Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effects of multiple doses of ck-2017357 in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the study will generate data on safety, tolerability and pharmacokinetics after multiple daily doses of ck-2017357 in patients with als. patients will be randomized into one of four different treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of ck-2017357 for 14 days.

in part a, approximately 24 patients will be randomized to one of four different treatment groups. after a 7-day washout of riluzole, patients in each treatment group will receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of ck-2017357 for 14 days. patients will take daily doses of ck-2017357 or placebo (day 1 through day 14) and will return to the study site on day 2, day 8 and day 15. all patients will return for a follow-up visit 7 days (± 2 days) after their last dose. in part b, approximately additional 24 patients will be randomized to one of four different treatment groups as in part a. patients in part b will be required to decrease their riluzole dose to 50 mg once a day (qd) for 7 days prior to randomization. after this 7 day period, patients will take riluzole at 50 mg qd concurrently with their morning dose of blinded study drug.

Eligibility criteria:
key inclusion criteria: 1. able to comprehend and willing to sign an informed consent form (icf) 2. males or females 18 years of age or older 3. a diagnosis of familial or sporadic als (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of als according to the world federation of neurology el escorial criteria) 4. maximum voluntary grip strength in at least one hand between 10 \& 40 pounds (females) and 10 \& 60 pounds (males) 5. upright slow vital capacity (svc) \>50% of predicted for age, height, and sex 6. able to swallow tablets with water 7. willing and able to remain off riluzole for 4 weeks (part a only) 8. currently taking and tolerating a stable dose of 50 mg bid riluzole (part b only) 9. willing and able to reduce daily dose of riluzole to 50 mg for 4 weeks (part b only) 10. willing and able to refrain from caffeine-containing products during study participation 11. willing and able to remain off warfarin and theophylline-containing medications during study participation 12. has a caregiver who is capable of observing and reporting patient status, and also assisting in the proper use of nocturnal oximetry equipment 13. able to perform pulmonary function tests key exclusion criteria: 1. life expectancy \<3 months 2. participation in any trial in which receipt of investigational study drug occurred within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing 3. any prior treatment with ck-2017357 4. use of non-invasive positive pressure ventilation (nippv) for any part of the day or night other protocol-defined inclusion/exclusion criteria may apply.
online peri-operative education program for patients undergoing major head & neck surgery

Conditions: Head and Neck Cancer; Head and Neck Neoplasms

Summary: this phase of the project will evaluate the utility and efficacy of a personalized online patient education platform developed from efforts in phase 1 in 1) increasing patients' and caregivers' pre- and post-operative preparedness and satisfaction, and 2) reducing readmission, ed/urgent care/unplanned clinic visits and telephone calls to clinic staff.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * have had or are undergoing free flap surgery and/or total laryngetomy * have internet access * english speaking exclusion criteria: * younger than 18 years of age * no internet access * non-english speaking

Keywords: head and neck cancer careorbit peri-operative education
the caudal space in children: ultrasound evaluation

Conditions: Hydrocele; Inguinal Hernia; Hypospadia; Cryptorchidism; Genitourinary Disease

Summary: caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery. an exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block. the aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.


Eligibility criteria:
inclusion criteria: * patients aged 0 - 84 months who were scheduled to undergo elective urological surgery. exclusion criteria: * patients with any contraindication to caudal epidural block were excluded. * coagulopathy * allergy to local anesthetics * infection at the puncture site

Keywords: caudal space children ultrasound evaluation
impact of a fourth hexavalent vaccine after hematopoietic stem cell transplantation

Conditions: Haemopoietic Stem Cell Transplantation; Allograft

Summary: it is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-hib-hbv) within 2 months followed by a booster dose one month after. the patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, haemophilus influenza b, hepatitis b virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. if the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. the antibody response will be again measured one month after the 1 year booster dose.

it is recommended for patients who underwent an hematopoietic stem cell transplantation to receive, 6 months after the graft, 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-hib-hbv) within 2 months, followed by a booster dose one yrar after. however, this strategy do not constantly lead to efficient antibody levels. the investigators aim to determine whether a 4th dose in the initial vaccine schedule (month 0, 1, 2, and 3) allows to obtain a better response. after informed consent, the investigators will recruit 6 months after the graft 200 patients who had received an hematopoietic stem cell transplantation . the participants will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, haemophilus influenza b, hepatitis b virus, poliomyelitis virus) at month 0 (before the 1st hexavalent vaccine injection), and one month after the 3rd injection of this vaccine. if the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. the one year booster dose will be then injected to all participants, and the antibody response will be again measured one month after this dose. the primary endpoint is to compare the antibody levels at this date in patients who had an unsufficient immune response after the 3rd dose and who received or not a 4rth dose in the initial vaccine schedule.

Eligibility criteria:
inclusion criteria: * having received an hstc 6 months before (not more than 2 years) * not receiving immunosuppressive therapy at inclusion exclusion criteria: * having received an hstc 6 months more than 2 years before * receiving immunosuppressive therapy at inclusion

Keywords: haemopoietic stem cell transplantation vaccine diphteria tetanus haemophilus influenza poliomyelitis hepatitis b
phase 1b study of a cancer vaccine to treat patients with advanced stage ovarian, fallopian or peritoneal cancer

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: as a follow-on study to nct01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine dpx-survivac and low dose oral cyclophosphamide. the combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.


Eligibility criteria:
key inclusion criteria: * histologically confirmed stage iic-iv epithelial ovarian, fallopian tube or peritoneal cancer * complete or partial response following standard of care surgery and first line chemotherapy * may have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment * previous investigational biologic therapy allowed, must be more than 56 days prior to first injection * previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection * ambulatory with an ecog 0-1 * life expectancy \> 6 months * meet protocol-specified lab requirements * provide informed consent and have ability to comply with protocol requirements key exclusion criteria: * concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol) * prior receipt of survivin based vaccines * participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies * progressive disease (rising ca-125 acceptable) * more than one course of chemotherapy for recurrent disease * concurrent bevacizumab as maintenance therapy * concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer * history of autoimmune disease * recent history of thyroiditis * presence of a serious acute infection or chronic infection * brain metastases * other serious intercurrent chronic or acute illness * ongoing treatment with steroid therapy or other immunosuppressive * acute or chronic skin disorders

Keywords: vaccine immunotherapy combination therapy
gastrointestinal bleeding management

Conditions: Gastrointestinal Bleeding

Summary: unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists for the emergency management of patients with acute gastrointestinal bleeding. the aim of our study is to develop optimal diagnostic and therapeutic algorithms for the management of acute upper and lower gastrointestinal bleedings.

acute upper gastrointestinal bleeding is a common medical emergency. up to 15% of patients still die worldwide. the gastroduodenal ulcer disease is the most common cause of gastrointestinal bleeding. even lower gastrointestinal bleeding occurs especially in patients of older age. the goal of our data acquisition and evaluation is to learn whether existing diagnostic or therapeutic procedures are of relevance in the management of acute gastrointestinal bleedings. unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists on patients with acute gastrointestinal bleedings. the aim of our study is to develop optimal diagnostic and therapeutic algorithms of acute gastrointestinal bleeding. therefore our prospective data registry should answer different questions: when is the right time for a gastroscopy or colonoscopy? should every patient with a suspected gastrointestinal bleeding receive endoscopy? which clinical und laboratory findings influence the success of therapy? does endoscopic procedures have an influence on the length of hospital stay? against this background we will record treatment findings separately. this includes clinical (e.g. age, sex, date of admission, department of admission, onset of symptoms), laboratory (e.g. blood count), history of medications (e.g. new anticoagulation's) and endoscopic findings (e.g. active bleeding). furthermore the length of inhospital stay will be recorded. participants will be followed for the duration of hospital stay, an expected average of 7 days.

Eligibility criteria:
inclusion criteria: * all patients with suspicion or symptoms of gastrointestinal bleeding. exclusion criteria: * patients younger than 18 years
real-life study in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-vegf) treatment in diabetic macular edema (dme) patients.

the study included patients who were being observed in the retina departments of 8 tertiary hospitals in the northern marmara region of turkey (istanbul's asian side, kocaeli, and sakarya). the records of dme patients treated with an anti-vegf agent between january 2015 and december 2018 were reviewed.

Eligibility criteria:
inclusion criteria: * diabetic macular edema treated with intravitreal anti-vegf injection * having at least 4 or more annual examination visits exclusion criteria: * phacoemulsification surgery in the last 1 month * prfk / grid / focal / micropulse in the last 4 months * previous intraocular surgery (excluding ppv and phacoemulsification)
a study to evaluate the safety, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in treatment-naïve patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic hcv infection.


Eligibility criteria:
inclusion criteria: * 18-65 years of age, inclusive * primary diagnosis of chronic hcv infection, genotype 1 * interferon-based treatment-naïve * body mass index of 18 to 30, inclusive exclusion criteria: * patients previously treated with interferon-based therapy * patients with diabetes mellitus

Keywords: hepatitis c celgosivir hcv genotype 1 treatment-naive early viral kinetics
the use of chewing gum for xerostomia and hyposalivation after radiotherapy for oral and oropharyngeal tumors

Conditions: Head and Neck Cancer; Radiation Therapy Complication; Xerostomia; Hyposalivation

Summary: this study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.

radiation-induced xerostomia and hyposalivation are frequent side effects after completed treatment for oral and oropharyngeal cancers. this may induce eating and swallowing difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. as a consequence, quality of life is often impaired for this group of patients even after completing treatment. this study hypothesize that chewing gum can stimulate salivary flow from the residual functional salivary glands and thereby improving the patient's oral well-being. primary endpoint: - to assess whether the difference between the unstimulated and stimulated salivary flow after a one-month period of using chewing gum will result in improved oral well-being. secondary endpoint: * to assess if unstimulated and stimulated salivary flow differs between the two groups of patients * to evaluate changes in quality of life with eortc qlq h\&n-35 for patients using chewing gum * to evaluate differences in quality of life with eortc qlq h\&n-35 between the two groups of patients. all patients who have received curative intended treatment for oral or oropharyngeal carcinomas at the department of oncology, odense university hospital, will be invited to participate in the study. if the eligibility criteria are met the patient will be randomized 2:1 to either the intervention arm with chewing gum or the control arm with standard oral care. the study intends to include 210 patients in total. of these, 140 patients in the intervention arm and 70 in the control arm. recruitment to the study was initiated in september 2016 and is expected to be completed in july 2018. the duration of the study is one month from inclusion and randomization to final follow up. for all included patients, saliva samples are collected (unstimulated and stimulated sialometry) and the eortc qlq h\&n-35 questionnaire and a xerostomia specific questionnaire are completed. the patients in the control arm are only introduced to chewing gum at the last follow up visit. in the intervention arm, all patients are instructed to use the chewing gum on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document compliance.

Eligibility criteria:
inclusion criteria: * over 18 years of age * diagnosed with oral or oropharyngeal carcinoma * received curative intended radiation therapy (primary or postoperative), 60-66gy including concurrent chemotherapy * within 6 to 60 months after radiation therapy * complains of xerostomia level 1 (according to danish head and neck cancer group) * written informed consent exclusion criteria: * poor teeth condition or full set of dentures * recurrence of cancer or palliative treatment

Keywords: saliva substitute
a post-market clinical performance and safety evaluation of gamcath highflow dolphin protect catheter

Conditions: AKI - Acute Kidney Injury; Acute Renal Failure; CKD; ESRD

Summary: the goal of this retrospective chart review is to obtain clinical safety and performance data for the gamcath highflow dolphin protect catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease. the main questions to answer are: 1. duration of catheter use (survival) 2. reason(s) for catheter removal

the objective of this retrospective chart review is to obtain clinical safety and performance data for the gamcath highflow dolphin protect catheter related to the duration of use (catheter survival) throughout its lifetime.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age at the time of catheter insertion. * patients diagnosed with aki, arf, and/or ckd (including end-stage renal disease \[esrd\]). * patients who required vascular access to perform extracorporeal blood purification using gamcath highflow dolphin protect catheter inserted by a physician in the subclavian, jugular, or femoral veins. exclusion criteria: * patients who required the gamcath highflow dolphin protect catheter for any indication other than extracorporeal blood purification. * patients who had a local infection at the vascular access site prior to catheter insertion. * patients who required surgical intervention (e.g., cutdown procedure) for gamcath highflow dolphin protect catheter placement. * patients who had a prior catheter in place at the same vascular access site (i.e., r/l jugular vein, r/l femoral vein, r/l subclavian vein) within the last 7 days. * patients who do not have complete patient records to support the primary endpoint analyses.

Keywords: extracorporeal blood purification continuous renal replacement therapy
genetic testing for all breast cancer patients (get facts)

Conditions: Breast Cancer; Invasive Breast Cancer; In Situ Breast Cancer; Genetic Testing

Summary: this study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer this research study involves an expedited and surgery-specific form of genetic counseling. the names of the study methods involved in this trial are/is: * quantitative genetic counseling (discussion is guided by tables and graphs) * standard genetic counseling

* the research study procedures include screening for eligibility and study interventions including evaluations and follow up visits * after receiving genetic testing, participants will be placed into one of two counseling methodology groups: * standard genetic counseling: standard of care discussion * quantitative genetic counseling: discussion is guided by tables and graphs. * participants will be on the research study for up to six months, with an optional extension to two years. * it is expected that about 450 people will participate. * this research study is a feasibility study, which is the first-time investigators are examining this form of genetic counseling. * this is a randomized study. randomization means being put into a group by chance. it is like flipping a coin. neither the participant nor the investigator will choose the group the participant is assigned to.

Eligibility criteria:
inclusion criteria * patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing * patients with good understanding of written and spoken english * patients with apparent cognitive capacity to make surgical decisions for themselves * patients who are medically cleared for surgery * patients must be at least age 18 but under 79 exclusion criteria * previous breast cancer diagnosis (invasive or dcis) * metastatic breast cancer * patients who have received prior broad-based panel testing (prior brca1/2 testing with negative results allowed) * bilateral breast cancer * known medical or surgical contraindication to contralateral mastectomy * hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers.

Keywords: breast cancer invasive breast cancer in situ breast cancer genetic testing quantitative genetic counseling standard genetic counseling
role of hvni in severe chest trauma

Conditions: Chest Trauma

Summary: to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma

* chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia. * the two main goals of therapy are pain management and pulmonary care and support. there is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis. * oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures. high -velocity nasal insufflation (hvni ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. high-flow humidified oxygen with flow rates from 30 to100 l/min with high fraction of inspired oxygen( fio2) is able to be delivered. positive end-expiratory pressure can be generated, preventing alveoli collapse. the washout of carbon dioxide (co2)and replacement with enriched o2 purportedly decreases work of breathing and increases breathing effectiveness. * routine tests for chest injuries include chest x-rays and computed tomography (ct) scans. ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation . * in thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. the ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.

Eligibility criteria:
inclusion criteria: * chest trauma patients with lung injury confirmed by ct imaging * the age from 15-55 years old * no indication of mechanical ventilation at the time of admission to the intensive care unit exclusion criteria: * • patients \< 15years old * requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause * facial fractures or base of skull fractures * who did not receive a chest computed tomography (ct) scan * glasgow coma scale \<10 * massive surgical emphysema * copd patients ( chronic obstructive pulmonary disease )

Keywords: high velocity nasal insufflation