Kornimate/medical-research-clean huggingface dataset:
12 month open extension of tns for adhd.

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: participants who exhibit sufficient adhd symptom improvement in a prior study of active tns will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active trigeminal nerve stimulation (tns). participants randomized to sham in the double-blind, were then invited into a 4-week open tns trial. participants who met positive response criteria to active tns, either during the original double-blind study or the open-treatment followup, were invited to continue their tns treatment in a 12-month open extension phase. participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.

Eligibility criteria:
inclusion criteria: * male and female children ages 8-13 with dsm-5 adhd, and current presentation, as determined by ksads and clinical interview * received active tns therapy in a previous trial and demonstrated a cgi-i score \<= 2. * parents able and willing to monitor proper use of the tns device and complete all required rating scales * parent and participants able to compete study rating scales and other measures in english exclusion criteria: * none

Keywords: adhd neuromodulation trigeminal nerve stimulation
impacts of static magnetic fields on dysmenorrhea pain

Conditions: Period Pain

Summary: study to determine the effectiveness of a certain type of magnet to reduce period pain

young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. the pain score after wearing either the magnet or sham will be recorded.

Eligibility criteria:
inclusion criteria: female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 - exclusion criteria: 1. pain not experienced on almost all menstrual cycles 2. having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease 3. having a pacemaker or any implanted wires or devices -
a study to learn more about tukysa once it is out in the korean market

Conditions: HER2-positive Locally Advanced Unresectable; Metastatic Breast Cancer

Summary: the objectives of the re-examination system in korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in korea. this surveillance is conducted for preparing application material for re-examination under the pharmaceutical affairs laws, the regulations on safety of pharmaceuticals, etc. and the re-examination regulation for new drugs and others.

the purpose of this study is to understand the safety of tukysa (tucatinib hemiethanolate) once it is out in the korean market. tukysa will be given to participants aged 18 or over in republic of korea. surveillance design patients with the approved indication who are treated with tukysa within the local label will be enrolled. adverse events (aes) will be collected in the usual practice during administration and for 28 days following cessation of tukysa, and orr will be evaluated through radiographic imaging in the usual practice. the total follow-up period will not exceed 1 year. safety through the evaluation the safety profile of tukysa including important identified risks, important potential risks, missing information, which are defined about tukysa in table2, will be examined. drug safety is evaluated through the following items: efficacy drug efficacy will be evaluated through the bor. the orr which is defined as the proportion of the subjects in the analysis population who have best response as cr or pr will be presented. surveillance for long-term use the follow-up period for each patient will vary according to tumor response, treatment of tukysa and others. any patients who are treated with tukysa for more than or equal to 180 days including dose interruption will be evaluated for surveillance for long-term use.

Eligibility criteria:
inclusion criterias. 1. patient who is treated with tukysa according to the current tukysa label for the approved indication. 2. patient who is treated with tukysa for the first time. 3. patient who is aged 18 or over. 4. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criterias. 1. patients to whom tukysa is contraindicated as per the local labeling note: the summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.

Keywords: safety
study for the reliability and validity of the eortc patsat-c33 and the eortc out-patsat7 questionnaires

Conditions: Cancer

Summary: the aim of this study is to validate the eortc patsat-c33 and eortc out-patsat7 questionnaires scale structure in a large international field study.

patient satisfaction is now recognized as an important indicator of care quality. measures of patient satisfaction with care can facilitate monitoring initiatives for care improvement over time. the eortc quality of life group has cross-culturally validated a stand-alone in-patient satisfaction with cancer care questionnaire, the in-patsat32. advances in cancer care delivery required further development of this questionnaire to assess patients' perceived quality of the care received in outpatient cancer care settings. phase i to iii of this process have been completed, resulting in the eortc patsat-c33 satisfaction with cancer care core questionnaire to assess cancer care delivery as a whole and the complementary eortc out-patsat7, a questionnaire for the specific outpatient care settings. these questionnaires concern all patients treated for their cancer, in the assessed service, regardless of the stage and type of cancer.

Eligibility criteria:
inclusion criteria: patients regardless of cancer site or stage of disease (i.e. local, loco-regional, metastatic, in remission) will be invited to participate if they meet the following criteria: 1. diagnosis of cancer confirmed histologically. 2. patients are 18 years or older (to be adapted for compliance with each country regulation). 3. patients are willing to express their non-opposition to participate in the study. 4. patients are able to read and understand the language of questionnaires. 5. patients have the cognitive ability to complete the questionnaires. 6. patients have had a sufficient experience of the cancer treatment setting : a. for outpatients consulting in a chemotherapy day clinic/consultation for oral treatment, ambulatory radiotherapy or consultation for follow-up surveillance to check for signs of recurrence : i) between 3 to 6 cycles of chemotherapy or at least 2 cycles of other cancer treatment (e.g., biological oral therapy) or ii) between 2 to 6 weeks of radiotherapy or iii) within the 3rd to 24th month post-cancer treatment. b. for inpatients consulting on an oncology or a surgery ward at least 3 days of hospital stay exclusion criteria: patients will be excluded if they are : 1. participating in another patient-reported outcome investigation that may interfere with this study. 2. experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.

Keywords: quality of life cancer care pathway patient satisfaction care improvement
cognitive impact associated with surgery for gastric or esophageal cancer

Conditions: Gastroesophageal Cancer (GC); Postoperative Delirium (POD); Quality of Life (QOL); Frailty; Malnutrition; Sarcopenia; Chemobrain; Chemotherapy; Depression

Summary: the primary objective of this observational study is to investigate the incidence of post operative delirium (pod) after gastroesophageal cancer surgery. secondary objectives are to investigate the relationship between pod, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. participants identified with pod will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. the main objective aims to answer: what is the incidence of pod after gastroesophageal cancer surgery.


Eligibility criteria:
inclusion criteria: * patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery. * age ≥18 at the time for inclusion. * participate on a voluntary basis and can (for any reason) end its participation during the study. * capable of giving informed consent. exclusion criteria: * patients with preoperative cognitive dysfunction such as dementia. * patients who are inoperable due to metastases. * patients unable to communicate due to severely impaired hearing and/or - seeing. * patients with ongoing drug and/or alcohol abuse. * patients who cannot give informed consent.

Keywords: postoperative delirium gastroesophageal cancer frailty quality of life preoperative depression malnutrition sarcopenia chemobrain chemotherapy
looking at triple negative breast cancer patient experience patterns in medical trials

Conditions: Triple Negative Breast Cancer; Breast Cancer

Summary: clinical trials can sometimes favor certain demographic groups. additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. the goal is to identify the obstacles and challenges that prevent participation in triple negative breast cancer clinical trials, as well as the reasons for withdrawal or discontinuation. the insights gained from this study will ultimately benefit those with triple negative breast cancer who may be invited to participate in clinical research in the years to come.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. * capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (icf) and in the protocol exclusion criteria: * pregnant or lactating woman * any mental or medical condition that prevents the patient from giving informed consent or participating in the trial * inability to perform regular electronic reporting

Keywords: triple negative breast cancer breast cancer
combined static and dynamic orthotic treatment of the pip joint

Conditions: Health Behaviour

Summary: study design: randomized controlled clinical study. introduction: physiotherapeutic intervention aiming to restore mobility using different techniques as stretching, hot packs, exercises, therapeutic ultrasound and orthotics. no scientific evidence has been found correlating improved joint mobility and the use of these techniques. application techniques of orthoses to reshape the soft tissues have been well detailed, however, no scientific evidence supporting their effectiveness on proximal interphalangeal joint (pipj) lag extension resolution using them as a single treatment has been found. purpose of the study: the purpose of the study was to test the effectiveness of static and dynamic orthosis in patients with a pipj flexion retraction using them as a single treatment compared with traditional combined therapies. method: 63 participants were included in the study. patients who used splints were compared to a control group who received conventional treatment. active and passive mobility were measured before the experiment and again three months after. all the patients were measured under the same conditions and treated by the same hand therapist. the relationship between contracture resolution and function was measured using the dash spanish version.


Eligibility criteria:
inclusion criterio: * 18 years old * had given their consent * having suffered trauma to the hand or finger which has resulted in joint damage with a consequent loss of full extension of the pipj * duration of the injury being between four and 30 weeks. exclusion criteria: * patients who had no proper joint alignment, * patients those with a presence of nerve or tendon associated dupuytren, * campodactilea * tubular bone fractures * acute inflammatory signs * joint instability * avascular necrosis * infection of the affected finger were not included in the study.

Keywords: proximal interphalangeal joint orthoses
mobile apps to reduce distress in breast cancer survivors using an adaptive design

Conditions: Depression, Anxiety; Engagement, Patient

Summary: the overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (intellicare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. to achieve these goals, an innovative experimental study design, known as a sequential, multiple assignment, randomized trial (smart), will be used to test the effects of the intellicare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. participants will initially be randomized to receive the intellicare apps or app-delivered patient education (control) for 8 weeks, and the impact of the intellicare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (aim 1). we will monitor the app usage data of participants who receive the intellicare apps. those who are high-engagers will continue to use the apps with no change. those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. the hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (aim 2), for low-to-moderate engagers. finally, semi-structured exit interviews will be conducted with participants that receive the intellicare apps and coaching. interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (aim 3).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years (age 19 if in nebraska, given age of consent); 2. 0-5 years post-diagnosis of stage i, ii, or iii female breast cancer; 3. elevated symptoms of depression as measured by the patient health questionnaire-8 (phq-8) score ≥ 10 and/or symptoms of anxiety as measured by the generalized anxiety disorder-7 (gad-7) score ≥ 8. exclusion criteria: 1. taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks; 2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care; 3. do not have an app-compatible phone (i.e., ios 10.3 or later or android 4.0.3 or later); 4. cannot read and speak english (current intervention only available in english).

Keywords: breast cancer
"the effect of the combination therapy of statin and sglt2i in the treatment of ischemic heart disease"

Conditions: 2 Drugs Are Statin and SGLT2i

Summary: correlate the serum level of statin and sglt2i when given as polytherapy with hplc in ischemic heart failure patients and their laboratory tests (cholesterol, ldl, hdl and tg...)

this is a prospective study that will carried out in department of cardiology, faculty of medicine, fayoum university during the period from 1 april 2024 to 1 juley 2024. the study includes 90 outpatients clinic patients who met the inclusion criteria. patients will provide written informed consent before involving in this study. * we will split the 90 patients into three groups: 1. 30 patients will take statin. 2. 30 patients will take sglt2i. 3. 30 patients will take both of statin and sglt2i. * by collecting their blood samples and calculate the serum level of statin by using hplc and calculate plasma level of sglt2i by using hplc as baseline first then after three months to predict the effect of each drug to another one, we will follow their cholesterol, triglyceride, low density lipo-protein and high density lipo-protein and we will also inspect their adverse effects.

Eligibility criteria:
inclusion criteria: * we include patients established ischemic heart failure seen by a primary care provider to diagnose ischemic heart disease, * they assessed the use of statin with sglt2i. exclusion criteria: * we exclude patients with 1. liver dysfunction. 2. renal dysfunction. 3. fungal infection. 4. coagulation disorder. 5. pts using drugs that interact with sglt2i. 6. patients that will refuse to be enrolled in the study or refuse to write informed consent.
use of predictive model to assist patients having an embryo transfer after ivf

Conditions: Infertility

Summary: to determine in women undergoing ivf who are at high risk of multiple births (\>35%), as calculated by the application of a predictive model - ivfsingletm, if single embryo transfer will lead to both comparable clinical pregnancy rate (cpr) and other secondary outcomes such as live birth rate (lbr) and cumulative live birth rate (clbr) in comparison to det while reducing the incidence of multiple births (a secondary outcome measure).


Eligibility criteria:
inclusion criteria: under 38 1st or second ivf attempt - exclusion criteria: over 37 years old donor egg third or greater ivf attempt cancellation in previous cycle for poor response successful pregnancy with ivf -

Keywords: predictive model in vitro fertilization elective single embryo transfer
low-intensity focused ultrasound pulsation (lifup) for the treatment of generalized anxiety disorder (gad)

Conditions: Generalized Anxiety Disorder

Summary: there are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. existing brain stimulation methods such as rtms fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. in this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.

anxiety disorders have tremendous disease burden in the united states. up to 1 in 3 americans will be diagnosed with an anxiety disorder in their lifetimes. anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). with major depressive disorder, rtms is a suitable alternative treatment for refractory depression, rtms is not approved for treatment of anxiety, nor can rtms stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. in this study, the investigators propose to randomize 48 individuals to either active or sham treatment. each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). one week and one month after the last treatment session, the investigators will conduct follow-up evaluations.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18-65 3. normal or corrected-to normal vision and hearing 4. primary diagnosis of generalized anxiety disorder, moderate/severe per dsm-5. (ham-a\>17) 4a) the duration of the illness must exceed one year. 5. must be medically stable as determined by investigator 6. patient must have attempted and failed treatment with at least 2 ssri and 1 augmentation 7. history of rtms is permitted, but not required. exclusion criteria: 1. diagnosis of primary dsm-5 anxiety disorder other than gad 1a) affective disorders such as unipolar or bipolar depression are permitted as long as gad is primary 2. current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of gad) 3. contraindication to enter the mri environment 4. pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term) 5. inability to adhere to treatment schedule 6. initiation of new anxiolytic treatment at the time of study randomization

Keywords: focused ultrasound
evaluation of the practice of the tep choline at patients with prostate cancer

Conditions: Prostate Cancer

Summary: the prostate cancer is a heterogeneous disease the care of which varies according to the status: localized, locally advanced, or in recurrence after local or metastatic treatment. the precise evaluation of the degree of extension of the disease is thus essential because it is going to allow to adapt at best the therapeutic strategy. contrary to the abdomino-pelvic scanning and to the osseous scintigraphy which(who) are a member(part) of the balance assessment of standard extension of the prostate cancer, the place of the tomography with broadcast of positrons to scan (tep scan) in choline in the management of patients affected by prostate cancer is not clearly defined in the national and european recommendations. the current marketing authorization ( amm) is the research for bones localizations in the prostatic cancers at high risk. it indeed seems that this examination is more successful than the standard radiological examinations (bone scintigraphy and abdomino-pelvic scanning) in the detection of the bone metastatic hurts, with a sensibility of about 100 % and a precision of the order of 93 % according to certain studies. the recent data of the literature suggest a quite particular interest at the patients in situation of biochemical recurrence in terms of localization of (or) tumoral site (s). the amm however not specifying if this examination has to be made within the framework of the initial balance sheet of extension, at the time of the biochemical second offense or at the known metastatic stage, there is a big variability of the practices according to the centers. the current indications being very ill-assorted, he is interesting being able to estimate the heterogeneousness of the practices of way multicentre, by leading a study observationally retrospective in region provence-alpes-côte d'azur (paca).


Eligibility criteria:
inclusion criteria: * have had a tep scan in the choline * prostate cancer exclusion criteria: * not applicable