Kornimate/medical-research-clean huggingface dataset:
effect of tu-100 on gastrointestinal and colonic transit in humans

Conditions: Postoperative Ileus

Summary: the purpose of this study is to compare the dose related effects of orally administered tu-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.


Eligibility criteria:
inclusion criteria: * subject is willing and able to provide written informed consent * males and non-pregnant, non-breastfeeding females; * subject is willing to undergo multiple radionuclide scans * subject bmi is between 18 and 35 kg/m2 * subject has a negative urine drug screen * subject has screening laboratory values that are within normal range for the analyzing laboratory exclusion criteria: * structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. * unable to withdraw medications 48 hours prior to the study: * alter gi transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, ssri and newer antidepressants. * analgesic drugs including opiates, nsaid, cox 2 inhibitors * gabaergic agents * benzodiazepines note: low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible. * female subjects who are pregnant or breast feeding. * clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. * history of allergic reactions to ginseng, ginger, and sichuan pepper. * history of lactose intolerance. * subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers. * subjects who have participated in another clinical study within the past 30 days.

Keywords: gastric emptying small bowel transit colonic transit whole gut transit postoperative ileus
post-approval study for the mosaic® bioprostheses

Conditions: Aortic Valve Stenosis and/or Insufficiency; Mitral Valve Stenosis and/or Insufficiency

Summary: a single center non-interventional post-market release, long term follow up study of patients who underwent isolated aortic valve replacement or isolated mitral valve replacement with a medtronic mosaic bioprosthesis. the purpose of this study is to evaluate the long term safety, efficacy and clinical performance of the mosaic bioprostheses.

objectives: the primary objectives of this study are to evaluate the long-term safety, efficacy and clinical performance. study design: this is a prospective, single center, non-interventional, non-randomized, post-market release clinical study sample size and study duration: a total of 255 patients had aortic valve replacement and 47 patients had mitral valve replacement in the albertinen-krankenhaus (hamburg, germany) during the previous mosaic pre-market approval (pma) study. all surviving patients from the mosaic pre-market approval study at this center, will be invited to participate. approximately 225 patients will be invited. this study is intended to serve as an ongoing source of information on long-term durability and safety of the ce-marked medtronic mosaic bioprosthesis. as such the study is to continue indefinitely until the last follow-up visit (until patient study exit due to patient death, withdrawal of patient consent,...) of the last study patient. patient selection: inclusion criteria: * all patients who were enrolled and implanted with the mosaic bioprosthesis in the albertinen-krankenhaus (hamburg, germany) during the previous mosaic pma study, will be invited to participate in this long- term follow-up study. * patients who are able to provide informed consent exclusion criteria: * patients who are not from the albertinen-krankenhaus (hamburg, germany) and who did not participate in the mosaic pma study are ineligible for this study. * patients refusing or not able to provide informed consent. * patients not willing and unable to comply with the clinical investigation plan (cip)-requirements. data requirements and analysis: for each patient enrolled in the study, information will be collected annually. data will be collected on the patient status and device hemodynamic performance by echocardiography. patient identity is anonymized. appropriate statistical analysis will be performed for the collected clinical data.

Eligibility criteria:
inclusion criteria: * all patients who were enrolled and implanted with a mosaic bioprosthesis in the albertinen-krankenhaus (hamburg, germany) during the previous mosaic pma study, will be invited to participate in this long-term follow- up study. * patients who are able to provide informed consent exclusion criteria: * patients who are not from the albertinen-krankenhaus (hamburg, germany) and who did not participate in the mosaic pma study are ineligible for this study. * patients refusing or not able to provide informed consent. * patients not willing and unable to comply with the cip-requirements
comparing different startegies of positive pressure ventilation in children

Conditions: Ventilation Therapy; Complications

Summary: the most basic modes of mechanical ventilation are volume-controlled ventilation (vcv) and pressure-controlled ventilation (pcv). vcv guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (ppeak) during the gas insufflation . in pcv mode, on the other hand,

the laryngeal mask airway (lma) provides a useful alternative for airway management during general anaesthesia. inflation of the lma cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (ppv). the use of lma as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. in addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. however, the ventilation volume varies according to the patient's respiratory mechanics . pressure-controlled ventilation-volume guaranteed (pcv-vg) combines the advantages of both vcv and pcv, which delivers a stable ventilation volume using a decelerating flow pattern.

Eligibility criteria:
inclusion criteria: 1. age between 1 and 5 years. 2. patient scheduled for laparoscopic inguinal hernia repair. 3. american society of anesthesiologists classification of physical status of i-ii. exclusion criteria: 1. cardiopulmonary disease. 2. severe hepatorenal dysfunction. 3. history of upper respiratory tract infection 2 weeks before the operation. 4. overweight \[more than 20% of standard body weight\]. 5. neuromuscular disease. 6. anticipated difficult airway. 7. hiatus hernia or gastroesophageal reflux disease.
inflammatory bowel disease (ibd) research registry

Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Summary: patients seen at the center for inflammatory bowel disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their inflammatory bowel disease to be placed in center's research registry for the purpose of facilitating retrospective research studies directed at inflammatory bowel disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving inflammatory bowel disease. information obtained from the inflammatory bowel disease registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of ibd and may permit the development of better therapies and the potential for preventive therapies.


Eligibility criteria:
inclusion criteria: all patients age 18 and above seeking medical care at the center for inflammatory bowel diseases clinic at upmc exclusion criteria: n/a
diagnostic importance of the c-reactive protein from blood and saliva in children with acute appendicitis

Conditions: Acute Appendicitis

Summary: diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. c-reactive protein in blood can be elavated in children with acute appendicitis. the aim of this research is to compare the diagnostic value of c-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.


Eligibility criteria:
inclusion criteria: * children with age from 5 to 17 with acute abdominal pain * children with clinical signs of appendicitis exclusion criteria: * previous diagnosis of chronic and/or malignant disease * children wich had previous abdominal surgery * pregnancy
post-exercise hypotension after a power training session in older adults with hypertension

Conditions: Hypertension

Summary: the main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. as secondary outcomes, the investigators compared post-exercise hypotension, bp variability, and endothelial function between older men and women with hypertension. the working hypothesis was that a single bout of power exercise would decrease both office and 24 h bp in comparison to a non-exercising control session and men and women would respond differently after a power training session.

participants randomly performed two experimental sessions: power exercise training (pt) and non-exercising control at seated rest (con). they maintained their current antihypertensive medications throughout the trial. each session was composed of 20 min of rest in the supine position, 40 min of pt or con protocols, and 60 min of rest in supine position after protocols. the pt was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-rm and two-minute intervals between sets and exercises. the concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. during the con, the participants remained seated rest on the same exercise machines, but without any exercise. standardized office bp was performed before and during the first hour (in intervals of 15 min) after exercise and control sessions. together with the office bp evaluation in the pre and post sessions, the endothelium-dependent brachial vascular function was evaluated using flow-mediated dilation. afterwards, participants underwent 24h ambulatory bp monitoring..

Eligibility criteria:
inclusion criteria: * office blood pressure between 130-179 and 80-110 mmhg for systolic and diastolic blood pressure, respectively; * non-engaged in structured programs of exercise for the last 3 months since the beginning of this study; * able to perform the proposed exercises. exclusion criteria: * underlying cardiovascular disease previously diagnosticated by a doctor, occurred in the last 24 months, such as: acute myocardial infarction, angina, stroke or heart failure; * diseases that reduce life expectancy; * smokers and ex-smokers for less than six months; * bmi \> 39.9 kg/m² * diabetic proliferative retinopathy.

Keywords: exercise aging ambulatory blood pressure monitoring power exercise
microdrilling surgery for full thickness chondral lesions of the knee augmented with concentrated bone marrow aspirate, platelet rich plasma and hyaluronic acid

Conditions: Unilateral Primary Osteoarthritis of Knee; Osteoarthritis Knee; Degeneration; Articular Cartilage, Knee; Degenerative Lesion of Articular Cartilage of Knee

Summary: this study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (bmac), platelet rich plasma (prp) and hyaluronic acid (ha).


Eligibility criteria:
inclusion criteria: mri-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis. exclusion criteria: * inflammatory arthritis * body mass index (bmi) greater than 35 * presence of significant varus or valgus knee instability or unusually stiff knee * greater than 50% deviation of the mechanical axis * presence of active cardiac disease * presence of active pulmonary disease * prior septic arthritis of the involved joint * presence of active bacterial or mycobacterial infection * presence of a known hypercoagulable state * pregnant or lactating females * subject known to be positive for hepatitis b, hepatitis c, or hiv * known allergy to hyaluronic acid * patients who are unable or unwilling to participate fully in post-operative physical therapy * patients with a contraindication to mri scanning * any disorder that compromises ability to give consent or comply with study procedures * patients who are felt to be at significantly increased risk for elective orthopedic surgery * non-ambulatory patients * patients with cognitive impairment
safety and efficacy of enteric-coated mycophenolate sodium (ec-mps) plus valsartan in patients with kidney transplants (mythos

Conditions: De Novo Renal Transplantation

Summary: the primary aim of this study is to evaluate the safety and efficacy of ec-mps plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with ec-mps plus standard practice of care in recipients of a first cadaver donor kidney transplant given csa-me, basiliximab, and short-term steroids.


Eligibility criteria:
inclusion criteria 1. male and female patients aged 18 to 70 years 2. patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive csa-me and anti-cd25 antibody as primary immunosuppression; 3. patients able to receive the first dose of ec-mps within 48 hours of graft reperfusion exclusion criteria 1. multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ. 2. recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours 3. recipient who is hla-identical to the donor 4. patients with a pra level (past or current level) higher than 50% 5. patients with a known hypersensitivity to ec-mps or other components of the formulation (e.g. lactose). 6. patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dl at screening or baseline. 7. hiv-positive 8. positive hbsag test for both donor and recipients. 9. unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure nyha class iii-iv or hemodinamically significant valvular heart disease 10. liver injury as indicated by transaminase serum levels (alt and/or ast) greater than 2 x uln 11. creatinine kinase (ck) levels greater than 5 x uln. additional protocol-defined inclusion/exclusion criteria may apply

Keywords: renal transplantation, ec-mps
a study to check how often people treated with darvadstrocel for crohn's disease are diagnosed with cancer

Conditions: Crohn Disease; Complex Perianal Fistula

Summary: the main aim is to learn about the risk of cancer after treatment with darvadstrocel compared to other standards of care in people with crohn's disease (cd). in this study, the study doctors will review each participant's past medical records. this study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

this is a retrospective, non-interventional study of participants with complex perianal fistula in crohn's disease (cpf-cd). this study will assess tumorigenicity risk and all-cause and cancer-specific mortality in participants with darvadstrocel. the study will enroll approximately 5850 participants. data will be collected retrospectively from european secondary data sources. participants will be assigned to two cohorts: * darvadstrocel cohort * matched control cohort: alternate soc. this multi-center trial will be conducted in france, germany, netherlands, and spain. the overall duration of the study will be approximately 96 months, including index period (the time in which eligible participants are included in the study) and 12 months follow-up period.

Eligibility criteria:
inclusion criteria: darvadstrocel cohort 1. participants will be included in the darvadstrocel cohort if they have at least one record of prescription/dispensation/administration of darvadstrocel at some point during the study period. comparator cohort 1. a comparator cohort of controls (matched control cohort) will be composed of participants with cd and pf randomly selected from a pool of eligible participants with no history of administration of darvadstrocel. exclusion criteria: 1. has less than 12 months of uninterrupted data within country-specific data source prior to index date. 2. has not meet quality indicators for country-specific data source (if applicable). 3. has diagnosis of cancer prior different from non-melanoma skin cancer to index date. this will minimise the misclassification of prevalent or metastatic cancer as incident cases for the analysis of the study objectives. 4. has diagnosis of ulcerative colitis at any point during the study period and medical history period. this will avoid potential ascertainment bias as there is currently no gold standard for differential diagnosis in ibd. approximately 5 percent (%) to 15% of cases do not meet strict criteria for either ulcerative colitis (uc) or cd and in up to 14% of participants classified as uc and cd, the diagnosis changes over time. 5. has record of proctectomy or colectomy prior to index date. proctectomy and colectomy are considered "last chance" surgery options for anal fistulas or other complications of cd. these participants are not the target population for darvadstrocel. they would not be eligible for darvadstrocel administration and loss of their gastrointestinal tract would affect the risk of colorectal cancer; the most common cancer associated with cd.

Keywords: drug therapy
hcg priming in women with low ovarian reserve

Conditions: Infertility, Female; Ovarian Reserve; In Vitro Fertilization

Summary: the aim of this trial is to examine the possible effects of hcg administration for eight weeks prior to ivf/icsi in women with low ovarian reserve. primary outcome is the proportion of the antral follicle count that reach the pre-ovulatory stage.

one of the fundamental goals in in vitro fertilisation (ivf) is obtaining a high number of good quality oocytes, in order to select and transfer embryos with the highest possible implantation potential thereby optimizing the chance of a pregnancy and ultimately a live birth. this is done by applying an individualized controlled ovarian stimulation (icos) protocol, primarily based on ovarian reserve markers like antral follicle count (afc) and anti-müllerian hormone (amh), when deciding the follicle stimulating hormone (fsh) stimulation dose. certain patients, the so called "poor ovarian responders' (pors), pose a clinical challenge because they have a poor ovarian reserve and develop a limited number of pre-ovulatory follicles in respond to ovarian stimulation despite high fsh stimulation doses, thus experiencing reduced live birth rates. the aim of the present study is to examine the possible effects of long-term lh activity by the administration of hcg for eight weeks in between two identical ivf/icsi cycles and compare cycle characteristics and outcome. the primary outcome is the follicular output rate (fort) which reflects the proportion of antral follicles at the start of controlled ovarian stimulation that reaches the pre-ovulatory state. secondary outcomes include amongst others amh and antral follicle count at baseline (cd 2-3), number of pre-ovulatory follicles, oocytes retrieved, and embryos developed. we hypothesize that eight weeks of androgen priming by hcg increases the proportion of antral follicles that reaches the pre-ovulatory state during controlled ovarian stimulation for ivf/icsi in women with poor ovarian reserve.

Eligibility criteria:
inclusion criteria: * regular menstrual cycle (23-35 days) * 1.-5. ivf/icsi cycle at inclusion * amh \< 6.29 pmol/l (elecsys® amh assay) exclusion criteria: * uterine malformations or hydrosalpinx * submucosal uterine myomas * uterine polyps * allergy to standard ivf/icsi medication * endometriosis stage iii-iv * severe comorbidity * preimplantation genetic testing * testicular sperm aspiration/extraction * tumors in the hypothalamus or pituitary gland * active thromboembolic disease

Keywords: ivf poor ovarian reserve controlled ovarian stimulation ovarian stimulation hcg priming
conmed helixar™ electrosurgical generator with argon beam coagulation technology study

Conditions: Mastectomy; Lymphedema

Summary: a prospective, randomized, controlled study to evaluate device efficacy between the helixar electrosurgical generator (heg) vs. conventional electrosurgical coagulation (cec) for cutting and/or coagulation of tissue during mastectomy procedures

the objective of this study is to evaluate device efficacy between the helixar electrosurgical generator (heg) and conventional electrosurgical coagulation (cec) systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery. the study is designed and powered to demonstrate the superiority of the heg to cec in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. these outcomes will be evaluated in a controlled population undergoing mastectomy procedures.

Eligibility criteria:
inclusion criteria: 1. 18 to 80 years of age; 2. capable and willing to give informed consent; 3. acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. all subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest. exclusion criteria: 1. advanced refusal of blood transfusion, if necessary; 2. active systemic or cutaneous infection or inflammation; 3. pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4. uncontrolled diabetes mellitus 5. known, significant history of bleeding diathesis, or coagulopathy, or von willebrand's disease or current platelet count \< 100,000 cells/mm3, or baseline inr ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6. severe co-existing morbidities having a life expectancy of less than 30 days; 7. currently involved in any other investigational clinical studies that could influence outcomes; 8. significant anemia with a hemoglobin level less than 10 g/dl or a hematocrit less than 30%; 9. renal insufficiency (serum creatinine of \> 2.5 mg/dl); 10. females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 11. patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.

Keywords: comparison of ablation devices