Kornimate/medical-research-clean huggingface dataset:
protection of rectum from high radiation doses

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the usefulness of diluted duraseal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.

radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. a resorbable spaces between prostate and rectum could decrease the incidence of these side effect. in this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited. diluted duraseal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. after the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. the proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. after that, duraseal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using duraseal applicator. the resolution of the spacer will be followed by repeated plain computer tomography (ct) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation. in addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation. the space created between prostate and rectum will be documented by plain ct and magnetic resonance imaging. rectum radiation dose will be calculated based on these scans. time to duraseal resolution will be evaluated from the scans. possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Eligibility criteria:
inclusion criteria: * prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer exclusion criteria: * not willing to participate this study

Keywords: prostate cancer brachytherapy spacer side effect
first-in-human study of gfb-024 in healthy overweight and obese participants, and participants with type 2 diabetes

Conditions: Kidney Diseases; Diabetic Nephropathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Summary: gfb-024 is intended for use in patients with kidney disease such as diabetic nephropathy. this study is the first time gfb-024 has been used in humans. the first part of the study will assess the safety of a single dose of gfb-024 in healthy overweight and obese volunteers and the effect of gfb-024 on the body as compared to an inactive placebo medication. the second part of the study will assess the safety of repeated doses of gfb-024 in participants with type 2 diabetes and the effect of gfb-024 on the body as compared to an inactive placebo medication.

this is a first-in-human study. it is intended to provide the initial safety, pharmacokinetics (pk), and pharmacology data for gfb-024 in humans. this study will comprise a single ascending dose (sad) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, pk, and immunogenicity in participants with type 2 diabetes mellitus. it will also explore potential cannabinoid-1 receptor (cb1) activity, participant selection, pharmacodynamics, and differential response biomarkers.

Eligibility criteria:
inclusion criteria: * 18 to 75 years of age at the time of signing informed consent. * body mass index (bmi) between 25.0 and 40.0 kg/m2, inclusive, at screening. * female participants will be of non-childbearing potential. * male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention. * sad cohorts only: participants must be in good health. * repeat-dose cohort only: type 2 diabetes mellitus (t2dm) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with t2dm, such as hypertension and dyslipidemia. exclusion criteria: * history of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the screening visit. * participants with a history of attempted suicide or clinically significant suicidal ideation. * history of cardiovascular disease. * blood pressure \>155 mmhg systolic or \>95 mmhg diastolic. * history of alcoholism or drug/chemical abuse within 2 years prior to screening. * alcohol consumption of \>21 units per week for males and \>14 units for females. one unit of alcohol equals 12 oz (360 ml) beer, 1.5 oz (45 ml) liquor, or 5 oz (150 ml) wine. * history of significant hypersensitivity, intolerance, or allergy to more than one class of drugs. * positive hepatitis panel and/or positive human immunodeficiency virus test. participants whose results are compatible with prior immunization may be included. * sad cohorts only: fasting glucose \>126 mg/dl.
cranial remolding orthosis registry

Conditions: Plagiocephaly; Brachycephaly; Asymmetric Head

Summary: a registry of infants fitted with a cranial remolding orthosis.

the intention of the cro registry is to gather real-world data of traditional and 3d-printed cranial remolding orthoses to compare outcomes.

Eligibility criteria:
inclusion criteria: * patient has been evaluated and successfully scanned for a mycro band or similar cro * patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry. * parent(s) or legal guardian(s) are willing to provide informed consent. exclusion criteria: * patient is geographically inaccessible to comply and participate in the registry.

Keywords: cro mycro cranial helmet cranial orthosis cranial remolding orthosis
study of the safety and efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: study of the safety and efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * subject completed prior ps study exclusion criteria: * subject has other active skin diseases * multiple concomitant therapy restrictions and/or washouts (topicals, uv, other systemic ps therapies) * poorly controlled medical conditions * history of neurologic symptoms suggestive of central nervous system (cns) demyelinating disease * history of cancer or lymphoproliferative disease * history of active tb or listeriosis, or persistent chronic or active infections * known to have immune deficiency or is immunocompromised * clinically significant abnormal laboratory test results * erythrodermic psoriasis or generalized pustular psoriasis
assessment of an app based on artificial intelligence for purulent aom diagnosis in a pediatric department

Conditions: Otitis Media, Suppurative

Summary: otitis media (om) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . an artificial intelligence-based tool could help physicians refine their diagnosis

ear infections in children are very common, particularly acute otitis media (aom) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. however, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. moreover, the accuracy of the aom diagnosis depends on the subjectivity of the physician mostly. this can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ. artificial intelligence (ai) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. i-nside, an app based on artificial intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (smartscope®). therefore, the investigators aim to assess the accuracy of aom diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app

Eligibility criteria:
inclusion criteria: child under 18 years presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) for which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained exclusion criteria: a sign (s) of vital distress trans-tympanic drains -
efficacy and safety of asenapine in the prevention of recurrence of mood episodes in participants with bipolar 1 disorder (p06384)

Conditions: Bipolar 1 Disorder

Summary: this study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with bipolar 1 disorder. after a screening period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.


Eligibility criteria:
inclusion criteria: * male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. * each participant must be willing and able to provide written informed consent. * each participant must have an identified external contact person or an identified responsible person. * current diagnosis of bipolar 1 disorder, and a current manic (diagnostic and statistical manual of mental disorders, fourth edition, text revision \[dsm-iv-tr\^tm\] code 296.4x) or mixed (dsm-iv code 296.6x) episode as determined by a structured clinical interview (mini international neuropsychiatric interview \[mini\]) at screening. * each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode. exclusion criteria: * uncontrolled, unstable clinically significant medical condition. * clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at screening. * current primary axis i disorder other than bipolar 1 disorder. * meets the current dsm-iv-tr\^tm criteria for substance abuse or dependence (excluding nicotine). * imminent risk of self-harm or harm to others.
impact of theraworx foam on symptom relief in thumb arthritis

Conditions: Arthritis

Summary: thumb carpometacarpal osteoarthritis (cmc oa) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the cmc joint. treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. the conservative treatment options, however, are limited to nsaids and bracing or steroid injections. advances in topical therapies have the potential to deliver focused treatment to the cmc joint. novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. theraworx relief is an fda registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.

this pilot study seeks to investigate potential benefit in the use of theraworx foam in patients diagnosed with thumb cmc oa. patients presenting to the upper extremity orthopedic surgery clinic for thumb/hand/wrist pain will be diagnosed by a board certified hand surgeon as per standard protocols. patients who are recommended to follow a conservative treatment modality and are interested in participating in this study will be randomized into treatment or control groups. both groups will undergo symptom assessment, strength testing, and range of motion testing prior to starting the standard conservative treatment of bracing. the treatment group will use the theraworx topical foam and the compression wrap nightly for 2 weeks for at least 6 hours per night. control group will use a compression wrap for the same time period. both groups will return at 1 and 2 weeks for repeat strength and range of motion testing and symptom assessment.

Eligibility criteria:
inclusion criteria: 1. thumb cmc arthritis 2. greater than or equal to age 18 3. interested in non-operative treatment of thumb arthritis exclusion criteria: 1. recent corticosteroid injection into the thumb joint 2. non-english speaking 3. skin lesions or rashes on the thumb 4. current use of topical anti-inflammatory medications 5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the pi) 6. known allergy to magnesium
clinical evaluation of copd butler in patient home management

Conditions: COPD; Hypercapnic Respiratory Failure

Summary: chronic obstructive pulmonary disease (copd) is a worldwide common disease with high morbidity and mortality and leads to heavy social and economic burden. health management of stable copd patients has been suggested to be essential for delaying diseases progress, reducing acute exacerbation events and improving patient quality of life. non-invasive ventilation (niv) is a widely used treatment in copd patients. there were studies shown that niv could improve ventilation, blood gases etc., and several clinical trials have shown improvements in survival, exercise capacity, quality of life and so on. compliance to niv and optimal parameter setting are important factors that will affect the effect of the use of niv, thus niv usage monitoring might also be a crucial element in the health management of copd patients. many studies have been designed to study the effect of tele-monitoring program on the management of copd patients. however, almost none of these studies were designed for specific population, and little is known about the effect of such program on the management of patients with niv treatment.

the copd home management program consists of 3 philips devices (niv bipap st, oximeter and blood pressure meter), a patient mobile app which is developed for self-management at home and a professional physician web portal which is designed for niv usage and other vital sign data monitoring. the program is intended to manage the post-discharge copd patient by enhancing copd patient condition monitoring and adherence to the home therapy, e.g. niv in this study. besides obtaining clinical proof points of the efficacy of such program on patients with niv treatment, it will provide potential evidence of the usability as well as the collect the insights for future product improvement.

Eligibility criteria:
inclusion criteria: 1. age 40-80, males and females 2. stage iii and iv copd 3. daytime hypercapnia (paco2 ≥ 50 mmhg) at rest without ventilatory support 4. possess home oxygen concentrator 5. participants/caregivers have access to and capable of using smartphone and internet 6. willing to participate in the study 7. able to provide informed consent exclusion criteria: 1. subjects with niv as routine therapy prior to the study 2. subjects with abnormalities of the lung or thorax other than copd 3. subjects with obstructive sleep apnea, copd with obstructive sleep apnea overlap syndrome, severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities 4. subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent) 5. subjects who participated in another trial within 30 days prior to the planned start of study
bach music in preterm infants: no "mozart effect" on resting energy expenditure

Conditions: Resting Energy Expenditure

Summary: exposure to mozart music significantly lowers resting energy expenditure (ree) in healthy preterm infants. whether this finding is related to music per-se or to music by mozart is unknown. the objective is to study whether j.s. bach music has a lowering effect on ree similar to that of mozart music.


Eligibility criteria:
inclusion criteria: * preterm infants at post menstrual age of 30-37 weeks who were appropriate for gestational age, clinically and thermally stable, gavage-fed, were eligible for recruitment. * at the time of the study they were all tolerating full enteral feeding (150-160 cc/kg weight/day) without significant gastric residuals (\<5% of total feed), they were all growing steadily, and had no electrolyte imbalance. * all infants who were recruited successfully passed a hearing screening test prior to discharge (otoacoustic emission and automated auditory brainstem response) exclusion criteria: * infants with significant complications of prematurity such as intraventricular hemorrhage, periventricular leucomalacia, necrotizing enterocolitis, active apneas of prematurity, patent ductus arteriosus, active infection, electrolyte imbalance and major congenital anomalies.
effect of yoga counselling on quality of life and psychological outcomes of prostate cancer patients

Conditions: Prostate Cancer

Summary: cancer is second leading cause of death worldwide. the psychological issues are related to all stages of the disease affecting outcome of treatment and overall quality of life. the study evaluated the effectiveness of yoga counselling among prostate cancer patients on their quality of life and psychological outcomes.


Eligibility criteria:
inclusion criteria: * primary diagnosis of prostate cancer * sign a consent form allowing related information to be included in this research. exclusion criteria: * have pre-existing diagnosed psychiatric conditions * currently taking psychotropic medications * have been diagnosed with cancer other than prostate cancer * evidence of active substance abuse.
accuracy of placenta accreta index in diagnosing placenta accreta spectrum

Conditions: Placenta Accreta Spectrum

Summary: the placenta accreta spectrum (pas) which includes accreta, increta, and percreta represents a significant obstetric challenge. pas complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. antenatal diagnosis of pas allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. this approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome. ultrasound evaluation, with grayscale and color doppler imaging, is the recommended first-line modality for diagnosing pas. grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity, and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color doppler. the placenta accreta index (pai) score (a nine-point score) was proposed in 2015 to predict pas based on us parameters in a high-risk population by retrospective data analysis. the probability of histological invasion was found to increase with increasing the pai score. this study aimed to prospectively evaluate the diagnostic performance of the pai in the prediction of pas in relation to histopathological findings.


Eligibility criteria:
inclusion criteria: * pregnant women in their third trimester * with a single fetus in the current pregnancy * a previous delivery by at least 1 cesarean section * having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment exclusion criteria: * cases with twin or multiple pregnancies, * cases with a non-previa placenta or posterior low lying or previa placenta, * cases without previous deliveries by cesarean section * cases before the third trimester of pregnancy.
patient positioning in lumbar fusion surgery and its impact on spinal sagittal balance and surgeon satisfaction

Conditions: Intervertebral Disk Degeneration

Summary: this is a parallel, randomized controlled trial comparing two types of patient positioning and their effect on radiologic measures (pre-surgery visit, in the operating room prior to surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks follow-up).

the investigators are evaluating how patient positioning affects radiologic metrics as well as surgeon satisfaction (surgeon being blinded to positioning). patients will be allocated to either a hyperlordotic or a standard positioning group by computer generated randomization. surgeons will perform all of their standard techniques to promote lordosis with instrumentation. adult patients, ages 18-65, undergoing lumbar surgical fusion will be asked to participate.

Eligibility criteria:
inclusion criteria: * adults patients, aged between 18 and 65 years of age * patients undergoing lumbar fusion for degenerative conditions exclusion criteria: * patients \ 65 years of age * patients who have a history of metastatic disease * patients who currently have a pending workman's compensation claim * patients who have had a previous spinal surgery * patients who have or have had a spinal infection * patients who have a spinal deformity, such as scoliosis * women who are pregnant * inpatients

Keywords: lumbar fusion surgery
impact of dietary intervention on weight change in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, and north and south america. the aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (oads).


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start * insulin naive subjects * hba1c: 7.0-9.0 % (both inclusive) * body mass index (bmi): 25.0-45.0 kg/m\^2 (both inclusive) exclusion criteria: * use of thiazolidinedione (tzds) or glucagon-like peptide-1 analogue (glp- 1) receptor agonists within the last 3 months prior to trial enrollment * cardiovascular disease within the last 6 months * recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months * uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment * cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements