Kornimate/medical-research-clean huggingface dataset:
study to evaluate dietary modification in patients with functional dyspepsia.

Conditions: Dyspepsia; Dietary Modification

Summary: the purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (fodmap) diet in functional dyspepsia (fd). the investigators will compare education in the low fodmap diet to a standard healthy diet for improving symptoms in fd.

functional dyspepsia (fd) is defined by the rome iii criteria as bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning in the absence of structural or systemic disease that can explain the symptoms. these symptoms have been present for at least 3 months with symptom onset 6 months prior to the diagnosis. the low fermentable oligo-di-monosaccharides and polyols (fodmap) diet has been studied in irritable bowel syndrome (ibs) patients and has been shown to have modest benefit in a limited number of small studies. the diet is generally started by complete elimination of fructose, lactose, fructans, galactans, and polyols. following symptom improvement, these groups are reintroduced one at a time while the patient monitors for symptoms. although the low fodmap diet has never been formally studied in patients with functional dyspepsia, we have noted the fd patients report improvement in their symptoms on the diet. this improvement could be explained by reduction in duodenal and gastric distention with the low fodmap diet or a change in the duodenal flora. to date, there have been no randomized trials evaluating dietary modification in fd. the purpose of this study is to evaluate the efficacy of the low fodmap diet in functional dyspepsia. the investigator's hypothesis is that the addition of the fodmap diet to standard medical treatment will result in improved symptom control in patients with functional dyspepsia.

Eligibility criteria:
inclusion criteria: * men and women 18 years and older * diagnosis of fd with either pds or eps as measured by rome iii criteria * patients describing inadequate relief of dyspepsia symptoms * endoscopy performed in the last 3 years and negative for an organic cause for dyspeptic symptoms * h pylori negative by non-invasive testing or biopsy. patients with a history of successfully eradicated h pylori will be included if follow-up testing by stool antigen, urea breath testing, or biopsy is negative * celiac disease excluded by serologies or biopsy exclusion criteria: * patients with ibs predominant symptoms that are not well controlled * patients with a diagnosis of gerd who have uncontrolled heartburn * history of esophagitis, ulcer disease, or other organic upper gi disease, including a diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper gi tract * history of surgery involving the esophagus, stomach, or duodenum * known lactose intolerance, unless symptoms persist on a lactose free diet * known fructose intolerance unless symptoms persist on a fructose free diet * patients undergoing active titration of any medications * pregnant or breastfeeding women * prisoners

Keywords: functional dyspepsia low fodmap dietary modification
aqueous vs alcohol chlorhexidine skin preparation for prevention of cesarean section wound infections

Conditions: Surgical Site Infection; Cesarean Section; Infection

Summary: this will be a single-center randomized control trial comparing the efficacy of two different formulations of chlorhexidine surgical skin preparation in preventing cesarean section wound infections. participants will be randomized to either 4% chlorhexidine gluconate aqueous solution (chg) or 2% chlorhexidine with isopropyl alcohol (chg-ipa) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. there will also be a cost-effectiveness analysis of the two preoperative skin preparations.


Eligibility criteria:
inclusion criteria: * women undergoing cesarean delivery at magee women's hospital exclusion criteria: * inability to obtain consent (language barrier, emergency cesarean section etc.) * allergy to chlorhexidine or alcohol * chorioamnionitis * emergency cesareans where cannot wait for chlorhexidine alcohol to dry * bowel injury at time of cesarean section * women who are delivered at another institution and are transferred postpartum to magees women's hospital
structured stroke management improves outcome at 6 months

Conditions: Stroke

Summary: background/aim of the study: to further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data. methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. the intervention consists of a structured therapeutic chain of 290 collaborating gps, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (los) and the quantitative analysis of physical and psychosocial impairments. the data are directly compared with the same endpoints of the swiss subgroup of the international stroke trial (ist).


Eligibility criteria:
inclusion criteria: * an acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (icb)) with the signs and symptoms of an acute stroke according to the world health organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention * no thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the swiss cohort of the ist trial * the informed consent of the patient or, if not possible, of the relatives * living at home before the event * lack of participation in another trial. exclusion criteria: * thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the swiss cohort of the ist trial * no informed consent of the patient or, if not possible, of the relatives * not living at home before the event * participation in another trial (26 patients were excluded because of tia with full recovery within 24 hours after the event)

Keywords: stroke treatment rehabilitation stroke chain stroke unit
to assess the bioequivalence of brotizolam tablets 250 mcg vs. lendormin tablets 250 mcg administered to healthy adult volunteers

Conditions: Healthy

Summary: the objective of the study was to assess the bioequivalence of lendormin tablets (delpharm reims) vs. lendormin tablets (synmosa biopharma co. ltd.) following oral administration


Eligibility criteria:
inclusion criteria: 1. healthy volunteers, provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. 2. healthy adult male, aged between 20 and 40 years old. 3. body mass index (bmi) between 18.5 and 25, inclusive, (bmi will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]). 4. physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram. 5. no significant deviation from normal biochemistry examination. 6. no significant deviation from normal haematology examination. 7. no significant deviation from normal urinalysis examination. exclusion criteria: 1. history of drug or alcohol abuse within the past one year. 2. medical history of allergic asthma or sensitivity to analogous drug. 3. evidence of chronic or acute infectious diseases from 4 weeks before the study. 4. evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. 5. ongoing peptic ulcer and constipation. 6. planned vaccination during the time course of the study. 7. taking any clinical investigation drug from 3 months before the study. 8. use of any medication, including herb medicine or vitamins from 4 weeks before the study. 9. donation of greater than 250 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing. 10. a positive hepatitis b surface antigen or positive hepatitis c antibody result. 11. a positive test for hiv(human immunodeficiency virus) antibody.
evaluation of vx-121/tezacaftor/deutivacaftor in cystic fibrosis (cf) participants 1 through 11 years of age

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of vx-121/tezacaftor/deutivacaftor (vx-121/tez/d-iva) in cf participants with at least 1 triple combination responsive (tcr) mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.


Eligibility criteria:
key inclusion criteria: * participants with stable cf and at least 1 tcr mutation (including f508del) in the cftr gene key exclusion criteria: * history of solid organ, hematological transplantation, or cancer * hepatic cirrhosis with portal hypertension, moderate hepatic impairment (child pugh score 7 to 9), or severe hepatic impairment (child pugh score 10 to 15) * lung infection with organisms associated with a more rapid decline in pulmonary status other protocol defined inclusion/exclusion criteria may apply.
trial of 6% hes130/0.4

Conditions: Hypovolemia; Hemorrhage

Summary: the study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% hes130/0.4 and 6% hes70/0.5, salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. the primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. it is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.


Eligibility criteria:
inclusion criteria: * patients with an expected blood loss of ≥ 300 ml undergoing elective orthopedic surgery * patients with a body weight (bw) ≥ 50 kg exclusion criteria: * known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs * asa classification ≥ iv * renal disease (serum creatinine ≥ 2mg/dl) * known bleeding disorders * congestive heart failure * fluid overload * intracranial bleeding * severe hypernatremia * severe hyperchloremia

Keywords: hypovolemia surgical blood loss orthopedic procedures treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
cataract lens hardness based on phaco tip resistance

Conditions: Cataract Senile

Summary: phacoemulsificaton tip elongation depends upon voltage once resonant frequency of piezoelectric crystals has been reached. purpose of the study is to record voltage data of 20 consecutive cataract surgeries in order to evaluate correlation between voltage and locs classification of lens nuclei using a system that deploys a feedback mechanism capable of keeping invariant elongation regardless of enountered resistence

the r-evolution (optikon 2000 rome, italy) phaco machine is equipped with a patented system named "minimal stress" that used the direct piezoelectric effect from the resonant ceramics that drive the phacoemulsificator tip to assess in real time and adjust phaco tip elongation that continuously varies according to encountered resistance. after priming in balanced salt solution, phaco tip elongation and the amount of potential difference (voltage) needed to obtain a ginev elongation in balanced solution is assessed. once the phaco tip is used during surgery, the resistence offered by the crystalline lens material to the phaco tip reduces actual elongaton which in turn reduces the voltage produced by the directo piezometric effect. the machine uses voltage produced by actual elongation to adjust the diving voltage and therefore can ensure accurate pahco tip elongation under any condition of lens material resistance. purpose of the study is to record driving voltage and its variations and evaluate if there is a correlation between phaco tip resistence and drving voltage. this is evaluated both in vitro activating the phaco tip in increasingly dense glycerol solutions and in real life phaco surgery recording the voltage requested by phaco tip resistence and correlating it to the classification of lens opacity (locs iii system) clinically used to grade cataract hardness.

Eligibility criteria:
inclusion criteria: diagnosis of nuclear or cortical cataract exclusion criteria: previous ocular trauma, previous ocular surgery, connective tissue disease
pharmacogenomic analysis in pediatric acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia, Pediatric; Adverse Drug Event

Summary: this is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

the study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

Eligibility criteria:
inclusion criteria: * pediatric acute lymphoblastic leukemia (all) subjects * received 6-mercaptopurine * available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (dna) can be extracted * white blood cell (wbc) levels exclusion criteria: * pediatric all subjects who did not receive 6-mercaptopurine * no biobank sample * no wbc level

Keywords: adverse drug event acute lymphoblastic leukemia mercaptopurine pharmacogenomics
study on the detection of pleuropulmonary manifestations in rheumatoid arthritis

Conditions: Rheumatic Arthritis; Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Summary: the aim of the study is to develop a standardized, risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. to assess the risk of these manifestations, a comprehensive range of functional and clinical evaluations will be performed and correlated with structural lung assessments using computed tomography (ct).

the objective of the study is the establishment of a standardized risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. to determine the risk of pleuropulmonary manifestation in ra, clinical (pulmonological and rheumatological specialist examination including standardized disease activity and symptom scores), laboratory (e.g. rf, acpa, crp, cea), lung function (incl. body plethysmography, tlco, feno, smwt), sonographic (thoracic ultrasound, joint ultrasound), and demographic (e.g., age, gender) factors will be considered. a machine learning (ml) based risk-modeling approach will be utilized to create the screening tool. for further external validation and clinical application, a freely accessible online tool and a mobile app will be developed based on the existing model.

Eligibility criteria:
inclusion criteria: * patients ≥18 years diagnosed with rheumatoid arthritis according to current acr/eular criteria * residence in austria * signed and dated consent of the patient in accordance with ich-gcp guidelines exclusion criteria: * pregnancy * age below 18 years * contraindications to study-related routine examinations (e.g., inability to draw blood due to needle phobia, no ct scan possible due to claustrophobia, pregnancy, etc.)

Keywords: rheumatoid arthritis interstitial lung disease risk prediction ra-ild
eus-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction

Conditions: Biliary Obstruction; Pancreas Neoplasm; Distal Cholangiocarcinoma

Summary: a prospective single-centre pilot study investigating the feasibility and safety of eus-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a fcsems through lams to reduce stent dysfunction.


Eligibility criteria:
inclusion criteria: * radiographically (ct or eus) distal malignant bile duct obstruction * histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after eus guided fine-needle sampling that is highly suspected of a malignancy suffices * indication for biliary drainage; in case of a resectable tumour this should be discussed during a clinical multidisciplinary meeting * written informed consent exclusion criteria: * age \< 18 year * surgically altered anatomy after previous gastric, periampullary or duodenal resection * cancer extending into the antrum or proximal duodenum * extensive liver metastases * who performance score of 4 (in bed 100% of time) * uncorrectable coagulopathy, defined by inr\>1.5 or platelets \< 50 x 10\^9/l\* * clinically relevant gastric-outlet obstruction * unable to complete sign informed consent * inclusion is allowed after corrective treatment measures are taken, according to local protocol and treating physician.
a study to evaluate the efficacy and safety of cyh33 in patients with recurrent/persistent ovary clear cell carcinoma

Conditions: Ovarian Cancer; Recurrent Cancer

Summary: the purpose of this study is to determine the treatment efficacy of cyh33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring pik3ca hotspot mutation, who received prior systemic anti-tumor treatment.

the purpose of this study is to determine whether treatment with single agent cyh33 significantly improves orr compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (occc) harboring pik3ca hotspot mutations who received prior systemic anti-tumor treatment.

Eligibility criteria:
main inclusion criteria: 1. female patients ≥ 18 years of age 2. provide informed consent voluntarily. 3. patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma. 4. patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified pik3ca status. 5. patients must have failed standard chemotherapy. 6. ecog-ps ≤ 1. 7. patient must have adequate organ and bone marrow function measured within 28 days of screening. main exclusion criteria: patients are ineligible for this study if they meet any of the following criteria: 1. patient has received any anticancer therapy 2. patients who had prior treatment with any pi3k, mtor or akt inhibitor. 3. radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks. 4. any toxicities from prior treatment that have not recovered to baseline. 5. patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug. 6. patients who have symptomatic cns metastasis. 7. major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects. 8. known hiv infection with a history of acquired immunodeficiency syndrome (aids)-defining opportunity infection within the past 12 months; active hepatitis b and hepatitis c. 9. history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis. 10. patients with clinically significant cardiovascular disease

Keywords: phase 2 study pharmacokinetics
impact of imipenem with amikacin pharmacokinetic and pharmacodynamic

Conditions: Ventilator Associated Pneumonia

Summary: the study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (pk) and pharmacodynamic (pd) parameters of imipenem, associated with amikacin as empirical therapy, impact microbiological and clinical outcome of patients with gram negative bacilli (gnb) ventilator-associated pneumonia (vap).

inappropriate initial antibiotherapy increases mortality of many serious infections. this is the case for ventilator-associated pneumonia, frequently occurring during intensive care unit (icu) hospitalization, and whose 48 first hours of treatment are decisive. it is well established that pharmacokinetic and pharmacodynamic parameters of antibiotics are correlated with their clinical and microbiological effectiveness. however in icu patients, pharmacokinetic parameters of antibiotics suffer great variations, and bacteria responsible for these infections are usually less sensitive to antibiotics, especially gram negative bacilli (gnb). an important pharmacodynamic variability may occur at the initial phase of the antibiotic treatment, decisive for the infection's outcome. we propose to evaluate the correlation between pharmacokinetic and pharmacodynamic profile of the empirical antibiotic therapy and the microbiological and clinical outcome of vap.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. mechanical ventilation for more than 48 hours 3. clinical suspicion of vap defined by a new persistent radiological infiltrate and one of the following signs: purulent tracheal aspirations, or temperature of 38°3 or higher, or leucocyte count \> 10000/ml 4. risk of multi resistant bacteria defined as follows: at least 6 days of mechanical ventilation or antibiotic treatment in the 15 previous days 5. distal pulmonary secretion sample obtained beforehand for microbiological diagnosis by bronchoalveolar lavage via bronchoscopy or blinded protected telescoping catheter via bronchoscopy or blindly 6. presence of gnb on direct examination of the distal pulmonary secretion sample 7. realization of a preliminary medical examination. 8- written inform consent from the patient or relatives. the consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives exclusion criteria: 1. time between distal pulmonary secretion sample taking and the 1st administration of imipenem exceeding 24 hours 2. pregnancy 3. severely impaired renal function (creatinine clearance lower than 10 ml/mn or renal replacement therapy) 4. allergy to imipenem or amikacin 5. treatment in progress with imipenem or amikacin 6. death expected within 48 hours following diagnosis of vap 7. myasthenia 8. simultaneous administration of others aminoglycosides 9. association with intravenous polymyxin or botulinum toxin

Keywords: intensive care unit ventilator associated pneumonia gram negative bacilli infection empirical antibiotic therapy pharmacokinetic / pharmacodynamic imipenem amikacin gram negative bacilli