Kornimate/medical-research-clean huggingface dataset:
diet and body composition

Conditions: Obesity

Summary: the investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.


Eligibility criteria:
inclusion criteria: * elevated waist circumference: * men: \> 40 inches (102 cm) * women\> 35 inches (88 cm) * poor dieters with tg\>150mg/dl and high-density-lipoprotein cholesterol \[hdl-c\] \<40 mg/dl for men and \<50 mg/dl for women exclusion criteria: * pregnant or lactating women * serum creatinine lt 2 mg/dl * disturbed liver function (lt 3 fold level of alt and ast enzymes) * active cancer * individuals who cannot start physical activity in the gym * individuals that are highly physically active (more than 4 hours/week) * active in other nutritional trial

Keywords: abdominal obesity
negative pressure incisional wound therapy for high-risk ventral hernia repair

Conditions: Ventral Hernia

Summary: the investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. the trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.

this study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs. the trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a prevena incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. the primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. these will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. secondary outcomes will include perceived difference in quality of life and cost-effectiveness of the intervention.

Eligibility criteria:
inclusion criteria: 1. patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter 2. have one or more of the following risk factors for post-operative surgical site complications: 1. body mass index (bmi) greater than or equal to 30 2. diagnosis of diabetes mellitus (either type i or ii) 3. previous history of hernia recurrence 4. active smoker 5. presence of colostomy or ileostomy 6. age greater than 64 7. chronic obstructive pulmonary disease 8. chronic kidney disease 9. clinically immunocompromised. exclusion criteria: 1. the abdomen is left open post-operatively, or 2. if the patient has a sensitivity to silver.
treatment of actinic keratoses with photodynamic therapy using sunlight versus red light

Conditions: Actinic Keratoses

Summary: the objective of the study is to evaluate the use of sunlight instead of red light during photodynamic therapy of actinic keratoses using methyl aminolevulinate


Eligibility criteria:
inclusion criteria: * symmetric actinic keratoses in scalp or face exclusion criteria: * porphyria, pregnancy, breast feeding
improving early reperfusion with adjuvant dornase alfa in large vessel ischemic stroke (extend-ia dnase)

Conditions: Ischemic Stroke

Summary: patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous thrombolytic therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for the trial. all participants will receive intravenous tenecteplase (or alteplase due to manufacturer shortage) and endovascular thrombectomy as standard care. the trial is a bayesian optimised phase 2 dose-finding umbrella trial (single arm versus objective performance criterion of 20% substantial reperfusion prior to endovascular thrombectomy based on the extend-ia tnk trials nct02388061, nct03340493). the aim is to determine the optimal dose of intravenous dornase alfa (recombinant human dnase 1) with sufficient promise to take forward in a seamless phase 2b/3 design.


Eligibility criteria:
inclusion criteria: 1. patients presenting with acute ischemic stroke eligible, using standard criteria, to receive iv thrombolytics within 4.5 hours of stroke onset 2. patient's age is ≥18 years 3. intention to perform endovascular thrombectomy imaging inclusion criteria 4. arterial occlusion on cta or mra of the ica, m1, m2 or basilar artery exclusion criteria: 1. intracranial hemorrhage (ich) identified by ct or mri 2. rapidly improving symptoms at the discretion of the investigator 3. pre-stroke mrs score of ≥ 4 (indicating previous disability) 4. hypodensity in \>1/3 mca territory or equivalent proportion of basilar artery territory on non-contrast ct 5. contraindication to imaging with contrast agents 6. any terminal illness such that patient would not be expected to survive more than 1 year 7. any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 8. pregnant or lactating women

Keywords: thrombolysis thrombolytic endovascular thrombectomy tenecteplase dornase alfa dnase
genetic study of immunodeficiency: search for new genetic causes for primary immunodeficiencies

Conditions: Immunologic Deficiency Syndromes

Summary: individuals with suspected primary immunodeficiency will be studied and the results compared with healthy controls. primary immunodeficiency may manifest as recurrent, severe or unusual infections as well as signs and symptoms of immune dysregulation such as autoimmunity or lymphoproliferation.

patients with a suspected immunodeficiency will be identified and invited to participate. upon agreement, an additional blood sample will be collected when they have their routine bloods taken. if the study participants undergoes anaesthesia for any other reason, a small skin biopsy will be taken as well. additional samples including blood samples or mouth swabs will be taken from healthy family members. blood from healthy controls will only be taken when there is a clinical need for blood sampling (or when the study participant is already anaesthetised for any other reason) and not for research purposes only.

Eligibility criteria:
inclusion criteria: * patient with suspected pid, healthy relative or healthy volunteer * consent exclusion criteria: * none
a study for collecting data on the motion analysis of stroke patients

Conditions: Stroke

Summary: an observational study to collect (functional evaluation and daily motion) for composing 3d kinematic data that will be the basis for setting rehabilitation goal points for each stroke patient and developing virtual reality rehabilitation contents via video shooting.


Eligibility criteria:
1. inclusion criteria 1. over 20 years of age 2. more than 1 month after onset of stroke 3. after hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions 2. exclusion criteria 1. patients who correspond to one or more of the following cannot participate in the study. 2. patients with systemic infectious symptoms at the time of participation in the study 3. in the case of a person with impaired ability to consent (less than 10 points on the mmse), a person without a guardian 4. those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health 5. other cases where the researcher judges that participation in this study is not suitable (patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)
comparing the outcomes of incisions made by colorado® microdissection needle

Conditions: Periodontitis

Summary: the aim of the present study was to compare the outcomes of incisions made by colorado® microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.

commercially, many microdissection needle systems are available, such as stryker colorado® microdissection needle (cmn) (stryker-leibinger, freiburg, germany) and optimicro™ microdissection needles. colorado® microdissection needle (cmn) combine the advantages of scalpel and electrosurgery. cmn® was introduced into clinical practice in 1997, with a wide array of applications in the field of ophthalmology, neurosurgery, and others. the primary feature of the colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. this allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain. the instrument tip is a delicately machined, insulated tungsten diathermy needle that is compatible with any standard cautery hand piece. tungsten, with its extremely high melting point (\>3400°c) provides a heat resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified widman flap were included in the study. exclusion criteria: * patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.

Keywords: incisions microdissection needle
open and endoscopic technique in female inguinal hernia repair. femalehernia

Conditions: Post Operative Pain

Summary: this randomized study compares open inguinal hernia repair (lichtenstein hernioplasty) to endoscopic repair (tep) in terms of chronic pain and recurrences in one and five years after operation.

the best operative technique in female inguinal hernia is not known. some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. our study compares operative complications, chronic pain and recurrences in lichtenstein operation to totally endoscopic hernia repair (tep) in 170 female patients with primary inguinal hernia. the patients are operated in six finnish hospitals, randomized into 85 lichtenstein vs 85 tep and followed 1 week, 4 weeks, 12 months and 5 years. main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.

Eligibility criteria:
inclusion criteria: * primary inguinal hernia in females exclusion criteria: * emergency operation * recurrent hernia * groin pain without hernia * frail and sick patient asa ≥ 4
effects of epinephrine and intravenous (i.v.) needle on cardiopulmonary resuscitation (cpr) outcome

Conditions: Cardiac Arrest

Summary: intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. it improves outcome in animal studies, but has never been investigated in a controlled study in humans. epidemiologic data indicate that it is an independent negative predictor for survival. if this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an i.v. needle and injecting drugs.

in a randomized, controlled study of all out-of-hospital cardiac arrest patients in oslo, norway, half the patients are treated according to the international guidelines for advanced cpr, and the other half according to the same guidelines, except for no i.v. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.

Eligibility criteria:
inclusion criteria: * cardiac arrest out-of-hospital exclusion criteria: * \<18 years old * trauma as cause of arrest

Keywords: cardiac arrest resuscitation epinephrine intravenous survival
fentanyl transdermal patch with chadd™ for breakthrough pain in patients with moderate to severe non-malignant pain

Conditions: Pain

Summary: a multi-center study to evaluate the efficacy of chadd (controlled heat-assisted drug delivery) applied over a 50 mcg/hr zr-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. the open-label study arm will last up to 12 days. the double-blind arm will last up to 15 days. eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.

zars pharma is developing a matrix transdermal fentanyl/chadd (controlled heat-assisted drug delivery) drug delivery system to be used for the treatment of chronic and breakthrough pain. the matrix transdermal fentanyl/chadd drug delivery system has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy. matrix transdermal fentanyl/chadd drug delivery system has 2 components: a matrix transdermal fentanyl patch (the zr-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the chadd (controlled heat-assisted drug delivery). the matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to duragesic®. during a breakthrough pain episode, a chadd unit is placed over (adhered to) the matrix transdermal fentanyl patch. the chadd is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. the application of heat delivers increased amounts of fentanyl when applied over the zr-02-01 matrix transdermal fentanyl patch.

Eligibility criteria:
inclusion criteria: * patient is 18 through 70 years of age. * patient has moderate to severe non-malignant chronic pain. * patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. patient must have been taking this dose for at least 2 weeks. * patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl. exclusion criteria: * patient has active cancer. * patient has a history of substance abuse or has a substance abuse disorder. * patient is pregnant or breastfeeding.

Keywords: chronic pain pain
autofluorescence in uveitic and diabetic macular edema

Conditions: Uveitis; Macular Edema

Summary: the aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.

after macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. furthermore we will compare the findings between diabetic and inflammatory edema.

Eligibility criteria:
inclusion criteria: * patients with diabetic or uveitis macular edema exclusion criteria: * children patients with known allergy to fluorescein
a dose escalation study in adult patients with advanced solid malignancies

Conditions: Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3; Squamous Lung Cancer With FGFR1 Amplification; Bladder Cancer With FGFR3 Mutation or Fusion; Advanced Solid Tumors With FGFR1 Amplication; Advanced Solid Tumors With FGFR2 Amplication; Advanced Solid Tumors With FGFR3 Mutation

Summary: the study will determine the maximum tolerated dose and thus the recommended phase ii dose and schedule of the compound and characterize the safety.


Eligibility criteria:
inclusion criteria: * patients with histologically/cytologically confirmed advanced solid tumors with fgfr1 or fgfr2 amplification or fgfr3 mutation, for which no further effective standard anticancer treatment exists * adequate bone marrow function * adequate hepatic and renal function * adequate cardiovascular function * contraception. * for women: must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing. * for men: must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period exclusion criteria: * patients with primary cns tumor or cns tumor involvement * patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis * history and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification * current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination. * history or current evidence of cardiac arrhythmia and/or conduction abnormality * women who are pregnant or nursing. other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors lung cancer bladder cancer bgj398 fgfr kinase inhibitor advanced solid malignancies
randomized study of propofol versus fentanyl and midazolam in pediatric patients requiring mechanical ventilation and sedation therapy

Conditions: Respiration Disorders

Summary: objectives: i. assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. ii. evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. iii. perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

protocol outline: this is a randomized, double blind study. patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. sedative doses may be reduced if necessary. treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced. patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.

Eligibility criteria:
* patients admitted to the rainbow babies and children's hospital pediatric intensive care unit who require mechanical ventilation and sedation therapy * mean comfort score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes * no other concurrent sedative therapy

Keywords: disease-related problem/condition oncologic disorders pulmonary complications rare disease respiration, artificial
maximal exercise capacity at 2500 m of high altitude

Conditions: High Altitude Pulmonary Hypertension; Maximal Exercise Capacity

Summary: the impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * ph class i (pah) or iv (cteph) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmhg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmhg during baseline measures at the diagnostic right-heart catheterization exclusion criteria: * resting partial pressure of oxygen \<8 kilopascal at zurich at 490 m low altitude * exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study * inability to follow the procedures of the study * other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
serum procalcitonin and post-cesarean wound infection

Conditions: Cesarean Wound Disruption

Summary: serum procalcitonin levels are important during infections and sepsis.the aim of this study is to evaluate the correlation between serum procalcitonin and severity of post cesarean wound infection

bacterial infection is primarily a clinical concept that may require the use of supportive bedside or laboratory tests to confirm or exclude. there are two broad factors that are always necessary to confirm the diagnosis: inflammation or systemic dysfunction and direct or indirect evidence of a compatible bacterial pathogen. inflammation may be localized or result in a systemic inflammatory response syndrome (sirs). infection handling and prevention are now improving with an effective antibiotic discovery, complete immunization and modern sanitation. however, infection remains the most common cause of morbidity and mortality rate in many health care services in the world. one of the most often serious complications in surgical procedure is surgical site infection. surgical site infection (ssi) is defined as the presence of liquid pus or abscess which extends on a wound within 30day (rcog press, 2008; bratzlr et al.,2006). surgical site infection is diagnosed with clinical and laboratory examination. the diagnosis begins with an inspection to check any pus, abscess or inflammation reaction extends on the surgical site. an open wound is also being checked, as well as pus liquid or abscess that leaks from thewound. pus or tissue specimen should be taken for culture examination and routine blood count for leucocyte count should be investigated and procalcitonin level procalcitonin (pct) and leucocyte count are indicators of systemic infection. procalcitonin is one of the applicable markers to detect bacterial infection in adults. plasma pct level is comparable with specific response of bacterial infection, particularly for invasive or probably-invasive bacteria. high concentration of pct indicates sepsis, severe sepsis or even septic shock condition. it may also represent another possibility and gives additional information towards conventional clinical data. some studies state that procalcitonin is better, or at least has the same diagnosis potency with another infection marker such as crp, leukocytosis and fever

Eligibility criteria:
inclusion criteria: * patients who will develop surgical site infection after their cesarean sections. * 18-40 years old exclusion criteria: * history of chorioamnionitis, premature rupture of membranes or prolonged rupture of membrane. * urinary tract infections. * any infectious condition other than surgical site infection.