Kornimate/medical-research-clean huggingface dataset:
evaluation of the 18f-psma positron emission tomography (pet)/ct in patients with medullary thyroid cancer

Conditions: Medullary Thyroid Cancer; Medullary Thyroid Carcinoma; Thyroid Carcinoma, Medullary; Thyroid Cancer, Medullary

Summary: rationale: in patients with medullary thyroid cancer (mtc), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. the currently most used tracer in clinical practice, f-18 labelled fluorodeoxyglucose (18f-fdg), does not accurately detect mtc tumors with an indolent growth rate. a new, complimentary tracer is warranted to detect different subtypes. objective: the primary objective is to assess the feasibility of using the f-18 labelled prostate specific membrane antigen (18f-psma) pet/ct for (re)staging patients with medullary thyroid cancer. the secondary objective is to compare the ability to detect mtc with the 18f-psma pet/ct to that of the 18f-fdg pet/ct. study design: prospective, single-centre, feasibility study. study population: patients (18 years of age or older) with biochemically and cytological/histological confirmed mtc, for whom the indication of an 18f-fdg pet/ct for tumor staging has already been determined on clinical grounds. main study parameters/endpoints: the primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18f-psma pet to detect mtc lesions in patients with cytologically/histologically confirmed disease. secondarily, the performance of the 18f-psma pet will be compared to the 18f-fdg pet/ct.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * histological or cytological proven mtc * biochemical evidence of disease activity (elevated/increasing calcitonin and/or cea) * clinical indication for an 18f-fdg pet/ct * able to follow instructions to participate in the study * able to give informed consent exclusion criteria: * patients with prostate cancer or renal cell carcinoma * pregnant patients * recent neck surgery (\<3 months ago)

Keywords: psma pet/ct 18f-psma pet/ct fluorine-18 labeled prostate specific membrane antigen prostate specific membrane antigen thyroid cancer medullary thyroid cancer medullary thyroid carcinoma
false positive results in newborn hearing screening

Conditions: Deafness

Summary: the purpose of this study is to investigate the rate of false-positive results in newborn universal hearing screening programs and it´s possible causes.

false-positive results in newborn hearing screening(nhs) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail nhs with otoacoustic emissions.

Eligibility criteria:
inclusion criteria: * healthy newborns exclusion criteria: * risk factors for hearing loss

Keywords: hearing newborn otoacoustic emissions
computational prediction and experimental validation of gastric cancer associated neoantigens

Conditions: Gastric Cancer; Neoantigens

Summary: this study is to develop methods for identification of neoantigens from patients with gastric cancer.

gastric cancer (gc) is the fourth most common cancer type and one of the leading causes of cancer-related death in vietnam. immunotherapy using checkpoint inhibitors (cpi) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. however, clinical outcomes of cpi are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. recent data published by the tumor neoantigen selection alliance (tesla) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. in the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 15 years and older 2. diagnosed with advanced gastric cancer (t2-4b/n0-3/m0-1 stage, according to the eighth edition of the american joint committee on cancer tnm (ajcc tnm) system) 3. treatment-naive 4. not known for other concomitant cancers 5. provide written informed consent exclusion criteria: 1. insufficient tumor tissues (less than 1 cm3) 2. unable to sign informed consent 3. underwent treatment
bhv-7000 open-label extension bipolar mania study

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of bhv-7000 in subjects with bipolar i disorder.


Eligibility criteria:
key inclusion criteria: 1. subjects must have successfully completed the parent study, bhv7000-204. 2. wocbp must have a negative urine pregnancy test at baseline visit. 3. wocbp must not be breastfeeding or lactating at baseline visit or any point in the study. key exclusion criteria: 1. any medical condition, based on the judgement of the investigator, that would confound the ability to adequately assess safety and efficacy outcome measures. 2. subjects who, in the opinion of the investigator, will not be able to adhere to the schedule of assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study. 3. investigator deems subject at imminent risk of danger to others or themself.

Keywords: bipolar mania manic episode manic state bipolar disorder type 1 manic depressive manic bipolar mixed features mixed episode mixed mania bipolar episode bipolar disorder
radiofrequency ablation using cooled-wet electrode

Conditions: HCC; Metastasis

Summary: to determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (rfa) for liver tumors.

to determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (rfa) for liver tumors in comparison with currently used separable clustered electrode in our institution. owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). the results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Eligibility criteria:
inclusion criteria: all conditions have to be fulfilled. * diagnosed with hcc (1\~5cm) according to aasld guideline or li-rads on mdct or liver mri within 60 days before rfa * liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging * signed informed consent * treatment naive index tumor (no history of local treatment for an index tumor) exclusion criteria: * more than three tumors in a patients * tumor size larger than 5cm * tumor attaches to central portal vein or hepatic vein * child-pugh classification c * uncorrected coagulopathy * presence of extrahepatic metastases

Keywords: rfa
comparison of laser lithotripsy with and without steerable ureteroscopic renal evacuation (sure)

Conditions: Kidney Stone; Renal Stone; Urolithiasis

Summary: the purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the sure procedure for stone evacuation to the standard treatment using a basket for stone removal.


Eligibility criteria:
inclusion criteria: * candidate for ureteroscopy with laser lithotripsy; * presence of renal stone(s); * be willing and able to return for all study-related follow up procedures; and, * have been informed of the nature of the study, agreeing to its requirements, and have signed the irb approved informed consent. exclusion criteria: * bmi \> 45; * significant comorbidities; * bladder, ureteral or kidney abnormalities; * pregnant individuals; or * unable to meet the treatment and follow up protocol requirements.
post-market clinical follow-up ontvt exact® continence system

Conditions: Stress Urinary Incontinence

Summary: the objective of this single arm, post market, clinical study is to evaluate the performance of gynecare tvt exact® continence system in women undergoing retropubic mid-urethral sling surgery for stress urinary incontinence (sui).


Eligibility criteria:
inclusion criteria: subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. stress urinary incontinence symptoms 2. stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test 3. female subjects ≥ 21 years of age requiring treatment of sui 4. desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling 5. planned surgery for primary stress incontinence without concomitant prolapse surgery 6. patient able and willing to participate in follow-up 7. subject or authorized representative has signed the approved informed consent exclusion criteria: subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires 2. any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. history of previous synthetic, biologic or fascial pubo-urethral sling 4. pregnancy or plans for future pregnancy 5. history of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice. 6. current genitourinary fistula or urethral diverticulum 7. reversible cause of incontinence (i.e. drug effect) 8. contraindication to surgery

Keywords: gynecare tvt exact® continence system sui
role of mirnas in cvd and periodontitis

Conditions: Cardiovascular Diseases; Periodontal Diseases

Summary: several micro-rna plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease. the investigators compared the impact of gingival health, periodontitis (cp), cardiovascular disease or of both diseases (cp +cardiovascular disease) on gingival crevicular fluid mirna 7a-5p, mirna 21-3p, mirna 21-5p, mirna 200b-3p, mirna 200b-5p, mirna 100-5p, mirna 125-5p levels.

the investigators compared the impact of gingival health, periodontitis (cp), cardiovascular disease or of both diseases (cp +cardiovascular disease) on gingival crevicular fluid mirna 7a-5p, mirna 21-3p, mirna 21-5p, mirna 200b-3p, mirna 200b-5p, mirna 100-5p, mirna 125-5p levels.

Eligibility criteria:
inclusion criteria: * presence of at least 15 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
reinvent registry (registry of the nerve gap repair from integra)

Conditions: Peripheral Nerve Injuries

Summary: this is a prospective, multi-center, observational registry designed to evaluate two of integra's collagen nerve gap repair products (neuragen® nerve guide and neuragen® 3d nerve guide matrix). this registry will collect data on the outcome measures throughout the follow-up period for each patient. data will be collected per standard of care.

integra neuragen nerve guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. integra neuragen nerve guide is used in this registry as a comparator to a next-generation advanced nerve guide, integra neuragen 3d nerve guide matrix, that is based on the original integra neuragen nerve guide technology but contains a regenerative matrix in the lumen. centers chosen for participation will be current users of integra's collagen nerve gap repair products listed above.

Eligibility criteria:
inclusion criteria: * subject has undergone nerve gap repair utilizing neuragen or neuragen 3d * subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc. * subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol. * subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand. * subject requires only a single repair per proper digital nerve branch exclusion criteria: * subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials. * subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol. * subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve * subject has debris due to injury of the affected hand where contamination cannot be ruled out. * subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., cubital or carpal tunnel syndrome) * subject has an infection of the area around the nerve defect. * subjects with diagnosed peripheral vascular disease and peripheral arterial disease * subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study. * subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing. * subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results.

Keywords: digital nerve gap repair
crossover bioequivalence study of quetiapine fumarate 25 mg tablets under fed conditions

Conditions: Bipolar I Disorder

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' quetiapine fumarate 25 mg tablet under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to quetiapine or any comparable or similar product.
genetics of hypertension associated treatments (genhat)

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Coronary Disease; Myocardial Infarction

Summary: to examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.

background: the study might shed important light on the variation in patient response to antihypertensive agents, and improve the ability to pick the right antihypertensive for specific patients. genhat is an ancillary study to allhat (the antihypertensive and lipid-lowering treatment to prevent heart attack trial). allhat recruited 42,515 hypertensives and randomized them to one of four antihypertensive agents (lisinopril, chlorthalidone, amlodipine, and doxazosin); follow-up will be completed in march, 2002. design narrative: genhat, a prospective study ancillary to allhat, will characterize hypertension genetic variants and determine their interaction with antihypertensive treatments in relation to coronary heart disease (chd). dna from frozen clots stored at the allhat central laboratory will be used to genotype variants of hypertension genes (angiotensinogen -6, angiotensin converting enzyme insertion/deletion, angiotensin type- 1 receptor, alpha-adducin, beta2 adrenergic receptor, lipoprotein lipase, and 10 new hypertension variants expected to be discovered during the course of the study). in addition to the primary aim, a number of secondary aims will be undertaken to evaluate gene- treatment interactions in relation to other endpoints, including all-cause mortality, stroke, heart failure, left ventricular hypertrophy, decreased renal function, peripheral arterial disease, and blood pressure lowering. because of the ethnic and gender diversity of allhat, an assessment will be made of the effects of these variants on outcomes in key subgroups (age \>65 years, women, african americans, type ii diabetics), and whether the gene-treatment interactions in relation to outcomes are consistent across subgroups.

Eligibility criteria:
* not taking anti-hypertensive medication * use of anti-hypertensives for less than two months with a baseline blood pressure between 140/90 and 180/110 * use of anti-hypertensives for greater than two months with a blood pressure not greater than 160/100 * at least one additional cardiovascular risk factor such as previous mi, stroke, type 2 diabetes, smoking, left ventricular hypertrophy or dyslipidemia
high map in septic shock with hypertension

Conditions: Septic Shock

Summary: we hypothesized that the increase in map from 65 mmhg to patients' usual level improved sublingual microcirculation.

the effect of mean arterial pressure (map) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. our goal was to assess the effect of map titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. we hypothesized that the increase in map from 65 mmhg to patients' usual level improved sublingual microcirculation.

Eligibility criteria:
inclusion criteria: * patients with septic shock for less than 24 hours * fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (cvp) for more than 8 mm hg and central venous oxygen saturation for more than 70% * patients requiring norepinephrine (ne) to maintain a map of 65 mm hg. septic shock patients with fluid resuscitation after cvp \> 8mmhg and mean blood pressure \> 65 mmhg exclusion criteria: * pregnancy * age \< 18 years * inability to acquire the usual level of map * refusal of consent by the patient or relative * participation in other trials during the last three months * hypertensive patients without hypertension treatment

Keywords: septic shock microcirculation norepinephrine fluid
allopregnanolone and dynamic gaba-a receptor plasticity in selective serotonin reuptake inhibitor responsive premenstrual dysphoric disorder

Conditions: Premenstrual Dysphoric Disorder (PMDD)

Summary: premenstrual dysphoric disorder (pmdd) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. neuroactive steroid hormones (nas) and the gamma-aminobutyric acid (gaba)-a receptor (gabaar) are thought to play a role in pmdd. this research will assess the blood levels of gabaergic nas, expression of associated enzymes, and expression of gabaar subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with pmdd. within the pmdd group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. the results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie pmdd, as well as therapeutic mechanisms of pmdd treatment.


Eligibility criteria:
inclusion criteria: * female sex, * fluent in the english language * regular menstrual cycles (24-35 days) * age 18-50 years old * ability to give written informed consent exclusion criteria: * psychiatric medication use in the past 2 months * substance use disorder in the past 6 months * lifetime history of psychotic disorder including schizophrenia * schizoaffective disorder, major depression with psychotic features * history of psychiatric disorder other than pmdd in past year * active suicidal ideation with plan or attempt in past 6 months * steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months * pregnancy in past 6 months * history of brain injury * current or history of endocrine disorder including uncontrolled diabetes or thyroid disease * bmi\>40 * history of arrythmias, severe liver impairment, history of seizure disorder * if currently taking the following meds: methylene blue, linezolid * other prohibited concomitant meds are monoamine oxidase inhibitors (maois), pimozide, and disulfiram

Keywords: pmdd premenstrual dysphoric disorder pms premenstrual symptoms premenstrual syndrome blood draw sertraline ssri mood symptoms women women with pms women with pmdd luteal phase follicular phase womens reproductive mental health womens health womens reproductive health menstrual cycle menses periods allopregnanolone neuroactive steroids inflammatory markers epigenetics