Kornimate/medical-research-clean huggingface dataset:
pharmacogenetic-directed treatment for major depression

Conditions: Depression

Summary: determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.

this study is designed to evaluate the clinical impact of pharmacogenetic (pgx)-directed treatment, as guided by interpretive, algorithmic report in the pine rest outpatient behavioral health clinics. the pgx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder (296.2, 296.3) or depressive disorder nos (311.0) by a board certified psychiatrist. * the patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study. * the patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons. * patient's baseline 17-item hamilton depression (hamd17) rating score is \>14. * provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine. * undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine. * the patient has signed the study informed consent form. exclusion criteria: * serious medical illness (as ascertained via inclusion criteria 6 and 7, above). * diagnosis of a bipolar disorder. * diagnosis of schizophrenia or schizoaffective disorder. * evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication. * history of prior pharmacogenomic testing.

Keywords: genesight assurex assurerx
safety of a herpes simplex candidate vaccine (gd2t) with mpl and its efficacy to prevent genital herpes disease

Conditions: Herpes Simplex

Summary: the purpose of the study is to evaluate the safety of herpes simplex candidate vaccine (gd2t) with adjuvant and its efficacy to prevent genital herpes disease in hsv positive or negative consorts of subjects with genital herpes disease.

this study was monitored by a data safety monitoring board at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 45 years of age at the time of first vaccination * written informed consent * females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control * the volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history exclusion criteria: * any previous history of or current clinical signs or symptoms of genital herpes disease. * any previous vaccination against herpes simplex. * any previous administration of mpl. * history of herpetic keratitis. * history of erythema multiforme. * female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose. * patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. topical corticoid therapy is allowed. * hiv positive at the time of enrollment * clinical signs of acute or febrile illness at the time of entry into the study. * any continuous suppressive antiviral oral therapy within the 6 months prior to entry. * any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination. * any vaccine administration less than one week before or after a study vaccination. * previous known hypersensitivity to vaccination or to any component of the vaccine. * simultaneous participation in any other clinical trial of an investigational compound. * recent history of alcoholism or drug abuse * recent clinical history or evidence of significant hepatic disease * recent clinical history or evidence of renal dysfunction * life-threatening or serious cardiac (nyha grades iii-iv), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study. * inability or unwillingness to comply with the protocol or not expected to complete the study period

Keywords: herpes simplex candidate vaccine herpes simplex
a translational understanding of obesity-related phenotypes using brain imaging and manipulation

Conditions: Obesity

Summary: this study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.

1) abstract of the study a positive energy balance (greater intake than expenditure) can explain weight gain and, when protracted, leads to overweight and obesity. the major question addressed in this proposal is if the timing of activation of specific regions of the brain is predictive of excessive food intake. functional near infra-red spectroscopy (fnir), seldom used in human eating studies, provides data similar to functional magnetic resonance imaging (fmri) but allows for measurement of brain activation during food consumption. the investigator's pilot fnir data reveal that varying patterns of regional pfc activation are associated with "loss of control" over eating, and that only 60% of individuals respond to acute protein intake with a reduction in food intake. using fnir and an acute protein challenge, the investigator will assess the effect of family history of obesity in humans on the satiation response to protein and concomitant activation of the prefrontal cortex (pfc). it is hypothesized that activation of the human medial pfc before the lateral pfc will result in greater intake of palatable food in those subjects with a proneness to obesity, and that these subjects will be less sensitive to the satiety-inducing effects of a protein preload. these results should provide an innovative and useful method for assessing risk for developing obesity and usefulness of preventative interventions.

Eligibility criteria:
inclusion criteria * bmi 20-40 * weight stable for at least 3 months * no parents with history of obesity in adulthood, or at least one parent with history of obesity in adulthood exclusion criteria * no current diagnosis of psychiatric disorders * no current diagnosis of neurological disorders * no current diagnosis or history of anorexia nervosa * no current diagnosis or history of bulimia nervosa * no pregnancy within the last 9 months * not currently breastfeeding * no use of investigational medication in the past 6 months * no use of prescription anti-seizure medications. * no use of prescription antidepressant medications * no use of prescription antipsychotic medications
helmet continuous positive airway pressure versus oxygen venturi in acute respiratory failure in cap: capoverso

Conditions: Pneumonia; Community-Acquired Infections; Respiratory Insufficiency; Acute Lung Injury

Summary: the purpose of this study is to compare the efficacy of cpap application by a helmet and o2 administration by a venturi mask in terms of gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.

community-acquired pneumonia (cap) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%. continuous positive airway pressure (cpap) has ben recently proved to be effective. to date, however, no prospective randomised study has been published on the comparison between cpap and o2 administration via a venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia. therefore, the aim of this study is to compare the efficacy of cpap delivered by a helmet and o2 administration via a venturi mask in terms of gas exchanges improvement in early acute respiratory failure (pao2/fio2 between 210 and 285)due to community-acquired pneumonia. a steering committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.

Eligibility criteria:
inclusion criteria: * community-acquired pneumonia (cap) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms * acute hypoxemic respiratory failure * respiratory rate \< 35 breaths/min * pao2/fio2 \> 200 and \< 300 while breathing oxygen for at least 15 minutes via a venturi mask with fio2 0.5 exclusion criteria * immunosuppression * acute cardiogenic pulmonary edema * patients belonging to class ii-iii-iv of the nyha * acute coronary syndrome * acute respiratory acidosis ph \ 45 mmhg * more than 3 acute organ failures * systolic pressure \< 90 mmhg under fluid resuscitation or vasopressor drug use * seizures * decreased level of consciousness (gcs \<12) * inability to clear secretions * pre-defined intubation criteria

Keywords: cpap community-acquired pneumonia acute respiratory failure hypoxemia continuous positive airway pressure
measured versus estimated energy requirement in the icu patients

Conditions: Critical Illness; Energy Requirement; Equation; Indirect Calorimetry; Malnutrition

Summary: the goal of this observational study is to compare energy requirements estimated by predictive equation and indirect calorimetry across different bmi categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to icu outcomes. the main questions it aims to answer are: 1. to evaluate whether predictive equation and/or indirect calorimetry provides accurate caloric targets in critically ill patients. 2. to identify high-risk malnutrition patients (underweight, normal and overweight, obese) who may benefit most from ic-based measurement. 3. to investigate the impact of caloric strategies and nutritional achievement during the acute phase on the length of icu stay.


Eligibility criteria:
inclusion criteria: * length of icu stay \> 4 days * mechanically ventilated adults (\>20 y/o) * tube feeding * at high risk of malnutrition by global leadership initiative on malnutrition (glim) criteria: underweight and obesity * doctor's preference: cachexia, hypermetabolic status, tpn etc.,... exclusion criteria: * length of icu stay \<4 days * mechanically ventilated adults (\<=20 y/o)
pepsinogen ii and helicobacter pylori test in gastric cancer

Conditions: Gastric Cancer

Summary: the aim of this study to validate the role of pepsinogens in gastric cancer screening.

serum pepsinogens (pgs) are the biomarkers for gastric cancer (gc), especially atrophic gastritis which is a precursor of intestinal type gc and severe gastric inflammation which is an indicator for diffuse type gc in young age. so, test for serum pgs can be used to identify high risk patients for gc. the aim of this study is to validate the role of pgs in gc screening. sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and pgs and anti-h. pylori (hp) antibody are measured. area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for pgs. to validate the usefulness of pgs to predict risk of gc, the subjects are divided into two groups based on each cut-off value for each pg value. adjusted odds ratios (ors) and 95% cis are calculated using multivariate logistic regression. risk stratification is conducted by combining each pg value and anti-hp antibody in gc subtype.

Eligibility criteria:
inclusion criteria: * who undergoes serum pepsinogens and anti-h. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at seoul national university hospital gangnam center (snuhgc) or seoul national university bundang hospital (snubh) exclusion criteria: * who do not receive serum pepsinogens or anti-h. pylori antibody studies * who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-h. pylori antibody tests * subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment * subjects with prior history of gastrectomy * subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma * subjects who do not agree to participate in the study or withdraw his/her consent

Keywords: gastric cancer pepsinogen helicobacter pylori
prospective multicenter study with the endomina® triangulation platform

Conditions: Obesity

Summary: this registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (tapes) when used in the frame of "real life" routine clinical practice

this is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. this registry is designed to further assess on a larger scale safety and efficacy of the endomina® and tapes devices. patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.

Eligibility criteria:
inclusion criteria: * patient must be willing to provide written informed consent * adult patients (between ≥ 18 years (legal age in europe) and 65 years of age at time of esg) * patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the instructions for use (ifu) exclusion criteria: * patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach) * any malformation from mouth to esophagus (including pharynx) * any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure * woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure. * impending surgery 60 days post intervention of the treated section of the gi tract * participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint

Keywords: obesity gastroplasty endoscopic gastroplasty endomina
repetitive transcranial magnetic stimulation (rtms) as an add-on treatment for resistant obsessive-compulsive symptoms in patients with schizophrenia

Conditions: Schizophrenia; Obsessive-Compulsive Symptoms

Summary: this is a study to evaluate the efficacy of rtms for relief of obsessive-compulsive symptoms in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (dsm-iv-tr) * ybocs ≥ 16 exclusion criteria: * mental retardation * substance abuse * any contraindication to rtms
vacuum-assisted dressings (v-ad) in the management of open chest wounds

Conditions: Open Chest Wounds

Summary: vacuum-assisted dressings (v-ad) are effective in treating patients with open chest wounds (ocw) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.


Eligibility criteria:
inclusion criteria: * subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection. exclusion criteria: * patent bronchopleural fistulas. severe respiratory failure requiring mechanical ventilation at the time of first consultation. * proven or suspected malignancy in the wound. coagulopathy due to medical or pharmacologic reasons. dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time. allergy to acrylic products.
open-label safety and tolerability study of lts-pdt in healthy volunteers

Conditions: Acne Vulgaris

Summary: the purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (lts) with exposure to red light (pdt), when applied to the backs of healthy volunteers.

this is an open-label, safety study in healthy volunteers. two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). each subject will have test areas identified on the back and receive a single lts, vehicle solution and red light (pdt) applied to the test areas on the back. subjects will be followed for safety at study visits occurring on day 1 (baseline and treatment), day 2, and day 7.

Eligibility criteria:
inclusion criteria: 1. healthy adults 18 years of age or older 2. fitzpatrick skin types i-iv exclusion criteria: 1. current pregnancy or lactation. 2. presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne. 3. poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition 4. subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of day 1 or 5 half-lives, whichever is longer. 5. subjects who have used any medicated topical therapy on the back within 3 days of day 1. 6. chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (nsaid), or an anticoagulant regimen such as warfarin (coumadin). 7. abnormal findings on screening ecg deemed clinically significant by the investigator. 8. active participation in an experimental therapy study or experimental therapy within 30 days of day 1. 9. screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the investigator. 10. subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
ketamine associated with morphine pca after total hip arthroplasty

Conditions: Arthroplasty, Replacement, Hip

Summary: ketamine (an analgesic drug often associated with morphine in the treatment of opioid induced hyperalgesia) is often mixed in morphine pca syringe. we make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect. we will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in pca syringe or alone in continuous infusion.

double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in pca syringe or alone in continuous infusion

Eligibility criteria:
inclusion criteria: * total hip arthroplasty exclusion criteria: * pre operative opioid administration

Keywords: ketamine morphine pca hyperalgesia nor-ketamine
β-lactam use in single-stage exchange of prosthetic infections (knee / hip) in a center of reference (β-septic)

Conditions: Infected of Hip or Kneeprosthesis

Summary: according to the official recommendations, infected prosthesis can be surgically treated by one or two-stage replacement. in strasbourg, the investigators only perform one-stage surgery, which means that the new materiel is put directly into an infected site. to prevent re-infection, probabilist antibiotherapy has to be started the earlier as possible and to have the larger specter as possible. official recommendations don't specify the best choice of antibiotherapy and let prescriptors make choice, according to the local epidemiology and patient's history. in strasbourg, the investigators systematically start an antibiotic against cocci gram positive: daptomycin. sometimes, the investigators add tazocillin, a broad-spectrum β-lactam against bacillus gram negative. to determine if the investigators use the second one, they focalized on the presence of fistula or not. indeed, enterobacteriae from gastro-intestinal tractus are also found on the skin and can move to the peri-prosthetic site if a fistula is created. the major disadvantage of this board-spectrum antibiotic is the selection and creation of resistant bacteriae, which can be responsible of failure, re-infection, or just spreading on the environnement. the primary purpose is to evaluate retrospectively the prescription of tazocillin, judging it's necessity thanks to antibiograms performed on samples taken during surgery. the aim is to evaluate if the criteria " fistula or not " is a good one to guide the prescription of board-spectrum β-lactam. secondary purposes are to find the etiology of failures ( bacteriological failure or re-infection with a new pathogen), evaluate the apparition of multi-drug resistant bacteriae and infections they are responsible for, looking for others criterias which could help the investigators to choose the probablist antibiotherapy


Eligibility criteria:
inclusion criteria: * adults ( \> 18 years-old) hospitalized from 1st january 2018 to 31th december 2018 in the septic orthopedic surgery unity of the university hospital of strasbourg for a prosthetic-joint infection (knee or hip) treated by replacement. * patients who mentioned they agree for scientific use of their medical data. exclusion criteria: * patients hospitalized only for the second surgery of a two-stage replacement. * patients who refused or didn't agree with scientific use of their medical data. * adults with legal protective measures.

Keywords: peri-prosthetic infection joint infection one-stage replacement broad-spectrum β -lactam
the effect of bike exercise on joint and muscles

Conditions: Knee Osteoarthritis

Summary: the design of our study is a prospective. it is planned to be completed in twenty-four weeks with 34 participants. the main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-35 * not exercising regularly * bmi between 18.9-24.9 kg/m2 * volunteering to participate in the study * absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program. * those who do not have a history of pregnancy, malignant hematological and oncological diseases * not smoking * no musculoskeletal problems of the lower extremity in the last 6 months * no previous history of lower extremity surgery in the last 1 year exclusion criteria: * being outside the age range of 18-35 * exercising regularly * being outside of the bmi 18.9-24.9 kg/m2 range * having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program * those with a history of pregnancy, malignant hematological and oncological diseases * individuals who smoke * any musculoskeletal problem of the lower extremity in the last 6 months * having a history of lower extremity surgery in the last 1 year

Keywords: knee joint exercise ultrasound bicycle