Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of intravitreal bevacizumab in the treatment of choroidal neovascular membranes associated to high myopia

Conditions: Myopia; Choroidal Neovascularization

Summary: the purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in high myopia´s choroidal neovascularization versus the standard treatment of photodynamic therapy.

bad response in choroidal neovascularization in high myopia to photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies. intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. in the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile. the lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.

Eligibility criteria:
inclusion criteria: * patient at least 18 years old * high myopia with one of the following: * 6 or more sphere diopters in the study eye * axial length of the eye greater than 26 millimeters * active subfoveal/juxtafoveal choroidal neovascularization confirmed by fluorescein angiography and ocular coherence tomography. * visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion. * patients previously treated with photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study. * signed informed consent. * signed data protection consent. * women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study. exclusion criteria: * previous vitrectomy surgery in the study eye. * tractional maculopathy and/or epiretinal membrane evaluated by ocular coherence tomography. * opacities that may not allow correct fundus assessment. * lack of integrity of the posterior lens capsule in pseudoaphakic patients. * patients that may not want/be able to complete the study, based in the investigator opinion.

Keywords: high myopia bevacizumab photodynamic therapy
qualitative study in patients with genodermatoses and healthcare professionals on reproductive counselling

Conditions: Quality of Life; Ichthyosis; Palmoplantar Keratoses; Epidermolysis Bullosa; Ectodermal Dysplasia; Basal Cell Nevus Syndrome; Birt-Hogg-Dube Syndrome; Tuberous Sclerosis; Cutis Laxa; Albinism

Summary: the goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. to achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.


Eligibility criteria:
inclusion criteria: * adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children * patients with clinically and molecularly confirmed variant of a genodermatosis * health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists) exclusion criteria: * not being able to communicate verbally in dutch or english
effect of atropine or glycopyrrolate on the prevention of bradycardia during sedation using dexmedetomidine in adult patients undergoing lower extremity surgery under spinal anesthesia

Conditions: Spinal Anesthesia

Summary: patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. in contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the icu and also in patients undergoing simple procedures. hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. the present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.


Eligibility criteria:
inclusion criteria: 1. patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia. 2. asa class 1-3 exclusion criteria: 1. patients with coagulation abnormalities 2. end organ diseases of liver, lung or kidney 3. severe aortic stenosis 4. high degree av block 5. heart failure 6. patients on mao inhibitors 7. history of seizures or epilepsy 8. glaucoma

Keywords: atropine glycopyrrolate bradycardia dexmedetomidine spinal anesthesia
spasticity registry evaluating epidemiology, treatment patterns and clinical needs

Conditions: Muscle Spasticity

Summary: this study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of cerebral palsy (cp), multiple sclerosis (ms), stroke, spinal cord injury (sci), or traumatic brain injury (tbi).


Eligibility criteria:
inclusion criteria: -diagnosis of cerebral palsy (cp), multiple sclerosis (ms), stroke, spinal cord injury (sci), or traumatic brain injury (tbi) for a minimum of 3 months exclusion criteria: -participation in a spasticity clinical trial in the past 5 years.
small intestinal bacterial overgrowth (sibo) in pancreatic adenocarcinoma (pdac)

Conditions: Pancreatic Adenocarcinoma; Weight Loss

Summary: the purpose of this study is to prospectively analyze the prevalence of sibo in patients with pancreatic adenocarcinoma (pdac) and understand its association with weight loss and pancreatic resection status. each patient will be tested for sibo using lactulose hydrogen breath test. 100 patients with diagnosed pancreatic adenocarcinoma and clinically diagnosed weight loss will be enrolled in this study.

small intestinal bacterial overgrowth syndrome (sibo) is a condition defined by excessive (greater than 105 cfu/ml) or abnormal bacteria in the upper gastrointestinal tract resulting in unintentional weight loss, diarrhea, nutritional deficiencies and osteoporosis. in healthy individuals, the growth of any remaining bacteria in the stomach is limited by biliary and pancreatic secretions. the location of pancreatic ductal adenocarcinoma (pdac) on the pancreas head hinders these exocrine secretions from reaching the small intestine, leading to exocrine pancreatic insufficiency in pancreatic cancer patients. patients with pancreatic adenocarcinoma suffer from similar symptoms including weight loss, diarrhea, and nutritional deficiencies. sibo has been linked to exocrine pancreatic insufficiency or anatomical abnormalities, both consistent in pdac patients, especially those who have undergone surgery. post-pancreatoduodenectomy physiological changes disrupt the way enzymes are secreted, which affects exocrine and endocrine functions of the pancreas. currently, there is a limited understanding of the prevalence of sibo in pdac patients. the primary objective of this study is to assess the prevalence of sibo in consecutive pdac patients with clinically significant weight loss. the secondary objective of this study is to assess the prevalence of sibo in patients who have undergone pancreatic resection versus those who have not undergone resection.

Eligibility criteria:
inclusion criteria: * men, women, and all genders * individuals 18 years old or older are included. * patients of the study investigators and team members * diagnosis of pancreatic ductal adenocarcinoma * all subjects must consent to this study * clinically diagnosed weight loss exclusion criteria: * minors * pregnant women * any records flagged "break the glass" or "research opt out." * patients who have received treatment for sibo in the past 3 months

Keywords: pdac
sutured vs sutureless mesh fixation for onlay ventral hernia repair

Conditions: Ventral Hernia

Summary: comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate

ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall . the mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.

Eligibility criteria:
inclusion criteria: * ventral hernia * both sexes exclusion criteria: * obstructed or complicated ventral hernia * incisional hernia * recurrent hernia * multiple ventral hernia * large hernia more than 5 cm
contraceptive awareness and reproductive education

Conditions: Contraception; Sexually Transmitted Diseases; Pregnancy

Summary: the purpose of this study is to increase the initiation and continuation of highly effective contraceptive use while incarcerated and upon release, as well as decrease unsafe sexual activity.

unplanned pregnancies and sexually transmitted infections are important and costly public health problems in the united states resulting from unprotected sexual activity. women with a history of incarceration are at increased risk for these problems given the high rates of substance abuse and commercial sex work in this population. this proposal is designed to evaluate an innovative intervention motivational interviewing with computer assistance (mica) designed to improve contraceptive use for incarcerated women who do not want a pregnancy and are soon to be released into the community. the investigators will utilize the title x program which, in conjunction with ri department of corrections (ri doc), provides reproductive health services in jail and then transitional services in the community after release. the investigators plan to recruit 400 women from the ri doc women's jail and randomize them to two interventions: two sessions of personalized mica or two sessions of didactic educational counseling (dec), both delivered individually by trained counselors. the two counseling interventions will be similar in length and timing, but will vary in content, counseling style and the individualized computer generated feedback that is reviewed with the counselor.

Eligibility criteria:
inclusion criteria: 1. age 18-35; 2. currently sexually active with men defined as having coital sex at least monthly in the past three non-institutionalized months; 3. expected place of residence after release in providence county or within 15 miles of follow-up site; 4. willing to comply with protocol, follow-up and provide at least one locator; 5. fluent in english. exclusion criteria: 1. inability to give informed consent secondary to organic brain dysfunction, not having own legal guardianship, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that impair ability to participate in computerize assessment or counseling); 2. pregnant or trying to become pregnant within the next year; 3. hysterectomy, bilateral oophorectomy, tubal ligation, iud or essure (coil), implantable contraceptive devices (implanon) or other procedures which make it very unlikely to become pregnant; 4. women who are monogamous for more than one year whose partner has had a vasectomy; 5. housed in segregation as we will be unable to recruit them for the study
laser therapy of benign thyroid nodules

Conditions: Benign Solitary Solid; Cystic Thyroid Nodules

Summary: nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. interstitial laser photo-coagulation (ilp) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. the aim of these studies are to evaluate if ilp will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. the investigations are listed below: 1. randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments 2. randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131i versus laser ablation 3. interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.


Eligibility criteria:
inclusion criteria: * patients with a solitary solid thyroid nodule confirmed by ultrasonography * patients with a solitary cystadenoma (cystic part more than 2 ml) confirmed by ultrasonography * patients with an autonomous functioning thyroid nodule. exclusion criteria: * no family history of thyroid cancer * prior radiation towards the neck * fine needle biopsy without valid diagnostic criteria for benign thyroid disease * nodules larger than 4 cm (largest diameter) * suspicion of malignancy * increased serum calcitonin * pregnancy or lactation * alcohol, medicine or drug abuse * no safe contraception * physical or psychic condition that hinders corporation

Keywords: interventional ultrasound interstitial laser theraphy tumor ablation nodule reduction adverse effects patient satesfaction
safety and efficacy of endoscopic ultrasound-guided portal pressure gradient measurement

Conditions: Liver Diseases

Summary: the purpose of this study is to evaluate the efficacy, safety, and adequacy of endoscopic ultrasound (eus) portal pressure gradient measurement (ppgm) in patients undergoing eus-guided liver biopsies.

patients undergoing eus-guided liver biopsy may qualify to participate in this study. the purpose of this study is to evaluate the efficacy, safety, and adequacy of eus- portal pressure gradient measurement (ppgm) in patients with liver disease referred for eus-guided liver biopsy.

Eligibility criteria:
inclusion criteria * age 18 years or older * patient who has been referred for eus procedure and direct ppg measurement and -undergoing eus-guided liver biopsy * history of liver disease or suspected cirrhosis and considered for ppgm exclusion criteria * patient is less than 18 or greater than 85 years of age * patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study * patient is unwilling or unable to sign and date the informed consent * patient for whom endoscopic procedures are contraindicated.
a study of a live intranasal influenza vaccine in children with cancer

Conditions: Cancer

Summary: eligible research subjects will be randomized to receive either flumist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. subjects requiring one immunization will be immunized at day 0. subjects requiring two immunizations will be immunized at day 0 and day 28. subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

the secondary objectives of this study are to: 1. describe the safety of flumist and inactivated influenza vaccine. 2. describe the incidence and duration of viral replication following immunization with flumist. 3. to examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum iga, igg and igm levels).

Eligibility criteria:
inclusion criteria: * age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study * participant or participants parent/legal guardian available by telephone during the course of the study; * written informed consent (and assent, if applicable) obtained * currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks; * if the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent; * estimated life expectancy of \> 1 year exclusion criteria: * history of hypersensitivity to any component of flumist or tiv, including egg or egg products, gelatin, or monosodium glutamate; * history of hypersensitivity to gentamicin; * close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment * history of guillain-barre´ syndrome; * history of asthma; * female who is breastfeeding or lactating;

Keywords: flumist inactivated influenza vaccine study of flumist versus inactivated influenza vaccine in children with cancer
r230c and c230c variants of abca1 and glyburide response

Conditions: Type 2 Diabetes

Summary: the objective of the study is to know if the r230c and c230c variants of the atp-binding cassette transporter a1 (abca1) gene are associated with a smaller glucose lowering effect compared to the wild type allele (r230r) in patients with type 2 diabetes.

specific objectives: 1. in patients with type 2 diabetes stratified by the existence of the risk alleles (r230c/c230c) or the wild variant (r230r) of abc-a1, compare the changes resulting from the treatment with glibenclamide on following continuous variables: * fasting glucose * percentage reduction * hemoglobin a1c, * cholesterol, triglycerides, hdl cholesterol, ldl cholesterol * weight 2. in patients with type 2 diabetes stratified by the existence of the risk alleles (r230c/c230c) or the wild variant (r230r) of abc-a1, compare the changes resulting from the treatment with glibenclamide on following binomial variables: * number of cases that reach fasting plasma glucose lower than 110 mg/dl * number of cases that reach an hba1c less than 7%

Eligibility criteria:
inclusion criteria: * adults 20 to 79 years * body mass index \>18 and 39.9 ≤ * men or women * mexicans mestizos. * moderate hyperglycemia (126 to 250 mg/dl and hba1c levels between 7 and 10%) despite being treated with a dietary program in combination or not with metformin (2 g/d). exclusion criteria: * patients with chronic complications of diabetes: ischemic heart disease, stroke, proliferative retinopathy or blindness, albuminuria, chronic diarrhea, gastroparesis, non-traumatic amputation of lower limbs. * patients with any monogenic syndrome, obesity, diabetes or hypoalphalipoproteinemia * patients with acquired diseases that produce secondarily obesity or diabetes. * treatment with anorexigenics or accelerate weight loss at the time of the selection. * cardiovascular event in the 6 months prior to study entry. * steroids, chemotherapy, immunosuppressive or radiotherapy. * infections or concurrent acute diseases. * catabolic diseases such as cancer or aids * pregnancy

Keywords: type 2 diabetes abca1 alleles glyburide
evaluation of a new orange-based beverage enriched with polyphenols in adult humans

Conditions: Overweight; Obesity

Summary: the purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. this study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the homeostatic model assessment (homa) index.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women, and having altered at least two markers of ms namely: * hypertension (diastolic pressure higher than 85 mmhg but lower than 110 mmhg) * hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl) * elevated plasma triacylglycerol concentrations (higher than 150 mg/dl) * decreased plasma hdl-c levels (lower than 40 for men and 50 for women) * volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations. exclusion criteria: * the presence of morbid obesity * blood pressure higher than 110 mmhg * plasma glucose levels higher than 130 mg/dl * the use of any medication for the control of blood pressure or glucose or lipid metabolism * medical history of consumption of hypocaloric diet in the last year * disorders of the food conduct * the presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.