Kornimate/medical-research-clean huggingface dataset:
the intra-drug eluting stent (des) restenosis study

Conditions: Coronary Artery Disease

Summary: a prospective, randomized, multi-center comparison of the cypher select™ sirolimus-eluting stent and balloon re-angioplasty for treatment of patients with intra-des restenosis.

this is a prospective, randomized study to be conducted at up to 33 sites in france with 3 groups of patients (1 group with intra-taxus™ restenosis, 1 group with intra-cypher™ restenosis and 1 control group with intra-bms restenosis). all patients will have a repeat angiography at 9 to 12 months post-procedure and will be followed up to 12 months post-procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii-iii) or patients with documented silent ischemia; * patient has an intra-des (taxus™ or cypher™) or intra-bms restenosis of \>= 50% and \<100% (by qca online of the mld compared to the distal reference diameter) in a native coronary artery; * study target lesion must be located in a restenotic native coronary artery \>=2.25mm and \<=3.5mm in lumen diameter and \<=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge; * study target lesion must have undergone coronary interventional treatment \>= 4 weeks previously. patients with one ore more prior ptca procedures at the target lesion are acceptable candidates. * study target lesion can not be located in a vessel containing another lesion requiring treatment. lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, but they must be successfully treated prior to the treatment of the study target lesion; * patient is candidate for a current percutaneous revascularisation technique; * patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up); * patient must provide written informed consent prior to the procedure using a form that is approved by the local ethics committee; exclusion criteria: * patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck \>2 times normal within the preceding 72 hours and the ck enzymes remain above normal at the time of treatment; * has unstable angina classified as braunwald a i-ii-iii; * unprotected left main coronary disease with ³50% stenosis; * significant (\>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff; * target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial; * stent implantation(s) is a non-elective, emergency procedure; * stent at the target restenosed lesion is neither taxus™ , cypher™ des nor a bms; * documented left ventricular ejection fraction \<=25%; * totally occluded vessel (timi 0 level).
investigating the effects of altering portion size reduction awareness on compensatory eating behaviour

Conditions: Eating Behavior; Obesity

Summary: the present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.

in the present study, all participants will participate in two sessions - the baseline session and the experimental session. in the baseline session, participants will be given ad libitum access to a lunch meal (followed by ad libitum access to dessert), and ad libitum access to a dinner meal (followed by ad libitum access to dessert). then, after a washout period of between 1-6 weeks, participants will return to complete the experimental session, where they will be randomised to one of three conditions: condition 1 (control condition): the same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session). condition 2 (reduced aware condition): the same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session). condition 3 (reduced unaware condition): the same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).

Eligibility criteria:
inclusion criteria: * united kingdom (uk) residents able to visit laboratory on campus in liverpool, aged ≥ 18 * body mass index (bmi) between 18.5 and 32.5 kg/m2 * proficiency in english language * self-report willingness to eat each of the test foods exclusion criteria: * current medication use which affects appetite * pregnant * currently or previously diagnosed with an eating disorder * currently on a diet * have any food allergies or intolerances * are vegan
comparison of the efficacy and safety of t2762 versus optive® in the treatment of moderate to severe dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to compare the efficacy and safety of t2762 versus optive® in the treatment of moderate to severe dry eye syndrome.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent. * male or female aged ≥ 18 years old. * diagnosis of moderate to severe dry eye syndrome exclusion criteria: * pregnancy, lactation. * childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised. * inability of patient to understand the study procedures and thus inability to give informed consent. * non-compliant patient * participation in another clinical study at the same time as the present study. * participation to the present study during the exclusion period of another clinical study. * already included once in this study. * ward of court. * patient not covered by government health care scheme
evaluation of acrysof iq vivity extended vision intraocular lenses

Conditions: Aphakia; Presbyopia; Residual Refractive Cylinder

Summary: the purpose of this post-market study is to describe the long-term safety and performance of acrysof iq vivity and acrysof iq vivity toric intraocular lens (iol) models in a real-world setting through routine clinical practice.

this study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified iols for 3 to 5 years in the real world. this study will be conducted in the us and in spain.

Eligibility criteria:
key inclusion criteria: * 22 years old or older at visit 1. * able to understand and sign an approved informed consent form. * implantation of acrysof iq vivity and/or vivity toric iol models in both eyes for 3 to 5 years prior to enrollment. * documented medical history and required pre-operative baseline information available for retrospective data collection. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * corneal refractive surgery after acrysof vivity or acrysof vivity toric iol implantation. * pregnant or nursing at the time of enrollment. * childbirth after iol implantation. * other protocol-specified exclusion criteria may apply.

Keywords: cataracts
bariatric surgery and sperm quality

Conditions: Obesity; Bariatric Surgery

Summary: the purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.

in order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits : first visit (inclusion, before surgery) : * signature of consent * patient interview (collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys)) * clinical examination and anthropometric assessment (bmi, blood pressure, expired co) * blood samples (metabolic and nutritional plasmatic biomarkers ; plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants) * sperm sample (sperm count-morphology ; dna fragmentation ; casa) bariatric surgery second visit (6 month follow-up) * report of adverse events if any * surveys * blood and sperm samples third visit (12 month follow-up) * report of adverse events if any * blood and sperm samples

Eligibility criteria:
inclusion criteria: * obese men with bmi ≥ 40kg/m² or 35 kg/m² with associated co-morbidities * selected for bariatric surgery by multidisciplinary team * from 18 to 50 years old included * with a first medical consultation and its results * with their written informed consent to participate in the study * no problem for understanding verbal or written french * an affiliation to social security exclusion criteria: * not candidates for surgery * with non idiopathic alteration of spermatogenesis

Keywords: obesity bariatric surgery sperm quality fertility
auriculotherapy on older people with insomnia

Conditions: Insomnia

Summary: objective to determine the optimum treatment protocol of auriculotherapy (at) on the improvement of sleep conditions and quality of life on the elders with insomnia. research hypothesis the use of combined lat plus mat is more effective than mat/lat alone on the improvement of sleep conditions and quality of life in the elderly with insomnia. design and subjects this is a 3-arm double-blinded randomised trial. subjects aged ≥65 and exhibit poor sleep conditions are recruited. interventions group 1: subjects will receive a deactivated laser treatment followed by mat. group 2: subjects will receive lat and placebo mat. group 3: subjects will receive a combined approach (lat plus mat). the treatment will be delivered 3 times/week, with a 6-week treatment period, on seven specific auricular points. main outcome measures sleep conditions and quality of life will be evaluated at baseline; end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods. data analysis descriptive statistics, chi-square analysis, anova, paired t-test, and mixed effect modeling will be conducted as appropriate. expected results this study would advance our knowledge the optimum treatment protocol of at in the improvement of the sleep conditions of the elderly population.


Eligibility criteria:
inclusion criteria: * volunteers who are aged 65 or above * report having difficulty falling or staying asleep, and/or frequent nocturnal awakenings * at least three nights per week, sleep disturbance has lasted for a minimum of six months * their sleep is of poor quality as indicated by a psqi score greater than five. exclusion criteria: * profound physical illness, such as stroke * diagnosed with obstructive sleep apnoea * having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from interfering with the devices) * receiving at within the preceding 6 months, * suffering from aural injuries or infections, and * inability to understand instructions or give consent.

Keywords: insomnia older people auriculotherapy
multilevel action toward colorectal cancer and hepatitis c education and screening

Conditions: Colorectal Cancer Screening; Hepatitis C Virus

Summary: this innovative multilevel action toward colorectal cancer (crc) and hepatitis c virus (hcv) education and screening (matches) intervention aims to promote concurrent hcv and crc screening among fqhc patients ages 45-75.

while this is a multi-level intervention study, only information related to the patient-level intervention is being reported for the purposes clinicaltrials.gov.

Eligibility criteria:
inclusion criteria: * participants must be receiving care at one of the participating fqhc clinics. * participants must be 45-75 years of age. * participants must not be up to date with colorectal cancer (crc) screening recommendations such as no colonoscopy in the past 10 years, occult blood test in the past 12 months. * participants must never have had hepatitis c virus (hcv) antibody screening. * participants must be able to read, write, and understand english or spanish. * participants must have no personal history of crc or current presumptive crc symptoms such as unresolved rectal bleeding or abdominal pain/bloating. * participants must be at average risk for crc (no hereditary crc syndromes such as lower gastrointestinal (gi) bleeding, persistent diarrhea, bloating, or lower gi pain, no strong family history of crc). * participants must be asymptomatic for hcv. * participants receiving intervention materials must be able and willing to complete surveys and receive the patient level intervention. * participants completing qualitative interviews must be willing to complete a remote interview via phone or teleconference software such as zoom. * participants completing qualitative interviews must be willing to be audio recorded. * participants recruited for qualitative interviews only (did not receive matches intervention materials) must have a clinic visit within prior two months. * all participants must be able to provide informed consent. exclusion criteria: * participants that do not meet all inclusion eligibility requirements will be excluded.

Keywords: screening hcv screening crc screening colorectal cancer (crc) hepatitis c virus (hcv)
prehospital laryngeal tube vs. bag-valve mask ventilation used by paramedics during cpr

Conditions: Cardiac Arrest During and/or Resulting From A Procedure

Summary: during cpr bag-valve mask ventilation is difficult for basically skilled rescuers. ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. no prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during cpr. thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during cpr.

during cpr bag-valve mask ventilation is difficult for basically skilled rescuers. ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. no prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during cpr. this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during cpr. this study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.

Eligibility criteria:
inclusion criteria: * cardiac arrest exclusion criteria: * paramedic does not want to use laryngeal tube * physician on site before paramedic * foreign body airway obstruction

Keywords: airway cardiac arrest cpr ventilation
cryobiopsy vs. forceps biopsy for peripheral pulmonary lesions

Conditions: Lung Cancer (NSCLC)

Summary: this multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. in the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. the study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.

this is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. in the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. the study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * obtained written informed consent * subjects having \<30mm nodule on computed tomography * subjects without contraindication to brochoscopy exclusion criteria: * patients with central lesions that can be visually confirmed by bronchoscopy or those with suspicious findings of cancer metastasis in the mediastinal lymph nodes, who do not require radial bronchial endoscopic ultrasound (rp-ebus). * patients who cannot discontinue medications that increase bleeding risk, such as antiplatelet agents or anticoagulants. * patients with bleeding disorders (e.g., platelet count \< 100,000/mm³). * patients with severe comorbidities (e.g., serious respiratory or cardiovascular diseases) that make bronchoscopy unsafe. * patients with hypersensitivity or allergies to drugs commonly used in endoscopic procedures, including lidocaine, midazolam, fentanyl, or flumazenil. * pregnant or breastfeeding patients. * patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.

Keywords: bronchoscpy cryobiopsy forceps biopsy lung cancer radial probe ebus
opscc n0 nodal control with reduced imrt

Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCCA); HPV (Human Papillomavirus)-Associated

Summary: the dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering. the purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (ct scans, pet ct scans, or mri scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

a pilot single arm study of intensity modulated radiation therapy elective nodal dose de-escalation for hpv-associated squamous cell carcinoma of the oropharynx.

Eligibility criteria:
inclusion criteria: * patient must be clinically referred for radiation for stage i-ivb opscca * tumor must be hpv-associated p16+ * patient must be able to lie flat and tolerate immobilization systems exclusion criteria: * patients may not be receiving any investigational agents * prior radiation to head and neck * any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years * any major medical, psychiatric, or neurologic illness * pregnant or breastfeeding women
multi-center study protocol: impact of sarcopenia in early-onset colorectal cancer.

Conditions: Colorectal Cancer; Early Onset Colorectal Cancer; Sarcopenia; Prognostic Factors; Overall Survival; Disease-free Survival

Summary: sarcopenia's role in early-onset colorectal cancer (eocrc), a subtype increasingly diagnosed in individuals under 50 years, has not yet been investigated according to recent literature. understanding the prevalence and prognostic impact of sarcopenia in eocrc could inform tailored therapeutic approaches and improve patient outcomes.

as reported by the globocan study, eocrc occurs in individuals younger than 50 years old. according to the globocan estimates, there were 188,069 new cases of eocrc, with an age standardized incidence rate (asrs) of 2.9 per 100,000 person-years worldwide. recent evidence suggested an increasing incidence rate for eocrc in different populations, with greater changes in both developed and developing countries. despite the declining trend in the incidence of crc in the total population of the developed countries, the incidence rates for eocrc were increasing both in the developed and developing world. sarcopenia's role in early-onset colorectal cancer (eocrc), a subtype increasingly diagnosed in individuals under 50 years, remains underexplored.

Eligibility criteria:
inclusion criteria: * histologically confirmed eocrc * emergency room access for suspected surgical pathology * age: 18-49 years at diagnosis. * available baseline ct or mri scans for sarcopenia assessment exclusion criteria: * presence of comorbidity conditions severely affecting muscle mass unrelated to cancer (e.g., neuromuscular disorders). * inadequate follow-up data or loss to follow-up * no past oncological history