Kornimate/medical-research-clean huggingface dataset:
sleep and behavior in children with cleft palate

Conditions: Cleft Palate

Summary: the purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.


Eligibility criteria:
inclusion criteria: * previous cleft palate repair * age 6-15 years exclusion criteria: * other condition that impacts the interpretation of psg or neurobehavioral assessments * being treated for sleep apnea with cpap

Keywords: cleft palate cleft lip obstructive sleep apnea sleep-disordered breathing behavior learning
cognitive stimulation therapy - effects on cognitive and functional domains in dementia - a retrospective data review

Conditions: Dementia

Summary: this retrospective, single-blind, parallel group study investigates the efficacy of cognitive stimulation therapy (cst) compared to reality orientation and reminiscence therapy (ro\&rm) in enhancing cognitive and functional domains in older adults with mild to moderate dementia.

through data review, this retrospective, single-blind, parallel group study investigates the efficacy of cognitive stimulation therapy (cst) compared to reality orientation and reminiscence therapy (ro\&rm) in enhancing cognitive and functional domains in older adults with mild to moderate dementia.

Eligibility criteria:
inclusion criteria: * participants had to be 65 years old or above, live in hong kong and had a diagnosis for dementia in medical history exclusion criteria: * any major neurological illness other than dementia, any psychiatric disorder or a known history of substance abuse.

Keywords: older adults dementia
efficacy of ferric carboxymaltose with or without epo reducing red-cell transfusion packs in hip fracture perioperative period

Conditions: Hip Fractures

Summary: in order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. required sample size is of 87 patients per arm (87x3 = 261). primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. adverse clinical events and side effects are assessed as safety variables. in addition health related quality of life will be measured at inclusion and after 60 days. a cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). the investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.

three arms of treatments: a: ferric carboxymaltose and erythropoietin, b: ferric carboxymaltose and placebo, arm c: two placebos. primary objective:reduction of red-cell packs needed for elderly patients with osteoporotic hip fracture which requires surgical intervention in the perioperative period.

Eligibility criteria:
inclusion criteria: * patients 65 years and older. * osteoporotic hip fracture which require surgical intervention * haemoglobin levels between 90-120 g/l * signed informed consent form exclusion criteria: * bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms) * blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses. * documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron. * patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.

Keywords: hip fractures blood substitutes blood transfusion intravenous infusion erythropoietin, recombinant frail elderly
utility of mri with doppler ultrasound gating for advanced fetal monitoring

Conditions: Congenital Heart Disease

Summary: we will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the mri scanner when to collect pictures of the fetal heart. this will help freeze motion of the fetal heart, to make mri pictures sharper. this will be important for assessing human fetal heart disease, an active area of research at our institution.


Eligibility criteria:
inclusion criteria: * pregnant adults (age 18 and up) with fetus affected by congenital heart disease * singleton pregnancy in their 2nd and 3rd trimesters * scheduled for a clinical fetal ultrasound examination at the fetal echocardiography clinic at sickkids exclusion criteria: * claustrophobia * cardiac pacemaker * non-mri compatible implants * non-singleton pregnancy * obesity (bmi \> 30)
cognitive processing therapy in syrian women exposed to ipv

Conditions: Depression; Anxiety; PTSD

Summary: this study aims to explore the efficacy of cognitive processing therapy (cpt) in treating depression, anxiety, ptsd, and difficulties with emotion regulation in syrian females who have suffered intimate partner violence (ipv). clinicians will conduct interviews with women and request that they complete the caps, beck depression inventory ii, beck anxiety inventory, and ders during pretreatment, posttreatment, and at the 12-month follow-up

this study aims to explore the efficacy of cognitive processing therapy (cpt) in treating depression, anxiety, ptsd, and difficulties with emotion regulation in syrian females who have suffered intimate partner violence (ipv). clinicians will conduct interviews with women and request that they complete the caps, beck depression inventory ii, beck anxiety inventory, and ders during pretreatment, posttreatment, and at the 12-month follow-up. cognitive processing therapy (cpt) may have a substantial therapeutic benefit in the treatment of depression, anxiety, ptsd, and difficulties in emotion regulation among syrian females who have suffered intimate partner violence.

Eligibility criteria:
inclusion criteria: * being a syrian female who currently exposes to intimate partner violence, * lives in egypt * has a good knowledge of english language because all assessments and therapy materials are in english. exclusion criteria: having: * cognitive difficulties * schizophrenia (or any other psychotic disorders).

Keywords: cognitive processing therapy syrian women mental health
clinical and functional outcome after lateral trochlear lengthening osteotomy lateral trochlear lengthening osteotomy

Conditions: Patellar Instability

Summary: the purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia dejour type a or b, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

a short lateral articular trochlea leads to failure in stabilizing the patella close to full extension of the knee. to address this type of pathology, a trochlear lengthening osteotomy was described. to date only case reports describing the clinical outcome of this new osteotomy exist and information on functional outcome regarding muscle strength and electromyography (emg) data is lacking. the purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia dejour type a or b, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

Eligibility criteria:
inclusion criteria: * 2 years (as of september 2019) since conducting a lateral trochlear lengthening osteotomy exclusion criteria: * inability to provide informed consent * neurological disorders potentially affecting lower extremity muscle strength. * surgery involving the patellofemoral joint prior to the lateral trochlear lengthening osteotomy

Keywords: lengthening osteotomy of the lateral trochlea lateral trochlear lengthening osteotomy trochlear dysplasia dejour type a or b short lateral articular trochlea
carbamazepine treatment for cocaine dependence - 5

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine dependence.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence carbamazepine
pregabalin in the obese patients undergoing laparoscopic sleeve gastrectomy (lsg).

Conditions: Obesity; Postoperative Pain; Postoperative Nausea and Vomiting; Opioid Use

Summary: the aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. the main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. the participants will be divided into 2 groups: with or without preemptive pregabalin administration.

pregabalin is a gaba analogue that has analgesic, anxiolytic and effects. there are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery. the investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.

Eligibility criteria:
inclusion criteria: * sleeve gastrectomy in patients with bmi \> 40 or \>35 with comorbidities * written informed consent exclusion criteria: * patient's refusal * known allergies to study medication * inability to comprehend or participate in pain scoring scale * inability to use intravenous patient controlled analgesia * changes of operation extent during procedure * revisional operations * end stage organ failure

Keywords: laparoscopic sleeve gastrectomy obesity pregabalin multimodal analgesia
study to assess the absorption, distribution, metabolism and excretion of azd1656 in type 2 diabetes mellitus (t2dm)

Conditions: Type II Diabetes Mellitus

Summary: the purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of azd1656 after administration of a single oral dose of 14c-labelled azd1656 solution in male type 2 diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: * male type ii diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years. * subjects treated with metformin alone or metformin and one other oral anti-diabetic drug. * subjects should have fpg in the range of 6.0 to 11.0 mmol/l at screening and hba1c less than 10% (hba1c value according to international dcct standard). exclusion criteria: * history of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease. * renal dysfunction. * use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent cyp450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of ip.

Keywords: type ii diabetes mellitus absorption distribution metabolism excretion 14c-labelled
voriconazole versus itraconazole in primary prophylaxis of invasive fungal infection (ifi) in subjects with allogeneic hematopoietic stem cell transplants (hsct)

Conditions: Antifungal Prophylaxis of Invasive Fungal Infections

Summary: study is to compare antifungal prophylaxis of voriconazole and itraconazole in subjects who have had a stem cell transplant. the success of the end point will be measured using evidence of infection, drug compliance and survival.


Eligibility criteria:
inclusion criteria: * allogeneic hsct for acute leukemia (aml, all or myelodysplastic syndrome) failed lymphoma therapy or transformation of cml * male and female over 12 years or greater exclusion criteria: * possible, probable or proven ifi at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (ascioglu et al 2002) * previous history of zygomycosis * anticipated survival less than one month
random urine protein-creatinin ratio to predict magnitude of proteinuria

Conditions: Pre-eclampsia

Summary: the aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. the cross-sectional longitudinal study design used, 209 patients with pre-diagnosed preeclampsia in which in our inpatients clinic included this study. random urine samples were taken before the 24 hour urine collection for spot urine analysis for evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in all patients as the gold standard of the urine total proteinuria.

group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. the predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were evaluated. the correlations of the severity of the disease and the tests of the proteinuria were evaluated.

Eligibility criteria:
inclusion criteria: * 16-50 years old, \> 20 gestational week pregnant women pre-diagnosed preeclampsia. * diagnosis and follow-up performed in inpatients clinic. exclusion criteria: * the history of chronic hypertension * the history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignancies, renal disease. * pre-existing urinary tract infections * premature rupture of membranes * patients who have previously been enrolled in the study

Keywords: pre-eclampsia proteinuria protein - creatinine ratio dipstick proteinuria severity of disease
nonlinear absorber in essential tremor treatment

Conditions: Essential Tremor

Summary: the goal of this study is to develop a non linear absorber for patients with essential tremor (et). it 's an extern passive medical device which should improve patients tremor. investigators will evaluate the impact of this medical device through one clinical scale (fahn-tolosa-marin) and accelerometry record. investigators focus on motor improvement.


Eligibility criteria:
inclusion criteria: * adult man or woman between 20 and 90 years old * diagnosis of et (essential tremor) established by a neurologist * et affecting the upper limbs, associated or not with head tremor * drug-resistant nature of et (failure of beta-blockers, mysoline, benzodiazepine) * affiliate to a social security or similar system * having given written consent to participate in the study, free and informed. exclusion criteria: * severe comorbidity * et affecting only the leader * wounds on the forearm * modification of treatment or surgery to manage et, planned within 3 months following inclusion * cognitive disorder known or suspected by the investigator * pregnant or breastfeeding woman * persons placed under guardianship, curatorship or under judicial protection * persons deprived of liberty, subject to psychiatric care or admitted to a health or social establishment for purposes other than that of clinical investigation criteria for premature discharge * mmse (mini-mental state examination) score\<24; * et of the patient with frequency range not between 4 to 6 hz or 8 to 12 hz and/or amplitudes of movement greater than 20°. * modification of treatment for et or performance of tremor surgery before the final visit; * withdrawal of consent or refusal to continue visits.

Keywords: essential tremor passive treatment nonlinear absorber
enhanced kidney follow-up for aki survivors in care transitions

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (aki).


Eligibility criteria:
inclusion criteria: * kdigo stage 3 aki * primary care provider at mayo rochester. exclusion criteria: * patient with need for dialysis at discharge from hospital or hospice. * enrolled in the primary care transition program. * non-english speaking. * cognitive impairment. * dementia. * mini-cog score of less than 3.

Keywords: transitions of care education patient reported outcomes chronic kidney disease acute kidney injury
preliminary performance study of the new tipi device in the prevention of stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence (sui) is most prevalent among women. sui is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. sui cause women to avoid routine physical activities, thus detracting significantly from their quality of life. the purpose of this study is to evaluate the performance of new designs of the tipi device, a conservative, disposable, treatment for temporary management of sui.


Eligibility criteria:
inclusion criteria: * females aged 18 to 60 years * had ≥ 1 deliveries * suffering from genuine stress urinary incontinence confirmed by urodynamic testing (urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine * baseline pwg (no usage of tipi device) ≥ 6gr/8hrs * average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared tipi g3 device * the patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form. * successful experience with the use of vaginal tampons * willing to undergo urodynamic investigation * normal pap smear within past 24 months * patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days. exclusion criteria: * patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study * patients with present or suspected urinary infection * patients with present or suspected vaginal infection * severely atrophic vagina * women who did not manage to insert a vaginal tampon, for any reason, in the past * abnormal vaginal bleeding * patient is currently participating in another clinical study that may directly or indirectly affect the results of this study * was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results * vaginal wall prolapse of any type reaching the level of the introitus (grade 2) * co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study
the effectiveness of two different methods in heel blood collection

Conditions: Infant Behavior; Pain

Summary: this study aims to evaluate the effectiveness of 2 non-pharmacological methods that will reduce the traumatizing effect of routine heel pricking in infant babies within the scope of the metabolic endocrine screening program. one of the interventions to be used in the study is kinesio taping, a type of taping that does not contain any medication. another intervention is shotblocker, which does not belong to any drug or device group.

studies on pain indicate that severe pain experienced in the early period of life causes a weakening of the cognitive functions of the infant, especially by shrinking the thalamic volume. pain management in the neonatal period aims to help the infant cope with pain by relieving it. for effective pain management, it is very important to diagnose and evaluate the baby's response to pain early and accurately within a multidisciplinary team approach, and to select appropriate interventions to alleviate the pain experience. it is stated that nonpharmacological methods in relieving procedural pain strengthen the baby's natural regulation and coping mechanisms when faced with painful intervention and reduce pain and stress. for this reason, this study aimed to determine the effect of kinesiology taping and shotblocker applied to the heel during heel blood collection in infant babies on pain, comfort and crying time.

Eligibility criteria:
inclusion criteria: * term birth infants, * infants with a birth weight of 2500 g and above * infants with stable clinical condition * infants who can perform vital functions without support, * infants who were fed, calm and not crying within one hour before the procedure will be included. exclusion criteria: * with a genetic or congenital anomaly, * neurological, cardiological and metabolic diseases, * in need of respiratory support, * infants receiving analgesics, antiepileptics before the procedure will be excluded.

Keywords: pain management kinesiotape nursing therapy
testing an adjustable ankle orthosis during walking in cerebral palsy

Conditions: Cerebral Palsy

Summary: this study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

our first aim is to confirm that the differential and adjustable stiffness (das) afo improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) afos during walking in cp. our second aim is to confirm that the differential and adjustable stiffness (das) afo improves plantarflexor muscle activity while maintaining improved posture compared to standard afos during walking in cp. our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the mvp.

Eligibility criteria:
inclusion criteria: * age between 8-35 years old, inclusive * diagnosis of cerebral palsy (cp) * gross motor functional classification score level i, ii, or iii * physician-prescribed afos of common design (i.e., rigid molded thermoplastic) * ability to walk for 6 minutes on a treadmill * at least 20° of passive plantar-flexion range of motion * no concurrent treatment other than those assigned during the study * no condition other than cp that would affect safe participation * no surgery within 6 months of participation. exclusion criteria: -excessive knee flexion during walking caused by cp