Kornimate/medical-research-clean huggingface dataset:
solarplast (r) supplementation effects following high-intensity resistance exercise

Conditions: Muscle Damage

Summary: the primary goal of this investigation is to assess whether solarplast (r) supplementation will improve recovery following heavy resistance exercise in active adults. the primary questions to be addressed are: does solarplast (r) decrease muscle damage and inflammation associated with heavy resistance exercise? does solarplast (r) reduce the decline in performance associate with heavy resistance exercise? researchers will compare solarplast (r) to a placebo (a look-alike substance that contains no active ingredients) to see if solarplast (r) is effective at improving recovery. participants will be asked to: take solarplast (r) or placebo daily for 4 weeks visit the laboratory at least once per week to receive their supplement report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.


Eligibility criteria:
inclusion criteria: * recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire. * subject is judged by the investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire) * subject has a body mass index of 18.0-34.9 kg/m2, inclusive * subject is willing to maintain habitual diet throughout the study period * subject is willing to abstain from dietary supplementation throughout the duration of the study. * subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators exclusion criteria: * subject is currently or will be enrolled in another clinical trial. * subject is a habitual consumer of tea/antioxidants defined as \> 8 oz/day of either green or black tea within the 14 days prior to the screening visit. * subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. * subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. * subject is unable to perform physical exercise (determined by health and activity questionnaire) * subject is engaged in an extreme diet including but not limited to, atkins, south beach, intermittent fasting, etc. * subject is allergic to the study product or placebo * subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire) * subject has any chronic illness that causes continuous medical care * taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
effect of conditioning on myocardial damage in stemi

Conditions: ST-elevation Myocardial Infarction

Summary: the lipsia-conditioning trial is an investigater initiated, randomized, single-center study that will assess the effect of different intrahospital conditioning protocols on myocardial damage assessed by mri in patients with acute st-elevation myocardial infarction. the following groups will be compared: 1. combined intrahospital pre- plus postconditioning versus 2. postconditioning versus 3. control

rapid reperfusion of the infarct-related coronary artery is essential to salvage ischemic myocardium in patients with acute st-elevation myocardial infarction (stemi). paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium. this phenomenon is described as 'ischemia/reperfusion injury' and the pathophysiological mechanisms are not fully elucidated. a cardioprotective effect of ischemic preconditioning as well for postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute stemi treated with primary percutaneous coronary intervention. aim of this study is to compare for the first time the combination of intrahospital pre- and postconditioning versus exclusive postconditioning versus control. the primary endpoint of this study will be the salvaged area at risk assessed by cardiac magnetic resonance imaging.

Eligibility criteria:
inclusion criteria: st-elevation myocardial infarction \<12 hours exclusion criteria: * age ≤ 18 years * patients presenting with pregnancy * thrombolysis \<12 hours * patients without informed consent * participation in another trial.

Keywords: stemi, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage
is pentoxifylline able to improve olfactory sensitivity?

Conditions: Olfaction Disorders

Summary: signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. pentoxifylline is a unspecific phosphodiesterase inhibitor. the hypothesis is that pentoxifylline could lead to increased sensitivity to odors.

olfactory signal processing is conducted by a g-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (camp). in the cilia of olfactory sensory neurons (osn) camp is degraded by phosphodiesterase 1c2 (pde1c2). inhibition of pde1c2 could result in an increased response of osn to chemical stimuli. aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.

Eligibility criteria:
inclusion criteria: * hyposmic or functionally anosmic patients tdi-score \<31 * age: 18-50 years * odor threshold: better than 1 * cause of smell loss: post traumatic, postinflammatory, idiopathic exclusion criteria: * normosmic patients, * patients with contraindications for application of pentoxifylline * patients that cannot give written agreement to the study * patients under 18 years and over 50 years of age

Keywords: smell olfaction olfactory sensitivity smell loss chemoreception
axial ablation versus terminal interruption of the reflux source

Conditions: Venous Ulcer

Summary: this randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. it is a non-inferiority trial comparing endovenous ablation of the axial (saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (tirs). for the purposes of this trial tirs will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.


Eligibility criteria:
inclusion criteria primary or recurrent venous leg ulcer long or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for \>0.5 seconds ankle-brachial pressure index (abi) ≥ 0.8 (if ulceration prevents abi toe-brachial index(tbi) ≥ 0.5 acceptable), or a palpable pulse ulcer size between 1 and 200 cm2 patient suitable for full compression bandaging exclusion criteria pregnancy (or breastfeeding and needing to feed within 48 hours of treatment) active infection of ulcer, or infection within the last two weeks leg ulcer of non-venous aetiology as determined by clinical assessment isolated perforator vein reflux only evidence of deep venous insufficiency or thrombosis known hypersensitivity to sotradecol or similar sclerosants previous inability to tolerate compression bandages presence of any contraindications for the use of compression bandages: absence of a palpable pulse, and ankle brachial index (abi) \<0.8 decompensated congestive cardiac failure (nyha class iv) known hypersensitivity to any of the component materials patients unable to provide informed consent patients attending the leg ulcer clinic already will be excluded from enrolment with the same ulcer but will be eligible to enrol with a contralateral ulcer. recurrent ipsilateral ulcers will not be excluded.
jy231(jy231) injection for the treatment of b-cell acute lymphoblastic leukemia(b-all)

Conditions: B-cell Acute Lymphoblastic Leukemia( B-ALL )

Summary: early exploratory clinical study of the safety, tolerability and initial efficacy of jy231 injection in the treatment of b-cell acute lymphoblastic leukemia( b-all )


Eligibility criteria:
inclusion criteria: 1. up to 75 years (child, adult) , either sex, sign informed consent (ice)； 2. histologically confirmed as b cell all ; 3. flow cytometry or histology confirmed positive expression of cluster of differentiation 19(cd19); 4. according to the researcher's assessment, the expected survival period is greater than 3 months; 5. eastern cooperative oncology group(ecog) physical condition score ≤ 3; 6. the patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 × upper limit of normal(uln), which can be relaxed to ≤ 5 × uln for patients with liver invasion; total serum bilirubin \ 30 ml/min; cardiac ejection fraction (ef) ≥ 40%, without pericardial effusion and significant arrhythmia; indoor oxygen saturation(spo2) ≥ 92%; 7. peripheral blood lymphocyte absolute count: absolute lymphocyte count(alc) ≥ 0.5 × 109/l, blood platelet(plt)\>30 × 109/l, hb\>80 g/l, with a single venous access and no other contraindications for blood cell separation; 8. mri examination showed no central involvement of lymphoma; no central nervous system leukemia; 9. individuals with fertility must agree to the use of efficient contraceptive methods; 10. the subject or their legal guardian can understand and voluntarily sign a written informed consent form. exclusion criteria: 1. pregnant or lactating women, as well as women with pregnancy plans within six months; 2. virological tests of hepatitis b, hepatitis c, aids, syphilis and cytomegalovirus were positive; 3. having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity); 4. previously received treatment targeting cd19; 5. received autologous hematopoietic stem cell transplantation within 6 weeks; 6. the presence of uncontrollable active bacterial or fungal infections; 7. allergies to research related drugs or cellular components; 8. active autoimmune diseases exist; 9. patients with unstable or active ulcers or gastrointestinal bleeding currently present; 10. individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation; 11. received other experimental drug treatments within the past 3 months; 12. existence of grade ii-iv acute graft versus-host disease(gvhd) or widespread chronic gvhd; 13. researchers believe that other reasons are not suitable for clinical trial participants.
remicade safety line (ankylosing spondylitis)(study p03275)(completed)

Conditions: Spondylitis, Ankylosing

Summary: this observational study is in line with the german educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with remicade according to the summary of product characteristics (smpc).

this study population was chosen from a non-probability sample.

Eligibility criteria:
inclusion criteria: * subjects with ankylosing spondylitis. exclusion criteria: * as per summary of product characteristics (smpc)
mk0782 + low-dose aspirin 7-day erosion endoscopy study (0782-001)

Conditions: Stomach Ulcer; Duodenal Ulcer

Summary: this study will determine how if mk0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of mk0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * healthy male or non pregnant female * 18 years of age or older (age at consent) * able to abstain from alcohol, tobacco, spicy foods, limit coffee * able to avoid strenuous activity * able to read and fill out a study diary exclusion criteria: * you have participated in an investigational drug study within 4 weeks of entering this study * your weight is not within a specific range for the study * you have a history of gi problems like a gastric ulcer * you have had gastric or intestinal surgery * you have had abdominal or chest surgery * you are currently abusing drugs or alcohol or have a history of abuse * you have a history of psychiatric disorders * you are a smoker or have smoked during the last year
prospective cohort with incident stroke

Conditions: Ischemic Stroke

Summary: the primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. for this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 3, 12, 24 and 36 months.

risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. about 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. the improvement of discrimination including these new variables in the models will be investigated. several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. the model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the prospective csb-stroke cohort.

Eligibility criteria:
inclusion criteria: * age ≥18 years * language: german * first ever acute ischemic stroke that occurred with stroke onset in the last 7 days * written informed consent by patient prior to study participation * willingness to participate in follow-up exclusion criteria: * prior stroke (definition according to who criteria) * patients presenting brain tumour or brain metastasis * participation in an intervention- / amg-study
post-market clinical follow-up on the balansys uni knee prosthesis implanted with a spacer block surgical technique

Conditions: Knee Arthropathy

Summary: the purpose of the study is the evaluation of the clinical and radiological long-term performance of the balansys uni fix in a multicenter routine clinical setting.

prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balansys uni fix knee prosthesis. in total at least 100 participants in 3 clinics are included in this multicenter study. the primary endpoint of the study is the knee society score (kss) 2 years after surgery. the following parameters will be collected during the regular clinical and radiological follow-up: knee society score, knee and osteoarthritis outcome score (koos), radiographic evaluation and detection of adverse events.

Eligibility criteria:
inclusion criteria: * informed consent form (signed by participant and investigator) * primary implantation * age at inclusion: between 18 and 90 years old * willing to participate in the follow-up exclusion criteria: * missing informed consent form * known or suspected non-compliance (e.g. drug or alcohol abuse) * enrollment of the investigator, his/her family, employees and other dependent persons * patient younger than 18 years old * revision surgery * does have a known allergy to metal in medical devices * suffers from acl rupture * pregnancy or in the breast feeding period
safety, effectiveness, and impact on quality of life on long-term administration of oros hydromorphone slow-release in patients with chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of oros hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.

this open label, extension study characterized the safety, effectiveness, and impact on quality of life of oros hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term study do-127 with oros hydromorphone slow release. up to 150 patients were to be enrolled and evaluated. patients were enrolled in this study immediately following study do-127. patients continued their therapy with oros hydromorphone slow release at the stable dose previously identified in the short-term study. the patient's initial prescribed dose of oros hydromorphone slow release in study do-127x was the same as the last dose of oros hydromorphone slow release in study do-127. patients returned monthly for evaluations during this extension interval. adjustments to dose were performed as needed, at the investigator's discretion. the duration of this study was six months. safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of oros hydromorphone (dose will be at investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study

Eligibility criteria:
inclusion criteria: * patients who have chronic low back pain who have successfully completed short-term study do-127 with oros hydromorphone slow release * patients who require at least 8 mg of hydromorphone hci (slow release) every 24 hours for the management of chronic low back pain * patients whose opioid requirements have been stable as demonstrated in short-term study do-127 with oros hydromorphone slow release exclusion criteria: * patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists) * patients who are pregnant or breast-feeding * patients with any gastrointestinal disorder, including pre-existing severe gi narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs * patients with significant cns disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture * patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic

Keywords: chronic low back pain oros hydromorphone slow release tablet quality of life
study of aerosolized liposomal 9-nitro-20 (s)- camptothecin (l9nc)

Conditions: Lung Diseases; Cancer

Summary: to determine the overall response rate to liposomal 9-nitro-20 (s)-camptothecin (l9nc) administered by aerosolization in patients with non-small-cell lung cancer (any stage. to determine toxicity profile of l9nc administered by aerosolization for 5 consecutive days per week x 8 weeks, every 10 weeks. to perform a pharmacology study of l9nc in the plasma, and the lungs after aerosolization. a specific protocol will be written for this part.

this is a single-arm, non-randomized phase ii trial of dlpc-9nc administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks. dose: 0.4 mg/ml of 9-nc in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day x5 every week, x8 weeks, then observe for 2 weeks. one course = 10 weeks. patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course.

Eligibility criteria:
inclusion criteria: * all patients, 18 years of age or older, with resectable lung cancer (any stage) or stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma, who have failed standard chemotherapy or radiotherapy for their disease or who refuse standard therapy are eligible. * patients must have a life expectancy of at least 12 weeks. * patients must have a zubrod performance status of 0-2. * patients must sign an informed consent. * patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \>1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement. * patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and sgot or sgpt \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. * patients must not have a known symptomatic respiratory disease other than cancer, and must have a pulmonary function test equal to \>50% fev1, \>50% fev1/fvc, \>50% tlc, and \>50% dlco of predicted values. exclusion criteria: * patients with symptomatic brain metastases are excluded from this study. * pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception. * patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * any criteria that is borderline and may lead to ineligibility will be reviewed by the pi, who may override the eligibility criteria, after receiving sponsor agreement, if entry into the study is deemed to potentially benefit the patient.

Keywords: phase ii aerosol delivery nsclc 9-nitrocamptothecin