Kornimate/medical-research-clean huggingface dataset:
nicotine replacement for smoking cessation during pregnancy

Conditions: Nicotine Dependence; Smoking Cessation

Summary: this is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

this project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. the specific aims are: (1) to examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) to compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) to identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) to explore mechanisms by which the nicotine inhaler increases birth weight and gestational age. subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population. pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. birth outcomes will be obtained on all participants

Eligibility criteria:
inclusion criteria: * smoking at least 5 cigarettes per day for the preceding 7 days * previous attempt to quit smoking during pregnancy by self report * 13-26 weeks gestation * at least 16 years of age * able to speak english or spanish * intent to carry pregnancy to term * stable residence exclusion criteria: * current drug or alcohol abuse or dependence (other than methadone maintenance) * twins or other multiple gestation * unstable psychiatric disorder * unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum) * known congenital abnormality

Keywords: smoking cessation pregnancy nicotrol inhaler placebo inhaler nicotine inhaler
safety and tolerability of acanya gel in combination with atralin gel for acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate whether cerave lotion followed by acanya gel in the morning in combination with cerave lotion followed by atralin gel in the evening is safe and effective for the treatment of acne vulgaris.


Eligibility criteria:
inclusion criteria: * males and females ≥ 12 years old. * subjects must be in good general health as confirmed by medical history and physical examination. * females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to be abstinent or use adequate birth control during the study (oral contraceptives, norplant, depo-provera, or double barrier methods (e.g., condom and spermicide). * clear diagnosis of facial acne vulgaris for at least 6 months. * subject must have a static physician's global assessment (pga) of 2 (mild severity) or 3 (moderate severity). * disease must be stable or slowly worsening for more than one week prior to entering the study. * subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration. exclusion criteria: * females who are pregnant, attempting to conceive, or breastfeeding. * subjects with known hypersensitivity to any ingredients in the study drugs. * subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation. * subjects with a current active skin malignancy or infection. * subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment. * subjects who have received systemic antibiotics within 2 weeks. * subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study. * subjects who have received any topical therapies for acne vulgaris within 7 days of entering the study. * subjects taking birth control pills used solely for acne control. * subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris. * subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject. * subjects who have crohn's disease, colitis, or if subjects ever developed colitis or severe diarrhea with past antibiotic use.

Keywords: acne vulgaris
impact of pacing mode and diastolic function on cardiac output

Conditions: Diastolic Function; Cardiac Output; Pacemaker Stimulation Mode; Stroke Volume; AV Block

Summary: background it is known from previous research that in patients with complete av (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with av-synchronous than with av-dyssynchronous pacing. however, the extent to which patients profited from av-synchronous stimulation varied substantially. aim of the study aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between av-synchronous and av-dyssynchronous pacing modes. methods patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. baseline data will be collected with a standardized questionnaire. during an echo examination, parameters of diastolic, systolic and atrial function will be assessed. then, the stroke volume/cardiac output will be measured twice in each patient, once with av-synchronous and once with av-dyssynchronous pacing. therefore, each patient will represent their own control. it will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). descriptive statistics will be applied and regression models will be fitted to explore the data.


Eligibility criteria:
inclusion criteria: * patient is able and willing to give informed consent and is above the age of 18. * patient is implanted with a dual chamber pacemaker system for at least 6 weeks. * patient is in sinus rhythm on the day of recruitment. * patient has a ventricular pacing rate exceeding 90%. * upon initial device interrogation, parameters are within normal ranges. * calculated battery life is more than 1 year. exclusion criteria: * patient is not in sinus rhythm on the day of echo examination. * intrinsic ventricular activation on the day of echo examination. * relevant shunt on the atrial, ventricular or pulmonary level. * moderate or severe heart valve dysfunction (stenosis or regurgitation). * presence of other medical devices that may interact with the pacemaker system. * women who are pregnant or breast feeding.

Keywords: diastolic function cardiac output pacemaker stimulation mode stroke volume
a bioequivalence study of apx001 high-load and low-load tablets

Conditions: Invasive Fungal Infections

Summary: a study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called apx001 in healthy participants.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive. * minimum body weight of 50 kg. * screening hematology, clinical chemistry, coagulation, and urinalysis consistent with overall good health and having an estimated glomerular filtration rate (egfr) \>80 ml/min, based on creatinine clearance calculation by the cockcroft-gault formula. exclusion criteria: * having any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential. * history or presence of neurological disorders including abnormal movements or seizures. * history or presence of malignancy within the past year. subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. * significant and/or acute illness or chronic infection, as judged by the investigator, including, but not limited to: upper airway infection, urinary tract infection, or skin infection within 30 days prior to the first study drug administration. * taking any drug or herbal cyp3a modulator (e.g., erythromycin; st. john's wort) within 4 weeks (or 5 half-lives, whichever is longer) or any other nutrients known to modulate cyp3a activity (e.g., grapefruit juice; seville orange) within 2 weeks prior to the first admission.

Keywords: fosmanogepix candida aspergillus scedosporium fusarium mucorales rhizopus
a randomized controlled study of the neurescue device as an adjunct to advanced cardiac life support

Conditions: Cardiac Arrest (CA); Cardiopulmonary Arrest

Summary: the neurescue device is the first intelligent balloon catheter for aortic balloon occlusion (abo), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. the catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. the purpose of this study is to compare the clinical safety and performance of advanced cardiovascular life support (acls) versus acls in combination with aortic balloon occlusion (abo) using the neurescue device in subjects with cardiac arrest.

subjects will be randomized into two arms: acls treatment or acls + abo treatment. those in the acls treatment arm will receive standard of care treatment for cardiac arrest, while those in arm 2 will receive acls in combination with abo. the neurescue device is an aortic balloon catheter designed to temporarily occlude the aorta. during the treatment, the neurescue catheter will be placed in the descending aorta and be connected to the neurescue assistant. the neurescue assistant facilitates pressure-regulated inflation and deflation of the balloon. throughout the treatment, cardiac rhythm and return of spontaneous circulation (rosc) will be monitored. the subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤80 years * witnessed arrest * cpr initiated within 7 min of arrest * cpr time less than 40 min at enrollment * non-shockable rhythm exclusion criteria: * traumatic cardiac arrest * known pregnancy * known terminal disease * known do-not-attempt-cpr order * known opposition to study participation
prospective randomized study of nasal high flow in treatment of acute exacerbation of chronic obstructive pulmonary disease

Conditions: Lung Diseases, Obstructive

Summary: the main oxygen therapy to the patients with acute exacerbation of chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed ph = 7.35, po2 \ 45mmhg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. all these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. the high flow nasal respiratory therapy (nasal high flow, nhf) utilises higher gas flow rates than conventional low-flow oxygen systems. the devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. this study is a prospective randomized study. aecopd patients with no severe respiratory failure are treated with nhf and conventional oxygen therapy respectively. the target is that nhf can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.


Eligibility criteria:
inclusion criteria: * aecopd patients. * the results of blood gas analysis showed ph ≥7.35, po2\ 45mmhg. exclusion criteria: * the study case has been incorporated into the hospital again. * refused to the nhf therapy. * the glasgow score \< 8. * severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, dic, etc.)

Keywords: acute exacerbation of chronic obstructive pulmonary disease nasal high flow therapy oxygen therapy
a study to evaluate rofecoxib versus placebo and diclofenac in patients with acute painful rotator cuff syndrome

Conditions: Pain

Summary: comparing the short-term efficacy of rofecoxib versus placebo. patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.


Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
acbt and high frequency chest wall oscillations in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) patients with mucus hyper secretion tend to demonstrate increased frequency of infective exacerbations and a steeper slope of decline in lung function. enhanced mucosal clearance with high frequency chest wall oscillation (hfcwo) devices previously used in cystic fibrosis and bronchiectasis patients may offer the opportunity for community based, self-managed therapy to improve quality of life and lung function. the aim of this study is to compare effects of active cycle of breathing and high frequency chest wall oscillations in chronic obstructive pulmonary disease .this study will be a randomized clinical trial and will be conducted at physical therapy department of dhq hospital narowal. the study will be completed within the time duration of six months. consecutive sampling technique will be used to collect the data. a sample size of total 42 patients will be taken in this study. patients will be divided into two groups. bode index will be used as outcome measurement tool. group a will receive the active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes. group b will receive high frequency chest wall oscillations at 13-15hz oscillating frequency for 20 minutes twice a day for 4 weeks. the collected data will be analyzed on spss - 25.


Eligibility criteria:
inclusion criteria: * patient with clear consciousness ,stable vital sign, and ability to cooperate * stage 3-4 copd according to gold criteria * adult patients * patient who had given informed consent exclusion criteria: * need for invasive mechanical ventilation * active lung tuberculosis * chest wall trauma * thoracic or abdominal operations in last three months. * presence of cardiac pacemaker, artificial stunt or heart failure

Keywords: chest wall oscillation respiration pulmonary disease chronic obstructive
fluoroethyltyrosine for the evaluation of intracranial neoplasm

Conditions: Intracranial Neoplasm

Summary: this is a single center study investigating the use of fluoroethyltyrosine (fet) in the detection of brain tumors. fet accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.

primary objectives: 1. to determine if fet positron emission tomography (pet) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas. 2. to determine if fet pet scan can differentiate between low-grade and high-grade gliomas in population 2. secondary objectives: 1. to determine if fet pet scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1. 2. to determine if fet pet scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas. exploratory objectives: 1. to assess relationships between serial fet pet scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas. outline: participants will receive a single pet scan lasting for about 40 minutes in an outpatient setting after an injection with fet. adult participants may undergo up to two repeat fet pet scans. adverse events will be recorded.

Eligibility criteria:
inclusion criteria: * presence or suspicion of intracranial neoplasm in two populations: * population 1: participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on mri. * three sub-populations will be considered: * recurrent metastatic lesions. * recurrent high-grade gliomas (grades 3 and 4). * recurrent low-grade gliomas (grade 2). * population 2: participants prior to primary treatment with planned biopsy or surgical resection. * age \> 3 years. participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid. exclusion criteria: * participants with known incompatibility to pet or computerized tomography (ct)/magnetic resonance imaging (mri) scans. * participants unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation. * sedation or anesthesia can be used for participants who cannot tolerate the exam.

Keywords: imaging studies
qol assessment in traditional glaucoma surgery and migs.

Conditions: Glaucoma

Summary: quality of life assessment before and after various glaucoma surgery (traditional and microinvasive (migs)).

patients qualified for glaucoma surgical procedure fill in qol questionnaire (nei vfq 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

Eligibility criteria:
inclusion criteria: patients qualified for glaucoma surgery in military institute of medicine - based on following inclusion criteria: * all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression * patients not tolerating antiglaucoma medications, * patients with poor compliance * progression in visual field exclusion criteria: * active inflammatory disease * pregnancy * mental disease or emotional instability * general steroid therapy * inability to fill in the questionnaire

Keywords: migs canaloplasty glaucoma glaucoma surgery glaucoma implant deep sclerectomy iridencleisis qol quality of life nei vfq 25
exercise and weight loss in pad

Conditions: Peripheral Arterial Disease

Summary: this study is designed to examine the added benefits of weight loss to an exercise program in older obese veterans with peripheral arterial disease. the investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

peripheral artery disease (pad) affects an estimated 12 -15 million adults in the us and an estimated 20% of older veterans. those with pad ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. it is estimated that over 60% of individuals with pad are overweight or obese. while pad itself worsens mobility, obesity adds a further functional burden to older adults with pad. individuals diagnosed with pad, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. studies of older obese adults without pad have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. while these findings likely translate to older adults with pad, this hypothesis has yet to be tested. this study is designed to determine whether weight loss and exercise (wl+ex) versus exercise ( ex ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. the investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese veterans with pad.

Eligibility criteria:
inclusion criteria: * bmi \>25 kg/m2 * ankle brachial index (abi) \<.90 * able to participate in a supervised exercise program at the baltimore va * no current plan for surgical revascularization * claudication or leg symptoms when walking exclusion criteria: * unstable angina or a recent heart attack * active cancer * dementia * current foot or leg ulcers * already exercise 2x/week or more.

Keywords: exercise weight loss mobility limitation