Kornimate/medical-research-clean huggingface dataset:
2-year post-approval study to investigate the scandinavian total ankle replacement system (star) ankle under actual conditions of use

Conditions: Primary Arthrosis; Post Traumatic Arthritis; Rheumatoid Arthritis; Osteoarthritis

Summary: this post-approval study is being conducted to examine the performance of the star ankle under actual conditions of use.

this investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. enrolled subjects will be assessed at pre-operative, operative/discharge, and at 6 weeks, 6, 12, and 24 months after the index procedure. safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.

Eligibility criteria:
inclusion criteria: * moderate or severe pain, loss of mobility and function of the ankle (buechel-pappas scale) * primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis * at least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record * willing and able to give informed consent exclusion criteria: * patients who have not reached skeletal maturity * active or prior deep infection inthe ankle joint or adjacent bones * prior arthrodesis at the involved site * history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol * obesity (weight greater than 250 lbs) * history of current prior drug abuse or alcoholism * any physical condition precluding major surgery * hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot * lower extremity vascular insufficiency demonstrated by doppler arterial pressure * avascular necrosis of the talus * inadequate skin coverage above the ankle joint * patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor * juvenile onset type i diabetes * adult onset type ii diabetes when accompanied by neuropathic changes or a history of foot infection in either foot * pregnancy * avascular necrosis of the tibia * significant bone tumor of the foot or ankle * severe deformity that would not normally be eligible for ankle surgery * prior surgery and/or injury that has adversely affected the ankle bone stock * severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone * insufficient ligament support * motor dysfunction due to neuromuscular impairment

Keywords: arthrosis rheumatoid arthrosis arthritic joint rheumatoid arthritis osteoarthritis total ankle replacement
resilience, grit, and stress in medical students

Conditions: Stress, Psychological

Summary: the incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. it is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. this quasi-experimental study is an ongoing study which is enrolling cohorts of students as they enter medical school.

the investigators will assess the effects of a year-long small process group intervention, led by a psychiatrist, which aims to improve self-awareness, mindfulness, and resilience in first and second-year medical students. students self-select into the process group, and a similar number are randomly recruited as controls from the rest of the preclinical student body. the psychiatrist is blinded to student participation in the study. students in the process and control groups will be surveyed with the perceived stress scale, the connor-davidson resilience scale, and the grit scale in september 2023, and again after nine months and 25 sessions, in may 2024, after the academic year. statistical analysis will be done with r studio. bandura's theory of self-efficacy was used to conceptualize the study. recruitment is done by email, as is data collection. the intervention includes guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy.

Eligibility criteria:
inclusion criteria: 1. the participant must be an enrolled student at the college of osteopathic medicine of the pacific-nw 2. participant must be in their first or second year of medical school 3. participant must be at least 18 years of age 4. participant must self-select into either the intervention group or control group 5. participant must sign informed consent exclusion criteria: 1. data will be excluded if a student goes on a loa during the course of the year 2. data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions 3. student does not give informed consent 4. student withdraws consent at any time

Keywords: medical students resilience grit stress
comparison of the functional walking outcomes of two settings of a commercially available afo in adult stroke patients

Conditions: Walking Aided by a Leg Brace in Stroke Subjects

Summary: the purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. the study brace is an ankle foot orthosis (afo) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. the results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

the purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. the study brace is an ankle foot orthosis (afo) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. participants undergo testing in the gaitlab after using the new brace for a period of time. the results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

Eligibility criteria:
inclusion criteria: 1. between the ages of 21 and 70 males and non-pregnant females 2. diagnosis of stroke more than 1 year ago 3. ambulatory at 0.5m/s or greater 4. require unilateral afos to ambulate 5. stable medical condition - no concomitant progressive diseases that could affect motor function 6. ability to comply with directions and cooperate with research team exclusion criteria: 1. subjects who are currently receiving physical therapy for gait problems 2. anticipated surgical or pharmacologic intervention for tone/contractures during the study period 3. additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures) 4. recent cardiac or active pulmonary disease, liable blood pressure 5. recent back surgery
antidepressant controlled trial for negative symptoms in schizophrenia

Conditions: Schizophrenia

Summary: the aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an ssri antidepressant, citalopram, in the management of persistent negative symptoms of schizophrenia over a year.

the negative symptoms of schizophrenia represent an important dimension of psychopathology, and reflect the absence or diminution of normal behaviours and functions. they include deficiencies in emotional responsiveness, drive, and emotional and social engagement. persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia, but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. the aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an ssri antidepressant, citalopram, in the management of negative symptoms of schizophrenia over a year. the study sample will be adults with a diagnosis of schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and characterised by persistent negative symptoms to a criterion level of severity.

Eligibility criteria:
inclusion criteria: * an opcrit (operational criteria checklist for psychosis: 57) diagnosis of schizophrenia, schizophreniform, schizoaffective disorder or psychosis nos as defined by dsm-iv. * a negative subscale score of 20 or more on the positive and negative syndrome scale for schizophrenia (panss). at least three of the seven items on the negative symptom subscale should be rated 3 or more. * age 18-75 years, inclusive * clinically stable for the last 3 months with a consistent antipsychotic regimen. * competent and willing to provide written, informed consent. exclusion criteria: * any medical contraindications to an ssri antidepressant. * currently receiving antidepressant or clinician wants to treat with an antidepressant; * taking any medications that risk interacting with citalopram * known congenital long qt syndrome, congestive heart failure, bradyarrhythmias * qt limit above the upper limit of normal as determined by an electrocardiogram (ecg) * serum potassium and/or magnesium levels below the lower limits of normal * currently fulfil criteria for major depressive disorder; alcohol/substance hazardous use or dependence in past 3 months * treated with ect in the last 8 weeks. * pregnant or planning to become pregnant * cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. * lack of consent, as judged by the patient's psychiatrist

Keywords: ssri antidepressant negative symptoms schizophrenia
iron absorption and variations of iron status, hepcidin, inflammation and sex hormones during the menstrual cycle

Conditions: Iron-deficiency

Summary: iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. with this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.

to date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. a better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency

Eligibility criteria:
inclusion criteria: * female, 18-30 years old * weight \<70 kg * normal body mass index (18.5 - 25kg/m2) * regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months) * depleted iron stores (serum ferritin ≤ 30 µg/l) * signed informed consent * able to read and understand english exclusion criteria: * use of hormonal contraceptives within a 3-month recall period * anemia (hemoglobin \< 117 g/l) * any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement) * women with severe menstrual cramps that would prevent them from attending study meetings during menstruation (judged by the women) * consumption of iron-containing supplements within 1 month prior to the start of study * known difficulties with blood sampling * pregnancy (serum human chorionic gonadotropin (hcg) \< 5 miu/ml) * current smoking (\>1 cigarette per week over a 1-month recall period) * women who are planning to get pregnant within the study period, as this would affect iron metabolism and subsequent study measurements. * inability to follow the study protocol

Keywords: anemia micronutrients iron trace elements menstruation hormones
comparison of laparoscopic sacrohysteropexy, modified laparoscopic lateral suspension and laparoscopic pectopexy.

Conditions: Pelvic Organ Prolapse; Laparoscopy

Summary: the aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between january 2017 and december 2019 in our clinic.(patients with at least 12 months of the date of surgery will be called for examination.)

the aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between january 2017 and december 2019 in our clinic.(patients with at least 12 months of the date of surgery will be called for examination.) we will evaluate pelvic organ prolapse quantitative system (pop-q), prolapse quality of life questionnaire (pqol), pelvic organ prolapse symptom score (pop-ss), visual analogue score (vas), routine gynecologic usg, failure, complication, operation time .

Eligibility criteria:
inclusion criteria: * patients requiring surgical treatment for the symptomatic stage of pelvic organ prolapse ≥ 2 exclusion criteria: * age \> 70 years * severe cardiovascular or respiratory disease * pregnancy

Keywords: laparoscopy pelvic organ prolapse modified lateral süspension pectopexy sacrohysteropexy hysteropexy sacropexy cervicopexy sacrocervicopexy
exploratory study of effective core formula of chinese medicine to treat primary insomnia

Conditions: Primary Insomnia

Summary: the objective of this study is to screen the effective core formulation in insomnia treatment with chinese medicine with a double-blind, randomized, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years, * meeting the diagnostic and statistical manual of mental disorders, 5th edition (dsm-v) of insomnia, * spiegel scale score is ≥ 18, * the informed consent must be obtained from patient exclusion criteria: * total sleep time ≤ 2 hours, * secondary insomnia, * self-rating anxiety scale (sas) score ≥ 18, * beck depression inventory (bdi) score ≥ 6, * having hypertension, diabetes, stroke, and coronary heart disease, * have drug abuse history, * pregnancy or preparing to pregnancy, * used immunotherapy or hormone therapy in past 1 years, * participating in another clinical trial.
dino rct - treating anxiety in children with autism

Conditions: Autism Spectrum Disorder; Anxiety Disorders

Summary: anxiety is prevalent in young children, under 7 years of age, with autism. yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. anxiety treatment models utilizing cognitive-behavioral therapy (cbt), adapted for children with autism, are empirically supported in school-age autistic children. further, preliminary evidence suggests cbt approaches may reduce intolerance of uncertainty (iu), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. this study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth cbt intervention, dino strategies for anxiety and intolerance of uncertainty reduction (dinosaur), which targets both anxiety and iu in young autistic children.

the purpose of this study is to examine the feasibility and preliminary efficacy of a new treatment that targets both anxiety and iu, i.e., dinosaur, in young autistic children with varying cognitive and language levels. to accomplish this goal, we will investigate if dinosaur is a feasible intervention for families of young autistic children. we will also investigate if dinosaur is superior to an active control condition in reducing anxiety and iu. a third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either dinosaur or the active control (35 in each group) over 14 weeks via telehealth. within each condition, children will be stratified based on cognitive level. anxiety and iu will be assessed following treatment and at 4-month follow-up.

Eligibility criteria:
inclusion criteria: * age 4 years 0 months to 6 years 11 months * dsm-5 asd diagnosis based on clinical impressions and results of the autism diagnostic observation schedule-2 (ados-2) * cbcl anxiety problems t-score \> 65 * sb-5 abiq \> 60 * receptive and expressive language age equivalent \> 36 months based on test of early language development, fourth edition (teld-4) * parent (or other caregiver) available and willing to attend 14-week intervention * absence of identifiable neurological (e.g., epilepsy), genetic (e.g., down syndrome, fragile x, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions * able to walk independently (a requirement for ados-2) exclusion criteria: * primary language other than english * child is in foster care * child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury) * participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)
prospective evaluation of topical anesthesia in children

Conditions: Skin Lacerations

Summary: this study is designed to assess efficacy and comfort of let solution vs. emla cream and topical infiltration of lidocaine.

pain caused by repair of torn skin is usually an unpleasant experience for pediatric patients. analgesia or pain control is conventionally achieved by local anaesthetic infiltration. local anaesthetics are a class of drugs that interrupt the transmission of electrical impulses along sensory nerves by inactivating sodium channels (eidelman et al., 2011). however, the infiltration of local anaesthetics, which involves injecting the medication into the skin, may itself cause significant pain and fear in children (kundu and achar, 2002, boettcher et al., 2012). pain management has been increasingly recognized as an element of high quality patient care, yet studies have shown deficiencies in pediatric emergency department (ped) pain management in children (lawton and hadj, 2014, fein et al., 2012). resolution of pain and perception of pain have been documented as one of the top indicators of patient and parent satisfaction and measure of quality of care in the ped (magaret et al., 2002). children are particularly susceptible to pain, even when caused by simple procedures (boettcher et al., 2012). well-managed pain has been associated with faster recoveries, fewer complications, and decreased use of health care resources (zhu et al., 2012). let gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. let gel offers many advantages for repair of tissue laceration including epinephrine-induced vasoconstriction, promotion of dry surfaces required for tissue adhesive laceration repair, and reduction of discomfort (maclean et al., 2007). topical anesthetics have been shown to improve procedural success rates and reduce procedural times, likely due to decreased patient movement and pain reduction (taddio et al., 2005). let has been shown to significantly reduce the need for injecting local anesthetics to the wound site, which is a cause of much anxiety and pain in children (taddio et al., 2005, singer and stark, 2001). in many ped - as in our department - let solution and emla pretreatment and subsequent lidocaine infiltration are used depending on the personal experience and preference of the physician. the objective of this study is to determine if let solution is as effective as emla and lidocaine infiltration in terms of comfort and effectiveness. primary hypothesis: let solution is as effective as emla and lidocaine infiltration in controlling pain. secondary hypothesis: let solution is superior to emla and lidocaine infiltration in terms of comfort.

Eligibility criteria:
inclusion criteria: 1. chronological age above 3 and below 18 years 2. dermal laceration that needs surgical repair 3. signed informed consent by the parent or guardian of the patient exclusion criteria: * skin laceration of nose tip, fingers, genitalia
drainage fluid biomarkers and anastomotic leakage in colorectal surgery. a monocentric prospective observational study

Conditions: Anastomotic Leakage

Summary: anastomotic leakage (al) is one of the most feared intra-abdominal septic complications (iasc) after colorectal surgery. it is defined as the leak of intestinal content due to an anastomotic dehiscence. incidence ranges from 2% to 20%. al is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. therefore, al is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (ct) scan or water-soluble contrast studies. nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. despite several studies about this topic and the plenty of known risk factors as mentioned above, al is still not easy to predict. different tools other than imaging have been studied in order to make diagnosis of al at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid. biomarkers as white cell blood count (wbc), c-reactive protein (crp), cytokines (e.g. tnfa, il-6, il-1b), markers of ischemia (e.g. lactate) and procalcitonin (pct) have been used for an early detection of al and other intra-abdominal septic complications. the primary aim of our study was to assess the role of drainage fluid crp and lactate-dehydrogenase (ldh) in the early detection of anastomotic leakage.


Eligibility criteria:
inclusion criteria: * patients aged \>16 y undergoing elective or emergency colorectal surgery for cancer * patients aged \>16 y undergoing elective or emergency colorectal surgery for diverticular disease * patients aged \>16 y undergoing elective or emergency colorectal surgery for inflammatory bowel-disease * patients aged \>16 y undergoing elective or emergency colorectal surgery for reversal of hartmann's procedure. exclusion criteria: * patients aged \< 16 y undergoing colorectal surgery; * patients undergoing hartman's procedure

Keywords: anastomotic leakage colorectal surgery biomarkers