Kornimate/medical-research-clean huggingface dataset:
comparison between laparoendoscopic single-site surgery and multi-port laparoscopy in treating uterine fibroids

Conditions: Uterine Fibroid; Uterine Sarcoma; Uterine Leiomyosarcoma

Summary: myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (tu-less) or multi-port laparoscopic surgery (mpls). power morcellation used in mpls was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. moreover, tu-less was reported to exceed mpls in fast recovery. therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between tu-less and mpls in myomectomy for the treatment of uterine fibroids.


Eligibility criteria:
inclusion criteria: * diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations * will consider tu-less or mpls for myomectomy exclusion criteria: * patients reluctant to long-term follow-up

Keywords: uterine fibroids tu-less multi-port laparoscopic surgery
sensor-based assessment and rehabilitation of balance in neurological diseases

Conditions: Stroke; Multiple Sclerosis; Parkinson Disease

Summary: balance impairment is one of the most common disorders due to a neurological diseases. sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. oak elderly care system (khymeia group, noventa padovana, italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.

the aim of the study is to compare the therapy provided by means of the oak elderly care system with conventional physiotherapy for balance rehabilitation in patients affected by stroke, multiple sclerosis (ms) and parkinson disease (pd). oak elderly care system consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. these components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment. 120 patients (40 stroke, 40 ms, 40 pk) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. both treatments lasted 15 sessions. before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.

Eligibility criteria:
inclusion criteria: common criteria: * berg balance scale \< 50/56; * ability to maintain the standing position with o without one support for 1 minute; * functional independence measure \< 100/126; * barthel index \< 80/100. stroke: * single ischemic stroke; * lesion occured after 2 and within 18 months; * national institute of health stroke scale ≤ 14. parkinson: * 1.5 \< hoehn \& yahr \< 3; * subitem "freezing when walking"of the updrs ≤ 2. multiple sclerosis: * relapsing remitting or secondary progressive multiple sclerosis; * expanded disability status scale ≤ 6.5. exclusion criteria: * untreated epilepsy; * major depressive disorder; * fractures; * dementia; * ideomotor apraxia; * neglect; * severe impairment of verbal comprehension; * severe acoustic and visual disorders.

Keywords: balance sensor-based rehabilitation virtual reality
dexmedetomidine versus fentanyl following pressure equalization tube placement

Conditions: Chronic Otitis Media

Summary: this is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (pe) tubes in providing analgesia and smoothing emergence from general anesthesia.


Eligibility criteria:
inclusion criteria: * functional status as assigned by the american society of anesthesiology (asa) classification of i or ii (no or minimal co-morbid disease) * patients scheduled for placement of bilateral myringotomy tubes exclusion criteria: * history of allergy to either dexmedetomidine or fentanyl * concomitant use of medications which may exaggerate the hr response of dexmedetomidine including digoxin or β-adrenergic antagonists.

Keywords: myringotomy pressure equalization tubes
phase ii randomized study of selective dorsal rhizotomy and physiotherapy vs physiotherapy alone for spastic diplegia

Conditions: Spastic Diplegia

Summary: objectives: i. assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.

protocol outline: this is a randomized study. patients are stratified by age and the ability to ambulate 50 feet unaided. each stratum is block randomized. patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone. the surgical procedure is a selective dorsal rhizotomy. physical therapy (pt) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. the pt schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). parents supervise exercise on non-pt days. patients are followed at 6, 12, and 24 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * spastic diplegia, i.e.: measurable spasticity with more lower than upper limb involvement * fair to good trunk and head control * little or no bulbar involvement * able to walk or has potential to walk indoors with assistive devices * no fixed musculoskeletal deformity greater than 15 degrees * prior orthopedic surgery acceptable if spastic muscle group is in physiologic biomechanical position and retains voluntary power * no detectable athetosis, rigidity, ataxia, or other movement disorder * no disease-related, treatable condition that may become urgent during study, e.g., hip subluxation requiring adductor release --patient characteristics-- * age: 3 to 18 * other: intelligence quotient greater than 50 developmental age 3 years or higher * able to follow multi-step commands * expressive communication skills at 3-year level or higher * mild dysarthria or drooling does not exclude * stable social environment * regular school and physical therapy attendance * normal psychiatric status * guardian able to give support and follow-up care * no medical contraindication to anesthesia or surgery, e.g.: previous anesthesia reaction * chronic lung disease * uncontrollable seizures * scoliosis vertebral anomaly * neural tube defect * no visual impairment sufficient to hinder mobility * able to come to children's hospital and medical center for follow-up insurance coverage adequate for surgery and postoperative physiotherapy

Keywords: cerebral palsy neurologic and psychiatric disorders rare disease spastic diplegia
effect of intermittent oral enteral nutrition tube in tracheostomized patients with intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: this was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with intracerebral hemorrhage. the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage. the main questions it aims to answer are: compared to nasogastric tube feeding, can the intermittent oro-esophageal tube feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of patients with intracerebral hemorrhage compared to nasogastric tube feeding, is the intermittent oro-esophageal tube feeding safer. participants will be divided into two groups randomly, with different nutritional support respectively.

safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge.the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage. the main questions it aims to answer are: compared to nasogastric tube feeding, can the intermittent oro-esophageal tube feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of patients with intracerebral hemorrhage compared to nasogastric tube feeding, is the intermittent oro-esophageal tube feeding safer. participants will be divided into two groups randomly, with different nutritional support respectively.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for intracerebral hemorrhage. * with placement of a tracheotomy tube. * requiring enteral nutrition support. * age over 18 years. * able to cooperate with treatment and questionnaire investigation. exclusion criteria: * combined with tumors in the head, neck, esophagus, or gastrointestinal tract * an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus * with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys * with severe hemorrhagic disease or bleeding tendency; * with dysphagia caused by non-stroke-related reasons in the past
a safety and efficacy study of golimumab (cnto148) in patients with active rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite dmard (disease-modifying antirheumatic drugs) therapy. another objective is to evaluate the pharmacokinetics of golimumab.

this study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-tnf (tumor necrosis factor) a monoclonal antibody produced by mean of humab mouse technology. other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with methotrexate (mtx). there will be 3 treatment groups in the study as follows: cnto148 50 mg group, cnto 148 100 mg group, and placebo group.

Eligibility criteria:
inclusion criteria: * patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the american college of rheumatology (1987) * patients who have previously not responded to at least one dmard (before informed consent is obtained) * patients who, if they are on the treatment with a dmard, the dmard can be washed out for at least 4 weeks before the first administration * patients having at least 6 swollen joints and 6 tender joints at the time of registration and immediately before the first injection exclusion criteria: * patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab * patients who have previously experienced or are suffering from any of the following diseases: (i) collagen diseases other than rheumatoid arthritis, (ii) latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) felty syndrome, etc * patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain

Keywords: rheumatoid arthritis fully human anti-tnfa monoclonal antibody cnto148 golimumab
animal-assisted trauma-focused therapy for children and adolescents

Conditions: Motivation; Alliance, Therapeutic

Summary: the study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (tf-cbt) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. participants must have experienced at least one traumatic event leading to post-traumatic stress symptoms. participants are randomly allocated to one of two groups: animal-assisted trauma-focused therapy (aa tf-cbt) or standard trauma-focused therapy (tf-cbt). parallel to the groups the parents/guardians of the participating children and adolescents take part in three parent meetings. the results of the study help to gain insights into how the inclusion of animals in trauma-focused psychotherapy can contribute to children and adolescents attending therapy, being more motivated in therapy, and can successfully complete therapy.


Eligibility criteria:
inclusion criteria: * age between 9 and 17 years * experienced a traumatic event * remembers at least one traumatic event * suffering from posttraumatic stress symptoms (screened via the cats-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver) * basic knowledge of child and parents in german to be able to understand content of the session and to fill in questionnaires * informed consent (given by legal guardian for participants younger than 14 years) * positive or neutral attitude towards animals exclusion criteria: * inability to complete questionnaires due to lack of language skills or cognitive impairment * diagnosed autism spectrum disorder; exclusion only if interaction with others and group ability is limited due to autism * reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis) * known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs) * fear of domestic animals * allergic reactions to domestic animals * reported aggressive behavior towards animals in the past

Keywords: ptsd animal-assisted therapy trauma-focused therapy motivation
international sars-cov-2 (covid-19) infection observational study

Conditions: COVID; COVID19; SARS-CoV 2; Dyspnea

Summary: the general aim of this study is to estimate the rate of disease progression for adults testing positive for sars-cov-2. the primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. in some locations special facilities are being built/utilized for quarantine/public health reasons for those who are sars-cov-2 positive. hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment. secondary outcomes include participant-reported health status and change in severity of dyspnoea.

sars-cov-2 is a coronavirus that emerged in china in late 2019 causing a novel corona-virus induced disease (covid-19). covid-19 is spreading rapidly throughout the world. while a proportion of people with covid-19 have sufficiently severe symptoms to require hospitalization at the time of initial symptom onset, in others the disease may remain mild, and in some cases there has been observed a worsening of symptoms a few days after initial presentation with relatively mild symptoms. there is an urgent need for understanding the progression of disease for individuals with sars-cov-2 infection/covid-19 who do not require immediate hospitalization. this is an international, observational cohort study of adults with sars-cov-2 infection/covid-19 managed as outpatients (not hospitalized). this study will also be a platform for the enrollment of outpatients for randomized trials that will be conducted by the insight group. those with confirmed sars-cov-2 infection will form an observational cohort study and be followed for 28 days. procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at insight sites around the world.

Eligibility criteria:
inclusion criteria: - not currently hospitalized exclusion criteria: - persons with a known positive sars-cov-2 test \> 28 days ago
ultrasound diagnosis of antibiotic associated diarrhea

Conditions: Antibiotic-Associated Diarrhea

Summary: the hypothesis is that there are unique sonographic characteristics of antibiotic-associated diarrhea. we will compare the ultrasound findings in patients who received antibiotics and developed diarrhea to toxin analysis for clostridium difficile in stool in order to find differences in the sonographic findings in the positive and negative cases.


Eligibility criteria:
inclusion criteria: * admitted patients who developed diarrhea in 72 hours since the beginning of admission * patients age above 18 years. * patients received antibiotics during admission exclusion criteria: * other reasons of diarrhea * drugs induced diarrhea * length of time since the beginning of diarrhea is shorter than 72 hours. * patients had diarrhea during the first day of admission

Keywords: focus study evaluate sonographic findings colon patients developed
prevalence and severity of surgical adhesions among women undergoing laparoscopic surgery at women's health hospital

Conditions: Surgical Adhesions

Summary: to assess the prevalence of surgical adhesions among women undergoing laparoscopy, and the severity of the adhesions according to proposed classification of intra-abdominal adhesions.

patients will be recruited from the women at women's health hospital assuit university that will undergo laparoscopy for any cause. after the patients has been examined and put on a list for laparoscopy, they will be counselled about our study and its benefits. written consent will be obtained. all women will be subjected to the following: 1. history taking: 1. personal history: demographic factors and age. 2. obstetric history: parity, last delivery, history of abortion. 3. menstrual history: regular or irregular cycles, p/c. 4. past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and pid. 5. surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section. 6. the complain of the patient and the indication of laparoscopy. 2. clinical examination: * general examination including pulse, blood pressure, temperature, bmi and pallor. * abdominal examination for scars of previous operations or fundal level. 3. investigations: * ultrasonography: to assess the uterus and adnexa. * blood sample: it will be examined for the following; complete blood picture and renal function test. 4. during laparoscopy: any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history. the prevalence of adhesions will be calculated according to the indication of laparoscopy. the prevalence of adhesions will be compared according to different items. comparison between patients with no past surgical history and those who have past surgical history. comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy. comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery. 5. the adhesions will be noticed, its site will be detected (between uterus and bladder, uterus and abd. fascia, uterus and omentum, omentum and abd. fascia or adhesions to other pelvic structure that interfere with the delivery), its consistency (filmy or dense) and thickness (either \ 6cm) and these informations will be subjected to the proposed classification and every case will have its score. the data will be analysed to find out which cases have high score and their common risk factors that are expected to be the cause of this high score.

Eligibility criteria:
inclusion criteria: * women who will undergo laparoscopic surgery at women's health hospital assuit university. women aged 18 years or more. exclusion criteria: * women who refused to participate in our study
long-term treatment outcome for stage iii npc patients and risk grouping by plasma ebv dna

Conditions: Nasopharyngeal Carcinoma; EBV Related Carcinoma

Summary: no previous study reported the treatment outcome of stage iii nasopharyngeal carcinoma (npc) patients. the investigators try to investigate the long-term treatment outcome of stage iii npc patients and do risk grouping by plasma epstein-barr virus (ebv) dna assay for future therapy improvement.

the stage iii npc patients were the majority group of the patient population of npc. but most clinical trials focused on the treatment of american joint committee on cancer (ajcc) 7th edition stage iva/ivb treatment for high risk of recurrence or metastasis. no previous study reported the treatment outcome of stage iii npc patients. the investigators tried to investigate the long-term treatment outcome of stage iii npc patients and do risk grouping by plasma ebv dna assay for future therapy improvement.

Eligibility criteria:
inclusion criteria: * biopsy-proven stage iii nasopharyngeal carcinoma (npc) * finished curative chemoradiotherapy * have pre-treatment and post-radiotherapy plasma ebv dna exclusion criteria: * no tissue proven npc * not finished curative treatment * no pre-treatment and post- radiotherapy plasma ebv dna

Keywords: nasopharyngeal carcinoma plasma ebv dna
changing the future of intestinal failure in intestinal chronic inflammation (int-fail)

Conditions: Intestinal Failure; Inflammatory Bowel Diseases; Crohn Disease

Summary: this is an interventional, prospective, no profit study that will be performed at cemad, from fondazione policlinico gemelli irccs, rome (uo1) and u.o.c. internal medicine and gastroenterology from ospedale brotzu di cagliari (uo4). adult patients with crohn disease (cd) and chronic intestinal insufficiency (cf) and adult patients with cd at high and low risk of cf.

the study involves an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsy (additional biopsy collection at the same time as clinical practice biopsy for study-specific analysis) will be performed. patients will then be re-evaluated nine months after the initial evaluation. in particular, faecal, blood and additional biopsy samples will be collected at the same time as the clinical practice biopsy and any changes in treatment will be recorded.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years-old and ≤ 75 years old * capable of expressing informed consent; * an established diagnosis of crohn's disease; * antibiotics treatment free for at least 15 days. exclusion criteria: * age \ 75 years old; * not capable of expressing informed consent; * pregnant or breastfeeding patients; * comorbidities including: cancer pathology present or under active treatment; coagulopathies; chronic hepatopathy, heart failure, renal failure, respiratory failure.