Kornimate/medical-research-clean huggingface dataset:
value of an intrathecal synthesis index of specific antitreponema igg for neurosyphilis diagnosis

Conditions: Neurosyphilis

Summary: a retro-prospective case-control swiss study was conducted to evaluate the diagnostic performance of measuring an antibody index (ai) for intrathecal synthesis of specific anti-treponema pallidum (t. pallidum) igg for the diagnosis of neurosyphilis.

the diagnosis of neurosyphilis (ns) lacks a true "gold standard" which makes the diagnosis challenging while consequences of a misdiagnosis are potentially severe. the aim of this study was to evaluate the diagnostic performance of measuring an antibody index (ai) for intrathecal synthesis of specific anti-treponema pallidum (t. pallidum) igg for the diagnosis of ns. csf parameters were analysed and specific anti-t. pallidum igg were measured simultaneously on paired cerebrospinal fluid (csf)-serum samples collected between 2007 and 2022 from patients suspected of ns, in switzerland. an ai was calculated to consider blood-brain barrier integrity. two ns definitions were used: ns1 included patients with suspicion of ns presenting neurological symptoms and/or acute neuro-sensory signs and positive tpha/tppa serology and csf-tpha/tppa≥320, and either csf-leucocytes \>5cells/mm3 and/or csf-protein \>0,45g/l and/or a reactive csf-vdrl/rpr test. ns2 included patients with ns suspicion presenting acute ocular and/or otologic symptoms, and positive tpha/tppa serology, and a favourable response to ns treatment. controls were patients diagnosed with any other cns pathologies and with positive tpha/tppa serology.

Eligibility criteria:
inclusion criteria: * all patients who have serum / csf sample pairs collected concomitantly (3 days maximum interval between blood test and lumbar puncture). * age \> or = 18 years old. exclusion criteria: * all patients for whom the stored samples do not meet the needs of the diagnostic study, or whose serum and csf collection date is more than 3 consecutive days. * age \< 18 years old. * no written consent form for the prospective part.

Keywords: neurosyphilis treponema pallidum intrathecal synthesis specific anti-treponema igg otosyphilis ocular syphilis
the effect of vitamin d supplementation on cardiovascular risk factors

Conditions: Vitamin D Deficiency

Summary: six-hundred subjects with vitamin d deficiency will be randomized to vitamin d 3000 iu per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint

vitamin d is a hormone with effects not only on the skeleton, but on most tissues in the body. lack of vitamin d is associated with cardio-vascular disease (cvd) and type 2 diabetes, and also with risk factors for these diseases like hypertension, dyslipidemia, insulin resistance, and endothelial dysfunction. however, intervention studies with vitamin d have been inconclusive regarding diseases and risk factors. most of these studies were done in white, western populations in subjects fairly vitamin d sufficient, and accordingly, no benefits were to be expected. also, in many studies the doses of vitamin d have been too low, and the studies underpowered. to firmly establish the role of vitamin d regarding cvd risk factors we will in the present study include 600 subjects with vitamin d deficiency (serum 25-hydroxyvitamin d (25(oh)d) \< 30 nmol/l) and randomize to high dose vitamin d (3000 iu per day) versus placebo for four months. the subjects will be recruited based on 25(oh)d measurements in the forthcoming 7th survey in the tromsø study where more than 20 000 subjects are expected to attend. if our hypotheses are correct and the vitamin d supplement has a positive effect, this will be of great importance not only in countries with low sun exposure, but particularly for subjects in developing countries where vitamin d deficiency is highly prevalent.

Eligibility criteria:
inclusion criteria: * participated in the 7th survey in the tromsø study * vitamin d deficiency exclusion criteria: * primary hyperparathyroidism * granulomatous disease * reduced kidney function * systolic blood pressure \> 174 mmhg * diastolic blood pressure \> 104 mmhg * diabetes * renal stones last 5 years * use of solarium on regular basis * planned holidays in tropical areas * clinical depression * clinical signs of vitamin d deficiency (muscle weakness) * use of vitamin d supplements * serious illness

Keywords: vitamin d blood pressure serum lipids glucose metabolism muscle function arterial stiffness depression psoriasis sleep bone density
to assess the safety and effectiveness of hyruan one versus a comparator for the treatment of knee osteoarthritis in europe

Conditions: Osteoarthritis (OA) of the Knee

Summary: to assess the safety and effectiveness of hyruan one versus a comparator for the treatment of knee osteoarthritis in europe


Eligibility criteria:
inclusion criteria: 1. subject is ≥40 years old. 2. subject has radiographic evidence of mild-to-moderate oa (kellgren lawrence scale grade ii iii) in one or both knees. radiographs to be taken within 12 months prior to the screening visit. 3. subject has oa pain in the target knee despite conservative physical treatments and/or analgesics. exclusion criteria: 1. subject has rheumatoid arthritis or other inflammatory metabolic arthritis. 2. subject has a documented history of hypersensitivity to ha. 3. subject has a documented infection or severe inflammation of the target knee joint. 4. subject has a skin disease in the area of the injection site. 5. subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap). 6. subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
an extension study evaluating safety and efficacy of proellex® in women who have previously completed zpu 003 ext

Conditions: Uterine Fibroids

Summary: an open label, extension study for subjects completing the zpu-003 ext 1 study.

this is an open label, extension study for subjects completing the zpu-003 ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. subjects will receive a 50 mg proellex® daily dose. total study participation for zpu-003 ext 2 (extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Eligibility criteria:
inclusion criteria: * four subjects at one site whom have completed zpu 003 ext 1 study exclusion criteria: * all other subjects

Keywords: uterine fibroids
bis of sedation depth during flexible bronchoscopy.

Conditions: Pulmonary Disease

Summary: fentanyl is analgesia medication. there has not pain nerve in the lung. flexible bronchoscopy(fb) is used in the respiratory medicine. so people will not feel pain in the process of fb. the purpose of the study is to know if fentanyl is useful in the conscious sedation of fb.

fentanyl is opioid receptor agonists. it is a fast-acting, short duration and potent analgesics. flexible bronchoscopy (fb) is mostly used in the diagnosis and therapy in the respiratory disease. as we know, there has not pain nerve in the lung. people will not feel pain when they are in fb. if fentanyl will be effective in fb? our study will observe the effect of conscious sedation in fb with fentanyl or without fentanyl.

Eligibility criteria:
inclusion criteria: cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy exclusion criteria: forced expiratory volume in one second\<1 l severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)

Keywords: bronchoscopy conscious sedation fentanyl bispectral index
real-time artificial intelligent (ai)-assisted muscle ultrasound for monitoring muscle mass reduction in icu patients

Conditions: Tetanus

Summary: this study aims to investigate the feasibility of using a real-time artificial intelligent (ai)-assisted tool for rectus femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination

this project proposes to develop computational methods to automatically analyze conventional 2d muscle ultrasound images in real time to assist operators circumvent achieve high quality reproducible views and measurements specifically for rectus femoris muscle. study design: this is a prospective observational study to test the reliability of ai-assisted muscle ultrasound at the patient's bedside compared to standard rfcsa ultrasound. all measurements will be performed in adult patients with severe tetanus (ablett grade 3 or 4) admitted to the adult icu at htd expected to stay at least 5 days. all patients are on mechanical ventilation, muscle relaxation and neuromuscular blockers following the ministry of health guidelines. study procedures: three ultrasound examinations will be carried out according to a standard operating procedure where patients are in the supine position with the leg in neutral rotation. measurements will be taken using 12l-rs linear probe, venue go ultrasound machine (general electric healthcare, london, uk). statistical analysis: study will compare the intra- and interobserver variability of measurements and examination duration. all statistical analysis was performed with r version 4.0.4.

Eligibility criteria:
inclusion criteria: * age ≥16 years * written informed consent * staff and equipment available for ultrasound * admitted to viet anh ward icu with a diagnosis of meningitis or encephalitis or ablett grade 3 or 4 tetanus * within 72 hours of icu admission * duration of icu stay expected at least 5 days exclusion criteria: * informed consent not given * contraindication to ultrasound scan

Keywords: muscle wasting intensive care unit muscle ultrasound artificial intelligence deep learning
apnea tests as the methods of brain death diagnosis.

Conditions: Brain Death; Apnea; Pupillary Anomaly

Summary: apnea test (at) is the most important clinical test performed usually at the end of brain death (bd) diagnosis procedure. traditional insufflation apnea test (i-at) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. therefore the investigators decided to verify alternative at options such as continuous positive airway pressure apnea test (cpap-at) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed polish bd criteria.

apnea test (at) is one of the most important examination during the diagnosis of brain death. it is usually performed at the end of each series of clinical examinations during diagnostic process. the most popular standard insufflation apnea test (i-at) may be potentially harmful. it may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic instability and even cardiac arrest. therefore, the investigators decided to analyze apnea test in cpap option (cpap-at) as a new tool. for safety of the study the investigators analyzed a method after bd diagnosis. methods: i-at and hypoventilation with 100 % oxygen (if needed) were performed according to polish guidelines. two hours after bd diagnosis was performed extra apnea test in cpap option (cpap-at). before cpap-at the patients were ventilated 100% oxygen. after then the ventilator settings were changed to cpap mode with peep 10 cm h2o, ps 0 cm h2o, fio2 1,0, flow 6l/min. emergency apnea ventilation was turned off. at the beginning of cpap mode and 10 minutes after, blood samples for arterial blood gases (abg) were collected. if were observed rapid desaturation defined as a decline in o2 saturation below 85%, cpap-at was aborted and study was finished. during routine diagnosis of brain death, pupillary dilation after a neck flexion was observed in one case. therefore, the investigators decided to use a pupillometer during brain death examination to find out how pupils react after a neck flexion and how often it happens. pupil measurements were taken immediately after the diagnosis of brain death. the measurements of pupil diameter were taken twice: a - before neck flexion; b - after neck flexion. we used pupillometer: algiscan (equip medkey bv).

Eligibility criteria:
inclusion criteria: * brain death diagnosis exclusion criteria: * no

Keywords: apnea test, brain death, pupillometry
vacuum assisted wound closure (vawc) and mesh mediated fascial traction

Conditions: Open Abdomen; Fascial Closure

Summary: the purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (vawc) and mesh mediated fascial traction for closure of open abdomens.

open abdomen treatment often results in difficulties in closing the abdomen. highest closure rates are seen with the vacuum assisted wound closure (vawc) technique. failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. a novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients. in this multicenter study we prospectively evaluate the technique. inclusion criteria: all patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with vawc and mesh mediated fascial traction will be included in the study in an intention to treat model. exclusion criteria: treatment of open abdomen with other techniques. method: * the first period of 2-5 days only the abdominal vawc dressing is applied. * on day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the vawc system, and tightened. * the vawc dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges. * finally the mesh is removed and the fascia is closed. * at closure the wound to suture length is registered. primary endpoint: frequency of primary fascial closure. secondary endpoints: * study of factors associated with failure of fascial closure and in-hospital mortality, * abdominal pressure variation attributable to the use of the technique, * duration of treatment with open abdomen, * frequency of incisional hernia after one and five years. duration of the study: 3-5 years. enrollment of open abdomen cases. follow-up schedule for patients: * clinical evaluation at 1 and 5 years. * ct-examination at 1 year.

Eligibility criteria:
inclusion criteria: * open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable exclusion criteria: * open abdomen patients treated otherwise

Keywords: open abdomen fascial closure vacuum assisted wound closure mesh abdominal compartment syndrome intraabdominal pressure incisional hernia
a clinical trial evaluating the efficacy of a skin cream in improving facial appearance and skin elasticity

Conditions: Atrophy, Hemifacial; Elastosis; Photoaging

Summary: a clinical trial evaluating efficacy of a skin cream targeting dermal fat in improving the skin elasticity of healthy volunteers.

this is a single-arm study with subjects serving as their own controls. the study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. the combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). the health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period * plans to undergo injectable filler treatment.

Keywords: sagging depletion atrophy photoaging
interest of fsl 2 in recently diagnosed type 2 diabetic patients

Conditions: Endocrinology; Type 2 Diabetes

Summary: therapeutic patient education (tpe) is a key element in the management of people living with type 2 diabetes. the benefit of therapeutic education (tpe) has been clearly established on glycaemic control. continuous interstitial glucose monitoring (cgm) can be considered as a tpe tool for people living with diabetes. a direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications. the investigators therefore propose a prospective randomised study in 2 arms : * a group of people living with diabetes receiving standard tpe vs * a group of people living with diabetes receiving standard tpe + fsl 28 days ourmain objective is to determine the benefit of cgm on hba1c at 3 months between 2 arms

main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard tpe (patient therapeutic education) vs standard tpe alone in newly diagnosed type 2 diabetics on hba1c at 3 months. the secondary objectives are to evaluate the effect of the tpe coupled with fsl vs tpe alone on : * hba1c at 6 months (assessment of persistence or not of a remote effect) * weight change at 3 and 6 months * other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months * eating behaviour/ eating habits at 3 and 6 months * treatment satisfaction, anxiety and quality of life scores

Eligibility criteria:
inclusion criteria: * recently diagnosed diabete mellitus (\<1 an) treated by non medical therapeutics and/or metformine * \> 18 years old * initial glycated hemoglobin between 7 and 8.5% exclusion criteria: * person whose physical and/or psychological health is severely impaired * person deprived of his rights, person under guardianship or curatorship * person deprived of liberty (by judicial or administrative decision) * person who does not speak the french language * absence of affiliation to/not beneficiary of a social security scheme * absence of written informed consent to participate in the study * unable to understand the nature, purpose and methodology of the study * bariatric surgery planned within 6 months of inclusion

Keywords: sensor therapeutic education diabete glucose
role of intraoperative thymoglobulin in decreasing ischemia-reperfusion injury in pediatric heart transplant recipients

Conditions: Ischemia Reperfusion Injury; Heart Transplantation

Summary: the restoration of normal blood flow following a period of ischemia may result in ischemia / reperfusion injury (i/ri), which is characterized by inflammation and oxidative damage to tissues. varying degrees of i/ri occur upon reperfusion of a donor heart after cold storage. medications containing antibodies against immune cells have been used for many years as powerful immunosuppressants. these medications, called polyclonal antibody preparations, are generally only used immediately following transplantation and/or to treat rejection. at our institution, one such antibody preparation (thymoglobulin) is used in most pediatric heart transplant recipients for 3-5 days immediately after transplantation. because standard immunosuppressive medications (called calcineurin inhibitors) are toxic to the kidneys, the use of thymoglobulin allows us to delay the initiation of calcineurin inhibitors until the kidneys of completely recovered from the shock of the transplant surgery. we hypothesize that thymoglobulin may be beneficial in reducing the damage caused by i/ri. thus, the present study seeks to evaluate the effectiveness of an intra-operative dose of thymoglobulin (in addition to the standard doses post-operatively) at reducing the effects of i/ri. the study will be a double-bind placebo-controlled trial involving 20 subjects. biologic markers for i/ri will be assessed at periodic intervals for six months post-transplantation. subjects receiving intra-operative doses of thymoglobulin will be compared to the controls in order to assess the effectiveness of intra-operative thymoglobulin in ameliorating the effects of i/ri.


Eligibility criteria:
inclusion criteria: * pediatric population (ages 0-21 years) * end-stage cardiac disease requiring heart transplantation * approval for listing by the ucla heart transplant committee exclusion criteria: * prior documented thymoglobulin allergy/adverse reaction * history of or current diagnosis of lymphoma * documented lymphopenia * documented thrombocytopenia * pregnancy

Keywords: ischemia reperfusion injury pediatric heart transplant atg induction therapy
rectal surgery evaluation trial (reset)

Conditions: Rectal Cancer

Summary: total mesorectal excision (tme) is the standard of care for rectal cancer, which can be combined with low anterior resection (lar) in patients with mid-to-low rectal cancer. the narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

the rectal surgery evaluation trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study tme with lar using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. all surgeries will be performed by surgeons experienced in a technique. oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, tme grade iii, and minimal postoperative morbidity (absence of clavien-dindo grade iii-iv complications within 30 days after surgery). secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure 3. high risk operative patients (two of these factors as assessed on mri): 1. obese patient with a bmi \> 30 (male or female) 2. narrow pelvis: inter-tuberous distance \< 10 cm 3. large tumoral volume with suspicion of close predictive margin (crm ≤ 1 mm) at diagnosis 4. expected coloanal or ultra-low colorectal anastomosis 4. patients with adequate performance status (eastern cooperative oncology group scale score of ≤2) 5. patient has signed and dated the informed consent before inclusion in the study. exclusion criteria: 1. patient with a comorbid illness or condition that would preclude the use of surgery. 2. patients with t4b tumors which impose a pelvectomy 3. patient requires an abdominal perineal resection (apr) 4. patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment 5. patient undergoing emergency procedures 6. planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections) 7. metastatic disease 8. pregnant or suspected pregnancy 9. patients unwilling to comply with all follow-up study requirements 10. patient included in another study which impact on the surgical technique or its choice.

Keywords: laparotomy laparoscopy low anterior resection rectal cancer robot assisted surgery total mesorectal excision transanal surgery