Kornimate/medical-research-clean huggingface dataset:
gnrha for luteal phase support in gnrh antagonist protocol cycles

Conditions: Infertility

Summary: evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (gnrha) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (icsi) following gnrh antagonist protocol

endometrial preparation for embryo transfer (et) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. the patients will be randomly divided into 2 groups for luteal phase support: (i) group a (gnrha group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (et) with subcutaneous administration of a single dose (0.2 mg) of gnrha (triptorelin) 6 days after oocyte retrieval, and (ii) group b (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after et

Eligibility criteria:
inclusion criteria: * women subjected to icsi through controlled ovarian hyperstimulation (coh) with pituitary downregulation by gnrh antagonist. exclusion criteria: * moderate or severe endometriosis. * hydrosalpinx. * uterine abnormalities. * myoma. * previous uterine surgery.

Keywords: luteal phase support, icsi, gnrha
safety and tolerability evaluation of pro-230 ophthalmic solution

Conditions: Myopia

Summary: phase i study to evaluate safety and tolerability of pro-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (ae), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (bncva)

a total of 29 healthy volunteers will apply pro-230 ocular solution on both eyes qd (one time per day) for 14 days. the safety variables will include non expected ae, pupillary diameter and expected ae; tolerability variables will include incidence of photofobia, and bncva. exploratory variables include best corrected visual acuity (bcva), intraocular pressure (iop), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the ocular confort index (oci) questionnaire. the presence of non-expected ae \< 10% will deem pro-230 as safe; while an incidence of photophobia \< 30% will deem pro-230 as tolerable.

Eligibility criteria:
inclusion criteria: * being clinically healthy * ability to voluntarily sign an informed consent form (icf). * ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study. * age between 18 and 35. * absence of history of contact lens use. * women of childbearing age must agree to continue (starting ≥ 30 days previous to the icf) the use of a hormonal contraception method of a intrauterine device (iud) during the period of the study. * best corrected visual acuity (bvca) of at least 20/30 (logmar 0.2) or better in both eyes. * best near corrected visual acuity (bnvca) of at least 20/25 (logmar 0.1) or better in both eyes. * presenting vital signs within normal parameters. * presenting an iop ≥10 and ≤ 21 mmhg exclusion criteria: * using any kind of ophthalmic topical products. * presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents. * using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration * for women: being pregnant, breastfeeding or planning to get pregnant during the period of the study. * having participated in any clinical study 90 days prior to the inclusion in this study. * having participated in this clinical study. * history of any chronic degenerative disease, including diabetes and hypertension. * presenting active inflammatory or infectious diseases when entering this study. * presenting unresolved lesions or trauma when entering this study. * history of any ocular surgery. * history of any surgery, non-ocular, within the previous 3 months of entering this studies. * being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.
b181: stimulation of thermogenesis by bio-active food ingredients

Conditions: Obesity

Summary: the primary aim was to measure the effect of green tea extract, tyrosine and caffeine on energy expenditure, appetite ratings and spontaneous energy intake together with recording of side effects in healthy normal weight subjects.

background: long-term weight maintenance of a weight loss is often unsuccessful. often a weight regain is observed in most studies that could indicate that most subjects are not able to change their eating habits. there is a need for simple and safe methods to prevent weight gain and re-gain i.e. by increasing thermogenesis and decrease spontaneous energy intake (ei). studies have shown that nutritional and food-related non-nutritional factors influence the adjustment of ei and ee as the compounds can enhance the diet-induced thermogenesis (dit) and suppress appetite. method: the present study was designed as a 4-way crossover, randomised, placebo controlled, dou-ble-blind study. each treatment was separated by \>3 d washout period. all treatments were administered as tablets containing either 500 mg green tea extract (whereof 125 mg cate-chins), 400 mg tyrosine, 50 mg anhydrous caffeine, or placebo. on each test day body weight and composition was assessed. all participants underwent a 4.5-h assessment of energy expenditure by indirect calorimetry in a ventilated hood. energy intake recorded of an ad libitum pasta salad brunch served after the last hood measurement subjects: twelve healthy lean (20\<bmi\<25) weight stable non-smoking subjects between 18-40 years of age were tested 4 times each with a wash-out period of at least 3 days.

Eligibility criteria:
inclusion criteria: * twelve healthy and normal-weight men (age: 23.72.6 y, bmi: 22.41.8 kg/m2) participated in the study. they were weight stable (within 3-kg in last 3 mo), non-smoking, non-athletic, and had no use of dietary supplements or frequent use of medication. exclusion criteria: -

Keywords: green tea caffeine tyrosine energy expenditure energy intake
effectiveness of a procedure for previously failed glaucoma surgery

Conditions: Glaucoma

Summary: transconjunctival mitomycin-c in needle bleb revision may be an effective procedure to treat cases with a previously failed trabeculectomy. we will investigate approximately 100 consecutive cases with follow up of up to 9 years. we anticipate that this procedure is an effective, safe, and appropriate option for successful glaucoma treatment.

the healing process after filtering surgery for glaucoma may cause an unsuccessful outcome for the trabeculectomy procedure. in order to control the rising intraocular pressure due to the failed trabeculectomy, medications may be restarted and/or filtering surgery may need to be repeated. our primary research showed that transconjunctival mitomycin-c in needle bleb revision may be an effective procedure to control this situation. this retrospective study will follow over 100 patients from may 1997 to may 2006. this long-term follow up will help assess the future role of this technique in glaucoma practices.

Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma * failed filtering procedures- defined as intraocular pressure exceeded target pressure thus inducing possible further optic nerve damage exclusion criteria: - needling combined with other ocular surgical or laser treatments

Keywords: glaucoma trabeculectomy filtering bleb revision intraocular pressure needling procedure mitomycin c
the effect of deep inhalation on mannitol responsiveness

Conditions: Asthma

Summary: the study will assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all.

this study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. this study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide. this is a single center, open label, randomized study. individuals with stable asthma will be eligible for enrollment. the study will consist of two parts, screening and testing. part 1: screening participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. if participants show airway responsiveness to methacholine (i.e. methacholine pc20 16mg/ml), they will be scheduled to undergo the testing part of the study. part 2: testing participants will be randomized to undergo two methacholine or two mannitol challenges. further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.

Eligibility criteria:
inclusion criteria: * signed informed consent * men and women between 18 and 75 years of age * fev1 at first measurement of greater than or equal to 65% predicted * methacholine provocative concentration causing a 20% in fev1 at screening that is less than or equal to 16mg/ml * generally good health * stable asthma exclusion criteria: * respiratory infection within 4 weeks of screening visit * worsening of asthma within 4 weeks of screening visit * lung disease other than asthma * significant medical comorbidity * current smoker or ex-smoker with significant smoking history * currently pregnant or breastfeeding

Keywords: mannitol methacholine deep inhalation tidal breathing
acupuncture with deqi and psychological effects in treatment of bell's palsy

Conditions: Bell's Palsy

Summary: the purpose of this study is to observe the influence of deqi and neuropsychological factors on effects of acupuncture treatment for bell's palsy.

through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. however,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.this study will adopt a series of international practice scales ,such as house brackmann scale,facial disability index(fdi),world health organization quality of life-bref (whoqol-bref), cattell personality factors (16pf),and cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for bell's palsy.

Eligibility criteria:
inclusion criteria: 1. patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms; 2. aged 18 to 65 years. exclusion criteria： 1. illiterate; 2. the facial paralysis is caused by herpes zoster; 3. recurrent facial paralysis; 4. noticeable asymmetry of the face before the illness which may affect the evaluation; 5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.

Keywords: bell's palsy，deqi，acupuncture, neuropsychology
testing of computer aided detection software for riverain medical group

Conditions: Lung Cancer

Summary: this is a clinical trial using retrospective data of two different software devices developed by riverain medical group: softview and onguard 5.0. the two studies will be run concurrently. riverain medical group's computer systems are designed to assist radiologists in their identification of lung cancer on chest radiographs. the current machine received fda pre-market approval. this is to test two new software approaches.

in 2000, data was presented to the fda to demonstrate that a new system for computer analysis could assist radiologists in the detection of small lung cancers on chest radiographs. radiologists using the system showed a statistically significant improvement in lung cancer detection rate when they used the system, compared to their interpretation of chest radiographs when they did not use the computer system. this study, along with other supporting data, resulted in the fda giving pre-market approval for the system. the system has undergone several improvements in software and hardware, and it is now intended to test two different software systems to determine whether radiologists using the systems can improve their detection of lung cancer on chest radiographs. one of these systems processes the chest radiograph to decrease the emphasis given to the shadow of the ribs and thereby enhances the ability of radiologists to detect disease in the lungs. the second system performs a series of evaluations on chest radiographs and, based on a complex system of analysis, points to locations on the chest radiograph that contain solitary pulmonary nodules having the characteristics of primary lung cancer or solitary metastases of cancer to the lungs. this will be a test of radiologists to determine the degree of improvement, if any, that results when they interpret chest radiographs that may or may not have cancer, first interpreted without the computer and, second, with the images output by the software.

Eligibility criteria:
inclusion criteria: * us american board of radiology certified radiologists in active clinical practice exclusion criteria: * specialists in pulmonary or chest or cardio-pulmonary radiology prior membership on expert panels for this study who prepared cases current or recent colleagues or trainees (within 10 years) of the principal investigator

Keywords: lung cancer chest radiograph computer-aided detection image processing
association between sleep quality and self-care in heart failure patients

Conditions: Heart Failure; Sleep Quality; Self Care; Cognitive Function

Summary: the research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (hf) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. the sample size was calculated using the multiple linear regression model with the g\*power version 3.1 program. based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants. data will be collected from patients who apply to the dokuz eylül university cardiology outpatient clinic and meet the inclusion criteria. after signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. the statistical package for social sciences (spss) 24.0 will be used to analyze the numerical data of the research. descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.


Eligibility criteria:
the study will include patients who: * are diagnosed with heart failure according to international guidelines, * are aged 18 years or older, * can communicate via phone, and * are willing to participate in the study. exclusion criteria: the study will exclude patients who: * have been hospitalized within one month prior to inclusion, * have experienced major psychological trauma or stress in the last three months, * have serious comorbidities or malignant cancers, * have advanced hearing impairment, * are using prescription drugs for insomnia or psychiatric conditions, * work night shifts, or * reside in nursing homes.
measurement of bladder pressure with a novel external device, comparison to urodynamics testing

Conditions: Urinary Bladder, Neurogenic; Urodynamics

Summary: the investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. the investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

for patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. this monitoring is currently done by in-office urodynamics testing (uds). this testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions. this study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. the investigators will be investigating if this device can achieve similar pressure measurements as uds. the investigators hope is that this device will provide similar measurements to uds, and can be developed as a home bladder-pressure monitoring tool. this study will enroll children with neurogenic bladder who are currently undergoing uds as part of their regular care. the measurements will be taken as part of the standard uds protocol (with insertion of the uds catheter) and will then be compared to the values obtained with uds testing.

Eligibility criteria:
inclusion criteria: * must have diagnosed neurogenic bladder * undergoing urodynamics testing as part of routine clinical care exclusion criteria: -none

Keywords: urodynamics neurogenic bladder
a six week, double-blind randomized, efficacy and safety, sleep lab trial with esmirtazapine (org 50081) (p05707)

Conditions: Insomnia

Summary: the purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (org 50081) compared to placebo in patients with chronic primary insomnia.

insomnia is a common complaint or disorder throughout the world. about one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. the majority of the insomniacs suffer chronically from their complaints. it has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. this raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. this double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

Eligibility criteria:
inclusion criteria: * documented diagnosis of chronic primary insomnia exclusion criteria: * other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders * has significant medical or psychiatric illness as causing the sleep disorder * diagnosed with major depressive disorder * substance abuse within the past year * night worker or work on rotating shifts * has had serious head injury, stroke, epilepsy * has a history of bipolar disorder or family (immediate family) history of suicide * smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory * drinks beverages containing more than 500 mg caffeine per day

Keywords: sleep initiation and maintenance disorders, sleep disorders, intrinsic dyssomnias, sleep disorders, nervous system diseases, mental disorders
nedaplatin combined with gemcitabine in the treatment of recurrent and/or metastatic nasopharyngeal carcinoma : a single arm and phase ⅱ clinical trail

Conditions: Recurrent and Metastatic Nasopharyngeal Carcinoma

Summary: the purpose of this single arm,phase ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility criteria:
inclusion criteria: * biopsy proved nasopharyngeal carcinoma; stage ivc according to union for international cancer control (uicc) edition vii,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs. exclusion criteria: * allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.
systematically assessing effects of colored light on humans with a multi-modal approach (substudy 5 of 7)

Conditions: Exposure to Man-made Visible Light

Summary: note: this is the fifth of in total 7 sub-studies related to the ethics committee of the canton of bern ref. no. kek-be 2016-00674. this sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies. general study information: this is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. the participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. the risk for the participants is negligible and comparable to the risk during daily life.


Eligibility criteria:
inclusion criteria: * normal color vision * right handed * written informed consent exclusion criteria: * smoking * any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months * acute severe traumas * chronic diseases with the necessity for medication * use of recreational drugs * regular intake of medication that would affect the outcome measures * regular excessive alcohol use (\> 18 standard units / week) * transmeridian travel in the last month (crossed \> 1 time zone border) * night shift word during the last month

Keywords: cerebral oxygen metabolism functional near-infrared spectroscopy partial pressure of carbon dioxide heart rate variability blood pressure affect mood respiration systematic randomized cross-over study systemic physiology electro-dermal activity pulse-respiratory quotient
retrospective collection of pillcam sb movies

Conditions: Inflammatory Bowel Disease, Crohn Disease

Summary: up to two hundred un-identified pillcam sb movies will be collected from 2 clinical sites, during up to 3 years and transferred to given imaging. demographical data and medical history will be collected. capsule transit time in the different sections of the gi will be evaluated.

up to two hundred un-identified pillcam sb movies that were created between the year 2008 and the date the study was approved by the irb, will be collected from 2 clinical sites, sourasky and sheba medical centers during up to 3 years and transferred to given imaging. demographical data and medical history will be collected. capsule transit time in the different sections of the gi will be evaluated by internal readers.

Eligibility criteria:
inclusion criteria: videos collected from any pillcam sb procedure exclusion criteria: none