Kornimate/medical-research-clean huggingface dataset:
18f-fluorocholine pet/ct imaging in hyperparathyroidism

Conditions: Hyperparathyroidism

Summary: to assess the efficiency of 18f-fluorocholine pet/ct in localization of hyperfunctioning parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical approaches with fewer complications and comparable success rates

primary hyperparathyroidism is a common endocrine disorder for which the diagnosis is biochemical and therapy surgical in the vast majority of cases; in secondary and tertiary hyperparathyroidism, surgical treatment is usually chosen when conservative measures fail to control the condition. the previously used surgical approach of bilateral neck exploration is being replaced by minimally invasive procedures, whose advantage is shorter duration of operation and general anesthesia, lower morbidity and fewer complications with comparable success rates. a prerequisite for minimally invasive surgery is successful localization of the offending parathyroid tissue. most commonly used imaging modality for this purpose is parathyroid scintigraphy with 99mtc-sestamibi, usually supplemented by ultrasound of the neck. overall, parathyroid scintigraphy is a sensitive method for localization of hyperfunctioning parathyroid tissue; however, its diagnostic performance is significantly lower in patients with multiple parathyroid lesions. in comparison to conventional nuclear medicine imaging approaches for localization of the offending parathyroid tissue, positron emission tomography with computed tomography (pet/ct) offers superior image resolution with an additional advantage of attenuation correction and co-registration of functional and anatomical information. 18f-fluorocholine is a pet tracer which is commonly used for prostate cancer imaging. in contrast to 18f-fluorodeoxyglucose (18f-fdg), it is also taken up by well-differentiated neoplasms in which 18f-fdg uptake is unreliable. the investigators hypothesize that 18f-fluorocholine might be efficiently taken up by parathyroid adenomata and/or hyperplasia. the aim of this study is to investigate the efficiency of localization of hyperfunctioning parathyroid tissue with 18f-fluorocholine pet/ct in patients with primary hyperparathyroidism and to compare its efficiency to conventional scintigraphic imaging methods for this purpose.

Eligibility criteria:
inclusion criteria: * age over 18 years * biochemically proven hyperparathyroidism (elevated ipth, elevated on normal ca2+) or elevated ca2+ and inadequately supressed ipth exclusion criteria: * age under 18 years * pregnancy * clinical history of oncological, inflammatory/infectious disease of the head and neck

Keywords: hyperparathyroidism imaging scintigraphy 18f-choline 18f-fluorocholine pet pet/ct
effect of afferent oropharyngeal pharmacological and electrical stimulation on swallow response and on activation of human cortex in stroke patients with oropharyngeal dysphagia

Conditions: Dysphagia; Aspiration; Stroke

Summary: oropharyngeal dysphagia (od) is a major complaint among many patients with stroke and causes severe complications. there is no specific treatment for these patients. impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection. swallow response is initiated by sensory afferent fibers in the oropharynx and cerebral cortex reaching the central swallowing pattern generator (cpg) in the medulla oblongata and brainstem motor nuclei. hypothesis: stimulation of pharyngeal sensory afferent fibers through trpv1 receptors and electrical stimuli might enhance the stimulation of the cpg and speed the swallow response. long-term treatment of od will improve clinical outcome of stroke patients. aim: to assess the effect of trpv1 agonists (capsaicin) and that of sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on vfs signs and swallow response at 3, 6 and 12 months after treatment in stroke patients with established od. to compare the clinical effect of classical rehabilitation strategies with that of these new afferent sensorial neurostimulation strategies in terms of nutritional status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection, quality of life, and mortality. methods: clinical screening of od with the volume-viscosity swallow test and assessment by vfs and quantitative measurements of swallow response. randomized controlled trial assessing the effect of standard rehabilitation with that of afferent sensorial neurostimulation strategies.


Eligibility criteria:
inclusion criteria: - person with persistent clinical signs or symptoms of od according to v-vst and confirmed with vfs (pa scale level 3 or more) secondary to a stroke episode in the last 3 months. exclusion criteria: * patient unconscious or in a coma * patients diagnosed with transitory ischemic accident * life expectancy less than 3 months * neurodegenerative disease
study to compare the diopsys nova and lkc reteval devices

Conditions: Retinal Disease

Summary: to compare the diopsys nova and lkc reteval devices using the diopsys lid electrodes and lkc reteval self-adhering electrode arrays.

this study is an open label, prospective study comparing the diopsys nova and lkc reteval devices using the diopsys lid electrodes and the lkc reteval self-adhering electrode arrays. subjects will receive the phnr test three times using the diopsys device and diopsys electrodes. next, subjects will receive the fl flicker test three times using the diopsys device and diopsys electrodes. there will be a short break (10 to 15 minutes), then subjects will receive the phnr test three times using the diopsys device with lkc electrode arrays, followed by the fl flicker test three times using the diopsys device with the lkc electrode arrays. subjects will receive another short break (5 to 10 minutes), then receive the phnr test three times using the lkc device with the lkc electrode arrays, followed by the fl flicker test three times using the lkc device with the lkc electrode arrays.

Eligibility criteria:
inclusion criteria: * male or female at least 22 years of age on day of enrollment * bcva letter score of 75 or better (snellen equivalent of 20/32 or better) on day of enrollment * eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. subject has not been diagnosed with any ocular pathology that could affect erg results. * able to communicate well with the investigator and able to understand and comply with the requirements of the study * informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines exclusion criteria: * a spherical refraction outside + 5.0 d and cylinder correction outside + 3.0 d on day of enrollment * intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment) * any prior macular or panretinal photocoagulation laser treatment * history of ophthalmic or neurologic condition known to affect visual function * inability to obtain a reliable erg test * history of diabetic retinopathy * history of glaucoma * history of armd * history of seizure disorder * has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays * in the opinion of the investigator, is unlikely to comply with the study protocol
effect of virtual glasses on pain and comfort during eswl

Conditions: Extracorporeal Shock Wave Lithotripsy; Lithotripsy

Summary: the aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during eswl. the data obtained in the research will be analyzed using the spss 23.0 "statistical package for social sciences" for windows program. descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. as hypothesis tests, analysis will be made with mann whitney u, student t test, and chi-square tests. the findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.

after obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo eswl procedure and explain the purpose of the research. informed consent will be obtained from patients who volunteered to participate in the study. the data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. data will be collected from the first patient who will undergo the eswl procedure. pain with vas and comfort level with general comfort scale will be checked 5-10 minutes before the procedure. according to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. when the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. no intervention will be performed on the patient in the control group. the first patient will go to the operation room. patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. no intervention will be performed on the patient in the control group. all patient groups will be checked for pain with vas and comfort level with general comfort scale 30 minutes after the end of the procedure. at the end of the procedure, the patient will come to the service. no intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.

Eligibility criteria:
inclusion criteria: * 18 years or older, * absence of hearing and perception problems, * absence of any visual impairment, * eswl procedure will be performed for the first time, exclusion criteria: * using any analgesic or anxiolytic before the procedure, * having a psychiatric disorder

Keywords: eswl pain comfort level virtual glasses
efficacy of double wire technique in difficult cases of common bile duct cannulation in ercp (udoguia-04)

Conditions: Bile Duct Diseases

Summary: the purpose of this study is to determine if the double guide wire technique is more effective than the conventional method in those cases of difficult selective biliary cannulation in the ercp procedures.

complications associated with ercp have been related with certain characteristics of the procedure. one is the number of attempts of selective biliary cannulation. our hypothesis is that double guide wire placement could be a useful technique for selective biliary cannulation in those cases of difficult ercp procedures, reducing the number of cannulation attempts and the complication associated with the procedure. we are conducting a controlled prospective multicentre randomized study to compare the double guide wire technique with the conventional method in two groups previously randomized after presenting a difficult selective biliary cannulation under the conventional method. the study is carried out in six public hospitals from spain. assignation is concealed to both groups, and the expected study period is 18 months for a number of randomized patients equal or over 262 (statistical power of 90% with an α-error of 0.05, to detect a success rate of 74% in the group undergoing double guide wire technique against a success rate of 60% in the control group). the main outcome variables are successful selective biliary cannulation (primary outcome variable), number of attempts and morbimortality associated in both groups (secondary outcome variables).

Eligibility criteria:
inclusion criteria: * age over 18 years * clinical and/or radiological suspicion of bile duct diseases which require ercp procedure with intention of selective biliary cannulation * patients must be admitted in the participant hospitals of the investigators units * written informed consent of the patient, relative or legal tutor exclusion criteria: * previous biliary or pancreatic sphincterotomy * previous pneumatic dilatation of duodenal papilla * presence of biliary-digestive derivation * previous diagnosis or suspected pancreas divisum * use of any biliary or pancreatic stent in the last 6 months * use of any drug aimed to reduce post-ercp pancreatitis * pregnancy or maternal feeding * previous inclusion in the study

Keywords: double guide wire technique difficult selective biliary cannulation ercp attempts of cannulation post-ercp complications.
a study to evaluate the efficacy and safety of adapalene-clindamycin combination gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: this is a study to see if adapalene-clindamycin combination gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. this new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.


Eligibility criteria:
inclusion criteria: * male or female, aged 12-40 years old * diagnosis of grade ii-iii acne vulgaris with pillsbury grading system * provide written informed consent if the subject is aged 18 or older. ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian. exclusion criteria: * known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution * secondary acne, such as occupational acne and steroid acne * has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema * history of crohn's disease, ulcerative colitis or antibiotic-associated colitis * history of serious heart disease or hypertension * serious liver or kidney disease, ast or alt more than twice the upper limit of normal, or cr above normal * serious endocrine, hematologic or psychiatric disease * known immunocompromised conditions, or require long-term steroids or immunosuppressants * females who are pregnant, lactating, or not willing to use effective contraception * drug or alcohol abuse * used any topical acne treatment within 2 weeks * used any systemic retinoid, antibiotic or other acne treatment * used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial * patient who the investigator deemed to be unsuitable for any reason
a phase 1 study of givosiran (aln-as1) in patients with acute intermittent porphyria (aip)

Conditions: Acute Intermittent Porphyria

Summary: the purpose of this study is to evaluate the safety and tolerability of givosiran (aln-as1) in aip patients as well as to characterize pharmacokinetics (pk) and pharmacodynamics (pd) of aln-as1 in aip patients.


Eligibility criteria:
parts a and b inclusion criteria: * diagnosis of aip * urine pbg at screening indicating patient is a high excreter * no clinically significant health concerns * women of child bearing potential must have a negative pregnancy test, not be nursing, and use effective contraception * willing to provide written informed consent and willing to comply with study requirements. exclusion criteria: * porphyria attack within 6 months of screening * started a new prescription medication within 3 months of screening * clinically significant abnormal laboratory results * received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study * history of multiple drug allergies or intolerance to subcutaneous injection part c inclusion criteria: * diagnosis of aip * patient experienced a porphyria attack or was taking medication to prevent attacks recently * no clinically significant health concerns * women of child bearing potential must have a negative pregnancy test, not be nursing, and use effective contraception * willing to provide written informed consent and willing to comply with study requirements. exclusion criteria: * stared a new prescription medication within 3 months of screening * clinically significant abnormal laboratory results * received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study * history of multiple drug allergies or intolerance to subcutaneous injection

Keywords: rnai therapeutic porphyria aip
monitoring system for cranial orthoses

Conditions: Plagiocephaly; Brachycephaly; Deformational Plagiocephaly; Deformational Posterior Plagiocephaly

Summary: this is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

this is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time. in total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately 60 minutes\], (3) fitting of research helmet (if not done at visit #2) and in-office testing \[approximately 2 hours\], (4)/(5)/(6) follow up visits for research helmet \[approximately 30-60 minutes each\], and (7) final follow up visit and in-office testing for the research helmet \[approximately 2 hours\]. during the 8-9 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day (after a break-in schedule), and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. the child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups). at the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet.

Eligibility criteria:
inclusion criteria: * infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly) exclusion criteria: * non-english speaking caregivers * infants with craniosynostosis or those not indicated for cranial remolding * infants with developmental comorbidities which affect cranial growth
effectiveness of trauma therapy using prolonged exposure for patients with ptsd and a comorbid psychotic disorder

Conditions: Post Traumatic Stress Disorder; PTSD; Psychosis

Summary: psychosis patients with comorbid ptsd will be treated with trauma therapy.

this is a monocentric, controlled, prospective, randomised trial. (rct). the study population is outpatients with psychotic illness and comorbid post-traumatic stress disorder who have applied for outpatient psychotherapy at the psychotherapeutic outpatient clinic (hsa) of the medical school hamburg. it will be investigated whether trauma therapy (prolonged exposure) reduces ptsd and psychosis symptoms in comparison to the waiting group. the study will be conducted from 01.09.2023 to 30.04.2028. patients with suitable symptoms should be seen in the psychotherapeutic outpatient (psychotherapeutic consultation hours) at the hsa should be made aware of the study. in the next step, a detailed diagnosis is made and, if consent is given and the inclusion criteria listed below are met, the patients are enrolled in the study. the sample size for the longitudinal intent-to-treat (itt) analysis with a linear mixed model (lmm) was chosen. models (lmm) was calculated based on a previous rct (van den berg et al., 2016, effect size for pe in caps versus waitlist (tau) d = 0.78, p \< 0.001; effect size for pe in paranoia versus waitlist (tau) d = 0.62, p = .005). itt analyses with llm are relatively robust to missing data, despite which we calculate a 20% dropout rate. with an alpha of 0.05; a mean effect size of 0.5, 3 measurement replicates (baseline measurement t0, post-treatment t1, 6-month follow-up after post, t2), we require 28 patients per treatment arm. a total of 56 patients will be included in the study.

Eligibility criteria:
inclusion criteria: * presence of a psychotic disorder (f20) or affective disorder with psychotic symptoms(f30) according to dsm-5. * comorbid post-traumatic stress disorder (ptsd) according to dsm-5 (caps-5 score ≥ 23) * at least 18 years old * good knowledge of the german language * willingness to participate in randomisation and trauma-focused therapy exclusion criteria: * changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects). * any substance dependence with continued use other than nicotine and/or caffeine dependence. * iq of 70 or less * acute suicidality * pregnant women

Keywords: ptsd schizophrenia prolonged exposure
effect of preoperative clindamycin on postoperative endodontic pain

Conditions: Symptomatic Periapical Periodontitis

Summary: the aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

medical and dental history will be obtained from all patients participating in this trial. clinical and radiographic evaluation for each tooth included in this study will be recorded. clinical diagnosis of symptomatic apical periodontitis is to be confirmed. before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. single-visit root canal treatment will be performed. each patient will receive a 7-day diary to record postoperative pain and swelling.in case of pain, the participant will be instructed to take an analgesic. post-operative pain will be measured as a primary outcome on 11-point scale (nrs) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. the occurrence of swelling will be reported by participant as a secondary outcome

Eligibility criteria:
inclusion criteria: 1. patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement. 2. mandibular posterior teeth. 3. patients in good health. 4. patients who can understand pain scales (nrs). 5. patients able to sign informed consent. exclusion criteria: 1. patients who have draining sinus tract. 2. retreatment cases 3. patients with weeping canals.