Kornimate/medical-research-clean huggingface dataset:
diaphragmatic paralysis comparison between local anesthetic volumen doses after interscalene block

Conditions: Diaphragmatic Paralysis; Brachial Plexus Block

Summary: arthroscopic shoulder surgery involves dynamic and severe postoperative pain. interscalene brachial plexus block (ibpb) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of hemidiaphragmatic paralysis acute (hdpa). this is a comparative, prospective, unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included. this rct would demonstrate a low volume dose ibpb decrease the hdpa after ibpb in patients undergoing sas, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative pca in comparison to standard volume dose used in current practice.

arthroscopic shoulder surgery involves dynamic and severe postoperative pain. interscalene brachial plexus block (ibpb) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of hemidiaphragmatic paralysis acute (hdpa). the primary study objective is to determine the hdpa diagnosed by using diaphragmatic thickness index in ultrasound (us) after low volume (10 ml) versus standard volume (20 ml) of levobupivacaine 0,25% for ibpb. secondary end-points are 1) hdpa diagnosed by using fvc and fev1 in spirometry, 2) hdpa diagnosed by using diaphragmatic excursion in us, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of patient-controlled analgesia (pca) pump of morphine iv and (4) postoperative harms between two trial-arms. this study is a comparative, prospective, unicenter, double-blind and two-arm rct. 48 patients will be included. this rct would demonstrate a low volume dose ibpb decrease the hdpa after ibpb in patients undergoing sas, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative pca in comparison to standard volume dose used in current practice.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years. * asa i-iii. * scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block. exclusion criteria: * age \ 80 years. * pregnancy. * exclusión to perform ibpb or spirometry. * allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs. * background of pulmonary diseases (chronic obstructive pulmonary disease (copd) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral morphine 1 mg 1-month). * coagulation disorders (inr\>3, ttpa \> 35 y ap \<50%).

Keywords: diaphragmatic paralysis interscalene brachial plexus block ultrasound postoperative pain arthroscopic shoulder surgery.
desmopressin in cardiac surgery

Conditions: Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage

Summary: patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products. desmopressin (ddavp), already used for patients with von willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.


Eligibility criteria:
inclusion criteria: * undergoing cardiac surgery * excessive bleeding exclusion criteria: * age\<18 y * not signing written consent

Keywords: blood loss postoperative blood loss
weight variation during chemotherapy in breast cancer patients

Conditions: Breast Cancer

Summary: weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. to date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. however, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied. thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.


Eligibility criteria:
inclusion criteria: * menopausal women * breast cancer * patients requiring chemotherapy treatment * who performance status 0-2 exclusion criteria: * diabetics * patients with metastases * other cancer

Keywords: chemotherapy metabolism weight body composition
development of celiac-q kids: a patient-reported outcome measure for pediatric celiac disease

Conditions: Celiac Disease in Children; Celiac Disease; Patient-reported Outcome Measures

Summary: a multicentre, prospective observational study to develop the celiac-q kids patient reported outcome measure for children and adolescents with celiac disease. the celiac- q kids will contain a comprehensive set of independently functioning scales designed to measure outcomes that matter to children with celiac disease, as well as scales to measure patients experience with the gluten-free diet.

the study will be conducted in three stages: stage i - conceptual framework development: a scoping review will be carried out to map initial concepts that have been measured by patient report in pediatric patients with celiac disease. findings will be used to develop a preliminary conceptual framework. stage ii - item generation: approximately 20 interviews will be conducted with children and adolescents with celiac disease and their caregivers to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. the interviews will be audio recorded and transcribed verbatim. the qualitative data will be analyzed thematically, and key quotes extracted which will be used to create a draft item list. interviews will be conducted either in person or virtually depending on patient preference. the data from stage i will be used to develop a preliminary version of the celiac-q kids patient-reported outcome measure. stage ii - scale refinement: the celiac-q kids scales will be refined through multiple rounds of cognitive debriefing interviews using the "think aloud method." during each interview round, approximately 7 children and adolescents with celiac disease will be interviewed to determine if patients understand the instructions, response options and items of the celiac-q kids instrument and to identify missing content. interviews will take place in a series of rounds to allow time to make changes to the instrument and then obtain feedback on those changes until data saturation is achieved. between rounds of cognitive debriefing interviews, the celiac-q kids will be shown to experts for feedback. a multidisciplinary, international group of approximately 10 healthcare providers who care for children and adolescents with celiac disease will be surveyed to determine if healthcare providers feel there are any items missing from the patient-reported outcome measure, if any items are not relevant and to provide feedback on the instructions and response options. once again, feedback provided by the experts will be used to revise the celiac-q kids scales.

Eligibility criteria:
inclusion criteria: * patients diagnosed with celiac disease. * pediatric patients (18 years and younger). * ability to understand and communicate in the english language exclusion criteria: * patients who do not have celiac disease. * non-pediatric patients (over 18). * unable to understand and communicate in the english language
safety, efficacy and pharmacokinetics of oms302 in subjects undergoing intraocular lens replacement with phacoemulsification

Conditions: Intraocular Lens Replacement

Summary: the purpose of this study is to determine the safety, efficacy and pharmacokinetics of oms302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing intraocular lens replacement (ilr) surgery.


Eligibility criteria:
inclusion criteria: * competent and willing to voluntarily provide informed consent * 18 years of age or older * in good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia exclusion criteria: * no allergies to the medications and/or the active ingredients of any of the study medications * no medications with the same activities of the active ingredients in oms302 for defined time intervals prior to and after surgery * no other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication

Keywords: cataract lens replacement
menopausal vaginal microbiome

Conditions: Menopause; Hormone Replacement Therapy; Genitourinary Syndrome of Menopause

Summary: in this study the investigators will analyze the vaginal microbiome of menopausal women in order to shed light on its potential implication on menopausal symptoms and quality of life. moreover, the investigators will assess the effect of hormone replacement treatment on symptoms and overall quality of life during menopause and whether women under hormone replacement treatment have distinct vaginal microbiome profiles.


Eligibility criteria:
inclusion criteria: * women who are females from birth * women between 40-70 years old * women that are us residents, understand, and speak english * women of all race and ethnicities * women that are postmenopausal (at least 12 consecutive months without a period) * women with a naturally occuring menopause * women willing to abstain from all sexual activity, feminine hygiene products (eg. douches, wipes, washes, sprays, powders, moisturizers/lubricants, deodorant suppositories, tablet suppositories, anti-itch creams, hot tubs) on the vaginal area, and any vaginal suppositories for 48 hours before sampling * women who are healthy (without gsm) * women who have gsm: 1. with formal diagnosis of gsm, or 2. who regularly experience a couple of the following symptoms: (i) vaginal dryness, vaginal burning, vaginal discharge \& genital itching, vaginal irritation, (ii) light bleeding, discomfort or pain during or after intercourse, decreased lubrication during intercourse, decreased arousal, orgasm, libido, (iii) painful or difficult urination (dysuria), urinary frequency and urgency, recurrent utis (urinary tract infections). * women who either take or do not take hrt, including estrogen-only medicines, combination of estrogen/progestin medicines, combination of estrogen/other medicines. exclusion criteria: * women suffering from gynecological diseases including polycystic ovary syndrome, endometriosis, pelvic inflammatory disease, active hpv (human papillomavirus) or herpes simplex virus in the past few months, bv (bacterial vaginosis), yeast infections, or positive for any std (sexually transmitted disease; genital warts, chlamydia, gonorrhea, syphilis, trichomoniasis), hiv (human immunodeficiency virus), cancer, type i diabetes, type ii diabetes, chronic kidney disease. * women having any genital surgery including removal of one or both ovaries, uterus or cervix. * women whose menopause occurred by surgical operation (hysterectomy, oophorectomy), or drug/treatment (eg. chemotherapy, radiation therapy). * women using douches daily or weekly. * women who use on a regular basis one of the following: metformin, antihistamines, antidepressants, corticosteroids, boric acid, laxatives, antifungal/antimycotic medication. * women using any oral or vaginal prebiotics, probiotics, or antibiotics in the past 6 months. * women who take progestin-only medicines including progestin-only hrt.

Keywords: vaginal microbiome menopause hormone replacement therapy genitourinary syndrome of menopause
efficacy and safety of biphasic insulin aspart 30 in type 1 or 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes for at least 3 months * stabilised on current treatment with premixed human insulin for at least 4 weeks * body mass index (bmi) between 18-40 kg/m2 * hba1c below 13.0% * able and willing to perform self-blood glucose monitoring exclusion criteria: * the receipt of any investigational drug within the last three months prior to this trial * has a history of drug abuse or alcohol dependence within the last 5 years * active proliferative retinopathy requiring laser or surgical intervention within the last year * recurrent major hypoglycaemia as judged by the investigator * known or suspected allergy to trial product or related product
proximal row carpectomy vs four-corner fusion for osteoarthritis of the wrist

Conditions: Wrist Osteoarthritis; Scapholunate Advanced Collapse

Summary: study purpose is to compare the outcome after proximal row carpectomy (prc) vs four-corner fusion (fca) for slac/snac ii-iii type osteoarthritis (oa) in a double-blinded randomized controlled study setting. patients with radiologically and clinically confirmed oa are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either prc or fca. the study will be patient and assessor blinded. baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. unveiling of the allocation is at 12 months post-intervention.


Eligibility criteria:
inclusion criteria: * slac/snac ii-iii * age 18 - 75 * symptom duration \> 3 months * american society of anaesthesiologists physical status (asa) i-ii exclusion criteria: * patient eligible for sl reconstruction or scaphoid * ulnocarpal/pancarpal arthritis * lunate fossa, proximal lunate arthrosis or both * age \ 75 years * rheumatoid arthritis * heavy smoking (\> 20 cigarettes per day) * condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids) * alcohol or drug abuse * neurological condition affecting upper limb function

Keywords: wrist osteoarthritis scapholunate advanced collapse scaphoid non-union advanced collapse wrist arthrodesis proximal row carpectomy
effects of trunk training in patients with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of our study is to compare the effects of ngt-based trunk training, video-based trunk training and video-based trunk training applied with theratogs in children with hemiparetic type cerebral palsy.

the aim of our study is to compare the effects of ngt-based trunk training, video-based trunk training and video-based trunk training applied with theratogs in children with hemiparetic type cerebral palsy. it is planned to include 45 patients with hemiparetic cerebral palsy between the ages of 5-15 and with gross motor function classification system (gmfcs) level i-iii. patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. then, structured trunk training will begin. ngt-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and video-based trunk training (45 minutes) will apply with theratogs to the third group. treatments will be applied two days a week for 8 weeks.

Eligibility criteria:
inclusion criteria: * patients with i-iii levels according to communication function classification system * patients with i-iii levels according to gmfcs * patients with hemiparetic cerebral palsy * continuing regular physiotherapy and rehabilitation program for six months. exclusion criteria: * presence of visual or auditory impairment * presence of epilepsy * patients who have undergone orthopedic surgery in the last 6 months * patients who received botulinum toxin-a injection in the last 6 months

Keywords: trunk training theratogs exercise game video-based training
long term follow up mesenchymal stem cell therapy for patients virus-related liver cirrhosis

Conditions: Liver Cirrhosis

Summary: this is a study to assess safety and preliminary clinical activity of treatments of liver cirrhosis in patients with caused by hepatitis c and hepatitis b or nonalcoholic steatohepatitis of mesenchymal stem cell. patients who will be enrolled in the study will be under supervision and monitoring to ensure clinical significance

liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. it can result from a variety of causes, ranging from hepatitis b and c infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course. liver cirrhosis is irreversible and most patients will progressively worsen over time. once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%. the definitive treatment of decompensated cirrhosis is liver transplantation. while a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. the vast majority do not have an effective option at all, thus the need to develop alternative therapies. various types of stem cells had been investigated as a regenerative therapy for liver cirrhosis. these stem cells include bone marrow mesenchymal stem cells (msc). some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. there was improved liver function in these patients with cirrhotic livers. the sponsor is proposing a study to look into the role of msc therapy for patients with liver cirrhosis in ukraine. this will be a phase i study with the main emphasis on the safety and efficiency profile first. the trial will be conducted in compliance with the protocol, gcp and local regulatory requirement(s).

Eligibility criteria:
inclusion criteria: provision of written informed consent for this study by subject or as applicable legal guardians able to comply with study requirements еру rates with rvr defined as serum hcv rna undetectable after 12 month after antiviral therapy. subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease subject must have documented history screening laboratory result indicating hepatitis c virus (hcv) genotype 1, 2, 4, 5 or 6 (gt1,2,4,5,6) infection exclusion criteria: positive test result at screening for hepatitis b surface antigen or anti-human immunodeficiency virus (anti-hiv) antibody hcv genotype performed during screening indicating co-infection with more than 1 hcv genotype.

Keywords: liver cirrhosis fibrosis pathologic processes liver diseases digestive system diseases stem cell msc therapy mesenchymal
transversus abdominis plane block and postoperative pain after laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy; Postoperative Pain; Abdominal Muscles; Nerve Block

Summary: transversus abdominis plane (tap) block has gained popularity for the control of postoperative pain in various surgeries. three studies showed inconsistent result on pain control after tap block in laparoscopic cholecystectomy. the tap technique used in these studies was classic ultrasound guided tap block. besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. as typical posterior tap rarely extend above t8, the investigators undergo subcostal tap block for this type of surgery. the investigators are going to investigate the effect of subcostal tap on early postoperative pain after laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * asa i-ii * age 20-65 patients scheduled elective laparoscopic cholecystectomy exclusion criteria: * patient refusal * allergy to ropivacaine * coagulopathy * morbid obesity (bmi\>35 kg/m2) * previous abdominal surgery.

Keywords: laparoscopic cholecystectomy ultrasound transversus abdominis plane block
emotional and oral characteristics of patients that attend a dental consultation for the extraction of third molars

Conditions: Anxiety and Fear

Summary: analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the master of oral medicine, surgery, and implantology program at the university of barcelona.


Eligibility criteria:
inclusion criteria: * individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars. exclusion criteria: * systemic diseases (asa iii or iv) that contraindicate the performance of the surgical procedure * pregnant women * individuals that did not understand and/or could not respond the given questionnaire. * patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time. * patients who had undergone extraction of a third molar in the twelve months prior to the current visit. * patients taking antidepressant medication or anxiolytic medication
pivotal response treatment for infants at-risk for autism spectrum disorder

Conditions: Autism Spectrum Disorders

Summary: the purpose of this study aims to investigate the utility of pivotal response treatment (prt), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (sibs - asd) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.


Eligibility criteria:
inclusion criteria: * toddlers, age 12 - 15 months, who have an older sibling with asd * delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing * scores that exceed the asd cutoff on standardized measures of social-communicative behavior exclusion criteria: * physical or neurological disorder (e.g., seizures, cerebral palsy)