Kornimate/medical-research-clean huggingface dataset:
diagnostic accuracy of saline sonohystrography vs. 3d transvaginal ultrasound for cesarean scar defect assessment

Conditions: Cesarean Scar Defects; Cesarean Section Complications; Uterine Scar Dehiscence; Vaginal Birth After Cesarean; Abnormal Uterine Bleeding

Summary: to compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

cesarean section (cs) is a frequently performed surgical procedure in obstetric practice. with a significant number of women undergoing this procedure annually, studying its impact on future reproductive capacity has become increasingly important. the prevalence of cesarean deliveries is rising and constitutes about one-third of all births in both the usa and italy. as the use of cesarean delivery increases, so do the associated complications, including cesarean scar pregnancy, morbidly adherent placenta, and cesarean section scar dehiscence and rupture. cesarean scar defects (csd) are described using various terms (pouch, niche, or isthmocoele) and are characterized by thinning of the myometrium or a uterine scar dehiscence, often appearing as a triangular shape within the endometrial cavity. the exact prevalence of symptomatic cesarean scar defects varies due to factors like population differences and lack of standardized criteria. clinical presentations of cesarean scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia, and pelvic pain. women with a history of cesarean section are considered high-risk during pregnancy and require specialized assessments to ensure scar integrity. saline-infused sonography (sonohystrography) is effective for demonstrating caesarean niches, although transvaginal ultrasound (tvs) is more accessible and commonly used. experts generally agree that a niche should be defined by an indentation at the cs scar site with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or complex with multiple branches. additional measurements, such as the distances between the niche and the vesicovaginal fold, are useful for surgical planning. given the increasing frequency of cesarean deliveries, healthcare providers will encounter related complications more frequently. cesarean scar defects are common yet often go undiagnosed. encouraging vaginal birth after cesarean (vbac) can help reduce cesarean rates and raise questions about future obstetric practices, especially in developing countries.

Eligibility criteria:
inclusion criteria: * age between 20 and 45 years * previous 1-3 cesarean sections * the duration from the last cesarean section ranging from 6 months to 5 years. exclusion criteria: * pregnancy (positive pregnancy test) * recent pelvic infection. * active pelvic infection. * recent surgery on the tubes or the uterus. * active vaginal bleeding. * menstruation. * suspected malignancy. * intrauterine device in situ.
effectiveness and safety of synvisc® versus usual treatments in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: comparison of treatment cost of knee osteoarthritis (oa) in patients treated with synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.


Eligibility criteria:
inclusion criteria: * male or female outpatient aged at least 18 years * patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. the diagnosis must be based on american college of rheumatology (acr) criteria. radiological grade will be assess according to kellgren-lawrence scale * assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm vas * patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (nsaid) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs * patient's informed written consent obtained in accordance with french legislation exclusion criteria: * patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present: * nocturnal disturbances due to knee pain * morning stiffness over 45 minutes * increase of knee pain more than 50% within the last week * articular reddening * articular heat * intra-articular administration of hyaluronic acid in the target knee within the previous year * intra-articular administration of hyaluronic acid in the target knee within the three previous months * any other intra-articular injection in the target knee within the last 6 months * any contraindication to intra-articular injections * present or past history of infected target knee joint * previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee * arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year * planned knee surgery within the nine following month * any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity * known hypersensitivity to avian products * presence of lymphatic or venous stasis * pregnancy or breastfeeding * clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance * participation in another clinical trial during this study or during the previous month * previous participation in this trial * patient who requires help concerning shopping or house keeping * patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)
lower limb resistance training in older inpatients

Conditions: Muscle Weakness

Summary: the primary aim of this feasibility study is to evaluate the feasibility of delivering a prt programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.

this is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit. feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. there are two groups (i) exercise intervention and (ii) control. it will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design. the study will be based in st james's hospital, dublin. assessments and the delivery of the exercise intervention will be conducted in the physiotherapy department. patients will be recruited in the inpatient setting. appropriate patients will be approached, and the intervention explained to them. the patient will be given an information leaflet and 24-hours to consider involvement in the study

Eligibility criteria:
inclusion criteria: * patients, male and female elderly inpatients 65 years. * patients must be medically stable. * patients who are able to follow one-stage commands. * patients must be able to give informed consent. exclusion criteria: * unstable medical condition. * patients who are unable to follow one-stage commands. * acute pain or fracture * patients who are unable to stand or require more than assistance of two staff to mobilise/transfer. * patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.

Keywords: older adults strength training muscle mass function inpatients
real-world evidence of anticoagulation treatment in non-valvular atrial fibrillation in italy

Conditions: Anticoagulation

Summary: to quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of oral anticoagulants (oacs) prescribed in routine clinical practice.


Eligibility criteria:
inclusion criteria: * are at least 18 years of age at index date * initiated new oac therapy ( no previous prescriptions of the same index oac in the last 12 months prior to the index date ) during the study period * had at least 1 claim with diagnosis of af anytime in their records exclusion criteria: * have a record that is indicative of valvular atrial fibrillation during this period * have a history of the oacs prescribed during the study period as assessed during the period of data availability(i.e. history of index oac, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or vka) * have more than one oac exposure which starts on the same date
safety study of depakote versus lithium in african americans with bipolar disorder

Conditions: Bipolar Disorder

Summary: it is hypothesized that depakote will be better tolerated then lithium in treating african americans with bipolar disorder.

this is a 14 week randomized open study of 50 inpatients or outpatients with bipolar i r ii. african american subjects will receive lithium or depakote er. measures will be made of psychopathology, reported side effects, and study completers. measures will also be made of rbc/plasma lithium to determine if this level is better predictive of lithium tolerability.

Eligibility criteria:
inclusion criteria: * male or female * females must be using a contraceptive * understand and sing informed consent * meet criteria for dsm iv bipolar i or ii * must have been receiving treatment with depakote or lithium for at least 4 weeks * must not have used illicit substances 48 hours before the study exclusion criteria: * not takin g lithium o valproate at time of screening * alcohol intoxicated or using drugs of abuse other then cannibis * presence of psychotic features * participation in clinical trail within 1 month of study * female subjects pregnant or nursing * serious unstable medical or psychiatric illness * uncorrected hypothyroidism or hyperthyroidism * seizures without a clear and resolved etiology * hypersensitivity or intolerance to lithium or valproic acid * treatment with injectable depot neuroleptic less then one dosing interval * treatment with reversible maoi, guanethidine, or guanadrel within i week of study * treatment with fluoxetine within 8 weeks of study * treatment with clozapine or ect 3 months prior to study * current diagnosis of schizophrenia or other psychotic disorder * judged to be at serious suicidal risk

Keywords: bipolar affective disorder african american antimanic lithium depakote
comparison between hypoglycemic counter regulatory responses in type 1 diabetics vs control subjects

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Summary: this study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia

iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. it causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. this phenomenon is known as hypoglycemia-associated autonomic failure (haaf), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.

Eligibility criteria:
type 1 diabetics inclusion criteria: * more than 5 years of disease duration * hba1c 42-86 mmol/l * no known haaf * bmi 22-28 * written consent exclusion criteria: * other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance * medication f.x beta-blockade, steroids, psychotropics * smoking * drug abuse control subjects inclusion criteria: * bmi 22-28 * written consent exclusion criteria: * diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance * medication f.x beta-blockade, steroids, psychotropics * smoking * drug abuse

Keywords: hypoglycemia-associated autonomic failure (haaf)
effects of individualized cognitive training on cognition in heart failure

Conditions: Heart Failure

Summary: the synapse trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.

the purpose of the synapse study is to evaluate the effects of an individualized home-based training program aimed to improve cognitive functions and well-being in heart failure patients. heart failure is characterized by the inability of the heart to pump blood efficiently through the body. nearly half of patients with heart failure present with cognitive deficits. memory and executive functions that allow us to perform complex tasks are mainly affected. these cognitive deficits are linked to an increased risk of hospitalization and mortality, in addition to decreasing patients' well-being and ability to care for themselves. although rehabilitation programs that include physical activity and counseling help reduce heart and brain health risks, these programs are unpopular. among the few who enroll, between 24% and 50% drop out before the completion of the program. offering alternative options such as cognitive training would help to reach this proportion of patients. the literature has shown that cognitive training is effective in preventing or reducing cognitive deficits in older adults with or without cognitive loss. although still understudied in patients with heart failure, a better understanding of the association between heart failure and changes in cognition would allow better adaptation of patient care to their situations and needs.

Eligibility criteria:
inclusion criteria: * adult aged 50 or older * have access to internet * have access to a computer or a tablet; * have the ability to perform cognitive training; * have the ability to read, understand and consent to the informed consent form; * have chronic heart failure on tolerated therapy for at least two months; * without limitation of physical activity to severe limitation of physical activity (i.e. nyha class i, class ii, class iii or class iv). exclusion criteria: * acute cardiovascular event 1 month before randomization; * cardiovascular procedure scheduled within 3 months; * uncontrolled diabetes or untreated thyroid dysfunction; * current or recent malignancy with a life expectancy of less than 1 year; * neurological disease; * chronic hemodialysis or peritoneal dialysis.

Keywords: heart failure cognition individualized cognitive training home-based intervention remote monitoring
digitally delivered exercise in helping people to move more

Conditions: Obesity

Summary: the main objective of this study is to examine the influence of the digital exercise prescription platform in increasing habitual physical activity in people on a weight management programme.

participants will be provided with individualised exercise training from exercise specialists. participants will be recruited from the bcuhb nhs kindeating programme for people who have obesity (bmi of \>30 kg/m2). participants will be recruited remotely, via their kindeating dietitian. the assessments and exercise programme will be conducted remotely in the participants' own home.

Eligibility criteria:
inclusion criteria: * enrolled into the kindeating programme with bcuhb * ≥ 18 years of age * able to provide written informed consent exclusion criteria: * any uncontrolled medical condition that is exacerbated by exercise * unstable angina, unstable or acute heart failure, new or uncontrolled arrhythmias, resting or uncontrolled tachycardia, uncontrolled hypertension \>180/100 (in either), symptomatic hypotension, febrile illness, acute uncontrolled psychiatric illness, other rapidly progressing terminal illness, uncontrolled diabetes \>16.7mmol, patient's currently undergoing anti-biotic treatment for cellulitis, acute infections active foot ulceration * inability to provide informed consent

Keywords: physical activity
multi-component early intervention for socially inhibited preschool children

Conditions: Behavioral Inhibition; Anxiety

Summary: this project is intended to provide a rigorous test of the turtle program, an early intervention program for behaviorally inhibited preschoolers. the proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the turtle program to the best available treatment for preschool behavioral inhibition, the cool little kids (clk) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.


Eligibility criteria:
inclusion criteria: * child must be attending preschool; child must score within top 15% on parent-rated behavioral inhibition questionnaire exclusion criteria: * child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on social communication questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
mri t1 relaxation time in rectal cancer

Conditions: Rectal Cancer; Locally Advanced Rectal Carcinoma

Summary: the goal of this observational study is to learn about the t1 relaxation time and t1 relaxation time properties of the disease in people with locally advanced rectal cancer. the main question it aims to answer is: does mri t1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer? participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.


Eligibility criteria:
inclusion criteria: * rectal cancer, age \>18 years exclusion criteria: * contraindications for mri (pacemaker, claustrophobia, implanted medical injectors and nerve stimulators), * previous radiochemotherapy or another disease which investigator judges inappropriate for the persons continued participation.
8 weeks study to evaluate the efficacy and safety of valsartan in combination with aliskiren compared to valsartan alone in patients with stage 2 hypertension

Conditions: Stage 2 Hypertension

Summary: to evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with stage 2 hypertension.


Eligibility criteria:
inclusion criteria: * patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed. * men or women 18 years and older. * patients with stage 2 systolic hypertension; defined as having a mssbp ≥160 mmhg and \<180 mmhg at visit 5 (randomization). exclusion criteria: * use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of visit 1. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>5 miu/ml). * women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \>40 miu/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. * severe hypertension (an office cuff msdbp ≥110 mmhg and/or mssbp ≥180 mmhg). * refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmhg). * patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually). * history or evidence of a secondary form of hypertension.

Keywords: hypertension, aliskiren and valsartan
behavioural interventions for postnatal depression: a rct study

Conditions: Postnatal Depression

Summary: randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using cognitive-behavioural therapy treatment by nurses as adjunct to management by medical officer as compared to medical officer alone

this was a two-group double-blind randomized controlled trial (rct) conducted in six primary care clinics at klang valley, with 27 subjects in each arms. all post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered edinburgh postnatal depression scale for symptoms of depression. those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained research assistants using mini international neuropsychiatric interview, a diagnostic interview tool. those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the family medicine specialist for appropriate management. consented eligible women were randomized into either control group; managed by medical officers alone, or intervention group; managed by both medical officers and trained nurses. medical officers were given standard refresher course on postnatal depression management based on clinical practice guideline while nurses were trained using brief cognitive-behavioural therapy (cbt) module, which consists of 6 modules for 6 weekly sessions. depression level and its severity were assessed using self-administered beck's depression index (bdi) and automatic thought questionnaire (atq), at baseline, week 3 and week 6.

Eligibility criteria:
inclusion criteria: * postpartum 4-24 weeks * registered with selected primary care clinics * edinburgh postnatal depression score: 12 or more; and mini diagnostic interview: positive (mild to moderate depression) * consented to participate exclusion criteria: * severe depression or psychosis

Keywords: cognitive-behavioral therapy