Kornimate/medical-research-clean huggingface dataset:
express: examining pagoclone for persistent developmental stuttering study

Conditions: Persistent Developmental Stuttering

Summary: the objective of the study is to determine the effects of pagoclone on the symptoms of persistent developmental stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.


Eligibility criteria:
inclusion criteria: * pds defined as dsm-iv-tr criteria, symptoms starting before age 8, and a total overall score of 18-36 on the ssi-3 * english-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance * not pregnant or breastfeeding * able to consent exclusion criteria: * no diagnoses of other cns/mental health disorders in the last 6 months * no use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening * no use of non-medicinal stuttering treatments for 5 months prior to the study * no use of illicit drugs or opiates of any kind

Keywords: persistent developmental stuttering
long-term safety, tolerability and efficacy of oms906 in paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the purpose of this study is to assess the long-term safety and tolerability of repeat-dose oms906 5 mg/kg iv administration at 8-week intervals in patients with pnh.

this is a multicenter, open-label, single arm study. the primary objective is to assess the long-term safety and tolerability of oms906 in patients with pnh. secondary objectives of this study include assessment of the long-term efficacy of oms906 in patients with pnh. patients will receive oms906 5 mg/kg administered as intravenous (iv) injections at 8-week intervals.

Eligibility criteria:
inclusion criteria: 1. have completed the last dosing visit of the prior oms906 pnh study. 2. female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of oms906. 3. females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug. 4. males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug. 5. have current vaccination status for neisseria meningitidis, streptococcus pneumonia and hemophilus influenza and agree to maintain vaccination throughout the study. 6. have provided informed consent exclusion criteria: 1. platelet count \<30,000/µl or absolute neutrophil count \<500 cells/µl at the start of the evaluation period. 2. elevation of liver function tests, defined as total bilirubin \> 2 x uln, direct bilirubin \> 1.5 x uln, and elevated transaminases (alanine or aspartate aminotransferase), \> 2 x uln unless due to pnh-related hemolysis. 3. history of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the oms906 preparation. 4. patients with unresolved serious infections caused by encapsulated bacteria including h. influenzae, s. pneumoniae and n. meningitidis. 5. pregnant, planning to become pregnant, or nursing female patients. 6. history of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension. 7. unable or unwilling to comply with the requirements of the study.

Keywords: pnh
urinary tract injuries during caesarean section for morbidly adherent placenta: prospective and retrospective study

Conditions: Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study

Summary: m1- evaluates the cases of lower urinary tract injuries during caesarean section with or without hysterectomy in cases with morbid placental adherence in the period between years 2018 and 2021. this study was carried out in assiut university women health hospital m 2- clarification of the risk factors and outcome of urinary tract injuries.

placenta accreta spectrum disorder (pas), also called abnormally invasive placenta (aip), describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding(1-2) the incidence of pas is rising worldwide(3) pas is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality.(4) pas may occur after any kind of procedure that causes damage to the endometrium, including curettage, manual removal of the placenta, uterine-artery embolization, or myomectomy(5-6) a full thickness surgical scar is associated with both the absence of endometrial re-epithelialization and vascular remodelling around the scar area, and this may lead to abnormally invasive placentation (increta/percreta).(7) ultrasound is the first-line imaging tool for the screening and diagnosis of pas. however, it is now well-established that magnetic resonance imaging (mri) has a role in the diagnosis of pas, with high sensitivity and specificity(8-9) urinary bladder injury is one of the operative morbidities of cesarean section. it occurs in 0.08% - 0.94% of cesarean sections(10) repeated cesarean section and type of morbidly adherent placenta (map) are considered the major risk factors for urinary tract injuries during cesarean delivery(11) urinary bladder injury complicates about 11.7% of cesarean sections in women with placenta accreta spectrum (pas)(12) the presence of tough adhesions between the bladder and the lower uterine segment carries the risk of urinary bladder injury. trial of separation of the bladder in such circumstances may result in bladder injury. filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection (13)

Eligibility criteria:
inclusion criteria: * all cases in the 3rd trimester admitted to asyut university women health hospital and diagnosed antenatally as having morbidly adherent placenta * confirmed diagnosis of map. * peri partum hysterectomy for map. * complicated cs without hysterectomy * maternal age between 18 and 45 yrs * no other medical diseases exclusion criteria: * associated other uterine pathology * refusal of the patient * emergency cs before confirming map diagnosis. * urinary tract injuries due to other causes than map * presence of major medical disorders e.g. dm, pe, cardiac lesion, coagulopathy, liver diseases or kidney diseases * postpartum depression.
screening of septo-optic dysplasia during a fetal examination at 16-20 weeks of gestation

Conditions: 2D Ultrasound; Cavum Septum Pellucidum; Septooptic Dysplasia; Optic Chiasma; Willis Polygon

Summary: evaluation of prenatal optic chiasm (oc) is important for the differential diagnosis of septo-optic dysplasia (sod), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (csp). septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, csp agenesis, and developmental delay.

up to now, optic chiasm measurement were all done in the third trimester. in the present study, oc will be measure directly in a 2d ultrasound in coronal plane within the second trimester. in fetuses with sp agenesis, the morphology and width of the oc visual pathway may be a suitable tool to assess its development. it can also assist in the difficult task of providing prenatal counseling when faced with a diagnosis of cp agenesis. therefore in the present study, it was planned to show the optic chiasm in the screening of septooptic dysplasia by ultrasound between 16-20 weeks of gestation, and to measure the optic chiasma width and length, and to determine the mean values in the second trimester.

Eligibility criteria:
inclusion criteria: * aged greater than 18 years old * having singleton pregnancy exclusion criteria: * being under the age of 18 * having ivf pregnancy * having multiple pregnancy * comorbidity during pregnancy * smoking history * presence of familial genetic disease
peri-operative risk factors for postoperative pressure ulcer in surgical patients

Conditions: Postoperative Pressure Ulcer

Summary: the aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.


Eligibility criteria:
inclusion criteria: * patients in icu with a greater than 48 hours * underwent a surgical procedures, * absence of pressure ulcer present at admission to the icu and developed a stage ii or higher pressure ulcer, deep tissue injury, or unstageable ulcer, as defined by the pressure ulcer staging guidelines of the national pressure ulcer advisory panel. exclusion criteria: * patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery * pediatric patients
a study to evaluate a therapeutic vaccine, asp0113, in cytomegalovirus (cmv)-seropositive recipients undergoing allogeneic, hematopoietic cell transplant (hct)

Conditions: Cytomegalovirus (CMV)-Positive Recipients; Allogeneic, Hematopoietic Cell Transplant (HCT)

Summary: the purpose of the study was to evaluate the efficacy of asp0113 compared with placebo as measured by a primary composite endpoint of overall mortality and cmv end organ disease (eod) through 1 year post-transplant. safety of asp0113 in participants undergoing allogeneic hct will also be evaluated.

participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

Eligibility criteria:
inclusion criteria: * participant is a cmv-seropositive hct recipient * participant is planned to undergo either of the following: * sibling donor transplant * unrelated donor transplant * participant has one of the following underlying diseases: * acute myeloid leukemia (aml) * acute lymphoblastic leukemia (all) * acute undifferentiated leukemia (aul) * acute biphenotypic leukemia * chronic myelogenous leukemia (cml) * chronic lymphocytic leukemia (cll). * a defined myelodysplastic syndrome(s) (mds) * primary or secondary myelofibrosis * lymphoma (including hodgkin's) exclusion criteria: * participant has active cmv disease or infection or has received treatment for active cmv disease or infection within 3 months (90 days) prior to transplant * participant has a modified hematopoietic cell transplant comorbidity index (hct-ci) score ≥ 4 * participant has received a prior hct and has residual chronic graft-versus-host disease (cgvhd) * participant who is scheduled to have a cord blood transplant or a haploidentical transplant * participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed) * participant has aplastic anemia or multiple myeloma

Keywords: asp0113 cytomegalovirus (cmv) hematopoietic cell transplant (hct)
effect of intravenous low-dose ketamine infusion with intravenous lignocaine infusion on post-operative pain in patients undergoing laparoscopic choleysystectomy under general anesthesia

Conditions: Cholelithiases

Summary: objective: to determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing lc under general anesthesia in a tertiary care hospital. sample selection: patients of both the gender of age at least 18 years, planned for elective lc with asa grade i-ii were included. patients with obesity, history of alcohol consumptions, drug abusers, uncontrolled hypertension and diabetics, with chronic pain, allergic to study drugs, having neurological disorders, unable to understand pain scoring system and converted to open lc were excluded.


Eligibility criteria:
inclusion criteria: * patients of both the gender of age at least 18 years * patients planned for elective lc * patients with asa grade i-ii were included. exclusion criteria: * patients with obesity, * patients with history of alcohol consumptions, uncontrolled hypertension and diabetics, * drug abusers * patients with chronic pain * patients allergic to study drugs * patients having neurological disorders or unable to understand pain scoring system * patients converted to open lc

Keywords: cholelithiases cholecystectomy laparoscopy
ischemic post-conditioning in acute ischemic stroke thrombectomy

Conditions: Acute Ischemic Stroke

Summary: ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. the purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: * age 18-80 years; * acute ischemic stroke caused by middle cerebral artery m1 segment occlusion; * successful recanalization (mtici 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography; * written informed consent provided by the patients or their legal relatives. exclusion criteria: * known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia; * difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; * stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures; * \> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures; * moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization; * difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.

Keywords: acute ischemic stroke ischemic postconditioning endovascular thrombectomy
flow-controlled ventilation (fcv) in moderate acute respiratory distress syndrome (ards) due to covid-19

Conditions: COVID-19 Acute Respiratory Distress Syndrome; Respiration, Artificial

Summary: flow controlled ventilation (fcv) is a fairly new mode of mechanical ventilation, consisting of a constant inspiratory and expiratory flow. inspiration is thus comparable to volume controlled ventilation (vcv). the actively controlled, constant flow during expiration is unique. fcv is known to minimize dissipated energy to the lung \[ref\] and is therefore supposed to aid in lung protective ventilation. the vicar study is designed as a prospective single cohort crossover trial. the intervention consists of a sequence of respiratory modes: baseline pressure controlled ventilation (pcv) during 5 minutes, followed by 30 minutes of fcv with an evone respirator (ventinova medical b.v., eindhoven, the netherlands) and eventually 30 minutes of vcv. every participant will receive the intervention. respiratory rate (rr), positive end-expiratory pressure (peep) and inspiratory fraction of oxygen (fio2) will be held constant. according to the manufacturers guidelines, an i:e ratio of 1:1 will be pursued during fcv. during fcv, the respirator will be set with the same pip as during baseline pcv. for vcv, the same tidal volume as during baseline pcv will be set.


Eligibility criteria:
inclusion criteria: * p/f-ratio: 100-200 (moderate ards) * spo2 88-94% * pao2 60-80 mmhg * covid-19 positive on a pcr test exclusion criteria: * bmi \> 40 kg/m² * prone ventilation * already invasively mechanically ventilated for more than 10 days * refusal to participate

Keywords: flow controlled ventilation (fcv)
exercise effects on adipose tissue structure and function

Conditions: Obesity; Metabolic Syndrome; Metabolic Disease; Insulin Resistance; Weight Loss; Weight Gain

Summary: participants will be randomized into one of two different experimental groups: 1) exercise group and 2) no exercise (control group). subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). after completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases. overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). the research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain). participants will be randomized into one of two different experimental groups: 1) exercise group and 2) no exercise (control group). subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). after completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. after the participant completes the study, the study team will help the participant to lose more weight. total involvement in the study for each participant will likely be about 8-10 months.

Eligibility criteria:
inclusion criteria: * age: 18-40 * body mass index: 27-45 kg/m2 * no regularly planned exercise/physical activity for at least 6 months * women must have regularly occurring menses and must be premenopausal exclusion criteria: * evidence/history of cardiovascular or metabolic disease * medications known to affect lipid or glucose metabolism, or inflammation * weight instability ≥ ± 6 pounds in the last 3 months * tobacco or e-cigarette users * women must not be pregnant or actively lactating
study of specimens obtained during epilepsy surgery

Conditions: Epilepsy

Summary: this study will collect brain tissue samples for research purposes from patients undergoing surgery to treat epilepsy. the standard surgical procedure for medically intractable epilepsy i.e., epilepsy that cannot be controlled with medicine requires removal of more brain tissue than is needed for diagnostic study. this extra tissue, which would otherwise be discarded, will be used for research purposes. in addition, a blood vessel in the scalp, called the superficial temporal artery, is also normally cut during surgery, and a piece of this vessel will be taken for research use. patients 4 years of age or older who undergo surgery for medically intractable epilepsy may be eligible for this study. brain tissue collected under this protocol will be used for studies of brain cells in other diseases and of serotonin receptors. any remaining brain tissue will be frozen for use in future research. the superficial temporal artery will be used for comparison with carotid arteries (a neck artery that supplies the brain) from patients with blockage of this blood vessel.

this is a protocol to perform research studies on tissues that are removed in the operating room during surgical procedures for drug resistant epilepsy. our aim is to acquire and supply useful tissue specimens for intramural nih research projects. the investigators will evaluate participants with medically intractable drug resistant epilepsy who are considered for surgery to determine whether surgical specimen may be available for this protocol. surgery and standard care for these participants will be performed under a separate protocol, 11-n-0051 epilepsy surgery. the intent of this protocol is solely for procuring tissue that is resected for standard clinical care during surgery. this protocol is not designed to test any new treatments. these are the research aspects of the protocol: 1) any brain tissue that is removed and is not required for diagnostic studies will be used for laboratory studies, consistent with institutional guidelines. 2) blood tests to test for immune and inflammatory mediators will be performed. 3) saliva will be collected to test for immune and inflammatory markers.

Eligibility criteria:
* inclusion criteria: to be eligible for entry into the study, candidates must meet al the following criteria: 1. be 4 years of age or older. 2. able to give informed consent, or, assent if a child. 3. have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-n-0051 epilepsy surgery. exclusion criteria: candidates will be excluded if they: 1. are not a surgical candidate as specified in appropriate protocols.

Keywords: serotonin receptor cell culture temporal lobe endothelial cells superficial temporal artery natural history epilepsy intractable epilepsy