Kornimate/medical-research-clean huggingface dataset:
study of nasonex® for the treatment of nasal polyps in pediatric subjects between ages of 6 and less than 18 years old (p04292)

Conditions: Nasal Polyps

Summary: the purpose of this study is to evaluate the safety and efficacy of nasonex® (mometasone furoate nasal spray(mfns)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. safety will be the primary focus of this study.


Eligibility criteria:
inclusion criteria: * a subject must be 6 to \<18 years of age, of either sex, and of any race. * a subject must have a diagnosis of bilateral nasal polyps. * a subject must have a minimum nasal congestion/obstruction * an asthmatic subject may be included. * a subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. * the subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules. * a female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to screening and must continue using it while receiving protocol-specified medication. if a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit exclusion criteria: * a subject with antrochoanal polyps. * a subject with cystic fibrosis. * a subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the screening visit. * a subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. * a subject who is immunocompromised. * a subject with ongoing rhinitis medicamentosa. * a subject with churg strauss syndrome. * a subject with dyskinetic ciliary syndromes, eg, young's syndrome (sinopulmonary infections and obstructive azoospermia) or kartagener's syndrome (immotile cilia). * a subject with any clinically significant pretreatment laboratory, vital sign, or ecg abnormality. * a subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients. * a subject who has not observed the medication washout times outlined in the protocol prior to the screening visit. * a female subject who is breast-feeding, pregnant, or intends to become pregnant. * a subject who has used any investigational drug within 30 days of screening. * a subject who is part of the staff personnel directly involved with this study.
effects of inspiratory muscle training on type 2 diabetes mellitus patients with inspiratory muscle weakness

Conditions: Diabetes Complications; Inspiratory Muscle Weakness

Summary: the purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.

in congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. in type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. for this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.

Eligibility criteria:
inclusion criteria: * diabetes melittus * sedentary * inspiratory muscle weakness with pimax \< 70% of the predicted exclusion criteria: * mass index \> 33 kg/m2 * exercise-induced asthma history * infectious disease * osteoarticular disease * regular alcohol or tobacco consumption in the past 6 months * cardiac disease * pulmonary disease

Keywords: inspiratory muscle weakness autonomic modulation diabetes mellitus heart rate variability functional capacity
spark neuro remind study

Conditions: Alzheimer Disease; Cognitive Impairment

Summary: the study utilizes investigational software, the spark test, with an fda-cleared electroencephalography (eeg) amplifier and eeg cap to collect and then analyze patient eeg data.

the aim of this study is to develop an algorithm and then evaluate it to determine whether applying machine-learning techniques to resting-state electroencephalography (eeg) can characterize patient's cognitive status and detect the presence or absence of ad on the basis of the patient's eeg.

Eligibility criteria:
inclusion criteria: 1. age 55 to 85 at the time of consent 2. informant available and willing (remotely or in-person) to provide information about sleep patterns and cognitive functioning who spends \>8 hours per week with primary subject 3. subject or legally authorized representative (lar) has the ability to provide informed consent and comply with the protocol. exclusion criteria: 1. unable to remain still for up to 30 minutes during eeg data recording 2. subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) thc; 10) anticholinergics 3. previous history of stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage 4. medical or psychiatric illness that would interfere with study participation 5. history of epilepsy or chronic seizure disorder 6. presence of non-dental metal in head 7. currently experiencing a skin disease on scalp that would affect electrode contacts 8. tics score indicative of cognitive impairment at screening 9. substance use disorder, including alcohol

Keywords: eeg electroencephalography machine learning
pilot study of velcade® in iga nephropathy

Conditions: Chronic Kidney Disease; IgA Nephropathy

Summary: the primary objective of this study is to investigate the ability of velcade® (bortezomib) to induce complete or partial remission in patients with severe iga nephropathy. the secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.

this exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe iga nephropathy. subjects will receive 1 cycle of velcade® to induce clinical remission. follow-up visits will occur monthly for a year. for this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older. 2. must have iga nephropathy documented by kidney biopsy. 3. must have greater than 1gm of proteinuria a day. 4. must be on a stable dose of angiotensin converting enzyme inhibitor (acei) and/or angiotensin receptor blocking agent (arb) for at least 4 weeks prior to screening. exclusion criteria: 1. low platelet count and neutrophil count within certain limits defined for enrollment. 2. underlying peripheral neuropathy. 3. having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 4. allergic to velcade®, boron or mannitol. 5. female subjects who are pregnant or breast-feeding. 6. recent use of investigational drug within 14 days before enrollment. 7. having serious medical conditions and infections (including hiv,or hepatitis b or c) or psychiatric illness likely to interfere with participation in the study. 8. diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.

Keywords: chronic kidney disease iga nephropathy velcade® proteinuria bortezomib proteasome inhibitor
the benefit of 5% ivig for patients with primary immunodeficiency disorders who experience adverse events on 10% ivig preparations

Conditions: Primary Immunodeficiency

Summary: patients with primary immunodeficiency disorders (pid) on intravenous immunoglobulin (ivig) treatment may experience adverse events (aes). patients who experience aes on any 10% ivig solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of aes on a lower concentration ivig product.

patients with pid require life long immunoglobulin (ig) replacement therapy with ivig being the most common form. as more 10% ivig products are fda approved, the older and well characterized 5% ivig products are becoming less used. currently, the standard of care for patients who experience aes on ivig is to move to a subcutaneous (scig) delivery and product. this study will evaluate the aes on a 10% product and octagam 5%. the study will enroll 15 patients after an ae on any 10% product who will then be infused with octagam 5% for six infusions. aes will be documented and compared to the 10% product along with changes in biomarkers. the study data may document another therapeutic option for patients who experience aes - scig and octagam 5%.

Eligibility criteria:
inclusion criteria: * participants, or legal guardians with assent by underage children, will sign informed consent/assent and are willing to comply with all aspects of the study * diagnosis of cvid according iuis expert committee * participants on a 10% product who experience aes * ages between 10 and 75 years of age * participants on 10% ivig therapy every 21±3 days or 28±3 days between 300 - 800 mg/kg body weight exclusion criteria: * acute infection requiring antibiotic therapy within 7 days prior to visit 1 * presence of any condition that is likely to interfere with the evaluation of the study medication or satisfactory conduct of the trial * history of anaphylactic or severe systemic reactions to human immunoglobulin * iga deficient patients with antibodies against iga and a history of hypersensitivity * females who are pregnant or lactating
metastatic breast cancer-specific prognostic tool

Conditions: Metastatic Breast Cancer

Summary: in this qualitative study, investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. these interviews will be conducted by the unc chai core and will continue until thematic saturation (estimated 20-30 participants). the investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the consolidated framework for implementation research (cfir). the information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

if this study is successful, investigators will implement an mbc-specific prognostic tool to help clinicians identify patients who are at high risk of death in the next 30 days. based on the input from clinicians in this proposal, as well as additional qualitative studies with patients and families, investigators will design an implementation protocol to inform how to use this tool in clinical practice. rather than simply publishing a prognostic tool that may not be adopted into practice, this project aims to ensure successful implementation of an evidence-based tool into the routine care of patients with mbc. doing so will serve as an important step towards identifying high-risk patients and connecting ort to ensure high-quality, patient-centered end-of-life care.

Eligibility criteria:
inclusion criteria: 1. in order to participate in this study a subject must meet all of the eligibility criteria outlined below. 2. subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. 3. diagnosis of metastatic breast cancer or primary caregiver for someone with a diagnosis of metastatic breast cancer 4. age \> 18 years 5. verbal informed consent obtained to participate in the study. 6. subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. exclusion criteria: 1. non-english speaking -

Keywords: patients end of life caregivers
individualized tumor-informed ctdna analysis for monitoring postoperative recurrence in escc (neocrtec2401)

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor dna (ctdna) and recurrence risk using a novel, tumor-informed ctdna detection technique, thus laying the foundation for further promoting ctdna detection to guide postoperative adjuvant therapy decisions. this study focuses on patients with esophageal squamous cell carcinoma who did not achieve pcr following neoadjuvant therapy combined with surgical resection. the main question it aims to answer is: is there a correlation between postoperative ctdna changes and tumor recurrence? participants will be asked to undergo postoperative ctdna detection.


Eligibility criteria:
inclusion criteria: 1. operable locally advanced esophageal squamous cell carcinoma; 2. have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pcr after r0 resection; 3. can tolerate postoperative adjuvant immunotherapy; 4. sufficient baseline tumor tissue and blood samples available for ngs testing; 5. eastern cooperative oncology group (ecog) performance status score of 0-1; 6. consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures 7. expected postoperative survival time of ≥ 6 months. exclusion criteria: 1. concurrent other malignant tumors; 2. lack of a detailed histopathological diagnostic report for determining the nature of the lesion; 3. severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results; 4. any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation; 5. unable to undergo long-term, regular postoperative follow-up at the current medical institution; 6. unwilling or unable to comply with the study protocol.

Keywords: ctdna recurrence detection esophageal squamous cell carcinoma
edmonton symptom assessment scale: self-completion vs. assisted-completion

Conditions: Advanced Cancers

Summary: the goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.

if participant agrees to take part in the study, basic information about them will be collected from their medical record (such as their age, gender, ethnicity, religion, diagnosis, marital status, educational level, performance status, and any drugs they may have taken in the past or are currently taking). participant will also be given a list of words and asked to read them out loud. the research nurse or assistant will write down if participant pronounced the words correctly. this should take up to 7 minutes. participant will then be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. this is done because no one knows if one study group is better, the same, or worse than the other group. * if participant is enrolled in group 1, they will complete the symptom questionnaire alone and then a research nurse or assistant will go over their answers with them. * if participant is enrolled in group 2, they will complete the symptom questionnaire with the help of the research nurse or assistant. after participant has completed the symptom questionnaire, they will be asked if they preferred completing the questionnaire alone or if they preferred to have a nurse help them answer the questions. this should take about 1 minute to answer. length of study: it should take about 15 minutes total to complete the study. patient's participation on this study will end after they have completed the symptom questionnaire. additional information: participant is taking part in this study alone. participant's family members will not be in the room with them. this is an investigational study. up to 128 participants will be enrolled in the study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer 2. patients must know their cancer diagnosis 3. patients referred for consultation to the supportive care team 4. age \>/= 18 5. patients must be able to understand, read, write, and speak english 6. patients have never done the esas before 7. patients must sign an informed consent 8. ability to independently complete the study as assessed by the research staff exclusion criteria: 1. patients who have clinical evidence of cognitive impairment as determined by the research staff 2. patients who have already done the esas in the past. 3. patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff 4. patients who refuse to participate in the study.

Keywords: advanced cancers recurrent locally advanced metastatic edmonton symptom assessment scale esas survey interview symptom questionnaire
consequences of obstructive sleep apnea on respiratory function following weight-loss surgery

Conditions: Obstructive Sleep Apnea; Obesity

Summary: the investigators propose to compare two different treatments, continuous positive airway pressure (cpap) versus breathing of atmospheric pressure, in subjects with obstructive sleep apnea (osa)recovering from weight loss surgery in the post anesthesia care unit (pacu). we hypothesize that subjects with osa will have a higher apnea-hypopnea index (ahi) with desaturation and the investigators expect that post-operative cpap treatment in the pacu will significantly improve the ahi and therefore improve patient safety in the pacu. the investigators also hypothesize that subjects with osa have a greater decrease in oxygen saturation in response to opioid administration by patient-controlled opioid analgesia (pca).

patients with morbid obesity have an approximately 60-80 percent incidence of osa depending on the criteria used for making diagnosis, and they are suggested to be at increased risk to develop serious perioperative complications, especially during the postoperative period. weight loss might be considered as an appropriate treatment of osa but in turn it has recently been reported that osa is an independent risk factor for development of perioperative complications, importantly oxygen desaturation, in patients undergoing weight loss surgery. it seems logical to evaluate if these patients would benefit from post-operative cpap treatment in the pacu. the results of this multidisciplinary study will have an impact on pacu treatment of patients with osa and will further optimize patient care at mgh.

Eligibility criteria:
inclusion criteria: * patients scheduled for weight loss surgery at massachusetts general hospital * male and female subjects * age ≥ 18 years exclusion criteria: * cns disease with impairment of cognitive function and/or muscle paresis such as stroke, or dementia * age \< 18 years * missing or insufficient psg data to make diagnosis osa * impaired decision making capacity

Keywords: obstructive sleep apnea obesity respiratory function weight loss surgery
tension-type headache and masseter thickness in fibromyalgia

Conditions: Fibromyalgia

Summary: this study aims to investigate the relationship between tension-type headaches and masseter muscle thickness in women with fibromyalgia syndrome (fms) and to explore the potential for new therapeutic approaches in the treatment of both headaches and fms. additionally, the study seeks to evaluate the impact of headaches on the quality of life in individuals with fms. does tension-type headache associate with increased masseter muscle thickness in women with fibromyalgia syndrome (fms)? does tension-type headache negatively impact the quality of life in women with fms?

fibromyalgia syndrome (fms) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, cognitive dysfunction, and tenderness, affecting approximately 5% of the global population, predominantly women. central sensitization plays a key role in its pathophysiology. tension-type headaches, the most common in fms (59.01%), are associated with pericranial muscle sensitivity, anxiety, and reduced quality of life. increased masseter muscle activity has been observed in tension-type headaches, but its relationship with fms remains unexplored.

Eligibility criteria:
inclusion criteria: * women aged 18-65 years. * diagnosed with fibromyalgia syndrome (fms) according to the 2016 american college of rheumatology (acr) diagnostic criteria. * at least one year since the fms diagnosis. * chronic tension-type headache lasting for at least six months. * diagnosed with tension-type headache by a neurologist based on the international classification of headache disorders (ichd-3) criteria. exclusion criteria: * patients with neurological or psychiatric disorders. * patients using medications related to the central nervous system. * those with temporomandibular dysfunction. * patients with rheumatologic diseases. * individuals undergoing dental treatment or using dental prostheses. * those with facial tumors or a history of facial surgery. * pregnant women.

Keywords: tension type headache masseter muscle
the impact of therapy dogs on anxiety and emotional management in the pediatric emergency department

Conditions: Anxiety; Emotional Regulation

Summary: the purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.


Eligibility criteria:
inclusion criteria: * children with a sud score of 30 or higher indicated by the caregiver exclusion criteria: * active infection: abscesses, fever, respiratory issues, vomiting * patients presenting for burn care, dog bite, esi triage category 1 or 2, or transferred from outside facilities * sterile procedures * oncology patients / patients with known neutropenia in past medical history * parent/caregiver or patient fear of dogs * parent/caregiver or patient allergy to dogs * dog bite injury * already underwent procedure during their visit

Keywords: pediatric emergency medicine therapy animals animal assisted therapy anxiety emotional regulation