Kornimate/medical-research-clean huggingface dataset:
oral administration or nasal feeding of huzhangxiefei decoction for treatment in sepsis induced acute lung injury

Conditions: Acute Lung Injury; Sepsis

Summary: hypothesis 1a: oral administration or nasal feeding of huzhangxiefei decoction will significantly attenuate sepsis-induced systemic organ failure as measured by overall response rate. hypothesis 1b: oral administration or nasal feeding of huzhangxiefei decoction will attenuate sepsis-induced lung injury as assessed by the respiratory rate and oxygenation index. hypothesis 1c: oral administration or nasal feeding of huzhangxiefei decoction will attenuate sepsis-induced lung injury as assessed by chest x-ray scale score, chinese medicine scale score. hypothesis 1d: oral administration or nasal feeding of huzhangxiefei decoction will attenuate biomarkers of inflammation (c-reactive protein, procalcitonin), vascular injury (thrombomodulin, angiopoietin-2), alveolar epithelial injury (receptor for advanced glycation products), while inducing the onset of a fibrinolytic state (tissue factor pathway inhibitor).

huzhangxiefei decoction is a prescription formulated by a professional doctor of traditional chinese medicine

Eligibility criteria:
inclusion criteria: * patients must have suspected or proven infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for acute respiratory distress syndrome (ards). suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system). the presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection): sepsis associated hypotension (systolic blood pressure (sbp) \ 40 mm hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/\> 5mcg, phenylephrine, vasopressin); arterial hypoxemia (pao2/fio2 \ 6lpm; lactate \> upper limits of normal laboratory results; urine output \ two hours despite adequate fluid resuscitation; platelet count \ 1.5); bilirubin \> 2 mg/dl; glasgow coma scale \< 11 or a positive cam icu score. ards characterized by all the following criteria lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules) respiratory failure not explained by heart failure or volume overload decreased arterial pao2/fio2 ratio ≤ 300 mm hg minimum peep of 5 cmh2o (may be delivered noninvasively with cpap to diagnose mild ards exclusion criteria: * inability to obtain consent; * age \< 18 years; * pregnancy or breast feeding; * moribund patient not expected to survive 24 hours; * for patients with chronic liver insufficiency, renal insufficiency, blood system disease, etc., it is impossible to judge that the organ insufficiency occurred after this infection

Keywords: acute lung injury sepsis chinese traditional medicine chinese herbal drugs acute respiratory distress syndrome
rebalancing thoraco abdominal heart disease in infants (rtac)

Conditions: Infants With Heart Disease; Respiratory Therapy; Techniques

Summary: it gave a clinical trial which will be included in the 60 infants, aged up to 24 months, diagnosed with congenital's population will be divided by simple randomization into three groups: 20 infants in the intervention group, 20 infants in the control group, not receive the rta technique and another 20 infants in a placebo group, we just get the support manual therapist for 5 minutes. initially the data will be collected cardio heart rate, respiratory rate and oxygen saturation. then the researcher will apply three specific rating scales, based on clinical presentation and behavior of infants. hypothesis: the rta improves cardiorespiratory parameters and reduces signs of discomfort and pain of infants with congenital heart acyanogenic.


Eligibility criteria:
inclusion criteria: * newborns admitted to the nursery without ventilatory support or oxygen therapy, and whose parents agree with the child's participation in the study. will be excluded newborns who have some problems during any of the study procedures and those whose condition will change after the intervention, with shift in ventilatory support or oxygen therapy. exclusion criteria: * in case of inability to collect some of the parameters evaluated at the appropriate time, the rn also will no longer part of the sample, as well as those who show no contraindication to therapy.

Keywords: infant physical therapy
psma-pet guided hypofractionated salvage prostate bed radiotherapy

Conditions: Prostate Cancer; Cancer Recurrence

Summary: after radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (br) within 5 years. the standard treatment of post-prostatectomy br is salvage external beam radiation therapy (sebrt). sebrt can provide long-term disease control; with 5 year biochemical progression-free survival (bpfs) up to 60% and with most treatment failures in the first 2 years after sebrt. the main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent pca can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 gy. the study is designed as a prospective open phase iii randomized multicenter trial. all patients with biochemical recurrence with a psa \ 0.1 ng/ml or three consecutive rises will be included. all eligible patients will be randomized to one of the following two treatment arms: arm 1 = conventional sebrt to apply a total dose of 70 gy in 35 daily fractions of 2 gy during 7 weeks. arm 2 = hypofractionated sebrt to apply a total dose of 60 gy in 20 fractions of 3 gy during 4 weeks. the primary endpoint will be the 5-year progression-free survival (pfs) after treatment.


Eligibility criteria:
inclusion criteria: * patients with prostate adenocarcinoma treated with radical prostatectomy; * tumour stage pt2-4, r0-1, pn0, or cn0, cnx according to the uicc tnm 2009, only with gleason score available; * no lymph node or distant metastases. a recent psma-pet scan (\< 60 days) without evidence of lymph node or distant metastases; * psa progression after prostatectomy defined as two consecutive rises with the final psa \> 0.1 ng/ml or 3 consecutive rises. the first value must be measured at least 6 weeks after radical prostatectomy; * psa at inclusion \< 1.0 ng/ml; * who performance status 0-2 at inclusion; * age at inclusion between 18 and 80 years; * written (signed and dated) informed consent prior to registration. exclusion criteria: * prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy; * previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers; * patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: psma-pet/ct scan, 60 days prior to registration; * double-sided metallic hip prosthesis; * inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out qol questionnaires.

Keywords: psma-pet/ct salvage hypofractionation radiotherapy prostatectomy
adherence to continuous positive airway pressure among obstructive sleep apnoea patients.

Conditions: Sleep Apnea, Obstructive

Summary: prospective study designed to identify factors that would predict patient adherence to cpap (continuous positive airway pressure) therapy.

prospective study designed to identify factors that would predict patient adherence to cpap therapy. comparison between data recorded among patients and the data of the cpap microchip.

Eligibility criteria:
inclusion criteria: * adults (\> 18 patients) * all patients under cpap (continuous positive airway pressure) therapy coming for annual visit in the sart-tilman sleep study center exclusion criteria: * patient refusal

Keywords: sleep apnea, obstructive continuous positive airway pressure perioperative period
all-trans retinoic acid (atra) combining dexamethasone versus high-dose dexamethasone for initial treatment of primary immune thrombocytopenia (itp)

Conditions: Purpura; Idiopathic Thrombocytopenic Purpura

Summary: the project was undertaking by qilu hospital of shandong university in china. in order to report the efficacy and safety of all-trans retinoic acid (atra) combining with high-dose dexamethasone for the treatment of adults with primary immune thrombocytopenia (itp), compared to conventional high-dose dexamethasone therapy.

the investigators are undertaking a parallel group, randomised controlled trial of 80 primary itp adult patients from qilu hospital of shandong university in china. one part of the participants are randomly selected to receive all-trans retinoic acid(10mg tablet by mouth every 8 hours a day for 12 consecutive weeks, combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given orally at a dose of 40 mg daily for 4 days). patients were monitored every 1 to 3 days at the first two weeks and every 1 to 4 weeks afterwards for platelet counts, and were monitored every 1 month for transaminitis and other side effects

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. 5. willing and able to sign written informed consent exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(ivig)in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. severe medical condition (lung, hepatic or renal disorder) other than itp. 4.unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7.patients who are deemed unsuitable for the study by the investigator.

Keywords: purpura idiopathic thrombocytopenic purpura
study to evaluate the efficacy and safety of vibegron administered orally for 12 weeks to women with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-ar) agonist, in the treatment of pain associated with irritable bowel syndrome (ibs) due to ibs with predominant diarrhea (ibs-d) or mixed episodes of diarrhea and constipation (ibs-m).


Eligibility criteria:
inclusion criteria: * diagnosis of irritable bowel syndrome (ibs) with predominantly diarrhea (ibs-d) or ibs with mixed episodes of diarrhea and constipation (ibs-m) according to the rome iv criteria * has completed a colonoscopy according to the american gastroenterological association criteria, with no clinically significant findings in the last 5 years * has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the investigator. serum tissue transglutaminase antibody (iga) must be negative. fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (ibd) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator. exclusion criteria: * diagnosis of ibs-c or ibs-u per rome iv criteria * history of chronic idiopathic constipation or functional constipation * structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility * history of a gastrointestinal motility disorder other than ibs (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, parkinsons disease, multiple sclerosis, spinal cord injury) * prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease * planned gastrointestinal or abdominal surgery within the next 6 months * co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to ibs symptoms * symptoms or diagnosis of a medical condition other than ibs that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)

Keywords: irritable bowel syndrome irritable bowel syndrome with predominantly diarrhea (ibs-d) irritable bowel syndrome with mixed episodes of diarrhea and constipation (ibs-m) vibegron beta-3 adrenergic receptor (β3-ar) pain
755nm alex laser for treatment of pigmented and vascular lesions and scars

Conditions: Benign Pigmented and Vascular Lesions and Scars

Summary: evaluation of the safety and efficacy of the 755nm alex laser for the treatment of benign pigmented and vascular lesions and scars


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects between 18 and 85 years of age. 2. subjects with fitzpatrick skin types i to vi. 3. subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars 4. subject who are willing to consent to participate in the study. 4.2 exclusion criteria 1. subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule 2. hypersensitive to light exposure. 3. active localized or systemic infections. 4. taking medication for which sunlight is a contraindication. 5. history of squamous cell carcinoma or melanoma. 6. history of keloid scarring. 7. use of oral isotretinoin (accutane®) within 12 months of initial treatment or during the course of the study. note: skin must regain its normal degree of moisture prior to treatment. 8. prior treatment with laser or other devices in treatment area within 3 months 9. history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. 10. subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period. 11. subjects that the physician determines ineligible based on standard of care treatment. - -
first study to evaluate the capacity of maraviroc drug to protect against hiv infection in samples of rectal mucosa from healthy volunteers

Conditions: HIV

Summary: pre-exposure prophylaxis (prep) is a method of preventing hiv infection through the use of antiretroviral (arv) medications before exposure to hiv. this study will assess the potential of mvc as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of hiv infection in men who have sex with men (msm).

several clinical trials are currently under way evaluating the safety and effectiveness of arv-based prep for preventing hiv infection. the results of the first efficacy trials of arv-based prep showed fewer hiv infections among study participants receiving the study drugs compared to those receiving placebo. although the results are promising, concerns about adherence, pharmacokinetics, and toxicity still needs further exploration so new and more effective preventive pharmacological approaches should be evaluated. this trial will evaluate the safety, pharmacokinetics and efficacy of ex vivo hiv infection of rectal mucosa by the ccr5 antagonist drug maraviroc (selzentry) administered to healthy volunteers. this trial will last approximately one year. twenty-one volunteers will receive mvc 300 mg orally in a single dose. study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. all study visits will include a physical examination, blood collection and storage and in the basal visit and a day 7 or 9 the participants will undergo a colonoscopy. ex vivo hiv infectivity in rectal mucosa biopsies and plasma/mucosa mvc levels will be evaluated.

Eligibility criteria:
inclusion criteria: 1. men who have sex with men (msm) 2. age 18 years or above 3. hiv negative at the time of inclusion 4. signed informed consent exclusion criteria: 1. existence of sexually transmitted infection (sti) or active systemic infection 2. submit a contraindication to rectal biopsy 3. take any drugs concomitantly with interactions with the mvc 4. subject unable to follow protocol

Keywords: hiv, maraviroc, prep, ex vivo infection, rectal mucosa.
post-marketing non-interventional safety evaluation of obizur in the treatment of bleeding episodes for patients with acquired hemophilia a

Conditions: Acquired Hemophilia A

Summary: the overall objective is to enroll patients with acquired hemophilia a (aha) who are prescribed and treated with obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.

this study is a multi-center, uncontrolled, open-label, non-interventional post-marketing safety surveillance study to describe the use of obizur in patients with acquired hemophilia a (aha), and secondarily, where data are available, to describe the hemostatic effectiveness and immunogenicity of obizur. patients should be enrolled at the earliest possible time point after initiating obizur. in an attempt to collect safety and utilization data on patients treated with obizur since food and drug administration (fda) approval in october 2014, baxalta will make an effort to identify all persons treated with obizur and to collect data for as many patients as possible.

Eligibility criteria:
inclusion criteria: 1. participant is ≥18 years of age at the time of informed consent. 2. participant has aha, and is being treated/was treated with obizur. 3. participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required exclusion criteria: 1. participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein. 2. participant has a concomitant bleeding disorder(s) other than acquired hemophilia a (aha). 3. participant has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
intra-operative adductor canal blocks

Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic; Anesthesia

Summary: adductor canal blocks (acb) have been recommended in total knee arthroplasty (tka) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. acb is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sacb) during surgery. however, there is currently very limited data on the clinical efficacy of such sacbs, and no studies assessing this technique in the context tka that are discharged the same day. as such, this randomized control trial (rct) is being done to compare sacbs to conventional anesthesiologist-performed adductor canal blocks (aacb).


Eligibility criteria:
inclusion criteria: 1. male and female patients aged 18 years or older 2. primary tka booked as sdd 3. diagnosis of osteoarthritis exclusion criteria: 1. inability or refusal to sign informed consent form 2. non-english or french speaking, and no licensed translator, family member or substitute decision maker available. 3. non-osteoarthritis primary diagnosis 4. allergy to analgesic medications 5. contraindication to spinal and/or regional anaesthesia 6. any use of opioid pain medication within four weeks of the index procedure(13) 7. pain catastrophizing scale score ≥16 (8, 9, 14) 8. history of cirrhosis 9. history renal insufficiency 10. history or sensory and/or motor neuropathy to the ipsilateral limb 11. simultaneous, bilateral tka 12. non-tka prosthesis 13. scheduled for non-sdd tka. 14. preoperative varus/valgus of \>10 degrees. 15. planned general anaesthetic 16. use of intrathecal morphine
effect of ketone ester supplementation on hypoxic tolerance

Conditions: Ketosis; Hypoxia

Summary: this wp specifically aims to elucidate the effects of iek on hypoxic tolerance and the development and severity of ams symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia.

acute altitude exposure impairs exercise tolerance and performance, decreases the rate of maximal oxygen uptake (v̇o2max), cognitive function and sleep quality, and often also induces symptoms of acute mountain sickness (ams). previous studies have clearly indicated that ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as improve hypoxic tolerance in rodents. in support of these earlier observations, recent pilot experiments in young volunteers in our laboratory provide proof of concept that iek can attenuate oxygen desaturation during exercise in hypoxia. therefore, given that impaired exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in active tissues (brain and muscle), we hypothesize that iek can increase blood and tissue (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic tolerance, as well as improve exercise tolerance and endurance exercise performance.

Eligibility criteria:
inclusion criteria: * males or females between 18 and 35 years old * body mass index (bmi) between 18 and 25 * physically fit and regularly involved in physical activity (2-5 exercise sessions of \> 30min per week) * good health status confirmed by a medical screening * non smoking * normal sleep pattern as assessed by the pittsburgh sleep quality index (psqi, appendix 2) exclusion criteria: * any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise * intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep * intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study. * recent residence or training under hypoxia; more than 7 days exposure to altitude \> 1500m during a period of 3 months preceding the study. * night-shifts or travel across time zones in the month preceding the study * blood donation within 3 months prior to the start of the study * smoking * more than 3 alcoholic beverages per day * involvement in elite athletic training at a semi-professional or professional level * any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Keywords: acute mountain sickness sleep cognitive decline