Kornimate/medical-research-clean huggingface dataset:
impact of the residual gastric volume in laparoscopic sleeve gastrectomy's failure

Conditions: Obesity

Summary: obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. the surgical management of this illness consists in different techniques such as laparoscopic sleeve gastrectomy but this treatment could not be efficient enough. the causes of failure after laparoscopic sleeve gastrectomy are not known but could include the residual gastric volume. the aim of the present study was to determine whether the residual gastric volume is involved in laparoscopic sleeve gastrectomy's failure.

this study can be done in three steps: 1. from a prospective database, patients are selected if they were operated by laparoscopic sleeve gastrectomy at least two years before. 2. these patients are convoked by their surgeon, who proposed them to participate at this study. during this consultation, the baros score is calculated by the surgeon and reported in the case report form of the patient. 3. after checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.

Eligibility criteria:
inclusion criteria: * older than 18 years old * laparoscopic sleeve gastrectomy performed two years before * surgery performed in the digestive surgery department of the amiens university hospital exclusion criteria: * pregnancy or breastfeeding * death of the patient or lost of follow-up * patient under legal or administrative protection * contraindication to the volumetry (pregnancy, technical impossibility)

Keywords: laparoscopic sleeve gastrectomy obesity follow-up
effectiveness and safety of the dexcom™ g6 continuous glucose monitoring system

Conditions: Diabetes Mellitus

Summary: effectiveness and safety of the dexcom g6 continuous glucose monitoring (cgm) system

the objective of the study is to establish performance of the system compared to a laboratory reference measurement. the effectiveness of the system will be evaluated by comparison of cgm values to a laboratory reference, yellow spring instrument (ysi), using arterialized venous sample measurements. performance will be evaluated in terms of point and rate accuracy of the system in reference to ysi. the safety profile of the system will be characterized by the incidence of device-related adverse events (aes) experienced by study subjects.

Eligibility criteria:
inclusion criteria: * ages 2 or older * diagnosis of type 1 diabetes or type 2 diabetes, on intensive insulin therapy * willing to participate in a clinic session involving venous sampling for evaluation of study end point exclusion criteria: * use of acetaminophen * known allergy to medical-grade adhesives * pregnancy * hematocrit outside specification of the study-assigned blood glucose meter
preemptive femoral & lateral femoral cutaneous nerve blocks for tha acute pain

Conditions: Internal Derangement of Hip; Acetabular Labrum Tear

Summary: the goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (nrs scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.

the purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. in addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.

Eligibility criteria:
inclusion criteria: * \>18 year old, * asa physical status classification system score (asa) \<=3 * due to undergo elective unilateral hip arthroscopy by one surgeon dr. nho (co-principal investigator) exclusion criteria: * asa physical status classification system score) (asa) \>3 * history of opioid dependence or abuse * current chronic analgesic therapy (daily use =\>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use \>=4 weeks) * allergy to study medications (fentanyl and ropivicaine) * any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy) * diagnosis of hypertension and/or current treatment for hypertension * pregnancy

Keywords: hip arthroscopy regional anesthesia peripheral nerve block
topical treatment of scalp psoriasis with the fixed combination of calcipotriol and betamethason (xamiol® gel)

Conditions: Scalp Psoriasis

Summary: this non-interventional, prospective, non-controlled study of xamiol® gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis


Eligibility criteria:
inclusion criteria: * patients with scalp psoriasis if a treatment with xamiol® gel is planned anyway exclusion criteria: * contraindications of xamiol® gel listed in the german package insert * pretreatment with xamiol® within the last 4 weeks * systemic treatment of psoriasis * uv light therapy
insecure attachment and psychosocial functioning in autistic adults are mediated by depression and paranoid ideation

Conditions: Autism Spectrum Disorder

Summary: the present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults.

the present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults. within a cross-sectional design, we used mediation analysis to clarify the roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment to psychosocial functioning in autistic adults. questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

Eligibility criteria:
inclusion criteria: * a primary clinical diagnosis of dsm-5 asd (apa, 2013) * age ≥ 18 years * at least eight years of education. exclusion criteria: * intellectual disability (iq ≤ 80) * presence of current suicidal ideation.

Keywords: autism attachment psychosocial functioning adults
safety and efficacy of topamax versus carbamazepine in benign rolandic epilepsy

Conditions: Epilepsy, Rolandic

Summary: the purpose of this study is to determine the efficacy and safety of topiramate in comparison to carbamazepine in benign rolandic epilepsy.

benign rolandic epilepsy (bre) is a common seizure disorder confined solely to children. the disorder is marked clinically by nocturnal generalized tonic-clonic seizures and diurnal seizures consisting of simple partial seizures consisting of brief unilateral facial clonic activity, dysphasia, and drooling. the eeg abnormalities are unique, consisting of generally high amplitude, centrotemporal spikes that are activated by sleep. the seizures typically begin in the first decade and almost always stop by age 16 years. the seizures are usually infrequent although clusters of seizures do occur. when the physician elects to treat, the seizures are usually easily controlled. this is a randomized, open label, active controlled, multi-center based clinical trial to determine the efficacy and safety of topiramate comparing with carbamazepine in benign rolandic epilepsy. the study hypothesis is that topiramate will be more effective in treatment of benign rolandic epilepsy than carbamazepine, as evaluated by seizure-free rate at 24 weeks and intellectual functioning : kedi-wisc (korean educational development institute wechsler intelligence scale for children-revised) and is generally well-tolerated. topiramate (target dose) 4mg/kg/day, b.i.d, oral, for 24 weeks, carbamazepine(target dose) 30mg/kg/day, b.i.d, oral, for 24 weeks.

Eligibility criteria:
inclusion criteria: * subjects whose guardians submitted written consent * subjects with more than 2 seizures in last 1 year * subjects showing one of the following additional criteria * psychological burden due to seizure * seizure in daytime * more than 3 seizures in last 6 month * convulsive seizure exclusion criteria: * abnormalities on mri, eeg * mental retardation * history of seizure relapse * seizures due to organic causes * medically serious acute or chronic disease or progressive and degenerative disorders * patients who have received an investigational medication

Keywords: benign rolandic epilepsy topiramate
spinal cord injury collaborative care study

Conditions: Spinal Cord Injury

Summary: the objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall quality of life for patients with sci.

individuals with sci were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. this was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of traumatic spinal cord injury by medical record review * receives primary sci care from a provider at the university of washington or harborview medical center's rehabilitation outpatient clinic * positive screening for pain related to sci diagnosis and/or * positive screening for low mood and/or * negative screening for physical activity levels * able to speak and understand english exclusion criteria: * psychiatric condition that would interfere with participation * major surgery in the next 8 months

Keywords: chronic pain mood physical activity
effects of uca-pscs in women with pof

Conditions: Premature Ovarian Failure

Summary: this study was a single-center randomized controlled trial at the affiliated drum tower hospital of nanjing university medical school. there were patients who underwent clinical follow-ups since 2018 in pof clinic. patients were given treatment of either uca-psc or wj-msc.

at entry, all patients had already received a standard non-physiologic hormone replacement regimen. according to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. one group received uca-psc transplantation plus horone replacement treatment (hrt) (uca-psc group), while the other group received wj-msc transplantation plus hrt (collagen/wj-msc group)

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of premature ovarian failure 2. patients show no response to drug treatment 3. willing to receive follow up 4. willing to conceive a baby 5. age between 18 to 39 exclusion criteria: 1. patients with chromosome abnormalities 2. patients with congenital ovarian malformations 3. patients with severe endometriosis 4. patients with thyroid dysfunction 5. patients with pregnancy contraindications 6. patients with hormone replacement therapy contraindications 7. past history of ovarian tumors or after radiotherapy 8. can not take the follow-up, or want to take other treatment during the follow-up period 9. patients with immune system diseases

Keywords: pof
the effect of antacids on the pharmacokinetics (pk) of raltegravir in human immunodeficiency virus (hiv)-infected participants (mk-0518-824)

Conditions: HIV Infection

Summary: in order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in hiv-infected participants already taking 400 mg raltegravir twice daily as part of their hiv treatment regimen.


Eligibility criteria:
inclusion criteria: * is hiv positive * is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (arv) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current arv therapy throughout the study. * be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening) * has a body mass index (bmi) =\< 32 kg/m\^2 exclusion criteria: * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding hiv) * has a history of gastric bypass surgery * has a history of cancer (malignancy) * has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit * has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the pre-trial visit * has participated in another investigational trial within 4 weeks prior to the pre-trial visit * is currently taking rifampin or atazanavir or is unable to refrain from the use of 1) any proton pump inhibitor from two weeks prior to the study through the completion of period 4, and 2) any h2-blockers, over-the-counter antacids, calcium supplements or multivitamins from one week prior to the study through the completion of period 4 * consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day * consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day * is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months of screening
survey on anemia therapy in participants with chronic kidney disease (ckd) not on dialysis

Conditions: Chronic Kidney Diseases

Summary: this study is a prospective, non-interventional, cross-sectional multicenter survey. the aim is to better understand the current therapy pattern for anemia in ckd treated with erythropoiesis-stimulating agents (esas) and not on-dialysis participant population in israel. participating physicians will be requested to interview eligible participants with ckd not on dialysis and to complete for them a satisfaction survey for anemia treatment. the survey will be completed twice, once at study start and once at six months' follow-up.


Eligibility criteria:
inclusion criteria: * adult participants with ckd stage 3-5 * treated with esas * participant is speaking the same language as the investigator interviewer exclusion criteria: * past or current treatment with dialysis
multicentre booster & immune memory study of a booster dose of gsk biologicals' 10-valent pneumococcal conjugate vaccine or a single dose of 23-valent plain polysaccharide vaccine in healthy children aged 11-18 mths, previously vaccinated in study 103488

Conditions: Acellular Pertussis; Tetanus; Hepatitis B; Diphtheria; Haemophilus Influenzae Type b; Poliomyelitis

Summary: booster and immune memory study

total: all 689 subjects enrolled in study 103488. 23ps group: aventis pasteurs' 23-valent polysaccharide pneumococcal vaccine (pneumovax 23) + dtpa-hbv-ipv/hib; 10v group: gsk biologicals' 10-valent pneumococcal conjugate vaccine + dtpa-hbv-ipv/hib

Eligibility criteria:
inclusion criteria: male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11pn-pd-dit-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. administration of any additional pneumococcal vaccine or dtpa combined vaccine since study end of 11pn-pd-dit-002 study
effects of the sglt2-inhibitor empagliflozin on patients with chronic siadh - the sandx study

Conditions: SIAD - Syndrome of Inappropriate Antidiuresis; Hyponatremia

Summary: syndrome of inappropriate antidiuresis (siadh) is characterized by an imbalance of antidiuretic vasopressin (avp) secretion. the impaired avp regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. especially chronic (\>72h) siadh is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary. empagliflozin is a sodium glucose co-transporter 2 (sglt2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. the inhibition of sglt2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. this mechanism could result in a therapeutic effect in patients with chronic siadh, as it resembles the aquaretic effect of urea. the aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic siadh.


Eligibility criteria:
inclusion criteria: adult patients (age ≥ 18 years) with hyponatremia (\ 72h) siadh defined as * serum osmolality \<275mosm/kg * urine osmolality \>100mosm/kg * urine sodium \>30mmol/l exclusion criteria: * acute (\<72h) or transient hyponatremia * severe symptomatic hyponatremia in need of hospital treatment * diabetes mellitus type 1 * uncontrolled hypothyroidism * uncontrolled adrenal insufficiency * renal impairment (gfr \<45ml/min) * cardiac failure * symptomatic liver disease / severe hepatic impairment (alat / aspartate transaminase (asat) \> 3x upper limit) * treatment with sglt 2 inhibitors, lithium chloride, urea or glitazone * severe immunosuppression * pregnancy or breastfeeding * palliative situation (end of life care)

Keywords: sglt2-inhibitor treatment
unrestricted rehabilitation following primary tha

Conditions: Osteoarthritis, Hip

Summary: the purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.

the current standard of care following total hip replacement is to restrict patient activity and range-of-motion with the goal of avoiding dislocation of the operative hip. these restrictions are commonly referred to as "hip precautions". several recent studies have demonstrated these precautions may be safely abandoned with no increased risk of dislocation when the surgery is carried through an anterior/lateral approach. previous work has failed to address the issue of patient satisfaction and functional performance when patients are managed with an unrestricted rehabilitation protocol post-operatively. we propose a prospective, randomized clinical trial to determine whether an unrestricted postoperative rehabilitation protocol has an impact on patient satisfaction and functional performance following primary total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * age greater than 50 years * undergoing primary total hip arthroplasty at holland orthopaedic and arthritic centre exclusion criteria: * any previous surgery about the ipsilateral hip * patients being considered for simultaneous bilateral total hip arthroplasty * patients with a neuromuscular disorder or recognized hypermobility syndrome * patients without sufficient language skills to communicate in spoken and written english

Keywords: arthroplasty, hip replacement, hip postoperative care rehabilitation
dose-finding and safety study for oral single-agent to treat advanced malignancies

Conditions: Solid Tumor; Metastatic Bladder Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose of rx-3117 in subjects with advanced or metastatic solid tumors (phase 1). the purpose of the phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).

this is a dose-finding, open-label, single agent study of rx-3117. once the maximum tolerated dose is identified additional subjects will be treated in a dose expansion followed by a 2-stage phase 2 study. subjects will be treated for up to 8 cycles of therapy. a cycle will be 4 weeks. rx-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off treatment. all subjects will be followed for at least 30 days after the last dose of rx-3117.

Eligibility criteria:
inclusion criteria: * males or females who are 18 years or older * able to swallow capsules * histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer * able to discontinue all anticancer therapies 2 weeks prior to study start * measurable or evaluable disease using response evaluation criteria in solid tumors * life expectancy of at least 3 months * ecog performance status of 0 or 1 * provide written informed consent exclusion criteria: * primary brain tumors or clinical evidence of active brain metastasis * systemic corticosteroid use within 7 days before planned start of study therapy * active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy * uncontrolled diabetes as assessed by the investigator * prior or current history of hepatitis b, hepatitis c or human immunodeficiency virus * history of bone marrow of solid organ transplantation * history of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes * any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results * known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside * pregnant, planning a pregnancy or breast feeding during the study * concurrent participation in another therapeutic clinical trial

Keywords: oncology tumor metastatic bladder