Kornimate/medical-research-clean huggingface dataset:
pancreatitis - microbiome as predictor of severity ii

Conditions: Acute Pancreatitis; Acute Pancreatitis With Infected Necrosis

Summary: the goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. the main questions it aims to answer are: * can the orointestinal microbiome robustly predict the course of acute pancreatitis? * how does the microbiome impact the severity of an acute pancreatitis? buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.

despite intensive research, early prediction of the course of acute pancreatitis (ap) is still not satisfactorily possible. results of a european multicenter study showed that the intestinal microbiome is superior to established scores as a marker of severity in patients with ap. hereby, a classifier was established using 16 differentially abundant rectal species and systemic inflammatory response syndrome (sirs) and achieved an auroc of 85%. surprisingly, all species in the severe ap group were members of taxonomic families known for their short-chain fatty acid (sfca) production. this observation contrasts with translational pancreatitis studies in mice. based on these publications, a clinical trial is currently being initiated to treat severe ap with scfa (nct06147635). however, previous well-designed rct that analyzed the effects of probiotics in predicted severe ap resulted in a worse outcome for patients in the probiotic arm. consequently, national and international guidelines recommend against the usage of probiotics in ap. collectively, more research is needed to further elucidate the role of the oro-intestinal microbiota in the development of severe ap. to validate the results of previously mentioned multicenter study and to profoundly analyze the role of microbial metabolites and the fungeome, patients with ap will be prospectively recruited. 1. buccal and rectal swabs, stool and plasma will be obtained to analyze the orointestinal microbiome and microbial derived metabolites. 2. centers from different continents with different ethical background and dietary habits will enroll patients to gain a more generalizable microbial profile. 3. microbial shifts were observed between severe ap (rac 3) and mild/ moderate severe (rac 1+2). 4. it is expected that the microbial compositions change during the inflammatory process upon early phase of pancreatitis. to minimize this microbial alternating effect a short time frame from hospital admission to recruitment (48h) is set.

Eligibility criteria:
inclusion criteria: * patients with initial diagnosis (\< 48h) of acute pancreatitis * age ≥ 18 years * patients able to understand/ give their written consent exclusion criteria: * recurrent acute pancreatitis (\>2 previous episodes) * clinical or imaging signs of chronic pancreatitis * referred patients with length of hospital stay \> 48h

Keywords: pancreatitis microbiome
outpatient cardiac tele-rehabilitation in a public sports center

Conditions: Acute Coronary Syndrome; Cardiac Rehabilitation; Telerehabilitation; Secondary Prevention; Wearable Electronic Devices; Exercise Therapy

Summary: the aim of this study is to establish an innovative cardiac tele-rehabilitation (ctr) model. it could expands assistance resources through coordination with public administrations, developing a physical exercise program (pep) assistance model in phase ii that resolves the current situation of lack of adherence in the pep due in part to the long waiting time to start it. to sum up this study could improve adherence in cardiac rehabilitation phase iii. it represents an opportunity to validate an innovative model for the realization of the pep for phase ii that could be expanded to other centres.

cardiac rehabilitation (cr) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. the use of new information and communication technologies (ict) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (ctr) and proving to be safe. the investigators intend to evaluate a new model of cr in phase ii in acute coronary syndrome (acs), based on the implementation of the physical exercise program (pep) in a public sports centre (psc) with tele-monitoring by means of a wearable electronic device, s-patch3-cardio, to compare the adherence of a pep based on a ctr-psc model with the traditional in-hospital program (pep-h) maintaining the efficacy and safety of the cr program. patients with recent stratified acs of low and / or moderate risk will be included who will be randomly assigned to the pep-h group who will perform 18 pep sessions with strength training and cardiorespiratory resistance in a hospital, or a ctr-psc group that performs the 18 sessions of the pep with strength training and cardiorespiratory resistance in the psc. all patients will perform the rest of the cr program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 workshops in a cardio-healthy classroom.

Eligibility criteria:
inclusion criteria: * recent acs (1-12 months) of low / moderate risk for the realization of a pep and without physical impediments for it * availability of a mobile phone with android operating system where you can install the s-patch3-cardio application * patients who recognize that they are trained to operate the s-patch3-cardio device after being instructed in its operation and perform a 24-hour simulation. * signature of informed consent exclusion criteria: * baseline ergospirometry that does not reach maximalist criteria (respiratory quotient\> 1.1) * mental disability * associated comorbidity that prevents performing pep

Keywords: cardiac rehabilitation telerehabilitation secondary prevention wearable electronic devices exercise therapy
a "negative"dendritic cell-based vaccine for the treatment of multiple sclerosis: a first-in-human clinical trial

Conditions: Multiple Sclerosis

Summary: a first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with tolerogenic dendritic cells (toldc), generated using good manufacturing practice (gmp) will be conducted. in doing so, the feasibility and safety of administering myelin-derived peptide-pulsed toldc in patients with ms will be assessed.

a phase i dose-escalating clinical trial will be conducted in a coordinated and comprehensive manner to determine safety and tolerability, and to enable selection of a suitable dose regimen for phase ii trials. the primary objective of the phase i study will be to determine whether toldc-based therapy is safe and well tolerated and to establish the dose-response, with clinical relapse rates, neurological disability (assessed using various scales) and mri endpoints, measured over 12 months. patients will serve as their own controls pre- and post-vaccination. completion of screening assessments and confirmation of eligibility criteria should take no longer than 6 weeks. first-line treatments will be stopped 6 weeks before baseline at the latest.

Eligibility criteria:
inclusion criteria: * ms according to 2010 revised mcdonald criteria (76); * expanded disability status scale (edss) of 0-6.5 inclusive; * disease duration of maximum 15 years and first signs or symptoms at least 6 months prior to enrolment in the study; * active ms (relapsing and progressive): -1 relapse in the past year and/or * at least 1 enhancing lesion on brain mri in the past year * new or enlarging t2 lesion(s) in comparison with a reference scan from maximum 1 year before * neurologically stable with no evidence of relapse for at least 30 days prior to start of screening and throughout during the screening phase; * positive t cell reactivity response to a mix of 7 myelin-derived peptides; * able to sign informed consent; * ability to comply with the protocol assessments; * appropriate venous access. * use of adequate contraceptive measures exclusion criteria: * previous use of immunosuppressive or cytostatic treatment, including mitoxantrone, alemtuzumab or bone marrow transplantation or stem cell transplantation at any time prior to enrolment; * treatment with fingolimod or natalizumab or dimethylfumarate or teriflunomide within the last 3 months prior to study enrolment; * pregnancy or planning pregnancy in the next 12 months and breast feeding; * drug or alcohol abuse; * inability to undergo mri assessments; * history of or actual signs of immunodeficiency or malignancies; * concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease; * hepatitis b, c, hiv, syphilis or tuberculosis * splenectomy; * dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.

Keywords: patient safety tolerogenic dendritic cells toldc
a phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.

Conditions: Pulmonary Arterial Hypertension

Summary: a phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * current diagnosis of either pph or pah secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or hiv infection at the screening visit * right heart catheterization, completed prior to screening visit must meet pre-specified hemodynamic criteria * female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit * male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the informed consent form exclusion criteria: * pah due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea * portopulmonary hypertension * bosentan within four weeks prior to screening * phosphodiesterase type v inhibitor or chronic prostanoid therapy within four weeks prior to screening * iv inotrope use within two weeks prior to screening * alt or ast lab value that is greater than 1.5 times the upper limit of normal * pulmonary function tests not meeting pre-specified criteria * contraindication to treatment with an era * history of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years * females who are pregnant or breastfeeding
bioequivalency study of famciclovir 500 mg tablets under fed conditions

Conditions: Herpes

Summary: the objective of this study was to prove the bioequivalence of famciclovir 500 mg tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.

Keywords: treatment of herpes
perioperative sleep quality and postoperative pain outcomes

Conditions: Surgery; ACL Injury; Pain; Sleep

Summary: this is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. the investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. they will then compare postoperative pain and opioid use between groups for two weeks following surgery. for a secondary aim, investigators will use electronic medication vials (ecap) to monitor participants' medication use at home and compare to self-reporting.


Eligibility criteria:
inclusion criteria: * able to read, understand, and speak english * are undergoing acl repair or reconstruction * have availability of a mobile device/computer to receive text messages exclusion criteria: * \ 18 years of age * have a history of sleep-disordered breathing including sleep apnea * have a history of chronic pain or current opioid use * have a history of developmental delay that would preclude study participation
progressive relaxation exercises on anxiety levels

Conditions: Anxiety; Exercises Therapy; Total Knee Replacement Surgery

Summary: the research will be conducted to determine the effect of progressive relaxation exercises on the anxiety level of patients who have had total knee replacement surgery.

the sample will not be selected from the universe and all patients who meet the inclusion criteria will constitute the sample. the minimum sample size of the study was determined by performing power analysis with the g-power 3.1.9.4 program. in the calculation made according to the two-way independent samples t-test, the effect size was taken as 0.80, with a margin of error of 0.05 and a power of 90%, the total sample number was calculated as 60 (cohen, 1998). considering the losses within the scope of the study, 66 patients who meet the inclusion criteria will be randomly divided into the experimental group (33 patients) and the control group (33). finally, in order to minimize the risk of contamination, the first 33 patients who meet the inclusion criteria after being admitted to the clinic will constitute the control group, and the following 33 patients will constitute the experimental group. data will be collected using the 'patient identification form' and the 'beck anxiety scale'. progressive relaxation exercises were first applied by dr. it is a technique of voluntary muscle contraction and relaxation developed by edmund jacobson in the 1920s. the main purpose of progressive relaxation exercises is for patients to understand the difference between muscle relaxation and tension and to be able to relax on their own. it combines the contraction and relaxation of large muscle groups such as the face, arms, legs, neck and back with deep breathing exercises. before applying progressive relaxation exercises, the environment should be quiet, dimly lit, in a comfortable chair or armchair, sitting or lying down, and clothing should be loose and comfortable, and it is recommended to apply it one hour after eating. in the application of progressive relaxation exercises, it is first asked to breathe regularly. after our breathing rhythm is regulated, the hands, arm muscles, shoulder and neck muscles, chest, abdominal and hip muscles, legs, feet and facial muscles are contracted with a 5-7 second breathing exercise and relaxed during exhalation. this is repeated with 4-5 breathing exercises for each muscle and the exercise is ended when the eyelids are opened.

Eligibility criteria:
inclusion criteria: * being 18 years old and above * speaking and understanding turkish * having total knee replacement surgery * staying in the ward for approximately 96 hours after surgery * volunteering to participate in the study * not having a psychiatric diagnosis exclusion criteria: * being under 18 years old * having speech and comprehension problems * not having total knee replacement surgery * early discharge after surgery * having complications after surgery * not volunteering to participate in the study * having a psychiatric diagnosis

Keywords: anxiety exercises total knee replacement surgery
a study of avastin (bevacizumab) in combination with mfolfox-6 or folfoxiri in patients with metastatic colorectal cancer.

Conditions: Colorectal Cancer

Summary: this 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with avastin in combination with 5-fu, leucovorin and oxaliplatin with irinotecan (folfoxiri) or without irinotecan (mfolfox-6) as first line treatment. patients will be randomized to receive avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. the anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * unresectable liver metastasis secondary to cancer of colon or rectum; * scheduled for standard first line chemotherapy; * ecog performance score of 0 or 1; * condition feasible for major abdominal surgery after first line treatment. exclusion criteria: * diagnosis of metastatic disease \>3 months prior to study entry; * evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes; * prior systemic or local treatment of metastatic disease; * prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry; * history or evidence of cns disease unrelated to cancer.
an open dose-finding study of oral applied hexaminolevulinate (hal) imaging in patients with suspicion or high risk of neoplasia in the colon

Conditions: Colon Cancer

Summary: the purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.

carcinoma of the lower gi-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients. the primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of hal fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. the secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of hal fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of hal fluorescence colonoscopy.

Eligibility criteria:
inclusion criteria: * female and male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy * female and male patients with verified neoplastic lesions exclusion criteria: * known or strong suspected porphyria * contraindications to colonoscopy
cetuximab combined with irinotecan in first-line therapy for metastatic colorectal cancer (crystal)

Conditions: Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer

Summary: drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. however, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. this open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-fluorouracil (5fu)/folinic acid (fa) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (egf) receptor. patients expressing this egf receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). an independent safety board of experts will also monitor safety data. after participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator. the entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.


Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * inoperable metastatic disease * immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue * presence of at least 1 bi-dimensionally measurable index lesion exclusion criteria: * previous irinotecan-based chemotherapy * previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment * radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment * brain metastasis

Keywords: metastatic colorectal cancer egfr irinotecan cetuximab first-line treatment
the role of tomotherapy in hypofractionated/dose escalated conformal radiation treatment for high risk prostate cancer

Conditions: Prostate Cancer

Summary: helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. the radiation to the gross disease in the prostate is hypofractionated and dose escalated. magnetic resonance spectroscopic imaging (mrsi) is incorporated into pre- and post-treatment evaluation.


Eligibility criteria:
inclusion criteria: * high risk localized prostate cancer exclusion criteria: * low/intermediate risk, metastatic cancer * patient refusal

Keywords: tomotherapy mrsz high risk prostate cancer
doac in unusual site venous thrombosis

Conditions: Splanchnic Vein Thrombosis; Cerebral Vein Thrombosis; Ovarian Vein Thrombosis; Renal Vein Thrombosis; Retinal Vein Thrombosis

Summary: unusual site venous thromboembolism (vte) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (svt), cerebral vein thrombosis (cvt), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. the use of the novel direct oral anticoagulants (doac), thrombin or factor xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual vte in clinical practice is increasing. through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the doac for the treatment of unusual site vte and to assess the safety and effectiveness of this approach in real life clinical practice.


Eligibility criteria:
inclusion criteria: * objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries * treatment with one of the doac (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) exclusion criteria: • enrolment in interventional studies evaluating the doac for the treatment of unusual site vte