Kornimate/medical-research-clean huggingface dataset:
supplementation of polyunsaturated fatty acids in children with attention deficit/hyperactivity disorder (adhd)

Conditions: ADHD

Summary: the purpose of the study is assessing the efficacy of omega - 3 and omega - 6 treatment in boys with attention-deficit/hyperactivity disorder (adhd) compared with control group healthy boys.

the study is designed as a randomized, double-blind placebo-controlled trial with a total duration of 6 months. 100-120 boys with adhd aged 8-16 years and 30 healthy boys will will be randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "eye q" per day divided in two daily doses (558 mg eicosapentaenoic acid (epa), 174 mg docosahexaenoic acid (dha), 60 mg gamma-linolenic acid (gla) per day) or to placebo (olive oil). at 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive active treatment for the remaining 3 month period. control group will receive active treatment for 6 month. the assessment of children will be made 3 times: at the point of start, after 3 months, and after 6 months. the assessments will be made using standardized interviews and questionnaires, neuropsychological tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess level of polyunsaturated fatty acids (pufa) in serum and in cell membranes of erythrocytes.

Eligibility criteria:
inclusion criteria: 1. patients will be boys between the ages of 8-16 years. 2. patients must meet diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) diagnostic criteria for adhd confirmed by schedule for affective disorders and schizophrenia - present and lifetime version (k-sads-pl) 3. patients must be of normal intelligence as assessed by the wechsler intelligence scale for children - revised edition (wisc-r). 4. treatment of adhd by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with adhd without pharmacological treatment exclusion criteria: 1. patients who have a documented history of bipolar i or ii disorder, psychosis or autism. 2. patients with a history of epilepsy 3. patients with a history of asthma treated with corticosteroids. 4. patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism. 5. patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study. 6. patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).

Keywords: adhd, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, pufa
a study to examine the efficacy and safety of posaconazole when introduced early in the treatment of refractory fungal infections (p05090 am2)

Conditions: Mycoses

Summary: the purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.

in the past two decades, invasive fungal infections (ifi) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with hiv infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. there is a high rate of morbidity and mortality associated with ifi. over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. this has demonstrated the need for the development of a new generation of azoles.

Eligibility criteria:
inclusion criteria: * proven or probable invasive fungal infection (ifi) including breakthrough infection while on antifungal treatment for at least 7 days. * refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy. * age ≥13 years old. * expected to survive \>1 month. * negative pregnancy test (serum or urine) at baseline for women of childbearing potential. exclusion criteria: * serum bilirubin \>10 times upper limit of normal (uln). * serum aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>10 times uln. * documented allergy to azoles. * unable to take oral suspension medications or enteral feeding. * pregnant or breastfeeding. * participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the sponsor. * requires surgery.

Keywords: triazoles
quantifying muscle tone in patients with brain injury - a feasibility study

Conditions: Treatment Outcome; Muscle Dystonia; Spasticity, Muscle; Muscle Tightness; Acquired Brain Injury; Muscle Tone Abnormalities

Summary: this project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (psad) (movotec, charlottenlund, denmark) and an ultrasound measurement called shear wave sonoelastography (swe).

the purpose of this study is to investigate the feasibility and validity of measuring hypertonia in the elbow flexors of patients with severe acquired brain injury in their sub-acute rehabilitation and collect data to determine the necessary size for a definitive study to determine the clinimetrics of the test methods. the long-term goal is to establish a valid and clinically feasible method for physiotherapists to quantify muscle tone in patients with neurological disorders. the study hypotheses are: 1. swe, psad and modified ashworth scale (mas) measurements can be obtained for elbow flexion hypertonia in all patients (no missing data due to test procedure), 2. swe and psad have a moderate to good intra-day intra-tester reliability (icc two-way mixed effects model with absolute agreement. icc\>0.5, bland altman) 3. passive muscle stiffness measured using the psad and swe have a fair concurrent validity with mas (spearmans correlation \>0.3) 4. swe and psad are responsive in measuring a reduction of the effect of routine clinical treatment of the hypertonic muscles with botulinum toxin type a (btx-a) (paired t-test or wilcoxon test, p\>0.05)

Eligibility criteria:
the project will include five patients admitted to the clinic for highly specialised neurorehabilitation/tbi. inclusion criteria for the patients are that they: 1. fulfil the normal clinical requirements for treatment with btx-a in at least one of their elbow flexors, (have increased stiffness in at least one of their elbow flexors, mas greater than 0), 2. have given the normal informed consent to routine clinical treatment with btx-a, 3. have given written informed consent or that proxy consent has been obtained, to participate in the study exclusion criteria for patients are that they: 1. are unable to cooperate with the measurements due to uncontrolled non-voluntary movements 2. cannot be positioned safely or comfortably for the measurements.

Keywords: shear wave elastography portable spasticity assessment device feasibility outcome measure reliability validity clinimetrics
pancreatic cancer screening of high-risk individuals in arkansas

Conditions: Pancreatic Neoplasms; Peutz-Jegher's Syndrome; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Ataxia Telangiectasia; Familial Atypical Mole-Malignant Melanoma Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Pancreatitis

Summary: 100 subjects who have a family history of pancreatic cancer (pc), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. this data will be used to determine the pancreatic cancer and precancerous lesion detection rate in high risk individuals (hris). subjects may agree to annual imaging and annual biomarkers or to biomarkers only.


Eligibility criteria:
inclusion criteria: * have a family history of pc as listed below or who have one of the following syndromes: peutz-jeghers syndrome - stk11; brca 1 and 2; palb2; atm; fammm / p16; hnpcc (lynch) / mmr genes; hereditary pancreatitis - prss1 * individuals with three or more affected blood relatives (1st, 2nd or 3rd degree) * individuals with two or more affected blood relatives with pc, with at least one affected fdr, should be considered for screening. * patients with a history of peutz-jeghers syndrome should be screened, regardless of family history of pc. * patients with a known p16 (fammm syndrome) with one affected 1st or 2nd degree relative will be considered for screening. * patients with a known brca1 or brca2 mutation with one affected 1st or 2nd degree relative should be considered for screening. * patients with a known palb2 mutation with one affected family member should be considered for screening. * patients with a known mismatch-repair gene-mutation carriers (lynch syndrome) with one affected family member should be considered for screening. exclusion criteria: * not candidates for surgery
immune response and risk of serious infection to sars-cov2

Conditions: SARS Cov2, Immune Response

Summary: to date, nearly 2 million people, including at least 100,000 in france, have been infected with sars-cov-2 (severe acute respiratory syndrome coronavirus 2). this infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. the median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. the mechanisms involved in the occurrence of these secondary worsening patterns are unclear. one hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. the objective of this study is to measure the intensity of the t lymphocyte response in patients hospitalized for cov2 sars infection in order to determine whether the intensity of the response is associated with worsening of symptoms.


Eligibility criteria:
inclusion criteria: * person having given his or her non-opposition * patient hospitalized with an sars-cov2 infection proven by virological sampling (nasopharyngeal or sputum pcr) less than 8 days old. exclusion criteria: * person subject to a legal protection measure (curatorship, guardianship) * person subject to a safeguard measure of justice * pregnant, parturient or breastfeeding woman * major incapable or incapable of giving consent * minor
multiple arterial phase computed tomography examination to improve detection of tumors in the liver and pancreas

Conditions: Contrast Media; Computed Tomography; Imaging; Pancreatic Cancer; Hepatic Cancer

Summary: to examine inter-subject variations of optimal late arterial phase contrast-enhancement defined as the greatest difference in contrast attenuation of hepatocellular carcinoma (hcc) compared to background liver parenchyma resp. pancreatic lesions compared to pancreatic parenchyma. to evaluate which time-points best depict an optimal late arterial phase.

background: many previous studies have analyzed and proposed different strategies to achieve optimal contrast timing and enhancement in the late arterial phase to best depict arterialized lesions in the liver and hypoattenuating tumors in the pancreas(1-12). but even with the use of state-of-the-art protocols, inter-subject variations of optimal contrast enhancement in liver lesions and pancreas parenchyma are still very common. the aim of this study is to first analyze these alterations and to, secondly, use the newly gained knowledge to design a dose-neutral multiple arterial phase protocol. an optimized arterial phase protocol might improve the detection of hepatocellular carcinoma (hcc) and/or pancreatic adenocarcinoma. purpose: to measure when the greatest difference in attenuation occurs in hcc compared to background liver parenchyma resp. in pancreatic lesions vs. pancreatic parenchyma. to describe the inter-subject variation of these enhancement times and to evaluate at which time-points an optimal late arterial phase can be achieved. the investigators will use the perfusion scanning technique, bolus-tracking and high body-weight-adjusted volumes of contrast media (cm). anticipated results: the aim is to find the best time points for optimal cm-enhancement in hcc lesions and pancreas parenchyma. the results will show the extent of the inter-subject temporal enhancement differences and will be used to design an optimized late arterial phase protocol for clinical practice and future studies.

Eligibility criteria:
inclusion criteria: * patients, who are scheduled for a multiphasic liver or pancreas ct because of known or suspected malignancy in the liver or pancreas. exclusion criteria: * below 50 years of age, contrast media allergy or decreased kidney function

Keywords: computed tomography ct angiography hepatic imaging pancreatic imaging hepatocellular cancer pancreatic adenocarcinoma liver pancreas
strategies for reducing sperm dna fragmentation in icsi semen samples: a prospective randomized controlled trial

Conditions: Male Infertility

Summary: comparing second ejaculate and physiological icsi (picsi) as strategies for improvement of abnormal sperm dna fragmentation in patients undergoing icsi.

sperm dna fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. and a positive correlation with the miscarriage rate. abnormal sperm dna fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. picsi is a robust sperm selection technique that can select individual mature intact sperm dna. in our study, we will compare picsi as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal sdf. in addition to a normal sdf arm as a control.

Eligibility criteria:
inclusion criteria: * male partner with abnormal sperm dna fragmentation index (\>20%) by tunel assay * male partner with at least 1 million progressive motile count * male aged 18-50 years * male with adjusted sexual abstinence days (1-2 days) * female aged 18-37 years * normo-responder females (at least 5 mature oocytes) exclusion criteria: * leukocytospermia * varicocele * known genetic abnormality * use of oocyte or sperm donors * use of a gestational carrier * presence of any endometrial factors that can affect embryo implantation * any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Keywords: sperm dna fragmentation second ejaculate sperm selection picsi
evaluation of anti-xa levels in surgery patients receiving fixed dose heparin

Conditions: Deep-Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Summary: the purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-xa of 0.1-0.35 iu/ml for venous thromboembolism (vte) prophylaxis in patients undergoing microvascular surgery. additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient vte prophylaxis. all patients will be enrolled in the observational arm of the study and receive anti-xa level monitoring. patients with out-of-range anti-xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. the primary outcome measured will be the percentage of patients with anti-xa levels in the target range of 0.1-0.35 iu/ml while on a heparin infusion at 500 units/hour.


Eligibility criteria:
inclusion criteria: * patients undergoing surgical procedures * initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively exclusion criteria: * age \<18 years old * pregnant * incarcerated * mentally disabled
clinical feasibility of disease managing mobile app for hyperthyroidism

Conditions: Hyperthyroidism

Summary: this randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. the study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.


Eligibility criteria:
inclusion criteria: * subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at bundang seoul national university hospital. * subjects must be able to use the smartphone app required for the use of wearable devices and their integration. exclusion criteria: * subjects who have constraints on normal activity due to diseases other than thyroid dysfunction. * subjects who are currently taking medication that affects heart rate. * subjects with heart conditions such as arrhythmia that affect heart rate. * subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.
utility study in diffuse large b-cell lymphoma (dlbcl)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this study is a prospective, cross-sectional survey to be administered to real patients in remission from dlbcl using a 15-minute postal or online survey. the project is designed to describe the impact of dlbcl remission on health utility and quality of life. data collection will occur over a 4-month period.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (\>/=) 18 years of age * diagnosis of dlbcl and currently in first remission * prior drug treatment for dlbcl exclusion criteria: * receiving active treatment for dlbcl * relapsed following any treatment for dlbcl
efficacy of estrogen-intrauterine stent system after intrauterine adhesiolysis

Conditions: Intrauterine Adhesion

Summary: this is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.

patients suspect to be suffering from iua will be recruited following a systematic pre-operative assessment process. this will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3d transvaginal ultrasound. the severity and extent of intrauterine adhesions will be scored according to the afs score. all patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. after adhesiolyis, the patients will assigned to two groups randomly,namely,the e-ius(estrogen intrauterine stent system) group and the control group. adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.

Eligibility criteria:
inclusion criteria: * female patients aged 18-40 years; * meets the diagnostic criteria for moderate to severe uterine adhesions; * has the indication for tcra surgery and is intending to undergo tcra surgery; * female subjects are not breastfeeding at the time of the screening visit; ⑤ voluntary acceptance of the treatment and has signed the informed consent form. exclusion criteria: * known allergic reactions to or contraindications for silicone rubber materials, estradiol and its metabolites, foley balloon catheters and/or intrauterine cross-linked sodium hyaluronate gel; * presence of contraindications for tcra surgery; * requires oral hormonal medications for a prolonged period of time; * has used high-dose estrogen medication within one month prior to surgery; * suffering from diseases such as genital tract tuberculosis, acute genital tract inflammation, pelvic inflammatory disease, abnormal uterine bleeding caused by systemic disease or malignant tumours of the genital organs; ⑥ perimenopausal and menopausal females; ⑦ comorbid with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal or hematopoietic system, or peptic ulcer disease, or severe diseases affecting patient survival (such as tumours or aids), or mental illness; ⑧ drug or alcohol dependence; ⑨ has enrolled in other clinical trials within the last 1 month; ⑩ patients with factors considered by the investigators to be unsuitable for enrollment.

Keywords: intrauterine adhesion recurrence estrogen intrauterine stent
inspiratory muscle training and behavioral support to alleviate dyspnea and promote walking in lung cancer survivors: a pilot study

Conditions: Lung Neoplasm

Summary: this is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage i-iiia lung cancer survivors following curative intent therapy. the specific aims and hypotheses are: specific aim 1: conduct a pilot, phase iib, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage i-iiia lung cancer survivors following curative intent therapy (n=40). hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program. hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (telemedicine satisfaction and usefulness questionnaire ≥4). there will be 0 intervention adverse events. specific aim 2: explore the effects of the tele-rehabilitation program (n=40). hypothesis 2: at 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including: 1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).


Eligibility criteria:
inclusion criteria: * history of stage i-iiia lung cancer; * completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months; * access to a mobile phone or personal computer with internet access; * willingness to wear activity trackers exclusion criteria: * dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent; * acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months; * spontaneous pneumothorax in past 12 months; * parkinson's disease; * multiple sclerosis; * amyotrophic lateral sclerosis; * additional movement/gait disorders that may be identified by chart review

Keywords: pilot study tele-rehabilitation remote rehabilitation exercise therapy aerobic exercise physical activity