Kornimate/medical-research-clean huggingface dataset:
protecting preterm infants from respiratory tract infections and wheeze by using bacterial lysates.

Conditions: Wheezing; LRTI; Premature

Summary: the primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

this is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. participants will receive bacterial lysate (om-85/broncho-vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. at 12 months, parents of participants are asked to join in protea-2. if they do, participants in the treatment arm of year 1 are randomised again over placebo and om-85 and treated until the age of 24 months. clinical data will be continuously collected by e-health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. and in case of participation in protea-2 also at 24 months. main study parameters are doctor diagnosed lower rti and wheezing episodes in the first year of life. biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. also, biomarkers for risk-group selection and/or treatment success will be examined.

Eligibility criteria:
inclusion criteria: * gestational age at delivery between 30+0 and 35+6 weeks * postnatal age at least 6 weeks at randomization \& postmenstrual age at least 37 weeks * written informed consent by both parents or formal caregivers exclusion criteria: * underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. * lower rti before randomization * dysmaturity and/or weight \< 2.5 kg at age of randomization. * maternal tnf-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding * parents unable to speak and read dutch/english language * known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
assessment of onset, safety & toleration of uk-369,003 in male erectile dysfunction

Conditions: Impotence

Summary: to determine the onset of action, safety and toleration of different formulations and doses of uk-369,003 in patients with erectile dysfunction. patients should have been previously treated with pde5 inhibitors and have been responders to the drugs. duration of treatment is 4 weeks.


Eligibility criteria:
inclusion criteria: * erectile dysfunction as defined by dsm-iv. patients should have been pde5 inhibitor respondents exclusion criteria: * alpha blockers and nitrates of any preparation
intralesional cidofovir for the treatment of recalcitrant warts in the pediatric immune-suppressed population.

Conditions: Warts

Summary: the primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy. the secondary objective is to determine the tolerability of this new mode of administration of cidofovir in the pediatric population

this study includes pediatric patients with history of either primary or iatrogenic immune-suppression who are seeking treatment of warts that have already proven recalcitrant to standard therapy. the first cohort will include 4 patients ages 12 to 17. after all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.

Eligibility criteria:
inclusion criteria: * 1. the first cohort will include a total of 4 patients ages 12 to 17. after all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.patient is in immune-suppressed status by one of the following: 1. primary immunodeficiency, which may include but is not limited to the following: 1. chronic granulomatous disease (cgd) 2. common variable immunodeficiency (cvid) 3. digeorge syndrome (dgs) 4. selective iga deficiency 5. severe combined immunodeficiency (scid) 6. x-linked agammaglobulinemia (xla) 2. pharmacologic immune-suppressed status from medications including but not limited to: 1. prednisone 2. cyclosporine 3. azathioprine 4. tacrolimus/ fk506 5. mycophenolate mofetil 6. sirolimus 2. patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable 3. patient has a total wart burden of at least 1cm 4. patients must have tried and failed at least 2 other conventional treatments for cutaneous warts, including but not limited to: * cryotherapy * topical salicylic acid * imiquimod * topical 5fu * pulsed dye laser therapy * sinecatechins * tretinoin or other topical retinoid * intralesional candida injection * bleomycin * electrocautery * topical cidofovir cream or gel there will be a one month washout period for all treatment modalities, with the exception of intralesional candida, which will be 3 months. 5. patient desires ongoing treatment of their warts 6. patient and/or their parent/guardian consents to participating in this study exclusion criteria: 1. treatment area is either ulcerated, secondarily infected, or significantly inflamed 2. treatment area is on face or groin area 3. patient is pregnant, attempting to become pregnant, or lactating 4. patient reports active kidney disease, or chart review reveals recent serum creatinine ≥1.5mg/dl or a history of renal disease/insufficiency or history of diabetes 5. patient is currently receiving a nephrotoxic medication 6. patient has history of hypersensitivity to cidofovir 7. patient is severely ill and/or hospitalized 8. patient is receiving chemotherapy

Keywords: wart
physical recovery after laparoscopic vs. open liver resection

Conditions: Postoperative Complications; Liver Diseases; Physical Stress; Surgery

Summary: the role of laparoscopic liver surgery with respect to clinical outcome remains unclear.

the role of laparoscopic liver surgery with respect to clinical outcome remains unclear. the investigators hypothesized that laparoscopic liver resection (llr) is associated with better postoperative recovery than open liver resection (olr). twenty-one patients who underwent lr were included in this study (11 olr (52.4%) and 10 llr (47.6%), respectively). postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. postoperative recovery was compared between groups as change of performance (%).

Eligibility criteria:
inclusion criteria: * all patients undergoing liver resection (open vs. laparoscopic) * all patients willing participate and gave written informed consent exclusion criteria: * pregnancy * significant traumatic injury within 30 days prior to study enrolment * inability or unwillingness to comply to the protocol or to perform bicycle ergometry

Keywords: laparoscopic minimal invasive physical recovery liver surgery
utility of pet in the pre-operative assessment of patients with hepatic colorectal metastases

Conditions: Colorectal Carcinoma

Summary: this study aims to determine whether a test, called the pet scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests. the pet scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. the study will compare pictures of the cancer from the pet scan to other x-ray exams, such as a ct scan, as well as to what your doctors find at the time of surgery. if the study results show that the pet scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed. additionally, by comparing the results of pet scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery.


Eligibility criteria:
inclusion criteria: * initial diagnosis of colorectal carcinoma confirmed by the pathology department of memorial hospital or by diagnostic barium enema if the primary tumor is still in place. * a candidate for liver resection for metastatic colorectal cancer as defined by members of the department of surgery of memorial hospital. patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. in addition, patients with limited, resectable pulmonary metastases are eligible. exclusion criteria: * patients must not be pregnant; females of child bearing age must use an adequate form of contraception.
multi-centre study of htl0018318 in patients as an add-on to standard-of-care

Conditions: Alzheimer's Disease

Summary: multi-centre study of htl0018318 in patients with alzheimer's disease as an add-on to standard-of-care

this is a multi-centre study conducted in four countries. a total of 60 subjects with alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active htl0018318 or placebo for a period of four weeks

Eligibility criteria:
inclusion criteria: 1. diagnostic evidence of alzheimer's disease according to the 2011 national institutes of aging-alzheimer's association (nia-aa) criteria 2. participants with alzheimer's disease on stable standard of care exclusion criteria: 1. presence of illness apart from alzheimer's disease that could contribute to cognitive dysfunction 2. a current or history of clinically significant suicidal ideation within the past 6 months 3. subjects who have been on anti-cholinergic and/or anti muscarinic treatment

Keywords: alzheimer's disease
personality and drug use (pdu)

Conditions: Personality

Summary: the study aims to assess whether the use of drugs relates to personality ratings. specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and past).

the study aims to assess the association between the use of various substances (including psychedelic and non-psychedelic drugs) and personality profiles. specifically, the association between past drug usage and personality profiles will be investigated. as psychedelics were found to influence changes in personality over time, the present study aims to measure both the current personality profile (via the big five inventory-44 (bfi)) and perceived retrospective changes in personality (via a self-constructed retrospective personality scale (rps)). to our knowledge, no study has explored the diversity of substance use histories in relation to individual current and retrospective personality traits and aggregate personality profiles. this project aims to survey a large number of participants from all around the world, using a mobile app-based survey. the remote character of the study will increase its accessibility and diversity, which are common shortcomings in the psychedelic line of research. additionally, a remote, anonymous study setup with no face-to-face interactions might help overcome any potential concerns participants may have regarding the sharing of sensitive information (e.g., reports on illicit substance use). to increase scientific transparency and for educational purposes, the study team plans to share results summaries (comparisons of personalized results with the aggregated ones among participants sharing similar characteristics e.g., age, substance use history), which might be an additional motivating factor for study completion. lastly, given that drug use in the natural environment (excluding laboratory/experimental setting) is characterized by large substance diversity and poly-drug use, we aim for a large sample size (with a minimum of 36 subjects per substance(s) category) to perform subgroup analyses. therefore, this large-scale, low-budget, naturalistic, retrospective, observational study aims to shed light on the aforementioned gap in the literature and to lay a foundation of evidence for further (observational and experimental) research within the field.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * full legal and mental capacity * access to a smartphone (ios and android) with internet exclusion criteria: * not fluent in english * not able to read

Keywords: personality substance use psychedelics drugs changes in personality
clinical decision tree analysis of hemodialysis arteriovenous access choices and creations - a multiple-center retrospective cohort study

Conditions: Decision Tree Analysis

Summary: our study aim was to utilize a decision tree analysis (dta) model to gain insight into the decision-making process within a multiple-center cohort.

scientific research focuses on limited parameters, aims to confirm hypotheses, and has minor uncertainties. in contrast, medical decisions involve many unknowns. physicians must use all available knowledge to make the best decisions. however, decision-making can become unpredictable when limited evidence exists, leading to non-reproducible outcomes. according to clinical guidelines, patients who need pre-kidney replacement therapy (pre-krt) and opt for hemodialysis (hd) with a reasonable life expectancy should have arteriovenous (av) access created. nevertheless, constructing an avf has limitations. \[additionally, the maturation rate of avf is suboptimal. therefore, after careful consideration of the patient's end-stage kidney disease (eskd) life plan, the suggested order of av access types and locations starts a native distal forearm radiocephalic avf, followed by a native proximal forearm avf, a forearm arteriovenous graft (avg), then an upper arm avg creation.\[lok et al., 2020\] however, the decision-making process for selecting hemodialysis access is shared between patients, physicians, and the surgeon's discretion. therefore, clinical kidney practice requires effective decision-making to address eskd life plan and av access concerns while minimizing harm. decision analysis models can bridge the gap between research and decision-making. our study aim was to utilize a decision tree analysis (dta) model to gain insight into the decision-making process within a multiple-center cohort.

Eligibility criteria:
inclusion criteria: - adult patients between the ages of 18 and 80 who were referred for primary hemodialysis (hd) av access creation. we included those in the pre-kidney replacement therapy (pre-krt) stage and those who in the early end-stage kidney disease (eskd) urgently started hd without sufficient time to plan for av access exclusion criteria: - patients who underwent a secondary av access surgery, like a transposed radiobasilic avf or a revision of avg.

Keywords: arteriovenous fistula av graft hemodialysis decision tree analysis
ultrasound screening of congenital anomalies of kidney and urinary tract in neonates

Conditions: Urinary Tract Anomalies; Kidney; Anomaly

Summary: this cross sectional study will be conducted to investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at tanta university hospital.

this cross sectional study will be conducted for one year from october 2023 to october 2024 at pediatric and radiology departments tanta university hospital (tuh). this study will be conducted on neonates who will be born or admitted at tanta university hospital. all patients included in the study will be subjected to: history taking, clinical examination and ultrasound screening: by (sonoscape a6, yizhe building, yuquan, road shenzhen, 518051, china). general-purpose diagnostic abdominal ultrasound equipment was used, with a 7.5-mhz linear-type probe. screenings will be performed by radiologist with appropriate practice. the ultrasound examination will take 10 min for each patient. the recordings will consist of two bilateral renal images will be obtained and one transverse and longitudinal images. the urinary bladder will be observed with the patient in a supine position, and images will be recorded when abnormalities will be identified. the following will be investigated by ultrasound: number, size (including differences between sides), and location of the kidneys; pelvic dilatation; echogenicity, and other findings indicating cysts or tumours. shape and wall thickening of the urinary bladder, as well as ureter dilatation, will be also examined.

Eligibility criteria:
inclusion criteria: * neonates in the first month of life. exclusion criteria: * no exclusions
health effects of recreational soccer in type 2 diabetic men

Conditions: Type 2 Diabetes; Hypertension; Obesity; Metabolic Syndrome

Summary: the present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. testing consisting of fasting blood samples, muscle biopsies, dexa-scans, echocardiography, maximal oxygen consumption, yo-yo interval test, bloodpressure, resting heart rate, and endothelial function (itamar, endopat)will be performed at baseline, after 12 and 24 weeks, respectively. the study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed * 35-60 years old men exclusion criteria: * smoker * ischaemic heart disease * congestive heart failure * joint or limp pains to an extent where recreational soccer can not be performed. * apoplexia. * anticoagulant therapy (aspirin accepted)

Keywords: type 2 diabetes hypertension obesity metabolic syndrome
clinical and economic outcome of simvastatin in critically ill septic patient

Conditions: Critical Illness

Summary: determination of the effectiveness and the cost-effectiveness of simvastatin(zocor 40 mg) plus standard therapy (sscg)versus standard therapy alone in critically ill septic patient from the societal perspective over one year.

prospective double blinded randomized controlled study will be carried out at ain-shams university hospital method: - after approval of the research ethics committee of ain shams university and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (icu) diagnosed to have sepsis/severe sepsis defined by american college of chest physicians (acp) \*will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups. group i (control group):-50 patients will be treated according to "surviving sepsis campaign guidelines (sscg) (dellinger, et al. 2013) group ii (intervention group):-50 patients will be treated according sscg plus simvastatin. outcomes:- primary outcome measures: 28 day icu and hospital mortality. secondary outcome measures: * requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation * total icu length of stay.(los) * number of patients alive 3, 6, and 12 months * incremental cost effectiveness ratio

Eligibility criteria:
inclusion criteria:- 1. age \>18 and less than 70 2. sepsis for less than 24 hours from icu admission exclusion criteria:- 1. elderly (defined as older than 70). 2. pediatrics (defined as younger than 18). 3. pregnancy and nursing. 4. unable to receive enteral medications. 5. history of hypersensitivity to the trial drug. 6. are receiving drugs known to interact with simvastatin. 7. acute liver failure and chronic liver disease (child c). 8. high risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(\>60%), baseline creatinine kinase (ck) ≥ten-times upper limit of normal. 9. patients with dyslipidemia or prior statin user. 10. sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism 11. have a history of known or suspected porphyria 12. are unlikely to survive more than 24 hours
neurescue device as an adjunct to in-hospital cardiac arrest (arise)

Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases

Summary: the neurescue device is the first intelligent catheter for aortic balloon occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. the catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body. the objective of this study is to investigate the feasibility of the neurescue device as an adjunct to advanced cardiac life support (acls) in adults with cardiac arrest.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤80 years 2. cpr initiated within 7 min of presumed arrest 3. 8 min of continuous acls without rosc exclusion criteria: 1. traumatic cardiac arrest 2. intraoperative cardiac arrest 3. known pregnancy 4. known terminal disease 5. known do-not-attempt-cpr order 6. subjects whose femoral arterial access site cannot accommodate an 8 fr introducer sheath 7. subjects currently on mechanical circulatory support
effect of low-magnitude, high frequency vibration treatment on femoral shaft fracture healing

Conditions: Fracture, Closed, Comminuted, Healing

Summary: diaphyseal long bone fractures are usually associated with high energy trauma in which femoral shaft fracture is one common fracture in young age group. surgery is usually needed for the diaphyseal lone bone fractures and the painful conditions always hinder weight bearing which is important for fracture healing and functional recovery. fracture healing in cortical bone is less predictable than trabecular bone because they are less active and blood supply is more critical. therefore accelerating fracture healing and rehabilitation of long bone fracture will absolutely bring significant economic benefit to the society in term of hospitalization and sick leave cost. low-magnitude, high-frequency vibration (lmhfv) treatment can provide systemic mechanical stimulation and is reported with multiple effects on musculoskeletal tissues. lmhfv can enhance the blood circulation and osteogenic effect in normal subjects and animals. our previous clinical study also indicated that lmhfv could enhance the balancing ability and muscular function in normal post-menopausal women after treating whole-body vibration. for the fracture healing effect, an acceleration of healing by inducing callus formation and maturation in rat model was also reported in our previous studies. in this study a total of 50 unilateral closed femoral shaft fracture patients of either gender aged 20-40 years old will be recruited and they will be randomized to either control and vibration group. the vibration group will be treated with lmhfv for 6 months. the findings of this study will provide very useful scientific data to support the application of lmhfv for fracture healing.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female aged 20-40 years old * patient with unilateral femoral shaft fracture * fractures fixed with titanium intramedullary nail * patient able to comply with study protocol including follow evaluation exclusion criteria: * open fracture * bilateral fracture * patient with multiple system injuries * fracture gap \> 10mm * pathologic fracture * pregnant women * history of medication or disease affecting bone metabolism such as hypo- or hyperparathyroidism and hypo-, hyperthyroidism

Keywords: vibration treatment fracture healing muscular function