Kornimate/medical-research-clean huggingface dataset:
midcab versus des in proximal lad lesions

Conditions: Coronary Artery Disease

Summary: percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.


Eligibility criteria:
inclusion criteria: 1. single-vessel disease of the proximal lad with a stenosis \> 50% (multivessel disease only if further coronary vessel stenoses do not require treatment) 2. patients with angina pectoris (ccs 1-4) 3. asymptomatic patients if clear signs of ischemia in the segments supplied by the lad as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo 4. patients for whom both methods of treatment are equally possible 5. consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case 6. informed consent of the patient. exclusion criteria: 1. patients \< 18 years 2. pregnancy 3. previous coronary artery bypass surgery 4. concomitant diseases that lead to a greater risk for each of the treatment strategies 5. significant peripheral arterial occlusive disease 6. concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated) 7. objective follow-up examination not possible due to physical or mental handicap 8. participation in another study. angiographical exclusion criteria: 1. left main stem stenosis 2. multivessel disease for which surgical or interventional therapy on other vessel areas is required. 3. diagonal/septal branch \> 1.5 mm, which might be compromised by a stent 4. need for acute intervention (e.g. acute myocardial infarction) 5. total occlusion of the lad

Keywords: stent drug-eluting stent minimally invasive bypass surgery left anterior descending
genetic analysis of congenital diaphragmatic disorders

Conditions: Congenital Diaphragmatic Hernia; Congenital Diaphragmatic Eventration; Congenital Hiatal Hernia; Congenital Diaphragmatic Disorders

Summary: the purpose of this study is to understand the genetic causes of congenital diaphragmatic disorders (cdd), namely congenital diaphragmatic hernia (cdh), eventration and hiatal hernia. specifically, the investigators plan to: 1. ascertain informative families and sporadic cases with congenital diaphragmatic disorders and obtain appropriate phenotypic data and genetic material (peripheral blood and/or diaphragm tissue sample). 2. localize the gene(s) for cdd to specific chromosomal segments using linkage analysis, and determine the role of somatic mutations in cdd. 3. isolate and characterize genes involved in the pathogenesis of cdd. 4. develop molecular markers that will facilitate accurate diagnosis (including prenatal diagnosis) and permit correlation of phenotypic variation with specific mutations. 5. compare rna-sequencing from tissue samples of children without cdh to those children with cdh.


Eligibility criteria:
inclusion criteria: * diagnosed with a congenital diaphragmatic disorder exclusion criteria: * none
comparison efficacy in patients with asthma using foster mdi and relvar medications

Conditions: Asthma

Summary: this is a randomized study to compare asthma patients using foster or relvar.

the global asthma association (gaa) and the world allergy organization (wao) recently issued statements stating that the small airway is caused by asthma and chronic obstructive pulmonary disease (copd). both pathogenesis and treatment play an important role. the small airway is an airway with diameter less than 2 mm and is one of the main sites where airflow obstruction occurs. small particles (\<2 μm) and large particles are more likely to deposit in the distal airways, and have shown to have better effects on asthma and pulmonary obstruction. at the same time, real-life research has also shown that extra-fine particles provide better asthma control than large particles, and can better improve quality of life.the aim of the study is to compare the efficacy of asthma inhalers between extra-fine particles and non-extra-fine particles.

Eligibility criteria:
inclusion criteria: * patients diagnosis with asthma with treatment naive * asthma patients with poor controlled status exclusion criteria: * copd * smoking history * pregnancy * cardiaovascular disease * patients with acute respiratory infection
cerebral hemodynamic effects of hypertonic solutions in severely head-injured patients

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Summary: this is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (tbi).

this is a study comparing effects of two hypertonic solutions (mannitol, 6.4% hypertonic saline) on intracranial hypertension, cerebral blood flow, serum/urine osmolarity in patients with increased intracranial pressure caused by traumatic brain injury. the study is conducted during first 72 hours after the injury without any interference with standard medical treatment as performed at the institution. when the hypertonic solution is indicated by caregiver, the study team is informed and performs a set of physiologic bedside measurements including evaluation of cerebral blood flow and changes in plasma and urine osmolarity. the study is noninvasive and the study protocol does not hamper, in any way, standard care of treatment for these patients.

Eligibility criteria:
inclusion criteria: * patients with severe tbi (motor glasgow coma scale \[gcs\] score \< 5) * age \> 18 years * health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent exclusion criteria: * brain dead (gcs 3, fixed dilated pupils) * life-threatening systemic injuries (ais \> 4 in an organ system other than brain); ais = abbreviated injury score * hypotension not responsive to fluid resuscitation and low doses of dopamine * clinical or imaging sign/suspicion for internal carotid artery injury

Keywords: hypertonic saline mannitol intracranial hypertension cerebral blood flow traumatic brain injury
fatigue and cancer treatment(fact)- an exercise intervention

Conditions: Cancer; Fatigue

Summary: the purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. the sample will be randomized into exercise (ex) or usual care (uc) groups. the independent study variable is participation in a walking exercise program. outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. the effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy


Eligibility criteria:
inclusion criteria: confirmed diagnosis of cancer (stage 1,2,or 3), 21 years of age or older, free of cognitive or physical deficits that would preclude entry into study, not currently exercising 120 min/wk or more exclusion criteria: concurrent major health problems or disabilities that would limit participation in an exercise program. stage 4 cancer (metastisis)

Keywords: fatigue cancer treatment
transversus abdominis plane (tap) block laparoscopic hysterectomy

Conditions: Postoperative Pain

Summary: the transversus abdominis plane (tap) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the t7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of l1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (ioam) and the transverse abdominal muscle(tam)this technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. it was first described by mcdonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery. hebbart et al. subsequently described an ultrasound guided technique for the tap block which they named posterior tap block. the ultrasound allows identification of the external oblique abdominal muscles (eoam),ioam and tam. previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics. clinical trials of the single shot posterior tap block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. more recently, el-dawlatly et al. demonstrated that ultrasound guided tap block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%. this is the first study to evaluate the effect of tap block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.


Eligibility criteria:
inclusion criteria: * age: 18-64 years * surgery: laparoscopic hysterectomy surgery * asa status: i and ii * fluent in english exclusion criteria: * history of allergy to local anesthetics * history of chronic opioid use * pregnant patients * bmi greater than 30 drop-out criteria: * patient or surgeon request * complications related to the procedure

Keywords: pain post operative opioids laparoscopic surgery hysterectomy
esg with fundal mucosal ablation

Conditions: Obesity and Obesity-related Medical Conditions

Summary: endoscopic sleeve gastroplasty (esg) have emerged as an effective primary endoscopic therapy for weight loss. while esg recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (lsg). a major difference between esg and lsg is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure. recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. combining endoscopic gastric fundus mucosal ablation with esg could potentially enhance the weight loss effects of esg while maintaining an acceptable safety profile. this pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (esg-fuma) in obese patients eligible for endoscopic bariatric therapies.


Eligibility criteria:
inclusion criteria: * bmi equal or more than 30kg/m2 (27.5kg/m2 for chinese or south asian) to 40kg/m2, or bmi equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, and * failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination exclusion criteria: * previous upper gi surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery) * previous esg * gastroparesis * active smoking * an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment * previous pyloromyotomy or pyloroplasty * gastrointestinal obstruction * use of any medication that may interfere with weight loss or gastric emptying * severe coagulopathy * esophageal or gastric varices and/or portal hypertensive gastropathy * underlying uncontrolled endocrine problem that leads to obesity. (e.g. hypothyroidism, cushing syndrome, eating disorder etc.) * any inflammatory disease of the gastrointestinal tract (including but not limited to severe (la grade c or d) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as crohn's disease) * malignancy * pregnant or breast feeding * patients not fit for general anesthesia * asa grade iv or v * mental or psychiatric disorder; drug or alcohol addiction * other cases deemed by the examining physician as unsuitable for safe treatment * refusal to participate
waterinmotion aquatic therapy in obese men with knee osteoarthritis

Conditions: Osteoarthritis; Knee; Obesity

Summary: this rct evaluates whether waterinmotion aquatic therapy improves pain, function, and quality of life more effectively than land-based exercise in obese men with knee osteoarthritis (oa). we will assess clinical outcomes (womac), serum biomarkers (comp, il-6), and real-world activity (accelerometry) at baseline, 8 weeks, and 6 months.

100 participants (bmi ≥30, age 45-65, radiographic knee oa) will be randomized to: aquatic group: 24 sessions over 8 weeks (3x/week) in 32°c water, progressing from buoyancy-assisted to resistance exercises. land group: matched duration/intensity land-based rehabilitation. primary outcomes: womac pain/function. secondary outcomes: sf-36 quality of life, serum comp, 6-minute walk test, and accelerometer-measured step count.

Eligibility criteria:
inclusion criteria: * males aged 45-65 * bmi ≥30 kg/m² * radiographic knee oa (kellgren-lawrence grade 2-3) * womac pain score ≥25/50 exclusion criteria: * inflammatory arthritis (e.g., rheumatoid) * intra-articular injections within 3 months * contraindications to aquatic exercise

Keywords: aquatic therapy exercise therapy quality of life biomarkers wearable electronic devices
early healing of oral soft tissues: a clinical and biomolecular analysis. part ii

Conditions: Wound Heal; Wound Surgical; Oral Soft Tissue Conditions; Chlorhexidine Adverse Reaction

Summary: the purpose of the present study is to evaluate the influence of the post-surgical chlorhexidine indication in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues. the main hypothesis is that the post-surgical use of chlorhexidine affects the gene expression and the celular behavior in the early wound healing process of the soft oral tissues.

the bacterial infection control in the wound healing is a very important aspect to considerer. local antiseptic administration after the surgical procedures has been used to control the bacterial contamination. chlorhexidine (chx), widely used as antiseptic, especially as post-surgical indication, has a toxic effect both in vivo and in vitro and their influence on wound healing has been studied for a long time. one of the first animal studies, in 1980, concluded that intensive rinsing with high concentrations of chlorhexidine after oral surgical operations, could result in delay and disturbance of wound healing. another more recent animal study concluded that chx induces apoptosis or necrosis in the fibroblasts. mariotti and rumpf, in 2016, carried out a studied incubating human gingival fibroblasts in chx. the results have been suggested that chlorhexidine could induce a dose dependent reduction in cellular proliferation and that concentrations of chlorhexidine that have little effect on cellular proliferation can significantly reduce both collagen and non-collagen protein production of human gingival fibroblasts in vitro. hence, the introduction of commercially available concentrations (0.12%) or diluted commercial concentrations (as low as 0.00009%) of chlorhexidine to surgical sites for short periods of time prior to wound closure can conceivably have serious toxic effects on gingival fibroblasts and may negatively affect wound healing. all the previous mentioned studies permit understand that the chx is not harmless to the oral tissues. however, its effect is not entirely clear and should be evaluated in depth taking into account that it is one of the most indicated antiseptics after surgery. currently, there are no studies that evaluate if the post-surgical use of chx affect the gene expression in the early wound healing.

Eligibility criteria:
inclusion criteria: * patients that required periodontal surgery; * patients age between 30-60 years; * patients with full mouth plaque score and full mouth bleeding score \< 15%; * patients with a good general healthy status; * patients without any medicaments or drug consumption that can affect the healing process; * non-smoking patients. exclusion criteria: * patients in pregnancy; * patients in lactation period; * patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months; * patients with systemic diseases.

Keywords: early wound healing real-time polymerase chain reaction gingiva oral mucosa palatal tissue chlorhexidine
lung cancer registry for lung cancer patients

Conditions: Lung Cancer

Summary: in the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (nsclc) and small cell (sclc) lung cancer patients from a tertiary oncology clinic in an electronic data base (edb).

investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (nsclc and sclc) who are referred to a tertiary oncology clinic. documentation will include: a) patient demographics, co- morbidities, tobacco exposure in pack-years, b) disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of tnm for lung cancer) and metastatic sites if any, c) molecular status: mutation status for epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), proto-oncogene tyrosine-protein kinase ros, hepatocyte growth factor receptor (hgfror cmet), human epidermal growth factor receptor 2 (her2), proto-oncogene b-raf, and programmed-death ligand 1 (pd-l1) testing when available, d) type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) clinical outcome: overall survival (os), response rate (rr), and progression free survival (pfs).

Eligibility criteria:
inclusion criteria: - since this will be a non-interventional study all adult patients who will be consent for registration of their data to edb will be enrolled. exclusion criteria: * patients with insufficient epidemiological or clinical data will be excluded such as patients with no demographic data or patients that have not taken at least 2 cycles of therapy.

Keywords: nsclc sclc molecular biomarkers
diagnostic utility of f-18 florbetapir pet/mr in peripheral nerve amyloidosis

Conditions: Amyloidosis

Summary: the primary aim of this study will be to examine the diagnostic utility of 18-f florbetapir pet/mr (positron emission tomography/magnetic resonance) in imaging patients with pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare these results to non-amyloid diseased controls.

patients with pathologically proven amyloidosis involving the peripheral nervous system will undergo 18-f florbetapir pet/mr on a ge (general electric healthcare) signa pet/mr scanner. a control arm comprised of patients with pathologically-confirmed non-amyloid causes of peripheral neuropathy will also undergo 18-f florbetapir pet/mr scanning. all images will be reviewed for peripheral nerve uptake.

Eligibility criteria:
inclusion criteria: * adults: 18-100 * pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy exclusion criteria: * metallic devices that are not mr safe (cardiac pacers, stents, aneurysm coils, etc.) * claustrophobia * bmi over 38

Keywords: peripheral nerve amyloidosis
study of wst09 in prostate cancer after radiation: repeat procedure

Conditions: Prostate Cancer

Summary: this is a multi-centre, phase ii, open-label, 12-month clinical trial for patients previously treated with wst09 (tookad) who have positive prostate biopsies for cancer. the study aims at delivering a second wst09 treatment for the purpose of eradicating the localized prostate cancer.

multi-centre, phase ii, open-label, 12-month clinical trial for patients that previously received a vascular-targeted photodynamic treatment (vtp) with wst09 (tookad) and still have histological findings (prostate biopsies) indicating the presence of localized cancer. the wst09-mediated vtp procedure consists of an i.v. infusion of wst09 (tookad) at 2 mg/kg, in combination with the per-cutaneous interstitial delivery of monochromatic laser light (of a wavelength of 763nm) via the trans-perineal implantation of illumination fibres, positioned in the prostatic lobes. in a previous tookad trial, escalating doses of laser light were used with a fixed dose of wst09 (2 mg/kg) in patients with localized prostatic cancer. patients who underwent the procedure but still have positive prostate biopsies (residual cancer) may benefit from an additional wts09-mediated vtp procedure. thus, the aim of this study is to treat patients still presenting with localized prostate cancer with a second wst09-mediated vtp procedure.

Eligibility criteria:
inclusion criteria: * patients previously treated with wst09-mediated vtp, with a positive biopsy of the prostate 6 months following treatment * disease confined to the prostate * life expectancy greater than 5 years exclusion criteria: * unwilling or unable to give informed consent * patients who have received another treatment for their prostate cancer since their previous wst09-mediated vtp

Keywords: treatment of localized prostate cancer localized prostate cancer
characterizing the microbiome in postmenopausal women with vulvar lichen sclerosus

Conditions: Vulvar Lichen Sclerosus

Summary: vulvar lichen sclerosus (ls) is a chronic inflammatory disease, often diagnosed at late stages after scarring has obliterated normal vulvar architecture and severely affected a woman's quality of life. first line therapy for vulvar ls is ultrapotent topical steroids. if left untreated, this condition can cause complete stenosis of the vaginal introitus and 5% of patients may develop squamous cell carcinoma (scc). lichen sclerosus is more common in pre-pubertal children and in post-menopausal women suggesting that hormonal shifts may contribute to disease pathogenesis. small studies in children with ls have also shown that the microbiome is altered in ls. little is known about the skin microbiota in postmenopausal patients with vulvar ls. to determine if the microbiome is altered in vulvar skin of postmenopausal patients with ls, this study will use 16s sequencing to broadly characterize the microbiota of vulvar skin with ls compared to control vulvar skin. the study team hypothesizes that patients with vulvar ls will have a unique vulvar microbial signature compared to age-matched controls. this study also seeks to elucidate differences in the vulvar microbiome of patients with ls after treatment of their underlying condition. the study team hypothesizes that the vulvar microbiome will change after treatment for vulvar ls. vulvar dermatoses are an understudied area in dermatology with limited therapeutic options. innumerable women often suffer in silence with vulvar ls. the long-term goal of this work is to understand factors that contribute to vulvar ls so that intervention may be undertaken before irreversible scarring and scc develop.


Eligibility criteria:
inclusion criteria: * postmenopausal exclusion criteria: * use of systemic hormone replacement * use of antibiotics in prior three months * urinary incontinence, which is defined by: 1) two incontinence episodes in the past three days and also 2) regular incontinence over the past three months that has necessitated use of incontinence protection garments