Kornimate/medical-research-clean huggingface dataset:
transcatheter repair of tricuspid regurgitation with edwards cardioband tr system post market study (triband)

Conditions: Tricuspid Regurgitation; Tricuspid Insufficiency

Summary: the purpose of the study is to assess the safety and the effectiveness of the cardioband tricuspid reconstruction system.

the purpose of the study is to assess the safety and the effectiveness of the cardioband tricuspid reconstruction system. this is a multi-center, prospective, single-arm post-market clinical follow up study.

Eligibility criteria:
* inclusion criteria: * eighteen (18) years of age or older * moderate or greater functional tricuspid regurgitation (tr) * patient is eligible to receive the edwards cardioband tr system per the current approved indications for use. * exclusion criteria: * patients deemed anatomically unsuitable for the device by echocardiography * patients in whom transesophageal echocardiography (tee) is contraindicated * previous tricuspid valve repair or replacement * severe aortic, mitral and / or pulmonic valve stenosis * severe aortic, mitral and / or pulmonic valve regurgitation * renal insufficiency requiring dialysis or severe kidney renal disease * life expectancy of less than twelve months * patient is pregnant or lactating

Keywords: edwards cardioband tr annuloplasty tricuspid repair tricuspid valve
post-operative nausea and vomiting study in female patients

Conditions: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative

Summary: the primary purpose of this study is to determine an effective dose of this nk-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase ii study to evaluate the safety and efficacy of oral dosing with gw679769 (50 mg or 150 mg) for three consecutive days when administered with a single intravenous dose of ondansetron hydrochloride for the prevention of post-operative nausea and vomiting and post-discharge nausea and vomiting in female subjects with known risk factors for post-operative nausea and vomiting who are undergoing laparoscopic/laparotomic surgical procedures associated with an increased emetogenic risk

Eligibility criteria:
inclusion criteria: * known, specified risk factors for ponv (post operative nausea and vomiting) * undergoing gynecologic or gallbladder surgery. exclusion criteria: * pregnant or breastfeeding * post-menopausal

Keywords: neurokinin-1 receptor antagonist gw679769 post-operative nausea nk-1 receptor antagonist ponv post-discharge nausea and vomiting pdnv vomiting
the high cup/disc ratio in children

Conditions: Glaucoma

Summary: to investigate of high cup/disc ratio in children.

ophthalmologic examination 1. cycloplegic refraction 2. axial length and anterior chamber depth 3. intraocular pressure b. optic nerve head and retinal nerve fiber layer 1. disc photography 2. heidelberg retina tomograph

Eligibility criteria:
inclusion criteria: * high cup/disc ratio more than 0.5 * age : five to twelve exclusion criteria: * previous surgery (except strabismus surgery) previous glaucomatous medication history poor cooperated children.

Keywords: high cup disc ratio glaucoma suspect
a single patient will be treated with individual patient tcr-transduced pbl


Summary: a single patient will be treated with individual patient tcr-transduced pbl

background: -please refer to national cancer institute surgery branch (nci-sb) protocol 18-c-0049, amendment f. objective: -under individual patient expanded access, to treat a patient with metastatic breast cancer with autologous peripheral blood lymphocytes (pbl) that have been transduced with genes encoding t-cell receptors that recognize mutated neoantigens in the autologous cancer. eligibility: * must have measurable, metastatic disease as assessed per recist v1.1 criteria. * must sign the informed consent document. * willing to sign durable power of attorney form. * must have all regulatory approvals prior to start of treatment. design: * please refer to nci-sb protocol 18-c-0049, amendment f. * the patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced pbl and then high-dose aldesleukin. the patient will also receive pembrolizumab on day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -
reducing depression-related stigma and increasing-treatment seeking among black adolescents

Conditions: Depression; Racism

Summary: the purposes of this study are to: 1. test among adolescent the utility of brief video-based interventions to reduce stigma-related attitudes and increase help-seeking intentions toward depression; 2. examine the role of race (black vs other) as an independent factor in the primary outcome.

intervention videos will each be of \~120-second duration and feature an underage female professional (age 16) acting as a simulated patient. all three videos will focus on her as an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness. assessments will occur at baseline and post-intervention, and will include: 1. demographics (baseline only); 2. primary outcome: depression-related stigma(depression stigma scale \[dss\]) summary score. 3. secondary outcomes: a. dss individual items; b. help-seeking (general help-seeking questionnaire \[ghsq\]) summary score and individual items; and bc racial attitudes: feelings thermometers. the investigators intend to randomly assign \~1,000 individuals aged 14-18 as follows: subjects oversampled for black participants (50% black; 50% other); randomized, in equal proportions, and stratified by race, to view one of three \~120-second videos of a girl with: 1. no depression control (black; bc); 2. depression (black, following same script as in our earlier study (amsalem and martin, 2021), db); and 3. depression adjusted (black, with script adjusted based on input from focus group of black girls and women; dba).

Eligibility criteria:
inclusion criteria: * english-speaking * living in the us * ages 14 - 18 exclusion criteria: * none
exploratory study of norepinephrine to prevent alopecia in head and neck cancer patients treated with radiotherapy

Conditions: Alopecia; Radiodermatitis

Summary: the study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (imrt). the study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.


Eligibility criteria:
inclusion criteria: * be ≥ 18 years of age with documented pathological diagnosis of h\&n (head and neck) cancer. * planned to receive h\&n region imrt treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 gy. * have a palpable nuchal prominence (external occipital protuberance) * have the ability to understand the informed consent document. * be able to comply with protocol schedule. * have a negative serum pregnancy test if a female of childbearing potential. * consent to utilize medically acceptable methods of contraception throughout the study if of childbearing potential. * be treated with imrt alone or with concurrent platinum based chemotherapy * receive definitive treatment for oropharyngeal squamous cell carcinoma exclusion criteria: * with clinical or radiographic evidence of adenopathy to the high level v posterior cervical nodes, post-auricular or occipital cervical nodal stations * planned to receive h\&n region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50gy * with underlying active untreated cardiac disease (e.g. arrhythmia) * receiving concurrent chemotherapy other than single agent platinum based * with generalized skin disorders that have required treatment within the past 6 months. * with connective tissue disorders * with unhealed wounds or scars in the study area * with rashes, ulcerations, or poorly healed scars in the treatment area * with a known allergy to norepinephrine * with a known clinically significant abnormal ecg (electrocardiogram) within the past 6 months. * taking mao (monoamine oxidase) inhibitors or antidepressants of the triptyline or imipramine types * taking β-blockers * with nci-ctcae version 4.0 grade 2 or higher hypertension at the time of study entry.

Keywords: alopecia hair loss prevention radiotherapy head & neck cancer radiodermatitis radiation dermatitis radiation-induced alopecia
efficacy of neoadjuvant folfirinox regimen in patients with resectable locally advanced rectal cancer

Conditions: Cancer of the Rectum

Summary: national, multi-center, open-label,randomized, 2-arm phase iii superiority trial, comparing neoadjuvant chemotherapy (ct) with mfolfirinox followed by preoperative chemoradiotherapy (crt), versus preoperative crt in patients with locally advanced rectal cancer.

methodology this is a biomedical research, national, multicenter, open-label randomized, 2-arm phase iii superiority trial, comparing neoadjuvant ct with mfolfirinox then preoperative crt, versus immediate preoperative crt, in patients with locally advanced rectal cancer randomized phase iii study with stopping rules stratification : center, gender, tumor location in the rectum (\<6 cm from anal verge versus ≥6 cm), initial stage (ct3 vs ct4, and cn0 vs cn+)

Eligibility criteria:
inclusion criteria: * histologically proven rectal adenocarcinoma * stages ct3 with risk of local recurrence or ct4, m0 and for which a multidisciplinary meeting recommend preoperative crt * resectable tumor, or considered as potentially resectable after crt * no distant metastases * patient eligible for surgery * patient aged from 18 to 75 years * world health organization (who)/eastern cooperative oncology group (ecog) performance status 0/2. * no heart failure or coronary heart disease symptoms (even controlled). * no peripheral neuropathy \> grade 1 * no prior radiotherapy of the pelvis for any reason and no previous ct * no major comorbidity that may preclude the delivery of treatment and no active infection (hiv or chronic hepatitis b or c). * adequate contraception in fertile patients. * adequate hematologic function * adequate hepatic function * signed written informed consent exclusion criteria: * metastatic disease * unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles * contraindication to 5-fu, or to oxaliplatin or to irinotecan, including gilbert disease or genotype ugt1a1 * medical history of chronic diarrhea or inflammatory disease of the colon or rectum * medical history of angina pectoris or myocardial infarction * progressive active infection or any other severe medical condition that could jeopardize treatment administration * other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma * patient included in another clinical trial testing an investigational agent. * pregnant or breast-feeding woman. * persons deprived of liberty or under guardianship or incapable of giving consent * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Keywords: rectum cancer locally advanced
brief title * (in english and sufficiently descriptive) role of mri in anti-lgi1 encephalitis

Conditions: Autoimmune Encephalitis

Summary: the term "autoimmune encephalitis" denotes an heterogenous group of diseases commonly associated with autoantibodies targeting neural or glial antigens. patients harboring antibodies against the leucine-rich glioma-inactivated protein 1 (lgi1) usually respond well to immunotherapy, but a significant percentage develop cognitive sequelae and disability nonetheless. these patients would likely benefit for more aggressive and prolonged immunotherapy, aiming to prevent permanent neurological deficits. identifying features predicting poor outcome would be crucial to guide treatment decisions. brain magnetic resonance imaging is a key diagnostic tool in the acute phase, but radiological changes may also appear in follow-up studies, including global brain atrophy, hippocampal atrophy and mesial temporal sclerosis. we hypothesize that specific changes identifiable in the acute and chronic phase underlie a higher risk of poor outcome and persistent neurological deficits.


Eligibility criteria:
inclusion criteria: * - patients with a definite diagnosis of lgi1-antibody-associated encephalitis * available mri records * ascertained positivity for lgi1-antibodies in serum and/or csf exclusion criteria: * - positivity for another antibody against neural or glial antigens * mri images not available * not enough clinical data to ascertain outcome

Keywords: autoimmune encephalitis lgi1 antibodies mri
safety and efficacy of cbx129801 in patients with type 1 diabetes

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of the study is to determine the beneficial effects of cbx129801 (pegylated synthetic human c-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (t1dm) with mild to moderate diabetic peripheral neuropathy (dpn).


Eligibility criteria:
key inclusion criteria: * give informed consent; * 18-65 years old; * have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months); * have clinical signs of diabetic peripheral neuropathy at screening; * have abnormal sural nerve conduction observed bilaterally during screening; * be c-peptide deficient; * be in good general health (besides having type 1 diabetes mellitus); * practice effective contraception during and for at least 12 weeks after study participation; * have a body mass index (bmi) ≥18.0 and \<35.0 kg/m2. key exclusion criteria: * any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease; * unstable or inadequate glucose control; * any clinically significant laboratory value at screening; * occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the investigator; * have had an islet cell, kidney, and/or pancreas transplant; * if female, is pregnant or lactating; * history of alcohol or substance abuse within 2 years; * positive screen for hepatitis b, hepatitis c antibody, or human immunodeficiency virus (hiv) antibody; * initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days; * previous treatment with cbx129801 or unmodified c-peptide; * receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days; * chronic use of oral steroids or use of ampyra (dalfampridine) within 60 days.
safety and efficacy of different intervals of pulsed dye laser sessions on improvement of surgical scars

Conditions: Scar

Summary: the appearance of skin after surgery plays an important role in patient's self confidence and life style. in fact, keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. this study will assess the efficacy and safety of different intervals of pulsed dye laser sessions on improvement of surgical scars.


Eligibility criteria:
inclusion criteria: * surgical scar with minimum length of 6 cm exclusion criteria: * history of light sensitivity or photodermatoses * history of adverse reactions to laser treatment

Keywords: scar surgery lasers
family process, adherence, and child asthma outcome

Conditions: Asthma; Lung Diseases

Summary: to examine the role of family processes in asthma regulation in three groups of children with mild to moderate asthma.

design narrative: the study, which was ancillary to the childhood asthma management program (camp), clarified the extent to which and the mechanisms whereby specific family processes might be protective or deleterious in the adherence behaviors and treatment outcome in three groups of children with mild to moderate asthma: 80 children participating in the denver site of the camp, 80 children receiving asthma-related care in a large, nationally recognized health maintenance organization, and 60 children recruited by using school records to identify children with asthma receiving their care in a variety of different health care systems across the denver metropolitan area. the study examined the extent to which family process variables were cross-sectionally associated with and longitudinally influenced adherence to asthma treatment and asthma treatment outcome as well as the consistency of this relationship across the three sites. the study also determined whether adherence with treatment mediated the relationship between specific family processes and asthma treatment outcome, as well as the consistency of this relationship across the three sites. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
combination metformin and oral contraception for polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome; PCOS; Insulin Sensitivity

Summary: the purpose of this research study is to determine if adding metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with pcos

inclusion criteria: pcos women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.

Eligibility criteria:
inclusion criteria: * ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia exclusion criteria: * diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of deep vein thrombosis, pregnancy and lactation.
efficacy of hall technique in atypical lesions on primary teeth

Conditions: Dental Caries

Summary: atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. however, most of them have shown a great failure percentage. a randomized clinical trial will be developed with the objective of assessing the hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. selected teeth will be randomly allocated into two groups. teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months. treatment's efficacy will be assessed by means of four main outcomes: 1. longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression; 2. patient-focused criteria (satisfaction, discomfort and quality of life impact); 3. cost-efficacy; and 4. treatment-related parents', children' and operators' perception. other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. comparisons between groups will be addressed using the kaplan-meier survival test as well as long-rank test. cox regression will be used to enable the assessment of other variables' influence in the results. significance value of 5% will be adopted for all analysis.


Eligibility criteria:
inclusion criteria: * children must have at least one molar with atypical caries lesion (involving more than two surfaces); * parents or legal guardians accept and sign the informed consent form. exclusion criteria: * children with special needs and/or systematic diseases with oral impairment; * teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.

Keywords: stainless dental crown composite resin primary teeth
addressing hypertension care in africa program

Conditions: Hypertension; High Blood Pressure

Summary: the adhincra program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, provider-, and health system-level factors. the successful implementation of the adhincra program will provide a rigorous and scalable model for improving hypertension control in africa, which would ultimately reduce the risk of cardiovascular disease, stroke and kidney disease.


Eligibility criteria:
inclusion criteria: * aged 18 -70 years. * diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmhg) on the most recent clinic visit (within the previous 6 months) without a diabetes diagnosis. * receives primary care at one of the participating sites. * willing and able to provide informed consent in english, twi, dagbani, ewe or yoruba. * owns a smartphone (android or ios). exclusion criteria: * age \ 70 years. * severely elevated bp (≥180/110mmhg). * diagnosis of stroke, coronary artery disease, or kidney disease. * diagnosis of end-stage renal disease (esrd) treated with dialysis. * serious medical condition which either limits life expectancy or requires active management (e.g., cancer). * cognitive impairment or other conditions preventing study participation * pregnant or currently nursing a child * unwilling to provide informed consent