Kornimate/medical-research-clean huggingface dataset:
bioavailability study of tramadol/apap tablets under fasting conditions

Conditions: To Determine Bioequivalence Under Fasting Conditions

Summary: to compare the relative bioavailability of kali and ortho-mcneil's

to compare the relative bioavailability of kali's tramadol/apap 37.5mg/325mg with ortho-mcneil's ultracet tablets 37.5mg/325mg

Eligibility criteria:
inclusion criteria: * healthy males and females between 18 and 45 years of age inclusive * informed of the nature of the study and given written informed consent. * have a body weight within 15% of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 100lbs. exclusion criteria: * hypersensitivity to tramadol/ acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures. * any history of a clinical condition which might affect drug absorption, metabolism or excretion. * recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism. * donation of greater than 500ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. * received an investigational drug within the 4 weeks prior to study dosing. * currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing. * this prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician. * tobacco use(\>5 cigarettes per day)in the 3 months prior to study dosing. * if female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. * females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. * medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. * females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Keywords: bioequivalence, tramadol apap, fasting
efficacy of immunomudulatory therapy with all-trans retinoid acid for adults with chronic immune thrombocytopenia

Conditions: Immune Thrombocytopenic Purpura

Summary: the purpose of this study is to determine whether all-trans retinoic acid (atra) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (ritp).

idiopathic thrombocytopenic purpura(itp), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. at least 30% adult patients turn into refractory itp. the pathogenesis of itp remains to be elucidated. now ,cd4+ helper cells have been classified as belong to t-helper 1(th1), t-helper 2(th2), t-helper17and regulory t cell(tregs). all-trans retinoic acid(atra) mainly applied in skin disease and acute promyelocytic leukemia. recently, atra is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. in the international, the investigators first treat ritp with atra. to investigate the therapeutic effects of atra on ritp, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of refratory idiopathic thrombocytopenic purpura * hormone and immune suppression, splenectomy is invalid exclusion criteria: * other autoimmune diseases

Keywords: idiopathicthrombocytopenic purpura all-trans retinoic acid regulory t cells
transfusion and covid-19

Conditions: COVID-19

Summary: alsace was particularly and early on affected by sars-cov-2 and quickly implemented a reduction in scheduled admissions and non-urgent surgical interventions, making it possible to reduce requests for labile blood products linked to non-urgent surgical procedures. as has been reported in the literature; the population containment measures also led to a major reduction in traffic - and consequently accidents on the public roads. at the same time, other demands for blood products related to activities such as onco-hematology were little affected. finally, the blood banks have adapted their collection procedure. to answer these questions, we propose to conduct a retrospective study over two parallel periods of 2019 and 2020 of the consumption of blood products on the one hand and the availability of stocks on the other hand.


Eligibility criteria:
inclusion criteria: * adults patient (≥18 years old) * patients admitted to strasbourg university hospitals for suspicion of covid-19, between february 24 and may 31 of 2019 and 2020 * labile blood products consumed between february 24 and may 31 of 2019 and 2020 * subjects not having his opposition, after information, to the reuse of his data for the purposes of this research. non-inclusion criteria: * patients who expressed opposition to participating in the study * patients under legal protection * patients under guardianship or curatorship

Keywords: covid-19 blood donation blood transfusion labile products blood platelets psoralen ecmo sars-cov-2 consumption of blood products
joint replacement or interpositional arthroplasty for cmc1 arthritis, a prospective trial

Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Summary: interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. the results are generally good, but the rehabilitation time can be long and failures are difficult to treat. total joint replacements now exist with modern uncemented designs that can be an alternative treatment. short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. currently no prospective randomized trials have compared these two treatment options. our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.

eligible: patients \>18 years with pain and dysfunction from the first cmc joint. clinical and radiological arthritis. exclusion: degenerative changes in the stt joint (all patients are assessed by ct), other injuries in the hand/thumb, pregnancy outcome measures: quick-dash, nelson hospital score, range of motion, grip strength complications are registered. the patients are observed for two years and the investigators aim to include a total of 40 patients.

Eligibility criteria:
inclusion criteria: * cmc 1 arthritis * pain and dysfunction * adult patients * general good health exclusion criteria: * pregnancy * stt arthritis (ct scan preoperatively for all patients) * other injuries in thumb/hand

Keywords: cmc1 arthritis degenerative arthritis thumb interpositional arthroplasty total joint replacement
brain network disruptions related to traumatic coma

Conditions: Traumatic Coma

Summary: to provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (tbi) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural mri, fmri and positron emission tomography (pet) scan (neuroinflammation ligands).

so far, the gold standard for neuroprognostication of severe traumatic brain injury (tbi) or anoxic encephalopathy is the bedside behavioural evaluation. nevertheless, the predictive value of such an exclusive clinical approach has been consistently reported as limited and insufficient in this challenging clinical setting. recent theoretical and experimental data converge towards the idea of the critical implication of long-range brain connection in consciousness access and maintain. nevertheless, previous studies have focused on the specific analysis of some targeted connections (regions of interest), and have used exclusively a single approach in neuroimaging (structural or functional imaging), with no interest in the neuro-inflammatory and neurodegenerative mechanisms likely associated with these disconnection phenomena. so, cerebral disconnection characterization at the level of the whole brain, at different stages of pathological abolition of consciousness must be made, on an anatomical, functional and metabolic scale. this descriptive study represents a first step in the identification of relevant multimodal imaging biomarkers. this will then lead to a larger study to identify the prognostic impact of these different biomarkers obtained in the acute phase of patient management.

Eligibility criteria:
inclusion criteria for patients: * male or female / age between 18 to 75 years. * coma of traumatic or anoxic aetiology (gcs \< 10). * early (\< 1 month after tbi) and after the complete withdrawal of sedative agents. * written agreement for participation (legal responsible). inclusion criteria for controls: * male or female / age between 18 to 75 years, paired with patients (gender and age). * written agreement for participation exclusion criteria: * patients without public insurance regime. * pregnancy. * specific contraindication to the use of mri (metallic material) or pet (specific allergy related to the ligand). exclusion criteria for controls: - pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)

Keywords: coma traumatic brain injury anoxic encephalopathy brain connectome neuroinflammation prognosis
combination therapy of 5-fluorouracil and calcipotriol versus 5-fluorouracil in the treatment of actinic keratosis

Conditions: Actinic Keratoses

Summary: 5-fluorouracil (5fu) is proven to be the most effective therapy in field directed treatment for ak, with jansen et al. reporting a 1-year probability of treatment success of 74.7%. however, treatment with 5fu is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. this long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5fu therapy. therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5fu in the treatment of ak. addition therapy, which can shorten the duration of treatment, might be the key to success. calcipotriol (cal) enhances thymic stromal lymphopoietin (tslp), an epithelium-derived cytokine, which promotes antitumor immunity. therefore, it is known to have a synergistic effect when combined with 5fu in the treatment of ak. this suggests that short-term treatment with 5fu-cal is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen. however, no study compared 5fu-cal combination therapy with standard 5fu treatment for a duration of 28 days. this study aims to evaluate whether a short course of combination therapy with 5fu-cal is non-inferior to a full course of 5fu monotherapy with respect to the 1-year probability of treatment success.


Eligibility criteria:
inclusion criteria: * adults above 18 years of age * clinical and dermoscopical diagnosis of ak by a dermatologist, in one or more area(s): * face, ears, (balding) scalp * neck/shawl area, including the sun-exposed chest area * upper extremities * number of ak lesions ≥4 in a continuous treatment area of up to 100 cm2 * ak olsen grade i-iii exclusion criteria: * previous field treatment for ak within 2cm of the treatment area, within 3 months * (non) melanoma skin cancer in treatment area * mucosal lesions * genetic skin cancer disorder * women who are pregnant or breastfeeding * women of childbearing potential, who are not willing to use effective contraceptive measures * previous allergy or intolerance to either 5fu or calcipotriol * patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction * concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication * concurrent use of other topical treatments registered as treatment for ak * limited understanding of the dutch language and not being able to give informed consent (incapacitated patients)

Keywords: 5-fluorouracil calcipotriol
effect of high magnification on quality of life and success after endodontic microsurgery: a randomized controlled trial

Conditions: Periapical Lesion

Summary: effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"

: residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. the prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. magnification has been recommended for better visualization of apical terminus. various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). however, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices. to the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.

Eligibility criteria:
inclusion criteria: * patients between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (bharathi et al 2021) tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. asa-1 patients according to the classification of the american society of anesthesiologists). exclusion criteria: patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade iii, hepatic/renal disease, or systemic bleeding disorders) combined endodontic-periodontic lesions pregnancy -
a phase ii study comparing pegylated rhg-csf（hhpg-19k） and rhg-csf in breast cancer patients receiving chemotherapy

Conditions: Breast Cancer; Neutropenia; Febrile Neutropenia

Summary: neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. a newly pegylated rhg-csf was independently developed by jiangsu hengrui medicine co., ltd, china. phase 1a, 1b trials have shown that pegylated rhg-csf has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhg-csf. the purpose of this study is to determine the safety and effectiveness of pegylated rhg-csf in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * pathology diagnosis of breast cancer,chemotherapy naïve * ecog performance status 0-1 * age 18 to 70 years * available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy * white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥2.0 × 109/l; platelet count ≥ 100 × 109/l * alanine aminotransferase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine ≤1.5×uln * no obvious cardiac dysfunction exclusion criteria: * prior bone marrow or stem cell transplantation * received systemic antibiotics treatment within 72 h of chemotherapy * other disease might have influence on bone marrow function * radiation therapy within 4 weeks of randomization into this study * previous exposure or or allergic to pegylated rhg-csf * pregnancy, lactation

Keywords: breast cancer neutropenia febrile neutropenia
epidural hydromorphone compared with hydromorphone infusion in treating patients with prostate cancer undergoing radical prostatectomy

Conditions: Pain; Prostate Cancer

Summary: rationale: giving hydromorphone in different ways may relieve the pain associated with cancer surgery. purpose: randomized double-blinded phase iii trial to compare the effectiveness of epidural hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical prostatectomy.

objectives: i. define the duration of action of hydromorphone (spinal vs supraspinal) in patients who have undergone radical prostatectomy. ii. demonstrate that the duration of the analgesic effects of equal blood concentrations of hydromorphone is dependent on the method used to attain this concentration by comparing continuous epidural infusion with that of a continuous intravenous infusion. outline: this is a double blinded, randomized study. after all patients have undergone radical prostatectomy, hydromorphone is administered in two different ways. patients receive either a hydromorphone bolus injection through an epidural catheter using a patient controlled analgesia pump or a hydromorphone bolus injection through an intravenous catheter using a patient controlled analgesia pump. infusion for both groups is stopped at 24 hours. patients are followed every 30 minutes for 6 hours. projected accrual: a total of 40 patients will be accrued into this study over a 3 year period.

Eligibility criteria:
disease characteristics: histologically confirmed prostate cancer not metastatic must be undergoing radical prostatectomy patient characteristics: age: 18-70 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified neurologic: no presence of an intracranial lesion associated with increased intracranial pressure pulmonary: no chronic obstructive pulmonary disease no cor pulmonale no emphysema no kyphoscoliosis no status asthmaticus other: no contraindications for the insertion of epidural catheter no known hypersensitivity to hydromorphone no history of alcoholism, drug abuse, mental dysfunction, or cognitive deficiencies prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: not specified for prior surgery(ies) other: no preoperative opioids for any reason

Keywords: prostate cancer pain
efficacy of maxillo-facial treatment on cleft lip and palate patients faces: aesthetic considerations

Conditions: Cleft Lip and Palate; Growth and Development; Cicatrix; Randomized Controlled Trial

Summary: the aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (clp) patients. the aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-d images of clp patients following primary lip repair by laypeople.

the management of cleft lip and palate patient's generally involves the soft palate reconstruction as well as the repair of lip and nasal soft tissue defects. from an esthetic point of view, the primary repair, usually performed between 9 and 18 months of age, prepares the patients to grow into childhood and succeed in life without focusing on their deformity. an increasing number of outcome measure rating systems has been raised, suggesting a lack of consensus to a reliable, validated and reproducible scoring system for facial aesthetics in cleft patients. many templates and lay panel scoring systems have been described, yet never fully validated. advanced 3d imaging technologies may produce validated outcome measures in the future, but presently there remains a need to develop a robust method of facial aesthetic evaluation based on standardised patient photographs. the aim of the study is to to determine and compare the level of agreement among examiners' subjective aesthetic evaluation of full-face and nasolabial region 3-d images of clp patients following primary lip repair by laypeople, developing some recommendations for a consistent scoring protocol.

Eligibility criteria:
inclusion criteria: * age, between 20 and 25 years * sex, in order to have at least 25 male and female raters * sociocultural status: the layperson panel includes undergraduate students without extensive professional knowledge on cleft lip and palate patients exclusion criteria: * previous participation in research studies * familiarity or close friendship with cleft lip and palate patients * lack of blindness about the study protocol (it could bias the reported results)

Keywords: reconstructive surgical procedures therapy, soft tissue treatment outcome outcome assessment (health care) photogrammetry physical appearance, body
mineralocorticoid receptor and obesity induced cardiovascular complications

Conditions: Obesity; Insulin Resistance

Summary: the purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. the investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years 2. good health as evidenced by history and physical exam 3. body mass index (bmi): \>30 kg/m2 and \<45 kg/m2 exclusion criteria: 1. medical illnesses other than treated hypothyroidism 2. blood pressure (bp) \>135/85 or systolic bp \<90 mm hg 3. hepatic disease (transaminase \> 3 times normal) 4. renal impairment (creatinine clearance \<60 ml/min) 5. baseline serum potassium (k) \>5.0 mmol/l 6. history of drug or alcohol abuse 7. allergies to spironolactone 8. participation in any other concurrent clinical trial 9. women using oral contraceptives within the last 3 months

Keywords: obesity insulin resistance mineralocorticoid receptor