Kornimate/medical-research-clean huggingface dataset:
a multiple dose study of avd-104 for geographic atrophy (ga) secondary to age-related macular degeneration (amd)

Conditions: Geographic Atrophy of the Macula; Macular Degeneration

Summary: investigate the safety, pharmacokinetics, and treatment effects of single and multi-dose of intravitreal avd-104 in participants with geographic atrophy secondary to age-related macular degeneration.

part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (ga) secondary to macular degeneration. they will receive a single intravitreal injection of study drug (avd-104) and will be followed for 3 months for safety observation. they will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations. part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of avd-104 on participants with geographic atrophy secondary to macular degeneration. participants will be randomized to high dose avd-104, low dose avd-104, or active comparator (avacincaptad). the primary endpoint will be the difference in the rate of growth of the ga area as measured by fundus autofluorescence.

Eligibility criteria:
inclusion criteria: part 1: 1. bcva in the study eye using etdrs chart visual acuity scale (vas) of 5 to 55 letters (equivalent to snellen va of approximately 20/800 - 20/80) 2. if ga is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 da) 3. ga may be center involved. part 2: 1. bcva in the study eye using etdrs chart vas of 24 letters or better (equivalent to snellen va of 20/320 or better) 2. confirmed diagnosis of amd that is non-center involving (i.e., non-sub-foveal) ga in 50% of participants. center involvement allowed in 50% of participants. 3. the entire ga lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy. exclusion criteria: participants are excluded from the study if any of the following criteria apply: part 1 and 2 - presence of the following ocular conditions - in the study eye: 1. exudative amd or choroidal neovascularization (cnv), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (sd-oct) imaging and/or fluorescein angiography as assessed by the reading center. 2. any ocular condition other than ga secondary to amd that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period.

Keywords: age-related macular degeneration geographic atrophy dry amd
study to assess the efficacy and safety of nbi-1065845 in adults with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy of nbi-1065845 compared with placebo in participants with mdd on improving symptoms of depression.


Eligibility criteria:
key inclusion criteria: participants must meet all of these criteria for inclusion in the study: 1. the participant has completed written informed consent. 2. at the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive. 3. the participant has a primary diagnosis of recurrent major depressive disorder (mdd) or persistent depressive disorder. 4. participant must have had inadequate response to antidepressant treatment. 5. participant must have a total hamilton depression rating scale-17 item (hamd-17) score ≥ 22 at screening. 6. participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression. 7. participants must be willing and able to comply with all study procedures. key exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: 1. participant is pregnant or breastfeeding or plans to become pregnant during the study. 2. participant has an unstable medical condition or unstable chronic disease. 3. participant has a history of neurological abnormalities. 4. participant has a current or prior psychiatric disorder that was the primary focus of treatment other than mdd. 5. the participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ect). 6. the participant has an alcohol or substance use disorder. 7. in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Keywords: depression mdd major depressive disorder nbi-1065845 mental disorders tak-653 madrs savitri
trends of renal biopsy in pediatric patients at tanta university hospital for 10 years from 2012 to 2022.

Conditions: Renal Diseases

Summary: this study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at tanta university hospital from 2012 to 2022.

this study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at tanta university hospital from 2012 to 2022. the data will be collected from records: 1. history taking including age and sex. 2. indications for renal biopsy. 3. methods of renal biopsy 4. complications of renal biopsy 5. adequacy of samples 6. the results obtained by light microscopy 7. the results obtained by electron microscopy, immunofluorescence when indicated

Eligibility criteria:
inclusion criteria: * all pediatric patients less than 18 years' old who underwent renal biopsy. exclusion criteria: * no exclusions
to evaluate the relative abuse potential of hydrocodone bitartrate and acetaminophen

Conditions: Healthy

Summary: evaluation of abuse potential in recreational abusers of hydrocodone bitartrate and acetaminophen versus norco®.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects 18 to 55 years of age. 2. opioid users who have used opioids for recreational purposes and or is an avid opioid user. exclusion criteria: 1. substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years. 2. heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods. 3. difficulty swallowing large number of pills. 4. subjects who have had a tattoo or body piercing.
phase 3 study to assess the efficacy and safety of batoclimab as induction and maintenance therapy in adult participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gmg. in period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (sc) once a week (qw) or 340 mg sc qw or placebo. the primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (mg- adl) score in acetylcholine receptor antibody seropositive (achrab+) participants. in period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg sc qw or 340 mg sc every two weeks) or receive placebo treatment. the secondary endpoint of maintenance of efficacy will be assessed by change in the mg- adl score in achrab+ participants. participants demonstrating a response to batoclimab during either period 1 or 2 may enter the long-term extension (period 3). participants who complete period 3 are eligible to participate in period 4 (optional long-term extension) according to their treatment assignment in period 3.


Eligibility criteria:
inclusion criteria: 1. are ≥ 18 years of age at the screening visit. 2. have mild to severe gmg by myasthenia gravis foundation of america (mgfa) classification class ii, iii, or iva at the screening visit. 3. have a qmg score ≥ 11 at the screening and baseline visits. 4. have a mg-adl score of ≥ 5 at the screening and baseline visits. 5. additional inclusion criteria are defined in the protocol. exclusion criteria: 1. have experienced myasthenic crisis within 3 months of the screening visit. 2. have had a thymectomy performed \< 6 months prior to the screening visit or have a planned thymectomy during the study period. 3. have any active or untreated malignant thymoma. 4. have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year. 5. have used anti-fcrn treatment within 3 months prior to the screening visit or have a documented history of non-response to prior anti-fcrn treatment. 6. additional exclusion criteria are defined in the protocol.

Keywords: monoclonal antibody batoclimab imvt-1401 myasthenia gravis acetylcholine receptor rvt-1401
calcium hydroxide, mineral trioxide aggregate and biodentine (trademark) as direct pulp capping of permanent teeth

Conditions: Caries; Dental Pulp Exposure

Summary: background: dental caries is considered an oral health problem worldwide. in chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. objective: the main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; biodentine compared mta and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

methodology: it is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; patients will not have knowledge of the material to be used in the coating. the patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. in each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. in radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Eligibility criteria:
inclusion criteria: * systemically healthy patients * patients with at least one full or partial tooth root development * clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis * radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration * teeth that have pulp exposure not exceeding 1 mm in size. exclusion criteria: * every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic * teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

Keywords: dentin substitute vital pulp therapy biodentine caries
fatigue and recovery: a comparison between trail and marathon

Conditions: Healthy

Summary: road marathon is a famous running race known for hundreds of years. trail running is an emerging running discipline which count new runners every year. trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. while marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. in spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.

some studies focused on fatigue and recovery following 30-to-40-km trail races or marathon but no direct comparison between both disciplines have been done yet. a direct comparison between marathon and trail would aim to better understand if the occurrence of fatigue is more important or if the recovery is longer in one of the two disciplines. the comparison is also a way to better understand mechanisms involved in fatigue and recovery following a trail and a marathon. then, this research could be applied to improve specificity of training and prevent risk of injuries. this project aims to compare fatigue and recovery following a trail and a marathon.

Eligibility criteria:
inclusion criteria: common for marasim, trailsim and trailnat: * male or female * 18-55 years old * endurance runners who run at least one running session of 20 km per week * being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years * refrain from participating to a competition one month before the first visit and during the duration of the study * to have a medical certificate of no contraindication of running practise in competition * registered with a social security scheme * having given the written consent freely specific for the 3 groups : * specialist of trail running (trailsim and trailnat) * specialist of road running (marasim) exclusion criteria: * subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems) * subjects who present chronic or central neurological pathologies * subjects deprived of liberty or who should be legally deprived * subjects who report to take forbidden products by the world anti-doping agency * pregnant or breastfeeding woman

Keywords: running marathon trail fatigue
comparison of newer colonoscopy devices with standard forward viewing (sfv) colonoscopes in daily practice

Conditions: Adenoma Detection Rate

Summary: retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (fuse full spectrum colonoscopy with 330° angle of view vs pentax standard hd-colonoscopes and pentax plus endocuff): medical device of the category iib (ce-marked device used within its intended purpose)

from march 2015 through february 2017 (phase a) patients referred for ambulant colonoscopy in a private swiss gastroenterologist's practice were alternatingly allocated to one of the two endoscopy theatres. one equipped with a fuse® endoscopy system from endochoice (later: boston scientific, na/fuse®=1044 examinations), the other with an epki processor and pentax i10 colonoscopes (na/pentax=934 examinations). in march 2017 a second doctor joined the practice, but did not contribute to the study. these organizational changes required randomization to be switched from per-patient alternation to per-day alternation in phase b from march 2018 through september 2019. in phase b the fuse® system was unchanged (nb/fuse®=1386 examinations), while the pentax i10 colonoscopes were additionally equipped with endocuff® (nb/endocuff®=750 examinations). patients with contraindica-tion against endocuff® (known or found diverticular stenosis) were excluded from the study (nb/removed=127). patients were given their appointments to any free slot throughout the week without stratification. the study and data analysis was consented by the ethical committee eknz ethikkom-mission nordwest- und zentralschweiz (project-id 2019-01643). all procedures were performed by one experienced endoscopist (board certified 2004) under nurse assisted propofol sedation (naps). baseline characteristics, age, sex, bmi, smoking habits, diabetes as well as quality of bowel prepara-tion (measured by bbps score) and indication for colonoscopy (screening, surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were assessed. amount of sedatives, other medications given during endoscopy (e.g. buscopan®) and time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention time) and time for intervention were measured by the assistant with a stopwatch. these parameters, polyp counts, size and their localisation (entered in a table and to an anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall satisfaction) were realtime entered to the database by a tablet computer. the data entry was done coded. only the main investigator could subdue each single patient. statistics were done with a professional statistics, the co-author dr. leiner

Eligibility criteria:
inclusion criteria: * all patient fit for ambulatory colonoscopy exclusion criteria: * for endocuff stricturing divertculosis
a phase 1 trial to determine dosimetry, biodistribution and safety of lmi 1195-101 in healthy subjects and patients with heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of lmi1195 in healthy subjects and heart failure patients undergoing positron emission tomography (pet)


Eligibility criteria:
cohort 1 inclusion: * healthy, age 18-40 cohort 1 exclusion: * significant or chronic medical illness * pregnant females * smoking within one month of enrollment * use of any prescription drugs within 4 weeks prior to dosing cohort 2 inclusion: * 30-70 year old subjects with a diagnosis of nyha class ii-iii heart failure * ejection fraction less than or equal to 35% * rest spect imaging within 90 days prior to enrollment cohort 2 exclusion: * significant or chronic medical illness * pregnant females * known history of arrhythmogenic disorder or rhythm disorder

Keywords: heart failure, pet imaging, implantable cardioverter-defibrillator, dosimetry
a dose-finding study to evaluate the change in weight after treatment with lik066 in japanese patients with obesity

Conditions: Obesity

Summary: the purpose of the study is to evaluate the efficacy, tolerability and safety of lik066 to support dose selection for phase 3 development in japanese adults with obesity disease.


Eligibility criteria:
inclusion criteria: * patients with obesity disease and inadequately controlled body weight with diet and/or exercise * bmi ≥ 25 kg/m\^2 combined with at least two obesity-related comorbidities, or bmi ≥ 35 kg/m\^2 at least one obesity-related comorbidity * patients with fpg ≥ 110 mg/dl and/or 5.6% ≤ hba1c ≤ 10.0%, or t2dm with hba1c ≤ 10.0% * waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female * visceral fat area ≥ 100 cm\^2 * agreement to comply with the study-required life-style intervention and treatment during the full duration of the study exclusion criteria: * pregnancy or lactating women * use of pharmacologically active weight-loss medications * bariatric surgery * ketoacidosis, lactic acidosis, hyperosmolar coma * symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening * gastro-intestinal (gi) disorders associated with chronic diarrhea * congestive heart failure, new york heart association (nyha) class iii or iv

Keywords: obesity disease over weight t2dm interventional study weight loss
post-marketing surveillance study of adalimumab in pediatric chronic severe plaque psoriasis patients in korea

Conditions: Psoriasis

Summary: the objective of this study is to evaluate the real world safety and effectiveness of adalimumab (humira) for the treatment of korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.


Eligibility criteria:
inclusion criteria: * children and adolescents who are diagnosed with pediatric chronic severe plaque psoriasis. * prior to participating in the study, adalimumab treatment was determined according to clinical judgement of the physician. * participants (or legal representative) who voluntarily agreed to participate in this study and signed informed consent. exclusion criteria: * participants with contraindication to adalimumab as listed in the approved korean label. * participants with prior treatment with adalimumab.

Keywords: post-marketing adalimumab humira pediatric chronic severe plaque psoriasis psoriasis
non-steroidal anti-inflammatory drugs alone or with a triptan and reports of transition from episodic to chronic migraine

Conditions: Migraine Disorders

Summary: chronic migraine (cm), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with episodic migraine (em) defined as 14 or fewer migraine headaches per month. limited work has begun to examine factors that increase or decrease the risk of developing cm. one factor that appears especially relevant is symptomatic medication use. the current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (nsaid) and/or triptan use has on the likelihood of developing cm. this study is a retrospective observational cohort study of data collected via mail survey and collated in the american migraine prevalence and prevention (ampp) database. survey results from the ampp study will be analyzed retrospectively. the ampp is a longitudinal, population-based, mailed-questionnaire survey. in 2004, 120,000 united states (us) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. this analysis uses data from respondents who meet second edition of the international headache classification-2 (ihcd-2) criteria for em in 2005 with follow up results in 2006, 2007, 2008, and 2009. em is defined as 1 to 14 headaches per month and cm is defined as 15 or more headaches per month.


Eligibility criteria:
inclusion criteria: * respondents age 18 or older at the time of survey completion * respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009) * based on the respondents answers to the 2004 survey, their symptoms meet the criteria for em which is characterized by headaches meeting international classification of headache disorders - 2 (ichd-2) criteria for migraine 1-14 days a month exclusion criteria: * responses to questions suggest that the respondent's diagnosis is not migraine or cm

Keywords: mailed survey non-steroidal anti-inflammatory drug migraine disorders headache