Kornimate/medical-research-clean huggingface dataset:
phase i/ii study of avelumab in pediatric cancer participants

Conditions: Refractory or Relapsed Solid Tumors; Lymphoma

Summary: this is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy. the study was planned to be conducted in 2 parts: the dose-finding part (phase i) and the tumor-specified expansion part (phase ii). however, phase ii was cancelled due to limited clinical benefit of pd-l1 monotherapy in pediatric participants.


Eligibility criteria:
inclusion criteria: * male or female subjects 0 to less than 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors (including cns tumors) or lymphoma for which no standard therapy is available * confirmed progression on or refractory to standard therapy or no standard therapy available. * availability of archival formalin-fixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment for subjects in phase 2 * adequate bone marrow, kidney, and liver function * other protocol defined inclusion criteria could apply exclusion criteria: * prior therapy with any antibody or drug targeting t-cell coregulatory proteins * concurrent anticancer treatment or immunosuppressive agents * prior organ transplantation * significant acute or chronic infections * other significant diseases or conditions that might impair the subject's tolerance of trial treatment * other protocol defined exclusion criteria could apply

Keywords: avelumab anti pd-l1 solid tumors cns tumors lymphoma pediatric subjects
effect of nasal steroid in the treatment of anosmia due to covid-19 disease

Conditions: Clinical Trial

Summary: background: anosmia is a debilitating common symptom of covid-19. the therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. however, the effect of local steroid was not assessed before. objective: to estimate the efficacy of local steroid in the treatment of anosmia in covid-19 patients.

background: anosmia is a debilitating common symptom of covid-19. the therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. however, the effect of local steroid was not assessed before. objective: to estimate the efficacy of local steroid in the treatment of anosmia in covid-19 patients. materials and methods: a double-blinded randomized controlled trial was conducted at al-ramadi teaching hospital and tikrit teaching hospital during the period from 23th august to 30th september. proven cases by real-time polymerase chain reaction and presented with anosmia alone or with ageusia were enrolled in the study. the patients divided into 4 groups according to the treatment modalities. group a (local steroid nasal drops), group b (local normal saline nasal drops), group c (systemic and local steroid), and group d (systemic steroid and local normal saline). comparison between the groups concerning the fate and the recovery time of the anosmia was analyzed. results and conclusion: depends on the finding of the studied patients.

Eligibility criteria:
inclusion criteria: proven cases of covid-19 infection by real-time polymerase chain reaction (pcr) of the nasopharyngeal and oropharyngeal swabs and presented with recent onset of anosmia alone or with ageusia or other symptoms of the disease were enrolled in the current study. - exclusion criteria: patients with pregnancy, children \<18 year, psychological disturbances, previous anosmia, severe sinonasal diseases, previous sinonasal surgery, refuse to participate in the study, and those who lost to follow-up were excluded from the study. -

Keywords: anosmia covid-19 nasal steroid
patient self monitoring of physical therapy exercise

Conditions: Patellofemoral Syndrome

Summary: our objective is to develop an ibehr (image-based electronic health record) to show patients how to reproduce at home the exercises prescribed by their physical therapist (pt) in clinic. the ibehr can also record home exercise sessions for review by and feedback from the pt. the health care benefits of the ibehr for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist pt decision making.

our objective is to develop an ibehr (image-based electronic health record) to help patients to transfer and reproduce at home the exercises they were prescribed by their physical therapist (pt) in clinic. more than 17 million (m) patients are diagnosed with conditions that may benefit from pt in the u.s. each year. adherence to home exercise is the most important factor in functional recovery, and feedback from the exercise prescriber is the most important factor in achieving patient adherence. however in current practice the patient only gets feedback at clinic visits which may be weeks apart. the proposed ibehr will give patients visual feedback in real time comparing their performance at each repetition at home with a recording of themselves performing the exercise correctly in the clinic under the pt's supervision. the visual graphics show the patient how to better position his/her body and extremities. such feedback is likely to improve adherence with the treatment regimen in terms of frequency, duration, and correctness of exercise, and thus facilitates transition of care between clinic and home. the ibehr is also a telemedicine tool because the patient can transmit recordings of home exercise to the pt for rapid review and feedback. a third benefit of the ibehr is to improve health care decision making by the pt. in current medical practice, it is difficult for a pt to determine why a patient fails to recover as expected. by recording the exercise performed at home, the ibehr provides monitoring data that informs the pt whether the patient adhered poorly to prescribed exercise frequency or duration, the patient performed the exercise incorrectly, or the pt prescribed the wrong exercise. our specific aims are to 1) develop the ibehr software, 2) perform alpha testing of device accuracy and beta testing of user interface ease of use, and 3) perform preliminary evaluation of the efficacy of the ibehr to improve adherence. the health care benefits of the ibehr for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist pt decision making.

Eligibility criteria:
inclusion criteria: * anterior knee pain or anterior cruciate ligament (acl) injury, including non-operative and post-surgical patients exclusion criteria: * non computer literate * nonambulatory * non english speaking

Keywords: musculoskeletal, physical therapy
duet trs used in pulmonary resections

Conditions: Lung Cancer

Summary: the objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as \> 5 days by the society for thoracic surgery) when using the endo gia staplers with endo gia single use loading units (sulus) buttressed with duet trs tm in an anatomic pulmonary resection via video assisted thoracoscopic surgery (vats). anatomic pulmonary resection is defined as either a lobectomy or segmental resection. results of the study will be compared to contemporary literature for a similar population.


Eligibility criteria:
inclusion criteria: * the patient must be 18 years of age or older * the patient must be scheduled to undergo segmentectomy or lobectomy via video assisted thoracoscopic surgery (vats) for a lung nodule suspicious for or clinically proven to be primary lung cancer * the patient must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure * the patient must be willing and able to comply with all study requirements and have understood and signed the informed consent. exclusion criteria: * the patient is pregnant or breastfeeding * the patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or lung volume reduction surgery (lvrs), or lung biopsy for suspected interstitial lung disease * the patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected * the patient is scheduled to receive intra-operative brachytherapy * the patient has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months * re-operative surgery is excluded if it is on the same side as the previous surgery * the patient requires chest wall reconstruction

Keywords: lobectomy segmentectomy pulmonary resection
gastric electrical stimulation for abdominal pain in gastroparesis

Conditions: Abdominal Pain

Summary: to conduct a pilot study to evaluate the effects of new ges programming settings on abdominal pain in patients with gastroparesis and existing ges devices, whose abdominal pain has so far been refractory to drugs and/or devices.

eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. patients existing ges devices will be reprogrammed to new setting for 4 week and their gi symptoms including pain will be evaluated by a daily diary. at the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.

Eligibility criteria:
inclusion criteria: * should be able to give informed consent for the study * has enterra ges device in place for at least 2 months * continue to have moderate to severe abdominal pain on at least one pain questionnaire or \>5 score (on a scale of 0-10 for pain) on the vas questionnaire for at least 2 months. * abdominal pain should be either persistent; for example, daily for at least \>1 hour, be chronic for \>2 months, and refractory to original enterra ges settings exclusion criteria: * unable to provide informed consent * pregnancy * any other active health problems that would render patient unable to complete the study
effectiveness of a web-based prevention program for postpartum depression

Conditions: Depression; Postpartum Depression

Summary: the original trial will evaluate the effectiveness of a web-based program in preventing postpartum depression. the site has been modified to provide materials from both conditions.

depression is a mental health condition in which symptoms such as sadness, inability to feel pleasure, and loss of energy interfere with a person's normal life. postpartum depression is a type of depression experienced by women after giving birth to a child. in this study an intervention for preventing postpartum depression that has been adapted for use over the internet will be tested. administering a depression-prevention program over the internet has several advantages: after the initial investment is made to develop the program, costs are lower for treating each patient; online treatment is more accessible to a greater number of people than any given clinic; and participants who may be worried about a stigma associated with mental health problems often feel more comfortable seeking information through the internet. previous research has shown that symptoms of depression can be reduced through internet-based interventions, but no research has examined such interventions specifically for postpartum depression. the program tested in this study is not aimed at replacing in-person mental health care-in fact, people who have signs of serious depression will be directed to in-person mental health care. instead, the program is aimed at providing an additional mental health service among the range of available options. the original trial was a two-arm pilot prevention of postpartum depression trial comparing the internet-based course called "mothers and babies/mamás y bebés" (m\&b) to informational materials on postpartum depression. in the original trial, 1088 pregnant women were recruited and randomized (as anticipated) to either condition. the study website has therefore been modified such that all participants who consent to participate will now receive materials from both conditions. we have eliminated the randomization procedure. as in the original study, participants be allowed to enroll at any time during their pregnancies and will be followed for 6 months after the birth of their children, so the length of participation will vary between 6 and 15 months. after undergoing a screening process, participants will now have access to both the internet-based course called "mothers and babies/mamás y bebés" (m\&b) and the informational materials. the informational materials will include information about postpartum depression and depression that may occur before childbirth. all participants will be invited via email to complete monthly assessments for the duration of the study. these assessments will measure mood, depression, and satisfaction with the assigned intervention.

Eligibility criteria:
inclusion criteria: * pregnant * fluent in english or spanish

Keywords: postnatal depression cognitive behavioral therapy mood management self-help internet
bicuspid aortic valve stenosis and the effect of vitamin k2 on calciummetabolism on 18f-naf pet/mri

Conditions: Aortic Valve Stenosis; Bicuspid Aortic Valve

Summary: early development of calcified aortic valve disease (cavd) is a commonly occurring complication in patients with a bicuspid aortic valve (bav, an aortic valve consisting of two leaflets instead of three). in general, cavd is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. cavd progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of cavd. the primary objective of our study is to test the hypothesis that supplementation of vitamin k2 will slow down the calcium metabolism in cavd. vitamin k2 is essential in the activation of matrix gla protein (mgp), an important inhibitory factor in the regulation of calcification. in this randomized controlled trial, 44 patients will be allocated to either the vitamin k2 or placebo group. to assess the calcification process in a detailed manner in these patients, a positron emission tomography (pet) scanner using a tracer (18f-fluoride \[naf\]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used. we expect that vitamin k2 supplementation will reduce the calcium metabolism in the aortic valve on 18naf-pet (primary endpoint) and slow progression of cavd as measured by the calcium score on ct and echocardiography after 18 months (secondary endpoints), when compared to placebo.


Eligibility criteria:
inclusion criteria: * known bicuspid aortic valve * calcified mild to moderate aortic valve stenosis on prior echocardiography * informed consent provided exclusion criteria: * absence of calcified aortic valve stenosis on echocardiography * presence of severe aortic valve stenosis * history of aortic valve repair or replacement * accepted atrial fibrillation * use of oral anticoagulants * claustrophobia * presence of a pacemaker, icd or ferromagnetic materials in the body * life expectancy \<2 years * pregnancy (current or wish for near future) * soy allergy * use of vitamin k-containing supplements

Keywords: calcium metabolism matrix gla protein vitamin k2
adjuncts to ivra, a comparison between ketorolac and paracetamol

Conditions: Postoperative Pain

Summary: the study was planned to compare the effect of ketorolac 20 mg to 300 mg of paracetamol when added to lidocaine 3 mg/kg for intravenous regional anaesthesia.

all patients were premedicated 15 minutes before the surgical procedure with i.v. 0.06mg/kg of midazolam. in the operating room, patients were monitored for non invasive blood pressure (nibp), oxygen saturation (spo2) and pulse rate (pr). two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. the operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. a pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm hg above systolic bp. circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers. the solutions were prepared by an anesthesiology assistant not involved in any part of the study. the solutions were injected over 90 s by an anaesthesiologist. during surgery if patient reported pain during operation (vas 4 or greater) inj. fentanyl 1 μg/kg was given and total amount used was recorded. postoperatively patients were questioned for pain and if vas \> 4, 75 mg intramuscular diclofenac was given.total amount used was recorded.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) physical status i or ii, who will be scheduled for surgery of the hand or the forearm were included in this study after informed consent exclusion criteria: * severe raynaud's disease * sickle cell disease * crush injury to the limb * a history of allergic reaction to lidocaine * liver disease or kidney disease * significant cardiovascular disease * highly nervous and uncooperative patients * patient with history of opioid dependence * drug or alcohol abuse * psychiatric disorder * neurological diseases
the effect of the training program given to permanent colostomy patients on self-efficacy

Conditions: Stoma Colostomy; Colo-rectal Cancer

Summary: the planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. it highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.

stomas can be either temporary or permanent. stomas can cause physical issues such as uncontrolled gas output, bad odor, leakage, and local skin irritation, as well as psychological and social problems such as sexual dysfunction, changes in body image, decreased self-esteem, interpersonal relationship issues, depression, anxiety, loneliness, fear, and shame. these problems can reduce individuals' self-care abilities, negatively affect daily living activities, increase their vulnerability to stoma/peristomal complications, and further delay the closure of temporary stomas. regardless of the type of stoma, all of these issues negatively impact patients' self-efficacy. many of these problems and potential complications after stoma formation are preventable. patient education provided through a holistic approach covering pre-operative, post-operative, and home care and follow-up is of great importance in preventing complications and improving patients' adaptation to the stoma. however, a review of the literature reveals that stoma-related education programs typically focus on assessing quality of life and similar factors. some of the studies reviewed include educational content on pre-operative patient preparation and post-operative care, while others focus only on post-operative complication management. however, high-evidence guidelines, such as enhanced recovery after surgery (eras) protocols, emphasize that the first step toward a successful surgical process should be patient education delivered through a holistic approach covering the entire surgical process. therefore, the planned research will be conducted to evaluate the effect of a training program provided to patients with permanent colostomies on self-efficacy.

Eligibility criteria:
inclusion criteria: * • patients scheduled for permanent colostomy following colorectal surgery, * aged 18 years and older, * conscious, with orientation to person, time, and place, * able to speak turkish, * without auditory or visual impairments, * using a phone, were included in the study. exclusion criteria:• patients who could not be contacted during the study period, or those who developed post-operative complications (such as stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.) were excluded from the sample.

Keywords: stoma colo-rectal cancer consulting self-efficacy
application of dce-mri in the diagnosis of brucellar spondylitis

Conditions: Brucella Spondylitis

Summary: brucellosis, also known as mediterranean fever, undulant fever, or malta fever is a zoonotic disease caused by brucella infection.with the rapid development of animal husbandry and aquaculture and increasing consumption of dairy products in urban residents, the incidence of this disease in inner mongolia and even in the mainland area of china is significantly increased. the disease can damage multiple systems including nervous system, circulatory system, reproductive system and bone joints, etc. the sooner the diagnosis of brucellar spondylitis is diagnosed and treated, the better will be the prognosis of the patients which can prevent the development of severe complications and diminish the need for surgical therapy. thus the early diagnosis of brucellar spondylitis was of great significance.we quantitatively analyzed the brucellar spondylitis with dce-mri to explore the application of dce-mri in the early diagnosis of brucellar spondylitis.

about 100 patients with brucellosis were conducted with conventional mri and dynamic contrast-enhanced mri(dce-mri) scan. the variations of the value of ktrans（endothelial transfer constant），kep（reflux rate）,ve(fractional extracellular fluid space volume) and vp(fractional plasma volume) between the vertebral lesions,early lesions of vertebral body and normal tissues were measured and compared. and under the receiver operating characteristic（roc） curve analysis,we will calculate the sensitivity and specificity of ktrans,kep,ve and vp in the diagnosis and early diagnosis of brucella spondylitis .the values of ktrans,kep,ve and vp will be studied between the vertebral lesions and normal tissues, the early lesions of vertebral body and normal tissues.the sensitivity and specificity of both parameters (ktrans、kep、ve、vp)will be done.the valve of dce-mri in the diagnosis and early diagnosis of the brucella spondylitis will be analysed.

Eligibility criteria:
inclusion criteria: the epidemiological exposure history of different extents, accompanied with symptoms including * low fever * night sweats * intermittent lower back pain * movement limitation exclusion criteria: * with other disease like tuberculous spondylitis,vertebral metastases,etc

Keywords: dynamic contrast -enhanced mri brucella spondylitis