Kornimate/medical-research-clean huggingface dataset:
internet-based support for adjustment to prostate cancer

Conditions: Psychological Distress; Depression - Major Depressive Disorder; Insomnia; Anxiety; Prostate Cancer

Summary: the study aims to study the efficacy of internet-based cognitive behavior therapy (icbt) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. once recruited, they will be randomized to receive either a tailored, eight-week long icbt intervention or an attention control group. both group receive weekly support by a trained therapist.

men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms. this study investigates a tailored approach to providing help for men diagnosed with prostate cancer. participants randomized to the treatment condition will receive an eight week icbt intervention which is tailored to the problem profile of the participant in question. the treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. the primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. participants will be recruited in sweden with a nationwide recruitment.

Eligibility criteria:
inclusion criteria: * subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis. * a sum score above 19 on the primary outcome measure (kessler-10). * an age of 18 or older. * ability to speak, read, and write swedish. * access to a computer/laptop/tablet/smartphone and internet access. * sufficient computer profiency to be able to use the treatment platform. exclusion criteria: * planned medical treatment or planned change in medication related to the prostate cancer during the treatment period. * recently finished (within the past six months) medical treatment for prostate cancer. * severe psychiatric or somatic conditions that impedes participation in the study. * ongoing substance use problems. * acute suicidality. * other ongoing psychological treatment. * psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.

Keywords: psychological distress prostate cancer cancer icbt cognitive behavior therapy
proof of concept study for safety and efficacy of edp239 in hepatitis c subjects

Conditions: Hepatitis C

Summary: the purpose of this study is, to assess whether edp239 can reduce the hcv viral load in hcv gentotype-1 in chronically infected subjects and to further evaluate the safety profile of edp239.


Eligibility criteria:
inclusion criteria: * subjects must have chronic genotype-1 hepatitis c virus infection and plasma hcv-rna ≥ 105 iu/ml at the time of screening. * subjects must have chronic hcv infection as determined by any of the following: * be anti-hcv (+) for at least 6 months per subject history or medical records * an anti-hcv test, viral load, or genotype \> 6 months ago * in the setting of a recent positive anti-hcv test (\< 6 months), liver biopsy demonstrating chronicity * subjects must have il-28b genotype "cc" * subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 36 kg/m2. bmi = body weight (kg) / \[height (m)\]2 exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations. * previous treatment, including the use of any investigational agents, for the treatment of hcv infection. * women of child bearing potential. * subjects with il-28b genotype "ct or tt". * alt γ-gt, and ast must be below 5 x the upper limit of normal (uln). * serum bilirubin must not exceed uln. * the pt (inr) must be within normal limits. * if necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error. * use of drugs that inhibit or induce cyp3a4.

Keywords: hepatitis c infected subjects
preventing depression recurrence in diabetes

Conditions: Major Depression; Diabetes

Summary: to study the effectiveness of sertraline (zoloft) in treating depression in adults with diabetes. the study will also determine whether depressed diabetic patients who have successfully responded to sertraline (zoloft) are more likely to have depression recur if the sertraline (zoloft) is discontinued.

part a: prevention of depression recurrence in diabetes 1. to determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes. 2. to determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment. 3. to determine clinical features predictive of depression recurrence in diabetes. part b. longitudinal study of the interrelationship of glycemic control and depression 1. to determine the effects of depression remission and recurrence on glycemic control. 2. to determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control. 3. to determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.

Eligibility criteria:
inclusion criteria: * 18-80 * type 1 or type 2 diabetes * screen positive for depression exclusion criteria: * are pregnant or lactating * are known to be hypersensitive to the drug * have a recent history of myocardial infarction or unstable heart disease * have severe hepatic disease or renal impairment (serum creatinine \> 3 mg/dl) * the subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation

Keywords: depression diabetes mellitus depression recurrence
a comparison between ffr guided and cag guided treatment using deb in isr of des

Conditions: In Stent Restenosis; Drug Eluting Stent; Coronary Artery Disease

Summary: this is a prospective single center, randomized controlled clinical study aimed to compare the clinical and angiographic follow-up results of patients with in-stent restenosis(isr) after coronary drug eluting stent(des) implantation treated by fractional flow reserve -guided and angiography guided drug eluting balloon(deb) intervention. this study intends to confirm the clinical benefits of optimizing deb intervention of des-isr by ffr.

420 patients with des-isr will be recruited in this study. after angiography, patients with des-isr to be treated with deb will be randomly assigned to ffr-guided and angiography-guided groups. in ffr group, ffr at maximum hyperemia will be measured after pretreatment of des-isr lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). if ffr \ =0.9, deb will be used and final ffr will be measured at the end of the procedure. in angiography group, the operator will treat the des-isr lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then deb without ffr guidance.

Eligibility criteria:
inclusion criteria: in-stent restenosis(isr) occurred more than 6 months after drug eluting stent (des) implantation exclusion criteria: 1. isr in bare metal stents and biodegradable stents 2. complicated with immune diseases 3. isr in left main des 4. suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment 5. severe cardiac insufficiency (lvef \<30%) 6. subjects with st segment elevation myocardial infarction within 7 days of onset of chest pain 7. pregnant or lactating women 8. combined with other diseases, life expectancy \<1 year 9. follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk

Keywords: fractional flow reserve in stent restenosis drug eluting stent
the copd patient management european trial (comet)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the goal of the study is to evaluate a home-based disease management program specifically developed for patients with gold iii/iv copd. by improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this home-based copd management program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

primary objective: to evaluate a strategy of chronic obstructive pulmonary disease (copd) management to reduce the number of hospital days in patients with severe gold iii/iv copd: a home-based copd management program versus usual patient education and follow-up. secondary objectives: * to assess the clinical outcome and the health-related quality of life, * to assess safety, * to evaluate medico-economic impact.

Eligibility criteria:
inclusion criteria: * confirmed gold iii/iv copd * current or ex-smoker with a smoking history ≥ 10 pack-years * at least one copd exacerbation leading to hospitalization in the year before selection. exclusion criteria: * ltot for another reason than copd * severe concomitant disorder associated with a limited probability of survival (\< 6 months) * tracheostomy * long term oral corticosteroids therapy

Keywords: copd comet disease management
platelet rich plasma injection versus surgical and medical treatment of mild-moderate carpel tunnel syndrome.

Conditions: Carpal Tunnel

Summary: to evaluate the therapeutic efficacy of single ultrasound guided platelet rich plasma injection of the carpal tunnel vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.

carpal tunnel syndrome (cts) accounts for approximately 90% of peripheral entrapment neuropathy cases. existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .surgery indicated in patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. empirical evidence indicates that many patients with cts have self-limiting symptoms and respond to splinting and anti-inflammatory medications. recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.

Eligibility criteria:
inclusion criteria: * patients with signs and symptoms of cts and a confirmed diagnosis of mild and moderate cts based on clinical and electrophysiological studies were included. exclusion criteria: 1. pregnancy. 2. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.). 3. history of local corticosteroid injection in the past 3 months. 4. atrophy of thenar muscles. 5. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy. 6. patients with autoimmune or hematologic disorders, nsaid consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, hb level under 12 g/dl, and platelet count under 150,000 in ml.
preclinical research for personalized tcr-t therapy for head and neck cancer

Conditions: Head and Neck Cancer

Summary: this study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized tcr-t therapy for head and neck cancer by determining the reactive tcr clone sequences in head and neck cancer.


Eligibility criteria:
inclusion criteria: 1. gender is not limited, age 18-75 years old; 2. estimated survival is greater than 3 months; 3. newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment; 4. patients with head and neck cancer whose tumor tissue can be surgically harvested; 5. volunteer to join the study and sign the informed consent. exclusion criteria: 1. infected or had been infected with covid-19; 2. active hepatitis b or c virus, hiv infection, or other uncured active infected persons; 3. patients with head and neck cancer who had received the following treatments: the patient had a history of using pd-1 and other immune checkpoint inhibitors 8 weeks before surgery; history of chemotherapy drug use 8 weeks before surgery; a history of hormone drug use within 4 weeks before surgery; 4. other situations that are not appropriate to be included in the clinical trial.

Keywords: tcr-t therapy
dexmedetomidine sedation in orthopedic surgery

Conditions: Hallux Valgus and Bunion; Sedation

Summary: 60 patients asa i-iii, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group a (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group b (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group c (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). all patients will receive spinal anesthesia. duration of postoperative analgesia, total dose of patient controlled iv morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.


Eligibility criteria:
inclusion criteria: physical status according to american society of anesthesiologists (asa) i-iii patients scheduled for orthopedic surgery exclusion criteria: patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, bmi above 30, serious psychiatric, mental and cognitive disorders, language barrier, illicit substances abuse,
physiological effects of hfnc during exercise in patients with fibrosing interstitial lung diseases

Conditions: Interstitial Lung Disease; Pulmonary Rehabilitation

Summary: in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (hfnc) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ild) during an endurance test


Eligibility criteria:
inclusion criteria: * cared for as part of a respiratory rehabilitation program (adir association) * presenting diffuse fibrosing interstitial pneumonitis, documented by ct scan data and whatever its etiology * presenting severe hypoxemia in ambient air (spo2\<90%) during an exercise test (6-minute walk test or functional exercise test) exclusion criteria: * patient with a contraindication to carrying out a respiratory rehabilitation program * patient having presented an exacerbation of pid, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion * tracheostomized patient * patient with a contraindication to the placement of a nasogastric tube * pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out) * protected adult patient (guardianship or curatorship) * patient deprived of liberty by court or administrative decision * refusal of patient participation or consent

Keywords: interstitial lung disease nasal high flow oxygen therapy endurance test pulmonary rehabilitation
effects of hormonal anabolic deficiency and neurovascular alterations on mortality in male patients with heart failure

Conditions: Heart Failure

Summary: heart failure (hf) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. these alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and fatigue. the investigators tested the hypothesis that hormonal anabolic deficiency associated with neurovascular alterations may worsen the prognosis of patients with heart failure.

one hundred and fifty six patients have been enrolled so far. methods were as described below: * muscle sympathetic nerve activity (msna) was directly recorded from the peroneal nerve using the microneurography technique ; * all patients underwent symptom-limited cardiopulmonary exercise test performed on a cycle ergometer, using a ramp protocol with workload increments of 5 or 10 watts per minute; * body composition measurements were performed using dual-energy x-ray absorptiometry (dxa); * muscle strength was assessed by handgrip dynamometer using the mean value of three attempts; * blood samples were drawn in the morning after 12h overnight fasting. the laboratory tests included b-type natriuretic peptide (bnp; pg/ml) plasma level, serum sodium (meq/l), serum potassium (meq/l), creatinine (mg/dl), haemoglobin level (g/dl), high-sensitivity c-reactive protein (crp; mg/l), lipid profile (triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein; mg/dl), and fasting glucose (mg/dl). blood sample to assess hormone plasma levels were also drawn at the same time: total testosterone (tt), free testosterone (ft), sex hormone binding globulin (shbg), dehydroepiandrosterone sulfate (dheas), luteinizing hormone (lh), follicle-stimulating hormone (fsh), thyroid stimulating hormone (tsh) and insulin-like growth factor 1 (igf1).

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old; * at least1 year of diagnosed hf; * left ventricular ejection fraction (lvef) lower than 40% measured by echocardiography; * non-ischaemic and ischaemic aetiologies; * compensated hf with optimal medication for at least 3 months prior the study; * new york heart association (nyha) class of i to iv. exclusion criteria: * patients with autonomic diabetic neuropathy; * patients with chronic renal failure with haemodialysis; * heart transplantation; * presence of pacemaker; * patients with muscular dystrophy (i.e. duchenne muscular dystrophy); * patients submitted to any hormonal treatment; * history of cancer; * ongoing infection; * myocardial infarction with percutaneous coronary intervention or revascularization 6 months prior to the study entry.

Keywords: testosterone deficiency sympathetic overactivity exercise intolerance
elastography and fnac in thyroid nodule

Conditions: Thyroid Nodule

Summary: evaluate the accuracy of use in comparison with fnac in characterization of solitary thyroid nodule and assessment the risk of malignancy

thyroid nodules occur commonly in the general population, mostly as incidental findings, with a prevalence of 19-68% at ultrasound (us) evaluation . however, although us is an established and very sensitive method for detecting thyroid nodule , it has a relatively low diagnostic performance when it comes to differentiating between benign and malignant nodules. therefore, when a patient presents with normal thyroid-stimulating hormone levels but us shows suspicious signs , a fine-needle aspiration biopsy (fnab) is advised, fine-needle aspiration (fna) is not a conclusive diagnostic method in all cases, considering its specificity, which ranges from 60 to 98%, and its variable sensitivity, which ranges from 54 to 90%, as well as the frequent eventual clinical need to repeat the test. however, in consideration of the financial burden on health services, and to avoid unnecessary anxiety for patients, it is unrealistic to biopsy every thyroid nodule to obtain histological diagnosis. in recent years, several studies have proposed the potential use of (us-elastography)to increase the accuracy of baseline us. moreover, ultrasound elastography (use) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, especially in comparison with tirads (thyroid imaging reporting and data systems). a firm or hard nodule consistency at palpation is associated with a high risk of malignancy. due to its ability to assess stiffness as an indicator of malignancy, use has recently become an additional tool for thyroid nodule differentiation, in combination with conventional us and fna. in particular, strain ratio elastography (sre) has shown high sensitivity and specificity, leading the efsumb (european federation of societies for ultrasound in medicine and biology) to recommend that it should be part of the work-up of thyroid nodule characterization.

Eligibility criteria:
inclusion criteria: * all patients referred to radiology department presented clinically with solitary thyroid nodule . exclusion criteria: * patients previously underwent thyroid surgery * patients with severe uncorrectable bleeding diathesis. * patients refused to sign consent.
prevalence of thrombosis in covid-patients

Conditions: Covid19

Summary: examination of the prevalence of thrombosis in covid-patients, especially in an out-patient setting. assessment by duplex sonography. if thrombosis is detected, we will correlate it with immunity status. assessment of health issues and cognitive function as late complication after infection.


Eligibility criteria:
inclusion criteria: * sars cov 2 positive swap, at least 4 weeks after infection exclusion criteria: * under 18 years old no consent anemia
comparison of absorption of budesonide and formoterol from budesonide/formoterol easyhaler and symbicort turbuhaler

Conditions: Asthma

Summary: the purpose of this study is to compare the test product budesonide/formoterol easyhaler with the marketed product symbicort turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria:
inclusion criteria: 1. healthy males and females aged 18-60 years. 2. normal weight, at least 50 kg. exclusion criteria: 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease. 2. any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. 3. any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. 4. known hypersensitivity to the active substance(s) or the excipient of the drug. 5. pregnant or lactating females.