Kornimate/medical-research-clean huggingface dataset:
a clinical pharmacology trial of brexpiprazole long acting injectable (lai) administered as a single dose in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the pharmacokinetics (pk), tolerability and safety of brexpiprazole lai following a single administration in subjects with schizophrenia.


Eligibility criteria:
inclusion criteria: * japanese patients who are between 18 and 64 years of age, inclusive, at the time of informed consent * patients with a diagnosis of schizophrenia as defined by the dsm-5® criteria * patients who are able to remain at the trial site for the protocol-defined hospitalization period * patients with a body mass index \[bmi = body weight (kg) / height (m)2\] of no less than 18.5 kg/m2 and less than 35.0 kg/m2 at screening * patients who are able to provide written informed consent (if the patient is a minor or is hospitalized for medical protection, his or her legally acceptable representative must also give informed consent) prior to commencement of any trial procedure and are judged by the investigator or subinvestigator to be able to meet all protocol-defined requirements exclusion criteria: * patients with a diagnosis of a concurrent mental disorder besides schizophrenia (eg, schizoaffective disorder, major depressive disorder, bipolar i disorder, bipolar ii disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder) as defined by the dsm-5® criteria. however, this exclusion does not apply to caffeine- or tobacco-related disorders. * patients who fail to meet the mandatory washout periods for the prohibited concomitant drugs and foods before commencement of imp administration, or patients who are anticipated to take any of the drugs or foods during the trial period * patients who have received electroconvulsive therapy (ect) within 60 days prior to the administration of imp * patients with clinically significant nervous, hepatic, renal, metabolic, blood, immune, cardiovascular, respiratory, or digestive system disorders however, such patients may be enrolled if the condition is mild or well controlled and is considered to not affect safety or pk evaluations. * patients who have met the dsm-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days prior to the administration of imp * patients with a positive drug test at screening (according to the results from the central laboratory). however, such patients may be enrolled if their condition is not diagnosed as a substance-related or addictive disorder, according to the dsm-5® diagnostic criteria.
exteriorization versus non-exteriorization of the uterus during repair of uterine incision in a repeated cesarean section

Conditions: Intrapartum Hemorrhage

Summary: cesarean section is one of the most frequently performed major operations worldwide. it accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. in egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. in 2015 ,incidence of cesarean section rate in woman health hospital in assiut university is 51.3% of all deliveries. different operational techniques for cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay. also, intraoperative blood loss is one of important complications during cesarean section. a systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. in egypt, prevalence of iron deficiency anemia among pregnant women about 51% of pregnant women. after baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). there had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. the conclusions drawn from these trials have been conflicting.


Eligibility criteria:
inclusion criteria: * pregnant women in 28 weeks * women who will undergo repeated lower segment cesarean section exclusion criteria: * first cesarean section * placenta previa. * rupture uterus. * classical caesarean section.(upper segment cesarean section) * sever preeclampsia. * chorioamnionitis. * prolonged or obstructed labour. * fibroid. * polyhydramnios. * multiple pregnancy.
evorpacept (alx148) in combination with pembrolizumab in patients with advanced head and neck squamous cell carcinoma (aspen-03)

Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Summary: a phase 2 study of evorpacept (alx148) in combination with pembrolizumab in patients with advanced head and neck squamous cell carcinoma.

this is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (alx148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent hnscc that is pd-l1 positive (cps ≥1 by an fda-approved test) and who have not yet been treated for their advanced disease. the study comprises an initial safety lead-in cohort followed by a randomized portion.

Eligibility criteria:
inclusion criteria: * patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (hnscc) that is pd-l1 positive (cps \> 1) and who have not received prior systemic therapy for their advanced disease. * adequate bone marrow function. * adequate renal and liver function. * adequate ecog performance status. exclusion criteria: * patients with known symptomatic cns metastases or leptomeningeal disease requiring steroids. * history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * prior treatment with any anti-cd47 or anti-sirpα agent. * prior treatment with anti-pd-1 or pd-l1.

Keywords: alx148 cd47 sirpα hnscc pembrolizumab evorpacept
addressing emotional and cognitive factors in behavioral weight loss treatment (part 2)

Conditions: Overweight; Obesity

Summary: behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. current treatment approaches do not adequately address these antecedents. the aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. the study targets men and women with bmi of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. the study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. the long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.


Eligibility criteria:
inclusion criteria: * age between 21 and 70 years * body mass index between 27 and 40 * score 5 or above on the internal disinhibition scale of the eating inventory exclusion criteria: * are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months * are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire (par-q). individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.

Keywords: weight loss
cytokine adsorption in sepsis and acute kidney injury

Conditions: Renal Insufficiency or Renal Failure &or End-stage Renal Disease

Summary: aim of the study is to reduce the incidence of rifle stadium l and e after acute kidney injury in patients with severe sepsis/septic shock

patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (rifle i) or kidney failure (rifle f), were randomized in two groups. one group is treated with cvvhd/ local citrat anticoagulation (standart clinical practice). the other group ist treated with an additional cytokine adsorber ( 300ml cytosorb device, 3804606ce01) cytosorb therapy is performed for 24h, then the adsorber is changed into a new device. cytosorb therapy is stopped, when interleukin 6 leves drop below 1000 pg/ml in patient serum.

Eligibility criteria:
inclusion criteria: * severe sepsis or septic shock according to esicm guidelines not older than 24 h exclusion criteria: * preexisting renal disease kdigo stadium 4 and 5

Keywords: sepsis, acute kidney injury , cytosorb
comparison between remifentanil target-controlled infusion and dexmedetomidine bolus administration for smooth emergence from general sevoflurane anesthesia

Conditions: Thyroid Neoplasm

Summary: remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. the investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.


Eligibility criteria:
inclusion criteria: * female patient, * aged 20-60 yr, * asa physical status 1-2, * patients undergoing elective thyroidectomy under general anesthesia exclusion criteria: * sighs of difficult airway, * history of respiratory disease or chronic cough, * cardiovascular disease, * pregnant or breast-feeding woman.

Keywords: dexmedetomidine remifentanil target-controlled infusion
study "hemorroidal surgery and chronic inflammatory bowel disease"

Conditions: Hemorrhoids; Chronic Inflammatory Bowel Disease

Summary: hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (ibd). patients with crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. in addition, patients with ibd (crohn's or rectocolitis haemorrhagic, uc) may have rectal involvement. in both cases, hemorrhoidal surgery can be harmful to the anorectal level. however, recent data from the literature has proven to be reassuring. indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with ibd, especially when the disease is quiescent. the main objective is to assess the morbidity of hemorrhoidal surgery in ibd patients who have been operated on at our center. postoperative complications will be the main elements sought in the study. the secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with ibd. this requires an exhaustive collection of clinical data.


Eligibility criteria:
inclusion criteria: * patient whose age is ≥ 18 years * patient with ibd (crohn's or uc) with a diagnosis prior to hemorrhoidal surgery * patient operated on for hemorrhoidal surgery performed between november 1, 2013 and july 7, 2020 in our center * french-speaking patient exclusion criteria: * patient with severe inflammatory disease * patient with ano-perineal involvement of crohn's disease * patient under guardianship or curatorship * patient deprived of liberty * patient under legal protection * patient objecting to the use of their data for this research
matrix metalloproteinase (mmp) in heart failure

Conditions: Chronic Stable Heart Failure

Summary: the purpose of this study is to evaluate the production of mmp in failing hearts.

myocardial fibrosis is observed in failing hearts and parallel to the progression of chronic heart failure (chf) and myocardial remodeling. matrix metalloproteinases (mmps) are considered markers of fibrosis. recently, circulating mmps can be measured and are elevated in patients with chf. however, mmps it is still unclear whether mmps are produced in failing hearts. thus, the purpose of this study is to evaluate the production of mmp in failing hearts.

Eligibility criteria:
inclusion criteria: * chronic stable heart failure

Keywords: heart failure mmp coronary sinus
role of early point of care ultrasound in management of sepsis in emergency department

Conditions: Sepsis

Summary: aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management .

two groups of patients will be studied one group will undergo pocus examination and the other will not undergo pocus examination then comparison between them will be done regarding accuracy of diagnosis and time taken to reach diagnosis.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the emergency department (ed) of alexandria main university hospital (amuh) with sepsis. * patients presented with septic shock. exclusion criteria: * age less than 18 * trauma patients. * pregnant females. * patients with terminal malignancy. * patients taking immunosuppressive drugs or chemotherapy.

Keywords: point of care ultrasound sepsis emergency department
comparison of ctg and t-prf on peri-implant soft tissue

Conditions: Peri-implant Mucositis; Peri-Implantitis; Thin Gingiva

Summary: the present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the ctg or t-prf membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. the null hypothesis was that t-prf used simultaneously with implant placement can be considered an alternative to ctg.

although connective tissue graft (ctg) is considered as the best technique for soft tissue augmentation, limited supply of donor tissue because of palatal vessels and nerves, and postoperative pain may require alternative methods. the purpose of this study is to reduce the crestal bone resorption around the implant site by augmenting the peri-implant soft tissue with t-prf (titanium prepared platelet-rich fibrin) or ctg and to compare the effectiveness of the two techniques. through simultaneous augmentation of the soft tissue by t-prf or ctg, a total of 30 implants were implanted in 30 patients (12 males, 18 females) with a mean age of 38.4 years. in the test group, implants were placed in thin tissues and thickened with t- prf membrane at the same time, while in the control group, implants were placed in thin tissues and thickened with ctg at the same time. during the surgery (t 0 ) and at postoperative 3 months (t 1 ), keratinised tissue width (ktw) and peri-implant soft tissue thickness (stt) were measured from three points: occlusal part of the alveolar crest (oac), midbuccal mucosa level (mbml), and over 1 mm of mucogingival junction (mgj1).

Eligibility criteria:
inclusion criteria: * patients older than 18 years, * thin gingiva biotype, * one missing tooth in the incisor, canine and premolar area and presence of two natural adjacent teeth * no bone increasing procedures prior to and during dental implant, exclusion criteria: * history of a bleeding disorder or on anticoagulant therapy, * immunocompromised state and debilitating disease, * smoking and alcoholism, * poor oral hygiene, * diabetes.

Keywords: clinical research implant implantology prospective randomized controlled trial soft tissue grafting single-tooth implants
feasibility trial of getting better bite by bite for eating disorders

Conditions: Eating Disorders; Bulimia Nervosa; Binge-Eating Disorder

Summary: this is a mixed method feasibility randomized controlled trial to explore the feasibility and acceptability of therapist delivered, culturally adapted, manualized ca-gbbb intervention for eating disorders (eds) - bulimia nervosa (bn) and bing eating disorder (bed) in pakistan.

evidence on psychological management of eating disorders in low and middle income countries ( lmics) is limited, and non-existent in pakistan. a cognitive behaviour therapy (cbt) based guided self-help manual "getting better bite by bite: a survival kit for sufferers of bulimia nervosa and binge eating disorders" (gbbb), has found to be feasible and acceptable for patients with bn. quantitative phase of this research aims to determine if the culturally adapted gbbb (ca-gbbb) programme is feasible and acceptable for individuals with eating disorders- bn and bed compared to treatment as usual. the qualitative part of the study will include focus groups and in-depth digitally recorded one-to-one interviews with participants by trained qualitative researchers at two time points both before and after the intervention. these focus groups and in-depth interviews will continue till the data saturation is achieved. moreover, in-depth digitally-recorded interviews with stakeholders (nutritionists, dietitian, educationist, therapists, health professionals, etc) will also be conducted by trained researchers.

Eligibility criteria:
inclusion criteria: 1. age18 years 2. screen positive on the binge eating screening questionnaire and/or bulimic investigatory test, edinburgh 3. residents of the study catchment area 4. able to provide informed consent exclusion criteria: 1. aged under 18 2. presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments. 3. temporary resident unlikely to be available for follow-up

Keywords: getting better bite by bite (gbbb) culturally adapted intervention low resource settings pakistan eating disorders feasibility study
bioimpedance evaluation of therapeutic titration in essential, refractory hypertension

Conditions: Hypertension

Summary: to determine whether impedance cardiography (icg) parameters can predict favorable or unfavorable blood pressure (bp) response and time to bp control prior to initiation or intensification of specific antihypertensive drug classes and drug combinations, independent of initial bp levels.

* patients with higher vascular resistance index and/or lower arterial compliance index will lower bp faster and to a greater degree overall when receiving vasodilating agents - such as acei's, arb's, dihydropyridine ccb's, direct vasodilators, and central alpha agonists. * patients with an elevated cardiac index will lower bp faster and to a greater degree overall when receiving agents that reduce contractility, heart rate, or blood volume - such as beta blockers, non-dihydropyridine ccb's, and other agents that are known to reduce cardiac index. * patients with an elevated thoracic fluid content or lower orthostatic change in thoracic fluid content will lower bp faster and to a greater degree overall when receiving diuretics (thiazide, loop, potassium sparing), however - one of these agents will emerge as a superior alternative to reduce bp in patients with high thoracic fluid content / low orthostatic change in thoracic fluid content.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * able to provide written consent * meet jnc definition of hypertension * lab results with 6 months for: serum creatinine, urine albumin/creatinine ratio, and at least one of the following: serum glucose, or glycated hemoglobin, or hemoglobin a1c exclusion criteria: * active cardiovascular disease (unstable angina, stage c or d heart failure, uncontrolled superventricular arrhythmia, hx of ventricular arrhythmia, stroke or tia within 6 months, acs within 6 months) * implantation of activated ventricular pacemaker * known hypersensitivity or allergy to sensor gel or adhesives * skin lesions prohibiting sensor placement

Keywords: hypertension
alcohol and gender effects on stress circuit function

Conditions: Alcoholism; Stress; Alcohol Dependence

Summary: the purpose of this study is to look at the stress hormone response to medication-induced stress and a placebo (an inactive compound) in non-drinking, recovering male and female alcoholics, with a specific emphasis on the differences between men and women in the two recovering alcoholic groups.

women and men differ in the ways stress affects the development and maintenance of alcoholism. however, no published studies in alcohol dependent patients have examined sex differences in stress responsiveness that most likely mediate these effects and influence the clinical course and treatment of the disorder. the long-range goal of this research program is to define aspects of the neural, genetic and environmental mechanisms differentially regulating the stress response in alcohol dependent women and men. the proposed study extends prior work revealing sex-dependent alterations in basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. our central hypothesis is that sex differences in serotonin function or hpa sensitivity conspire with genetically influenced alterations in serotonin signaling to produce maladaptive stress responses in some alcoholic women. these altered stress responses may serve as the target of novel, sex-specific pharmacotherapies.

Eligibility criteria:
inclusion criteria: * able to provide written consent. * are actively engaged in a recovery program for alcoholism; * have a current (within the past 12 months) diagnosis of dsm-iv alcohol dependence in early- (modified to a minimum of 4 months) full remission; and * are residing in a controlled sober living environment; and * agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only). exclusion criteria: * have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease; * are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone); * are pregnant, or planning to become pregnant during the next 9 months; * have taken other psychotropic drugs (including ssris, mao inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session; * have taken any investigational drug within 90 days of the first laboratory session; or * are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.

Keywords: alcoholism stress gender differences addiction alcohol dependence