Kornimate/medical-research-clean huggingface dataset:
the programmed intermittent epidural bolus adrenaline study

Conditions: Labor Pain

Summary: this study evaluates the use of intermittent epidural boluses compared to continuous infusion in maintaining epidural pain relief in labor. the medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in both groups.

labor is often painful for the woman going through it, and thus many women choose to have pain relief by an epidural catheter. this is done by placing a thin plastic catheter in the epidural space in the lower back of the patient, and injecting a medicine solution usually consisting of local anesthesia and opioids. to ensure an effective pain relief through the labor process, additional medicine solution is injected through the catheter. traditionally, this is done by a continuous infusion, often with the addition of patient controlled boluses. in this study the investigators investigate if maintaining the pain relief through programmed hourly intermittent boluses is more effective than continuous infusion. this is done in other studies with promising results, but the difference in this study is the addition of adrenaline to the medicine solution in order to make it more effective.

Eligibility criteria:
inclusion criteria: * pregnant women in labor requesting epidural analgesia * asa group 1 and 2 * 0 or 1 previous births * must be at least 18 years of age. * singleton pregnancy * active labor * signed informed consent and expected cooperation of the patient exclusion criteria: * poor communication skills in norwegian or english * adverse reactions to local anesthetics or synthetic opioids * body height below 150 cm * gestational age below 37 weeks, 0 days * any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc) * pre-eclampsia * sound reason by the investigator to suspect patient non-compliance (e.g. with use of pcea)
effect of intermittent oro-esophageal tube feeding on severe traumatic brain injury patient

Conditions: Traumatic Brain Injury

Summary: this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding or the control group with nasogastric tube feeding for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

the safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. nasogastric tube feeding has been the mainstream choice in china but with the risk of complications. intermittent oro-esophageal tube feeding is an established modality of enteral nutrition support that can be used with routine treatment. this study reports the clinical outcomes of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding, in patients receiving routine treatment. this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding or the control group with nasogastric tube feeding for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, meeting the diagnosis of severe traumatic brain injury, confirmed through mri * score of glasgow coma scale (gcs) \<8; * presence of no contraindication for enteral nutrition; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; * informed consent form was obtained from the patients' family members, indicating their full understanding of the study and agreement to participate. exclusion criteria: * unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; * complicated with other intracranial lesions, such as stroke; * with severe consciousness disorders caused by other diseases.
prevention of thromboembolic events in total knee replacement patients

Conditions: Thrombotic Disorders

Summary: the purpose of the study is to find out whether maa868, is able to prevent blood clots following your medical condition (surgery for knee replacement)


Eligibility criteria:
inclusion criteria: * scheduled to undergo elective unilateral total knee arthroplayts (tka) * willing to comply with study requirements including bilateral venography at day 12 ± 2 days * body weight between 50 kg and 130 kg inclusive. * normal aptt, pt, inr at screening exclusion criteria: history of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; mi or unstable angina pectoris within 12 months of the screening; uncontrolled hypertension (sbp/dbp ≥ 150/95 mmhg at the screening). medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; egfr \ 10%); liver dysfunction (alt/ast \>3 xuln or tbl \>2 x uln); bmi ≥ 40 kg/m2

Keywords: biologic, venous thromboembolism, unilateral knee arthroplasty
children food neophobia - a playful intervention at a kindergarten

Conditions: Preschool Children

Summary: the aim of this project is to investigate the efficacy of taste exposure-plus small reward in acceptance and consumption of vegetables among preschool children at school. in this context, interventions were attended at school in order to capture the influence of this environments towards consumption of vegetables among preschool children. for this, the methodology applied will be a repeated exposure protocol by introducing small rewards to encourage children to taste an unfamiliar or dislike food. child intake (weight or number of pieces) and liking (hedonic scale) will be assessed at baseline sessions and exposure sessions. moreover, child's neophobia will be evaluated and additional determinants of child neophobia, such as child's eating behaviour

food neophobia, understood as the rejection of novel foods, is considered one of the biggest barriers to the consumption of fruits and vegetables in preschool children. some factors like food preferences, gender, genetic characteristics, psychological factors and family factors are also crucial for the acceptance of vegetable in childhood. some strategies used to modify food preferences of children are repeated exposure and the use of rewards. the aim of this project is to investigate the efficacy of taste exposure-plus small reward in acceptance and consumption of vegetables among preschool children at school. in this context, interventions were attended at school to capture the influence of this environment towards consumption of vegetables among preschool children. for this, the methodology applied will be a repeated exposure protocol by introducing small rewards to encourage children to taste an unfamiliar or dislike food. child intake (weight or number of pieces) and liking (hedonic scale) will be assessed at baseline sessions and exposure sessions. moreover, child's neophobia will be evaluated and additional determinants of child neophobia, such as child's eating behaviour. quantitative data analysis will be performed by software ibm-spss statistics®. in conducting this research is expected to achieve techniques to overcome neophobia in preschool children and promote vegetable consumption in school and at home. the results may contribute to improve food quality in childhood and consequently in adulthood.

Eligibility criteria:
inclusion criteria: * children attending an educational institution exclusion criteria: * children with cognitive impairment

Keywords: food neophobia preschool children
combined procedures in the treatment of severe acne scars

Conditions: Atrophic Acne Scar

Summary: many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, subcision and chemical peels. these procedures can be used individually or as a combination therapy. combining procedures give better results. in our study we will try in the period from march 2024 to march 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma, polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.

this is a prospective controlled trial that will be conducted at dermatology, venereology, and andrology department, al-azhar university hospital, assiut, in the period from march 2024 to march 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma , polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy

Eligibility criteria:
inclusion criteria: • patients with severe atrophic acne scars (as per goodman and baron's acne qualitative scar grading scale) exclusion criteria: * patients with active acne lesions. * patients having a keloid formation tendency. * patients with a history of bleeding disorder or severe anemia. * pregnant or lactating women. * patients received any treatment for scars in the last 6 months. * patients using drugs causing photosensitivity or systemic retinoids in the previous 6 months (for laser group).
ultrasound-guided interscalene brachial plexus block: single bolus vs continuous catheter placement in arthroscopic rotator cuff repair

Conditions: Anesthesia

Summary: shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. patients may experience severe postoperative (po) pain, that can last for a month and can influence successful rehabilitation. our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (isbss) versus continuous interscalene brachial plexus block (isbc) in controlling perioperative pain and avoiding po pain chronicization. this prospective randomized unblinded trial hypothesizes that the po perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than isbss during the long-term follow-up period.

blocks will be performed under ultrasound guidance with 15 - 20 ml of 0.75 % ropivacaine.

Eligibility criteria:
inclusion criteria: * american society of anesthesia (asa) physical status of 1 to 2, * body mass index (bmi) of less than 30 kg/m², * paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears. exclusion criteria: * skin infection on the puncture site, * coagulopathy * brachial plexus neuropathy * alcohol or drug abuse * diabetes * severe lung disease * history of allergy to one or more study drugs.

Keywords: interscalene block, pain management, regional anesthesia, shoulder arthroscopy
uterine niche after cesarean section

Conditions: Uterine Scar From Previous Cesarean Delivery (Diagnosis)

Summary: in the past decade several articles have described a defect that can be seen on ultrasound at the site of cesarean delivery scar, known as a 'niche' .an incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. this study aimes to evaluate the prevalence of niche in a large cohort study after long term follow up since operation, and characterize the risk factors for its development and for symptoms to appear.

as the rate of cesarean deliveries continues to increase, concern regarding the association between delivery by cesarean section and long-term maternal morbidity has been growing . in the past decade several articles have described a defect that can be seen on ultrasound at the site of the cesarean delivery scar, known as a 'niche' .a 'niche' describes the presence of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a discontinuation of the myometrium at the site of a previous cesarean delivery . an incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. the reported prevalence of a niche in non-pregnant women varies depending on the criteria used to define a niche, the time of evaluation since operation, method of detection, and study population. osser et al. used the definition 'any visible defect' , bij de vaate et al. used 'any indentation of at least 1 mm and van der voet used a cut-off level of 2 mm, however, consensus on the exact cut-off levels is lacking. as approximate evaluation to the operation, the prevalence reported is higher, as early scanning may facilitate the recognition of the location of the caesarean delivery scar in the uterine wall due to incomplete scar healing, with no definition of the most appropriate time since operation. commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound, sonohysterography and hysteroscopy with detection rate of approximately \~50% of women with previous cesarean section in all methods with no definition of the gold standard. the aim of this study in to evaluate the prevalence of niche in a large cohort study after long term follow up since operation and characterize the risk factors for its development and for symptoms to appear.

Eligibility criteria:
inclusion criteria: * women after cesarean delivery * minimum interval of 3 months since operation exclusion criteria: * uterine scar other than low segment cesarean section ( s/p myomectomy, s/p t scar) * morbidly adherent placenta during pregnancy * cesarean hysterectomy * uterine anomaly

Keywords: cesarean section, niche, uterine scar defect
a national study in patients with unexplained splenomegaly

Conditions: Gaucher Disease; Splenomegaly

Summary: primary objective: to estimate the prevalence of gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes) secondary objective: to describe the exams and tests conducted for diagnosis purpose and the more frequent associations

study duration per participant is between 1 and 12 months

Eligibility criteria:
inclusion criteria: * participants referred for the first time for splenomegaly exploration defined as : * either a palpable mass on left upper abdominal quadrant, further confirmed by a ≥ 13 cm craniocaudal length on abdominal imaging * or a non palpable splenomegaly discovered on abdominal imaging and with a craniocaudal length ≥ 13 cm * participants with splenomegaly (as defined above) of unknown origin exclusion criteria: * participants with obvious diagnostics based on clinical exam, patient's interview and the previous initial routine biological tests : * diagnosis of portal hypertension * diagnosis of hemolytic anemia * diagnosis of hematological malignancy * known diagnosis of gaucher disease the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the role of imaging in the diagnosis of acute appendicitis during the covid-19 pandemic

Conditions: Appendicitis

Summary: this is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the covid-19 pandemic in the united kingdom. the study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between march 2020 and february 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between march 2019 and february 2020. the final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.


Eligibility criteria:
inclusion criteria: * patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis * patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis exclusion criteria: * patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon * patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours * patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed

Keywords: appendicitis covid-19 negative appendicectomy rate computer tomography ultrasonography pre-operative imaging
an observational study of the mean duration of trastuzumab (herceptin) treatment in participants with early or metastatic human epidermal growth factor receptor 2 (her2)-positive breast cancer

Conditions: Breast Cancer

Summary: this single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic her2-positive breast cancer. data will be collected from female participants treated with trastuzumab according to the summary of product characteristics and local protocols. duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.


Eligibility criteria:
inclusion criteria: * her2-positive breast cancer * treated with trastuzumab in accordance with summary of product characteristics and local protocols * written informed consent to data collection exclusion criteria: * any contraindication to trastuzumab * clinically relevant cardiovascular disorder or disease
lyric self-replacement clinical investigation

Conditions: Hearing Loss

Summary: this study is designed to investigate the effectiveness and safety of the phonak lyric self-replacement procedure, as compared to the hcp-replacement procedure.


Eligibility criteria:
inclusion criteria: * meets requirements outlined on lyric self-replacement candidacy form * current lyric hearing instrument user with 3+ months of lyric experience * 22 years of age or older at the time of enrollment in the study * mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally) * good understanding (read/write/speak) of the english language * willingness to comply with all study requirements exclusion criteria: * does not meet requirements outlined on lyric self-replacement candidacy form * difficulty understanding/reading instructions when corrected for vision loss * impairments that would restrict participation in any of the evaluations * ear health conditions present at baseline that prevent immediate device replacement * conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
pilot testing of an online rehabilitation intervention for people with heart failure (porias-hf).

Conditions: Heart Failure

Summary: the inability of the heart to pump out blood to the rest of the body organs is called heart failure (hf). hf affects almost 920,000 people in the uk, costing the nhs up to £2.33bn/year. physical exercise programmes aiming to improve the heart's ability to pump out blood are used to a) reduce the risk of life-threatening events (e.g., heart attack), b) reduce admissions to hospital and c) improve individual's physical independence (e.g., walking unsupported, being able toperform daily essential activities). however, these physical exercise programmes have been cut short under the current covid-19 pandemic, with support in most uk regions being restricted to online videos and advice. with many people with hf being asked to be "shielded" or "self-isolate" for an unknown duration, it is important to develop a reliable and cost-effective physical exercise service to support this clinical group. the research team has developed a novel physical exercise programme, fully-delivered online. before assessing if it could improve clinical outcomes (e.g., heart's ability to pump out blood) and how cost-effective it could be, a 10-month pilot study is proposed that will assess if the proposed online physical exercise programme could be performed in people with hf. thirty participants will be allocated at random into two groups: group a will receive up to 24 exercise sessions and up-to 3 lifestyle workshops, in addition to usual care over a 2-month period. group b will receive a self-care exercise programme (≥3 sessions per week) for a two-month period in addition to usual care. prior to the group random allocation, online assessments will be performed including demographics and clinical history, the ability to perform daily activities, sedentary or physical activity habits and quality of life. the assessments including interviews to assess participant's experiences will be repeated at 2 months


Eligibility criteria:
inclusion criteria: * age \> 18 yrs. of either gender * confirmed diagnosis (by echocardiography) of hf reduced left ventricular ejection fraction * sinus rhythm n-terminal pro-brain natriuretic peptide (ntprobnp) is \>400 ng/l at the time of referral to the diagnostic clinic if in sinus rhythm. * ability to exercise exclusion criteria: * non-ambulant status * current pregnancy * scheduled major cardiac surgery * the presence of an icd or crt-d device * severe pulmonary hypertension defined as systolic pap of \>60 mmhg * nyha function class iv * lack of internet connection * inability/unwillingness to give informed consent
concentrated exposure and response prevention for children with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (ocd) in regular clinical practice. it is a non-randomised open label evaluation where children 6-12 years with ocd who are patients at the child and adolescent psychiatry (cap) at uppsala university hospital will be rectruited together with their legal guardians. the treatment will be delivered by trained therapists in regular outpatient care. the main question the study aims to answer is: what are the preliminary treatment effects of concentrated exposure and response prevention with regards to ocd-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement? participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format). outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.


Eligibility criteria:
inclusion criteria: * the patient fulfills the diagnostic criteria of obsessive-compulsive disorder * the patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment exclusion criteria: * the patient/legal guardians are unable to communicate in swedish

Keywords: obsessive-compulsive disorder exposure response prevention pediatric cognitive behavioral therapy