Kornimate/medical-research-clean huggingface dataset:
single dose escalation study of tr02 (sustained lipid inhalation technology [slit™] amikacin) in participants with cystic fibrosis (cf) having chronic infections of pseudomonas aeruginosa

Conditions: Cystic Fibrosis

Summary: the primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a slit™ formulation.


Eligibility criteria:
inclusion criteria: * study participants must produce sputum that is positive for pseudomonas aeruginosa. * confirmed diagnosis of cf (positive sweat chloride \>60 milliequivalents (meq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with cf accompanied by one or more clinical features with the cf phenotype. * forced expiratory volume (fev1) ≥40% predicted at screening as calculated by the knudsen reference equations. * clinically stable with no evidence of current pulmonary exacerbation. exclusion criteria: * history of lung transplantation. * use of intravenous antibiotics or oral quinolones within 14 days of screening. * use of low dose oral antibiotics (e.g. tetracycline, sulfa) for acne or other conditions within 30 days of screening. * use of systemic corticosteroids (≥20 milligrams \[mg\] of prednisone per day) within 30 days of screening. * initiation of tobi® (tobramycin), high dose ibuprofen, recombinant human dnase (rhdnase), or macrolide antibiotics within 60 days of screening. * history of sputum or throat swab culture yielding burkholderia cepacia complex within 2 years of screening or growth of burkholderia cepacia complex from the sputum or throat swab culture obtained at screening. * history of biliary cirrhosis, portal hypertension, or splenomegaly or splenomegaly on physical exam at screening or enrollment. * history of daily continuous oxygen supplementation or requirement for more than 2 liter per minute (l/min) at night. note: other inclusion/exclusion criteria may apply.
open-label study to evaluate long-term safety and efficacy of spn-812 (viloxazine extended-release capsule)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: open label extension, long-term multicenter study of safety and efficacy of spn-812 in pediatric adhd patients

this is a multicenter open-label extension study assessing long term safety and efficacy of spn-812 in pediatric subjects with adhd (a) who completed a phase 2 (812p202: children 6 to 12 years of age) or one of four phase 3 trials (812p301/812p303: children 6 to 11 years of age; 812p302/812p304: adolescents 12 to 17 years of age) or (b) who complete a phase 4 trial (812p401). the study is divided into two phases, optimization and maintenance phases. subjects in cohort 'a' who completed a phase 2 or phase 3 trial followed protocol schedule 'a' (exposure up to 72 months). subjects in cohort 'b' who complete the phase 4 trial will follow schedule 'b' (exposure up to 24 months).

Eligibility criteria:
inclusion criteria: 1. completion of a previous blinded study of spn-812 for the treatment of adhd. 2. continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ecgs). 3. weight of at least ≥5th percentile for age and sex if 4 to 5 years old, at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older. 4. written informed consent obtained from the subject's parent or legally authorized representative (lar); and written informed assent obtained from the subject if appropriate; written informed consent obtained from the subject if he/she is 18 years old. 5. females of childbearing potential (focp) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study: 1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration 2. surgically sterile male partner 3. simultaneous use of male condom and diaphragm with spermicide 4. established hormonal contraceptive exclusion criteria: 1. current diagnosis of significant systemic disease or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. history of major depressive disorder is allowed if the subject is free of episodes currently and for the last six months. 2. current evidence of suicidal ideation and/or behaviors (assessed with columbia suicide severity rating scale or c-ssrs). 3. body mass index (bmi) greater than 95th percentile for the appropriate age and gender (according to the cdc bmi-for-age growth charts for boys and girls). 4. pregnancy, breastfeeding, or refusal to practice contraception during the study for female subjects of childbearing potential (focp). 5. current substance or alcohol use. 6. any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
bisphosphonate and anastrozole trial - bone maintenance algorithm assessment

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.


Eligibility criteria:
inclusion criteria: * postmenopausal * adequately diagnosed and treated stage i-iiia early breast cancer * oestrogen receptor and/or progesterone receptor positive breast cancer * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * hormone replacement therapy (hrt) must be discontinued at least 2 weeks prior to registration * any prior tamoxifen taken for a total of 8 weeks or less * any prior anastrozole taken for a total of 4 weeks or less * anastrozole is clinically indicated to be the best adjuvant strategy * signed written informed consent exclusion criteria: * clinical or radiological evidence of distant spread of disease * prior treatment with bisphosphonates within the past 12 months * prior treatment with continuous systemic corticosteroids within the past 12 months * prior use of parathyroid hormone for more than 1 week * prior use of systemic sodium fluoride for \> 3 months during the past 2 years * currently treated with any drugs known to affect the skeleton * abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/l) * history of diseases with influence on bone metabolism. patients with lactose intolerance are also excluded * delayed oesophageal emptying such as stricture or achalasia * hypersensitivity to alendronate or anastrozole * previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * ast/sgot and/or alt/sgpt \> 3 x uln in combination with other laboratory and clinical abnormalities indicating liver insufficiency * fracture due to minimal trauma, demonstrated radiologically
regeneration of immature teeth. case series

Conditions: Revascularization

Summary: this clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. the quality of root development (thickness and length) will be assessed radiographically.

all teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of ethylene diamine tetra acetic acid (edta). then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. all the teeth will be monitored clinically and radiographically on a biannual basis.

Eligibility criteria:
inclusion criteria: 1. teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis. 2. an immature/open apex. 3. tooth does not need post and core restoration. 4. medically healthy patients with no known allergy to used materials. exclusion criteria: 1. medically compromised patient, 2. teeth with periodontal involvement 3. teeth with vertical root fractures, 4. non-restorable teeth,

Keywords: immature teeth, necrotic teeth
study of efficacy and safety of amg 334 in adult episodic migraine patients

Conditions: Episodic Migraine

Summary: this study is to evaluate the efficacy and safety of amg334 in adult patients with episodic migraine

this study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. the subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). a screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. after randomization/day 1, visits occurred at four week intervals until week 12, which was the end of treatment. the final visit, last patient last visit was a safety follow-up visit, which occurred 12 weeks later, at week 24.

Eligibility criteria:
key inclusion criteria: 1. documented history of migraine in the 12 months prior to screening 2. 4-14 days per month of migraine symptoms 3. \>=80% diary compliance during the baseline period key exclusion criteria: 1. \>50 years old at migraine onset 2. pregnant or nursing 3. history of cluster or hemiplegic headache 4. evidence of seizure or major psychiatric disorder 5. score of 19 or higher on the bdi 6. active chronic pain syndrome 7. cardiac or hepatic disease

Keywords: amg334 erenumab episodic migraine headache cgrp calcitonin gene-related migraine adult
car-multicenter analysis (car-ma): retrospective study to characterize car t-cell outcomes and related toxicities in children and young adults with b-all

Conditions: Leukemia, Acute Lymphoblastic; Lymphoblastic Leukemia, Acute, Childhood

Summary: study description: this retrospective protocol focuses on characterizing clinical outcomes and toxicities following car t-cell therapy. objectives: primary to evaluate the response free survival (rfs) at 6 months following cd19 car stratified by prior blinatumomab vs no prior blinatumomab to retrospectively evaluate outcomes following car t-cell therapy across children and young adults with b-all secondary to evaluate the rfs at 12 months following cd19 car stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. to evaluate the incidence of cd19 negative versus cd19 positive relapse following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. to evaluate the complete response (cr) rate following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. to evaluate the minimal residual disease (mrd) negative remission rate following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. study population and source of data: subjects who were less than \< 25 years of age at the time of diagnosis and received a car t-cell product for b-all.

study description: this retrospective protocol focuses on characterizing clinical outcomes and toxicities following car t-cell therapy. objectives: primary to evaluate the response free survival (rfs) at 6 months following cd19 car stratified by prior blinatumomab vs no prior blinatumomab to retrospectively evaluate outcomes following car t-cell therapy across children and young adults with b-all secondary to evaluate the rfs at 12 months following cd19 car stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. to evaluate the incidence of cd19 negative versus cd19 positive relapse following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. to evaluate the complete response (cr) rate following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. to evaluate the minimal residual disease (mrd) negative remission rate following cd19 car stratified by prior blinatumomab vs no prior blinatumomab. study population and source of data: subjects who were less than \< 25 years of age at the time of diagnosis and received a car t-cell product for b-all.

Eligibility criteria:
* subjects will not be recruited for this study; however, up to 210 subjects records will be selected from treatment protocols who received car therapy for b-all. subject who opted out of the future use of his/her data will be excluded. the subjects enrolled to a car t cell therapy treatment protocol within the pediatric oncology branch unless, are \< 25 years of age at the time of diagnosis and must have received prior a car t-cell product.

Keywords: relapsed disease mrd-positive cd19+ all natural history
effects of oral motor therapy in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: : cp is a neurodevelopmental condition. a set of irreversible impairments of movement and posture development, resulting in activity limitation. acquired cp can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence. a cp diagnosis can now be made as early as 16 weeks. speech-language pathologists (slps) began collaborating with ots and pts for infants and toddlers who also struggle with speech impediments, feeding and swallowing disorder. oral motor exercises (omes), also known as "mouth exercises," "non-speech oral motor training," and "oral motor treatment" were designed for their treatment. the objective of this study was to assess the effects of oral motor exercises in children with cerebral palsy having feeding and swallowing difficulties.

over 17 million people throughout the world are living with cerebral palsy (cp), making it the most common physical disability among children. cp is a neurodevelopmental condition\[1\]. cerebral palsy is a fitting classification of the condition and its associated deficits because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle control." a set of irreversible impairments of movement and posture development, resulting in activity limitation, that are linked to non-progressive disruptions that occurred in the developing foetus or infant brain, was chosen as the official definition of cp in 2005 by the international consensus \[2\]. it's important to keep in mind that the phrase "cerebral palsy" refers to a spectrum of conditions, each of which has its own unique appearance, set of symptoms, and prevalence rate within the general population. in addition to the musculoskeletal and neurological symptoms of cp, epilepsy and other sensory and cognitive impairments are also common

Eligibility criteria:
inclusion criteria: 1. cp children already diagnosed with feeding and swallowing difficulties. 2. age range: 4 to13 years exclusion criteria: 1. patients with any co morbid conditions like uncontrolled epilepsy. 2. patients on ng or feeding tube.

Keywords: oral motor therapy cerebral palsy drooling scale feeding and swallowing
intraoperative folate targeted fluorescence in renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: primary • to explore the use of otl38 and fluorescence imaging to detect rcc in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.

administration of the study drug, otl38, will begin prior to skin incision in the preoperative area where safety monitoring will occur. the tumor resection occurs approximately 2 hours after being brought back to the operating room and so there is no wait time between infusion and being taken back to operating room. intraoperative fluorescent imaging will be utilized in parallel with the standard operating procedure to capture images during surgery. images also will be taken of the excised specimen on the back table. the excised specimen will be sent to the pathology department for fluorescent imaging and immunohistochemistry for fr. subjects will have a 2-5 day hospital stay (normal nephrectomy recovery period) where safety measurements will be taken. final safety measurements will be taken at the 10-day and 1-month follow-up visits.

Eligibility criteria:
inclusion criteria for localized rcc treated with partial nephrectomy to be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * have primary or suspected diagnosis of rcc, with presence of ct1-2 renal mass by diagnostic ct assessment. * scheduled for partial nephrectomy of renal mass. * expected survival of at least 3 months. * written informed consent available. * ecog ≤ 1 (appendix g). * negative serum or urine pregnancy test within 24 hours for females of child bearing age * recovered from toxicity of any prior therapy to ≥ grade 1. inclusion criteria for advanced rcc treated with radical nephrectomy to be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * have pathologic or suspected diagnosis of rcc with presence of ct1-4 renal mass and evidence of nodal or metastatic involvement by diagnostic ct assessment * scheduled for radical nephrectomy and lymph node dissection. * expected survival of at least 3 months. * ecog ≤ 2. * negative serum or urine pregnancy test within 24 hours for females of child bearing age. * recovered from toxicity of any prior therapy to ≥ grade 1 * written informed consent available. exclusion criteria for both localized and advanced rcc * history of any anaphylactic reaction, any severe allergy, or any allergy to folate. * brain metastases * baseline gfr \< 50 ml/min/1.73m2) * hepatic toxicity ≥ grade 2 (using ctcae version 4 standard definitions). * participation in another investigational drug trial either concurrently or 30 days prior to surgery * any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient's ability to complete the study, and/or compromise the objectives of the study. * known sensitivity to fluorescent light

Keywords: fluorescence imaging partial nephrectomy radical nephrectomy
investigation of scapular dyskinesia, shoulder mobilization and serve speed variables in asymptomatic adolescent tennis players

Conditions: Healthy

Summary: tennis is a sport where high performance, strokes and wide ranges of motion around the court must be created and high-strength movements are repeated repeatedly. speed and control are important in terms of sportive performance during the serve throw in tennis. while these actions are taking place, a dynamic load that exceeds the physiological limits of the joint is placed on the shoulder. disruption in the kinetic chain can cause injury to the shoulder. in this regard, the incidence of tennis injuries is approximately 21.5 injuries per 1000 training hours. the glenohumeral joint creates a wide range of motion for the shoulder and is also biomechanically related to the scapula. scapular dyskinesia, the pathological position of the scapula, has been associated with common pathologies such as rotator cuff tears, labral tears, and shoulder impingement. although there are studies with different opinions about the causality of scapular dyskinesia, the current literature has reported that scapular dyskinesia is indirectly associated with shoulder pain in overhead athletes. achieving maximum shoulder performance in sports that require overhead activities such as tennis largely depends on the delicate balance between the scapula and the clavicle, humerus and rib cage joints. tennis, which is an increasingly widespread sport in our country, exposes the shoulder joints to high stresses. if changes are not detected and necessary precautions are not taken, the shoulder structure may be at risk of injury. in the current literature review, no study was found that evaluated the relationship between scapular dyskinesia, shoulder mobility and serving speed in tennis players. the aim of our study is to evaluate the effects of scapular dyskinesia, glenohumeral joint mobility and posterior capsule tension on serving speed in tennis players. it is thought that the results to be obtained from our study will guide the creation of appropriate exercise programs in athlete training by determining the effects on sportive performance by determining the changes seen or to be seen in the shoulder complexes of tennis athletes.


Eligibility criteria:
inclusion criteria: * 12-20 ages * volunteer * does not have any cognitive, mental and psychological problems, * does not have any systemic diseases such as rheumatoid arthritis, * does not have any neurological problems, * additionally, the criteria for the tennis players included more than 1 years of tennis experience. exclusion criteria: * having severe neurological, visual and auditory problems that may prevent the application of assessment parameters * children and their families who cannot obtain written consent from their families. * having communication problems

Keywords: tennis adolescent scapular dyskinesia shoulder mobilization serve speed
sustained release oral formulation for treatment of parkinson's disease

Conditions: Idiopathic Parkinson Disease

Summary: achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of pd and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced parkinson's disease. the aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in pd.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic pd * experiencing motor fluctuations exclusion criteria: * inability to consent for thmeselves * inability to fast

Keywords: idiopathic parkinson disease levodopa/carbidopa