Kornimate/medical-research-clean huggingface dataset:
stereotactic volumetric radiotherapy in prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective, single arm, phase ii, multicentric study. it evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. all participants receive a total dose of 36.25 gy in 5 fractions, twice a week, 7.25 gy per fraction.


Eligibility criteria:
inclusion criteria: * histology of prostate adenocarcinoma * age≥ 18 years * life expectancy≥ 10 years * clinical negative nodes (n0) * no metastasis presence (m0) * no previous pelvic radiation therapy * total psa≤10 ng/ml * gleason score ≤ 6 * t1-2 * ≤ 3 positive biopsy at prostatic mapping * signed informed consent exclusion criteria: * positive nodes (n+) or metastatic disease (m+) * inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders * anticoagulant treatment in progress * hip or pelvic presence of medical devices that could prevent a correct image acquisition * symptomatic haemorrhoidal disease * adverse reactions to iodinate or paramagnetic contrast media * previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years * previous pelvic radiotherapy * psychiatric disorder that preclude to obtain informed consent

Keywords: hypofractionated radiotherapy sbrt
evaluation of sonelokimab in patients with active psoriatic arthritis and anti-tnfα inadequate response

Conditions: Arthritis, Psoriatic

Summary: this is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (tnf)α therapy.

m1095-psa-302 is a phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (tnf)α therapy.

Eligibility criteria:
inclusion criteria: 1. participants must be ≥18 years of age . 2. participants have a confirmed diagnosis of psoriatic arthritis (psa) per the 2006 classification for psoriatic arthritis (caspar) criteria with symptoms for ≥6 months before the screening visit. 3. participants have moderate to severe active disease (defined by a 68 tender joint count \[tjc68\] of ≥3 and a 66 swollen joint count \[sjc66\] of ≥3). 4. participants have current active plaque psoriasis (pso) or a dermatologist-confirmed history of plaque pso. 5. participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the screening visit. 6. participants must have received 1 or 2 tnfα inhibitors for psa or pso and must have experienced an inadequate response to treatment with the tnfα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a tnfα inhibitor. exclusion criteria: 1. participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients. 3. participants who have a diagnosis of chronic inflammatory conditions other than pso or psa. 4. participants with a diagnosis of inflammatory bowel disease. 5. participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the baseline visit. 6. participants who have an established diagnosis of arthritis mutilans. 7. previous exposure to sonelokimab. 8. participants who have ever received biologic immunomodulating agents for psa or pso whether investigational or approved, except for those targeting tnfα
removal of lung nodules after being marked with a microcoil

Conditions: Lung Cancer

Summary: the objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using ct and marked with a microcoil device. the addition of real-time ct imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.

lung cancer is the most common cause of cancer death for both men and women in the industrialized world. small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. the remaining 75% of lung cancers are collectively termed non-small cell lung cancers. when presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. more than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. individuals with peripheral lesions less than 3 cm in diameter (t1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 patients with small subcentimeter pulmonary nodes may have even better survival with resection. computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 however, suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. forty percent of those nodules were found to be malignant.4 the most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.

Eligibility criteria:
inclusion criteria: * subcentimetre lung nodule exclusion criteria:

Keywords: microcoil subcentimetre nodules
efficacy of biofeedback-based serious game for pain alleviation in middle-aged and older ovarian cancer patients: a randomized controlled trial

Conditions: Cancer Pain

Summary: consistent pain affects most middle-aged and older ovarian cancer patients. non-pharmacological pain interventions, such as serious games, offer a promising approach to alleviating this pain by providing an effective sense of immersion. however, current games on the pain alleviation lack examination of its efficacy in middle-aged and older population and real-time monitoring of immersion level, particular since immersion level is highly associated with pain alleviation effect and adjustable to challenging level of game difficulty. this study developed a serious game with biofeedback-driven dynamic difficulty. then examined its feasibility and efficacy through a two-arm, single-blinded randomized controlled trial. a total of 52 participants were recruited and randomized into intervention group and control group to receive biofeedback-based dynamic-difficulty serious game or fix-difficulty serious game for 15 mins each, respectively. the primary outcome was the assessment of the pain level, measured using the visual analog scale. the secondary outcomes included pain-related anxiety, immersion level, and user experience.


Eligibility criteria:
inclusion criteria: * meeting the diagnostic standards established by the international association for the study of pain (iasp) and having a pain severity level between 3 and 6 (classified as mild to moderate) at the time of enrollment, * diagnosed with ovarian caner * demonstrating clear cognitive and expressive abilities, * being aged 45 or older, * providing voluntary consent after fully understanding the study's objectives. exclusion criteria: * individuals with a history of mental illness or communication disorders, * those experiencing vision or cognitive impairments, * individuals undergoing pain medication treatment during the intervention period.
curve correction of early onset scoliosis by mehta serial casts

Conditions: Scoliosis

Summary: assessment of the role of mehta serial casts in curve correction of early onset scoliosis

early onset scoliosis refers to various types of scoliosis with onset before 10 years of age .in addition to spinal deformity progressive scoliosis will also affect the development of thoracic cage and lungs . so early correction is important . curve correction can done by operative and nonoperative techniques . our study include the curve correction by mehta serial casts which not need for blood transfusion and has a good role in stop progression and delay the need for surgery .

Eligibility criteria:
inclusion criteria: * all cases with early onset scoliosis up to 10 years age presenting to assiut university hospitals during 2 years period . exclusion criteria: * cases with previous spine surgery and those whose guardians refuse to participate in the study .
validation of myocardial perfusion imaging

Conditions: Coronary Artery Disease

Summary: the new cadmium-zinc-telluride (czt) technology is a powerful tool for cardiac nuclear medicine. the increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress tl-201/rest tc-99m protocol for use with high-speed spect mpi). the use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. however, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. the investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.

the new cadmium-zinc-telluride (czt) technology is a powerful tool for cardiac nuclear medicine. indeed, recent clinical validation studies of czt technology have documented a scan time reduction and low radiation dose without degradation of myocardial perfusion imaging in comparison with standard dual detector cameras. the increased photon counting sensitivity of camera can be used to explore novel protocols that may offer advantages over standard protocols used for myocardial perfusion imaging. berman et al. showed that rapid stress tl-201/rest tc-99m protocol for use with high-speed spect mpi has offered the superior qualities of tl-201 for stress imaging and of the tc-99m agents for rest imaging can be preserved. nuclear medicine presents the most level of scientific validation for diagnosis and prognosis of coronary artery disease. a lot of studies have compared performance of standard dual detector cameras vs. invasive coronary angiography. fiechter et al. reported the first validation of ultrafast dedicated cardiac gamma camera with czt versus invasive coronary angiography. but he used a novel hybrid spect /ct device and 99m-tc-tetrofosmin pharmacological stress/rest examination. however, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. moreover, diagnosis performance of this high-speed protocol versus fractional flow reserve for stenosis evaluation is unknown. the investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive procedures (coronary angiography and fractional flow reserve) as the standard of reference.

Eligibility criteria:
inclusion criteria: * stable angina * cadmium-zinc-telluride gamma camera spect with dual isotope imaging * coronarography exclusion criteria: * pregnant woman * patient with terminal illness, * terminal renal failure * allergy to iodine

Keywords: coronary artery disease cardiac nuclear medicine myocardial perfusion imaging invasive coronary angiography
effects of an amino-acid supplement on hepatic lipid metabolism

Conditions: Metabolic Syndrome

Summary: 10 healthy male volunteers will be studied after * a 6 day weight maintenance, balanced diet * a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day * a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day at the end of each 6 days period, the following measurements will be obtained * intrahepatic lipids (1h-mrs) * metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma vldl-kinetics) this is a randomized, double blinded study


Eligibility criteria:
inclusion criteria: * age 18-30 years * sex: males * bmi between 19 and 25 kg/m2 * less than 3 30min- exercise session/week exclusion criteria: * smokers * alcohol consumption more than 50g/week * consumption of drugs * history of diabetes in first degree relatives * presence of ferro-magnetic prosthesis, cardiac pacemakers, or any contra-indication to nmr

Keywords: hepatic fat content hepatic de novo lipogenesis
efficacy of plant sterol-fortified dairy product on plasma lipid and plant sterol concentrations in humans

Conditions: Hypercholesterolemia

Summary: the aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (wd-ps) preparation versus plant sterol esters (ps-ester), consumed within dairy products.

forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Eligibility criteria:
inclusion criteria: * healthy individuals aged 19-60 yr * plasma ldl-c levels \> 3.0mmol/l * tg \< 4.5mmol/l * body mass index (bmi) between 20 and 30 kg/m2. exclusion criteria: * history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months * history of chronic use of alcohol (\>2 drinks/d) * smoking * myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
the princess alexandra hospital and the qimr berghofer medical research institute head and neck cancer study

Conditions: Head and Neck Squamous Cell Carcinoma; Human Papillomavirus

Summary: this study is designed to refine the aetiological causes of cancers of the head and neck and investigate the ways in which human papillomavirus and life-style factors cause head and neck cancers. this study will determine if these factors affect the treatment of cancer. all patients attending the head and neck clinic at the princess alexandra hospital is invited to complete a risk factor questionnaire and give consent for their clinical data and tissue samples to be available for future research activities. the risk factor questionnaire is based on existing validated instruments developed by the qimr berghofer medical research institute cancer control group, and will collect standardised information relating to demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition, asprin and non-steroidal anti-inflammatory drugs (nsaids), height, weight, physical activity, diet quality etc) and behaviours (oral sex etc)

data is collected using a simple four-page paper-based questionnaire. information to be collected include age, sex, height and weight (at age 20, current age, and heaviest ever), history of cancer (own and partner). questions about recreational physical activity, smoking history and alcohol consumption, acid reflux, heartburn, denture use and tonsillectomy, frequency of use of paracetamol, antihistamine and nsaids. the questionnaires also ask participants some detailed questions about sexual behaviour and history if they are comfortable to give this information.

Eligibility criteria:
inclusion criteria: * all patients presenting to the head and neck cancer clinic at the princess alexandra hospital brisbane australia. exclusion criteria: * nil

Keywords: head and neck squamous cell carcinoma human papillomavirus aetiology prevalence risk factors clinical outcome
a non-drug study on the relationship between exploratory biomarkers and functional dimensions in individuals with autistic disorder or asperger's syndrome

Conditions: Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

Summary: this multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with autistic disorder or asperger's syndrome and healthy volunteer controls. subjects will undergo a number of assessments on study visit day 1.


Eligibility criteria:
inclusion criteria: individuals with autistic disorder or asperger's syndrome: * male adults, 18 to 45 years of age inclusive * diagnosis of autistic disorder or asperger's syndrome as defined by dsm-iv * iq \>70 * body mass index (bmi) 18 to 35 kg/m2 * availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms healthy controls: * healthy male adults, 18 to 45 years of age inclusive * iq \>70 * body mass index (bmi) 18 to 30 kg/m2 exclusion criteria: general exclusion criteria: * positive test for drugs of abuse or alcohol * confirmed systolic blood pressure \>140 or \ 90 or \<50 mmhg * resting pulse rate \>100 or \<40 beats per minute * alcohol and/or substance abuse/dependence during the last 12 months * concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study additionally for individuals with autistic disorder or asperger's syndrome: * history of epilepsy/seizure disorder (except simple febrile seizures) * significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study additionally for healthy controls: * clinically significant abnormalities in laboratory test results * history of or current psychiatric, neurological disorder or pervasive developmental disorder
continuous lidocaine infusion via closed chest drainage tube for pain control after thoracoscopic partial lung resection

Conditions: Lidocaine; Analgesia; Pain, Postoperative; Thoracic Surgery

Summary: the goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. the main questions it aims to answer are: * to explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy. * whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery. for participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). the comparison group only accept the intravenous analgesia after surgery.

at present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia. the investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. in the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored. in the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. the experimental group received a continuous infusion of lidocainethe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. the control group received only standard intravenous analgesia。in addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.

Eligibility criteria:
inclusion criteria: 1. participants ages 18-70 years. 2. participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery. 3. american society of anesthesiologists classification (asa)i-iii. exclusion criteria: 1. severe heart failure, cardiac arrhythmias,the new york heart association(nyha) classification≥iii. 2. hypersensitivity to lidocaine,history of local anesthetic poisoning. 3. severe renal or hepatic dysfunction. 4. body mass index (bmi)\>35 kg m-2. 5. severe pleural adhesions.
sevelamer hydrochloride in peritoneal dialysis patients

Conditions: Endstage Renal Disease

Summary: to test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in esrd patients. hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in esrd patients and is largely attributed to the increased prevalence of vascular calcification.

Eligibility criteria:
inclusion criteria: * esrd patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only * patients who cannot afford to self-pay sevelamer hydrochloride. * patients who provided informed consent for the study exclusion criteria: * patients with underlying active malignancy * patients with cyanotic congenital heart disease * patients with poor general condition * patients with plan for living related kidney transplant within coming 1 year * female patients with pregnancy

Keywords: vascular, valvular calcification, phosphate binder, sevelamer, endstage renal disease peritoneal dialysis