Kornimate/medical-research-clean huggingface dataset:
efficacy of mk0557 in combination with sibutramine or orlistat (0557-015)(completed)

Conditions: Obesity

Summary: study medicine will be given alone, or in combination with either sibutramine or orlistat, to obese subjects to compare the effect on body weight over a six month period.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18-65 who are considered obese (have a body mass index between 30 and 43) exclusion criteria: * subject has high blood pressure or is taking any high blood pressure medicine * history of psychiatric disorder, stroke, or heart disease
ultrasound-guided tap block and spinal morphine for pain relief after caesarean section

Conditions: Post Operative Pain

Summary: this interventional double-blind randomized controlled study was carried out on 60 cases underwent elective caesarean section delivery, they were divided into 2 groups; patients were randomly allocated into two equal groups; group m: received intrathecal 150 microgram morphine in a 0.5 ml volume, mixed with 10 mg of hyperbaric bupivacaine 0.5 % in a 2 ml volume (total volume 2.5 ml). group b: received intrathecal 10 mg hyperbaric bupivacaine 0.5% 2ml volume + 0.5 saline (total volume 3ml) and at the end of surgery patient received bilateral tap block with 20 ml volume of 0.25% bupivacaine on each side.


Eligibility criteria:
inclusion criteria: * pregnant females scheduled for elective cesarean section exclusion criteria: * patient refusal patients with known allergies or with past history of allergy to local anesthesia patients having an infection at the site of injection either in the back or in the abdominal region, patients with coagulopathy or on systemic anticoagulation, chronic opioid abuse, significant neurological, psychiatric or neuromuscular disease, drug abuse and alcoholism, obesity (bmi 30 and higher), cardiovascular disease and endocrine disorders.

Keywords: ultrasound-guided transversus abdominis plane block, morphine, caesarean section
osseointegration of tha grafted by polynass (actisurf-cerafit® ) versus non-grafted tha (cerafit®

Conditions: Osteoarthritis, Hip

Summary: the infection rate after total hip arthroplasty (tha) is about 1%. it is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment. the treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis. prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis. a new prosthesis was developped, grafted by polynass (polysodium styrenesulfonate). this bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility, bio-integration in preclinical studies. this first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting. no previous clinical trial


Eligibility criteria:
inclusion criteria: * tha following a primary or secondary osteoarthritis * tha following an aseptic osteonecrosis * social insurance * informed and signed consent exclusion criteria: * patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment * rheumatoid arthritis * steroid treatment on-going * tumor pathology of the hip bone * loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis * acetabular or femoral bone graft associated * infectious hip arthritis history * evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy * surgical history on the affected hip * allergy known to any component of prostheses * known hypersensitivity to polystyrene sulfonate resins * native cotyl with a diameter of less than 42mm or greater than 68mm * significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb * charcot's disease * immunocompromised patients * difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation) or understanding of the protocol * patient refusal * pregnant and lactating women
sex differences in vascular markers of stroke risk

Conditions: Stroke

Summary: the purposes of this study are to quantify and compare vascular function in men and women, and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on vascular measures to establish gender-specific models.

men and women with stroke have different risk factor profiles. women tend to develop stroke risk factors, subclinical disease, and have vascular events following menopause, presumably related to the depletion of estrogen. men, however, tend to develop vascular disease at a younger age. sex differences in subclinical disease are poorly understood. identification of subclinical disease could lead to more aggressive interventions to prevent stroke and other vascular events. the objectives of this study are to quantify and compare vascular function in men and women by measuring carotid atherosclerosis, endothelial dysfunction, and ankle-brachial index and then to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on these vascular measures to determine gender-specific models. the aims of this project are to determine if middle-aged men and women at risk for stroke have differences in functional and structural vascular assessments, and to develop comprehensive vascular health profiles in men and women. in this trial, researchers will use a cross-sectional design to study gender differences in vascular functions and other vascular risk factors in 150 women and 100 men with 1 or more cardiovascular risk factors but without evidence of stroke, heart disease, or peripheral vascular disease. participants will be divided in two age groups: 45 to 54 and 55 to 64 and will be followed for two years for vascular outcomes, such as stroke, transient ischemic attack or tia, or acute coronary syndromes. information from this study will help develop a comprehensive gender-specific model of subclinical disease, discover novel biological and vascular markers for stroke, and provide critical data to be used in future studies aimed at slowing progression of vascular dysfunction and preventing stroke.

Eligibility criteria:
inclusion criteria: one or more cardiovascular risk factors * non-insulin dependent diabetes * hypertension * hyperlipidemia * metabolic syndrome, (ncep atpiii criteria) * tobacco smoking exclusion criteria: * history of prior stroke (ischemic or hemorrhagic) * tia * known carotid stenosis * peripheral vascular disease * coronary heart disease * venous thromboembolism * polycystic ovarian syndrome, * morbid obesity (bmi \> 45 kg/m2) * women using hormone therapy (hormone replacement, contraceptive pills or patches)

Keywords: stroke vascular marker stroke risk risk factors sex differences
study of ibi3020 treatment in participants with late-stage solid tumors

Conditions: Solid Tumors

Summary: the main purpose of this study is to evaluate the safety and tolerability of ibi3020 and to determine the maximum tolerated dose (mtd) and/or the recommended dose for expansion (rp2d) of ibi3020.


Eligibility criteria:
inclusion criteria: participants must satisfy all of the following criteria to be enrolled into the study: 1. participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. male or female participants ≥ 18 years old. for part 1, age ≥ 18 years and ≤ 75 years; 3. histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications; 4. at least 1 measurable lesion as defined per recist v1.1 within 28 days prior to the first dose of ibi3020; 5. eastern cooperative oncology group (ecog) performance status score of 0-1; 6. minimum life expectancy of 12 weeks; 7. adequate bone marrow and organ function confirmed at screening period; 8. participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study. exclusion criteria: participants who meet any of the following criteria will be disqualified from entering the study: 1. previous treatment with ceacam5-targeted therapy; 2. prior anti-cancer therapy within the wash-out period; 3. received live vaccines within 4 weeks or cancer vaccine within 3 months; 4. potent cytochrome p450 3a4 (cyp3a4) inhibitors within 2 weeks or 5 half-lives; 5. has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to grade 0 or 1 toxicity according to nci ctcae v5.0; 6. known allergies, hypersensitivity, or intolerance to ibi3020 or its excipients; 7. undergone major surgery within 4 weeks, or who have severe unhealed wounds; 8. known symptomatic central nervous system (cns) metastases; 9. uncontrolled diseases or conditions; 10. history of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases; 11. history of thromboembolic event within 6 months; 12. under neurological, psychiatric or social condition; 13. women who are pregnant, have positive results in pregnancy test or are lactating; 14. not eligible to participate in this study at the discretion of the investigator; 15. participating in any other interventional clinical research.
ventilatory settings and monitoring variables associated with weaning failure in critically ill patients

Conditions: Mechanical Ventilation; Weaning Failure; Weaning Failure of Mechanical Ventilation; Intensive Care Unit ICU

Summary: mechanical ventilation (mv) is essential in managing acute respiratory failure. its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the icu. the process of weaning refers to the set of procedures and evaluations carried out to discontinue mv. regardless of the definition used, within the population undergoing weaning, there is a group of patients who successfully pass the daily screening but fail the spontaneous breathing trial (sbt) or the separate attempt (sa). in argentina, this figure is 39.5%, and 31.4% in patients with covid-19. on the other hand, another group of patients successfully passes the sa, is extubated, but fails in post-extubation. this failure rate varies in the literature, ranging from approximately 10 to 20%. in our country, this figure is 16% in the general population and rises to 29.7% in covid-19 patients. additionally, this population is divided into those who cannot tolerate ventilation without an artificial airway due to upper airway patency issues (such as laryngeal edema), i.e., "airway failure," and those who experience acute respiratory failure. in 2023, the wean safe study reported novel findings regarding variables associated with weaning failure. in multivariable analysis, it was found that the mv settings and monitoring variables at the time of the first sbt - respiratory rate, positive end-expiratory pressure (peep), dynamic airway pressure difference (peak pressure (ppeak) minus peep) on the day of the sa - were associated with weaning failure. in this context, the investigators will conduct a retrospective cohort study, whose primary objective will be to assess which mv settings and monitoring variables are associated with weaning failure. \*\*primary objective\*\* to determine if there are any mv settings or monitoring variables that are associated with extubation failure. \*\*secondary objective\*\* to determine if there are any mv settings or monitoring variables that are associated with failure in the first sbt.


Eligibility criteria:
inclusion criteria: * over 18 years * mv for at least 48 hours, regardless of the cause of onset * undergone at least one extubation, regardless of the outcome * at least one spontaneous breathing trial (sbt) during their icu stay, regardless of the outcome exclusion criteria: * mv records containing incorrect or inconsistent data * did not have adequate or continuous monitoring during the weaning process

Keywords: weaning failure mechanical ventilation
comparison of the effectiveness of the usg and cbct combined with intraoral scanning determing the gingival phenotype in the healthy periodontium

Conditions: Periodontal Diseases

Summary: compare two diagnostic methods: ugtm and cbct/cad/pdip in determing the gingival phenotype in group of 30 periodontally healthy patients. both methods were useful to establishing the gingival phenotype, however, ultrasonic method was more precisely for measurement of gingival thickness. there was positive correlation between the mean values of sgt and wkt and this indicates the need to measure these parameters in order to determine gingival phenotype.

gingival phenotype (gp) should be determine in each dento-gingival unit as a 3d volume of gingiva with the following parameters: width of keratinized tissue (wkt) and gingival thickness (gt). the phenotype determination is extremely important during many dental procedures, such as in dental surgery, orthodontics, prosthetics or implantology because it allows to dental treatment planning and reduce the risk of complications. previous methods of determining the gingival phenotype were based on the shape of the crowns of the upper incisors and transparency of the free gingiva. these methods are non-invasive, but innacurate. the gingival phenotype may be determined more precisely by using biometry of wkt and gt. there are several possible methods to measure the thickness of the gingiva, such as bone sounding, cone beam comuted tomography (cbct) measurement or parallel profile radiographs, cbct/cad (cbct and computer-aided design) and ultrasound method. the ultrasonic gingival tissue measurement (ugtm) method is non-invasive, removes the need for anesthesia, which may increases the volume of tissues, but requires the experience of the researcher. however, it is considered as effective and reproducible method of the measurement soft tissue thickness. cbct/cad/pdip (cbct/cad and prosthetic-driven implant planning) method also can be used to establishing the gingival phenotype. measurements of wkt are most often carried out using a periodontal probe calibrated every 1mm. in each case, a necessary condition for the proper examination of the patient and determination of gp is healthy periodontium.

Eligibility criteria:
inclusion criteria: * lack of general diseases * good oral hygiene * healthy periodontium - api ratio\&lt;15%, bop\&lt;10% * no loss of clinical attachment in the examined areas (cal=0) * no use of drugs * no addictions, especially cigarette smoking * no use of mobile prosthetic restorations and orthodontic appliances * no contraindications for x-ray examinations exclusion criteria: * general diseases * poor oral hygiene * non healthy periodontium - api ratio\&gt;15%, bop\&gt;10% * loss of clinical attachment in the examined areas (cal\&gt;1) * use of drugs that could influence the structure of the periodontal tissues * addictions, especially nicotinism * use of mobile prosthetic restorations and orthodontic appliances * contraindications for x-ray examinations
real-time targeted fluorescence endoscopy for detection of the primary cancer lesion in patients with a metastasis of unknown primary tumor in the head and neck

Conditions: Unknown Primary Tumors; Oropharynx Cancer

Summary: in current diagnostic work-up of patients with a cancer of unknown primary (cup), approximately 50% of the primary tumor lesions remains undetected. identification of the primary tumor site results in minimizing the potential morbidity from treatment by reducing morbidity by omitting the need for a mucosectomy of the bilateral base of tongue and tonsils, reducing the radiation field and better oncologic outcome than those with unidentified primary tumor. clearly, new endoscopic 'real-time' imaging techniques are needed to visualize mucosal changes associated with head and neck squamous cell carcinoma and increase detection rate of the primary tumor. targeted fluorescence endoscopy enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. this could improve the detection of the primary tumor in cases where the primary tumor is not detected with white light endoscopy.


Eligibility criteria:
inclusion criteria: * cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head \& neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary head and neck tumor board of the umcg; * the primary tumor was not identified during standard diagnostic work-up in the outpatient clinic including physical head and neck examination, fiberoptic laryngoscopy, chest x-ray, ct and pet/ct; * age ≥ 18 years; * written informed consent; exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent; * concurrent uncontrolled medical conditions; * received an investigational drug within 30 days prior to the dose of cetuximab-800cw; * history of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (alt \>3x upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment; * inadequately controlled hypertension with or without current antihypertensive medications; * history of allergy or infusion reactions cetuximab or other monoclonal antibody therapies; * pregnant or lactating women. documentation of a negative pregnancy test must be available for women of childbearing potential. moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause; * evidence of qt prolongation on pretreatment ecg (greater than 440 ms in males or greater than 450 ms in females) * patients receiving class ia (quinidine, procainamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * life expectancy \< 12 weeks; * karnofsky performance status \< 70%.
impact of work activity on sud outcomes

Conditions: Substance-related Disorders

Summary: to date, there are no studies of the therapeutic effects of varied work-focused programs in veterans undergoing outpatient substance use disorder (sud) treatment. the investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in veterans early in the course of recovery from sud. veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.

the investigators propose a trial to test the effects of incentive therapy (it) and other therapeutic and supported employment services (other tses) on improving sud outcomes in newly recovering veterans in outpatient treatment. in line with eligibility criteria for different tses programs, the investigators will employ a two branch study: one branch will be for veterans who are not interested in pursuing competitive employment, and will be a two arm rct with randomization (2:1) to referral for it + treatment as usual (tau; including usual sud outpatient treatment) or tau alone. the second branch will be for veterans who express interest in competitive employment, and will be a two arm rct with randomization (2:1) to referral for tses competitive employment services + tau or tau alone. total intent to treat sample will be 140 (n=70 per branch). primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.

Eligibility criteria:
inclusion criteria: * participants will be veterans enrolled in vachs substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record. * additional criteria will be as follows: * 18 years of age and older, * meeting dsm-v criteria for any current substance use disorder (sud) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol), * competent to give written informed consent and hipaa authorization. exclusion criteria: * involvement in a legal case that may lead to incarceration during study period; * developmental disability or medical illness that would prevent therapeutic work activity, as judged by pi or clinical staff providing this service; * plans to relocate outside geographic area that would make follow-up unlikely; * and/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that we are unable to maintain contact directly.

Keywords: substance-related disorders rehabilitation, vocational
post-covid-19 pneumo-hematocele

Conditions: COVID-19 Respiratory Infection

Summary: introduction. as the covid-19 pandemic has continued, an increasing number of long-term complications are emerging. recently, the appearance of characteristic pulmonary lesions has been noted, being described as post covid-19 pneumatocele. the aim of this study is to describe the clinical, histopathologic and imaging features of post covid-19 pneumo-hematoceles (phc) and secondarily to suggest a treatment algorithm in these patients. methods. a retrospective study was performed in patients admitted with diagnosis of sars-cov2 infection from march 2020 to september 2021 who presented phc on imaging studies. clinical and demographic variables were recorded and ct scans were analyzed. a logistic regression analysis was performed to determine the risk for rupture according to phc characteristics. it appears that phc occurs secondary to encapsulation of blood accumulation, the result of micro capillary bleeding, with partial reabsorption of blood and subsequent air filling. the recommendation is to operate on patients with phc of 5cm and those with persistent lesions of 3cm.


Eligibility criteria:
inclusion criteria: * adults with a positive protein chain reaction for sars-cov2, * phc on imaging studies. exclusion criteria: * loss of follow up * age out of range.

Keywords: covid-19 pneumohematocele giant bullae pneumatocele