Kornimate/medical-research-clean huggingface dataset:
comparison of effectiveness of transrectal ultrasonography-guided saturation biopsy and 10-12 core biopsy in repeated prostate biopsies

Conditions: Prostate Cancer

Summary: objective to assessment the results of repeated saturation and 10-12 core biopsy protocols in patients with a negative initial biopsy but continued suspicion for prostate cancer materials and method data of the patients who underwent prostate biopsy between june 2007 and june 2012 were retrospectively assessed. patients with an abnormal digital examination findings and/or abnormal serum prostate specific antigen levels were biopsied. the indication for a repeated biopsy was determined as the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. patients who underwent saturation and core 10-12 biopsies at repeated biopsies were compared. statistical analyses were performed with shapiro-wilk test and mann- whitney u test. a p value less than 0.05 was accepted as statistically significant.


Eligibility criteria:
inclusion criteria: 1. abnormal digital examination 2. high serum prostate specific antigen (psa) level. 3. the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia (hgpin) or atypical small acinar proliferation (asap). exclusion criteria: 1. patients with coagulopathies 2. patients with unsuitable general conditions for prostate biopsy.

Keywords: prostate-specific antigen digital rectal examination transrectal ultrasonography needle biopsy prostate cancer
validation of digital-pcr analysis through programmed imatinib interruption in pcr negative cml patients

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to assess the capability of the dpcr technique to predict the absence of disease relapses after imatinib discontinuation in cml patients with negative q-rt-pcr results for longer than 18 months.

this study will recruit approximately 100 cml patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard q-rt-pcr as performed in their own centers. after signing the informed consent form (icf), the patients will be tested for dpcr and will discontinue imatinib therapy. then they will be monitored by standard q-rt-pcr to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. at the end of this period, a peripheral blood sample for dpcr analysis will be obtained from those patients who will still have undetectable bcr-abl transcripts by q-rt-pcr to verify cml eradication. the maintenance of molecular remission by q-rt-pcr and the survival will be monitored every six months during an additional follow-up of 24 months. patients found to be positive to bcr-abl transcripts by standard q-rtpcr will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive bcr-abl positive tests with at least one with bcr-abl/bcr value above 0.1%, or until the end of the study, whichever come first.

Eligibility criteria:
inclusion criteria: 1. signed and dated irb/iec-approved informed consent 2. age\>=18 years 3. male or female patients with cml diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy 4. sustained complete molecular response (as defined by the treating center) for at least 18 months with imatinib treatment 5. a minimum of 3 cmr determined by q-rt-pcr analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date 6. willingness and ability to comply with scheduled visits laboratory tests and other study procedures exclusion criteria: 1. allogenic hematopoietic stem cell transplantation 2. known active infections including human immunodeficiency virus (hiv) positivity 3. current enrollment another clinical trial 4. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results
combined fluoroscopy and ct guided radiofrequency ablation of thoracic dorsal root ganglia in severe thoracic pain

Conditions: Cancer-related Problem/Condition

Summary: in the current study, extra-guidance other than conventional fluoroscopy - will be integrated to improve the success of the transforaminal approach to the thoracic dorsal root ganglia (drg). the investigators hypothesize that joining ct scan with fluoroscopy to guide rf ablation through the transforaminal route may enhance its efficacy and safety in relieving the intractable pain associated with chest malignancies. the current study aimed to compare the results of thermal radiofrequency ablation (trfa) of the thoracic drg under combined ct and fluoroscopy guidance with the classic standard fluoroscopy technique.

thoracic pain represents about 3-5% of pain clinics' visitors worldwide .post-thoracotomy pain occurs in 30%-50% of patients undergoing thoracotomy .interventional therapies include epidural or intrathecal drug injection, intercostal nerve block, sympathectomy, rhizotomy, and percutaneous cervical cordotomy. rhizotomy refers to the selective segmental destruction of the dorsal sensory rootlets to interrupt pain perception by the spinal cord. this could be accomplished either neurosurgically, chemically or using selective percutaneous procedures such as cryoanalgesia and radiofrequency (rf) ablation.there are many technical difficulties in approaching the deep-seated thoracic dorsal root ganglia (drg) through the transforaminal route.the spine is kyphotic - with the tip at t6 - and slightly scoliotic to the right side even in normal subjects . spinous processes are acute, especially at t5-t8 level. besides, broad and wide laminae together with narrow intervertebral foramina are other obstacles .the intervertebral foramina are further masked by the facet joints and the crowdedness of the costovertebral and the costotransverse joints .for all these factors, more guidance - other than conventional fluoroscopy - may improve the success of the transforaminal approach to the thoracic drg. the investigators hypothesize that joining ct scan with fluoroscopy to guide rf ablation through the transforaminal route can enhance its efficacy and safety in relieving the intractable pain of chest malignancies. the current study aimed to compare the results of thermal radiofrequency ablation (trfa) of the thoracic drg under combined ct and fluoroscopy guidance with the classic standard fluoroscopy technique.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more * suffering from chronic moderate-to-severe pain ( vas score ≥ 40 mm) * due to malignancy involving the chest and pain was refractory to the maximally tolerated dose of opioids for at least four weeks. malignancies included : lung cancer, pleural mesothelioma, chest wall tumors and metastatic deposits of the chest. exclusion criteria: * sepsis, coagulopathy * malignant epidural invasion * distorted local anatomy * severe cardiorespiratory compromise * neuropsychiatric illness * history of drug dependence and known allergy to contrast media or the used medications.
safety and pharmacokinetics study of fbf001

Conditions: Avian Influenza

Summary: the purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of fbf001.


Eligibility criteria:
inclusion criteria: * subject between 21-40 years old * with body mass index in the range 18 to 30 kg/m2 exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness * any vaccination within three months before the inclusion * any vaccination against h5n1 virus * planned receipt of any vaccine during the study * any infectious disease within the month before the inclusion * any history of animal proteins allergy, animal allergy and/or any drug, food and pollen allergy * who has received blood or plasma derivatives (human or animal) in the three months preceding the initiation of the study * any medication within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug
evaluation of the fluid response of sars-cov-2 (covid-19) patients in intensive care; pleth variability index

Conditions: Pleth Variability Index

Summary: in this study; we aimed to investigate the role of pleth variability index, which is a noninvasive method, in showing fluid response in sars-cov-2 (covid-19) patients, which we know is appropriate fluid management.


Eligibility criteria:
inclusion criteria: * patients hospitalized in covid 19 anesthesia intensive care unit * patients over the age of 18 exclusion criteria: * patients under the age of 18
open-label safety study of dipraglurant (adx48621) in patients with parkinson's disease receiving levodopa-based therapy

Conditions: Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Summary: this open-label study is designed to assess the long-term safety and tolerability of dipraglurant in pd patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an addex sponsored double-blind clinical trial of dipraglurant.


Eligibility criteria:
inclusion criteria: * completed an addex randomized controlled study of dipraglurant and, in the judgement of the investigator, may benefit from open-label treatment * able to take study drug 3 times daily and no less than 3 hours apart * must be taking levodopa not less than 3 times daily throughout the study * must maintain stable regimen of antiparkinson's medications (including levodopa) and be willing to continue the same doses and regimens for the first 4 weeks of the study exclusion criteria: * patient is judged by the investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the addex randomized controlled study of dipraglurant) * use of amantadine or amantadine er throughout the study * use of memantine throughout the study * any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks of study participation other protocol-defined inclusion and exclusion criteria may apply

Keywords: parkinson's disease dyskinesia levodopa-induced dyskinesia
transdermal radiofrequency v eraser versus polidocanol sclerotherapy for reticular veins and telangiectasias

Conditions: Varicose Veins Leg; Telangiectasias

Summary: this study tested v eraser, transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs

chronic venous disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. the v eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions. methods: this was a prospective, randomized, and comparative study comparing v eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. forty-one patients were randomized to either v eraser or polidocanol sclerotherapy and underwent a single treatment session. efficacy was assessed using the aberdeen varicose vein questionnaire and vessel clearance analysis in pre- and post-treatment images.

Eligibility criteria:
inclusion criteria: * patients willing to sign informed consent * patients from 18 to 80 years old with cvd classified as ceap clinical classes c1 to c5, but only telangiectasias and reticular veins not connected to larger varicosities exclusion criteria: * patients with great saphenous or small saphenous vein insufficiency. * patients with allergies to polidocanol * patients with contraindications to treat varicose veins

Keywords: radiofrequency sclerotherapy varicose veins
study to evaluate the efficacy of arrae's bloat & calm alchemy capsules to reduce bloating, heartburn and gas, and alleviate the intensity of ibs symptoms

Conditions: IBS - Irritable Bowel Syndrome; Anxiety

Summary: this is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of ibs (such as bloating, gas, heartburn, and other symptoms).

it is hypothesized that the dietary supplement marketed as "arrae bloat" will improve subjective wellbeing in trial participants. it is further hypothesized that a second dietary supplement marketed as "arrae calm" will support the effects of "arrae bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.

Eligibility criteria:
inclusion criteria: * female over 18 years old * self-reported (undiagnosed) ibs symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals * must be in good health (don't report any medical conditions asked in the screening questionnaire) * following a stable, consistent diet regimen * agree to refrain from any lifestyle changes that may affect their gi tract and ibs symptoms for the duration of the study * may have self-reported sleep issues * may have self-reported mild anxiety/depression * may have self-reported occasional panic attacks exclusion criteria: * prior prescriptions for ibs * current ibs treatment (e.g. proton pump inhibitors, laxatives) * follow an extreme diet intervention * experienced severe weight loss in the past 3 months prior to study participation * antibiotic usage within 3 months prior of study participation * usage any medication or herbal remedies which can affect the gi tract * food intolerances/allergies * pineapple sensitivity/allergy * taking cortisol lowering prescription medication * has any of the following medical conditions: history of gi tract cancers celiac disease / gluten intolerance gi bleeding rectal bleeding heme-positive stool iron-deficiency anemia systemic signs of infection insomnia moderate to severe depression/anxiety moderate to severe panic attacks - females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
detrusor contraction during the ice-water-test

Conditions: Urinary Bladder, Neurogenic; Neuropathic Bladder

Summary: in this randomized, double-blind clinical trial including patients with a neurogenic lower urinary tract dysfunction undergoing urodynamic investigation at the spinal cord injury center, balgrist university hospital, zürich, we aim to investigate whether the detrusor contraction during the ice-water-test is provoked by the ice water or the rapid filling.

the ice-water-test (iwt) was first described 1957 by bors and blinn and it was thought to differentiate between lesions of the upper and lower motoneuron. in cat studies, it was shown that the iwt is a c-fiber mediated lower motoneuron segmental reflex and that these unmyelinated c fibers are associated with cold receptors. this explains the positive iwt in patients with upper motoneuron lesions. in healthy humans, the iwt is positive up to the age of 4 years and becomes negative thereafter since the reflex is centrally inhibited. however, this reflex might be unmasked by a neurological disease and/or injury. considering that c-fibers are involved in the pathogenesis of detrusor overactivity, the iwt seems to be a useful diagnostic tool in daily practice. however, although there are many studies published on the iwt, it is unclear whether the detrusor contraction during the iwt is provoked by the ice water or whether it might be caused by the rapid filling. therefore, we designed this randomized, double-blind trial.

Eligibility criteria:
inclusion criteria: * neurogenic lower urinary tract dysfunction * urodynamic investigation * written informed consent * ≥ 18 years old exclusion criteria: * symptomatic urinary tract infection * \< 18 years old * ≥ 90 years old * no written informed consent * pregnancy

Keywords: lower urinary tract bladder neuropathic bladder overactive bladder
mitochondria and muscle health in elderly

Conditions: Muscle Weakness

Summary: the aim of this study is to characterize the relation between skeletal muscle mitochondrial metabolism and muscle health in elderly, physically compromised humans. to study this relation, a cross-sectional study will be performed in well-defined, distinct subject groups. thus, to obtain insight in the relation between mitochondrial health and muscle function, not only subjects that differ in mitochondrial function (based on physical activity) will be compared but also subjects with high- versus low muscle function will be selected.

aging is associated with a decline of mitochondrial and skeletal muscle volume, -quality and -function. if a causal link exists between the loss of mitochondrial function and muscle health is unknown, however, both appear with advancing age and are associated with the loss of functional capacity, which increases comorbidities and annual healthcare costs. the aim is to test the hypothesis that a compromised muscle function in sedentary elderly is related to an impaired mitochondrial health. a detailed characterization of mitochondrial metabolism and muscle function is performed in well-defined, (physically compromised) elderly humans, in a cross-sectional design. to obtain insight in the relation between mitochondrial health and muscle function, not only elderly subjects that differ in mitochondrial function (based on physical activity) will be compared but also elderly subjects with high versus low muscle physical function will be selected. healthy, young (20-30 years,) individuals with normal physical activity levels will be included as absolute controls.

Eligibility criteria:
inclusion criteria: * males and females * subject should be in sufficient health to participate in the experimentations, to be judged by the responsible md based on the subject's medical history * caucasian origin (see study groups) exclusion criteria: * any contraindications for mri scan: aneurysm clips implanted neural stimulator implanted cardiac pacemaker of defibrillator cochlear implant iron- containing corpora aliena in the eye or brain artificial (heart) valves which is contraindicated for mrs claustrophobia * diagnosed with diabetes mellitus * poor health as judged by the responsible medical doctor * heart problems: in case of an abnormal ecg in rest, this will be discussed with both the participant and the responsible medical doctor

Keywords: mitochondrial health muscle function aging
certolizumab pegol for the treatment of patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase iiib multicenter study to evaluate the safety and efficacy of certolizumab pegol (czp) administered to patients with moderate-to-severe rheumatoid arthritis.

the treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. in the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (czp) or placebo up to and including week 10. the randomization will be stratified according to the three factors: concomitant use of methotrexate (mtx, yes or no), prior anti-tumor necrosis factor (anti-tnf) use (yes or no), and disease duration categories (\< 2 years or ≥ 2 years). from week 12 all patients remaining in the study receive open-label czp for a minimum 16 additional weeks until czp is commercially available.

Eligibility criteria:
inclusion criteria: * adult patient with established moderate to severe rheumatoid arthritis exclusion criteria: * all concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment * previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials

Keywords: certolizumab pegol cimzia rheumatoid arthritis joint disease chronic arthritis
safety and pharmacokinetics of a single oral tpn171h in healthy elderly subjects

Conditions: Erectile Dysfunction

Summary: it is a single-center, open-label, phase i clinical study evaluating the safety and pharmacokinetics of a single oral tpn171h in elderly subjects.


Eligibility criteria:
inclusion criteria: 1. ≥ 65 years old； 2. male≥50kg，femal≥45kg, body mass index should be between 18 and 30 kg/m2 (inclusive)； 3. no major organ dysfunction；normal heart, liver and kidney function; 4. physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ecg, abdominal ultrasound, chest x-ray results were normal or abnormal but investigator judged suitable for participating in this trial; 5. fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent exclusion criteria: 1. allergies to test preparations, any of their ingredients, and related preparations; with allergies or allergic diseases; 2. surgical condition or condition that may significantly affect adme of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study 3. myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion; 4. taken any of drugs(inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with nitrate/nitric oxide (no) donors。 5. with a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (naion), abnormal color vision, hereditary retinopathy (e.g. retinitis pigmentosa), and macular degeneration； 6. a history of sudden decrease or loss of hearing； 7. a history of postural hypotension； 8. blood loss ≥400 ml within 3 months before inclusion； 9. participated in other drug clinical trials or medical devices clinical trials within 3 months before administration； 10. drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(drink alcoholics defined as 125 ml of wine, 220 ml of beer, or liquor50ml； alcoholism is defined as 5 or more drinks in approximately 2 hours) ; 11. a history of drug use or have been screened positive for drug abuse; 12. smoked more than 10 cigarettes a day within 6 months prior to inclusion; 13. hepatitis b surface antigen (hbsag),hepatitis c virus antibody,treponema pallidum antibody,human immunodeficiency virus antibody (hiv)positive; 14. other factors that the investigator considered inappropriate for the study.