Kornimate/medical-research-clean huggingface dataset:
vienna preserflo cohort study

Conditions: Glaucoma; Glaucoma Surgery; Post-Op Complication; Efficacy, Self; Safety Issues

Summary: the vienna preserflo microshunt cohort study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a preserflo microshunt (pms) as standalone procedure or in combination with cataract extraction in the time period between january and november 2019 at the department of ophthalmology, medical university of vienna. it is estimated that approximately 70 patients will be included of this cohort. the cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. this examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (iop) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of pms position, anterior segment optical coherence tomography (oct) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. additionally, retrospective information concerning iop, medication and visual fields of all patients will be collected from the department of ophthalmology as well as from the referring ophthalmologists where possible. additionally, we will perform a comparison between two groups to compare differences in outcome measures.

during the inclusion period two slightly different surgical approaches have been used. at the beginning of the surgery, the conjunctiva is opened and the tenon capsule is getting dissected from the sclera. in the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the pms in the anterior chamber via a 25g needle track. in the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27g needle was used. the outcomes of these two groups will be compared.

Eligibility criteria:
inclusion criteria: * glaucoma patients who received a pms in the time period between january and november 2019 at the department of ophthalmology, medical university of vienna, austria, will be invited exclusion criteria: * unwilling or unable to give informed consent. * pregnancy or lactation
study of viral transduction of human auditory sensory cells for the development of gene therapy

Conditions: Hearing Loss, Sensorineural

Summary: gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and associated adenovirus (aav) is shown as a good viral vector for inner ear therapy in animal models. this study aims to study in vitro viral transduction of aav in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient * informed consent obtained * patients with a french social protection (ame excluded) exclusion criteria: * intravestibular or intra-cochlear extension of the tumor * pregnant woman * patient with administrative control * medical contra-indication
carbohydrate metabolism disorder frequency in hypertriglyceridemia induced by bexarotene of cutaneous t cell lymphoma

Conditions: Hypertriglyceridemia; Cutaneous T Cell Lymphoma

Summary: bexarotene is a rxr-selective retinoid, licensed for the treatment of cutaneous t cell lymphoma. the most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. the purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. bexarotene is licensed for the treatment of epidermotropic cutaneous t cell lymphoma .the most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). central hypothyroidism is also present in 40-80% of cases. these adverse effects are dose-dependent. the management of hyperlipidemia induced by bexarotene is difficult. the mechanism of lipid disorder induced by bexarotene is not well known. associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia. the main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (tg\> 1.5 g / l) induced by bexarotene treatment of cutaneous t cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.

Eligibility criteria:
inclusion criteria: * patient aged over 18 years * diagnosis of epidermotropic ctcl confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage iib-iv) or earlier stage if resistance to previous treatment . * tsh, ft3 and ft4 within normal limits * ast and alt ≤ 2 \* upper limit of normal * creatinine clearance ≥ 30 ml / min * agreement after written information and informed to participate in the study * patient accepting the constraints of the study * membership of a social security system. exclusion criteria: * pregnant or lactating woman * women of childbearing potential without effective contraception * insufficient thyroid or hyperthyroidism * diabetes known or detected * hyperlipidemia known or detected * hepatic insufficiency * difficulties to understand * persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent

Keywords: hypertriglyceridemia bexarotene
acid-associated heartburn symptoms and dose of esomeprazole

Conditions: Heartburn

Summary: this is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. the safety and tolerability of esomeprazole magnesium in doses up to 40 mg bid will also be assessed.


Eligibility criteria:
inclusion criteria: * males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand english and provide written informed consent * a history of heartburn for at least 6 months * a history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy * a positive esophageal acid perfusion test * at least 3 days of 'moderate' severity heartburn over the previous 7 days * no use of any acid suppression therapy (ppi, h2ra, etc.) within 14 days of randomization exclusion criteria: * a history of gastric or esophageal surgery * h. pylori positive * a history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization * currently taking higher than the standard approved proton pump inhibitor doses * historical evidence of a number of other gi, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
irinotecan/oxaliplatin/5-fluorouracil/leucovorin/cetuximab as first line treatment in colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this study will evaluate the efficacy of folofoxiri plus cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

the combination of folfoxiri plus cetuximab is reasonable safe regimen especially for patients with good performance status. the estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. it will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

Eligibility criteria:
inclusion criteria: * patients with histologically proven metastatic adenocarcinoma of the colon or rectum * previous chemotherapy for metastatic disease not allowed. patients who received prior adjuvant 5-fu-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy * patients with operable metastatic disease are excluded from the study * age 18-70 years * performance status (ecog) 0-1 * at least one bidimensionally measurable lesion of \>= 2cm * life expectancy of at least 6 months * adequate hematologic parameters (absolute neutrophil count \>= 1.5x109/l and platelets \>=100x109/l) * creatinine and total bilirubin \< 1.25 times the upper limit of normal * aspartate and alanine aminotransferase \< 3.0 times the upper limit of normal (\<5 times in case of liver mets) exclusion criteria: * absence of active infection or malnutrition (loss of more than 20% of the body weight) * no history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated * patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields. * patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded. * all patients will have to sign written informed consent in order to participate in the study

Keywords: colorectal cancer cetuximab folfoxiri
assessing cost and effectiveness of training and supervision of front line workers on early breastfeeding practices

Conditions: Malnutrition

Summary: the aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing tbas/cvs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and increase early exclusive breastfeeding in research areas of rural bangladesh.

suboptimal early infant feeding practices are the norm in bangladesh, and contribute to its poor infant health and nutrition. however, the modern health services are unable to help because approximately 85% of births take place at home. the government has begun the huge process of training the informal community traditional birth attendants (tbas) who, along with community volunteers (cvs), deliver the majority of babies, especially in the rural areas. the proposed operations research will take place in one of the poorest rural districts. it will compare the cost effectiveness of practical training of these relatively uneducated community members, with or without supportive supervision in improving early infant feeding practices, using a cluster-randomized study design. the practices to be measured before and after on probability samples include: 1) delayed cord clamping, 2) early skin to skin contact and 3) newborn-led initiation of breastfeeding within one hour of birth, 4) avoidance of the traditional prelacteal feeds, and 5) exclusive breastfeeding, at least for the early months. costs will be carefully monitored so as to compare the cost per behavior improved per infant.

Eligibility criteria:
inclusion criteria: * lactating women of children ages 0 to 5 months and pregnant women with second and third trimester exclusion criteria: * first trimester women and lactating women of children ages 6 to 23 months.

Keywords: exclusive breastfeeding skin to skin contact cord clumping prelactial feeding
a see and treat paradigm for cervical pre-cancer

Conditions: Cervical Pre-cancer

Summary: the purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. in this study the investigators are using an investigational device called the transvaginal colposcope. the word investigational means that the device is still being tested in research studies and is not approved by the u.s. food and drug administration (fda).


Eligibility criteria:
inclusion criteria: * patients undergoing cervicography or colposcopy or via or patients undergoing leep for the treatment of cervical cancer. * age 25 and greater * patients of all ethnic backgrounds will be included. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * children and subjects under 25.
the effect of pediatric patient temperament on postoperative outcomes

Conditions: Emergence Delirium; Temperament

Summary: the goal of this study is to determine if preoperative temperament is associated with postoperative pain, emergence agitation, emotional and behavioral changes, and overall parent satisfaction. this is a prospective observational study to assess preoperative temperament in pediatric patients undergoing tonsillectomy and adenoidectomy, gather demographic data, intraoperative data regarding surgical and anesthetic technique, and collect immediate postoperative data to assess pain, emergence agitation (ea), parental satisfaction as well as remote postoperative data to assess emotional and behavior changes. these data will be used to determine if patients with a specific temperament profile are more likely to experience increased pain, emergence agitation, emotional changes, and behavioral disturbances postoperatively.


Eligibility criteria:
inclusion criteria: * asa i or ii * undergoing tonsil and/or adenoid removal at boston children's hospital exclusion criteria: * history of prematurity * major chronic medical conditions * neurological impairment or developmental delay * parents/guardians who do not speak english or are unable to understand the questionnaires
monitoring of overdose patients with and without supplemental oxygen in the emergency department

Conditions: Overdose

Summary: this study will compare the data from pulse oximeters to capnographers as they are used to monitor patients who are being observed in the emergency department for a suspected overdose of alcohol or other drugs. the investigators will compare monitor data from patients who are and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of airway interventions, and to detect ventilator changes noted on the opposing monitor. there will not be any interventions during this study other than the collection of data from the monitors and observation of the care of patients.


Eligibility criteria:
inclusion criteria: * airway is being monitored as a result of overdose exclusion criteria: * under 18 years old * unable to give informed consent at baseline * prisoners

Keywords: overdose emergency department supplemental oxygen pulse oximeter capnography
effect of early rest on recovery from pediatric concussion

Conditions: Mild Traumatic Brain Injury; Concussion; Post-concussive Syndrome

Summary: the purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.

the purpose of this study is to find out if strict rest for 5 days helps children get better after concussion. this research is being done because, currently, there is no effective treatment for concussion. physical activity (for example; running, playing sports) and brain activity (for example; homework and tests) may make concussion symptoms worse. we are studying whether strict rest after concussion may help improve symptoms. about 110 children, ages 11-22 years old will take part in this study at the children's hospital of wisconsin. this study is being funded by the injury research center. the research grant pays for study procedures, follow-up testing, and patient reimbursement. research staff is not being provided incentives to enroll subjects.

Eligibility criteria:
inclusion criteria: * 11-22 years * present to the emergency department within 24 hours of a head injury exclusion criteria: * patients who are being admitted, * non-english speaking patient/family, * mental retardation (iq \< 70) * suspected intoxication * restricted used of dominant hand or limited vision * injury or conditions affecting balance assessment * prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy) * known intracranial injury (e.g., intracranial bleeding, cerebral contusion) * patients for whom a legal guardian is not present or cannot be contacted. * ed clinician preference

Keywords: mild traumatic brain injury concussion postconcussive syndrome
comparison of needlescopic vs. conventional laparoscopic adrenalectomy for tumor less than 4 cm

Conditions: Post Operative Pain, Acute

Summary: the investigator conduct a randomized clinical trial for the needlescopic and conventional laparoscopic adrenalectomy to assess whether mini laparoscopic adrenalectomy is better than conventional laparoscopic adrenalectomy in terms of pain, complication rate , and wound cosmetics

if the participant with unilateral pa tumor less than 4cm is willing to enter the clinical trial, he/she will be randomly assigned to two groups (conventional vs needlescopic laparoscopic adrenalectomy) in a 1:1 ratio, followed by preoperative assessement. all procedures were performed by experienced laparoscopic urologists (number of complex laparoscopic procedures \> 50 cases/yr for 10 yrs). the participant were blinded to the type of surgical procedure underwent until the pain assessment was completed in the morning of the second days after surgery

Eligibility criteria:
inclusion criteria: 1. over the age of 20 years old. 2. primary aldosteronism with unilateral adrenal lesions smaller than 4 cm 3. indications for laparoscopic surgery. 4. informed consent exclusion criteria: 1. over 80 years old 2. suspected adrenal malignancy or pheochromocytoma 3. other concurrent surgery 4. patients who underwent bilateral adrenal tumor resection at the same time 5. history of peritonitis or having undergoing major ipsilateral abdominal surgery. 6. american society of anesthesiologists (asa) class iii or iv (with severe cardiovascular disease, uncontrolled hypertension, diabetes, chronic pulmonary obstructive pulmonary disease, morbid obesity (bmi \> 40), dialysis patients, myocardial infarction, stroke, coronary artery disease, liver or coagulation dysfunction, etc.) 7. opioid addiction 8. patient have side effects from taking of acetaminophen, celecoxib or opioids 9. acute intoxication of alcohol, sleep aids, anesthetics, centrally acting analgesics, opium or psychotropic drugs has occurred. 10. patients using monoamine oxidase inhibitors (maois) concurrently or within the past 14 days. 11. patients with chronic pain or respiratory depression (such as chronic obstructive pulmonary disease) 12. pregnancy

Keywords: visual analogue scale post operative pain dosage of analgesic cosmetic
comparative study between outcome of ict drainage and vats in management of second stage empyema

Conditions: Second Stage Empyema

Summary: the goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema. it compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.


Eligibility criteria:
inclusion criteria: * patients both adults and children diagnosed as empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis exclusion criteria: * empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.
oral isotretinoin in melasma a randomized controlled trial

Conditions: Melasma

Summary: melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. melasma is challenging to treat. treatment is often a multimodality approach. due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. so in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.

melasma has a significant impact on the quality of life and self-esteem of those affected. darker skin photo types e.g. egyptians have excess potential to develop melasma. melasma is a chronic and challenging condition to manage. previous treatment modalities have been unsatisfactory. oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet. in this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"

Eligibility criteria:
inclusion criteria: 1. age between 18 and 50 years 2. patients complaining of melasma. 3. patients with all types of melasma (epidermal, dermal and mixed) 4. sexually active women who is willing to follow at least 2 types of contraceptive methods during study period 5. patients with skin type i-v exclusion criteria: 1. pregnant or nursing women. 2. women on any concurrent therapy for melasma. 3. patients that are using any therapy for melasma for the last 45 days. 4. patient with abnormal liver function test or lipid profile. 5. patients with allergy or hypersensitivity to the assigned drugs. 6. women not willing to follow contraceptive methods at time of study. 7. patients on facial treatments or photosensitizing drugs within previous 6 months. 8. patients with back or joint pain. 9. patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study
study of the efficacy of dienogest in the treatment of uterine leiomyomas when compared to desogestrel and goserelin

Conditions: Uterine Leiomyoma

Summary: the investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (gnrh) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.

uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. the standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. gnrh analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. a newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. the investigators are aiming to compare dienogest with the gnrh analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.

Eligibility criteria:
inclusion criteria: * women with 35 - 55 years of age * uterine volume between 50cc and 500cc * abnormal uterine bleeding probably associated to intramural uterine leiomyomas exclusion criteria: * pregnancy * liver or kidney dysfunction * women with only submucosal or subserosal uterine leiomyomas * women with contraindications to any of the drugs (categories 3 and 4 of who eligibility criteria) * use of anticoagulants * others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)