Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of sp-624 in the treatment of adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a phase 2b clinical study evaluating the effectiveness and safety of sp-624 as compared to placebo in the treatment of adults with major depressive disorder.


Eligibility criteria:
key inclusion criteria: * males and females, aged 18 to 65 years, inclusive. * meet dsm-5 criteria for moderate to severe mdd, as confirmed by the mini international neuropsychiatric interview (mini). * in generally good physical health, in the opinion of the investigator. * body mass index (bmi) must be ≥ 18 and ≤ 45 kg/m2. key exclusion criteria: * female who is pregnant, breastfeeding, or less than 6 months postpartum at screen. * a history of or current dsm-5 diagnosis of mdd with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder. * presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension. * presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (sbp) \>160 mmhg or consistent sitting diastolic blood pressure (dbp) \>95 mmhg despite present therapy. * screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the investigator (clinical chemistry, hematology, thyroid function, and urinalysis).
sbrt in the management of solid spinal metastases

Conditions: Extradural Tumor; Spinal Metastases

Summary: documenting efficiency of sbrt in the management of epidural spinal metastases from solid tumors

the department of radiotherapy in uzleuven recently included stereotactic body radiotherapy (sbrt) in the standard of care for the management of patients with spinal metastases. the aim of this study is to prospectively document neurological outcome, performance and quality of life following surgery + sbrt for spinal metastases with imminent / actual spinal cord compression, and compare outcomes with the historical cohort of the uzleuven patients included in the global spine tumor study group database between 2011 and 2019 in whom prospective neurological, performance and quality of life outcomes were collected following surgery + conventional radiotherapy

Eligibility criteria:
inclusion criteria: * radiological diagnosis of spinal metastasis from solid tumor with epidural imminent or actual spinal cord compression, with or without neurological deficits. patients will be scheduled for surgery + sbrt. if contra-indications preclude surgery and only sbrt is performed, patients will still be included. * written informed consent to participate in the study must be obtained from the subject or proxy /legal representative * males and females \> 18 years exclusion criteria: * any concomitant condition or disease which, in the opinion of the investigator, would affect the reliability of the collected data. * patients that had previous radiotherapy on the index spinal level without the possibility for additional sbrt at that particular level.
reminerlization potential of innovative biomimetic material in caries white spot lesions

Conditions: White Spot Lesion of Tooth

Summary: to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( clinpro tooth creme versus gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.

dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. a large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. the process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization. the development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (wsls), is often observed in patients with poor oral hygiene during treatment .in many instances, these wsls continue to be visible after the removal of fixed appliances and after natural remineralization. the remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. the early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments. recaldent™ is derived from the milk protein, casein. for many years it has been known that milk and its derivatives have a tooth protective effect. research has shown that this activity is due to a part of the casein protein called casein phosphopeptide (or cpp), which carries calcium and phosphate ions in the form of amorphous calcium phosphate (or acp) which used in reminerlization of white spot caries lesions. clinpro tooth crème (3m espe) is a 0.21% w/w sodium fluoride (naf) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-tcp) ingredient.one major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. furthermore,it has been suggested that fluoride combination with f-tcp not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,

Eligibility criteria:
inclusion criteria: * patients should have at least one white spot caries lesion * age from 18 to 40 years * no gender restriction exclusion criteria: * patients with a compromised medical history. * severe or active periodontal disease * patients with developmental hypo-calcified lesions
a phase 3 study in participants with moderate to severe psoriasis

Conditions: Psoriasis

Summary: this study will assess the safety and efficacy of ly2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization * at least 10% body surface area (bsa) of psoriasis at screening and at randomization * static physician global assessment (spga) score of at least 3 and psoriasis area and severity index (pasi) score of at least 12 at screening and at randomization * candidate for phototherapy and/or systemic therapy * men must agree to use a reliable method of birth control during the study * women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment exclusion criteria: * pustular, erythrodermic, and/or guttate forms of psoriasis * history of drug-induced psoriasis * clinically significant flare of psoriasis during the 12 weeks prior to randomization * concurrent or recent use of any biologic agent * received systemic psoriasis therapy \[such as psoralen and ultraviolet a (puva) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization * cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study * have participated in any study with interleukin (il)-17 antagonists, including ly2439821 * serious disorder or illness other than plaque psoriasis * serious infection within the last 3 months * breastfeeding or nursing (lactating) women.
"effects of kinesio-taping on pain, postural stability and function in persons with discogenic low back pain"

Conditions: Low Back Pain; Low Back Pain, Mechanical

Summary: low back pain is the leading cause of disability worldwide, the prevalence of low back pain can be as high as 43%. past research has shown the positive effects of kinesio taping in patients with chronic and nonspecific low back pain in pain reduction, improvement in postural stability, and improvement in function. however, no study has yet evaluated the effects of kt in persons with discogenic lbp. if found to be effective kt can be prescribed as a conservative \& cost-effective treatment for patients with discogenic low back pain.


Eligibility criteria:
inclusion criteria: * age20-45 years. * positive straight leg raise (slr) * posterolateral disc bulge, herniation or prolapse indicated by mri. * positive centralization and peripheralization phenomenon. exclusion criteria: * participants having spondylolisthesis, fractures, tumors, osteoporosis, infection, or spinal stenosis. * history of lumbar spine surgery and patients that are already receiving any physical therapy or exercise * skin allergy or sensitivity to the tape. * neurological, rheumatologic, or psychiatric disease
trial for the diagnosis of sarcoidosis

Conditions: Sarcoidosis

Summary: this randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage i/ii. the objective is to assess the role of endosonography (ebus/ eus - fna) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (tblb + ebb). also the researchers investigate the additional value of bal, in relation to endosonography and conventional bronchoscopy (tblb + ebb), in diagnosing sarcoidosis. thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.

sarcoidosis is the most prevalent interstitial lung disease in western-europe and the us. the disease is most prevalent in young adults. to set the final diagnosis of sarcoidosis, the following parameters need to be present: 1. a clinical and radiological suspicion of sarcoidosis stage i/ii. 2. a tissue diagnosis of disease-specific non-caseating granulomas. 3. exclusion of possible alternative diagnoses as lung cancer or tuberculosis. nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. however, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse. since recently, a new diagnostic procedure has come available. this procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. the associated risk of complications appears to be small (\<1%) we consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. we expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis. also we hypothesize that this technique is safer and more preferred by patients.

Eligibility criteria:
inclusion criteria: * patients with suspected pulmonary sarcoidosis stage i/ ii * age \> 18 years * both males and females * written informed consent is obtained. exclusion criteria: * patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed. * löfgren's syndrome * inability to undergo fiberbronchoscopy, ebus or eus (e.g. respiratory insufficiency, esophageal stenosis * contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia) * pregnancy * inability to obtain informed consent

Keywords: sarcoidosis diagnosis non-caseating granulomas bal eus-fna ebus-tbna tblb
impact of screens on children's growth

Conditions: Growth Disorders

Summary: short stature is defined as a height less than -2 standard deviations (sd) for age and a slowing of growth velocity by a loss of 1 sd/year. the causes of short stature are multiple (chronic diseases, growth hormone deficiency, hypothyroidism, hyperadrenocorticism, genetic syndromes, etc.). however, nearly 30% are considered idiopathic, with no identified etiology (naccache et al., unpublished). growth hormone (gh) is secreted in a pulsatile manner with maximum peaks primarily at night, raising questions about the relationship between sleep disturbances and short stature. in children, one of the main causes of sleep disturbances in the digital age is screen use, which is becoming increasingly important, particularly in the pediatric population.

during the night, physiologically, the retina, which no longer receives light signals, sends a message to the suprachiasmatic nucleus, the main key element of the internal clock, and to the pineal gland, which synthesizes melatonin, the sleep hormone. exposing screens to blue light therefore disrupts melatonin secretion, which leads to a disruption of the circadian rhythm and therefore sleep. note that this effect of light on melatonin secretion depends on the time of day of exposure, the intensity, and the duration. thus, exposure to screens before bedtime can be responsible for a delay or even an absence of melatonin synthesis, particularly in the case of nighttime awakenings. while many studies have examined the impact of screens on children's psychological balance, weight, etc., none, to our knowledge, has examined the potential impact of screens on children's height growth. hypothesis of this project: 70% of gh synthesis takes place at night, a few minutes after entering slow-wave sleep, sleep disturbed by screens could mean a lower secretion of gh and consequently a delay in height growth. the objective of this project is to evaluate the impact of screen consumption on sleep and the impact of sleep on idiopathic growth disorder.

Eligibility criteria:
inclusion criteria: * children aged 6 to 16 years old coming to the day hospital for a growth hormone stimulation test or an oral provocation test (without growth disorders) * not opposed to participating in the study * patients affiliated with the social security system exclusion criteria: * growth hormone deficiency confirmed by 2 tests * hypothyroidism * hypercorticism * all chronic diseases * skeletal pathologies: turner syndrome, constitutional bone disease intrauterine growth retardation * pubertal delay defined by absence of puberty onset \>13 years in girls and 14 years in boys * patient under guardianship

Keywords: growth hormone
lutetium-177 (lu177) prostate-specific antigen (psma)-directed endoradiotherapy

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: this was an open-label, multicenter, prospective trial to assess safety and efficacy of 177lu-psma-617 in patients with metastatic castration resistant prostate cancer.

upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. radioligand therapy (rlt) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (gbq) (+/- 10%) or 7.4 gbq (+/- 10%) 177lu-psma-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 gray (gy). all doses after labeling were presented in buffered solution for i.v. injection. in the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mcrpc) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. each patient underwent a screening visit within 14 days prior to receiving study drug. treatment was continued until either of the following conditions applied: * prostate-specific antigen (psa)/radiographic progression at \>= 12 weeks * completion of four rlt cycles * 23 gy kidney dose would be exceeded by the next cycle as estimated by dosimetry * patient withdrawal (e.g. appearance of intolerable adverse events).

Eligibility criteria:
inclusion criteria: 1. prostate cancer proven by histopathology 2. unresectable metastases 3. progressive disease, both docetaxel naive and docetaxel treated. 4. castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (adt) 5. positive 68ga-psma-11 pet/ct (positron emission computed tomography ) or diagnostic 177lu-psma-617 scintigraphy 6. ecog 0-2 7. sufficient bone marrow capacity as defined by wbc (white blood cell ) ≥2.500/μl, plt (platelet) count ≥100.000/μl, hb≥9.9 g/dl and anc≥1500 mm3 for the first cycle and wbc≥2.000/ μl,plt count ≥75.000/μl, hb≥8.9 g/dl and anc≥1000 mm3 for the subsequent cycles 8. signing of the informed consent form 9. patients enrolling in this trail should have received either enzalutamide or abiraterone exclusion criteria: 1. less than 6 weeks since last myelosuppressive therapy (including docetaxel, cabazitaxel, 223ra, 153sm) or other radionuclide therapy. 2. glomerular filtration rate (gfr) \<40 ml/min 3. serum creatinine \> 1.5 uln 4. ast and alt\>5xuln 5. urinary tract obstruction or marked hydronephrosis 6. diffuse bone marrow involvement confirmed by super-scans
a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety study of ns 2330 (tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) administered orally once daily over 14 weeks in levodopa treated parkinson patients with motor fluctuations

Conditions: Parkinson Disease

Summary: the primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated parkinson patients with motor fluctuations.

this is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated parkinson patients with motor fluctuations. patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks. the two co-primary efficacy endpoints are the change in off-time and the change in the unified parkinson disease rating scale (updrs) ii+iii total score study hypothesis: the null hypothesis is that there is no difference between placebo and tesofensine. the alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo. comparison(s): for the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the updrs ii+iii will be based on updrs ii averaged for on and off periods and updrs iii evaluated at on periods during the study visits.

Eligibility criteria:
main inclusion criteria: * male or female patient with idiopathic parkinson disease (pd) diagnosed for at least 2 years. * patient aged 40 years or over at time of diagnosis of pd and not older than 80 years at screening visit. * modified hoehn and yahr stage of ii to iii at "on" time. * treatment with levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit. * motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit. main exclusion criteria: * neuropsychiatric exclusions: non-idiopathic pd, dementia (mini mental state exam \<26), history of psychosis, history or current axis i or axis ii mental disorder according to dsm-iv, etc * other medical exclusions, like ecg abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc * pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
efficacy and safety assessment of t2345 in ocular hypertensive or glaucomatous patients

Conditions: Glaucoma

Summary: the purpose of this study is to assess the efficacy and safety of t2345 versus active comparator.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with glaucoma exclusion criteria: * under 18.
determination of risk factors for the development of obesity and hypertension in children according to perinatal programming of metabolism

Conditions: Metabolic Syndrome

Summary: to determine the risk factors for developing obesity in children with exogenous-constitutional obesity and arterial hypertension, according to the theories of early programming of metabolism

a retrospective cohort study of 55 children aged 12 to 18 years (average 14.60±0.24 years) with exogenous-constitutional obesity was conducted, with 24 girls (43.6%) and 31 (56.4%) boys. children were identified during dispensary examinations in family clinics in samarkand in the period 2018-2019. all the examined children belonged to the uzbek population.

Eligibility criteria:
inclusion criteria: * sds (standart deviation score) of body mass index (bmi) ranging from +2.0 to +3.0 exclusion criteria: * secondary obesity and overweight genetic syndromes, * refusal of the child and/or parents to be examined

Keywords: metabolic syndrome children obesity
stenting in the treatment of aneurysm trial

Conditions: Intracranial Aneurysm

Summary: the stat trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. the primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.


Eligibility criteria:
inclusion criteria: * all patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (\>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial * the anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting * the endovascular physician is a priori content to use either type of technique * the patient has not previously been randomized into the trial * treatment is elective * patient is 18 or older * life expectancy is more than 2 years * patient has given fully informed consent and has signed consent form exclusion criteria: * other aneurysms requiring treatment during the same session * patients with associated cerebral arteriovenous malformations * patients with recently ruptured aneurysms * when parent vessel occlusion is the primary intent of the procedure * any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including asa and clopidogrel * patients with recurring, previously stented aneurysms

Keywords: large aneurysm wide-necked aneurysm recurring aneurysm