Kornimate/medical-research-clean huggingface dataset:
bronchoscopy vs. clinical pulmonary infection score guided approach in suspected ventilator-associated pneumonia (vap)

Conditions: Ventilator Associated Pneumonia

Summary: the reported incidence of ventilator associated pneumonia (vap) is 10 to 15 per 1,000 ventilator days. vap leads to an excess cost exceeding $40,000 per patient and is associated with a crude mortality rate as high as 76%. the clinical criteria for the diagnosis of vap have low specificity and may lead to unnecessary antibiotic use. the clinical pulmonary infection score (cpis) and bronchoscopic approaches lower unnecessary antimicrobial use, antimicrobial resistance, and superinfection compared to the traditional clinical criteria. based on the available evidence and local microbiology data, we have developed a vap management protocol guided by cpis or bronchoalveolar lavage (bal) in adults with suspected vap. these two approaches have not been compared against each other. although the diagnostic studies in the cpis guided approach are inexpensive and easily available, bal has the potential to minimize the unnecessary use of antibiotics and reduce the development of drug resistant pathogens. in this study, we propose to test the hypothesis that bal leads to a reduction in antibiotic use compared to cpis in patients with suspected vap. the study design will be a randomized, clinical trial comparing cpis versus bal. the primary outcome measure will be antibiotic utilization. the secondary outcome measures will be mortality, morbidity, development of resistant pathogens and superinfection and infection related financial burden. completion of this trial will help us identify the best approach to avoid unnecessary antibiotic utilization and minimize the development of resistant pathogens (with their associated morbidity and mortality) in critically ill patients.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * endotracheal intubation * suspected vap with: * new or progressive pulmonary infiltrates plus two of the following (in patients with pre-existing ali or ards, physicians' suspicion of vap with two of the listed criteria will be used.): temperature \> 38 c or \ 12,000/ml or \< 4,000/ml, purulent endotracheal secretions. * patient or legally authorized representative is able to sign informed consent exclusion criteria: * prison inmates * immunocompromised patients * participation in another trial conflicting with the design of the current trial * previous history of vap during the same hospitalization * previous participation in the current study * concomitant non-pulmonary infection diagnosed within 3 days preceding the suspected vap * patient's primary care provider does not want subject to be enrolled in the study * contraindications for bronchoscopy

Keywords: ventilator associated pneumonia intensive care antibiotics mortality length of stay
new gentle biopsy method of cervix lesions using superficial curettage/protocol id: cx-cur

Conditions: CIN; Cervical Cancer

Summary: it is to investigate to what extent a gentle tissue extraction of cin lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat cin.


Eligibility criteria:
inclusion criteria: * women between 18 and 80 * karnofsky-index of 80 and higher * cytological suspicious cin and a colposcopical impression of a major lesion (therapeutical endpoint: conisation) exclusion criteria: * former malign disease oft he pelvic organs * pregnancy * serious internistic diseases * drug addiction
clinical performance of two daily disposable toric soft contact lenses

Conditions: Refractive Errors; Ametropia; Astigmatism

Summary: the purpose of this study is to compare the clinical performance of precision1™ for astigmatism (p1fa) contact lenses with 1-day acuvue moist® for astigmatism (amfa) contact lenses.

subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. the total duration of subject participation will be up to 22 days.

Eligibility criteria:
inclusion criteria: * successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months. * other protocol-defined inclusion criteria may apply. exclusion criteria: * habitual precision1 for astigmatism or 1-day acuvue moist for astigmatism contact lens wearers. * any spherical monovision and multifocal lens wearers. * routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses disposable
vinorelbine and oxaliplatin (vinox) with or without trastuzumab (herceptin®) in advanced breast carcinoma

Conditions: Breast Neoplasms

Summary: study objective : to assess the efficacy and the safety of the combination of oxaliplatin, and vinorelbine with or without trastuzumab as a salvage regimen in patients with metastatic breast cancer


Eligibility criteria:
inclusion criteria: * metastatic, histologically or cytologically proven breast cancer. * at least one bi-dimensionally measurable lesion. * previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the taxanes. * treatment as adjuvant is allowed. * world health organization-ecog performance status 0-2. * adequate renal function (creatinine \ = 30 ml/min) * adequate hepatic function (liver function tests not more than 3 times the normal values) * adequate bone marrow reserve is required (neutrophils (pmn) \>= 2000/mm2 and platelets \>= 100,000/mm2) * patient who will receive herceptin should have an over-expression of her2-neu. exclusion criteria: * symptomatic peripheral neuropathy (national cancer institute common toxicity criteria grade more than one). * pregnant or breast-feeding. * history of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma). * receiving or had received, any treatment with experimental drugs. * had known brain or leptomeningeal involvement. * had a serious medical condition like congestive heart failure or an ejection fraction ≥ 40 %. * the presence of bone as a sole site of metastasis. * radiation therapy to all areas of measurable disease less than four weeks before treatment. * creatinine two times above the normal range * hypercalcemia * evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - ascites - pericardial effusion. * concomitant steroid intake for \> 4 weeks * bilirubin two times above the normal range the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
combined anabolic therapy

Conditions: Osteoporosis, Postmenopausal; Osteoporosis

Summary: in this research study the study investigators want to learn more about the effect of two different fda-approved medication regimens in the treatment of postmenopausal osteoporosis.


Eligibility criteria:
inclusion criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture exclusion criteria: * no significant previous use of bone health modifying treatments * known congenital or acquired bone disease other than osteoporosis * significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease * abnormal calcium or parathyroid hormone level * serum vitamin d \<20 ng/dl * anemia (hematocrit \<32%) * history of malignancy (except non-melanoma skin carcinoma) * excessive alcohol use or substance abuse * known contraindications to romosozumab or teriparatide
zd6474 alone or in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of zd6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic nsclc. this phase of the trial is closed to enrollment. the purpose of the randomized phase of this study is to determine the efficacy of zd6474 alone versus that of zd6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic nsclc. this phase of the trial is closed to enrollment.


Eligibility criteria:
inclusion criteria: * signed informed consent * 18 years or older * histologically or cytologically confirmed locally advanced or metastatic nsclc * no prior chemotherapy/biological therapy/radiation therapy * one or more measurable lesions * life expectancy more than 12 weeks exclusion criteria: * brain metastases or spinal cord compression * currently active skin disease * history of significant hemoptysis * abnormal blood chemistry * cardiac abnormalities * recent significant cardiac event * coexisting malignancies

Keywords: non-small-cell lung carcinoma
ono-4538 phase i study in patients with advanced malignant solid tumors in japan

Conditions: Malignant Solid Tumor

Summary: evaluation of the safety, tolerability and pharmacokinetics (pk) of a single dose and multiple doses of ono-4538 in japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ono-4538.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm. * tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists. * ecog performance status of 0-1 * life expectancy ≥ 3 months * other inclusion criteria as specified in the study protocol exclusion criteria: * history of severe hypersensitivity reactions to other antibodies. * residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator. * two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years. * patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications. * other exclusion criteria as specified in the study protocol

Keywords: ono-4538 mdx-1106 solid tumors
definitive chemoradiotherapy and cetuximab in the treatment of locally advanced esophageal cancer

Conditions: Esophageal Neoplasm

Summary: in patients with esophageal cancer, treatment with curative intent can be given to medically fit patients without distant metastases. it may consist of chemoradiotherapy or surgery alone or in combination. surgery in combination with chemotherapy is another option. for patients who are not medically fit for surgery or with unresectable invasion in adjacent structures the only alternative with curative intent is, with current knowledge, definitive chemoradiotherapy. in the current study the investigators aim to improve prognosis for patients not suitable for surgery. patients receive treatment with conventional chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more recently developed drug, an antibody called cetuximab.

patients are treated with three cycles of oxaliplatin and fluorouracil 750 mg/m2/24 hours, day 1-5. each cycle lasts for 21 days. oxaliplatin is given with 130 mg/m2 in the first cycle and in cycle 2 and 3 which are administered concomitant with radiotherapy the dose is reduced to 85 mg/m2. a loading dose of cetuximab 400 mg/m2 is given one week before the start of radiotherapy, and thereafter 250 mg/m2 is given weekly during the course of radiotherapy. concomitant with chemotherapy radiotherapy to a total dose of 50 gy is given (2 gy once daily in 25 fractions, 5 days a week) with a photon beam linear accelerator. after treatment patients are followed every 6 months for three years with clinical examination and a ct-scan.

Eligibility criteria:
inclusion criteria: * histological verified squamos cell carcinoma or adenocarcinoma of the oesophagus or cardia * performance status who 0-2, age 18-75 years * locally advanced disease, non-resectable (t4 n0-n3 m0) or disease which is not operable for any other reason (t2/t3 n0-n3 m0) * adequate hematological, liver and renal function * written informed consent exclusion criteria: * distant metastases * prior chemotherapy or radiotherapy for oesophageal cancer or cancer of the cardia * symptomatic peripheral neuropathy equal to or greater than nci grade 2 * other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed consent * myocardial infarction within 6 months prior to study entry * second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 2 years * pregnancy

Keywords: phase ii study, clinical trial
prospective study on swallowing/breathing interactions in severe guillain barre syndrome.

Conditions: Tetraplegia; Respiratory Failure

Summary: to estimate, in a longitudinal and not invasive way, in patients with sgb at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.

context: the syndrome of guillain barré ( sgb) is the first causes of extensive paralysis of medical origin in industrial nations. a third of these patients going to require mechanical invasive ventilation during their stay in icu. this population of ventilated presents the strongest risk of infectious respiratory patient complications and death. the respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. the monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. the occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. besides the arisen of sleep apneas was never sought in this context. this dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances. method: longitudinal observational and in a one center study. the respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. the existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording. criterion of selection: patient admitted in icu with gbs and respiratory risk. number of patients, centre: 40 patients admitted in the intensive care unit of the hospital raymond poincare and 20 controls. duration of the study: 24 months perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.

Eligibility criteria:
inclusion criteria: * guillain barré syndrome * presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria * deficit evolving for less than 7 days * impossibility to stand up * impossibility to raise the head * ineffective cough * vital capacity\< 60 % exclusion criteria: * major confusions of gulp (spontaneous) at admittance * respiratory distress syndrome and intubation at admission buccal dental lesions * not membership to a regime of social security (beneficiary or legal successor) * patient under guardianship or custody

Keywords: guillain barré syndrome swallowing disorders respiratory failure
penile length restoration in men with diabetes mellitus, type ii

Conditions: Diabetes Mellitus, Type 2; Penile Diseases

Summary: the objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.

men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. one of these sexual dysfunctions includes diminished penile length. it is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. to accomplish the study, a population of men from mayo clinic with a diagnosis of diabetes, type ii will be enrolled and will be randomized to utilize the device for varying amounts of time. outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.

Eligibility criteria:
inclusion criteria: - men with diabetes mellitus, type ii exclusion criteria: * any evidence of end-organ failure attributed to dm (assessed based on medical history / patient history alone) * loss of fingers / toes. * ckd stage iv or greater. * retinopathy * myocardial infarction. * cerebrovascular accident. * indwelling penile prosthesis or prior history of penile prosthesis. * peyronie's disease at baseline.
exploring deployment stress and reintegration in army national guard chaplains

Conditions: Combat Stress Disorder

Summary: the purpose of this 2-year pilot study is to explore the impact of deployment on the psychosocial and health characteristics and reintegration of military chaplains, specifically those of the army national guard (arng). this pilot will serve as the foundation for subsequent investigations of chaplains from multiple branches of the military. in addition to spiritual and religious support, military chaplains play a key role in the behavioral health of deployed service-members, routinely participating in suicide prevention training, conducting critical event debriefing, and identifying service-members at risk for combat and operational stress reactions1. a high risk group for exposure to trauma2, military chaplains have suffered brain injuries, gunshot wounds and blast injuries in oef/oif theater3. in addition, many report combat related stress issues such as compassion fatigue, ptsd, and reintegration issues3. while the traumatic experiences of oef/oif deployed troops have been well documented, the effects on military chaplains caring for these service-members have received little attention in the research to date. we are collaborating with the national guard chaplain corps leadership on this program of research. the aims of this 2-year pilot cross-sectional study focus on describing and exploring deployment and its impact on psychosocial, health characteristics and reintegration of arng chaplains using a mixed method approach (web-based survey, in-depth interviews, social network analysis).


Eligibility criteria:
inclusion criteria: * current, active members of arng during timeframe of oif/oef/ond * chaplains * able to be contacted by email for survey explanation and participation * consent to participate in interview or network questionnaire exclusion criteria: * not current, active members of arng during timeframe of oif/oef/ond * not chaplains * not able to be contacted by email for survey explanation and participation * do not consent to participate in interview or network questionnaire

Keywords: war religion caregiver combat stress disorder
smartwatch-based ai model for osa prediction (swosa)

Conditions: Obstructive Sleep Apnea of Adult; Screening; Smart Watch

Summary: this study aims to develop an artificial intelligence (ai) model for more accurately diagnosing obstructive sleep apnea (osa) by collecting blood oxygen saturation and other health information during sleep using a smartwatch. osa is common but often underdiagnosed, and the gold-standard diagnostic test, polysomnography, is costly and time-consuming. smartwatches can provide a variety of health data, such as sleep patterns, blood oxygen saturation, and heart rate, which can help detect key symptoms and signs of osa. by developing an ai model that uses smartwatch data to screen for osa, this study seeks to offer a cost-effective and accessible diagnostic method, ultimately contributing to the early detection and improved treatment rates of osa.


Eligibility criteria:
inclusion criteria: * men and women aged 22 to 85 years who visited seoul national university hospital with suspected sleep apnea due to symptoms such as snoring, apnea, or excessive daytime sleepiness. exclusion criteria: * patients previously diagnosed with sleep apnea who are currently undergoing treatment (e.g., positive airway pressure \[pap\] therapy, mechanical ventilation, oral appliances, or surgery). * patients with neuromuscular diseases or a history of chronic opioid medication use. * patients with severe insomnia that is not controlled by medication. * patients receiving supplemental oxygen therapy due to underlying conditions such as heart failure, chronic obstructive pulmonary disease, interstitial lung disease, hypoventilation syndrome, or stroke, or whose baseline oxygen saturation is less than 90%. * patients with implanted cardiac pacemakers, defibrillators, or other electronic devices. * patients inexperienced in using smartphones, apps, or smartwatches. * pregnant women. * patients unable or unwilling to provide written informed consent.
contributing factors of solitary drinking among adolescents and young adults

Conditions: Alcohol Drinking; Alcohol Use Disorder

Summary: a convenience sample of 40 solitary drinkers aged between 10 and 24 will be invited to complete a structured questionnaire and a individual semi-structured interviews.


Eligibility criteria:
inclusion criteria: * 10-24 years old, * able to speak cantonese * self-report as exhibiting solitary drinking behaviour exclusion criteria: * none