Kornimate/medical-research-clean huggingface dataset:
heart rate variability (hrv)-guided transcranial direct current stimulation (tdcs)

Conditions: Depression

Summary: this technology development project will be informed and guided by initial data collection of human subject data. for this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (rs) tdcs protocol. enrolled participants will complete 10 days of 30-minute tdcs (2.0, dlpfc left anodal) using the rs-tdcs protocol. during each daily session, standard hr and impedance-based hr (i-hr), obtained from the tdcs headset, will be collected to identify a possible marker of response to tdcs in depression. participants will be randomized 2:1 to active vs. sham tdcs.


Eligibility criteria:
inclusion criteria: * mild to moderate depression (beck depression inventory(bdi)-ii 14-28) * diagnostic and statistical manual of mental disorders, fifth edition, text revision (dsm-v-tr) depressive episode * wide range achievement test (wrat)-4th reading recognition subtest standard score \>85 exclusion criteria: * primary neurologic, psychiatric (e.g., multiple sclerosis, stroke, parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (tbi), epilepsy, mild cognitive impairment (mci), or dementia), or major medical disorder (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation) (medical history review) * dsm-v-tr bipolar depression, psychotic disorder, or alcohol or substance use disorder (m.i.n.i.) * active or high suicidality risk (columbia-suicide severity rating scale, c-ssrs), or otherwise judged as inappropriate by the study clinicians * history of a heart transplant, presence of permanent pacemaker implant or left ventricular assist device * use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, or cardiac glycosides * use of antidepressant, antipsychotic, anxiolytic, or stimulant medications * pregnant or planning pregnancy during the study period * seizure disorder or recent (\<5 years) seizure history * presence of metal objects in the head/neck * any skin disorder or skin sensitive area near stimulation locations

Keywords: depression heart rate tdcs brain stimulation telehealth
robot-assisted gait training with self-observation in stroke rehabilitation

Conditions: Stroke

Summary: the aim of this study is to investigate the effects of robot-assisted gait training concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. the main question it aims to answer is: does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants? participants will be group 1 perform robot-assisted gait training combined with self-observation five times a week for four weeks. group 2 perform robot-assisted gait training five times a week for four weeks. all groups perform for 30 minutes per session.


Eligibility criteria:
inclusion criteria: * participants who have had a stroke for more than 6 months but less than 1 year * functional ambulation category (fac) ≥ 2 * able to walk 10 meters independently with or without an assistive device * participants eligible for application of the robot (angel legs m20, anger robotics) exclusion criteria: * inability to wear the robot due to open wounds or skin conditions * severe cognitive impairment (mmse-k \< 10) or significant difficulty in communication due to language disorders * spasticity of the paralyzed limb with a modified ashworth scale (mas) ≥ 2 * high risk of fractures, such as osteoporosis * severe cardiovascular or pulmonary diseases * neurological disorders affecting gait function, such as parkinson's disease or multiple sclerosis

Keywords: stroke gait cognitive function
the impact of intelligent patient management model on medication adherence of pyrotinib compared to traditional patient management model: a prospective, multicenter, randomized controlled clinical study

Conditions: HER2 Positive Breast Cancer; Pyrotinib Treatment

Summary: this is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of her2 positive breast cancer patients receiving pyrotinib treatment. pyrotinib is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit her1, her2, and her4.


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 years. * histologically confirmed her2-positive breast cancer (ihc 3+ or ihc 2+ with ish+). * patients expected to receive pyrotinib-containing regimens for neoadjuvant therapy or metastatic/unresectable breast cancer. ·≤1 prior line of anti-her2 therapy during the recurrent/metastatic stage. * ability to operate a mobile phone and read independently. * deemed psychologically and physically suitable for participation by the investigator. exclusion criteria: * history of cognitive impairment. * severe visual or auditory impairments. * prior use of pyrotinib. * pregnancy, lactation, or intention to conceive. * ineffective cognitive-behavioral interventions within the past year. * participation in other clinical trials within 1 month prior to screening. * investigator judgment of unsuitability due to psychological or physical conditions.
the effect of platelet-rich plasma in patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: osteoarthritis is the most common type of arthritis. the prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs. the current treatments which are already being used for osteoarthritis of the knee patients include: 1. symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs. 2. intra-articular injections of corticosteroids and hyaluronic acid. 3. current surgical therapy: knee arthroplasty, osteotomy, arthrodesis and debridement. as the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (prp) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee. prp consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure. this study is a prospective, randomized, controlled trial to assess the positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee

in this study all eligible patients (based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a stratified permuted block randomization method: group a received platelet rich plasma, group b (control group) received only placebo. all of the patients underwent a standard long protocol for knee osteoarthritis. all patients with grade ii,iii and iv of radiographic knee oa are selected. on average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level. group a: 1-3 cc injection of placebo group b: 1-3 cc injection of prp all patients received monthly injection for 3 times.

Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years 2. body mass index (bmi) ≤33 kg/m2 3. grade 2and above imaging of osteoarthritis 4. history of knee pain or swelling should have at least 4 months exclusion criteria: 1. treated with steroids and anti-coagulant or anti-platelet aggregation 2. history of infectious, systemic diseases, immune deficiency and coagulation disorders 3. patients with hb ≤11, plt ≤ 150000 4. varus \> 10 , valgus \> 10

Keywords: prp prgf osteoarthritis
non neutralizing antibodies: prevalence and characterization

Conditions: Hemophilia A

Summary: antibodies (abs) directed against factorviii (fviii) remain the main iatrogenic complication in haemophilia a (ha) patients. anti-fviii abs inhibiting pro-coagulant properties of the molecule are named inhibitors whereas abs directed towards non-functional epitopes are named non-neutralizing antibodies (nna). these nna are poorly studied and their prevalence is ill-defined. in a recent retrospective study the investigators evaluated, in a cohort of 210 patients without inhibitor, the nna prevalence and the nna epitope specificity against the heavy chain (hc)or the light chain(lc). for the first time, the investigators used two x-map based assays: the first to determine the specificity of anti-fviii abs against the hc or the lc, the second to display abs directed towards the b domain. nna were found in 38 out of 210 patients (18). among this nna positive population, 74% and 13% of patients had anti-fviii abs against both chains. the proportion of nna directed towards the b domain was 18%. considering an approximate inhibitor prevalence of 30% and a nna prevalence of 19% in severe ha patients, approximately 50% of severe ha patients develop an immune response against infused fviii. due to their unclear relevance, the nna detection does not yet belong to the routine clinical practice. however, in 2006, dimichele advancedf a hypothesis concerning the influence of nna on the variations in the kinectics of fviii observed in certain patients. the mechanism explaining the role of these nna in the fviii in the fviii kinectics has not still been demonstrated. the investigators propose to perform a multicentre prospective study with the aim to confirm, in severe, moderate and mild ha treated patietns, the nna prevalence observed in our retrospective study, to study the evolution over time of the epitopemapping of these nna and to explore the correlation between these nna and clinical/biological parameters.


Eligibility criteria:
inclusion criteria: * male with age \> 6 years * severe, moderate or mild treated ha patients with negative inhibitor titer (\<0.6ub) * an information form will be presented to the patient or his/her legal representative by the physician who includes the patient in the study protocol * patient with national insurance exclusion criteria: * patient without his agreement for this study * patient deprived of freedom * patient without national insurance

Keywords: non neutralizing antibody epitopic profile clinical relevance
pilot trial of a game embedded in a smartphone app for smoking cessation

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. the hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. a two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. primary outcomes relate to user engagement with the app. secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.

primary objectives: i. augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement. ii. test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification. outline: participants are recruited through the smoke free smartphone app and randomized to 1 of 2 arms. arm i: participants receive an educational intervention through the smoke free application (core app) with the embedded video game module. participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. arm ii: participants receive an educational intervention through the smoke free application without the video game module (core app only). participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Eligibility criteria:
inclusion criteria: 1. provides electronic informed consent. 2. male or female, aged 18 and older 3. has downloaded and opened the smoke free app 4. a smoker of at least 1 cigarette per day 5. plans to quit smoking within the next 7 days 6. speaks, reads, and writes english 7. lives in the united states exclusion criteria: none
pain after deep electrical stimulation in the groin in pain free subjects

Conditions: Persistent Postherniotomy Pain

Summary: sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper structures as well as the skin. whether this is one combined pain syndrome, where for instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain conditions, is unknown. by giving pain free subjects an intense non-harmful electrical stimulation in deeper tissues in the groin and recording the skin sensory function, this hypothesis will be tested


Eligibility criteria:
inclusion criteria: * male, age \>18 yr, pain-free, caucasian exclusion criteria: * previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.

Keywords: hyperalgesia persistent pain deep pain electrical stimulation groin hernia
a study of [f-18]hx4 (pet imaging)evaluated in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this trial is to determine what will be the optimal imaging protocol for head and neck cancer patients after \[f-18\] hx4 injection. this study will provide guidance for future studies involving \[f-18\]hx4 in cancer patients.

each consented patient will have a single administration of \[f-18\]hx4 and will immediately undergo one list mode pet/ct imaging session lasting 60 minutes followed by three additional list mode pet/ct acquisitions from 90 to 110 minutes, 150 to 170 minutes and 220 to 250 minutes after administration. the start times of the last three image acquisitions are permitted to be within ± 5 minutes. venous blood samples will be collected throughout the initial scan sequence and at the time of each subsequent acquisition for calibration and metabolite-correction of the image-derived input function. on the day of administration (visit 2) blood for clinical safety evaluations will be drawn pre- and post-dosing after all imaging is complete. the pre-surgery \[f-18\]fdg pet/ct clinical scan performed prior to the \[f-18\]hx4 procedure, and the surgery at visit 3 are standard of care for the consented patients.

Eligibility criteria:
inclusion criteria: * patient is \>18 years and male or female of any race / ethnicity. * patient or patient's legally acceptable representative provides written inform consent patient is willing and able to comply with protocol procedures. * patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx. * patient is scheduled to have or already has had a clinical \[f-18\]fdg pet/ct scan prior (recommended to be within 14 days prior) to the \[f-18\]hx4 pet/ct scan. * patient has a primary tumor ≥ 2.0 cm in longest axis measured by ct or mr; or lymph node ≥ 2.0 cm in shortest axis measured by ct or mr if primary tumor \< 2 cm on ct or mr; ct may be part of required \[f-18\]fdg pet/ct scan or a separate pre-surgery ct scan. * patient is scheduled to undergo complete tumor resection within 7 days for his/her cancer care after the \[f-18\]hx4 pet/ct scan is performed. * patient has not had nor will have neoadjuvant treatment, including radiation and chemotherapy, prior to patient's planned tumor resection. exclusion criteria: * female patient is pregnant or nursing. * patient is not capable of remaining still for duration of imaging procedure (\~ 4 hours). * patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period. * patient has chronic renal function failure or is on renal dialysis * patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data.

Keywords: newly diagnosed head and neck cancer pet imaging
safety and effectiveness of the uv-x system for corneal collagen cross-linking for compassionate treatment in pediatric patients with progressive keratoconus

Conditions: Progressive Keratoconus

Summary: this is a compassionate treatment protocol for the use of the uv-x system for corneal collagen cross-linking (cxl) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

this is a non-randomized study. all eyes that qualify for the study will receive the cross-linking (cxl) procedure. corneal collagen cross-linking is performed as a single treatment. depending on the patient's condition, the cxl procedure may be performed under sedation or anesthesia. subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Eligibility criteria:
inclusion criteria: * age 6 to 18 years * having a diagnosis of progressive keratoconus * signed written informed consent * having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies * willingness and ability to comply with schedule for follow-up visits exclusion criteria: * corneal pachymetry at the screening exam that is \<400 microns at the thinnest point * previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.) * a history of delayed epithelial healing in the eye(s) to be treated * pregnancy or lactation during the course of the study * a known sensitivity to study medications
establishing the clinical significance values of the lysholm knee score

Conditions: Knee Injuries

Summary: the goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. the main questions it aims to answer are: * what is the minimal clinically important difference value of the lysholm knee score? * what is the substantial clinical benefit value of the lysholm knee score? * what are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value? * what are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?


Eligibility criteria:
inclusion criteria: * to be over 18 years old * to undergo surgery for a ruptured anterior cruciate ligament exclusion criteria: * to have metabolic or autoimmune diseases * to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair * to have cognitive issues that will hinder the completion of the study forms * to lack sufficient proficiency in turkish

Keywords: lsholm knee score anterior cruciate ligament injury minimal important change substantial clinical benefit clinical significance patient reported outcome
long term follow up of failed back surgery syndrome(fbss)

Conditions: Failed Back Surgery Syndrome; Integrative Medicine; Medicine, Korean Traditional

Summary: the purpose of this study is to reveal the effectiveness and satisfaction of integrative korean medicine for failed back surgery syndrome(fbss) by observation patients treated with integrative korean medicine. this study is a prospective observational study. the subjects for study are patients diagnosed with failed back surgery syndrome(fbss) and who have been admitted to gangnam jaseng hospital of korean medicine and bucheon jaseng hospital of korean medicine for 2011.11-2014.09. medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. the survey questions are numeric rating scale (nrs), oswestry disability index (odi), quality of life, and patient global impression of change (pgic), etc.


Eligibility criteria:
inclusion criteria: * patients diagnosed with failed back surgery syndrome and was admitted to jaseng hospital of korean medicine. * patients have agreed to participate the study. * patients who had participated "long-term course of failed back surgery syndrome (fbss) patients receiving integrative korean medicine treatment: a 1 year prospective observational multicenter study" * patients aged 19-70 years on the date exclusion criteria: * patients who are difficult to complete the research participation agreement * other patients whose participation in the trial is judged by a researcher to be problematic

Keywords: integrative korean medicine
atrophic gastritis predicts the risk of gastric cancer

Conditions: Atrophic Gastritis

Summary: despite declining incidence rates, gastric cancer (gc) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in eastern asia. the 5-year overall survival rate of early gc exceeds 90%, which was well above advanced gc. most intestinal-type gcs follow the correa cascade-inflammation,atrophy, intestinal metaplasia (im), dysplasia and subsequent carcinoma. the presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for gc. the purpose of this study was to investigate the incidence of gc attributed to atrophic gastritis in a region with high incidence of gc.


Eligibility criteria:
inclusion criteria: * ability and willingness to participate in the study and to sign and give informed consent * biopsies were collected based on the recommendation of updated sydney system exclusion criteria: * under 18 or over 80 years old * history of gastrectomy * severe systemic diseases or malignancy

Keywords: atrophic gastritis gastric cancer