Kornimate/medical-research-clean huggingface dataset:
comparing efficacy and safety of inhaled sng001 to placebo

Conditions: Asthma

Summary: when people with asthma get respiratory virus such as a cold or flu it often increases asthma symptoms. the investigators will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs. sng001 contains interferon-beta that occurs naturally in the body. in this study, sng001 will be given by a nebuliser.

the study will consist of a pre-treatment phase into which subjects potentially eligible for the treatment phase will be recruited. subjects will remain in the pre-treatment phase until they experience respiratory virus symptoms at which time they will be further screened for eligibility for entry into the treatment phase. if eligible, subjects will be randomised 1:1 to receive sng001 or placebo once daily for 14 days. doses will be delivered by a ce marked breath actuated nebuliser (i-neb philips respironics). subjects will be assessed for changes in changes in respiratory virus symptoms and asthma symptoms at home using a text message system, and via telephone questionnaire. lung function will be measured both at home by the subjects (pefr only) and in the clinic. efficacy and safety will be monitored until at least 30 days post treatment.

Eligibility criteria:
1. male or female aged 18 to 65 years of age at the time of screening. 2. symptoms of asthma for at least 2 years pri or to the screening visit, confirmed by a medical history and: 1. ≥12% and 200ml bronchodilator reversibility at screening or documented in the past, or, 2. evidence of bronchial hyper-responsiveness at screening or documented in the past, or, 3. a documented hospital admission (including an accident and emergency admission) for asthma since the age of 18, or. 4. documented evidence that they have attended their gp surgery, out-of-hours clinic (or alternative health care provider) for worsening of asthma symptoms, since the age of 18 3. must answer "yes" to the question "does a cold make your asthma worse?" 4. to have had at least one asthma exacerbation suspected to have been caused by a respiratory virus in the last 24 months which required the use of oral steroids and/or additional treatment with antibiotics on one or more occasion. 5. must be taking regular inhaled corticosteroids. 6. pre-bronchodilator fev1 ≥ 40 % predicted at screening. 7. post-bronchodilator fev1 ≥ 50 % predicted at screening. 8. provide written informed consent. 9. females of childbearing potential must be using a medically acceptable adequate form of birth control and agree to maintain this usage throughout the duration of and four weeks post the treatment phase of the study. 10. motivation (in the investigator"s opinion) to complete all study visits, the ability to communicate well with the investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits.

Keywords: asthma
evaluation of exercise application technology in adolescents

Conditions: Type 2 Diabetes; PreDiabetes; Obesity

Summary: the purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and type 2 diabetes. participants will be asked to wear a continuous glucose monitor (freestyle libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.

patients will be recruited directly from the childrens of alabama pediatric endocrine clinic. thirty patients who have obesity, prediabetes or type 2 diabetes will be enrolled. during the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. our study team will approach interested participants during their routine clinic visit. consent will be obtained by study team during their endocrine clinic visit. review of their medical records will be done and age, gender and race will be extracted from the medical record. a baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. once enrolled, the patients will then be randomized.within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. the randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and type 2 diabetes. those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw. intervention group access provided to exercise application provided with fitbit to wear and measure activity weekly check-in with provider to determine how exercise goals have been that week. if unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week. meeting with nutrition at baseline visit continuous glucose monitor provided (plan to wear for 14 days during each month) non-intervention group meeting with nutrition at baseline visit continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)

Eligibility criteria:
inclusion criteria for type 2 diabetes arm * bmi \> 95th percentile * a1c\> 6.5% * age 14-17 (2 years post-menarchal) inclusion for prediabetes arm * age 14-17 (2 years post-menarchal) * a1c 5.7-6.4% inclusion for obesity arm * age 14-17 (2 years post-menarchal) * a1c 5.7-6.4% exclusion criteria for all arms * bmi \<95th percentile * specific obesity syndrome * inability to participate in exercise workouts
the efficacy and safety of temozolomide in patients with mppgl

Conditions: Pheochromocytoma, Metastatic; Paraganglioma, Malignant; Pheochromocytoma Malignant

Summary: metastatic pheochromocytoma / paraganglioma (mpp) are rare while the prognosis was poor. temozolomide (tmz) is a novel oral alkylation chemotherapeutic agent. tmz has been recommended in national comprehensive cancer network (nccn) guidelines version 1.2019 for treating mpp patients.however, studies investigating tmz efficacy in mpp patients are extremely limited. the largest study involved only 15 patients till date. the safety and efficacy of tmz treatment in mpp patients need to be verified in larger studies.

patients with histologically or radiologically confirmed mpp were enrolled. tmz was administered orally at an initial daily dose of 150 mg/m2 per day for 5 days, every 28 days. in patients with a good tolerance during the first cycle, the dose was increased to 200 mg/m2 per day for 5 days, every 28 days. plasma normetanephrine and metanephrine (mns), 24-hour urinary catecholamine excretion (24hca) and neuron specific enolase (nse) were measured at baseline and every 1-3 cycle. contrast-enhanced computed tomography（ct ）of chest, abdomen and pelvis were used to assess measurable target lesions at baseline and every 3 cycles. for patients who only had bone metastases or no measurable target lesions, tmz efficacy was evaluated by 18f-fluorodeoxyglucose (18f-fdg-pet/ct). the primary endpoint was objective response rate (orr) per response evaluation criteria in solid tumors（recist) 1.1/percist1.0. secondary endpoints included biochemical (catecholamine levels) response rate (brr), progression-free survival (pfs) and safety. the investigators will try to explore which patients are more suitable for tmz treatment.

Eligibility criteria:
inclusion criteria: patients with metastatic pheochromocytomas and paragangliomas. subjects with eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. estimated life expectancy longer than 6 months. having normal organ function as defined by hemoglobin levels ≥10 g/dl, absolute neutrophil count ≥ 1.5 x 109/l, platelet count ≥ 80 x 109/l, total bilirubin ≤1.5 institutional upper limit, aspartate aminotransferase ≤5 institutional upper limit, alanine aminotransferase ≤5 institutional upper limit, and serum creatinine \<3.0 mg/dl. exclusion criteria: didn't meet eligibility for organ function. pregnancy or breastfeeding. uncontrolled congestive heart failure and severe infection.

Keywords: pheochromocytoma or paraganglioma metastasis temozolomide
quality of life of patients with desmoid-type fibromatosis

Conditions: Desmoid Tumor; Desmoid-type Fibromatosis

Summary: rationale: desmoid-type fibromatosis (dtf) is a rare, histologically benign, soft tissue tumour. although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. health-related quality of life (hrql) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. additionally, hrql can be in important endpoint for future clinical trials. today, no hrql-tools are available which capture the needs of dtf patients. the hypothesis is that patients with dtf have issues on several hrql domains including physical, social and emotional well-being. for this reason we developed a list of items based on previous research. this study aims to evaluate hrql issues experienced by dtf patients. purpose: multi-centre, cross-sectional, observational study to measure hrql of dtf patients and to evaluate the prevalence of the experienced problems.

objectives: the primary objective is to evaluate hrqol problems in adult dtf patients. the secondary objectives are: 1) to compare the level of hrqol of dtf patients to the general population, 2) to identify patient subgroups who are at risk for developing certain hrqol problems, 3) to evaluate patient preferences regarding their health care needs for dtf. outline: all patients, aged above 18 years, with a histopathological proved dtf tumour and sufficient dutch language skills who have received their last check-up in the hospital within the last five years (april 2014). patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, eortc qlq-c30, dtf-specific questionnaire, and the eq-5d-5l). patients will only have to fill out these questionnaires once.

Eligibility criteria:
inclusion criteria: * aged 18 years and older * histopathological proven dtf, regardless of disease stage or treatment. * diagnosed between january 1990 and july 2020, with a visit to the hospital for their dtf (between october 2014 and july 2020) * sufficient dutch language skills * competent to complete a questionnaire * written informed consent exclusion criteria: • familial adenomatous polyposis (fap)

Keywords: health-related quality of life quality of life
exclusive enteral nutrition vs. infliximab in chinese cd patients

Conditions: Crohn's Disease; Exclusive Enteral Nutrition; Infliximab; Mucosal Healing

Summary: prospectively compared exclusive enteral nutrition with infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on chinese children with active crohn's disease


Eligibility criteria:
inclusion criteria: patients: 1. pediatric active crohn's disease ( cd) patients who were newly diagnosed at the children's hospital of fudan university from october 2020 to sep 2022，cd was diagnosed according to the porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography). 2. ses-cd\>4 and pcdai \>10 at initial 3. for the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment. healthy controls: 1. free medical history 2. had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal exclusion criteria: 1. patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or eb infection 2. for patients in the een group who could not finish the daily prescribed volume of formula for any reason; for the patients in the ifx group who could not finish the first 4 times ifx injection for any reason. 3. patients who were administered een, corticosteroids, immunosuppressive drugs, or biological agents prior to the study; 4. patients who could not attend consecutive follow-up sessions;
a study of microbiome transplantation for the treatment of constipation in patients with systemic sclerosis

Conditions: Constipation

Summary: the purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (prim- dj2727), to characterize the microbiome (α-diversity and β-diversity) and metabolome in patients with systemic sclerosis (ssc)related constipation, to examine improvement in constipation after microbiome transplant by comparing post-treatment with pre- treatment fecal samples and patient-reported outcome measures, to examine improved colonic transit after microbiome transplant , to examine subjective global improvement and improvement in ssc disease characteristics, to monitor change for change in concentration in systemic and fecal inflammatory markers to monitor for change in fecal short-chain fatty acids and metabolome and to provide data that will be used to determine the appropriateness of designing a properly powered clinical trial of microbial restoration treatment in the ssc population


Eligibility criteria:
inclusion criteria: * are seen in the ut houston scleroderma center (uthsc) * meet 2013 american college of rheumatology (acr)/european league against rheumatism (eular) criteria or crest criteria for ssc * meet rome iv criteria for constipation * subject willing to sign an informed consent form * subject deemed likely to survive for ≥ 1 year after enrollment * able to follow study procedure and follow-up * sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period * female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure * subjects who agree to adhere to a stable diet during the study * subjects must have an attending physician who will provide non-transplant care for the subject exclusion criteria: * subjects with constipation from causes not attributed to ssc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes or hypothyroidism, etc.) * subjects unwilling to stop taking probiotic supplements during the duration of the study * subjects who have diarrhea defined as loose, watery stools three or more times a day * subjects that have post-total or hemicolectomy or the presence of a colostomy * subjects unable to (a) tolerate microbiome transplant via enema for any reason or (b) swallow capsules * subjects requiring systemic antibiotic therapy 4 weeks before the study * if subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment

Keywords: systemic sclerosis
prescription-based fluid management versus usual care in critically ill patients on krt trial in uk

Conditions: Acute Renal Failure on Dialysis (Disorder)

Summary: the probe fluid uk randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.

severe acute kidney injury (aki) in the intensive care unit (icu) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. congestion resulting from fluid accumulation is believed to contribute to organ failure. removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (krt). however, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. if fluid is removed too slowly, fluid overload and its complications persist for longer. if fluid is removed too fast during krt, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications. the optimal fluid management strategy is currently unknown. the probe fluid uk study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with aki receiving krt. the fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. the primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to krt delivery.

Eligibility criteria:
inclusion criteria: 1. adult patients aged ≥18 years 2. admitted to the intensive care unit 3. acute kidney injury defined by the kdigo criteria 4. planned initiation of krt within 12 hours or the receipt of krt for aki for ≤48 hours exclusion criteria: 1. lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating clinician 2. probable discharge from the icu within 48 hours according to treating clinician 3. severe burn injury (\>10% of body surface area) 4. severe abnormality in serum sodium (\>155 or \<120 mmol/l) 5. important ongoing fluid losses are present and/or are expected to require continued maintenance iv fluids during the next 48 hours 6. the clinical care team believes that the proposed intervention is inappropriate

Keywords: acute kidney injury dialysis fluid removal
utsw norc pilot spinal cord injury dietary program

Conditions: Obesity and Obesity-related Medical Conditions; Spinal Cord Injury, Chronic

Summary: the goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the national diabetic prevention program (modified dpp-diet) in people with spinal cord injury on body composition and insulin sensitivity. the main question it aims to answer is: does 9 week modified dpp-diet reduce body fat percentage and insulin resistance? participants will: have 9 weeks of telehealth visit with dietician certified in providing dpp. visit the laboratory before, immediately and 9 weeks after completion of the modified dpp-diet. share with the researcher on the perceived benefit and obstacles in implementing the modified dpp-diet as part of their daily activities.


Eligibility criteria:
inclusion criteria: * age 18-65 years old * have had sci for more than one year * not independently ambulatory * primarily uses a wheelchair for mobility * community-dwelling * without comorbidities listed in the exclusion criteria exclusion criteria: * uncontrolled type 2 diabetes mellitus * pregnancy * active systemic disease, e.g., heart disease, real failure/insufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism.

Keywords: spinal cord injuries obesity insulin resistance
a phase 2 study of pf-00232798 in hiv positive patients

Conditions: HIV

Summary: to assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of pf 00232798 in hiv-positive patient volunteers.


Eligibility criteria:
inclusion criteria: * asymptomatic hiv-1 infected male patients between the ages of 18 and 55 years inclusive. * patients with ccr5 tropic virus as determined by the monogram phenosense entry assay. exclusion criteria: * patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another ccr5 antagonist. * patients with evidence of decompensated liver disease.

Keywords: treatment experienced treatment naive
developing a copd case finding methodology for primary care

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk copd cases in primary care and support content validity of the measure. this work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. specific objectives are as follows: objective 1: to elicit concepts and symptom descriptions of copd from patients with a recent diagnosis of copd and those without a diagnosis but with risk factors for the disease. the qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk copd cases in various clinic settings. objective 2: to review the new questionnaire with a new set of participants with a recent copd diagnosis or those at risk for copd to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. this will be done through one-on-one cognitive interviews. objective 3: to gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of copd and the consistency of readings between electronic and mechanical readings in these patients. this information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.


Eligibility criteria:
inclusion criteria: * 1. age ≥40 years * 2. current smokers (\>10 pk yrs.) or ex-smokers with a history of \>10 pk yrs. or never-smokers, defined as ≤100 cigarettes/pipes/cigars over life * 3. stable state pft values from within the last 12 months available or obtainable * 4. willing and able to attend the focus group session or cognitive interview * 5. able to read and speak in english * 6. willing and able to provide written informed consent exclusion criteria: * 1. cognitive impairment, hearing or sight difficulty, or severe psychopathology that could interfere with ability to participate in the study * 2. patient was hospitalized for respiratory infection within the past 30 days