Kornimate/medical-research-clean huggingface dataset:
comparison between combined allr with single bundle and double bundle anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Reconstruction

Summary: the goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (acl) injuries. the main questions it aims to answer are: * what are the optimal criteria for selecting between single-bundle acl reconstruction combined with anterolateral ligament (all) reconstruction versus double-bundle acl reconstruction combined with all reconstruction? * how do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates? participants will: * undergo pre-operative mri imaging, ligament stability testing, and motion analysis evaluations * be randomly assigned to either: * single-bundle acl + all reconstruction * double-bundle acl + all reconstruction * receive the assigned surgical procedure * participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year researchers will compare the single-bundle acl + all group and the double-bundle acl + all group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower acl re-tear rates.

anterolateral ligament(all) combined with anterior cruciate ligament reconstruction(acl) has become more and more popular in recent years, as all could protect the acl graft in tibial internal rotation, and prevent the acl graft from rupture. cottet et al. proposed a minimal invasive method with y-figure construct of all, without acquiring additional graft from the patient. their data showed significant lower graft re-rupture rate and faster return-to-sport(rts). there are many different techniques of acl combined all reconstruction. while these methods mostly are single bundle acl combined all reconstruction. previous cadaver studies told that the anterior cruciate ligament is composed of anteromedial and posterolateral bundle. it had been debated between single bundle and double bundle acl reconstruction for years. as a result, it is meaningful to compare the clinical outcomes between all combined with single bundle or double bundle acl reconstruction. our studies included mri image, arthrometer measurement and optical motion capture system. we hope to compare the clinical outcomes and sports function between a: single bundle acl combined all reconstruction and b: double bundle acl combined all reconstruction.

Eligibility criteria:
inclusion criteria: * patients plan to receive acl surgery * at least 18 years old exclusion criteria: * presented history of the injured leg or congenital abnormality

Keywords: anterior cruciate ligament anterolateral ligament single bundle double bundle optical motion capture graft rupture
safety and efficacy of obatoclax mesylate (gx15-070ms) in the treatment of hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. obatoclax is designed to restore apoptosis through inhibition of the bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. this is a multi-center, open-label, phase ii study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with relapsed or refractory hodgkin's lymphoma. infusions may be administered on an out-patient basis. no investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. supportive care measures including those directed at controlling symptoms resulting from hodgkin's lymphoma (blood products, growth factor, etc.) are allowed.


Eligibility criteria:
inclusion criteria: * pathological confirmation of hodgkin's lymphoma. * must have measurable disease. * evidence of progressive disease following at least one prior line of combination therapy. * must have failed, refused, or otherwise not a candidate for stem cell transplant. * patient's must have normal organ function. * willing to submit to blood sampling for planned pk and pd analyses. * ability to understand and willingness to sign a written informed consent form. exclusion criteria: * no other agents or therapies administered with the intent to treat malignancy. * patients with prior exposure to obatoclax. * prior allogeneic stem cell transplant if evidence of graft versus host disease, or requirement for steroids or other immunosuppressive therapy. * uncontrolled, intercurrent illness. * pregnant women and women who are breast feeding.
michigan sparc trial

Conditions: Alcohol; Drinking; Alcohol Use Disorder (AUD)

Summary: unhealthy alcohol use is a major contributor to morbidity and mortality in the us. although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (auds) can be provided in primary care (pc), they have historically not been included in routine services. as a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (sbi), but efforts to increase treatment of auds with medications have been less successful. moreover, implementation efforts have usually neglected smaller pc practices, in which most pc is provided. the michigan sparc trial is a partnership between kaiser permanente washington health research institute (kpwhri) in seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and altarum institute in ann arbor, michigan, bringing demonstrated success engaging over 500 small to medium michigan-based pc practices in effective quality improvement (qi) efforts. the project builds on altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (cme/moc) programs to pc providers, along with ongoing support for qi using evidence-based implementation strategies. the kpwhri team recently finished the highly successful ahrq-funded sustained patient-centered alcohol-related care (sparc) trial using similar implementation strategies in kp washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or auds and their pc providers. the michigan sparc trial combines altarum's expertise in qi in small-medium pc practices in michigan with kpwhri's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol sbi and medication treatment for auds. specific aims of the michigan sparc trial had to be markedly modified due to the trial beginning in march 2020 at the same time as the covid pandemic. a trial was not possible. the revised aims were to describe alcohol screening, brief intervention, aud diagnosis and initiation of medication treatment for aud, before and after the michigan sparc model was implemented, in small to medium pc practices in michigan.


Eligibility criteria:
inclusion criteria: * adults age 18 years and older * seen in primary care at a study practice during the practice's study period exclusion criteria: • none

Keywords: alcohol misuse unhealthy alcohol use alcoholism alcohol dependence alcohol abuse risky drinking
cefepime and unictam on preventing post-cesarean surgical site infections

Conditions: Cesarean Section; Infection

Summary: the aim of this study is to evaluate the efficacy of employing cefepime (cfm) versus ampicillin/sulbactam (ams) in lowering the rate of post-cesarean surgical site infections.

a prospective randomized clinical study conducted in the department of obstetrics and gynecology of beni-suef university hospital . a total of 213 women were assessed for eligibility, 13 of which were excluded. a total of 200 pregnant women who were eligible for elective cesarean sections (cs). the overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (ssi).

Eligibility criteria:
inclusion criteria: * pregnant women within age group more than18 years. * pregnant women with elective cesarean delivery. * previous and primary cesarean delivery. exclusion criteria: severe hepatic disease women emergent cesarean deliveries. women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia. women who had a skin infection adjacent to the operative site.

Keywords: surgical site infection cefepime
sensor-augmented pump versus multiple daily injections with degludec as basal insulin for insulin therapy in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: several studies have shown that continuous subcutaneous insulin infusion together with continuous glucose monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec. this study will assess the efficacy and safety of continuous subcutaneous insulin infusion (csii) combined with continuous glucose monitoring (cgm), as compared to multiple daily injections (mdi) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (smbg) in patients with type 1 diabetes. a crossover design was chosen in order to minimize study sample improving statistical power.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * duration of diabetes \> 2 years * current treatment with mdi, using insulin analogues as bolus and basal insulin * hba1c\<64 mmol/mol exclusion criteria: * hba1c\>64 mmol/mol * pregnancy or lactation
drug intervention in chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome

Summary: based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (cfs) patients may benefit from b-cell depletion therapy. the hypothesis is that at least a subset of cfs patients have an activated immune system involving b-lymphocytes, and that b-cell depletion may alleviate symptoms.


Eligibility criteria:
inclusion criteria: * verified chronic fatigue syndrome (cdc-criteria) * age \>18 and \<60 years * informed consent exclusion criteria: * pregnancy or lactation * previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ * previous long-term use of immunosuppressive drugs * previous exposure to rituximab * endogenous depression * multi-allergy with risk of serious drug reaction * reduced renal function (creatinin \> 1.2 x unl) * reduced liver function (bilirubin or transaminases \> 1.5 x unl) * known hiv infection * signs of active viral infection by pretreatment investigations

Keywords: chronic fatigue syndrome cfs myalgic encephalomyelitis rituximab b-lymphocyte depletion b-cell depletion
a study to evaluate pf-06730512 in adults with focal segmental glomerulosclerosis (fsgs)

Conditions: Focal Segmental Glomerulosclerosis (FSGS)

Summary: the purpose of this phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of pf-06730512 following multiple intravenous infusions in adult subjects with fsgs.


Eligibility criteria:
inclusion criteria: 1. adults age 18 years and older who have a confirmed biopsy diagnosis of fsgs. 2. estimated glomerular filtration rate (egfr) greater than or equal to 45 ml/min/1.73 m2. if egfr is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to screening) must demonstrate \< 50% tubulointerstitial fibrosis. 3. urine protein:creatinine ratio (upcr) greater than 1.5 g/g at screening. 4. treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment. exclusion criteria: 1. diagnosis of collapsing fsgs. 2. advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis. 3. organ transplant. 4. history of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years. 5. body mass index (bmi) greater than 45 kg/m2. 6. subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mtor inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.

Keywords: proteinuria
bright light therapy for non-motor symptoms in parkinson's disease

Conditions: Parkinson's Disease

Summary: disruption of sleep and alertness is one of the most disabling non-motor symptoms of parkinson's disease (pd). mechanisms leading to impaired sleep and alertness in pd are not well understood, and treatment options remain limited. the proposed research will examine markers of the circadian system, sleepiness and sleep quality in pd patients. further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in pd.


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic pd as defined by the united kingdom pd society brain bank criteria 2. pd hoehn and yahr stage 2-4 3. pittsburgh sleep quality index (psqi) score ≥ 5 4. treatment with levodopa and/or dopamine agonist; adjunctive pd medications will be allowed 5. stable dose of pd medications for at least 4 weeks prior to the study screening. exclusion criteria: 1. atypical or secondary forms of parkinsonism 2. co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep) 3. co-existent restless legs syndrome (rls), as assessed by the international classification of sleep disorders (icds) diagnostic criteria for rls 4. cognitive impairment as determined by the mini-mental state examination (mmse) score of ≤ 26 5. presence of depression defined as the beck depression inventory (bdi) score \>14 6. untreated hallucinations or psychosis (drug-induced or spontaneous) 7. use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed 8. use of selective serotonin reuptake inhibitors (ssris) / serotonin-norepinephrine reuptake inhibitors (snris) antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening 9. use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists 10. shift work, currently or within the prior 3 months 11. travel through ≥ 2 time zones within 60 days prior to study screening 12. hematocrit \<32 mm3 13. pre-existing glaucoma/retinal disease contraindicated for light therapy (lt) 14. dense cataracts 15. use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, st. john's wort) 16. unstable/serious medical illness. 17. pregnancy

Keywords: parkinson's disease excessive daytime sleepiness circadian rhythms light therapy
effect of resveratrol administration on metabolic syndrome, insulin sensitivity and insulin secretion

Conditions: Metabolic Syndrome X

Summary: the metabolic syndrome is a high prevalence disease worldwide. about a quarter of the adult population suffers the disease. resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in polygonum cuspidatum. there is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight. the aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion. the investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

a randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the international diabetes federation (idf). waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load. 12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months. the remaining 12 patients received placebo with the same prescription. area under the curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (stumvoll index) and insulin sensitivity (matsuda index). this protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. results are presented as mean and standard deviation. intra and inter group differences were tested using the wilcoxon signed-rank and mann-whitney u-test respectively; p≤0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * patients both sexes * age between 30 and 50 years * metabolic syndrome according to the idf criteria * waist circumference * man ≥90 cm * woman ≥80 cm * and two of the following criteria: * high density lipoprotein * man ≤40 mg/dl * woman ≤50 mg/dl * fasting glucose ≥100 mg/dl * triglycerides ≥150 mg/dl * blood pressure ≥130/85 mmhg * informed consent signed exclusion criteria: * women with confirmed or suspected pregnancy * women under lactation and/or puerperium * hypersensibility to resveratrol * physical impossibility for taking pills * known uncontrolled renal, hepatic, heart or thyroid diseased * previous treatment for the metabolic syndrome components * body mass index ≥39.9 kg/m2 * fasting glucose ≥126 mg/dl * triglycerides ≥500 mg/dl * total cholesterol ≥240 mg/dl * low density lipoprotein (c-ldl) ≥190 mg/dl * blood pressure ≥140/90 mmhg

Keywords: metabolic syndrome central obesity resveratrol insulin secretion insulin sensitivity
strain echocardiography during septic shock : an observational pilot study

Conditions: Shock, Septic; Echocardiography

Summary: the mortality of septic shock remains high nowadays despite a trend toward improvement.septic cardiomyopathy has been reported in most experimental models of sepsis shock. its relationship with mortality is unclear. a decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (lvef), but a recent meta-analysis did not support such results. in fact, it appears that high lvef are linked to profound vasoplegia which is associated to bad outcome. in the other hand, alterations of strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. moreover, the right ventricular strain was reported only by orde et al whereas the evolution of strain during fluid infusion have never been studied. the aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.


Eligibility criteria:
inclusion criteria: * septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min) * inclusion within the first 24h of septic shock exclusion criteria: * patient \< 18 year of age * pregnant women * history of myocardial infarction, valvular disease, atrial fibrillation

Keywords: shock, septic echocardiography speckle tracking strain
aloe vera and chlorhexidine against traumatic oral ulcers

Conditions: Oral Ulcer

Summary: the development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. the use of chemical agents such as chx, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment. the objective of this study was to determine the efficacy of aloe vera gel at 80% compared to 0.12% chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. a total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with aloe vera gel versus the conventional chlorhexidine gel with a sample of 70 subjects in each group participated. the index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.


Eligibility criteria:
inclusion criteria: * patients who have just begun orthodontic treatment after bracket cementation. * be willing and have signed the informed consent. * presence of cemented metal brackets throughout the upper and lower arches. * presence of good oral health: dental, periodontal and soft tissue exclusion criteria: * allergic or who have suffered adverse reactions to chlorhexidine or aloe vera. * pregnant, since they are not claimants of fixed multibrackets appliances. * presence of auxiliary extraoral appliances during the treatment that may cause additional injuries. * under 11 years old.
a multicenter case-control study of risk factors for premature ejaculation in china's shaanxi province

Conditions: Premature Ejaculation

Summary: through a multicenter case-control study on the risk factors of premature ejaculation in shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners.


Eligibility criteria:
inclusion criteria: * 1) case group 1. 18-64 years old, regular sexual life \> 6 months; 2. self-report of premature ejaculation; 3. able to complete questionnaires and scale scores independently. 2) control group 1. 18-64 years old, regular sexual life \> 6 months; 2. both partners are satisfied with their sexual life; 3. able to complete questionnaires and scale scores independently. exclusion criteria: * 1) case group 1. those who are unable to have sex due to genital malformation; 2. patients with serious cardiovascular and cerebrovascular diseases; 3. severe mental disorders (history of epilepsy, mania, etc.); 4. have a history of brain trauma; 5. people with a long history of substance abuse. 2) control group 1. patients with a history of mental illness; 2. oral selective serotonin (5-ht) reuptake inhibitors, tricyclic antidepressants, triazolidine antidepressants, tramadol and sedatives

Keywords: risk factor