Kornimate/medical-research-clean huggingface dataset:
zimura compared to sham in patients with autosomal recessive stargardt disease (stgd1)

Conditions: Stargardt's Macular Dystrophy

Summary: the purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to sham in participants with autosomal recessive stargardt disease 1 (stgd1).


Eligibility criteria:
inclusion criteria: * at least two pathogenic mutations of atp-binding cassette (abc)a4 gene confirmed by a clinical laboratory improvement amendments (clia)-certified laboratory * best corrected visual acuity in the study eye between 20/20 - 20/200 snellen equivalent, inclusive exclusion criteria: * macular atrophy secondary to any condition other than stgd1 in either eye * any prior treatment for stgd1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye * participation in an interventional study of a vitamin a derivative \</= 3 months prior to screening * presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia * any intraocular surgery or thermal laser within 3 months of trial entry. any prior thermal laser in the macular region * diabetes mellitus * hemoglobin a1c (hba1c) value of \>/=6.5% * stroke within 12 months of trial entry * any major surgical procedure within one month of trial entry or anticipated during the trial * any treatment with an investigational agent in the past 60 days for any condition * women who are pregnant or nursing * known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation

Keywords: zimura (previous name) arc1905 complement factor c5 inhibitor avacincaptad pegol stgd1 izervay stargardt disease 1 stargardt's macular dystrophy
modified versus conventional serratus anterior plane block

Conditions: Postoperative Pain, Acute

Summary: comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

comparing the quality of postoperative analgesia and opioid consumption in patients undergoing video-assisted thoracoscopic surgery when using preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

Eligibility criteria:
inclusion criteria: * patient consent. * both sex. * age: 21-70 years old. * bmi: 18- 30 kg/m2 * asa: i and ii. * scheduled for elective unilateral video-assisted thoracoscopy under general anesthesia. exclusion criteria: * history of allergy to the local anesthesia agents used in this study, * skin lesion at needle insertion site, * those receiving anticoagulant therapy or having bleeding disorders * patients with history of chronic pain and taking analgesics, * patients with sepsis and significant cardiac, liver or renal diseases * uncooperative patients or with psychiatric disorders.
resistance exercise to improve fatigue in workplace (rew)

Conditions: Fatigue; Musculoskeletal Diseases

Summary: studies show that exercise resistance in workplace can reduce the symptoms of induced labor, however, the effectiveness of such programs depends on the characteristics of the training fatigue. thus, it is expected that this study the intervention group with training heavy using progressive resistance exercise protocol will be better in reducing fatigue when compare with light training group.

background: this study is randomized clinical trial with double-blinded. the aim is evaluate the effectiveness the training heavy with resistance exercise program in the muscle fatigue control. methods: this is a randomized controlled trial by cluster, in which workers who participate in the intervention group will perform resistance exercise protocols; and workers in the comparative group held only stretching exercises and light resistance training with elastic bands. expected results: strong evidence that fatigue reducing after ten weeks in workers and improve in others outcomes. not found in literature studies in occupational evaluating this aspect of training.

Eligibility criteria:
inclusion criteria: * sign informed consent exclusion criteria: * restriction by the medical department.

Keywords: workplace industrial workers resistance exercise fatigue occupational risk physical therapy
asan aorta and peripheral registry

Conditions: Aorta Disease; Peripheral Artery Disease

Summary: the purpose of this study is to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at asan medical center.

this study is a single center retrospective and prospective observational study to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at asan medical center. data will be collected on approximately 6,000 subjects in asan medical center. individuals will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or hospital visit. data collected during all follow-up visits will include a composite of major adverse limb events, or death from any cause.

Eligibility criteria:
inclusion criteria: * patients underwent revascularization of aorta or peripheral artery from 2011 at the peripheral vascular disease center, asan medical center * patients with aortic and peripheral artery disease are defined as: thoacic aorta disease/ abdominal aorta disease 1. aneurysm 2. aortic dissection 3. penetrating aortic ulcer peripheral artery occlusive disease 1. chronic limb-threatening ischemia 2. claudication 3. acute limb ischemia exclusion criteria: * for prospective cohort, not agreeing to participate with written informed consent form

Keywords: revascularization of aorta or peripheral artery
docetaxel/cisplatin/5-fluorouracil (tpf) human papillomavirus (hpv) squamous cell carcinoma study

Conditions: Squamous Cell Carcinoma of the Head and Neck; Human Papilloma Virus

Summary: in this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. an approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. this treatment is effective but has many immediate and long-term side effects. people who have squamous cell carcinoma of the head and neck (sschn) that is related to an infection by the human papillomavirus (hpv) have been shown to have a high response to this treatment along with a high cure rate. the investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

objectives: primary to determine rate of local-regional control at 2 years secondary to determine progression free survival at 2 and 5 years to determine overall survival at 2 and 5 years to assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is hpv 16 positive as determined by ish and p16 positive as determined by ihc. * stage 3 or 4 disease without evidence of distant metastases * at least one evaluable or uni- or bi-dimensionally measurable lesion by recist 1.1 criteria * 18 years of age or older * no previous surgery, radiation therapy or chemotherapy for sschn is allowed at time of study entry * ecog performance status of 0 or 1 * no active alcohol addiction * adequate bone marrow, hepatic and renal function as defined in the protocol * women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment exclusion criteria * pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after * previous or current malignancies at other sites * symptomatic peripheral neuropathy of grade 2 or greater * symptomatic altered hearing greater than grade 2 * other serious illnesses or medical conditions * patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry * concurrent treatment with any other anticancer therapy * participation in an investigational trial within 30 days of study entry

Keywords: sschn hpv imrt
comparative effects of balance and resisted training in diabetic peripheral neuropathy.

Conditions: Diabetic Peripheral Neuropathy

Summary: the aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.

this randomized clinical trial will be conducted at mumtaz bakhtawar hospital in 7 months after the approval of synopsis. the sample size for this trial will be 58 patients with dpn. participants those meet inclusion criteria will be randomly allocated into two groups using online randomization tool, 29 participants will be assigned to group a which will receive balance training exercises for 35 minutes and group b will receive resistance training exercises for 45 minutes. each participant will receive intervention for 3 alternate days per week for 8 weeks. the michigan neuropathy screening instrument will be used for the assessment of dpn symptoms scores at baseline. balance will be evaluated using the de morton mobility index (demmi) test, while paindirect tool will be utilized to measure pain. the data will be entered and analyzed using spss version 24 for windows software.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with dnp with score ≥ 2.5 on michigan neuropathy screening instrument of both genders. 2. age between 40 to 65 years. 3. patients having the minimum history of diabetes is 7 years. 4. history of mild to moderate neuropathy . the patients ability to do resistance and aerobic exercises. exclusion criteria: 1. history of taking anti-inflammatory drugs. 2. history of recent surgical operations of joints in lower extremities. 3. patients suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy. 4. patients having any disability, fracture, or dislocation of at least six months before the study.

Keywords: diabetic peripheral neuropathy balance training resisted training pain management rehabilitation exercises
perfusion index and pain in ankle surgery

Conditions: Pain, Postoperative; Ankle Fractures

Summary: perfusion index (pi) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. thus pi holds potential for use as a tool for "objective pain measurement", although its practical usefulness and dependability as such have not previously been investigated. the investigators aim to explore associations between changes in pi and onset of pain following cessation of regional anaesthesia in alert patients following ankle fracture surgery. methods: the investigators report an exploratory, observational analysis of prospectively gathered pi data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for ankle fracture surgery as participants of the randomised anankle trial (eudract: 2015-001108-76). pi is measured on an unaffected extremity in approximately 20 consecutive patients already included in the anankle trial at herlev university hospital, evenly distributed between spinal anaesthesia (sa) and peripheral nerve block (pnb). both anaesthesia forms and pain medication regimes are standardised as part of anankle trial and participants register pain scores on a 0-10 numeric rating scale every three hours and register the time of cessation of anaesthesia identified by return of sensation to the ankle. morphine consumption is also registered. the investigators will explore correlations of changes in pi to increases in pain upon cessation of the regional anaesthesia and, secondly, differences in cessation related pi changes with sa versus pnb. ethics: all participants have already given informed, written consent for use of this data for the anankle trial. all necessary ethical and legislative approvals have been obtained for initiation of anankle trial in july 2015.


Eligibility criteria:
inclusion criteria: * scheduled for internal fixation of an ankle fracture * age \> 18 years * ability to read and understand danish and give informed written consent exclusion criteria: * allergy towards nsaid, paracetamol, morphine or local anaesthetics * bodyweight \< 52 kg; to avoid toxic doses of local anaesthetics * contraindications for sa * current gastro-intestinal bleeding * proximal fibular fracture or multitrauma / other simultaneous fractures * cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol * no available anaesthesiologist with pnb capability at scheduled time of operation * neuropathy / neurological dysfunction in the lower extremities * habitual daily use of opioids * pregnancy or breastfeeding * infection at anaesthesia injection site * nephropathy requiring dialysis * acute porphyria
under- and overdiagnosis in breastscreen norway

Conditions: Breast Cancer

Summary: this phd project will describe tumour characteristics and survival associated with of under- and overdiagnosed breast cancers, the rate of overdiagnosis in breastscreen norway, and whether women and family doctors are aware of, and knowledgeable about, under- and overdiagnosis in breast cancer screening.

mammographic screening among women aged 50-69 reduces breast cancer mortality but also carries some risk. this phd project will study under- and overdiagnosis, two risks associated with mammographic screening, in breastscreen norway. underdiagnosis can occur when a tumour is present but not detected as a result of screening, while overdiagnosis can occur when a woman is diagnosed with a slow growing cancer that would not become symptomatic during her lifetime. this project will address the following topics and research questions using observational study methods. study 1: to determine whether tumour histopathology and survival differentially associated with potentially under- or overdiagnosed interval and screen-detected breast cancers. * do women with potentially underdiagnosed interval cancers have different tumour histopathology and survival than those whose interval cancers showed no signs at the prior screen? * do women with potentially overdiagnosed screen-detected cancer have different tumour histopathology and survival than those whose screen-detected cancer showed no signs at the prior screen? study 2: to estimate overdiagnosis in the screening program using individual-level data: * what was the rate of overdiagnosis for women screened in the program during 1996-2003? * how does adjusting for sociodemographic factors affect estimates of overdiagnosis? study 3: to describe awareness and knowledge about under- and overdiagnosis and breast screening in general: * are women aware of and knowledgeable about under- and overdiagnosis in breast screening? * are family doctors aware of and knowledgeable about breast screening, and under- and overdiagnosis? are they confident in their ability to relay this information to their patients? study 1 is a quality improvement study and has approval from personvernombudet (pvo 2016-4696). study 2 has research ethics board (rek) approval (rek 2013/795), while rek approval will be sought for study 3.

Eligibility criteria:
study 1 inclusion criteria: * breast cancer diagnosed within breastscreen norway using digital mammography * prior screening images available for review study 2 inclusion criteria: * women born between 1927 and 1934 (inclusive) * legal resident in norway at any time between 1996 and 2003 (inclusive) study 3 inclusion criteria: * women residing in norway, aged 50-69 (inclusive) * practising family doctors in norway, aged 25-75 (inclusive) * provide informed consent

Keywords: screening mammography overdiagnosis womens' perspectives harms and benefits false negative quantitative methods survival
effectiveness and safety evaluation of aqueduct -100 device

Conditions: Cervix Uteri Dilation

Summary: the purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the aqueduct 100 device. the effectiveness of the aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.


Eligibility criteria:
inclusion criteria: 1. subjects, females, 18 years of age or older. 2. subjects undergoing any process that requires dilation (intrauterine procedures). 3. subjects understanding the nature of the study and willing to sign informed consent form. exclusion criteria: 1. subjects younger than 18 years of age. 2. subject with the following infectious diseases: hiv, hbv, hcv, syphilis. 3. subject has been treated with any cervix dilating agent within 2 months before the screening. 4. known contraindications or hypersensitivity to the components of the investigational product. 5. the patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures. 6. subjects undergoing abortion \ 9 weeks of pregnancy. 7. subjects unwilling to sign the informed consent form.

Keywords: cervix, cervical dilation, balloon catheter
a trial to study the effect of lamivudine in adult patients who suffer from chronic hepatitis b alone

Conditions: CHRONIC HEPATITIS B

Summary: the efficacy of lamivudine in hepatitis be antigen (hbeag) positive asian patients of chronic hepatitis has been well established.the evidence in hbeag negative patients is limited. limited sustained response was observed post-treatment following a one year treatment period. whether these results can be applied to patients in iran is uncertain. this study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult iranian population.


Eligibility criteria:
inclusion criteria: * confirmed active liver disease due to hepatitis b virus. * patients must have adequate blood \& liver functions. * female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. * patients who have serious concurrent illnesses other than hepatitis b like cancer, severe heart disease, uncontrolled diabetes mellitus or aids will not be eligible. exclusion criteria: * persons allergic to lamivudine or suffering from hepatitis c, d or e infection or taking alcohol will not be eligible.

Keywords: hbeag hbv chronic hepatitis lamivudine
prior study - a study of ibandronate (boniva) in postmenopausal women with osteoporosis or osteopenia

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (gi) side effects. the anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.


Eligibility criteria:
inclusion criteria: * women with postmenopausal osteoporosis or osteopenia * discontinuation of daily and /or weekly alendronate or risedronate therapy because of gi intolerance (eg, heartburn, acid reflux, stomach upset) exclusion criteria: * inability to stand or sit upright for 60 minutes * inability to swallow a tablet whole - hypersensitivity to any component of boniva * malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin d therapy * patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy
s90652 in paediatric hypertension

Conditions: Hypertension

Summary: the aim of the study is to assess the acceptability, safety and pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril given in hypertensive children


Eligibility criteria:
inclusion criteria: * hypertensive children exclusion criteria: * renal failure * unstable renal function * hyperkaliemia
the effectiveness of acupressure for managing postoperative pain and anxiety in patients with thoracoscopic surgery

Conditions: Lung Diseases

Summary: the purpose of this study is to explore the effectiveness of acupressure for managing postoperative pain, anxiety, analgesia consumption, early ambulation, and comfort in patients with thoracoscopic surgery.

thoracoscopic surgery is the surgical used to removal of a section or a segment of a lung lobe. one us national survey reported that 80% of patients undergoing pulmonary surgery experienced acute pain. 75-86% of these patients pointed out that experienced moderate, severe, or extreme pain, especially, on the 1st day after thoracoscopic surgery. however, inappropriate pain management after surgery is associated with limited the healing process, increased workload of heart, prolonged pulmonary rehabilitation, and increased medical costs, and can be a prediction of developing chronic pain. acupressure is a nonpharmacological treatment for the management of postoperative pain. recent studies have found that the application of acupressure is effective in decreasing operative pain intensity, morphine related side effects, and opioid consumptions after surgery. however, there was no further research about the role of acupressure applied to thoracoscopic surgery.

Eligibility criteria:
inclusion criteria: * pulmonary lung disease and will be scheduled to undergo a thoracoscopic wedge resection, segmentectomy, or lobectomy. * american society of anesthesiologist physical status of classes i-ii, * both forearms without missing limbs or arteriovenous fistula * ability to communicate in taiwanese or chinese, and * agreement to participate in this study. exclusion criteria: * diagnosed as malignant neoplasm with lung meta, * had a stroke or peripheral vascular disease * platelet count less than 20 x 10\^3/mm\^3 * using the patient controlled analgesia, and * any known mental illness or memory dysfunction.

Keywords: acupressure thoracoscopic surgery acute pain anxiety comfort