Kornimate/medical-research-clean huggingface dataset:
gene therapy for rpgr gene mutation-associated x-linked retinitis pigmentosa

Conditions: X-Linked Retinitis Pigmentosa (XLRP)

Summary: the aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of ft-002 in male subjects (8-45 years of age) with rpgr (retinitis pigmentosa gtpase regulator) gene mutation-associated x-linked retinitis pigmentosa, of xlrp. this study includes phase i (dose escalation phase) and phase ii (dose expansion phase).


Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form; * age: phase i dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the icf; phase ii dose extension stage, males 8-45 years old (including boundary values) at the time of signing the icf; * clinically diagnosed xlrp, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.; exclusion criteria: * have other retinal degenerative diseases, such as retinal degeneration caused by other known inherited retinal disease gene variants or previously received an gene therapy product.

Keywords: x-linked retinitis pigmentosa (xlrp) ft-002
fenestrated aaa endovascular graft post-approval study

Conditions: Abdominal Aortic Aneurysm (AAA); Aorto-iliac Aneurysm; Juxtarenal Aneurysm

Summary: this post-market study is approved by the us fda to evaluate the long-term safety and performance of the zenith® fenestrated aaa endovascular graft.


Eligibility criteria:
inclusion criteria: * abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm * aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for aaa repair exclusion criteria: * proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * renal artery stenosis greater than 50 percent

Keywords: aneurysm aortic aneurysm iliac aneurysm aortic aneurysm, abdominal vascular diseases cardiovascular diseases aortic diseases
a bioequivalence study comparing cilnidipine/valsartan combination with coadministration of cilnidipine and valsartan

Conditions: Hypertension

Summary: a randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of cilnidipine 10mg and valsartan 160mg in comparison to each component coadministered in healthy male volunteers


Eligibility criteria:
inclusion criteria: * age between 20 and 40 * signed informed consent exclusion criteria: * has a history of hypersensitivity to ip ingredients * hypertension of hypotension
continuation treatment protocol for patient who participated in the bia 9-1067-302 clinical trial

Conditions: Parkinson Disease

Summary: the purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the bia 9-1067-302 clinical trial according form 4a for additional three years.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with pd * subjects who are willing to participate in the trial. * subjects who participated in the bia 9-1067-302 clinical trial. exclusion criteria: * subjects who didn't take part at the bia 9-1067-302 clinical trial.

Keywords: pd off periods quality of life dyskinesia end-off-dose motor fluctuations
overcoming barriers to the uptake of cascade screening for lynch syndrome: workbook feasibility study

Conditions: Lynch Syndrome

Summary: the investigators will evaluate the feasibility of an intervention to improve lynch syndrome cascade screening uptake. the investigators will conduct a pilot study among 15 patients diagnosed with lynch syndrome and 5 genetic counselors to assess the feasibility and intermediate outcomes of an educational workbook containing exercises and resources to improve family communication among individuals with lynch syndrome and first-degree relatives of individuals with lynch syndrome.

genetic counselors of patients with lynch syndrome and patients with lynch syndrome will test a planning tool (referred to as an educational workbook) for cascade screening. five genetic counselors and 15 patients with lynch syndrome will be recruited from the unc health system and the ohio state comprehensive cancer center. genetic counselors will identify patients with lynch syndrome and introduce the study opportunity to potential patient participants. all patients and genetic counselors will complete a telephone enrollment call and provide informed consent to participate. enrolled patients will work with enrolled genetic counselors to complete the first workbook exercise and then patients will complete the remaining exercises alone for over approximately 1 month. after genetic counselors and patients have completed using the workbook, the investigators will conduct qualitative virtual interviews over zoom and a post-intervention electronic survey to understand the participants' experiences using the workbook. the investigators aim to understand the feasibility of using the workbook as an intervention in clinical practice to improve genetic testing uptake in families with lynch syndrome.

Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with lynch syndrome within the last 365 days. * patients and genetic counselors must be age 18 or older. * patients must be receiving care from genetic counselors at ohio state university comprehensive cancer center or at unc health system. * genetic counselors must provide lynch syndrome counseling for patient participants at ohio state university comprehensive cancer center or at unc health system. * patients and genetic counselors must be able to speak and read in english. * patients and genetic counselors must review informed consent documents and provide verbal consent to participate in the study. exclusion criteria: there are no exclusion criteria for study participants.

Keywords: implementation science cascade screening
ultrasound-guided serratus anterior plane block in pneumothorax surgery

Conditions: Analgesia; Postoperative Pain; Pneumothorax

Summary: a prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.

post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. the pain is known to last for an extensive period of time with significantly high intensity. in field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely. in field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. it began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block. many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. however, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in single port video-assisted thoracoscopic surgeries. the main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. this prospective study will discover the efficacy and differences between two methods.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status 1 or 2 2. primary spontaneous pneumothorax 3. elective single port video-assisted thoracoscopic wedge resection of the lung. exclusion criteria: 1. secondary spontaneous pneumothorax 2. reoperation in ipsilateral thorax 3. a history of drug allergy for analgesics 4. participants who have difficulty understanding the study protocol 5. refusal of participants
delineating swallowing impairment and decline in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to 1) evaluate the discriminant ability of simple clinical markers to detect swallowing impairment in individuals with als, 2) develop and validate a minimally invasive clinical screening tool for use at multidisciplinary als clinics, and 3) determine the natural history of swallowing impairment and decline in als.

this research study is being performed to determine screening tools or tests that are able to identify and track swallowing problems associated with amyotrophic lateral sclerosis (als) over time. also, this study will provide insight into the natural progression of swallowing impairment in persons with als over time. participants enrolled in this study will complete an evaluation at the university of florida aerodigestive research core laboratory located at shands hospital, gainesville every three months. each evaluation will take approximately 90 minutes. during these evaluations, a videofluoroscopy (x-ray of swallowing) examination, cough tests and questionnaires will be completed.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or definite als exclusion criteria: * allergies to barium or capsaicin * history of stroke * head and neck cancer * other disorder that might contribute to swallowing impairment * not enrolled in other research investigations that might impact swallowing * not pregnant
prospective data analysis of the development of hypernatremia in intensive care unit

Conditions: Hypernatremia

Summary: hypernatremia is frequently encountered in patients admitted to the intensive care unit (icu) and associated with increased mortality and length of stay. previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. however, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. this study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

hypernatremia is frequently encountered in patients admitted to the intensive care unit (icu) and associated with increased mortality and length of stay. the main mechanism is an imbalance between sodium and total body water. consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. however, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk. this study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

Eligibility criteria:
inclusion criteria: * adults \>17 years old * admitted \>48 hours in icu exclusion criteria: - expected discharge same day as day of inclusion

Keywords: water-electrolyte imbalance
theory based intervention program to support physical activity for individuals with multiple sclerosis: a case series

Conditions: Multiple Sclerosis

Summary: this study evaluates the effectiveness of personalized physical activity coaching combined with the use of a physical activity monitor to support increased levels of daily physical activity in individuals with multiple sclerosis. all five participants will receive the intervention over the four week intervention phase.

individuals with multiple sclerosis engage in less daily physical activity than the general population for a variety of reasons. this research project is intended to evaluate whether individualized coaching combined with the use of a fitbit physical activity wristband monitor will improve physical activity levels in individuals with multiple sclerosis. following admission into the study, participants will be visited once a week for four weeks at home by a physical therapist. the participants in consultation with the physical therapist will set daily physical activity goals for the following week and the participants will be taught how to monitor their daily activity using a fitbit physical activity wristband. the goals of this study are to determine whether this intervention is effective in helping participants increase their levels of daily physical activity and their confidence that they can successfully engage in daily physical activity. in addition, there will be an evaluation of changes from pre-intervention to post-intervention in quality of life measures.

Eligibility criteria:
inclusion criteria: * must have a physician diagnosis of multiple sclerosis and deemed suitable for engaging in a physical activity program by their physician * must be ambulatory with or without an assistive device * must be able to speak and read english * must have a home computer or device capable of tracking and recording the daily fitbit physical activity reports exclusion criteria: * participants will be excluded if any contraindications to engaging in independent exercise are identified during the intake examination by the physical therapist: cardiovascular issues or safety issues with walking.

Keywords: exercise motivational interviewing
the effect of mobilized stem cell by g-csf and vegf gene therapy in patients with stable severe angina pectoris

Conditions: Ischemic Heart Disease

Summary: the aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor (g-csf) treatment alone and in combination with vascular endothelial growth factor (vegf) gene therapy in patients with severe chronic occlusive coronary artery disease.

in recent clinical trials, vascular endothelial growth factor (vegf) delivered as plasmid dna percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be safe and to be associated with a reduction in angina and an increase in exercise time or an improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia. it has been demonstrated, that bm-derived stem cells mobilized by cytokines as granulocyte colony stimulating factor (g-csf) were capable of regenerating the myocardial tissue, leading to improve the survival and cardiac function after myocardial infarction. these data suggested that a combination therapy with exogenous administration of gene vascular growth factor combined with g-csf mobilization of bone marrow stem cells might induce both angiogenesis and vasculogenesis in ischemic myocardium

Eligibility criteria:
inclusion criteria: * reversible ischemia at an adenosine stress single photon emission computerized tomography (spect) * a coronary arteriography demonstrating at least one main coronary vessel from which new collaterals/vessels could be supplied * age above 18 years * canadian cardiovascular society angina classification (ccs) \> 3. exclusion criteria: * ejection fraction \<0.40 * unstable angina pectoris * acute myocardial infarction within the last three months * diabetes mellitus with proliferative retinopathy * diagnosed or suspected cancer disease * chronic inflammatory disease * premenopausal women

Keywords: gene therapy vegf stem cells myocardial ischemia angiogenesis
educational program for hearing aid users with internet support

Conditions: Hearing Impaired

Summary: the purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with internet support.

aural rehabilitation aims to improve communication for people with hearing impairment. education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. internet as a complement to aural rehabilitation has been tested in different studies with promising results. though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems. the purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population. participants were randomly assigned to an intervention or control group. the intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. the control group only had access to reading material. the hearing handicap inventory for the elderly (hhie), the hospital anxiety and depression scale (hads) and the communication strategies scale (css) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.

Eligibility criteria:
inclusion criteria: * the hearing aid users to be between 20 and 80 yr of age, * the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel hearing level pure-tone average measured across 500, 1000, and 2000 hertz), * the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes), * the hearing aid users to have a hearing handicap inventory for the elderly (hhie) score of \>20 points (indicative of some residual self-reported hearing problems), * the hearing aid users to provide informed consent to participate exclusion criteria: * the hearing aid users who are not fulfilling the conditions to participate

Keywords: audiologic rehabilitation hearing loss patient education patient participation structured rehabilitation counseling internet
the association between alpha 1 acid glycoprotein level and outcome metastatic cancer treated with docetaxel

Conditions: Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer; Metastatic Prostate Cancer; Metastatic Bladder Cancer

Summary: docetaxel based chemotherapy is a standard therapy in various metastatic cancers including lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer. one of the main plasma protein carriers of docetaxel is alpha 1 acid glycoprotein. retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in cancer patients. the investigators aim to prospectively study the association between the plasma level of alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.

docetaxel based chemotherapy is a standard therapy in various metastatic cancers including non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer. one of the main plasma protein carriers of docetaxel is alpha 1 acid glycoprotein retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in non small cell lung cancer patients. the investigators aim to prospectively study the association between the baseline plasma level of alpha 1 acid glycoprotein (measured on the first day of the first cycle of docetaxel) and the outcome (response rete, progression free survival, overall survival) of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, stomach cancer, prostate cancer, and bladder cancer.

Eligibility criteria:
inclusion criteria * patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin * patients must be treated with docetaxel based chemotherapy * patients must sign an informed consent form exclusion criteria * patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin * patients treated with chemotherapy other than docetaxel * patients that did not sign an informed consent form

Keywords: docetaxel alpha 1 acid glycoprotein outcome
effect of modified kinesio taping technique on morbidity after impacted third molar

Conditions: Impacted Third Molar Tooth

Summary: removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial clinics. the surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively

removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial clinics. the surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively. kinesio taping (kt), also termed ''elastic therapeutic bandage,'' is a popular technique used for the management of postoperative lymphedema after maxillofacial surgery. kt is an elastic therapeutic tape invented by dr kase in the 1970s. kt originated from sports medicine and is primarily used to support damaged soft tissues (muscles and joints), helping to reduce pain. kt is considered to regulate the blood and lymph flow and also to remove the congestion of lymphatic fluid or hemorrhage and, thus, has achieved popularity in the control of lymphedema. many studies had evaluate the kt technique in reducing the morbidity after surgical removal of third molar. there is a lack of adequate evidence regarding effects of kt techniques versus placebo and the effectiveness of kt with that of other methods and medical agents.

Eligibility criteria:
inclusion criteria: age \> 18 years, with no systemic disease(s) bilateral impacted mandibular third molar class ii position b on pell- gregory classification. exclusion criteria: * patients that had any local infection, tobacco use, oral contraceptive, pregnancy, lactation. * sensitivity to the tapes * reluctance to shave facial hair (for men) * known allergies to medication administered in the study,

Keywords: impacted third molar kinesio taping swelling