Kornimate/medical-research-clean huggingface dataset:
non-comparative trial of the combination of hcq and azi in the treatment of icu patients

Conditions: COVID-19

Summary: this research is designed as an open-label,non-comparative prospective trial.

the objects of this research are as follows: (1) to measure the duration of viral shedding in respiratory secretions of patients with moderate or severe covid-19 infection treated with the combination of hydroxychloroquine and azithromycin. (2) evaluate the case fatality rate, the clinical response and length of stay in hospitalized patients with moderate and severe covid-19 infection. (3) to report the safety of the drug combination in hospitalized patients with moderate and severe covid-19 infection.

Eligibility criteria:
inclusion criteria: 1. adults aged \>18 years of age with lower respiratory infection with sarsco2 documented by a positive rt-pcr in nasopharyngeal sample admitted to the university of new mexico hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory rate \>24 per minute, or hr\>125 per minute of a pao2/fio2\<150. 2. patient with life expectancy \>48 hours. 3. pregnant women may be included if deemed necessary. there is insufficient information regarding the safety of hydroxychloroquine and azithromycin during pregnancy. consequently, these medications are not recommended when pregnant or planning to become pregnant. however, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary. 4. azithromycin is excreted in human milk, therefore participants should not breast-feed whilst taking azithromycin, because it may cause side effects including diarrhoea and infection to a baby. it is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. additionally, hydroxychloroquine should not be taken whilst breast-feeding. however, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary. page 6 of 23 version date: 04.16.2020 5. adults unable to consent will be included with the consent of their legally authorized representative (lar). assent will be pursued from cognitively impaired participants if they are able to provide assent. note that this does not preclude the enrollment of cognitively impaired participants that cannot provide assent, but would allow those that can the opportunity to do so. exclusion criteria: 1. prisoners 2. pre-/co-existing medical conditions, including any of the following: known allergy to study drugs. contraindication to treatment with study drugs, including retinopathy, and qtc prolongation defined by qtc\>450 in males and \>470 in females. unless, it is the opinion of the treating physician(s) that the benefits to treat with medications outweigh the risks. known chronic kidney disease, stage 4 or 5 or receiving dialysis. glucose-6-phosphate dehydrogenase (g6pd) deficiency. 3. weight \<40 kg. 4. current use of: hydrocholoroquine or cardiac medicines of: flecainade, tambocor; amiodarone cordarone, pacerone; digoxin or digox, digitek, lanoxin; procainamide or procan,procanbid, propafenone, rythmal.
adaptative radiotherapy for locally advanced cervical cancer

Conditions: Uterine Cervical Cancer

Summary: this study evaluates the effect of adaptative intensity-modulated radiation therapy (imrt) in the treatment of locally advanced cervical cancer on acute genito-urinary (gu), and gastrointestinal (gi) toxicities. every patients will be treated according to the adaptative imrt strategy.


Eligibility criteria:
inclusion criteria: * cervix carcinoma proved by histology * according international federation of gynecology and obstetrics (figo) classification, stages ib2, iia, iib, iiia and iiib without lumbo-aortic lymph node damage (surgical or radiologic) * patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting * renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment * older than 18 years * good general status, world health organization less or equal to 1 * signed informed consent exclusion criteria: * history of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer) * history of pelvic irradiation * simultaneous participation to another research that could interfere with the study results * pregnant or breastfeeding patient * patient under tutor or guardian * patient not able to respect medical follow-up for geographical, social or psychological reasons * not affiliated to a system of french social security

Keywords: locally advanced
does cognitive rehabilitation demonstrate benefits in the group setting with people whom have experienced brain injury?

Conditions: Brain Injuries

Summary: the purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.

this research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. the assessments used: three step calendar approach, (sohlberg and mateer) satisfaction with life scale (swls), community integration questionnaire (ciq), independent living scale, and the vocational independence scale. the group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. techniques such as the problem solving format and a calendar system. analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting. of the 20 participants, 3 chose not to be included.

Eligibility criteria:
inclusion criteria: * all participants involved in the cognitive rehabilitation outpatient group within the study time frame are eligible to be in the study.

Keywords: cognitive rehabilitation
paroxetine in the treatment of chronic primary insomnia

Conditions: Primary Insomnia; Depression

Summary: the goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.

the primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia. paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment, compared to a placebo and sleep hygiene control condition, in a randomized, double-blinded, six-week acute treatment trial. eeg sleep, sleep quality, and daytime well-being, and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene, as compared with the placebo control condition. a total of 66 patients with primary insomnia, as defined by dsm-iv criteria, will be randomized (1:1) to receive paroxetine plus sleep hygiene therapy (p+sh-a) or placebo plus sleep hygiene therapy (pl+sh-a) in weekly acute treatment sessions evolving over a six-week interval in a double-blinded, parallel group design.

Eligibility criteria:
inclusion criteria: * age 55 or older * diagnosis of chronic primary insomnia * score of 8 or higher on the pittsburgh sleep quality index * free of all antidepressants and benzodiazepine for two weeks exclusion criteria: * lifetime diagnosis of any psychotic disorder,or bipolar disorder. * dsm-iv diagnosis of dysthymia or generalized anxiety disorder * diagnosis of major depression within the past 6 months * alcohol or drug abuse within the past 6 months * contraindication to ssri therapy * history of seizure disorder * baseline apnea/hypopnea index score greater than 15 * hyponatremia

Keywords: primary insomnia insomnia depression late life elderly sleep disorders
validation of a sensor for non-invasive measurements

Conditions: CHF; Renal Disease; Hypertension

Summary: subjects will be measured with both a sensor and a reference device

subjects will participate in a study measuring a single set of paired values. in this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 (eighteen) years of age at screening. 2. subject and/or legally authorized person/representative is willing to undergo the informed consent process prior to enrollment in the study. 3. subject selection will not be based on age, height, or weight. 4. subject is a candidate for this study based on the pi's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study. exclusion criteria: 1. subject is participating in another clinical study that may affect the results of either study. 2. subjects that are pregnant will not be included in the study. 3. subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours. 4. subject is considered by the principal investigator to be medically unsuitable for study participation.
noninvasive neuromodulation to reserve diastolic dysfunction

Conditions: Heart Failure, Diastolic

Summary: this is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (llts) to reverse diastolic dysfunction in patients with diastolic dysfunction. all patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham llts, but the sequence will be randomized. patients will be randomly assigned (1:1) to active/sham or sham/active llts. llts will be performed using a transcutaneous electrical nerve stimulation (tens) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. echocardiography will be performed after 30 minutes of llts or sham stimulation to assess diastolic function. five-minute ecgs will be obtained for hrv analysis every 15 minutes of stimulation (total of 4 recordings).


Eligibility criteria:
inclusion criteria: 1. male and female patients older than 18 year old 2. evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment exclusion criteria: 1. left ventricular dysfunction (left ventricular ejection fraction \<40%) 2. significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 3. recent (\<6 months) stroke or myocardial infarction 4. severe heart failure (nyha class iii or iv) 5. recurrent vaso-vagal syncopal episodes 6. unilateral or bilateral vagotomy 7. pregnancy or breast feeding 8. sick sinus syndrome (without a pacemaker), 2nd or 3rd degree av block, bifascicular block or prolonged (pr\>300ms) 1st degree av block
buzzy® application in pain

Conditions: Healthy

Summary: the research was conducted as a randomized controlled experiment to investigate the effect of buzzy® on pain level during the measles-rubella-mumps (mmr) vaccine injection in 12-month-old infants. this study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on november 2018-may 2019 in istanbul bakirkoy 9 family health center.

to determine the effect of buzzy® application on pain, which is a combination of cold and vibration, during measles-rubella-mumps (mmr) vaccine injection administration on 12-month-old infants. the study is a randomized contrlled experimental research. the research sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected mmr vaccine at bakırköy no. 9 family health center between november 2018-may 2019. as a data collection tool data collection form, flacc pain scale and buzzy® device have been used. while buzzy® was applied on infants in the trial group before, during and after the vaccine injection, the infants in the control group were applied routine vaccine injection. the pain response of the infants was evaluated by the nurse and the parent before, during and after the vaccine injection and the physiological parameters were evaluated by the nurse before and after the vaccine injection.

Eligibility criteria:
inclusion criteria: * the baby has completed 12 months, * mmr vaccine will be applied, * being at a suitable weight for the month, * the baby has not been given analgesic medication during the day, * it can be listed as the parent's willingness to participate in the research. exclusion criteria: * it can be listed as having a body temperature above 37.5.

Keywords: pain vaccination baby buzzy pediatric nurse
comparison of pain of two different methods in uterine artery embolization

Conditions: Leiomyoma

Summary: the primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

uterine artery embolization(uae) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. however, post-procedural pain after uae remains a major problem. the non-spherical polyvinyl alcohol particle and tri-acryl gelatin microsphere are two embolic materials used for uae.therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Eligibility criteria:
inclusion criteria: * uterine artery embolization due to multiple fibroids exclusion criteria: * severe liver or kidney dysfunction * drug allergy * bradycardia (\<45 bpm) or heart block * uncontrolled hypertension
high volume lactated ringer's solution and pancreatitis

Conditions: Pancreatitis

Summary: the purpose of this study is to examine whether giving large amounts of intravenous (iv) fluids will reduce the risk of developing a complication known as post-ercp pancreatitis (pep). pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ercp. typically, a small amount of iv fluids are given during this procedure (\~ 1 liter). we are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of pep.

this trial is designed as a phase ii/iii study. the phase ii portion of the trial will be completed to establish safety and efficacy data prior to proceeding with a phase iii study. the phase ii trial will enroll 110 patients that are undergoing elective ercp as outpatients. following the phase ii portion, if the data suggests that the intervention arm (high volume group) is safe, the investigators will begin enrolling patients who are undergoing ercp in a more urgent setting as inpatients. we plan on enrolling 1,400 consecutive high risk patients undergoing ercp. we are assuming a baseline pep risk of 9.2%. fluid administration will be based on ideal body weight (ibw) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes. all participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. analysis by a data safety monitoring board (dsmb) will take place throughout the study. the dsmb is comprised of a panel of experts independent of northshore university healthsystem.

Eligibility criteria:
inclusion criteria: patients to be included in the study are those undergoing ercp with the following: * clinical suspicion of sphincter of oddi dysfunction * history of post-ercp pancreatitis (at least one episode) * pancreatic sphincterotomy * pre-cut (access) sphincterotomy * ampullectomy exclusion criteria: * age \< 18 years old * intrauterine pregnancy or breastfeeding mother * congestive heart failure * advanced/symptomatic coronary artery disease * known ascites * renal failure * active or recent gastrointestinal hemorrhage * acute pancreatitis within 72 hours prior to ercp

Keywords: pancreatitis endoscopic retrograde cholangiopancreatography cholangiopancreatography, endoscopic retrograde ercp high volume lactated ringer intravenous administration sphincterotomy, endoscopic pancreas
hamstrings autograft versus tibialis allograft for reconstruction of anterior cruciate ligament

Conditions: Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

Summary: patients suffering from a rupture of the anterior cruciate ligament (acl) with instability of the knee joint are treated with an operative acl-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). the same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. follow-up will be done during 2 years.


Eligibility criteria:
inclusion criteria: * isolated rupture of the anterior cruciate ligament with instability of the knee joint * meniscal tear possible to suture * partial meniscectomies exclusion criteria: * chronic laxity (more than 9 months) * associated collateral laxity (grade iii) * subtotal or total meniscectomy * infection or inflammatory disease of the knee joint * large cartilage lesion
mobile phone multimedia messaging intervention for breast cancer screening

Conditions: Breast Cancer

Summary: korean american (ka) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of u.s. american women across racial/ethical groups. this innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. using the fogg behavioral model this study proposes to develop a mobile phone-based intervention designed to motivate ka women to undergo an annual mammogram (mmammogram). the overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mmammogram intervention designed to persuade ka women to undergo breast cancer screening.

specific aims over the three-year period include the following: (1) the first year will be devoted to intervention and protocol development. a major emphasis in year 1 will be developing the community advisory board (cab), conducting a series of pre-intervention focus groups, and working with pertinent persuasive technology consultants to develop and pilot-test the intervention. (2) the second year and the first half of the third year will focus on delivery of the intervention. (3) the second half of the third year will be devoted to data analysis and dissemination.

Eligibility criteria:
inclusion criteria: * korean american immigrant women * aged 40-79 * residence in minnesota * possession of mobile phone with text-message function * possession of active email account exclusion criteria: * mammogram receipt within the past 2 years

Keywords: breast cancer breast cancer screening mammogram
various insulin regimens for diabetic inpatients with cirrhosis trial

Conditions: Type 2 Diabetes; Liver Cirrhosis

Summary: liver disease is an important cause of death in type 2 diabetes. in the population-based verona diabetes study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. in another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. in egypt hepatitis c virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. patients with cirrhosis \& type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.

best management of hyperglycemia in non-intensive care unit cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using nph \& regular insulin or glargine \& glulisine.

Eligibility criteria:
inclusion criteria: * hospitalized type 2 diabetes mellitus with liver cirrhosis * entry blood glucose (fasting or random) greater than 180 mg% exclusion criteria: * type 1 diabetes mellitus * pregnancy * steroids: prednisone greater than 7.5mg/day or equivalent * serum creatinine \> 3 mg/dl * patients in intensive care units.

Keywords: diabetes cirrhosis insulin inpatient
a study of gastrointestinal tolerability of pf05212389 in obese subjects

Conditions: Obesity

Summary: this study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of pf05212389


Eligibility criteria:
inclusion criteria: obesity exclusion criteria: diabetes mellitus (type 1 or type 2) heart failure eating disorders psychiatric disorders history of suicide attempt history of pancreatitis
clinical audit of managment of gausher disease in children

Conditions: Gaucher Disease

Summary: clinical audit on managment of gausher disease in children

the main aim of study is to evaluate the management of gausher disease patient under enzyme replacement therapy in assuit university children's hospital and compare our policy for management with international guideline of management of gausher disease in children (8) * type of study : clinical audit * inclusion criteria: all cases with confirmed diagnosis of gaucher disease type 1 and type 3 receiving enzyme replacement therapy at assuit university children's hospital. * site of study :assuit university children's hospital methodiological * exclusion criteria 3-new diagnosed cases not on ert. 2-other lipid storage disease. * patient\& method the study will include 42 diagnosed gaucher disease patient under enzyme replacement therapy attend the hematology unit in assuit university children's hospital in one year reviewing the proposal will be carried out before starting via the ethical committee of assuit faculty of medicine. * ethical consideration the aim of the study will be explained to each patient before beginning of the process. we will compare our policy in management of gausher disease with international guideline of management of gausher disease 1-cases of gaucher type 2.

Eligibility criteria:
inclusion criteria: * all cases with confirmed diagnosis of gaucher disease type 1 and type 3 receiving enzyme replacement therapy at assuit university children's hospital. exclusion criteria: * 1-cases of gaucher type 2. 2-other lipid storage disease. 3-new diagnosed cases not on ert.
cryospray ablation (tm) gi patient registry

Conditions: Barrett's Esophagus; Esophageal Cancer

Summary: the purpose of this study is to create a patient registry to collect and analyze post-510k approval information on subjects treated endoscopically with the cryospray ablation™ system.

the proposed registry is a prospective, multi-center study of patients that are being currently undergoing cryospray ablation™. it will also be used to catalogue retrospective data from records of patients already treated with the device. a maximum of 40 investigational sites will participate in this study.

Eligibility criteria:
inclusion criteria: * the study population consists of patients who are being treated, or were treated, with the cryospray ablation™ system for malignant or pre-malignant conditions of the esophagus, including: * barrett's esophagus with or without dysplasia * squamous dysplasia of the esophagus * esophageal cancer, any stage exclusion criteria: * subjects with esophageal lesions whose pathology was not one of the above. * subjects with one of the above conditions who were not treated with the cryospray ablation™ system.

Keywords: barrett's esophagus high grade dysplasia low grade dysplasia squamous dysplasia esophageal cancer cryospray ablation cryotherapy cryospray