have been enrolled as a respondent on other clinical studies

Keywords: atrial fibrillation registry anticoagulant