Kornimate/medical-research-clean huggingface dataset:
pelvic floor muscle function, pelvic floor dysfunction and diastasis recti abdominis in postpartum women

Conditions: Pelvic Floor Disorders; Diastasis Recti

Summary: background: pregnancy and childbirth are factors that affect a woman's pelvic floor. pelvic floor disorders (pfd) often occur in the perinatal period. symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of pfd during pregnancy and postpartum is an important part of the prevention of these dysfunctions. diastasis recti abdominis (dra) is another common musculoskeletal issue related to pregnancy and postpartum period. in addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body. material and methods: primiparous women after vaginal delivery will be invited to this study. the study will consist of three stages. first phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (perfect scheme, oxford scale, reissing scale), palpation and ultrasound examination of diastasis recti abdominis. after 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated. objectives: the aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of pfd and/or dra 3 months postpartum. expected results: results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in poland. additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. to our knowledge this will be the first study in this area conducted in poland.


Eligibility criteria:
inclusion criteria: * vaginal delivery between 38-42 weeks of pregnancy * first delivery * agreement to participate * good command of spoken and written polish exclusion criteria: * contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization). * lack of consent to participate in the study * lack of good command of spoken and written polish
a study of max-40279combined with kn046 in patients with advanced / metastatic solid tumors

Conditions: Advanced / Metastatic Solid Tumors

Summary: this include two parts, stage 1 is a dose climbing study and stage 2 is a dose extending study.

this study is a study of max-40279 in patients with advanced / metastatic solid tumors. this study include two parts, the part 1 will assess the safety and efficacy of the dose climbing level of max-40279, and recommend a dose extending level of max-40279 for stage 2.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form. 2. males and/or females over age 18 and 75. 3. histologically or cytologically documented local advanced / metastatic solid tumors who have failed standard treatment or cannot obtain standard treatment in the dose escalation stage; dose expansion stage group a: relapsed and refractory advanced gastric cancer; dose expansion stage group b: relapsed and refractory extensive stage small cell lung cancer; dose expansion stage group c: other relapsed and refractory solid tumors except group a 4. at least one measurable lesion according to the response evaluation criteria in solid tumors (recist 1.1). 5. eastern cooperative oncology group (ecog) performance status of 0-1. 6. expected survival of more than 3 months. exclusion criteria: 1. the adverse reactions of previous anti-tumor treatment have not recovered to ctcae 5.0 grade evaluation ≤ 1 (except alopecia and other adverse reactions without safety risks judged by the investigator) 2. subject is known to have previous serious allergic reactions to macromolecular protein preparations/monoclonal antibodies, or known to any component of the test drug 3. active systemic infectious diseases requiring intravenous antibiotic treatment 2 months before the first medication 4. subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: such as: (1) nyha class ii or higher heart failure or lvef \< 50%; (2) unstable angina pectoris; (3) myocardial infarction and cerebral infarction within 6 months; (4) clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without clinical intervention or clinical intervention 5. brain metastases, spinal cord compression, carcinomatous meningitis with clinical symptoms, or other evidence of uncontrolled brain and spinal cord metastases, patients who are not suitable by the investigator's judgment 6. patients who have experienced ≥ grade 3 immune-related adverse events in immunotherapy (except grade 3 hypothyroidism that can be controlled by drugs) 7. patients who have other malignant tumors within 5 years before enrollment,exceptions: a. radical cervical carcinoma in situ or non-melanoma skin cancer; b. radical second primary cancer without recurrence within five years; c. the investigator believes that the double primary cancer can benefit from this study; d. the investigator has clearly excluded which primary tumor source the metastasis
the effect of diaper change position on preterm infants

Conditions: Infant, Premature, Diseases

Summary: the purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.

this study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the neonatal intensive care units (nicu) in a private hospital that has other branches in istanbul. during the data collection process, two methods will be applied to preterm infants during diaper change. in the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the premature infant comfort scale before, during, immediately after and 3 minutes after the procedure. the researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and premature infant comfort.

Eligibility criteria:
inclusion criteria: * the preterm infants whose * parents have agreed to participate in the study and have signed the informed consent form, * who have no congenital anomalies, * have no chronic illnesses, * have undergone underwent no surgical procedures, * have no neurological symptoms, * have not been diagnosed with sepsis, * have not been sedated, * have not received any pharmacological analgesic method four hours before, * have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included. exclusion criteria: the preterm infants whose * parents have not agreed to participate in the study and have not signed the informed consent form, * who have congenital anomalies, * have chronic illnesses, * have undergone surgical procedures, * have neurological symptoms, * have been diagnosed with sepsis, * have been sedated, * have received pharmacological analgesic methods four hours before, * were between \ 36+6 gestational weeks, will be excluded.

Keywords: preterm diaper change comfort position
urine retention rate between spinal and general anesthesia for anorectal surgery

Conditions: Anorectal Disorder

Summary: anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. general and spinal anesthesia were common anesthetic methods in anorectal surgery. we designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. deep level of anesthesia is required for these surgeries. excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. we designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects. inclusion criteria: * \>20 years old patients * asa 1-2 patients * patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty. exclusion criteria: * having known hypersensitivity to amide type local anesthetics * patients asa \>=3 * surgery methods: hemorrhoidopexy, laser hemorrhoidoplasty * fournier gangrene patients * surgery due to previous complications. characteristic data 1. age, gender, asa class, 2. past history: medical history, surgical history 3. previous anorectal history 4. type of anorectal surgery, number of hemorrhoidectomy 5. methods of anesthesia, posture during surgery 6. postoperative recovery room record: vital sign, post anaesthetic discharge scoring system (0-10, \>9 can discharge) 7. ward record: vital sign and urine retention need foley catherization

Eligibility criteria:
inclusion criteria: * \>20 years old patients * asa 1-2 patients * patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty. exclusion criteria: * having known hypersensitivity to amide type local anesthetics * patients asa \>=3 * surgery methods: hemorrhoidopexy, laser hemorrhoidoplasty * fournier gangrene patients * surgery due to previous complications

Keywords: anorectal surgery, hemorrhoid, anesthesia
sleeve gastrectomy versus medical management for remission of diabetes in mild to moderately obese patients

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: the investigators plan to randomize mild to moderately obese (bmi 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * body mass index (bmi) 30-34.9 * able to understand and comply with study process exclusion criteria: * pregnancy * prior bariatric surgery * diabetes mellitus, type 1 * renal impairment * cirrhosis or portal hypertension * diabetes secondary to a specific condition * recent internal malignancy (\<5 years) * recent major vascular event * drug or alcohol dependence * uncontrolled psychiatric disease * crippling cardiopulmonary disease * prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)

Keywords: obesity diabetes mellitus, type 2 sleeve gastrectomy metabolic surgery
thyroid hormone dose adjustment in pregnancy

Conditions: Pregnancy; Hypothyroidism

Summary: our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.

our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy

Eligibility criteria:
inclusion criteria: * women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy * less than 8 weeks pregnant exclusion criteria: * cardiac disease, renal failure * not euthyroid biochemically within 6 months pre-pregnancy

Keywords: pregnancy hypothyroidism levothyroxine
higher dose of alglucosidase alpha for pompe disease

Conditions: Glycogen Storage Disease Type II

Summary: this study is aimed to investigate that whether the higher dose ert improve safety and clinical outcomes of pompe disease patients. also, wish to develop a new therapeutic recommendation and hope that it could improve the long-term outcomes of pompe diesease patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis of pompe disease 2. currently receiving ert with regular clinic visits 3. agree to sign informed consent exclusion criteria: 1. lost follow-up for clinical visits 2. allergy to myozyme 3. refuse to sign informed consent
a study to compare the efficacy, safety and tolerability of ff/umec/vi with ff/vi in 12-17-year-olds with asthma

Conditions: Asthma

Summary: the primary purpose of this study is to evaluate the effects of fluticasone furoate (ff)/ umeclidinium (umec)/ vilanterol (vi) on lung function compared with ff/vi after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent. * participants who have a diagnosis of asthma as defined by the national institutes of health \[nih, 2020\] at least 1 year prior to visit 0. * participants who have required daily inhaled corticosteroids (ics)/ long-acting beta2-agonist (laba) treatment for at least 12 weeks prior to visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to visit 0 (including no changes to a stable total ics dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent). * in the 1 year prior to visit 1: a documented healthcare contact for acute asthma symptoms; or a documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent). * participants with inadequately controlled asthma (acq-6 score ≥1.5) at visit 1, despite ics/laba maintenance therapy. * a best pre-bronchodilator fev1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in fev1 with albuterol/salbutamol at visit 1. predicted values will be based on the european respiratory society (ers) global lung function initiative. exclusion criteria: * chest x-ray documented pneumonia in the 6 weeks prior to visit 1. * any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to visit 1. (participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ics) to treat an exacerbation in the 6 weeks prior to visit 1 are not explicitly excluded at visit 1 provided that, at the investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration) * history of life-threatening asthma * participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.). * current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to visit 1.

Keywords: fluticasone furoate gw685698 umeclidinium gsk573719 vilanterol gw642444 trelegy relvar breo
navigated ebus and functional imaging in lung cancer

Conditions: Bronchial Neoplasms

Summary: electromagnetic navigation systems have proved feasible for precise intraoperative guiding during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration (ebus-tbna), based on maps made of preoperative ct images. pet--ct, pet--mri and fmri can point out malignant lesions. when fused into a research navigation system, functional imaging can add information of optimal sampling points in lung cancer staging. correct image registration is then fundamental. this study is a build--on to nct02493023, assessing the position and image registration accuracy and clinical feasibility of a multimodal image guiding system in patients referred for lung cancer staging by ebus--tbna.

a research navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its position in 3d maps made from the patients' own preoperative images (pet-- ct, pet--mri or fmri). images are acquired ahead of study inclusion. the navigation system acquires position data, first from a videobronchoscope, then from an ebus--scope (same sort of output data acquired from both endoscopes) equipped with a position sensor for electromagnetic tracking. from intraoperative position data, the accuracy of the image--to--patient registration (for ct, pet--ct, pet--mri and fmri) and the navigation system accuracy are calculated. electromagnetic navigation fused with available image modalities can be used to navigate directly and precisely to the area with highest suspicion of malignancy. multimodal image guiding systems with functional imaging may thereby lead to improvements in endoscopic lung cancer staging, f. i. in diagnostic yield, procedure time and safety.

Eligibility criteria:
inclusion criteria: * referred to thoracic department st olavs hospital due to suspicion of lung cancer * informed consent exclusion criteria: * pregnancy

Keywords: bronchoscopy bronchoscopes
effects of animal assisted therapy on patients with severe disorders of consciousness

Conditions: Disorder of Consciousness

Summary: the study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. the focus lies on the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 10 patients during 16 therapy sessions. while half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. in this study, patients in a minimal conscious state are recruited.

this pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. the experimental condition is the standardised therapy session using therapy animals (aat), while the control condition is the comparable "standard" therapy session without the presence of an animal. over a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. in this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient. each therapy session lasts about 20 minutes. the study takes place at rehab basel. animal-assisted therapies are held in a special room at rehab basel in the presence of one or more small animals that will be selected by the therapist. patients are allocated randomly to start with either the experimental or the control condition.

Eligibility criteria:
inclusion criteria: * inpatients of rehab basel * disorder of consciousness: minimal conscious state defined via: * crs score (coma remission scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1 * bavesta score of 2.8 exclusion criteria: * enrolment of the investigator, his/her family members, employees and other dependent persons * medical contraindications for contact with animals as allergy, phobia etc. * if the patient's medication changes radically during the time of data collection
a secondary study evaluating aqueduct's smart external drain (sed)

Conditions: Hydrocephalus; Hydrocephalus in Children; Tumor, Brain; Subarachnoid Hemorrhage

Summary: aqueduct's smart external drain (sed) will be compared to the current gold standard for temporary csf management in a hospital setting. * evaluate the number of subjects requiring to be switched to a standard of care evd * evaluate subject transport while on the sed * evaluate sed system control from initiation of sed through discharge of external drain system

this clinical trial will evaluate aqueduct's smart external drain (sed) upon implementation of ventriculostomy or lumbar drain placement for temporary csf external management in a hospital setting. subjects will remain on study from the time of sed application through discharge of the external drain or switch to standard of care extraventricular drain.

Eligibility criteria:
inclusion criteria: 1. subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management. 2. age 0-80. 3. able to obtain consent or legally authorized representative (lar) consents for subject to be treated on study. exclusion criteria: 1. anticoagulant therapy (does not include dvt or pe prophylaxis). 2. known bleeding diathesis. 3. scalp infection. 4. in the opinion of the investigator the subject is not a good study candidate.