Kornimate/medical-research-clean huggingface dataset:
clinical genetics and screening for idiopathic pulmonary fibrosis

Conditions: Familial Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Summary: background: idiopathic pulmonary fibrosis (ipf) is the most common and severe form of interstitial lung disease. between 2% and 20% of patients with ipf have a family history of the disease, which is considered the strongest risk factor. therefore, genetic testing has been increasingly considered as a potential tool to identify patients at risk of developing ipf. according to some studies, genetic testing (particularly of muc5b and tert mutations) could be useful to rapidly identify unidentified and/or asymptomatic individuals (in families as well as in the general population) who have interstitial lung anomalies (ila) that may indicate a initial stage of pulmonary fibrosis. finding efficient screening methods and associated targeted treatments for ipf may be essential to improving the prognosis and quality of life of those suffering from this disease. objectives of the study: the study involves two populations of study subjects: * patients with fpf and sporadic ipf * first-degree relatives of patients with fpf and sporadic ipf (biological relatives, not spouses) the primary objective is to determine the prevalence rates of interstitial lung abnormalities in at-risk relatives of patient with ipf and fpf. study design: multicenter, cross-sectional study without drug and without device conducted in two major italian tertiary referral hospitals. the entire project is expected to last 24 months.


Eligibility criteria:
criteria for patients: inclusion criteria: 1. patients aged ≥18 years when signing the informed consent 2. diagnosis of ipf based on 2022 ats/ers/jrs/alat guidelines as confirmed by the investigator based on chest hrct scan and if available surgical lung biopsy 3. diagnosis of fpf defined as the presence of fibrotic ild in at least two members of the same biological family 4. at least one 1st degree relative \>40 years of age. exclusion criteria: 1. patients with interstitial lung diseases other than idiopathic pulmonary fibrosis, including but not limited to patients with granulomatous lung disease, autoimmune/collagen vascular disease associated interstitial lung disease, and drug induced interstitial lung disease 2. unwilling or unable to sign informed consent criteria for first degree biological relatives: inclusion criteria: a. subjects aged ≥40 years exclusion criteria: 1. previous diagnosis of ipf 2. a history of severe or poorly controlled anxiety, severe or poorly controlled depression according to the opinion of the investigators, suicidal ideation, or other psychiatric illness requiring hospitalization 3. unwilling or unable to sign informed consent 400 first-degree relatives of participating patients will be recruited
early staged consent before prostate biopsy

Conditions: Prostate Cancer

Summary: this is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. the investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for procedural pain at the time of prostate biopsy. in the two-stage design, patients will first be approached for consent to 1) have their routinely collected clinical data used for research purposes and 2) be randomly selected to be offered an intervention to improve the experience of prostate biopsy. only patients randomized to the experimental arm will be informed about the benefits and harms of the intervention and will sign a second consent for the experimental treatment. there will be two separate randomizations in this study, one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.


Eligibility criteria:
inclusion criteria: * all male patients that will be scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia and potentially consented to the mindfulness study of mind-body intervention for prostate biopsy within the next 12 months. * english fluent exclusion criteria: * patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy. * prior prostate radiation

Keywords: mind-body intervention 18-189
diuretics, hypertension, and arrhythmias clinical trial

Conditions: Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension

Summary: to determine whether hypertensive patients with ecg abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

background: the multiple risk factor intervention trial (mrfit) revealed an unexpected subgroup finding: an association between diuretic therapy (especially with hydrochlorothiazide) and an increased rate of sudden death in hypertensive men with left ventricular hypertrophy and other ecg abnormalities. the diuretics, hypertension, and arrhythmias clinical trial sought to determine whether the finding resulted from random variation or represented a serious toxic response to hydrochlorothiazide. design narrative: randomized, double-blind. following one month of withdrawal from all diuretics and repletion with oral potassium and magnesium, the study participants were randomized to two months of treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide and triamterene; chlorthalidone; or placebo. the main outcome measures were ventricular arrhythmias on 24-hour holter monitoring and serum and intracellular potassium and magnesium levels.

Eligibility criteria:
men, ages 35 to 70, with ecg abnormalities, diastolic blood pressure less than 95 mm hg at entry. subjects had been treated for at least six months by their own physicians with hydrochlorothiazide (hct), hct and potassium supplementation, triamteren
clinical trial evaluating the safety and efficacy of the use of chitosan gel in patients with chronic wounds

Conditions: Diabetic Foot Ulcer

Summary: type 1 and type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.


Eligibility criteria:
inclusion criteria: * written informed consent must be given * patient ≥ 18 years old * diagnosed with type i or type ii diabetes mellitus * glycosylated haemoglobin, hba1c, ≤ 12% * presence of diabetic foot ulcer or an amputation wound that meets following criteria: 1. size of the wound 0,5 - 12 cm\^2 2. wagner grade i or ii 3. wound is not infected 4. wound present for at least 4 weeks * if multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm * if there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria * adequate perfusion (good, strong foot pulses). if foot pulses are weak, evaluation of perfusion pressures with doppler ultrasound is performed. * able to understand and comply with the requirements of the trial exclusion criteria: * known history of alcohol or drug abuse * use of any antibiotic medication within the last 7 days prior to the first application of study product * patients presenting with wagner grade iii or higher ulcer * patients with serious concomitant disease (cancer, heart failure ( nyha class iv), severe anemia (hb\<100 g/l), neoplasia) * any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness) * patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the doctor * excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included) * patients diagnosed with autoimmune connective tissues diseases * previous treatment under this clinical protocol * participation in another clinical trial up to 30 days before the randomization visit. * receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing * medical condition likely to require systemic corticosteroids during the study period * allergic to shellfish, chitosan or one of chitocare product compounds * immobile patients * pregnant and lactating women * significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%) * bmi \> 39 kg/m2

Keywords: chronic wounds diabetic foot ulcer chitosan gel
effects of the physical activity and cognitive training program

Conditions: Cognitive Decline

Summary: investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities. the purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.

1. to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner. 2. to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.

Eligibility criteria:
inclusion criteria: * age 65 year and older * able to communicate verbally * able to discern 5\*5 cm2 picture from a viewing distance of 20 cm * able to hear a sound of normal speech from a distance of 20 cm * able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort * has cognitive decline status assessing by casi 2.0 * lived in long-term care facilities during the study exclusion criteria: * complete aphasia, blindness, deafness or completely dependent * unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression * thrombophlebitis, or malignancy of the limbs. * refusal by patient or family member. * others. reason to be well documented.

Keywords: physical activity cognitive training
cytosorb reduction of free hemoglobin during cardiac surgery

Conditions: Elective Cardiac Surgery

Summary: prospective, multi-center, randomized, feasibility clinical study. subjects will be randomized in a 1:1 ratio to either standard of care (soc) alone or standard of care and treatment with the cytosorb® device.


Eligibility criteria:
inclusion criteria: * elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of \>180 minutes exclusion criteria: * platelet count \< 20,000/ ul * body mass index \<18 * pregnant women * life expectancy of \<14 days * end stage organ disease * active infection * undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (cabg) or single valve procedure * contraindication to anticoagulation with heparin * declined informed consent

Keywords: cytosorb device plasma free hemoglobin inflammation extracorporeal bypass
clinical evaluation of the releaf analgesic infusion catheter & wound drain

Conditions: Low Back Pain

Summary: the purpose of this study is to evaluate the clinical performance of the releaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. one half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.

posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. however, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. this pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy. pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. a local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration. continuous local anesthetic infusion into the paraspinal musculature with the releaf catheter has the potential to reduce pain, narcotic demand \& usage, and accelerate the rate of recovery in lumbar spinal fusion patients.

Eligibility criteria:
inclusion criteria: * skeletally mature * diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy * physically and mentally willing to comply with the study requirements * signed the study informed consent exclusion criteria: * lumbar spine disease requiring more than two levels of instrumentation * any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery * patients requiring iliac crest bone graft for the procedure * intra-operative durotomy * any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months * physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, alzheimer's disease, presence of alcohol or substance abuse) * diagnosed with severe depression and on treatment * active infection at the operative level or a symptomatic infection * diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. paget's disease, renal osteodystrophy, lupus etc) * is pregnant or breast feeding * has any active malignancy or spinal arthrodesis being performed for a tumor decompression * has a known allergy to local analgesics * pending litigation related to back pain or injury or worker's compensation
long-term safety and efficacy of adipose-derived stem cells to treat complex perianal fistulas in patients participating in the fatt-1 randomized controlled trial

Conditions: Complex Perianal Fistula

Summary: the purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding fatt-1 trial \[clinicaltrials.gov identifier: ntc00475410\], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (asc)and/or fibrin glue.

complex perianal fistulas are a source of great distress for suffers. treatment options are limited and surgery is often associated with incontinence and recurrence. the biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered. this study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study \[clinicaltrials.gov identifier: ntc00475410\]. the present extension aims to collect safety and efficacy data for up to 12 month from initial administration. fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections \>2cm directly related to the fistula tract treated, as measured by mri.

Eligibility criteria:
inclusion criteria: * at least 1 dose of the treatment assigned in the fatt-1 trial * informed consent exclusion criteria: * other experimental drugs other than cx401 during the follow-up period

Keywords: complex perianal fistula adipose-derived adult stem cells fibrin glue
psychoeducational groups for adults with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-norway. all participants will receive standard treatment during the intervention period. assessment of client satisfaction (csq 8), general self-efficacy (gse-6), adhd-related quality of life (aaqol) symptoms of adhd (scl-9; asrs), and work participation will be conducted at time of recruitment prior to randomization (t0), pre- (t1), post-treatment (t2), with a 10 week follow-up.


Eligibility criteria:
inclusion criteria: * confirmed adhd diagnosis * speaking a scandinavian language exclusion criteria: * not able or willing to give informed consent * psychosis * severe learning difficulties

Keywords: psychotherapy, group adults
pixl for correction of hyperopia

Conditions: Hyperopia

Summary: this clinical study aims to investigate the efficacy and safety of pixl in the refractive correction of low hyperopia.

this clinical study aims to investigate the efficacy and safety of pixl in the refractive correction of low hyperopia.slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 d. aim is to evaluate the refractive outcome of this procedure.

Eligibility criteria:
inclusion criteria: * low hyperopia of spherical equivalent from +0.5 up to +1.75 d sp. eq. * astigmatism up to 0.75 dcyl * corneal thickness above 400 µm * endothelial cell density above 1500 cell/mm2 exclusion criteria: * any prior corneal surgery or any eye surgery within the last 3 months, * any corneal pathology e.g. corneal scar or dystrophy * unstable refraction * patient not able to understand and sign informed consent * patients with connective tissue disorder or uncontrolled diabetes * pregnant or lactating women * aphakic eyes or pseudophakic eyes without uv blocking iol

Keywords: hypeorpia crosslinking pixl
response surface pathway design with two interventional- and one response variable in estimating minimum efficacy dose

Conditions: GERD

Summary: response surface pathway (rsp) design was previously developed for dose-finding studies with one interventional and one response variable, but rsp to higher dimensions is requested. the aim of this study is to introduce and evaluate the rsp design with two interventional and one response variable exemplified by estimating minimum efficacy dose (med) of osteopathic manual therapy (omt) in treatment of gastroesophageal reflux disease (gerd).

15 gerd patients, divided in three design-level with three, five and seven patients. the study was performed as a two-dimensional randomized, between-patient rsp designed multicenter study with two interventional- and one response variable. the interventional variables "number of omt's" and "treatment interval" with common response variable formed two independent one-dimensional randomized between-patient rsp studies. the response variable was the percent reduction in sum of the five gerd score from baseline. three gerd patients were allocated on the first design level given six omt with five days' interval. based on results obtained in the first and second design level, five patients were included to the second design level and seven to the third.

Eligibility criteria:
inclusion criteria: * clinical diagnosed gastroesophigual reflux disease * known effect of anti-reflux medication exclusion criteria: * hiatus hernia ≥5 cm * gastric ulcer * cancer * uncontrolled bacterial, viral, fungal or parasite infection.

Keywords: two-dimensional randomized response surface pathway design osteopathic manual therapy omt in treatment of gerd dose-response
correlation between friedman classification and the apnea hypopnea index (aih) in a population with obstructive sleep apnea syndrome (osas)

Conditions: Obstructive Sleep Apnea Syndrome

Summary: introduction: osas is an important disease in the actual medic scene. it is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea. objectives: determinate the correlation between friedman classification and the obstructive sleep apnea syndrome (osas) gravity through ahi (apnea hypopnea index) in patients with osas for surgical indication and evaluation. materials and methods: the investigators evaluated and classified 84 patients, in the scale of epworth, friedman and how much the gravity of the sahos for the ahi.


Eligibility criteria:
inclusion criteria: * not exhibiting any exclusion criteria * age \> 21 years exclusion criteria: * nasal tumor * bmi \> 40 * no acceptance of study * nasal poliposis

Keywords: friedman classification apnea-hypopnea index obstructive sleep apnea syndrome
shr-1701 in combination with famitinib in patients with recurrent/metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is an open label, multi-center, phase i/ii study to evaluate the efficacy and safety of shr-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(r/m npc).


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent/metastatic nasopharyngeal carcinoma * subjects failure after platinum-based chemotherapy and anti-pd-1/pd-l1 antibody therapy; * able and willing to provide signed informed consent form, and able to comply with all procedures. * life expectancy \>= 12 weeks as judged by the investigator. * eastern cooperative oncology group (ecog) performance status of 0 to 1 at trial entry. * disease must be measurable with at least 1 uni dimensional measurable lesion by response evaluation criteria in solid tumors (recist) version 1.1. * adequate hematological, hepatic and renal function as defined in the protocol other protocol-defined inclusion criteria could apply exclusion criteria: * anticancer treatment within 28 days before the first dose of study drug. * major surgery within 28 days before start of trial treatment. * systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment. * with any active autoimmune disease or history of autoimmune disease. * with active central nervous system (cns) metastases causing clinical symptoms or requiring therapeutic intervention. * history of immunodeficiency including seropositive for human immunodeficiency virus (hiv), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy. * previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are not excluded.

Keywords: nasopharyngeal carcinoma shr-1701 famitinib