Kornimate/medical-research-clean huggingface dataset:
building sentences with preschoolers who use aac

Conditions: Down Syndrome; Speech and Language Disorder; Speech Disorders in Children; Speech Intelligibility; Speech Sound Disorder

Summary: the focus of this investigation is to compare the effectiveness of the aac generative language intervention approach to an aac standard of care condition on preschool sentence productions. all children will use existing aac ipad applications.

the central hypothesis is that preschoolers receiving aac generative language intervention will create longer, more grammatically complete sentences compared with the standard of care condition. specific aim 1 compares these interventions for preschoolers with severe speech impairments and typical receptive language, and specific aim 2 does the same for children with down syndrome. specific aim 3 tests for possible moderation of the intervention effect by age, dynamic assessment scores, sentence type, receptive language abilities, prior aac use, sex, mental age, and disability. aims 1 and 2 will be accomplished using randomized controlled trials.

Eligibility criteria:
inclusion criteria: * clinical identification of significant speech impairment * must speak english as a primary language * must be able to express at least 25 words (using any communication mode) * must be able to accurately select picture symbols on ipad communication app with at least 50% accuracy * vision and hearing within functional limits or corrected to be within functional limits for study activities exclusion criteria: * clinical diagnosis of autism or social communication disorder * primary language spoken is a language other than english
intravenous pantoloc in aspirin-induced ulcer bleeding

Conditions: Cardiovascular Disease; Cerebrovascular Disorders

Summary: the aim of the study is to investigate whether intravenous infusion of pantoprazole (pantoloc) is effective in preventing recurrent bleeding in patients who present with acute ulcer bleeding and continue to use aspirin

aspirin is an effective treatment for acute stroke and heart attack. however, aspirin also induces ulcer and provokes acute ulcer bleeding. thus, aspirin is often withheld in acute ulcer bleeding but this precipitate recurrent stroke or heart attack. we previously showed that intravenous infusion of a potent acid suppressant substantially reduced the incidence of recurrent ulcer bleeding in patients who withheld aspirin. the aim of this study is to investigate whether intravenous infusion of an acid suppressant (pantoprazole) is effective in preventing recurrent ulcer bleeding with continuous use of aspirin.

Eligibility criteria:
inclusion criteria: * patients received daily anti-platelet therapy for vascular prophylaxis before admission and will continue need to do so * patinets with bleeding peptic ulcers;ulcer actively bleeding or with srh (forrest i, iia and iib ulcers) * endoscopic haemostasis achieved exclusion criteria: * presence of ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention. * concomitant use of anticoagulant, nsaids or steroid * pending to undergo cardiac interventions that need double anti-platelet agent * pregnancy * terminal illness, or cancer
effect of vitamin d oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Conditions: Vitamin D Deficiency; Clomiphene Allergy; Polycystic Ovary Syndrome

Summary: effect of vitamin d oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

polycystic ovarian syndrome is the most common endocrine disorder . it is associated with chronic anovulation and infertility. the diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume \>10 cm 3) ovulation can be induced with clomiphene citrate (cc), however, \~20%-25% of anovulatory women with pcos do not respond to cc and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) vitamin d may serve as a key in preventing and attenuating the insulin resistance. vitamin d plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. it also affects glucose homeostasis . in this trial 100 women with pco disease that diagnosed by rotterdam criteria (must have any two of this findings: hyperandrogenism, oligomenorrhea, polycystic ovaries). who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. they will recieve vitamin d (ossofortin®, eva pharma) orally 10000 iu twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. number and size of the growing follicles will be monitored before and after taking vitamin d by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin d in ovulation rate.

Eligibility criteria:
inclusion criteria: * age: 18-40 years 2- polycystic ovarian syndrome diagnosis made according to eshre/asrm criteria. 1. polycystic ovaries (either 12 or more follicles or increased ovarian volume \[\> 10 cm3 2. oligo-ovulation or anovulation 3. clinical and/or biochemical signs of hyperandrogenism (azziz, 2006). 3- pcos infertile women resistant to cc for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days exclusion criteria: * causes of infertility other than pcos. 1. male factor.(normal semen analysis) 2. other factors e.g. endometriosis 3. tubal factor. (normal hysterosalpingography) 4. premature ovarian failure: day 3 fsh \> 14 mlu/ml or antimullerian hormone \<1 ng/ml. 5. normal ultrasound except for criteria of pco * causes of anovulation other than pcos. * patients with hyperprolactinemia * patients with thyroid dysfunction. * current or in last six months use of vit d treatment.

Keywords: poly cystic ovary syndrome vitamin d
pharmacokinetic study on the combination of everolimus-tacrolimus

Conditions: Kidney Diseases

Summary: the purpose of this study is to address the pharmacokinetic (pk) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. for comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.

to address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. for comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. patients will receive triple therapy steroids, tacrolimus and everolimus. tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. during the first 6 weeks (the pk study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. after day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.

Eligibility criteria:
inclusion criteria: * kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft exclusion criteria: * non-functioning kidneys

Keywords: kidney transplantation
effect of metal skin sensitivity on restenosis after stent implantation

Conditions: Coronary Stent Restenosis

Summary: this trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries


Eligibility criteria:
inclusion criteria: patients with 2 cardiac catheterization in one years time and in the first one stent implantation exclusion criteria: none

Keywords: restenosis, skin metal allergy
duvelisib with obinutuzumab in patients with cll/sll previously treated with a btki (synchrony)

Conditions: Lymphocytic Leukemia, Chronic; Lymphoma, Small Lymphocytic

Summary: to evaluate the safety, pharmacokinetics, and pharmacodynamics of duvelisib (ipi-145) in combination with obinutuzumab in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with a btki.

this is a phase 1b, open-label, dose escalation, safety and tolerability study of duvelisib (ipi-145) in combination with obinutuzumab in subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with a btki therapy.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma that meets at least one of the international workshop on chronic lymphocytic leukemia (iwcll) 2008 criteria for treatment (binet stage ≥ b and/or rai stage ≥ i with symptoms) * measurable disease with a lymph node or tumor mass \>1.5 cm in at least one dimension as assessed by computed tomography (ct) * previous exposure to btki therapy and meets at least one of the below criteria: * progressive disease while receiving a btki therapy, or stable disease as best response after 12 months of receiving a btki therapy * discontinued a btki therapy due to btki treatment-related intolerance * eastern cooperative oncology group (ecog) performance status of 0 to 2 (corresponds to karnofsky performance status \[kps\] ≥60%) * subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period exclusion criteria: * richter's transformation or prolymphocytic leukemia * refractory to obinutuzumab (defined as progression or relapse \<12 months of receiving obinutuzumab monotherapy or \<24 months of receiving an obinutuzumab-containing regimen) * progressive disease while previously receiving a pi3k inhibitor (e.g. gs-1101 \[idelalisib\], duvelisib) or a serious/severe ae related to pi3k inhibitor treatment * history of severe reaction to prior monoclonal antibody therapy (defined as a grade 4 event and/or requiring permanent discontinuation) * human immunodeficiency virus (hiv) or human t cell lymphotropic virus 1 (htlv-1) infection * prior, current, or chronic hepatitis b or hepatitis c infection * history of tuberculosis treatment within the preceding 2 years

Keywords: phase 1b, cll/sll, pi3k
aspirin as an ultraviolet (uv) protectant in human subjects at risk for melanoma

Conditions: Melanoma (Skin)

Summary: this is a phase ii placebo-controlled intervention trial assessing aspirin (asa) as a uv protectant in patients at risk for melanoma.

while melanoma risk is largely genetically determined, exposure to ultraviolet (uv) radiation in sunlight is the major environmental risk factor. although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly. this study will evaluate the downstream effects of aspirin (asa) in human blood and skin moles (nevi) following oral ingestion. we will determine if chronic ingestion of asa can modulate uv-sensitivity of the skin, uv-induced damage in nevi, and pge2 levels in blood and nevi.

Eligibility criteria:
inclusion criteria: * must have at least 2 nevi (each \>5 mm diameter) not clinically suspicious for melanoma that can be biopsied. * must be older than age 18. * must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines. exclusion criteria: * the patient cannot speak / understand english or spanish. * the patient is pregnant or breastfeeding. * the patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable. * the patient has history of allergic reaction to asa. * the patient has history of severe asthma. * the patient has been taking asa or any nsaid in the past 2 weeks. * the patient has been taking a blood thinner in the past 2 weeks. * the patient has history of bleeding disorder. * the patient has history of peptic ulcer disease. * the patient has had recent intense uv exposure in the past month.
feasibility study: heavy water tissue labeling protocol

Conditions: Skin Laxity

Summary: enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the ulthera® system compared to control tissue.

this study is a prospective, single-center, blinded, non-randomized clinical trial. two subjects who have chosen to have a surgical facelift procedure and agree to drink heavy water for tissue labeling, will be enrolled. subjects will consume heavy water and collect saliva specimens over the course of the study period, following a specific heavy water labeling protocol. two weeks after starting the heavy water protocol, subjects will return to the study site to receive one ultherapy® treatment to the pre-auricular region on one side of the face. the contra-lateral pre-auricular region will serve as a control. following ultherapy® treatment, subjects will continue to follow the heavy water protocol for 4 more weeks. subjects will then return to the study site to undergo resection of the treated and control tissue for analysis during their planned rhytidectomy procedure. subjects will send in saliva samples on a weekly basis to allow for confirmation that they are drinking the heavy water.

Eligibility criteria:
inclusion criteria: * male or female, age 30 to 65 years scheduled for rhytidectomy. * subject in good health. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at visit 1 and be willing and able to use an acceptable method of birth control. * absence of physical or psychological conditions unacceptable to the investigator. * willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). * willingness and ability to provide written informed consent and hipaa authorization prior to performance of any study-related procedure. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * significant scarring in areas to be treated. * open wounds or lesions in the area to be treated. * severe or cystic acne on the area to be treated. * presence of a metal stent or implant in the facial area to be treated. * inability to understand the protocol or to give informed consent. * microdermabrasion, or prescription level glycolic acid treatments to the submental area within two weeks prior to study participation or during the study. * excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area to be treated. * bmi equal to or greater than 30.

Keywords: ulthera® system ultherapy® treatment ulthera, inc. ultrasound treatment for skin tightening
colorectal cancers :a retrospective study

Conditions: Colorectal Cancer

Summary: clinico-epidemiological and endoscopic characteristics of patients with colorectal cancers:a retrospective study in sohag the aim : 1. determine the prevalence and clinicopathological pattern of patients with colorectal cancers 2. interpretative association between risk factors and severity of patient condition to define possible predictors 3. assess potential association between serum markers, imaging, endoscopic features and underlying condition.

methods : 1. all data will be obtained from patients as personal history (name, age, sex, occupation,residence , marital status, personal habits), history of illness at diagnosis, presence of diabetes or hypertension and other co-morbidity 2. general examination as general appearance,vital signs ,head and neck ,chest ,upper and lower limbs, abdomen and pelvis ,and local examination as per rectal examination. 3. laboratory test as complete blood count and tumor markers ,imaging as abdominal ultrasound, ct,mri, endoscopic findings and pathological features.

Eligibility criteria:
inclusion criteria: * patients aged 18 years old and above * patients with confirmed diagnosis of colon or rectal cancer ,supported by histopathological result exclusion criteria: * patients with missed pathological or endoscopic data * patients diagnosed with other malignancies rather than colorectal cancers

Keywords: clinical endoscopic pathological features
sleep quality underwent heart transplant, an observational study

Conditions: Ventricular Dysfunction

Summary: the sq_heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with vad (ventricular assisted device) and 98 cardiotransplant patients.

the primary objective of the sq_heart study is to evaluate the significant difference in sleep quality between patients with vad (ventricular assisted device) and cardiotransplant patients, using the pittsburgh scale sleep quality index (psqi), with a cut-off of \> 5 for poor sleepers. patients, to be enrolled, must provide: * age ≥ 18 and \< 90; * cardiotransplant patients, with vad or non; * patients with vad. * subjects able to sign informed consent. all the patients will have to complete some questionnaires: * questionnaire about the diagnosis of pathology and lifestyle; * questionnaire about the perceived quality of sleep through the use of pittsburgh sleep quality (psqi); * questionnaire about the perceived quality of life (euro quality of life 5d-5l). questionnaires are necessary for the data collection for the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and \< 90; * cardiotransplant patients, with vad (ventricular assisted device) or non; * patients with vad ; * subjects able to sign informed consent. exclusion criteria: * age \< 18; * subjects don't sign informed consent; * hospitalization for more than 30 days before compilation in intensive care unit.

Keywords: cardiotransplant
multi-site decision impact study for decipher

Conditions: Prostate Cancer

Summary: this prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing decipher results for selected patient cases.

the clinical utility of decipher will be evaluated at two time-points: 1. post rp - within 6 months after surgery 2. psa rise - defined as psa detectable and rising on 2 or more subsequent determinations patient cases will be retrospectively selected from at least 5 sites. participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. the resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . all study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome. the design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. patient cases will be de-identified and randomized amongst participating urologists . by the retrospective nature of this study, cases may be several years post-rp. it is not expected that that participation in this study will have any impact on actual clinical management of patients. participants will be asked to complete two web-based electronic case report questionnaires (ecrq): 1. pre-decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case. 2. post-decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the decipher test results.

Eligibility criteria:
inclusion criteria: patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by aua and nccn guidelines: * pathological t3 stage of disease (i.e., ece or svi) * positive surgical margins, or * detectable psa, defined as psa detectable and rising on 2 or more subsequent determinations exclusion criteria: 1. metastatic disease (m+) prior to surgery 2. failure of psa to nadir after surgery 3. received any neo-adjuvant prostate cancer treatment before radical prostatectomy 4. received any adjuvant chemotherapy 5. required patient clinical data (section 5.3) is not available for evaluation of eligibility criteria 6. lack of documented treatment or management recommendation on file 7. tissue specimen is inadequate for sampling and analysis
comparative study of the protein c pathway in septic and non septic patients with organ failure

Conditions: Severe Sepsis; Organ Failure

Summary: this is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects. the only intervention is a venous blood sampling at the onset of the disease. the purpose of the study is to compare the pc pathway and expression and inflammatory genes between the 3 groups. the main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.

analysis of the pc pathway * pc activity * ps activity * soluble thrombomodulin * soluble epcr * activated protein c * quantitative flow cytometry on monocytes (thrombomodulin and epcr) * whole blood mrna (tissue factor, thrombomodulin and epcr) * inflammatory gene expression analysis by mlpa

Eligibility criteria:
inclusion criteria: * severe sepsis patients or: * non-septic acute organ failure patients or: * healthy subjects matched for age and sex with severe sepsis patients exclusion criteria: * criteria for organ failure lasting for more than 24 hours

Keywords: severe sepsis organ failure activated protein c thrombomodulin epcr
the effect of covid-19 process

Conditions: Covid19; Participation, Patient

Summary: objective: the purpose of this study was to investigate the effect of the covid-19 process on time management, participation, and leisure time activity. methods: 531 individuals aged between 18-65 were included in the study. the individuals were evaluated with the assessment of time management skills (atms) in terms of time management, with the social isolation questionnaire (siq) in terms of participation, and with the interest checklist (ic) in terms of leisure time activities.


Eligibility criteria:
inclusion criteria: * aged between 18-65 * lived the covid-19 process in turkey exclusion criteria: * did not complete the scales * did not live in turkey

Keywords: covid-19 leisure time activities participation time management