Kornimate/medical-research-clean huggingface dataset:
study of bone histomorphometry, microarchitecture, and matrix structure in patients receiving alendronate or risedronate

Conditions: Postmenopausal Osteoporosis

Summary: patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. each patient will have received baseline bmd measurements performed at the spine and the hip by dxa. each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. one year later teh bone label and biopsy procedure will be repeated.


Eligibility criteria:
inclusion criteria: * women at least 5 years postmenopausal * subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years. exclusion criteria: * presence of metabolic bone disease other than pmo * use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis. uncontrolled hyperthyroidism. previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin. * alcohol or drug abuse, current or within the past 5 years. * allergy to tetracycline, novocain, or versed. * hip anatomy not conducive to transiliac bone biopsy or dxa scan. * previous bilateral transiliac bone biopsies.
a long-term extension study of jnj-77242113 in participants with moderate-to-severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to evaluate long-term clinical response of jnj-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

the populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. jnj-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates jnj-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. this is a long-term extension study of jnj-77242113 in eligible participants who have completed the week 16 visit of the originating study 77242113pso2001. the total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. safety will be assessed by adverse events (aes), clinical safety laboratory assessments, electrocardiograms (ecgs), vital signs and physical examinations.

Eligibility criteria:
inclusion criteria: * must have completed the week 16 visit in protocol 77242113pso2001 * in the opinion of the investigator, may benefit from inclusion in this long term extension (lte) study * must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study * must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (pasi) or investigator's global assessment (iga) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention * agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention exclusion criteria: * was permanently discontinued from study intervention in protocol 77242113pso2001 for any reason * has received any biologic therapy or experimental therapy since completion of the originating study, 77242113pso2001 * has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention * has received the bacille calmette-guerin (bcg) vaccine within 12 months of the first administration of study intervention * currently has hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) positive, or has other clinically active liver disease, or tests positive for hbsag or anti-hcv
keeping in touch (kit) with youth as they transition to adult type 1 diabetes care

Conditions: Diabetes Mellitus, Type 1

Summary: the investigators are testing the effectiveness of an ehealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care.

the intervention is an ehealth digital solution co-designed with patients and providers. the intervention is a text message based algorithm that operates similar to a chatbot and will send sms messages to participants in the experimental arm, consisting of t1d personalized support, education, resources, and a collection of outcome measures. participants in the control arm will also be onboarded to the kit algorithm but will only receive text-messages asking them to complete outcome measures at baseline, 6 and 12 months -- all outcome measures will be url linkouts to redcap surveys, housed on the sickkids redcap servers. an embedded process evaluation of high and low engagers will also be conducted to understand how and why the intervention achieved or failed to achieve the desired effects.

Eligibility criteria:
inclusion criteria: 1. diagnosed with type 1 diabetes, ascertained from patient's medical chart 2. receiving out-patient care for t1d at a pediatric diabetes center participating in this study 3. is within 6 months of either planned transfer or 18th birthday so research coordinator can approach patient and inform them about the study, and then can be re-approached for consenting and enrollment only within 3-4 months of either: planned transfer to adult diabetes care or 18th birthday 4. proficient in written and spoken english or french 5. possession of their own personal mobile device that can support sms with sufficient capacity to send and receive sms/texts 6. valid and working mobile phone number 7. valid email address 8. willing to engage with intervention if randomized to intervention arm 9. willing to complete study outcome measures (questionnaires) at all study time-points regardless of which arm they are randomized to: baseline, 6 months, and 12 months 10. willing to provide informed consent exclusion criteria: 1. unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening 2. non-resident of ontario or quebec 3. planning to move out of either province in the next 6-12 months and after moving, will not be receiving diabetes care in either province and/or will not have a valid and working mobile number 4. currently enrolled in any other clinical research trial with an sms-based intervention 5. currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit
randomized，controlled and open-label study of buspirone add-on treatment in patients with major depression disorder

Conditions: Major Depression Disorder

Summary: this is a multicenter, open lable, parallel randomized controlled clinical trial. this study aimed to evaluate the treatment onset time, efficacy and safety in patients with major depressive disorders , accompanying anxiety receiving buspirone and paroxetine.


Eligibility criteria:
inclusion criteria: 1. patients meeting statistical manual of mental disorders iv (dsm-iv) criteria for major depression disorder , hamilton depression rating scale(ham-d) score was 17 or above, hamilton anxiety scale（hama）score was 7 or above. 2. aged 18-65 years( including 18,65 years ) 3. male and female and inpatient as well as outpatient. 4. written informed consent was obtained from each patient before therapy. - exclusion criteria: 1. patients with pregnant or breast-feeding and not taking effective contraceptive measures 2. patients were allergic to buspirone or with a known intolerance to contraindication 3. patients with clinically severe and unstable disease ,and not suitable to participate the study judged by the investigators 4. patients with nervous system diseases(such as epilepsy, brain injury, multiple sclerosis, degenerative disease including acute lateral sclerosis, parkinson's disease, ataxy) 5. patients with a mental illness according to the dsm-iv, such as organic mental disorders, schizophrenia, shizoaffective disorder, delusional disorder, undifferentiated schizophrenia, bipolar disorder, and patients with a history of substance abuse including alcohol and active drug within 12 months of screening. 6. patients are taking other psychiatric drugs (such as antipsychotic drugs, anticonvulsant and mood stabilizer but not include antihistamine agents) and receiving ect that might be excluded. 7. patients worked on professional drivers or dangerous works 8. patients participated in clinical trials within the past 30 days and treated with drugs from sponsors are not eligible. 9. patients with clinically significant abnormalities on electrocardiogram or laboratory tests 10. patients with acute angle-closure glaucoma 11. patients with myasthenia gravis 12. patients who have used monoamine oxidase inhibitors (maoi) within 2 weeks of screening 13. patients who were refractory depression invalid or non-responsive to adequate dosage (therapeutic dose upper limit) and duration (up 6 weeks) with two or above different antidepressants. 14. patients who pose a suicidal risk, hamd suicide score was 3 or above . -

Keywords: major depressive disorder efficacy and safety of buspirone add-one treatment in patients with major depression disorder buspirone paroxetine anxiety
intra oral scan and cbct aided diagnosis of dental plaque and caries

Conditions: Dental Caries (Diagnosis); Dental Plaque (Diagnosis)

Summary: in this prospective controlled trial, patients will be enrolled at the university hospital ghent. inclusion criteria are: age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface. all participants have to sign an informed consent. pregnant women will be excluded. first an intra-oral scan will be taken for visual plaque detection. thereafter, plaque scores will be noted after visual inspection and with plaque staining. after supra-gingival calculus removal and oral hygiene instructions bite-wing radiographs will be taken and a visual caries inspection will be performed. finally, a new intra-oral scan will be taken for visual caries detection, followed by a cbct scan. minimally 2 weeks after this intervention, plaque-scores and caries-scores will be measured by an independent researcher and the same researcher on the intra-oral scans, cbct and radiographs(pictures taken with x-rays to view the inside of your teeth and jawbone)(for caries detection). the following variables will be measured: 1. plaque measurement: 1) plaque detection using intra-oral scan images (white light (and fluorescence)) will be performed and compared with 2) the assessment of visual plaque detection and 3) using plaque staining (golden standard). the findings will be recorded in a plaque status through the website www.parodontalstatus. and exported to be attached to the anonymized patient file. 2. caries: the results of caries detection by intra-oral scan and bite-wing radiographs will be compared with the results of clinical caries detection and bite-wing radiographs on one hand and the cbct images on the other hand. icdas scores will be registered for the visual assessment, cbct and bite-wing radiograph images assessment. the following step-by-step protocol will be used: the digital data, including images, that will be the subject of the research will be acquired using 3shape's trios 5 intra-oral scan. the cbct image will be made with the promax 3d of planmeca. these two imaging techniques will be the only study specific handeling during the study. 1. explanation to patients 2. take an intra-oral scan (study specific) 3. conventional visual inspection and palpation plaque scoring 4. plaque staining (record with parostatus.ch) 5. take an intra-oral scan with plaque staining in a situation that is viewed on site, in the mouth, without removing or moving anything.(study specific) 6. calculus removal and cleaning 7. take bite-wing radiographs 8. visual caries detection 9. take a thirth intra-oral scan (study specific) 10. cbct scan (study specific) 11. plaque detection on ios images and caries detection using ios images and cbct images


Eligibility criteria:
inclusion criteria:age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface - exclusion criteria:pregnant women will be excluded -
pvp-i nasal sprays and sars-cov-2 nasopharyngeal titers (for covid-19)

Conditions: COVID-19

Summary: the study aims to determine the safety and efficacy of povidone-iodine (pvp-i) containing nasal sprays as compared to isotonic saline nasal sprays in covid-19 positive patients. the primary outcome measure is sars-cov-2 viral titers in the nasal cavity and nasopharynx. in vitro studies have shown pvp-i to be highly virucidal against the viruses which cause sars and mers. additionally, clinical studies have shown pvp-i saline sprays to be well tolerated in human subjects. pvp-i oral rinses and sprays have been trialed as methods to reduce the incidence and symptoms of viruses which cause the "common cold."


Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 by lab test within 5 days of study participation exclusion criteria: * allergy to "iodine," shellfish, or food dye * receiving intranasal steroids * sinus surgery within 30 days of beginning the study * intubated at the time of enrollment * pregnancy * participation in other covid-19 studies - to be determined on a case by case basis

Keywords: nasal spray pvp-i covid-19
microbiota and metabolites alterations in pancreatic head and body/tail cancer patients

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Summary: pancreatic ductal adenocarcinoma (pdac) can be divided into pancreatic head cancer (phc) and pancreatic body/tail cancer (pbtc) according to the anatomical position of tumors. there is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of pdac patients. studies have shown that the prognosis of pbtc is worse than that of phc, which is partly attributed to the relatively late clinical presentation of pbtc patients and the lack of overt symptoms such as obstructive jaundice, which is common in phc. however, it has also been shown that the worse survival of pbtc compared to phc is not related to the disease stage. previous studies have investigated the molecular differences between phc and pbtc and found that the frequency of smad4 mutation in pbtc was significantly higher than that in phc at early stages (i-ii). in the late stage (iii-iv), pbtc had higher mutation frequency of kirsten rat sarcoma viral oncogene homolog (kras) and mitogen-activated protein kinase (mapk) pathway, but lower frequency of genomic alterations which can be targeted by drugs. the above genetic and molecular differences may be related to the clinical differences between phc and pbtc. however, the differences in microbial composition and metabolism between phc and pbtc have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. in this study, the investigators aimed to analyze the microbial and metabolic differences between phc and pbtc through 16s ribosomal ribonucleic acid (rrna) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of pdac at different anatomical positions.


Eligibility criteria:
inclusion criteria: 1. participants aged above 18 years. 2. patients who signed informed consent. 3. pdac patients diagnosed via postoperative pathology. exclusion criteria: 1. comorbidity with other cancers. 2. underwent preoperative chemotherapy, radiotherapy, or other biological treatment. 3. use of antibiotics, probiotics or prebiotics in the previous month.
to evaluate the efficacy and safety of co-administrated hodo-2224-1 and hodo-2224-2 in patients with essential hypertension and primary hypercholesterolemia

Conditions: Hypertension; Primary Hypercholesterolaemia

Summary: a multicenter, randomized, double-blind, active-controlled, parallel group, phase 3 trial to evaluate the efficacy and safety of co-administrated hodo-2224-1 and hodo-2224-2 in patients with essential hypertension and primary hypercholesterolemia

this trial is a phase 3 study to evaluate the efficacy and safety of co-administrated hodo-2224-1 and hodo-2224-2 in patients with essential hypertension and primary hypercholesterolemia. this is multi-center, double-blind, active-controlled, parallel-group, phase 3 study.

Eligibility criteria:
inclusion criteria: * age ≥ 19 * patients with essential hypertension and primary hypercholesterolemia exclusion criteria: * patients with differences between arms greater than 20 mmhg for mean sitsbp or 10 mmhg for mean sitdbp * patients with mean sitsbp ≥ 180 mmhg or mean sitdbp ≥ 110 mmhg
serratus block versus paravertebral block for post thoracotomy pain relief

Conditions: Post Operative Pain

Summary: this double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. patients were allocated into two equal groups (30 patients each). group s: standard anesthesia in addition to spb. ii. group p: standard anesthesia in addition to pvb.


Eligibility criteria:
inclusion criteria: * patients more than 18 ys undergoing thoracotomy operation exclusion criteria: * morbid obesity (body mass index \> 40) * impossibility of anatomical structures us identification in a satisfactory way * opioids treatment before surgery or substance abuse, * sepsis and/or infection at the puncture sites
influenza vaccination of nursing home workers.

Conditions: Influenza Disease

Summary: the objective of this study is to demonstrate that influenza vaccination of nursing home workers is an effective intervention for reducing mortality of elderly people.

nursing homes will be randomized within each pair in two arms "incentive to vaccinate", and "do-nothing". in the arm "incentive to vaccinate", vaccination campaigns will be carried out with face-to-face interviews of nursing home workers in order to achieve more than 80% of vaccination coverage. in the "do-nothing", nursing home workers will be vaccinated as usual. the main endpoint criterion is all-cause mortality of residents. population sets will be all residents who will be present at start of the influenza season (-2 weeks) or who will be admitted during the influenza season (+ 2 weeks). onset and end of influenza season will be given by regional influenza surveillance system. secondary criteria are hospitalizations of residents, morbidity of nursing home workers. a cost-effectiveness ratio of influenza vaccination will be calculated.

Eligibility criteria:
inclusion criteria: criteria for nursing home: * nursing home whose representative physicians agree to participate, with 50 to 200 residents, located in paris area, and where the vaccination coverage of nursing home workers was lower than 40% during the previous influenza season (2005). criteria for residents: * all residents who will be present at start of the influenza season (-2 weeks) or who will be admitted during the influenza season (+ 2 weeks). exclusion criteria: * people before 60 years not presences in the ehpad at the time of the beginning of the study (at the moment of the beginning of the epidemic - 2 weeks) or not allowed before the end of the study (before the end of the epidemic + 4, weeks)

Keywords: influenza
impact of an intervention combining self-care and hypnosis on the well-being of cancer patients and their partners

Conditions: Non-Metastatic Neoplasm

Summary: hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. however, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions. our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all tumour localisations accepted) an 8-week groupal intervention combining hypnosis and self-care techniques. primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be investigated at 3 measurement times: before the intervention (t1), 3 months later (t2 - right after the intervention of the experimental group, and right before the intervention of the control group) and again 3 months later (t3 - after the intervention of the control group). some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone application will be used to collect data. the indirect impact of the intervention on participants' partners will also be measured by questionnaires (emotional distress, conjugal communication). data collection has started on march 2017. our results should bring new knowledge about the efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer patients, which are often under-diagnosed and under-treated, but also about the indirect efficacy to improve partners' well-being. those results might contribute to spread this kind of inexpensive intervention in oncology settings.


Eligibility criteria:
inclusion criteria are: 1. age 18 years or older; 2. fluency in french; 3. having received a diagnosis of non-metastatic cancer (all tumour localisations accepted). 4. having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy). 5. not being in relapse at the time of inclusion 6. exhibiting some difficulties as established by responses of at least 4 out of 10 on 1 of the 6 chosen items of the edmonton symptom evaluation scale (chang, hwang, \& feuerman, 2000): physical fatigue, moral fatigue, depression, anxiety, fear of recurrence or ruminations). 7. wishing to receive help in order to improve the difficulties identified. exclusion criteria: psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations

Keywords: cancer fatigue hypnosis self-hypnosis self-care emotional distress cancer survivors
mri & qst analysis in trigeminal neuralgia and persistent idiopathic facial pain

Conditions: Facial Pain

Summary: patients with a definite diagnosis of classical tgn and pifp will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. clinical measures and sensory profiles will be correlated with mri measures.

patients with a definite diagnosis of classical tgn and pifp (according to the 2020 icop classification) will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. clinical measures and sensory profiles will be correlated with the presence and the geometry of neurovascular compression at mri. moreover quantitative structural neuroimaging analysis, such as trigeminal root volume, will be performed in each patient and correlated with clinical and qst data.

Eligibility criteria:
inclusion criteria: * definite diagnosis of classical or idiopathic trigeminal neuralgia or persistent idiopathic facial pain according to the latest icop 2020 criteria * naive to any surgical procedures exclusion criteria: * any major chronic painful or other neurological disease * diagnosis of secondary trigeminal neuralgia * diagnosis of other facial pain syndromes * cognitive disturbances