Kornimate/medical-research-clean huggingface dataset:
a clinical trial to investigate efficacy and safety of nt 201 injections compared with placebo injections in participants aged 18 years and older with chronic nerve pain after shingles or nerve injury

Conditions: Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury

Summary: in this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with nt 201 or placebo. the purpose is to measure the decrease of nerve pain with nt 201 compared to placebo. trial details include: * trial duration: 22-23 weeks; * treatment duration: 1 injection visit with a 20-week follow-up period; * visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).


Eligibility criteria:
inclusion criteria: * chronic peripheral neuropathic pain that persists for at least 6 months by the time of the screening visit and is plausibly related to either an episode of herpes zoster or a peripheral nerve injury (caused by surgery or mechanical trauma). * documented diagnosis of either chronic neuropathic pain after peripheral nerve injury (i.e., postsurgical/post-traumatic neuropathic pain) or postherpetic neuralgia with at least probable level of certainty according to the neupsig/iasp (neuropathic pain special interest group / international association on the study of pain) grading system. * a score of at least 4 out of 10 points on the neuropathic pain 4 questions (dn4) questionnaire. exclusion criteria: * complex regional pain syndrome type 1 and type 2. * any other painful condition or disease that requires treatment (only mild to moderate episodic migraine treated with triptans and/or non-steroidal anti- inflammatory drugs (nsaids), if any, is acceptable). * postsurgical/post-traumatic neuropathic pain due to amputation and/or phantom limb pain.
nodal staging in breast cancer with mrl

Conditions: Breast Neoplasms

Summary: the aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (mrl). the diagnostic performance of mrl will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. the pathologic examination of the sentinel lymph node biopsy (slnb) or axillary lymph node dissection (alnd) will be regarded as the golden standard for nodal involvement.


Eligibility criteria:
inclusion criteria: 1. female patient with histopathologically confirmed breast cancer about to undergo nodal staging. 2. willing and able to undergo all study procedures 3. has personally provided written informed consent. exclusion criteria: 1. age \<18, 2. pregnancy 3. contra indications for mrl such as pacemaker, aneurysm clips or severe claustrophobia. 4. allergy to any of the ingredients of gadofosveset (vasovist® /ablavar®) 5. being unable to give informed consent in person 6. acute or chronic severe renal insufficiency (glomerular filtration rate \<45 ml/min/1.73m2)1. 7. acute renal insufficiency of any severity due to the hepato-renal syndrome. 8. known (or suspicion of) qt- prolongation

Keywords: mri lymph node metastases breast cancer gadofosveset
assessment of 3d transperineal ultrasound imaging w/ matrix array transducers in prostate radiotherapy

Conditions: Prostate Cancer

Summary: specific study aims 1. to evaluate congruence between pelvic anatomical structures segmented on mri and/or ct scans co-registered with transperineal us scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer. 2. to estimate the achievable accuracy of anatomy tracking based on 3d us matrix-array transducer imaging and grey-level based image registration algorithms.

specific study aims 1. to evaluate congruence between pelvic anatomical structures segmented on mri and/or ct scans co-registered with transperineal us scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer. 2. to estimate the achievable accuracy of anatomy tracking based on 3d us matrix-array transducer imaging and grey-level based image registration algorithms.

Eligibility criteria:
inclusion criteria: * men that will undergo prostate radiotherapy as a primary treatment or post-prostatectomy. * age 18 or older * ability to understand and sign informed consent exclusion criteria: * younger than 18 yrs old * inability to provide written and spoken consent. * patients with implanted actively controlled devices that may be subject to electromagnetic interference from the uronav/pervunav electromagnetic tracking used in the study.

Keywords: prostate cancer
salivary microrna in endometriosis: correlation with response to progestin therapy

Conditions: Endometriosis

Summary: this study aims to analyze the salivary mirna specific for patients diagnosed with endometriosis, specifically evaluating the mirna profile of patients who respond versus those who do not respond to progestin therapy. ninety patients attending the chronic pelvic pain clinic will be recruited, and they will be asked to provide a saliva sample before starting medical therapy. the response to the therapy will be evaluated after 4 months from the beginning of the therapy itself.

in recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. among these, microrna (mirna) is emerging as a promising option. despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among mirnas. this study aims, therefore, to identify salivary mirna signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the obstetrics and gynecology clinic at the santa maria della misericordia hospital in udine will be enrolled. the investigators will ask them for a salivary sample before starting the progestin therapy. after 4 months from the beginning, the response will be evaluated. the researchers will evaluate the differences between salivary mirna of the responders vs non-responders.

Eligibility criteria:
inclusion criteria * age \> 18 years * fertile age * clinical-ultrasound diagnosis or histological diagnosis of endometriosis * informed consent exclusion criteria * pregnancy * pre-menarcheal or post-menopausal status * chronic pelvic pain syndrome with or without central sensitization assessed with the central sensitization inventory test (csi) * neoplasia, diabetes, bmi \> 30 kg/m2, coagulopathies, autoimmune diseases, or other conditions that may affect salivary mirna measurement * currently undergoing progestin therapy

Keywords: endometriosis mirna progesterone resistance
stepped care model for the wider dissemination of cognitive-behavioural therapy for insomnia among cancer patients

Conditions: Insomnia

Summary: insomnia is very common in cancer patients. when left untreated, insomnia can lead to numerous serious consequences (e.g., psychological disorders) for the individual and significant costs for society (e.g., increased medical consultations). cognitive-behavioural therapy (cbt), a form of psychotherapy, is now considered the treatment of choice for insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer patients. unfortunately, cbt for insomnia (cbt-i) is not widely accessible as only a few cancer clinics have mental health professionals formally trained in the administration of this treatment. innovative models of treatment delivery are therefore needed to make sure that every cancer patient with insomnia receives the care he/she needs. a stepped care approach in which patients only receive the level of treatment that they need, beginning with a minimal, less costly, intervention followed by more intensive treatment if required, has shown some promises for other psychological disorders (e.g., depression). although its relevance has been emphasized to make cbt-i more accessible, its utility has never been investigated. the main goal of this randomized non-inferiority study is to assess the efficacy and costeffectiveness of a stepped care cbt-i as compared with standard care. our hypothesis is that a stepped care approach will not be statistically inferior in terms of efficacy as compared to usual care, while being much less costly (better cost-effectiveness ratio). three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be assigned to: (1) stepped care cbt-i (n = 118) or (2) standard care (n = 59), consisting of 6 weekly sessions administered individually by a professional.


Eligibility criteria:
inclusion criteria: * have received a diagnosis of non-metastatic cancer (any type) in the past -18 months * to have an isi score \> 7 * to be aged between 18 and 75 years old * to be readily able to read and understand french exclusion criteria: * having a life expectancy \< 1 year * having a severe psychiatric disorder (e.g., psychotic, substance use, severe depressive disorder) * having severe cognitive impairments (e.g., diagnosis of parkinson's disease, dementia, or mini-mental state examination score \< 24) * having received a formal diagnosis for another sleep disorder (e.g., obstructive sleep apnea, periodic limb movement disorder) * shift work in the past 3 months or in the next 12 months * to have received a cbt for insomnia in the past

Keywords: stepped care model insomnia cancer cognitive-behavioural therapy self-help treatment web-based intervention non-inferiority design cost-effectiveness
ultrasound (us)-guided versus sham ultrasound corticosteroid (cs) knee injections

Conditions: Osteoarthritis

Summary: to determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.


Eligibility criteria:
inclusion criteria: * age between 40 and 89. * meet the american college of rheumatology criteria for knee oa with knee pain, aching or stiffness on most of the past 30 days and have evidence on radiograph of a definite osteophyte. * have a pain score of at least 4 out of 10 on an 11 point numeric rating scale. * for participants with bilateral knee oa, the most symptomatic knee will be considered the study knee. if both knees are symptomatic, the subject will choose the one they want treated. * be able to speak and understand english. * have a telephone. exclusion criteria: * prior hyaluronic acid injection. * scheduled knee hyaluronic acid injections, arthroscopy, or knee surgery. * comorbid conditions including: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain, knee instability defined as report of knee buckling or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent * current involvement in litigation or receiving workmen's compensation. these patients are to be excluded because they are expected to bias results. this group will be expected to over-report pain symptoms. this bias cannot be corrected for in the analysis. * contraindications to intra-articular injections: known bleeding disorder/diathesis. * prosthesis in the painful knee. * bilateral total knee replacements. * pregnancy if no recent knee x-rays are available. * wheelchair bound. * bmi greater than 40.

Keywords: ultrasound osteoarthritis knee corticosteroids intra-articular injections
a study to evaluate the acute bronchodilator effect of chf1535 nexthaler

Conditions: Asthma

Summary: the aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of chf 1535 nexthaler 200/6 µg and a single dose of chf 1535 nexthaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.


Eligibility criteria:
inclusion criteria: * patient's written informed consent obtained prior to any study-related procedures. * male or female aged between 18 and 65 years inclusive; * evidence for "partially controlled" or "uncontrolled" asthma; * medium daily dose of previous inhaled corticosteroids (ics) treatment; * fev1 between 60% and 85% of the predicted normal values; * a documented positive response to the reversibility test; * non-smokers or ex-smokers; * a cooperative attitude and ability to be trained in the proper use of a dpi. exclusion criteria: * pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception. * significant seasonal variation in asthma occurring or expected to occur during study participation; * history of near fatal asthma, brittle asthma, accident and emergency treatment or hospitalisation for asthma exacerbation in intensive care unit within 1 year before screening; * occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening; * diagnosis of chronic obstructive pulmonary disease; * history of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency; * diagnosis of restrictive lung disease; * patients treated with oral or parenteral corticosteroids in the previous 8 weeks; * intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids; * allergy, sensitivity or intolerance to study drugs or excipients; * patients who received any investigational drug within the last 8 weeks before the screening; * patients taking any of the non-permitted concomitant medication; * subjects unlikely to comply with the study protocol; * any clinically relevant abnormal value or physical finding at screening; * significant medical history; * abnormal and clinically significant 12-lead electrocardiogram; * patients with low compliance of qvar intake.
the safety and efficiency of sirolimus in primary antiphospholipid syndrome: a randomized control study

Conditions: Primary Antiphospholipid Syndrome

Summary: this study is an investigator initiated, randomized, multicenter, double-blind, placebo-control study. the aim of this study is to evaluate the safety and efficiency of sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.


Eligibility criteria:
inclusion criteria: 1. understand and sign the informed consent form 2. male or female 3. aged 18-70 at the time of screening visit 4. met 2006 sapporo classification criteria of aps or 2023 acr/eular classification criteria of aps 5. with the stable combination therapy exclusion criteria: 1. history of serious adverse events or contraindication to sirolimus 2. catastrophic aps within 90 days 3. acute thrombosis within 30 days 4. ≥4/11 american college of rheumatology classification criteria for sle or other systemic autoimmune diseases 5. historically positive hiv test or test positive at screening for hiv 6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis b infection, hepatitis c infection, cmv, ebv, syphilis, etc) 7. surgery treatment within one month 8. history of malignant neoplasm within the last 5 years 9. white blood cell counts\<3×10\*9/l 10. abnormal liver function tests: alt or ast ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value 11. pregnant or pregnancy preparation or breastfeed 12. any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects

Keywords: aps
training balance among people with neurodevelopmental disabilities

Conditions: Posture; Balance; Cerebral Palsy; Autism; Down Syndrome

Summary: this study is a case control pilot study to investigate the impact of a short-term intervention on training anticipatory postural adjustments in a population of people with neurodevelopmental disabilities.

data will be collected by using a weighted pendulum to provide a posterior perturbation to test subjects' postural reactions pre and post-intervention. intervention will include four sessions of weighted ball tosses/weighted tether ball stops to improve muscle activation patterns and efficiency. emg sensors, 3d motion analysis, and force plates will be used to collect the necessary data.

Eligibility criteria:
inclusion criteria: participants 1. able to stand without assistance 2. diagnosis of cerebral palsy, down syndrome, or autism spectrum disorder 3. able to stop weighted ball without falling 4. able to follow directions controls 1. able to stand without assistance 2. no neurodeveloopmental disability 3. able to stop weighted ball without falling 4. able to follow directions exclusion criteria: 1. pregnancy 2. unable to maintain standing when stopping a ball on a rope
translating telephonic diabetes self-management support to primary care practice

Conditions: Type 2 Diabetes

Summary: the goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout new york city. the program will be implemented by the new york city department of health, through their primary care improvement project.


Eligibility criteria:
inclusion criteria: * 21 years of age and older * receiving treatment for diabetes at selected primary care practices throughout new york city * most recent hba1c ≥ 7.5% (max 3 months prior to randomization) * ability to speak and read english or spanish (or someone in the household who will read to them) * access to a telephone * willing to give informed consent to participate and accept random assignment. exclusion criteria: * stated intention to move out of the new york city area during the next year * mental incapacity (e.g., confusion) evident on first telephone contact by department of health staff * treatment provider deems that the patient is inappropriate for the trial

Keywords: diabetes treatment adherence self-management emotional distress diabetes-related distress
experimental headache induced by vasoactive intestinal polypeptide

Conditions: Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound

Summary: we hypothesized that infusion of vip may induce headache in healthy subjects and that vip induced headache may be associated with dilatation of intra- and extracerebral blood vessels. to test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.

we hypothesized that infusion of vip may induce headache in healthy subjects and that vip induced headache may be associated with dilatation of intra- and extracerebral blood vessels. to test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters. in a double-blind, placebo-controlled, crossover design, the subjects were randomly allocated to receive 8 pmol/kg/min vip or placebo (isotonic saline) over 25 min. headache intensity, mean velocity of blood flow in the middle cerebral artery (vmeanmca), superfical temporal artery diameter, petco2, adverse events and vital signs were recorded at t-10, t0 and then every 10 min until 120 min after start of infusion. single photon emission computerized tomography (spect) was performed at t-0, t20 and t60.

Eligibility criteria:
inclusion criteria: - healthy volunteers exclusion criteria: - migraine cerebrovascular disorders pregnancy

Keywords: healthy volunteers, headache, migraine, hemodynamics, vip, spect, ultrasound
effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults

Conditions: Insulin Resistance

Summary: the purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.

polyphenols may have several favourable effects on health. dark chocolate (dc) is one of the highest sources of polyphenols in foods. the aim of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults. seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes will be recruited. participants will randomly receive 20g daily of one of the two different types of dc: placebo dc (low in polyphenols) or dc rich in polyphenols (500mg) for a period of four weeks. participants will be asked to make two appointments to the university clinical lab. anthropometric measurements (height, weight, waist circumference), blood and saliva samples will be taken during each of the 2 visits. compliance will be tested by the measure of total polyphenols in a 24-hour urine sample in some random samples before and at the end of the intervention. to monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary and a physical activity questionnaire will be collected before the start of the study and after four weeks. data will be analysed with an ancova with time (pre- and post-) and treatment (dc and placebo) as between-subject factor.

Eligibility criteria:
inclusion criteria: * adults with no history of hypertension, diabetes and cardiovascular diseases * bmi from 18-24.9 and bmi \>25 * males and females * age: 18-65 years exclusion criteria: * participants with cardiovascular diseases, hypertension or diabetes * smokers and heavy alcohol drinkers * participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure * participants taking dietary supplements containing high doses of antioxidants * postmenopausal women taking hrt (hormone replacement therapy) * participants who recently participated or are currently on a weight management program * participants with regular consumption of cocoa or dc (\> 1 serving/week)

Keywords: diabetes type ii, insulin sensitivity