Kornimate/medical-research-clean huggingface dataset:
health outcomes of parents with cystic fibrosis

Conditions: Cystic Fibrosis; Parenthood Status

Summary: this project will determine the health impact of parenthood on people with cystic fibrosis (cf). the study team will use retrospective data to provide relatively immediate evidence on parenthood's effect on pulmonary health.

this co-funded study sponsored by the national institutes of health and the cf foundation (cff) will seek to determine the health impact of parenthood on people with cf in the era of cf transmembrane conductance regulator (cftr) modulators. to provide relatively immediate evidence on parenthood's effect on pulmonary health and the influence of the introduction and use of all available cftr modulators, in aim 1 the study team will assess changes in pre- vs. intra-parenthood percent predicted forced expiratory volume in 1 second (ppfev1) in a retrospective longitudinal cohort study linking cff patient registry (cffpr) data with cross-sectional surveys collected from 249 new parents attending participating united states cf centers between 2012-2022. the study team will identify predictors and timing of lung function loss using 747 non-parents from participating centers as a comparison group and examine the impact of cftr modulators on parental health.

Eligibility criteria:
inclusion criteria: * confirmed cf diagnosis with sweat or genotype analysis * participant in the cffpr * became a first-time parent between the years 2012-2022 (exposure arm only) exclusion criteria: * lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control) * does not speak/read english or spanish

Keywords: cystic fibrosis parenthood highly-effective modulator therapy
the impacts of mindfulness on psychological wellbeing among nursing students

Conditions: Students

Summary: the aims of this study are to develop a mindfulness-based course for nursing students. as well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students.

a quasi-experimental study design will be used to examine the effects of a new elective course. convenient sampling will be used to invite nursing students at a university of science and technology in taiwan. the data will be collected four seven times, including baseline (t0), the end of the course (t1), before and after the nursing practicum (t2, t3). participants who enroll in an elective course in mindfulness education constitute the experimental group, while those who do not enroll in the elective form the comparison group. the total number of participants will be 240. participants will be excluded if they are unwilling to participate in the study or do not complete the consent form. intervention: the experimental group will enroll in the elective course named "mindfulness and happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. the comparison group will not participate in this course. the elective course is designed using the addie model (analysis, design, development, implementation, evaluation) and is based on mindfulness-based stress reduction principles.

Eligibility criteria:
inclusion criteria: * nursing students who participated in the elective mindfulness course exclusion criteria: * under 18 years

Keywords: mindfulness empathy stress anxiety competency
single-arm study to assess a potential effect of anti-il-17 (secukinumab) in the treatment of pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: the purpose of this study is to explore the efficacy and safety of anti-interleukin-(il)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.


Eligibility criteria:
* key inclusion criteria: * confirmed diagnosis of pyoderma gangrenosum * biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location * characterization of target lesion (size, pga, duration) * 18-75 years of age * body weight ≥ 40 kg and ≤ 160 kg * signed informed consent * key exclusion criteria: * permanent severe diseases, especially those affecting the immune system * pregnancy or breast feeding * history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia * myocardial infarction or cardiac arrhythmia which requires drug therapy * evidence of severe renal dysfunction or significant hepatic disease * history of irritable bowel disease * history of lymphoproliferative disorders * evidence for active infection including but not limited to active tuberculosis, hiv or hepatitis b/c that in the opinion of the investigator would compromise the patient's ability to tolerate therapy * history of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
"juego de llaves": study protocol of a universal school-based drug use prevention program (psidup)

Conditions: Behavior, Addictive; Adolescent - Emotional Problem; Alcohol Abuse; Smoking Behaviors; Adolescent Behavior; Psychological

Summary: "juego de llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. the outcome evaluation is critical to determine the quality of preventive interventions. this protocol describes the full protocol of the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. method: non-randomized control cluster trial in a set of spanish school centers at the compulsory secondary education level, with follow-ups at 12-, 24- and 36-months. participants will be allocated to an experimental or control (no intervention) group. using an electronic ad-hoc designed app, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. a piloting test will be conducted to test the implementation protocol and to calculate the sample size needed for the outcome evaluation. after implementing the program, longitudinal statistical approaches will be used to inform on the intervention efficacy and potential moderators and mediators. there is a lack of effectiveness assessments of school prevention programs, and it is expected that this protocol will expedite the monitoring and ongoing evaluation in prevention.


Eligibility criteria:
inclusion criteria: * schools having secondary education. * schools located in spain. * schools willing to participate under the conditions of the study before randomization. exclusion criteria: * schools having other interventions with a strong package on substance use prevention targeted the same grades.

Keywords: adolescents addictive behaviors evaluation universal school-based prevention transdiagnostic approach
a pilot study of switching from one pain medication to another (opioid rotation)

Conditions: Pain

Summary: the purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (opana®), will be helpful to patients. this study will examine if the switching from one pain medication to another can be done over a 24 hour period. oxymorphone, the drug being studied, is an fda approved drug for treatment of severe pain.


Eligibility criteria:
inclusion criteria: * age of 18 to no upper limit * chronic pain of nociceptive, neuropathic, or mixed origin * patients with chronic non cancer pain * ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone) * pain of moderate intensity (\>4, on the numerical scale 0-10) despite ongoing opioid therapy\> * non-pregnant, non-lactating women * sufficient language skills to communicate with research staff exclusion criteria:non-ambulatory patients * clinically significant respiratory, renal, hepatic, or cardiac disease. * documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea) * history of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors * severe depression (\> 26 on the bdi) * patients who exhibit a score on the mini mental status exam (mmse) of 26 or less. (the range of scores for mild dementia is 21-26 on the mmse). * workman compensation, current or pending medical-legal litigation * hypersensitivity to study medication (oxymorphone)

Keywords: sciatica diabetic neuropathies complex regional pain syndromes low back pain neck pain headache back pain arthritis brachial plexus injury (stinger/burner) chronic pain contractures diabetes fibromyalgia foot pain fracture hip herpes zoster (shingles) migraine neuropathic pain osteoarthritis osteoporosis rheumatoid arthritis scoliosis nerve pain opana opioid opioid rotation oxymorphone morphine neuropathic oxycodone
progression of bicuspid-related aortopathy in patients undergoing transcatheter aortic valve implantation (prospero-tavi)

Conditions: Bicuspid-related Aortopathy; Aortic Stenosis

Summary: transcatheter aortic valve implantation (tavi) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (bav) are commonly treated in daily tavi practice. indeed, several observational studies reported similar outcomes of tavi in bav patients compared to tricuspid aortic valve (tav) patients. notably, bav is frequently associated with aortic dilatation (20% to 84% of bav patients). surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). tavi patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after as treatment (6,7). the main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing tavi by computed tomography angiography (cta) assessment at follow-up.


Eligibility criteria:
inclusion criteria: * patients undergoing tavi with native bav from january 2018 to december 2019 exclusion criteria: * patients undergoing tavi without native bav * patients receiving first generation tavi device * patients undergoing tavi before january 2018 or after december 2019

Keywords: bav tavi aortopathy
extension study to evaluate nbi-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep

Conditions: Epileptic Encephalopathy; Continuous Spike and Wave During Sleep

Summary: the primary objective for this study is to evaluate the long-term safety and tolerability of nbi-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (eecsws).

this study will enroll participants who completed treatment in the phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study nbi-827104-csws2010 (nct04625101). participants who did not participate in study nbi-827104-csws2010 may also be eligible for enrollment.

Eligibility criteria:
key inclusion criteria: for participants who enroll directly following the completion of the study nbi-827104-csws2010: * completed 12 weeks of treatment in study nbi-827104-csws2010. for participants who do not enroll directly from or did not participate in study nbi-827104-csws2010: * have diagnosis of eecsws confirmed by the diagnosis confirmation panel (dcp). key exclusion criteria: for participants who enroll directly following the completion of the study nbi-827104-csws2010: * have developed any other disorder for which the treatment takes priority over treatment of eecsws or is likely to interfere with study treatment or impair treatment compliance. for participants who do not enroll directly from or did not participate in study nbi-827104-csws2010: * body weight \<15 kg at day 1. * clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator. * presence of relevant neurological disorders other than eecsws and its underlying conditions as judged by the investigator. symptomatic conditions underlying eecsws (for example, neonatal strokes) have to be stable for at least 1 year prior to screening. * planned surgical intervention related to structural abnormalities of the brain from screening through the week 6 visit. * used any active investigational drug other than nbi-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than nbi-827104) during the study. * have developed any other disorder for which the treatment takes priority over treatment of eecsws or is likely to interfere with study treatment or impair treatment compliance.

Keywords: epilepsy epileptic encephalopathy neurocrine nbi-827104 steamboat 2
predicting the development of myocardial depression in acute neurological patients

Conditions: Myocardial Depression; Takotsubo Syndrome; Subarachnoid Hemorrhage; Acute Ischemic Stroke

Summary: the purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (md) in patients with acute neurological injury.

the purpose of this study is to investigate the level of plasma catecholamines, associated with myocardial depression (md) as noted on transthoracic echo (tte) by evidence of wall motion abnormalities (wma) with or without drop in ejection fraction or symptomatic heart failure (hf). takotsubo syndrome (tts) is commonly diagnosed after the onset of hf once patients become symptomatic. the investigators intend to study whether early md can be detected by identifying certain levels of plasma catecholamines and whether the level correlates with severity of myocardial depression. identification of early md changes can lead to alteration of management strategies and may help prevent worsening of hf. highly selected patients with subarachnoid hemorrhage (sah) or acute ischemic stroke (ais) requiring induced hypertension with the use of norepinephrine infusion will be recruited to enroll in this pilot study. this group of patients are expected to have high circulating catecholamines and are more likely to develop md. given the prevalence of tts in females and elderly, 10 female patients \>50 years admitted to the neuro icu with diagnosis of either ais or sah will be enrolled. patients with history of coronary artery disease, smoking, poorly controlled diabetes with hba1c \>8 and uncontrolled hypertension will be excluded. patients with poor echo windows will also be excluded. baseline plasma catecholamine levels, transthoracic echo(tte), troponin t, ekg and bnp will be obtained and will be followed daily through the study duration.

Eligibility criteria:
inclusion criteria: * female patients \>50 years admitted to the neuro icu with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage * only patients predicted to be on norepinephrine infusion for at least 48 hrs will be selected. exclusion criteria: * patients with known history of heart failure will be excluded * patients with history of coronary artery disease, smoking, poorly controlled diabetes with hba1c \>8 and uncontrolled hypertension will be excluded. * patients with poor echo windows will be excluded
performance of xpert mtb/rif and xdr assay for diagnosis of pulmonary tuberculosis and resistant pulmonary tb

Conditions: Tuberculosis, Pulmonary

Summary: to determine how accurate xpert mtb/rif and xdr for diagnosis of pulmonary tb and rifampicin resistance

tuberculosis (tb) is one of the major public health threats, competing with the human immunodeficiency virus (hiv) as the cause of death due to infectious diseases worldwide. tuberculosis (tb) is the leading cause of death by a single pathogen worldwide. in 2019, 1.2 million people died from tb among hiv-negative patients, 208 000 among hiv-positive patients and 10 million were estimated to have fallen sick, although only 70% were diagnosed the gap between tb notifications and estimated existing cases is still unacceptable. the low tb case detection rate in many high-burden settings urgently demands effective strategies and tools to identify tb patients and ensure their linkage to healthcare mdr multidrug-resistant tuberculosis (mdr-tb), caused by mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs * according to current world health organization and the international union against tuberculosis and lung disease estimates, the median prevalence of mdr-tb has been 1.1% in newly diagnosed patients. the proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-tb treatment. * xdr tuberculosis is caused by a strain of mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines mdr tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin

Eligibility criteria:
inclusion criteria: * 1. patients with respiratory symptoms suggestive of pulmonary t.b 2. patients who were able to collect a sputum sample were included in the study 3. patients with positive xpert mtb/rif for xdr assay exclusion criteria: * patients who were unable to collect a sputum sample patient with negative xpert mtb/rif for xdr assay patients with extrapulmonary tb patients with positive culture for mott
intermittent fasting in multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is a randomized controlled trial that will test the effects of intermittent fasting (if) in subjects with relapsing-remitting ms (rrms). the goal of this clinical trial is to acquire objective evidence regarding whether an if diet has beneficial effects in ms patients.two dietary regimens, if and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in rrms patients. this is a single-center study.

rrms patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which if will be compared to a standard western diet. patients will be recruited at the john l. trotter ms center and randomly assigned to either a standard western diet or an if diet (1:1). enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). the primary outcome will be leptin at week 12 measured in the peripheral blood. secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.

Eligibility criteria:
inclusion criteria: * diagnosis of rrms (2010 mc donald criteria). * edss \<6.0 and disease duration ≤ 15 years. * on an injectable therapy for ms, glatiramer acetate (ga) or beta-interferon (beta-ifn) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration. * age ≥18 years. * bmi \> 22 and \< 35 kg/m2 with stable weight in the 3 months prior to screening. exclusion criteria: * history of any chronic disease process (excluding ms) that could interfere with interpretation of results. * diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating). * relapsing at the time of enrollment. * on corticosteroid treatment (oral or intravenous) in the past month. nasal corticosteroid treatments are allowed. * diagnosis of diabetes or at time of ogtt (fasting glucose \>126 mg/dl or \> 200 mg/dl at 2 hours with a load of 75 g of glucose * history of food allergies or food intolerance that would interfere with the study. * history of antibiotic treatment within the past 3 months prior to enrollment * use of anticoagulant drugs (like warfarin or coumadin) that need to monitor their intake of vegetables containing high levels of vitamin k. * currently on a special diet and not willing to stop at least one month prior to enrollment * currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment * currently pregnant or plan to become pregnant within 6 months * current tobacco or e-cigarette smoker

Keywords: multiple sclerosis intermittent fasting western diet microbiome
two different graft harvesting techniques applied in localized gingival recessions

Conditions: Gingival Recession, Localized; Sensitivity, Tooth; Attachment Loss, Periodontal

Summary: the primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. in addition, it is aimed to compare the postoperative gingival thickness between the two techniques. the secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists physical status class 1 and 2 patients,healthy patients 2. nonsmokers 3. periodontally healthy patients 4. localized gingival recessions (miller i, ii, and cairo i recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth exclusion criteria: 1. medically compromised patients, especially uncontrolled diabetes 2. pregnancy, lactation, or suspicion of pregnancy, 3. poor oral hygiene 4. recessions associated with caries or restoration
epidemiology, costs and psychosocial consequences of genital warts in valparaiso, chile

Conditions: Condylomata Acuminata

Summary: this is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of valparaiso, chile. the objectives are: to have an epidemiological profile, estimating cost of the disease for the health system and the patient and analyzing possible psychosocial consequences of the condition for the patients.


Eligibility criteria:
inclusion criteria: * men and women 18 years of age or older * having being diagnosed with genital warts * consulting the sexual health clinic only for genital warts * patients accepting to be included in the study exclusion criteria: * immunodeficiency * hiv positive * having being diagnosed with cancer or pre-cancerous lesions * pregnancy * presenting a sexual transmissible infection other than genital warts.

Keywords: genital warts