Kornimate/medical-research-clean huggingface dataset:
genetic analysis of familial melanoma

Conditions: Melanoma

Summary: in collaboration with members of the international melanoma consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (cdkn2 or p16) gene, or the cyclin-dependant kinase 4 (cdk4). cdkn2 and cdk4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. the purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. it is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

in collaboration with members of the international melanoma genetics consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (cdkn2a), or the cyclin-dependant kinase 4 (cdk4) genes. cdkn2 and cdk4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. the purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. it is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Eligibility criteria:
* inclusion criteria: inclusion into this study was restricted to families containing at least three cmm cases with dna available for genotyping, and cdkn2a and cdk4 involvement and had been excluded. all families must be mutation negative for both cdkn2a and cdk4. this study will also include families with at least one case of ocular and two cases of other cutaneous melanomas, or at least 2 ocular melanomas (except where they occur in parent and child). exclusion criteria: any family showing evidence of haplotype sharing in the 9p21-p22 region, where cdkn2a is located, was also excluded.

Keywords: genotyping linkage analysis cancer hereditary melanoma
severity postoperative pain prediction

Conditions: Anxiety; Pain; Postoperative Pain

Summary: a simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.

the purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery. study design: a total of 400 evaluable patients will be studied using the various surgical populations listed. for statistical purposes, the following will be the surgical population by procedure. two hundred healthy asa i-ii women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. the patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. at 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. the subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.

Eligibility criteria:
inclusion criteria: * healthy asa physical status class 1 or 2 * aged 18 years or above * pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections exclusion criteria: * asa \>3 * \< 36 weeks for cesarean section * \< 18 years of age

Keywords: preoperative somatic questions preoperative audio tone evaluations preoperative anxiety and previous experience with postop pain
comparison of the pharmacokinetics of tiotropium delivered from test inhaler products with a reference product

Conditions: Healthy

Summary: the purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Eligibility criteria:
inclusion criteria: * healthy volunteer * willing and able to give informed consent * willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration exclusion criteria: * evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders * any presence or history of a clinically significant allergy including any adverse reaction to study drug * history of drug or alcohol abuse within the past 2 years * smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) * donation or loss of greater than 400 ml of blood within the previous 3 months * have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) * have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) * upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months * if female, nursing, lactating or pregnant * regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)

Keywords: inhalation laba corticosteroid
extension study of etelcalcetide for treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis

Conditions: Hyperparathyroidism, Secondary

Summary: this is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of secondary hyperparathyroidism (shpt) in adults with chronic kidney disease (ckd) on hemodialysis.

this is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in amgen studies 20120231 (nct01785875), 20120334 (nct01576146), or 20120360 (nct01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent prior to initiation of any study-specific activities/procedures * subject has completed treatment in study 20120231 (also known as kai-4169-008) or study 20120360, or has participated in study 20120334 (also known as kai-4169-005-01) * female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. women of child-bearing potential (wocbp) must have a negative serum pregnancy test within 2 weeks prior to the first dose of amg 416 in the current study * subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months exclusion criteria: * currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies) * subject has known sensitivity to any of the products or components to be administered during dosing * subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with amg 416 in the current study * subject is receiving dialysis prescription dialysate calcium concentration \< 2.25 meq/l * subject is pregnant or nursing

Keywords: secondary hyperparathyroidism (shpt), chrominc kidney disease (ckd), hemodialysis
effects of mechanical, chemical, and combination methods on halitosis

Conditions: Halitosis

Summary: goal: the goal of this clinical trial is to evaluate the effectiveness of different oral hygiene methods (tooth brushing, tongue cleaning, and mouthwash use) in managing halitosis (bad breath) in adults. the main questions it aims to answer are: do oral hygiene methods (tongue cleaning, chlorhexidine mouthwash, and coconut oil mouthwash) reduce the levels of volatile sulfur compounds (vscs) in participants' breath? do these methods improve self-reported and clinically assessed halitosis? study design: researchers will compare three intervention groups: group i: tongue cleaning. group ii: chlorhexidine mouthwash. group iii: coconut oil mouthwash. after one week, groups ii and iii will add tongue cleaning, and in the third week, groups i and iii will use chlorhexidine mouthwash to ensure equitable benefits. participants will: follow their assigned oral hygiene regimen daily for 2 weeks. receive the halitosis assessments at baseline, 1 week, and 2 weeks post-intervention, including organoleptic testing and volatile sulfur compounds level measurements using the oralchroma device. complete self-reported assessments of halitosis using a visual analog scale (vas).


Eligibility criteria:
inclusion criteria: * age: participants must be 18 years or older. * diagnosis of halitosis: * clinically diagnosed halitosis with an organoleptic test (ot) score ≥ 2, and * volatile sulfur compound (vsc) levels exceeding: hydrogen sulfide (h2s) \> 1.5 ng/10 ml, or methyl mercaptan (ch3sh) \> 0.5 ng/10 ml. * study population: buddhist monks and nuns from selected temples in hue city, vietnam, to control for dietary and lifestyle factors. * willingness to participate: participants must provide informed consent and agree to follow the study protocol. exclusion criteria: * systemic diseases: presence of systemic conditions such as diabetes, gastrointestinal disorders, respiratory disorders, or cancer that could contribute to halitosis. * nonoral causes of halitosis:halitosis suspected or confirmed to be caused by gastrointestinal or respiratory diseases. * medication use: use of antibiotics or other medications within 1 month prior to or during the study period. * dental conditions: * presence of dental prostheses or orthodontic appliances. * untreated open caries lesions or deep periodontal pockets (\> 6 mm). * allergies: known allergies to any of the study interventions (e.g., chlorhexidine or coconut oil). * lifestyle factors: smoking or betel nut chewing habits. * inability to comply: inability or unwillingness to follow the study protocol or attend follow-up visits.
safest choice of antihypertensive regimen for postpartum hypertension

Conditions: Postpartum Complication; Maternal Hypertension; High Blood Pressure

Summary: the purpose of this investigator-initiated randomized control trial is to determine whether oral nifedipine versus oral labetalol is superior in controlling high blood pressures in the postpartum period.

high blood pressure (hypertension) is one of the most common medical disorders in pregnancy and affects 10% of all pregnancies in the united states, with possible short-term and long-term health complications including increased risk of stroke, and liver, kidney, and heart disease. management of severe high blood pressure after delivery involves medications to lower blood pressure, strict discharge instructions and close follow- up after delivery. both oral nifedipine and oral labetalol are considered safe agents for the treatment of postpartum high blood pressure, however few studies exist that directly compare the two. the investigators want to conduct this study because they want to compare the effects of oral nifedipine or oral labetalol on postpartum hypertension. in this study, subjects will get either oral nifedipine or oral labetalol. subjects will not get both. no experimental drugs or devices will be used.

Eligibility criteria:
inclusion criteria: * female * women who develop postpartum hypertension\* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control. * postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmhg or diastolic blood pressure greater than or equal to 90mmhg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmhg or diastolic blood pressure greater than 110mmhg sustained for more than 15 minutes. exclusion criteria: * history of moderate persistent asthma, coronary artery disease, heart failure, av heart block, pulmonary edema * contraindication to either nifedipine or labetalol * hr \ 110 * native language other than english or spanish

Keywords: postpartum hypertension
effect of retrograde autologous blood priming on pulmonary mechanics in pediatric cardiac surgery

Conditions: Congenital Heart Disease

Summary: the present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (rap) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

this prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. they comprised 64 patients with rap and 60 patients conventional cardiopulmonary bypass priming. the preoperative, intraoperative and postoperative data of the studied patients were reported.

Eligibility criteria:
inclusion criteria: * children complained of congenital heart disease with left to right shunt pressure or volume load exclusion criteria: * cyanotic heart disease

Keywords: retrograde autologous priming pulmonary mechanics
early intervention following mild tbi

Conditions: Mild Traumatic Brain Injury

Summary: the objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (cognitive interventions on sleep - anxiety - attention - memory) following mild tbi and observe their impact pre- and post-treatments. the ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. specific objectives: 1) measure the effect of an acute and brief non-pharmacological intervention on pcs symptoms, sleep, headaches, affect, cognition and functional outcome following mild tbi; 2)to redefine a model of outcome prediction following mild tbi.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild tbi exclusion criteria: * psychiatric diagnosis
prospective study assessing endopredict® genomic test impact on shared decision of adjuvant chemotherapy in patients with er-positive, her2-negative early breast cancer

Conditions: Breast Cancer

Summary: the trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pn1mi), estrogen receptor (er)-positive, her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments. obtaining material for test is at no risk as done from the surgery material. tumor molecular endopredict (ep)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in er+/node-negative breast cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * performance status 0 or 1, * patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer * fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery * available surgical material (formalin-fixed, paraffin-embedded) for epclin® evaluation * er-positive by ihc (\>10% cells stained or allred score≥4) * her2-negative by ihc (score 0 or 1+) and/or fish/cish * node-negative or pn1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance) * uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations: * lobular histology * or grade ii * or grade iii and pt \< 2cm * adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration * willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest * signed informed consent and health insurance coverage exclusion criteria: * non operable, bilateral, locally advanced, t4 or metastatic breast cancer * any lymph node involvement with the exception of pn0i+ or pn1mi * her2 overexpression * diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma * any previous systemic or locoregional treatment for the present breast cancer * documented inherited predisposition with brca1/2 or tp53 mutation * previous hormone replacement therapy (hrt) stopped less than 2 weeks before surgery * previous treatment for the present breast cancer * person unable to give informed consent

Keywords: genomic test chemotherapy decision
effectiveness of gentlewave system in endodontic treatment

Conditions: Pain, Postoperative; Root Canal Infection; Endodontically Treated Teeth

Summary: this study aims to evaluate the efficacy of the gentlewave® system compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.

new irrigation modalities such as the gentlewave® system, which integrates advanced multisonic ultrasound technology, have been developed to overcome limitations and improve root canal treatments success rates, by ensuring comprehensive cleaning while minimizing mechanical instrumentation. this system, featuring cleanflow technology, optimizes the delivery of irrigants and promotes efficient root canal debridement. postoperative pain is common, usually peaking within the first 24 hours after treatment and decreasing thereafter. in the presence of necrosis, microorganisms can colonize anatomical complexities, such as isthmuses, ramifications and dentinal tubules causing symptoms such as pain, inflammation, and in some cases even odontogenic sinusitis. conventional syringe irrigation (csi), which delivers irrigants (naocl, edta) through a needle-syringe system, often fails to reach the entire working length and the intricate anatomy of the root canal. this inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure; furthermore, positive pressure exerted during csi may cause the extrusion of irrigants beyond the apex, leading to complications.

Eligibility criteria:
inclusion criteria: * male and female patients from 18 years age or older (maximum of 80 years of age), both genders. * the patients in need of an endodontic intervention. * all dental groups in both arches were eligible. * patients who do or do not experience symptoms after the endodontic intervention. * patient-signed informed consent/assent form exclusion criteria: * patients\< 18 years old. * fractured teeth. * patients who were recommended extraction after the endodontic evaluation.
hmct/ct2401: abatacept gvhd prophylaxis following omidubicel hct

Conditions: Hematologic Malignancy

Summary: this study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (hct) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (aba/tac/mmf) graft-versus-host disease (gvhd) prophylaxis. the primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil gvhd prophylaxis following omidubicel hct. target enrollment is 10 participants. subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. patients will be followed for a total of 18 months and will have research blood draws and abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study. it is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. accrual will be reported by race, ethnicity, gender, and age. descriptive analyses are planned given the sample size.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing 2. adult patients (≥18 at the time of enrollment) 3. adequate organ function for transplant defined as: 1. left ventricular ejection fraction ≥ 40%; 2. dlco, fev1, fvc \> 50% predicted; 3. total bilirubin ≤ 2.5 mg/dl except for patients with gilbert's syndrome or hemolysis, and alt, ast, and alkaline phosphatase all \< 5 x upper limit of normal (uln); 4. serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance \> 40 ml/min/1.73m2; 5. karnofsky performance score ≥ 70; and 6. if applicable, \> 6 months since a previous autologous transplant. 4. female patients (unless postmenopausal or surgically sterilized) and male patients (even if surgically sterilized) must agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 100 days post-transplant. fertility preservation method will be left to treating physician's discretion. exclusion criteria: 1. patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material 2. presence of a donor-specific antibodies with mfi \>2000 3. uncontrolled bacterial, fungal or viral infection 4. treatment with any other investigational medical product (medications without any known fda approved indication) needs to be discussed with the pi for patient eligibility.