Kornimate/medical-research-clean huggingface dataset:
study of safety and immune response of the sm14 vaccine in adults of endemic regions

Conditions: Schistosomiasis

Summary: the clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the valley of the senegal river, a highly endemic area for schistosomiasis. two arms in the study will test different doses of gla-se adjuvant (2.5 and 5 μg). this phase iia in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to s. mansoni or s. haematobium, target population of the vaccine.

a phase 2a trial, self-contained, open-label, randomized, dose-escalation study in two parallel arms receiving three (3) injections at d0, d28, d56; both groups receiving 50 μg sm14 vaccine candidate solution, either combined with 2.5µg gla-se for the first group and 5µg for the second one in adults living in a s. mansoni and s. haematobium endemic area. sm14: recombinant protein produced in yeast following good manufacturing practices (gmp) conditions, presented in vials containing 0.55 ml solution sm14, 0.4 ml solution is diluted with 0.4 ml of gla (synthetic glucopyranosyl lipid a) for intramuscular administration. medical examinations are performed at d0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection. blood analysis: liver function tests - renal function tests - blood counts, at w-1 before inclusion, and then 7 days after each injections and at w13 and w21 during the follow-up. blood samples for immune response analysis at time of each injection, and then w12 and w20.

Eligibility criteria:
inclusion criteria: * adults, male, 18 to 49 years old (inclusive) at the time of inclusion. * living in one of selected villages in saint-louis region (senegal). * free of obvious/severe health problems except schistosomiasis, as established by clinical examination and blood analysis, i.e. hematological exams, liver and renal function tests. * written informed consent to participate obtained * treated with 40mg/kg praziquantel (pzq) before inclusion (w-5 to w-4 before the first injection) in case of infection with s. mansoni and s. haematobium * residence in the area during the period of the study. exclusion criteria: * adult who does not respond to one of the inclusion criteria * current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs. * known hypersensitivity to any component in the sm14 vaccine or history of allergic disease. * knowledge of non-infectious chronic disease * acute disease at time of enrollment. * other conditions which in opinion of the pi may potentially represent a danger for the patient to be enrolled. * non residence in the study area or intent to move during the study period

Keywords: schistosomiasis recombinant vaccine rsm14 gla-se fatty acid-binding protein (fabp) phase ii clinical trial senegal
prevalence of nocturnal hypoventilation in neuromuscular diseases according to different definitions

Conditions: Neuromuscular Disease

Summary: different definitions of nocturnal hypoventilation are used in the recent literature. the investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.

different definitions of nocturnal hypoventilation are used in the recent literature. basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.

Eligibility criteria:
inclusion criteria: * neuromuscular disease * age ≥18 years * non mechanically ventilated exclusion criteria: * long-term oxygen therapy
impact of covid-19 pandemic on hepatopancreatobiliary surgical services in singapore

Conditions: COVID-19; Surgery

Summary: this paper is intended to report our observational study in evaluating the impact of the covid-19 pandemic on tan tock seng hospital hepatopancreatobiliary unit's surgical workload from january to june across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as singapore entered the transition phase to covid-19 resilience.

this paper is intended to report our observational study in evaluating the impact of the covid-19 pandemic on tan tock seng hospital hepatopancreatobiliary unit's surgical workload from january to june across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as singapore entered the transition phase to covid-19 resilience. a comparative audit of the unit's surgical workload for the months of january-june across 2019 to 2022, which corresponded to pre-covid-19, the height of the pandemic, and a gradual normalization of surgical services. operations performed by the unit were collected from the surgeons' electronic case logs. these operations were sorted based on the singapore ministry of health's table of surgical procedures, which assigns charge codes to different procedures. the retrospective data across the 4 years were compared and analysed. no patient contact or identifiers were retrieved, stored or disseminated and thus exempt from ethics board review.

Eligibility criteria:
inclusion criteria: * all patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of january to june of 2019/2020/2021/2022. exclusion criteria: * anyone who does not fall within the inclusion criteria
immediate effect of proponent-nasal-spray on unspecific discomfort in the nose

Conditions: Unspecified Disorder of Nose and Nasal Sinuses

Summary: investigation of the immediate effect on subjective relief of symptoms by proponent - nasal - spray after a one time administration (following a single dose administration in each nostril) in an open, not randomised, non-blinded single centre observation study on 40 volunteers between 18-75 years of age with an unspecific discomfort in the nose such as enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or feeling of a dry nose.

by regularisation of environment of nasal mucosa and the following restitution and improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably enhanced, pathogens from the environment can be physically removed and a bacterial or viral infection may be prevented on this way. such an optimizing effect may be reached by the administration of an equilibrated saline solution with an optimal composition regarding osmolality, ph-value and buffer substance. in addition it would be very advantageous to support the efficacy of the local unspecific and specific immune mechanisms in the nasal respiratory mucosa (nalt) without any negative effects on the optimized mucociliary clearance. as demonstrated recently in airway mucosa sodium propionate is able to interact with macrophages, the interleukin system and other factors of the tnf receptor family. sodium propionate could therefore have an ancillary effect on the genuine immune mechanisms of nasal respiratory mucosa. on this way the primary effect of administration of saline solution is supported.

Eligibility criteria:
inclusion criteria: key inclusion criteria are one or more of the following symptoms: * nasal discharge/ secretion (runny nose) * congested nose * sneezing * itchy nose * feeling of a dry nose exclusion criteria: key exclusion criteria: * \<18 years of age * 75 years of age

Keywords: nose saline solution irrigation nasal spray sodium propionate locke-ringer solution
treatment of complex regional pain syndrome, a long-term follow-up

Conditions: Complex Regional Pain Syndromes; Chronic Pain

Summary: complex regional pain syndrome, crps, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. the diagnosis is subdivided in crps type 1 where no nerve injury has been identified, and crps type 2 when a major nerve injury has been verified. a combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating crps. the present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.


Eligibility criteria:
inclusion criteria: * has participated in multimodal treatment for crps at uppsala university hospital exclusion criteria: * other serious physical or mental condition
balance training using biodex stability system in knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: this was a randomized control trial, conducted with two group of patients, one has received balance and stability training on biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises

patients with symptomatic knee osteoarthritis have balance and stability deficits. in routine such patients are not evaluated and treated on balance and stability parameters. so this study was conducted with objectives to determine the effects of balance training using biodex stability system in patients with symptomatic knee osteoarthritis. experimental group has received balance and stability training on biodex stability system along with conservative protocol of traditional exercises. control group has received only conservative protocol of traditional exercises.

Eligibility criteria:
inclusion criteria: * bilateral knee pain * age 35-65, both genders * grade 2 or 3 on kellgren classification for knee arthritis exclusion criteria: * past history of total knee artthroplasty * intra articular steroid injection * rheumatoid arthritis * use of assistive devices e.g. canes, walkers and braces * knee injury

Keywords: balance training biodex stability system osteoarthrosis degenerative stability exercises
treatment of upper ureteric stones

Conditions: Ureteric Stones

Summary: this study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

this study will be conducted to compare the success and complication rates of flexible, semi-rigid urs, and swl approaches for proximal ureteric stones with size ≤1 cm.

Eligibility criteria:
inclusion criteria: * radio-opaque stones * less than or equal 1 cm exclusion criteria: * active uti * coagulopathy * pregnancy * ureteric stricture

Keywords: ureteral stones ureter ureteroscopy flexible swl
single-incision versus retropubic mid-urethral sling (solyx) for sui during minimally invasive sacrocolpopexy

Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders

Summary: sass (single-incision versus retropubic mid-urethral sling (solyx) for sui during minimally invasive sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

sass aims to compare the efficacy of a single-incision (sis) versus a retropubic mid-urethral sling (rp) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (sui).

Eligibility criteria:
inclusion criteria: * at least 21 years of age * vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the pfdi-sf20 * pop ≥ stage ii according to the pelvic organ prolapse quantification (pop-q) system45, with evidence of apical descent * women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy) * objective sui: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse * understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires * able to give informed consent exclusion criteria: * prior surgery for stress urinary incontinence including mid-urethral sling; burch/mmk; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection * any serious disease, or chronic condition, that could interfere with the study compliance * unwilling to have a synthetic sling * untreated and unresolved urinary tract infection * poorly-controlled diabetes mellitus (hgba1c \> 9 within 3 months of surgery date) * neurogenic bladder/ pre-operative self-catheterization * elevated post-void residual/pvr (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study) * prior pelvic radiation * inflammatory bowel disease * current genitourinary fistula or urethral diverticulum * planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy * pregnant or planning to conceive * incarcerated

Keywords: retropubic sling single-incision sling sacrocolpopexy
the effects of metformin on blood vessel structure and function

Conditions: Obesity; Hypertension; Hypercholesterolemia; Hyperglycemia

Summary: the purpose of this study is to evaluate whether the drug metformin has beneficial effects on the blood vessels of individuals with the metabolic syndrome (mes).

individuals with the metabolic syndrome (mes) are at increased risk for developing cardiovascular diseases. this increased risk may, in part, be related to abnormalities in the blood vessels. mes is defined as having 3 or more of the following 5 criteria: * abdominal obesity (waist measurement \>39.8 inches in men, \>34.4 inches in women) * elevated triglycerides (\>150 mg/dl) * low hdl or "good" cholesterol (\<40 mg/dl in men or \<50 mg/dl in women) * elevated blood pressure (\>130/85) or treatment for high blood pressure * elevated fasting blood sugar (\>100 mg/dl) metformin is a medication that is approved by the food and drug administration (fda) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. we are evaluating whether metformin reduces the stiffness of blood vessels and improves endothelial function. this study requires 4 visits to the nia clinical research center (located on the premises of harbor hospital) over a 5-month period. at the initial visit, patients will be given a physical examination with blood and urine tests, and an ekg. they will be randomized into one of two groups; one group will receive metformin (1700 mg per day), while the other group will receive a placebo. participants will take the medication for 4 months. subsequent visits will include additional blood tests, ultrasound and echo exams. taking part in this study is entirely voluntary. all testing and medications will be provided at no cost to the participant or their family.

Eligibility criteria:
inclusion criteria: participants with the metabolic syndrome, which is defined as having 3 or more of the following 5 alterations: * abdominal obesity (waist measurement \>39.8 inches in men, \>34.4 inches in women) * elevated triglycerides (\>150 mg/dl) * low hdl or "good" cholesterol (\<40 mg/dl in men or \<50 mg/dl in women) * elevated blood pressure (\>130/85) or treatment for high blood pressure * elevated fasting blood sugar (\>100 mg/dl) exclusion criteria: * diabetes treated with medication * blood pressure \>160/100 mmhg * clinical congestive heart failure * anemia with hematocrit \<32% * asthma or chronic obstructive pulmonary disease (copd) requiring daily medication or use of home oxygen therapy * major surgery planned within the next six months * a recent, unexplained weight loss of \>10% of body weight in the past 6 months * a known allergy or hypersensitivity to metformin * history of hepatitis or cirrhosis * history of kidney disease (defined as serum creatinine \>1.4 mg/dl in men, \>1.3 mg/dl in women) * pregnancy or the absence of an effective method of contraception * illicit drug or alcohol abuse * cancer requiring treatment currently or recently completed treatment in the last 2 months

Keywords: metabolic syndrome triglycerides hdl ldl high blood pressure high cholesterol high blood sugar
safety and efficacy of pulmonary artery denervation in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (padn) for the treatment of pulmonary arterial hypertension (pah). the primary objective is to assess effectiveness and safety of padn for the treatment of pah.

the current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6mwd) of padn on pah patients. based on the previous studies, the 6mwd was 13±24 m after 6-month treatment using target drugs. and our previous data showed that 6mwd at 6-month after padn procedure was 65±85 m. as a result, a total of 128 patients with group i pah are randomized at a ratio of 1:1 to either padn procedure plus phosphodiesterase-5 inhibitors (pde5i) group (padn group) or sham-padn procedure plus pde5i group (sham group) using a randomization schedule blocked by site. the combination therapy of pde5i with additional other pah-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.

Eligibility criteria:
inclusion criteria: provision of informed consent prior to any study specific procedures; men and women 18 years and older; group i pah, defined as a mpap≥25mmhg, pcwp\ 3.0 woods unit. exclusion criteria: general exclusion criteria: pregnancy and breast feeding mother; estimated life expectancy \< 12 months; scheduled major surgery in the next 6 months; inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days. procedural exclusion criteria: who group ii, iii, iv, v ph severe renal dysfunction (ccr\<30 ml/min) blood platelet count\<100,000/l expected life span\<6-month systematical inflammation malignant cancer(s) tricuspid valve stenosis, supra-pulmonary valve stenosis allergic to studied drugs or metal materials.
us expanded access program for magrolimab in patients with relapsed or refractory acute myeloid leukemia

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Summary: the goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the united states suffering from relapsed or refractory acute myeloid leukemia (aml).


Eligibility criteria:
key inclusion criteria: * individuals with confirmation of acute myeloid leukemia (aml) according to who 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks. * eastern cooperative oncology group performance status score of 0 to 3. * treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol. key exclusion criteria: * known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen. * prior treatment with cluster of differentiation (cd)47 or signal regulatory protein alpha (sirpα)-targeting agents. note: other protocol defined inclusion/exclusion criteria may apply.
the analysis of chinese medical syndromes differentiation on acute ischemic stroke

Conditions: Ischemic Stroke

Summary: background and objective: stroke, which means sudden onset of cerebral vascular accident. the earliest document was found in "neijing". the ancient physicians had different opinions and points of view on the etiology and pathogenesis of stroke. before the tang and song dynasty, the "exopathic wind" theory was talked about. and, after then, the "endogenous wind" theory was put forward. while in the ming dynasty, zhang jing-yue advocated that "stroke is not caused by wind etiology'', highlighting the much difference of the thinking. until nowadays, many famous physicians have their own unique way to determine the etiologic factor based on differentiation. to be practical, objectivity differentiating and determining the etiologic factor of stroke is the foundation of establishing the treatment guidelines. the investigators aim to establish the scientific epidemiological standard of traditional chinese medicine (tcm) syndromes of acute ischemic stroke in taiwan.

methods: the investigators use the ischemic stroke tcm syndromes diagnostic scale (istcmds) and the meridian energy analysis device (m.e.a.d.) to objectively analyze the diagnostic elements and detect the deficiency or excess performance of meridians of acute ischemic stroke patients from stroke center at linkou chang gung memorial hospital. the onset of stroke is set within 7 days, and the investigators expected to collect 300 patients. the investigators initially establish the scientific epidemiological study of acute ischemic stroke with tcm syndromes and deficiency or excess of meridian performances through statistical analysis to become a standard of chinese and western medicine integration. the data collection can gradually become a library, which will facilitate the assessment of the clinical efficacy of tcm adjuvant therapy and become a basis to assist western and chinese medicine integration.

Eligibility criteria:
inclusion criteria: * patient with acute ischemic stroke, approved by brain ct or mri * onset within 7 days * no other severe organic diseases * stroke for the first time or recurrent stroke with previous rankin's scale ≦1 status * signed inform consent exclusion criteria: * not meet the above diagnostic and inclusion criteria * complicated with sepsis or other infections * refuse to accept chinese medical syndromes differentiation, the meridian energy analysis device (m.e.a.d.), or refuse to sign inform consent * unconsciousness * with pacemaker or pregnancy