Kornimate/medical-research-clean huggingface dataset:
tailored internet-administrated treatment of panic symptoms - a randomised controlled trial

Conditions: Anxiety Disorders; Depression

Summary: the purpose of this study is to determine whether tailored internet-administrated cbt is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.


Eligibility criteria:
inclusion criteria: * be between the ages of 18-30 years old or 31-46 years old * have reoccurring panic attacks exclusion criteria: * suicide prone * alcohol addiction * ptsd * ocd * ongoing psychological treatment
cytid analysis of oral lesions

Conditions: Oral Cavity Cancer; Oropharyngeal Cancer

Summary: the purpose of this study is to correlate the results from a standard of care biopsy with cytid™ and hpvid™ swab tests for potentially premalignant and malignant oral lesions. the biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. the study-related data gathering will not influence the treatment decisions of the clinician.


Eligibility criteria:
inclusion criteria: * receive care at the avenue 360 health and wellness clinic, a not for profit dental clinic in the montrose area of houston * present with a potentially malignant oral lesion (pmol) for whom a biopsy is deemed necessary exclusion criteria: * do not receive care at the avenue 360 health and wellness clinic, a not for profit dental clinic in the montrose area of houston * do not present with a potentially malignant oral lesion (pmol) for whom a biopsy is deemed necessary
infant psychiatry home visitation program

Conditions: Aggression; Hyperactivity; Impulsive Behaviors

Summary: this is a proposed home visitation program for families of children with externalizing behaviors who are on the wait list for psychiatric assessment at bc children's hospital. the aim of this program is to implement and evaluate a home visitation strategy in order to support those waiting up to four months to consult a psychiatrist.

the home visitation program was developed in response to long wait lists for the infant psychiatry program. this home visitation program intervention consists of the following components: developmental guidance, empowerment of parents while respecting the parent-child attachment, and child centered interactional guidance. the home visitors ( a phd student and a masters level student) visit consenting families and gave the parents an opportunity to voice their concerns regarding their child's behaviors. they were instructed to co-construct a play that had to be child led. home visitors facilitated this task. parents completed the child behavior checklist and parenting stress index prior to and after the intervention. these home visitations occurred approximately once a month whilst the families were on the wait list for clinical assessment and treatment. those families that were randomized in control group did not receive any intervention. extended description of the protocol, including information not already contained in other fields.

Eligibility criteria:
inclusion criteria: * children with externalizing disorders referred to infant psychiatry clinic of children's hospital and on the wait list exclusion criteria: * children over 6 years old * children with internalizing disorder * families that reside outside of the vancouver due to practicality of home visitation, * families requiring an interpreter

Keywords: randomized home visitation externalizing disorder parenting stress childhood externalizing disorders positional defiant
nurse amie: addressing metastatic individuals everyday

Conditions: Metastatic Breast Cancer

Summary: determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. acceptability will be defined as the proportion of women offered the intervention who agree to participate. feasibility will be defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

goals of the nurse amie software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via youtube style videos, weekly phone calls with a patient navigator at penn state, and appropriate referrals to phone or in person consultations as needed. the proposed nurse amie software program will allow for the provision of resources (youtube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. this is an identified need on the part of both metastatic patients and their medical care teams. finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Eligibility criteria:
inclusion criteria: * women with metastatic breast cancer * ecog performance score ≤3. * english speaking * with sufficient vision/hearing or family support * willingness to be randomized exclusion criteria: * medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction). * patients who are receiving any other behavioral intervention

Keywords: exercise feasibility acceptability supportive care platform
cognitive neurology unit clinical registry

Conditions: Alzheimer Disease

Summary: a prospective comparative study of monoclonal antibodies for the treatment of alzheimer's disease

alzheimer's disease (ad) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. it causes progressive cognitive impairment, especially memory, and is invariably fatal. currently, there is no effective treatment for ad. a new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mabs) to reduce amyloid accumulation in brain. there are currently two anti-amyloid mabs, aducanumab and lecanemab, approved by the fda under fda's "accelerated approval" pathway. however, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mab therapy1. this study is designed to help determine the therapeutic benefit of anti-amyloid mabs therapy by treating ad patients in our clinic with anti-amyloid mabs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. this study has 4 specific aims. specific aim 1: to create a cnu anti-amyloid monoclonal antibody registry specific aim 2: to determine whether anti-amyloid mabs slow cognitive and functional decline specific aim 3: to identify any associations between sides effects and patient characteristics specific aim 4: to establish the time course of clinical benefits

Eligibility criteria:
inclusion criteria: * o patient meets clinical criteria for mild cognitive impairment or early dementia from alzheimer's disease * patient has evidence of cognitive impairment on neuropsychological testing * patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement * amyloid pet imaging and/or csf analysis consistent with alzheimer's disease * amyloid pet imaging positive * csf p-tau/abeta42 ration \>0.023 and abeta42 \< 1027\*\* * 3t mri in past 6 months * patient has a care partner * patient under the care of an appropriate bi-lahey amyloid clinic * patient is on a stable medication regimen exclusion criteria: * o recent stroke or suspected tia in the past year * pregnancy * active autoimmune or immunological disease * systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives * bleeding disorder with plts \ 1.5 * on warfarin, heparin, or doac * on dual antiplatelet therapy * non alzheimer disease cause of dementia/mci * apoe e4 homozygote
liver transplantation for unresectable liver limited colorectal metastases

Conditions: Unresectable Liver-limited Colorectal Metastases

Summary: this is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at weill cornell medical college. patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. the registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the colon or rectum 2. no evidence of extrahepatic metastases or local recurrence based on pet/ct and colonoscopy 3. no signs of extrahepatic metastases or local recurrence according to pet/ct 4 weeks prior to consideration of transplant 4. age 18-65 years old 5. good performance status with ecog 0-1 6. stability or regression of liver metastasis for at least 6 months 7. minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant 8. minimum of 6 months chemotherapy 9. cea \< 200 ug/l 3 months prior to transplant 10. adequate organ and marrow function with hb \> 10 g/dl, anc \> 1000/ul, platelets \> 100,000/ul, bilirubin \< 2x uln, ast/alt \< 5x uln, creatinine \< 1.25 x uln, albumin above lln exclusion criteria: 1. evidence of extrahepatic disease or local recurrence 2. previous resection of lung metastases 3. msi-h/dmmr or braf mutation 4. any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
mk-0431/ono-5435 phase iii clinical trial-rapid-acting insulin secretagogue add-on study in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this phase iii clinical trial will examine the safety, tolerability, and efficacy of the addition of mk-0431/ono-5435 to japanese patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.


Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy exclusion criteria: * patients with type 1 diabetes mellitus
the (pivotal) study

Conditions: ABDOMINAL AORTIC ANEURYSMS

Summary: the purpose of this study is to compare endovascular repair using any fda approved medtronic aaa stent graft system versus surveillance in subjects with smaller abdominal aortic aneurysms (aaa)(4-5cm), with respect to aaa rupture and aaa related deaths.


Eligibility criteria:
inclusion criteria: * 40 to 90 years of age * meet all indications for use as stated in the medtronic vascular aaa endograft instructions for use * maximum aneurysm diameter of 4-5cm * if female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion * patient is willing and able to comply with the specified follow-up evaluation * life expectancy at least 3 years exclusion criteria: * meet any of the contraindications stated in the medtronic vascular aaa endograft instructions for use * known co-existing condition with a life expectancy of less than 3 years * major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment * subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before. * planned conduit procedure for introduction of endograft

Keywords: aaa aneurysm aneurx talent
pain control in first trimester medical abortion: a randomized trial

Conditions: Pain

Summary: this trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. the primary study outcome is pain.

this trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. the primary study outcome is pain. secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Eligibility criteria:
inclusion criteria: * pregnant women with a gestational age of 63 days or less * desire a medical abortion with mifepristone and misoprostol exclusion criteria: - have contraindications to ibuprofen

Keywords: pain medical abortion
recommendations for a radiotherapy comfort intervention package radiotherapy

Conditions: Oncology

Summary: a consensus study using nominal group technique is planned to develop recommendations for a comfort intervention package for radiotherapy with patients and therapeutic radiographers. this includes completed work from a systematic literature review (prospero 59688) of comfort interventions applicable to radiotherapy and qualitative interviews (nct03984435) with patients and therapeutic radiographers exploring comfort management in radiotherapy.

study design the aim of this study is to develop a radiotherapy comfort intervention package with patients and therapeutic radiographers. the objectives are to: objective 1 - identify and prioritise intervention components for inclusion in recommendations for a radiotherapy comfort intervention package. objective 2 - determine the feasibility of delivering the component of the radiotherapy comfort intervention package. modified nominal group technique (ngt) will employed to develop recommendations for a comfort intervention package in radiotherapy in a consensus study with patients and therapeutic radiographers. this study follows earlier phases of the comfort study which included a systematic literature review of comfort interventions applicable to radiotherapy and qualitative interviews exploring comfort management in radiotherapy. study participants patients the inclusion criteria are: 1) diagnosed with a malignancy; 2) aged over 18 years owing to different treatment options for children and young adults; 3) recently referred for radiotherapy, currently receiving treatment or had had radiotherapy within the previous 3 months; 4) treatment delivery time exceeding 10 minutes (the time the patient is immobilised on the radiotherapy couch). therapeutic radiographers the inclusion criteria are: 1) practicing radiographers; 2) administering radiotherapy with treatment delivery times exceeding 10 minutes per radiotherapy treatment session (the time the patient is immobilised on the radiotherapy couch). the consensus study will be conducted by video conference. planned size of sample (if applicable) 6-12 participants (4-9 patients and 2-3 therapeutic radiographers) follow up duration (if applicable) follow up is not planned. planned study period 6 months research question/aim(s) the aim of this study is to develop recommendations for a radiotherapy comfort intervention with patients and therapeutic radiographers.

Eligibility criteria:
inclusion criteria: patients and therapeutic radiographers who previously participated in comfort study interviews exclusion criteria: patients and therapeutic radiographers who did not participate in comfort study interviews
improving dental care and oral health in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: a randomized controlled trial (at sites) comparing the efficacy of the established air-p dental toolkit (control condition) to a combined regimen involving the dental toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit experiences.

participation in routine dental care is a significant challenge for children with autism spectrum disorder (asd) due to a variety of factors, including considerations related to asd symptoms and associated anxiety and behavioral difficulties. lack of routine, effective dental care has contributed to a substantial unmet healthcare need for children with asd, who are at increased risk for excessive plaque, caries, and oral infections. the purpose of this study is to test a parent-training intervention designed to improve home dental hygiene, compliance with dental office visits, and oral health outcomes in children with autism spectrum disorder. families of children with an existing diagnosis of asd will be recruited for participation. all families will receive the autism intervention research network on physical health (air-p) dental toolkit, which is designed to provide parents with guidance and information about dental care and support strategies for children with asd. some families will also participate in a 10-week behavioral parent-training intervention focused on improving home dental care and dental office visit experiences.

Eligibility criteria:
inclusion criteria: * english-speaking families of children ages 3 to 13 years and 11 months. * current diagnosis of asd confirmed by baseline assessment. * parent-reported difficulty participating in dental care. * confirmed absence of dental screenings or exams/visits within the previous 6 months. * underserved status as defined by medicaid eligibility. exclusion criteria: * children who present with an acute dental condition requiring emergency treatment. * children who are currently taking, or have recently discontinued, medications that affect oral and gingival health. * anything that, in the opinion of the site principal investigator, would place the subject at unwarranted risk or materially reduce their contribution to the trial's aims due to inability or refusal to adhere to trial procedures and follow-up. families will be asked to refrain from participating in any non-study adaptive behavior interventions or therapies focused on dental hygiene. families will also be asked not to participate in any non-study dental screenings or exams for the duration of the investigation.

Keywords: parent training dental care
prophylaxis for covid-19: ivermectin in close contacts of covid-19 cases (ivernex-tuc)

Conditions: Covid19

Summary: randomized controlled clinical trial on using oral ivermectin in covid-19 prophylaxis supplying the drug to close contacts of confirmed cases.

this is a randomized, double-blind, and controlled clinical trial that aims to evaluate the use of oral ivermectin in covid-19 prophylaxis. the study has two arms in a relationship of 2:1: experimental group (eg n=500) and placebo group (cg n=250). the sample size was calculated by applying a two-proportion comparison test. type of two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% p1 (proportion in the placebo group), 65% p2 (proportion in the new treatment or intervention group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724 sample adjusted for losses. the hypothesis of the study is that treatment with ivermectin may decrease the chance of occurrence/progress of clinical manifestations and onset of severe disease. whereas control of the contagion on the first days of development of the disease, this treatment with ivermectin in suspected cases of covid-19 (by epidemiological nexus) would contribute to the control of contagion at the first part of the infection, even in the absence of symptoms. categorical variables will be represented with frequencies and proportions, while continuous quantitative variables will be expressed as mean ± standard deviation (sd) or as median and interquartile range (iqr). the proportions will be compared using pearson's chi-square test or fisher's exact test as appropriate, and continuous quantitative variables with student's t test. the estimation of the efficacy of intensive treatment with ivermectin will be calculated using kaplan-meier curves and the differences will be analyzed by means of the log-rank test. the risk will be calculated as a ratio of advantages for intensive treatment with ivermectin (odds ratio, or) with its 95% confidence intervals (95% ci). a value of p \<0.05 will be considered significant. analyzes will be performed using stata 11.2 software.

Eligibility criteria:
inclusion criteria: * over 18 years either sex * women of childbearing age with a negative pregnancy test * in close contact group or epidemiological nexus of a positive covid-19 case * able to understand and grant informed consent * real-time - polymerase chain reaction test with a negative result exclusion criteria: * known hypersensitivity or allergy to any component of the drug under evaluation * age under 18 years * use of immunosuppressants (including systemic corticosteroids) in the last 30 days * pregnant or lactating * patients with other acute infectious diseases * patients with autoimmune disease and/or chronic decompensated diseases * who have received a vaccine for covid-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another covid-19 prophylaxis study

Keywords: ivermectin prophylaxis covid-19 epidemiological link