Kornimate/medical-research-clean huggingface dataset:
factors association with poor physical function in older adults with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: older adults with schizophrenia are a growing segment of the population yet their physical health status is poor. in order to design effective interventions, the contributing factors must be understood. current data suggest the side effects of psychiatric medications, sociodemographic factors, and health care disparities are a few of the reasons for the poor physical health. there are only limited data on the impact of psychiatric symptomatology and neurocognition on the physical health of this population. these limited data indicate that worse symptomatology and poorer neurocognition may negatively impact physical functioning, a critical component to optimal physical health. the purpose of this pilot study is to begin to fill this knowledge gap by: 1. examining the relationship between neurocognitive function and physical function and 2. examining the relationship between schizophrenia symptoms and physical function. 3. examining the relationship between serum brain derived neurotrophic factor (bdnf) and physical function. using a descriptive correlational design, 50 older adults (55+) with schizophrenia or schizoaffective disorder will be assessed. bivariate associations will be used to examine the relationship between key variables including schizophrenia symptoms as measured by the positive and negative syndrome scale (panss), neurocognitive function as measured with the matrics consensus cognitive battery (mccb), physical function as measured objectively by the timed get up and go (tgug) test and subjectively with the physical component summary subscale of the 12-item short form health survey (sf-12), and serum bdnf. these pilot data will lay the foundation for a future health promoting intervention.


Eligibility criteria:
inclusion criteria: * english speaking adults older than or equal to 55 with a dsm-iv diagnosis of schizophrenia or schizoaffective disorder that pass a capacity to consent test based on comprehension of the consent form. exclusion criteria: * non-english speaking, * adults younger than 55, * no diagnosis of schizophrenia of schizoaffective disorder, and/or * not passing a capacity to consent test.
reducing intraoperative eskape transmission through use of a personal hand hygiene system

Conditions: Surgical Wound Infection; Cross Infection

Summary: the investigators hypothesize that the use of a personal hand hygiene system (safehaventm) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (or pathtrac) will decrease participant exposure to pathologic bacteria in the adult operating room.

this will be a prospective, single center, unmasked, controlled before and after study. intervention arm: use of safehaven hand hygiene system in the operating room control arm: standard of care hand hygiene operating room selection: two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for detection of pathogenic bacteria. the operating room for investigation will be randomly selected through the following process: 1. all the operating rooms with scheduled surgeries in the south operating rooms on a particular day will be entered into a random number generator (example: operating rooms 2, 3, 5, 7). 2. the random generator will sort these operating rooms into a rank list (example: operating rooms 5, 3, 2, 7). 3. the investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found (example: operating room 5 only has one surgery, operating room 3 has pediatric surgery, operating room 2 meets inclusion criteria) 4. this process will be duplicated for each case-pair the goal of the study is to map transmission of bacteria through the operating room and compare mapping with the safehaven hand hygiene system to mapping without the safehaven hand hygiene system. thus, case-pairs will be randomized to the same assignment. for example, subject 1 and 2 will have surgery in south operating room 8 and both will be randomized to the control group. the first 10 case-pairs will be assigned to the control arm and the second 10 case-pairs will be assigned to the intervention arm.

Eligibility criteria:
patient inclusion criteria: patients ≥ 18 years of age having surgery in an adult operating suite at the research center involving the following specialties: orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, and open urological, general abdominal, acute care, cardiothoracic, and plastic/breast. patient exclusion criteria: * patients with a known infection at the time of surgery. * prisoners * pregnant women * patients lacking capacity to consent * patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol * refusal of consent anesthesia provider inclusion criteria: • faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center. anesthesia provider exclusion criteria: * refusal of consent * open sores of the hands * known skin infection
fluid optimization with crystalloids and colloids in neurosurgery

Conditions: Postoperative Complications

Summary: fluid optimization in neurosurgical patients has an important impact on preservation of cerebral perfusion pressure and minimization of cerebral oedema during and after the craniotomy. the investigators would like to know if crystalloids or colloids are equally useful for goal directed therapy in this patients. the investigators will record haemodynamic stability, volume loading and postoperative complications and compare two groups of patients. one group will be optimised with crystalloids and the second with colloids. the investigators will compare also hospital stay and mortality in the two groups.

hemodynamic stability and maintenance of cerebral perfusion pressure (cpp) are important in neurosurgical patients. fluid management includes maintenance of intravascular volume, preservation of cerebral perfusion pressure and minimization of cerebral oedema. fluid management of the neurosurgical patient has advanced from "run them dry" to "run them isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by current strategies are still unknown. advanced techniques provide goal directed fluid therapy which is currently the gold standard in fluid strategy. in patients undergoing craniotomy diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding may lead to hypovolemia and poor cerebral perfusion. on the other hand fluid overload increases complications and hospital stay after surgery. it is, therefore, important that optimal fluid levels are achieved. the aim of the study was to compare intraoperative hemodynamic stability, volume loading and postoperative complications between group optimised with crystalloids and group optimised with colloids in patients undergoing neurosurgical procedure. the investigation will include 80 patients, 40 optimised with crystalloids and 40 with colloids. hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality will be monitored during and aftre the surgery.

Eligibility criteria:
inclusion criteria: * neurosurgery (tumour, vascular, adenoma), haemodynamic stability exclusion criteria: * arrhythmia
acupuncture in pediatrics and adolescents with chronic inflammatory bowel diseases

Conditions: Morbus Crohn; Colitis, Ulcerative

Summary: chronic inflammatory bowel disease (cibd) with its prevalence of 2.6 million people in europe is diagnosed in 25% before the age of 18 years. early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. additionally to conventional drugs one third of pediatric cibd patients use alternative treatment strategies. however, there is a lack of evidence of acupuncture as complementary medicine in pediatric cibd on the disease activity and inflammation. therefore, the main aim of this study is to evaluate the effect of acupuncture in children with cibd on the pediatric ulcerative colitis activity index (pucai) and the weighted pediatric crohn's disease activity index (spcdai), which are non-invasive validated instruments to measure the disease activity. furthermore, this study aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters of inflammation.


Eligibility criteria:
inclusion criteria: * mild/moderate cibd * stable pharmacological treatment at least for 8 weeks exclusion criteria: * complementary alternative medicine
different application rates of crisaborole ointment 2% in adults with mild to moderate atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (ad). in each subject four application areas will be identified. each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. the areas will be randomly assigned to treatment with topical crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of active atopic dermatitis (ad) with at least 6 month history prior to screening and that has been clinically stable for 1 month. * has four application areas of 3 cm in diameter with a tss of ≥5 and taa of moderate at day 1. the application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. the application areas should be ≥1 cm apart. exclusion criteria: * subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. * subject has clinically infected ad. * subject has a fitzpatrick's skin phototype ≥5. * subject is known to have immune deficiency or is immunocompromised. * subject has a history of cancer or lymphoproliferative disease within 5 years prior to day 1. subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded. * subject had a major surgery within 8 weeks prior to day 1 or has a major surgery planned during the study. * subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. * subject has a known history of chronic infectious disease (eg, hepatitis b, hepatitis c, or infection with human immunodeficiency virus). * subject with a known lack of efficacy to crisaborole. * subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container. * subject has a known history of clinically significant drug or alcohol abuse in the last year prior to day 1.
ceus for intraoperative spinal cord injury

Conditions: Spine Disease; Spinal Stenosis; Spinal Injury; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression; Spine Degeneration

Summary: spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. currently, intraoperative neuromonitoring (ionm) remains the gold standard for predicting and preventing post-operative deficits from these procedures. however, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. contrast enhanced ultrasound (ceus) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. the study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. in addition, the study team aims to assess the efficacy of ceus in detecting microvascular changes that correlate with ionm changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. the study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.


Eligibility criteria:
inclusion criteria: * patients consented and scheduled for posterior cervicothoracic decompression surgery with the pi for the diagnosis of cervicothoracic myeloradiculopathy * age 18-80 exclusion criteria: * pregnancy * patient's with known hypersensitivity to ultrasound contrast * patients with known hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (peg) * patients unable to actively participate in the consent process physically and/or cognitively * prior decompression at the intended level of decompression

Keywords: contrast enhanced ultrasound ceus
study of genotype and phenotype in patients with alpha 1-antitrypsin deficiency

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: objectives: i. establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine genetic traits that predispose to liver injury.

protocol outline: patients undergo blood draw and skin biopsy. cells are isolated from patients' blood and skin, cell lines are established, and genetic traits are examined.

Eligibility criteria:
* alpha 1-antitrypsin deficiency

Keywords: alpha 1-antitrypsin deficiency genetic diseases and dysmorphic syndromes rare disease
impact of debridement invasiveness on attachment gain after antiinfective periodontal therapy

Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal; Lesion

Summary: this study compared the gain of periodontal attachment after concomitant one-stage removal of bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.

the concomitant removal of subgingival calculus and soft bacterial biofilms in a one-stage procedure might impair periodontal healing in deep infrabony pockets due to the mechanical disruption of demineralized bone sections at the bottom of periodontal lesions. this randomized controlled clinical trial therefore aims at comparing the resulting attachment gain 6 months after one-stage antiinfective periodontal therapy comprising the concomitant subgingival removal of soft bacterial biofilms and calculus with a two-stage approach removing subgingival calculus only 6 weeks after the initial removal of soft subgingival bacterial biofilms.

Eligibility criteria:
inclusion criteria: * presence of periodontal disease * minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm * minimum of 15 natural teeth exclusion criteria: * systemic disease interfering with periodontal healing (e.g. diabetes) * antibiotic therapy ≤ 12 month prior to study participation * necessity for preventive antibiotic therapy during dental interventions * inability to comply with the study protocol

Keywords: periodontitis scaling attachment gain air polishing periodontal lesion
drug sensitivity and mutation profiling

Conditions: Ewing Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Wilms Tumor; Sarcoma, Spindle Cell; Sarcoma Rhabdoid; Childhood Sarcoma of Soft Tissue

Summary: this study is a prospective, non-randomized observational study. freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing (dst). in addition, the genetic profile of the tumor will be obtained from the medical records and correlated with drug response.

the excised tumors or a biopsy will be interrogated for sensitivity or resistance to fda-approved and/or available investigational agents. in addition, normal samples (blood or buccal swab) will be collected for genetic analysis of germline mutations and cancer predisposition markers. the timeframe between the sample acquisition and ex vivo dst results return will be approximately 5-10 working days. all drugs tested in the dst assay will be assigned a hybrid score reflecting the tumor's sensitivity and drug toxicity. this is an observational study and not a treatment protocol. it will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes (response, survival, or relapse). the treating physician will decide which of the standard treatment options is appropriate independent of the dst results. the results of dst will not be available to the treating physician at the time of decision on the treatment regimen. dst will include all drugs from the standard treatment regimens available for all types of sarcomas

Eligibility criteria:
inclusion criteria: * patients aged 21 years or younger at the time of enrollment on this study of any gender, race, or ethnicity. * subjects with suspected or confirmed diagnosis of all types of sarcomas. * subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers). * subjects are willing to have a blood draw or buccal swab done for the purposes of genetic testing. * subjects or their parents or legal guardians willing to sign informed consent. * subjects aged 7 to 17 willing to sign assent. exclusion criteria: * subjects who do not have malignant tissue available and accessible. * the amount of excised malignant tissue is not sufficient for ex vivo drug testing and/or genetic profiling. * patients with other types of tumors and tumors that have a high (\>90%) cure rate with safe standard therapy.

Keywords: ex vivo drug sensitivity assay genomic profiling
surveillance of synagis in korean pediatric patients

Conditions: Respiratory Syncytial Virus Infection

Summary: approximately 600 pediatric patients prescribed palivizumab (synagis) prophylaxis in usual practice according to the approved korean product label will be registered into this observational study. baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. at routine visits for synagis administration, which will occur according to usual medical practice, information on synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of synagis.


Eligibility criteria:
inclusion criteria: * pediatric patients at high risk of rsv disease, who need the prevention of serious lower respiratory tract disease caused by rsv, and meet any of the following criteria: * preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of rsv season (rsv season defined as oct. 1 to the following mar. 31). * newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (bpd) within the last 6 months preceding rsv season (rsv season defined as oct. 1 to the following mar. 31). * newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (chd). * obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study. exclusion criteria: * contraindications according to the approved label.

Keywords: postmarketing drug surveillance
anesthesia and cancer study: colon cancer

Conditions: Cancer of Colon; Anesthesia

Summary: this study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. the participants will be allocated to either the tiva group and the inhalation group.

the effect of anesthesia on cancer recurrence and survival is controversial. according to some retrospective studies and preclinical studies, total intravenous anesthesia (tiva) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. however, there is no randomized controlled study to determine this difference in colon cancer patients.

Eligibility criteria:
inclusion criteria: * adults undergoing surgery to remove colon cancer exclusion criteria: * pregnancy * colon cancer with invasion to perineum * palliative surgery * history of diagnosis or surgery for other cancer * emergent surgery * asa ps classification 4 and 5 * refusion to participate in the study * allergy to anesthetics

Keywords: anesthesia propofol cancer inhalational anesthetics
multicentre study of percutaneous mitral valve repair mitraclip device in patients with severe secondary mitral regurgitation

Conditions: Cardiovascular Diseases

Summary: the objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous mitraclip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation. this trial is a french, multicenter and randomized trial. patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).


Eligibility criteria:
inclusion criteria: * age \> 18 years old * severe secondary mitral regurgitation characterised, according to the european guidelines and recommendations, by a regurgitant volume\>30 ml/beat or an effective regurgitant orifice\>20 mm². * new york heart association class≥ ii. * left ventricular ejection fraction between 15% and 40% * minimum of 1 hospitalization for heart failure within 12 months preceding randomization * optimal standard of care therapy for heart failure according to investigator. * not eligible for a mitral surgery intervention according to the heart team. * willingness to participate in the study and signed written informed consent * affiliation to a health insurance system or a similar system exclusion criteria: * eligible for a mitral surgery intervention according to the heart team. * primary mitral regurgitation. * myocardial infarction or coronary bypass grafting surgery within three months prior to randomization. * cardiac resynchronization therapy within three months prior to randomization. * cardioversion within three months prior to randomization * transcatheter aortic valve implantation within three months prior to randomization * need for any cardiovascular surgery (including registration on cardiac transplant list). * coronary angioplasty within one month prior to randomization. * previous surgical mitral valve repair. * renal replacement therapy. * active infection requiring current antibiotic therapy. * severe hepatic insufficiency. * stroke within three months prior to randomization. * concurrent medical condition with a life expectancy of less than 12 months. * uncontrolled arterial hypertension. * hypersensitivity to nitinol. * participation to another trial. * pregnancy. * no affiliation to a health insurance system. * legal protection measure (guardianship or curatorship)

Keywords: heart valve diseases heart failure heart diseases mitral valve insufficiency