Kornimate/medical-research-clean huggingface dataset:
studies of in vitro b lymphocyte responses in subjects receiving tetanus toxoid booster immunization

Conditions: Healthy

Summary: one of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of b lymphocytes to produce antibodies. we are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (klh) (approved project number 77-i-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. the purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man. booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess b cell related immunologic profiles in patients and control normal subjects. we have recently developed a sensitive elisa assay for igm and igg in vitro specific antibody responses against tetanus toxoid. this will allow us to carefully and precisely monitor the evolution and immunoregulation of the human b cell responses to this recall antigen. this is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

one of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of b lymphocytes to produce antibodies. we are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (klh) (approved project number 77-i-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. the purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man. booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess b cell related immunologic profiles in patients and control normal subjects. we have recently developed a sensitive elisa assay for igm and igg in vitro specific antibody responses against tetanus toxoid. this will allow us to carefully and precisely monitor the evolution and immunoregulation of the human b cell responses to this recall antigen. this is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

Eligibility criteria:
male and female patients 18 years and older. patients admitted to the clinical center under other approved research protocols designed to investigate immune mediated or inflammatory diseases and who have not been immunized to tetanus toxoid within 6 months. no pregnant women.

Keywords: b cells humoral immunity lymphocytes tetanus toxoid
clinical performance of onlay restorations after cervical margin relocation (cmr)

Conditions: Dental Caries

Summary: the current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect computer-aided-design (cad)/ computer-aided-manufacture (cam) onlay restorations. this study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.


Eligibility criteria:
inclusion criteria: * good general health * good oral hygiene * patient aging 20-40 y * patients with proximal deep carious lesion * international caries detection and assessment system (icdas) 4 or 5 that diagnosed clinically and radiographically. * normal response to a vitality test. exclusion criteria: * poor general health * poor oral hygiene * teeth would need direct pulp capping * teeth act as abutment for fixed or removable prosthesis. * patients with excessive parafunctional habits * patient potentially unable to be compliant to recall visits
inetetamab plus chemotherapy ± pd-1/pd-l1 in her2+ advanced biliary cancer

Conditions: Metastatic Biliary Tract Cancer; HER2 Positive

Summary: to evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for her2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.


Eligibility criteria:
inclusion criteria: * males or females aged ≥18 years; * histologically confirmed her2-positive metastatic biliary tract cancer; * ecog performance status of 0 to 1; * no prior treatment with anti-her2 therapies; * patients have not received any systemic anticancer treatment in the recurrent/metastatic setting; * patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy; * presence of at least one measurable lesion; * adequate function of major organs as defined by the following criteria; * estimated survival of ≥3 months; * voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up. exclusion criteria: * known allergy or contraindication to any component of the study drugs; * previous treatment with anti-her2 therapies; * prior use of immunotherapy; * use of immunosuppressive agents within 14 days before the first dose, except: intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) systemic corticosteroids ≤10 mg/day prednisone or equivalent steroids for hypersensitivity reactions (e.g., premedication for ct scans) * known active central nervous system metastases or carcinomatous meningitis; * other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer; * major surgery or significant trauma within 4 weeks before randomization, or planned major surgery; * severe cardiac disease; * resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen; * neuropathy ≥ grade i per nci criteria; * active interstitial lung disease (ild) or pulmonary disease requiring bronchodilators; * history of immunodeficiency; * participation in another drug trial within 4 weeks before screening; * pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study; * any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.
effects of telerehabilitation based motor and cognitive dual task exercises in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the ability to respond to multiple stimuli is impaired in parkinson's patients. traditional rehabilitation approaches focus only on balance and gait training, but individuals with parkinson's disease need to perform multiple tasks in daily life.

the dual-task (dt) methodology aims to perform two tasks simultaneously. there is no study in which motor and cognitive dual-task exercises are given together and followed up remotely in elderly individuals with pd. therefore, it was aimed to compare the effects of telerehabilitation method and motor and cognitive dual-task exercises on cognitive function, balance, walking, fall risk and quality of life in individuals with parkinson's disease.

Eligibility criteria:
inclusion criteria: * being diagnosed with idiopathic parkinson's disease * getting at least 21 points from the montreal cognitive assessment scale test * stability of drug therapy taken in the last 1 month * being in the "ten" period of the patients * being able to walk independently on flat ground (3 and above according to functional ambulation classification) exclusion criteria: * • serious hearing or vision problems * having other neurological, cardiovascular or orthopedic disorders that may prevent walking * any other neurological disorder (eg dementia, cerebrovascular disease) * having an education level of less than 5 years * patients with a pacemaker * having vascular lower extremity pathologies * not having internet access with a smart phone or computer
ratio of the cross sectional area of median nerve to ulnar nerve in diagnosing carpal tunnel syndrome

Conditions: An Innovative Diagnostic Method for Carpal Tunnel Syndrome

Summary: an innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and compared between carpal tunnel syndrome patients and healthy volunteers.


Eligibility criteria:
inclusion criteria: * cts patients were required to have subjective symptoms of numbness, tingling pain, or dysesthesia over the median nerve innervated area of the involved hand. * patients should have positive response in either tinel's test or phalen's test during physical examination * evidence of median neuropathy at wrist level in ncs. * control subjects should have neither symptoms nor signs of cts along with no abnormal findings in electrodiagnostic study of the median nerve and the ulnar nerve across the wrist joint. exclusion criteria: * age younger than 20 years old * electrodiagnostic evidence of ulnar neuropathy at the wrist level * previous trauma or surgery history of hand * medical history of hypothyroidism, diabetes mellitus, uremia, rheumatoid arthritis, amyloidosis, and acromegaly * pregnancy
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss (ca-0002013)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: the purpose of the study is to evaluate the ability of injections ji gami(tm) to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * have no clinically significant disease or abnormal laboratory results taken at the screening visit. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * any clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * dermatologic condition in donation and/or study areas. * prior surgery in the treatment area. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness
evaluation of succinate metoprolol on heart rate in the stable angina patients

Conditions: Angina Pectoris

Summary: the purpose of this study is to evaluate the effects of succinate metoprolol(betaloc zok®) (95 - 190 mg) on heart rate in the stable angina patients.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * chinese patients * heart rate ≥ 65bpm * has been diagnosed as stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(please find the diagnose criteria of stable angina on appendix c) * with left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram; * has been on beta-blockers for at least 4 weeks\*, on the dose equivalent to betaloc zok® 23.75-47.5mg/day. exclusion criteria: * acute myocardial infarction within 6 months * unstable angina or prinzmetal's angina * ii degree of av block or greater * significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the investigator's opinion) including: * significant renal impairment (serum creatinine \> 2.0 mg/dl) * serum alanine aminotransferase or aspartate aminotransferase \> 3 x upper limit of reference range * serum potassium \< 3.0 meq/l * serum sodium ≤ 130 meq/l * acute or chronic hepatitis or cirrhosis (clinical diagnosis) * uncontrolled hyperthyroidism (clinical diagnosis) * systolic blood pressure ≥ 180 mmhg, or \< 100mmhg at enrolment * patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)

Keywords: angina pectoris chest pain heart rate
pregabalin and alpha-lipoic acid combination versus each monotherapy in patients with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: this study is a randomized, parallel, open-label, multicenter, phase iv clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.


Eligibility criteria:
inclusion criteria: * aged 19 to 75 * type 2 diabetes mellitus with hba1c (hemoglobin a1c) ≤ 10 % * peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks) * diagnosed with diabetic peripheral neuropathy (dpn) * vas pain score ≥ 40 mm * written informed consent exclusion criteria: * brittle diabetes mellitus * alt (alanine transaminase), ast (aspartate transaminase), cpk (creatine phosphokinase) level ≥ 3 times the upper limit of normal (unl) or active liver disease * severe renal impairment (egfr (estimated glomerular filtration rate) \< 60 ml/min/ 1.73m2) * treated with antiepileptic drugs within 1 week at randomization * other nervous system or neuropathic disorders that may affect pain evaluation * oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients * pregnant, lactating, or childbearing potential * alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems * have participated in other clinical trials within 30 days at screening
a study to asses wellness using a brain sensing device on physicians

Conditions: Stress, Emotional; Sleep; Quality of Life

Summary: a study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (qol), subjective stress, sleep and resilience.

participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. subjects will also complete questionnaires and cognitive based testing throughout participation.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of consent * practicing physicians at mayo clinic * not pregnant by subject self-report at time of consent * have the ability to provide informed consent * have the ability to complete all aspects of this trial * have access to a smart phone or tablet device * have no contraindicating comorbid health condition which would interfere with the proper use of the muse-s™ system, as determined by the clinical investigators exclusion criteria: * used an investigational drug within the past 30 days * currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis * currently (within 3 weeks) been enrolled in another clinical or research program (e.g. cam) which intervenes on the patients' qol, or stress * an unstable medical or mental health condition as determined by the physician investigator

Keywords: mindfulness wellness
mifepristone 10 or 5 mg for 6 months to treat uterine fibroids

Conditions: Uterine Fibroids

Summary: the objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. a 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time. the hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.

women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months. the decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.

Eligibility criteria:
inclusion criteria: * symptomatic uterine fibroids * reproductive age or premenopausal * accepting the use of non hormonal contraception * conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as the side effects of mifepristone * agreeing to have ultrasound examinations in every follow-up or evaluation visit * agreeing in two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination exclusion criteria: * pregnancy or desire to become pregnant * breastfeeding * hormonal contraception or any hormonal therapy received in the last three months * signs or symptoms of pelvic inflammatory disease * adnexal masses * abnormal or unexplained vaginal bleeding * suspected or diagnosed malignant neoplastic disease * signs or symptoms of mental illness * adrenal disease * sickle cell anemia * hepatic disease * renal disease * coagulopathy * any other severe or important disease * any contraindication to receiving antiprogestins

Keywords: uterine fibroids mifepristone antiprogestins
long-term outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial

Conditions: Breast Cancer Invasive

Summary: with the title of "long-term outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial", this study targets breast cancer patients after neoadjuvant therapy. a total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to endoscopic-assisted breast conserving surgery(e-bcs) or conventional breast conserving surgery (c-bcs) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. the co-primary endpoints are 5-year disease-free survival (5y-dfs) and breast-q score at 6 months after surgery. the secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-os) and 5-year local-recurrence rate (5y-lrr), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. this study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.


Eligibility criteria:
inclusion criteria: 1. age ranging from 18 to 75 years 2. pathologically confirmed invasive breast cancer 3. receiving preoperative chemotherapy (each molecular subtype corresponds to unanimous regimen) 4. ct1-3n0-3m0 5. unilateral breast tumor 6. eastern cooperative oncology group score 0-1 7. left ventricular ejection fraction (lvef) ≥50% 8. leukocytes ≥ 3.0×109/l, absolute neutrophil count ≥ 1.5×109/l, platelets ≥ 100×109/l, hemoglobin ≥ 90g/l, creatinine \<1.5 × institutional uln, total bilirubin ≤ 2.0 × institutional uln. exclusion criteria: 1. diffusely disseminated malignant calcification foci 2. not applicable for bcs after neoadjuvant therapy 3. pregnancy or breastfeeding 4. additional malignancy 5. severe cardiopulmonary, liver or kidney dysfunction or other systemic diseases (such as uncontrolled chronic heart failure, critical hypertension or diabetes with poor blood glucose control).
double-dorsal versus single-volar digital block

Conditions: Laceration of Skin; Anesthesia, Local; Pain; Nerve Block

Summary: the aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (nrs), anesthesia onset time, and success of anesthesia. it is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times. however, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. this difference is especially due to measurements in the volar region incisions. according to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia.

randomized, parallel controlled, open labeled experimental study

Eligibility criteria:
inclusion criteria: * between 18-65 years of age * isolated traumatic acute hand finger lacerations requiring suturing * admissions within 6 hours of injury * patients who can cooperate with the nrs score * patients who gave consent exclusion criteria: * vein, nerve and tendon lacerations on the hand that require repair * amputation or bone fracture * those who have used analgesics in the last 12 hours * hemodynamically unstable patients * known allergy to prilocaine hydrochloride

Keywords: digital nerve block finger lacerations single palmar injection double dorsal injection pain