Kornimate/medical-research-clean huggingface dataset:
68ga-psma pet/ct in prostate cancer

Conditions: Prostate Cancer

Summary: the objectives of this study are to replicate the safety and efficacy of 68ga-psma pet/ct and as a diagnostic and decision making tool in the management prostate cancer patients.the primary endpoints of the study are the incidence of adverse events (ae) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68ga-psma pet/ct vs ct on a per-patient and per-lesion basis.

positron emission tomography / computer tomography (pet/ct) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. a radiotracer in use today is 68ga-hbed-cc-psma (dkfz-11) - hereinafter abbreviated 68ga-psma - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (psma) pet/ct. imaging with 68ga-psma pet is used to characterize and localize prostate cancer in humans in vivo. there is extensive data in the literature showing the value of 68ga-psma pet/ct imaging in accurately staging and restaging prostate cancer. the objectives of this study are to replicate the safety and efficacy of 68ga-psma pet/ct and to establish our ability to reproduce results from the literature using 68ga-psma pet/ct as a diagnostic and decision making tool in the management prostate cancer patients. during the study eligible prostate cancer patients will undergo one 68ga-psma pet/ct. the primary endpoints of the study are the incidence of adverse events (ae) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68ga-psma pet/ct vs ct on a per-patient and per-lesion basis.

Eligibility criteria:
global inclusion criteria: * resident of canada * male sex * age 18 years or older * previously diagnosed with prostate cancer, under referring physician's care * ecog performance status 0 - 3, inclusive * able to understand and provide written informed consent * able to tolerate the physical/logistical requirements of a pet/ct scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation global exclusion criteria: * patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * patients who exceed the safe weight limit of the pet/ct bed (usually approximately 400 lbs.) or who cannot fit through the pet/ct bore (usually approximately 70 cm diameter) * patients with unmanageable claustrophobia clinical indication criteria subgroups: * bcr: biochemical recurrence as defined by serum psa \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management * hrs: staging of high risk patients as defined by any one of the following: * gleason score \> 7 * serum psa \> 10 ng/ml * t stage of t3 or greater on tnm staging * equivocal conventional staging such as ct, mri or bone scan * clinical suspicion of advance stage disease (e.g. bone pain)
drug-drug interaction study (telmisartan, amlodipine, chlorthalidone)

Conditions: Hypertension

Summary: to evaluate drug-drug interaction

the purpose of this study is to evaluate the drug-drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Eligibility criteria:
inclusion criteria: 1. participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight) 2. who has not suffered from clinically significant disease 3. provision of signed written informed consent exclusion criteria: 1. history of and clinically significant disease psychiatric, or malignancy. 2. a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. 3. administration of other investigational products within 3 months prior to the first dosing. 4. administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (otc) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study). 5. volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ecgs, or vital signs.
pain alleviation with testosterone in opioid-induced hypogonadism

Conditions: Opioid Use; Pain; Hypogonadism, Male

Summary: the aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

this single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Eligibility criteria:
inclusion criteria: * men, age 18 years and older. * chronic non-cancer spinal pain. * use of opioid analgesics for at least 6 months. * serum total testosterone (measured by mass spectrometry) \<348 ng/dl and/or free testosterone \<70 pg/ml. * ability and willingness to provide informed consent. exclusion criteria: * history of prostate cancer or breast cancer. * known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease). * use of testosterone within the past 6 months. * baseline hematocrit \>48%. * prostate-specific antigen (psa) level \>4 ng/ml in caucasians or \>3 ng/ml in african-americans. * presence of prostate nodule or induration on digital rectal examination. * uncontrolled congestive heart failure. * myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months. * serum creatinine \>2.5 mg/dl. * alanine aminotransferase (alt) level 3 times above the upper limit of normal. * diagnosis of bipolar disorder or schizophrenia. * presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (mri). in subjects who are otherwise eligible and either do not qualify for mri or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.

Keywords: pain opioid analgesics testosterone
a study to evaluate the effectiveness and safety of an implant in the treatment of osteoarthritis of the great toe

Conditions: Osteoarthritis of First Metatarsalphalangeal Joint

Summary: this study will evaluate whether cartiva is an effective treatment for individuals with osteoarthritis of the great toe.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis * presence of good bone stock * capable of completing self-administered questionnaires exclusion criteria: * \< 18 years of age * osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis * active bacterial infection of the foot * additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)

Keywords: first mtp joint hallux rigidus hallux limitus cartilage replacement osteoarthritis first mtp joint osteoarthritis big toe pain
specific clinical experience investigation for long-term use of exenatide (byetta subcutaneous injection)

Conditions: Type 2 Diabetes

Summary: the purpose of this investigation is to describe general safety profile of type ii diabetes mellitus (dm) japanese patients under exenatide therapy in real world medical practices

specific clinical experience investigation for long-term use of exenatide (byetta subcutaneous injection).

Eligibility criteria:
inclusion criteria: - patient diagnosed with type 2 diabetes mellitus and who is naive patient with byetta.

Keywords: diabetes mellitus (dm) byetta exenatide
mild traumatic brain injury registry

Conditions: Brain Injury, Traumatic

Summary: the purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

the mild traumatic brain injury registry is a prospective study which includes patients who have been seen in the cmc ed with a diagnosis of mild brain injury or concussion and a negative ct scan. the investigators will be collecting blood samples, and administering cognitive and balance tests. the investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.

Eligibility criteria:
inclusion criteria: * must have defined history of chi (closed head injury) which produced an altered state of consciousness or mood * must be awake and alert (glasgow coma scale 13-15) * must be enrolled within 72 hours of injury * must have ct or mri neuroimaging performed exclusion criteria: * diabetes mellitus with severe complications * intoxication at time of enrollment * major psychiatric disorder that is poorly controlled * prior stroke * history of social security defined "disability * uncontrolled seizure disorder * incarceration or arrest * concurrent injury requiring hospitalization * use of anticoagulant drugs * any condition the investigator deems as inappropriate for patient enrollment * personality disorder * heart, liver or kidney failure defined using common clinical practice guidelines * baseline cognitive impairment * homelessness * tbi associated with interpersonal violence * pregnancy * long bone fracture requiring surgical stabilization

Keywords: brain concussion
mcbct in combination with enb for the diagnosis of ppns

Conditions: Peripheral Pulmonary Nodules; Lung Cancer

Summary: this study aims to evaluate the clinical value of mobile cone-beam ct (mcbct) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mcbct in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mcbct adjustments.

this study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam ct (mcbct) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. the investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3d imaging findings of mcbct. the value of mcbct in improving diagnostic yield is explored by comparing the diagnostic yield post-mcbct with that of pre-mcbct. the pre-mcbct diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mcbct spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. the post-mcbct diagnostic yield is the proportion of diagnosed patients with and without adjustment after mcbct spin during the procedure in all enrolled subjects.

Eligibility criteria:
inclusion criteria: * subject with age of 18 years and older * chest ct imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology * pulmonary nodules of \> 8mm and ≤30 mm in largest dimension * patients without contraindications of bronchoscopy * patients have good medical adherence and signed informed consent exclusion criteria: * severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy * presence of concomitant endobronchial lesion during the bronchoscopy procedure * pre-operative mcbct spin scan showed no visible lesions

Keywords: peripheral pulmonary nodules diagnosis mobile cone-beam ct electromagnetic navigation bronchoscopy
predictive value of heart rate variability on outcome in patients admitted to the intensive care department

Conditions: Critical Illness

Summary: this study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department


Eligibility criteria:
inclusion criteria: * adults admitted to icu exclusion criteria: * rhythm other then sinus * presence of cardiac pacemaker
a long-term extension study of ustekinumab in pediatric participants

Conditions: Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic

Summary: the purpose of this study is to collect long-term safety data of subcutaneous (sc) ustekinumab


Eligibility criteria:
inclusion criteria: * must have completed the dosing planned in the primary pediatric ustekinumab study * benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study) * parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in informed consent process. an adolescent who signs the assent form will be given the opportunity to sign an adult icf at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * must be willing and able to adhere to the lifestyle restrictions specified in this protocol * females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration exclusion criteria: * are pregnant, nursing, or planning pregnancy or fathering a child * have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (sars-cov-2 \[covid-19\]) infection (test positive), or (b) suspected sars-cov-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected sars-cov-2 infection: exception: (i) may be included with a documented negative result for a validated sars-cov-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit * taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (lte) dose of study intervention * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. receipt of a live severe acute respiratory syndrome coronavirus 2 (sars cov-2) vaccine (against the virus that causes coronavirus disease 2019 \[covid-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor
incentives for postnatal care demand

Conditions: Maternal Death; Neonatal Death

Summary: the purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (pnc) referrals by traditional birth attendants (tbas), via a randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * community-based providers of antenatal and/or delivery care, and who are non-formally trained * must be resident within the community * must not plan to relocate over the intervention duration * identified in partnership with community leadership * be willing to participate fully in the study, including having their clients contacted for verification exclusion criteria: * plan to relocate over the intervention duration * refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification
atrial fibrillation treatment with cryoballoon in heart failure (afiche)

Conditions: Atrial Fibrillation; Heart Failure, Systolic

Summary: in this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). all patients with either have an icd or crt-d/p device implanted or an implantable electrocardiographic monitoring device. the primary study endpoint will be the time to af burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in af over total time).16 this af burden corresponds to 7.2 hours per month. a powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.


Eligibility criteria:
inclusion criteria: * a minimum of at least two separate af episodes recorded within the last 12 months, either on 12-lead rest ecg or on ambulatory ecg recordings (at least 5 minutes of af on holter recordings will be required), * lvef \<40% on sinus rhythm, * symptoms consistent with heart failure (new york heart association ii or higher) despite rate control treatment, * age \>21 years old. exclusion criteria: * previous left atrial ablation, * left atrial diameter \>28 mm/m2 bsa on tte (parasternal long axis view), * strong clinical suspicion that reduced lvef is primarily due to tachycardiomyopathy, * pre-existing device (icd or crt) without af detection algorithms and/or (for crt devices) diagnostics of effective biventricular pacing, * known primary electrical heart disease (e.g. brugada syndrome), * presence of thrombus in a heart chamber, * presence of prosthetic valve at any position, * moderate/severe valvular heart disease, * active infectious disease or malignancy, * moderate or severe hepatic impairment (child-pugh class b or c), * severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2), * inability or unwillingness to adhere to standard treatment or to provide consent.
thromboembolic events in severe covid-19 patients

Conditions: Pulmonary Thromboembolism

Summary: the main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in france for severe covid-19. the secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events


Eligibility criteria:
inclusion criteria: * confirmed infection with the sars-cov-2 virus (rt-pcr) * hospitalization in intensive care unit * age over 18 years old exclusion criteria: * refusal of the patient to participate in data collection

Keywords: covid-19 thrombosis d-dimers anticoagulation
taurine in periodontitis and aging

Conditions: Peridontal Disease; Aging

Summary: aging leads to a decline in physiological functions and increases the risk of chronic diseases. periodontitis is a chronic inflammatory disease that causes progressive destruction of the tissues supporting the teeth. taurine, an amino acid with anti-inflammatory and antioxidant effects, might impact both periodontitis and aging. this study investigated taurine, sirt1, and tnf-α levels in saliva and blood of 66 healthy people in different age groups, with or without periodontal disease. the findings showed that young people with healthy periodontal status had higher levels of taurine and sirt1 compared to others. tnf-α, a marker of inflammation, was linked to the severity of periodontitis and may help identifying it in younger individuals. overall, higher tnf-α levels are associated with periodontal inflammation, while taurine levels decrease with age-related inflammation.


Eligibility criteria:
exclusion criteria: * ages 18-25 or 45-64 * use of antibiotics, anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, or anticoagulants within the last 6 months * presence of diabetes, rheumatoid arthritis, or other systemic conditions such as cardiovascular, renal, hepatic, and neurodegenerative disorders * pregnancy or lactation * alcoholism * smoking * nonsurgical periodontal treatment in the past 6 months or surgical treatment in the past 12 months * having less than 20 natural teeth, excluding third molars * use of orthodontic appliances

Keywords: taurine periodontitis aging inflammation tnf-α sirt1 biomarker
whole genome scan of extended families with familial vocal cord paralysis

Conditions: Vocal Cord Paralysis

Summary: vocal cord paralysis is a common cause of congenital stridor and airway obstruction. in this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.

in a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. in one of the families the gene coding for the disease was located on chromosome 6q16. we will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. all family members will undergo a laryngoscopy to determine the extent of paralysis. for all family members we will isolate dna and determine their microsatellite polymorphism on chromosome 6q16. if the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.

Eligibility criteria:
inclusion criteria: * members of families suffering of familial vocal cord paralysis exclusion criteria: * none

Keywords: familial vocal cord paralysis genetic screening