Kornimate/medical-research-clean huggingface dataset:
(d)elayed vs. (e)arly (l)aparoscopic (a)ppendectom(y)

Conditions: Appendicitis

Summary: the delay trial will compare immediate (\< 6 hours from decision to operate) to delayed (surgery to take place the following morning) appendectomy in adult patients presenting to the emergency department with suspected acute appendicitis. the primary outcome will be 30 day postoperative complications.

this randomized controlled trial is designed to assess the effect of timing of surgery on surgical complications in patients undergoing appendectomy for acute appendicitis at one of two participating institutions. early appendectomy in patients diagnosed with acute appendicitis has been a mainstay of treatment. timely intervention is recommended to avoid the risks associated with perforated appendicitis, which has been shown to increase the risk of post-operative complications compared to non-perforated appendicitis. however, some studies have suggested that delaying appendectomy does not increase complications. several studies have also assessed the safety of nighttime operating with conflicting results. some suggest that delaying surgery until daytime is safe. this study is a prospective, randomized controlled trial with blinding of the outcome assessors. eligible participants will be adult patients diagnosed with acute appendicitis with an expected operative start time between 2000-0400. patients randomized to the intervention group will have delayed surgery after 0530 the following morning to avoid nighttime operating. patients randomized to the control group will receive immediate surgery within 6 hours of the decision to operate. the follow up period will be a minimum of 30 days. independent outcome assessors will assess patients during their postoperative course in hospital as well as in the outpatient follow up clinic. the primary outcome for this study is complication occurring within 30 days of surgery. complication includes any of the following: mortality, readmission to hospital, emergency department (ed) visit, percutaneous drain insertion, reoperation, prolonged hospital stay greater than 7 days, and a predefined list of postoperative complications. secondary outcomes include perforated appendicitis, operative time, and length of stay.

Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age * imaging confirmed diagnosis of appendicitis (ultrasound or ct or mri) * expected time of operation between 2200 - 0400 and occurs within 6 hours of the decision to operate exclusion criteria: * patients with hemodynamic instability * patients with suspected sepsis * unknown diagnosis * presence of abscess on ct scan * diagnosis of missed appendicitis * pregnancy * patients who are not surgical candidates * patients who are not competent to sign consent
study of the effects of sb 480848 (darapladib) on the electrical conduction of the heart

Conditions: Atherosclerosis

Summary: this is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. this a four period crossover design with each period lasting about 10 days. there will be a 7 to 10 day wash out in between each period.


Eligibility criteria:
inclusion criteria: * healthy * body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30 * signed and dated written informed consent prior to admission to the study * subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions exclusion criteria: * cardiac abnormalities * history of asthma or severe allergic reactions * history of alcohol or drug abuse * use of prescription or non-prescription drugs or vitamins or herbal supplements * history of cholecystectomy or biliary tract disease * pregnant or nursing women * history of allergy to the study drugs

Keywords: darapladib moxifloxacin qt study
evaluation of alveolar augmentation using tunneling surgical technique

Conditions: Bone Atrophy

Summary: patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing mpm as bone graft and patients followed up for 14 weeks .


Eligibility criteria:
inclusion criteria: * patients' age range from 18-60 years. * patients with horizontal bone defect in anterior maxillary area. * patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome. exclusion criteria: • patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).
bronchial response to mannitol and inflammation in steroid naive asthmatics.

Conditions: Asthma

Summary: study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

Eligibility criteria:
inclusion criteria: * steroid naive asthma. * non-smoker exclusion criteria:
cognitive behavior therapy (cbt) compared to stress management for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the study aims to compare two manualized treatments. they are based on cognitive behavior therapy or stress management. both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. the treatments last for 10 weeks. approximately 200 patients will be included in the study and randomized to either condition. the study hypothesis is that cbt will be superior to stress management on the main outcome measure, which is ibs symptom severity measured over 4 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of ibs given by physician * at screening fulfilling rome iii-criteria for ibs exclusion criteria: * severe depression * suicidal ideation * presence of unexplained ibs alarm symptoms

Keywords: cognitive behavior therapy exposure stress management
almond milk with vitamin d: impact on vitamin d status

Conditions: Renal Insufficiency, Chronic; Kidney Failure, Chronic

Summary: the overall goal is to enhance vitamin d status in a safe and effective manner. a 3-week randomized comparator-controlled trial among a cohort of adults with ckd (stages 3-5) (n=24) will test the main objective: evaluate the bioefficacy of d3 in micro- and nanoparticles (4000ius) in almond milk with the sub-objective of: explore the effect of d3 in micro- and nanoparticles (4000ius) in almond milk on inflammation markers crp, tnf-α and il-6.


Eligibility criteria:
inclusion criteria: * adults who have been diagnosed with ckd * have no gi disorders or gi disturbances * age 18 years or older * no food allergies or dietary restrictions * all with no contraindications to consuming anything by mouth as per their physician exclusion criteria: * no diagnosis of ckd * gi disorders * gastrointestinal disturbances * under 18 years old * food allergies to almonds * dietary restrictions as medically indicated * trouble chewing/swallowing as confirmed by physician
progression of diabetic retinopathy post bariatric surgery (bs)

Conditions: Obesity; Diabetes Mellitus

Summary: studies conducted assessing diabetic eye disease have shown a progression of diabetic retinopathy with rapid improvement of glycemic control during pregnancy and in patients with type 1 diabetes. it is also well documented that bariatric surgery may result in rapid improvement of glycemic control in obese patients with type 2 diabetes. to our knowledge the progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been studied in obese type 2 diabetics undergoing bariatric surgery. to this end, this study will examine the effects of rapid glycemic control which is seen in type 2 diabetics following bariatric surgery on the progression of diabetic retinopathy.

participants will be referred from the department of bariatric surgery at nyu. the investigators plan to enroll 50 patients in this pilot study. a baseline eye exam will be conducted prior to surgery. data, such as preoperative hba1c level, weight, bmi, duration and control of diabetes, current medication regimen, and the grade of retinopathy will be noted. study participants will have a baseline eye exam within three months of the scheduled surgery, followed by regular follow-up visits at 3 months, 6 months, 9 months, and 1 year. at each visit the following measures will be assessed: (1) weight, (2) blood pressure, (3) glycemic control as assessed by hba1c, (4)level of retinopathy, and (5) visual acuity using the edtrs acuity chart. the eye examinations will consist of a measure of best-corrected visual acuity, slit lamp examination to assess pressure, and a dilated funduscopic examination to determine the presence and/or level of retinopathy. the level of retinopathy will be characterized as: (0)none, (1) mild, (2) moderate, (3) severe, and (4) proliferative. in addition, the presence or absence of cystoid macular edema (cme) will be noted as (a) no cme or (b) cme present. at the initial visit, a baseline questionnaire will be given to participants to gather background information on demographics and pertinent medical history. during each follow up visit, an additional questionnaire will be given to monitor changes in factors such as medications, blood pressure, and weight that may occur after bariatric surgery. hba1c measurements will be checked every 3 months in accordance with current standard of care recommendations. due to established evidence of rapid improvement in glycemic control shortly after bariatric surgery, it is essential that the investigators have this lab data and perform funduscopic examinations at these intervals, to monitor improvement in glycemic control ascertain associations between changes in hba1c levels and progression of retinopathy.

Eligibility criteria:
inclusion criteria: * all patients, both male and female greater than 18 years old, with type 2 diabetes referred for bariatric surgery. exclusion criteria: * patients will not be included in the study if they are pregnant, have hiv or any retinal vascular diseases (e.g. brvo, crvo) besides retinopathy.

Keywords: obesity type 2 dm
phacoemulsification combined with intravitreal injection of ranibizumab prevent postoperative capillary non-perfusion zone progress in non-proliferative diabetic retinopathy

Conditions: Mild Non-proliferative Diabetic Retinopathy; Cataract Diabetic; Diabetic Retinopathy

Summary: diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. intravitreal injection of anti-vegf ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (npdr). however, there is no research about phacoemulsification surgery combine intravitreal injection of ranibizumab on diabetic retinopathy. the research focus on the effect of phacoemulsification surgery combine intravitreal injection of ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.

this research is a single-center prospective, randomized controlled study. patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of ranibizumab group. eye examination including visual acuity, intraocular pressure(iop), fundus fluoroscopy, macular optical coherence tomograph（oct） examination, were taken before cataract surgery. the anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. the aqueous humor concentrations of vascular endothelial growth factor（vegf）, interleukin（il）il-2, il-4, and tumor necrosis factor（tnf） were checked by real-time polymerase chain reaction assay（rt-pcr） and elisa analysis. the best corrected visual acuity（bcva）, iop and fundus lesions changes were observed in the two groups after operation. diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent * commitment to follow the research procedures and cooperate with the implementation of the whole process of research * no specific gender, 18+ years old * diagnosed in line with npdr, * phacoemulsification combined with anti-vegf therapy is planned * no obvious surgical contraindications exclusion criteria: * use of other investigational drug treatments or take part in other types of clinical studies * allergy to anti-vegf drugs * patients with other macular and optic disc diseases * patients with meaningful diabetic macular edema * patient with surgical complications

Keywords: phaco vegf diabetic retinopathy
inhaled treprostinil for pah: open-label extension

Conditions: Pulmonary Arterial Hypertension

Summary: open-label extension of rin-ph-302.


Eligibility criteria:
participation and completion of all required visits for study rin-ph-302.
proof of concept study evaluating bp1.3656 in patients with fatigue following ischemic stroke

Conditions: Fatigue

Summary: multicenter, randomized, double blind, parallel-group, placebo-controlled proof of concept study evaluating efficacy and safety of bp1.3656 in patients with fatigue following ischemic stroke.


Eligibility criteria:
inclusion criteria: * males or females 18 years old or more; * diagnosis of ischemic stroke at least one month and not more than six months prior to screening; * persistent fatigue since the stroke with a score ≥ 50 across all domains of the multidimensional fatigue inventory (mfi-20); * modified rankin score (mrs) \< 3; * capability to participate in all study tests according to the investigator; * patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to any study specific procedure; * females of child-bearing potential must have a negative pregnancy test performed at the screening and randomization visits and use a medically accepted effective method of birth control, agree to continue this method for the duration of the study up until three weeks after last treatment intake. exclusion criteria: * any identified etiology for fatigue other than stroke (except post-stroke depression) according to the investigator; * history of psychosis; * current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression, or organic brain syndrome preventing the patients from completing study assessments; * patients at risk of suicide according to the investigator; * major cognitive disorders, dementia according to the investigator; * history of epilepsy or seizures disorder; * history of alcohol or drugs (i.e. cannabis, cocaine, amphetamines or opioids) (ab)use/dependence within the 12 months prior to screening or with a positive drug test at screening; * glomerular filtration rate \<60 ml/min/1.73m² according to chronic kidney disease epidemiology collaboration (ckd-epi) formula; * clinically significant cardiovascular abnormalities (including clinically relevant ecg abnormalities) or, clinically significant hematological, neurological, endocrine abnormalities, severe hepatic impairment or liver function tests (asat, alat) \> 3 uln, or abnormal clinical laboratory results (in most cases \> 3uln); * other active clinically significant illness, infection, acid-related gastric disorder, or neoplastic pathology within the last 3 years (patients with fully cured non-melanoma skin cancer or in-situ carcinoma of the cervix are eligible) which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise his/her study participation.

Keywords: post-stroke fatigue
multicenter and prospective clinical registry study of autoimmune encephalitis in china

Conditions: Autoimmune Encephlitis in China

Summary: in recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. therefore, it is urgent to establish a database of autoimmune encephalitis in chinese population. the prospective clinical trial of atutoimmune encephalitis in china, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.


Eligibility criteria:
inclusion criteria: 1. older than 6 months. 2. encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours; 3. at least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in csf(cerebrospinal fluid inflammatory), changes in eeg (electroencephalogram), radiographic abnormalities; 4. clinical suspected encephalitis, but conventional detected methods cannot make etiology clear. 5. signed the informed consent. exclusion criteria: 1. infants less than 6 months; 2. the metabolic encephalopathy; 3. infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on; 4. non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.
a study to investigate safety and effect of sparsentan in combination with sglt2 inhibition in participants with igan

Conditions: Immunoglobulin A Nephropathy

Summary: this is a 28-week, open-label, multicenter, single-group phase 2 exploratory study to determine the safety and effect of sparsentan in participants with igan who are at risk of disease progression to kidney failure despite being on both stable raasi and sglt2 inhibitor treatment for at least 12 weeks prior to study entry

this is a 28-week, open-label, multicenter, single-group phase 2 exploratory study to determine the safety and effect of sparsentan in participants with immunoglobulin a nephropathy (igan) who are at risk of disease progression to kidney failure (kf) despite being on both stable renin angiotensin aldosterone system inhibitor (raasi) and sodium glucose cotransporter-2 (sglt2) inhibitor treatment for at least 12 weeks prior to study entry. participants who provide written informed consent will be assessed for eligibility and will undergo baseline evaluations including clinical laboratory tests. per the eligibility criteria, all participants are required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (acei) and/or angiotensin receptor blocker (arb) and on a stable dose of a sglt2 inhibitor at screening and will continue their stable treatments through the screening period. eligible participants will discontinue acei and/or arb therapy the day before the day 1 visit and remain on stable sglt2 inhibitor dosing for the duration of the study. study intervention will be administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following day 1. following the 24-week treatment period, study intervention will be discontinued for 4 weeks and standard of care raasi treatment resumed, with a safety visit at week 28.

Eligibility criteria:
inclusion criteria: * aged ≥18 years at the time of signing the informed consent. * biopsy-proven igan. the biopsy may have been performed at any time in the past. * ua/c ≥0.3 g/g at screening * an egfr value of ≥25 ml/min/1.73m2 at screening. * on a stable dose of an sglt2 inhibitor for at least 12 weeks prior to screening. * on a stable dose of acei and/or arb therapy for at least 12 weeks prior to screening that is: * the participant's maximum tolerated dose (mtd), and * at least one half of the maximum labeled dose (mld) exclusion criteria: * igan secondary to another condition or immunoglobulin a (iga) vasculitis. * undergone any organ transplant, with the exception of corneal transplants. * documented history of heart failure, clinically significant cardiovascular or liver disease. * taking high dose (defined as \>10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.

Keywords: igan
primitive immunodeficiency and pregnancy

Conditions: Primary Immune Deficiency

Summary: the management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner. the aim the research is to study the obstetric features and outcome of patients with primary immune defects.

primary immune deficiencies constitute a large group of immune system disorders of genetic origin which can associate, to varying degrees, an increased susceptibility to infections and immunopathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, tumors malignant. although their prevalence remains underestimated, there has been an increase in the number of cases diagnosed in the past 10 years. the national average prevalence is 8.6 patients per 100,000 inhabitants and the diagnostic incidence is 400 new cases per year in france. major improvement in the management of primary immunodeficiencies have drastically changed patients outcome. most patients now reach adulthood and the possibility of carrying out a pregnancy project, that has already reported for patients suffering from hypogammaglobulinemia or variable common immune deficiency, is now increasingly reported for other types of inherited immunodeficiencies. whereas the management of patients with hereditary immunodeficiencies is increasingly codified, contraception and pregnancy have not yet been the subject of recommendations: medical monitoring and the prevention of infectious complications thus remain at the discretion of the practitioner. the aim the research is to study the obstetric experiences of patients with a primary immune deficiency, paying particular attention to infectious complications.

Eligibility criteria:
inclusion criteria: * adult woman with hereditary immune deficits and entered in the reference center for hereditary immune deficits (ceredih, hospital necker-enfants malades, paris) register * patient having reported at least one pregnancy or attempted pregnancy * patient not opposing to participation in research exclusion criteria: - refusal to participate of the study

Keywords: primary immune deficiency obstetric experiences infectious complications pregnancy postpartum contraception
analysis of q10 coenzyme efficacy for long-term treatment of cyclic vomiting syndrome in children

Conditions: Cyclic Vomiting Syndrome

Summary: the main purpose of this study is the comparison of frequency of vomiting episodes (number of episodes per year) observed during the year after the begin of q10 coenzyme treatment to frequency observed during the year before the begin of this treatment in children with cyclic vomiting syndrome. secondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.


Eligibility criteria:
inclusion criteria: * cyclic vomiting syndrome as defined by rome iv criteria * treated with q10 coenzyme treatment for cyclic vomiting syndrome * q10 coenzyme treatment started between january 2000 and july 2006 exclusion criteria: - refusal of processing of personal data reported in patient medical files