Kornimate/medical-research-clean huggingface dataset:
progesterone for postpartum cocaine relapse

Conditions: Cocaine Abuse; Cocaine Dependence

Summary: the investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.

specific aim 1: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. hypothesis 1: compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use. specific aim 2: to obtain information about the safety and tolerability of progesterone treatment in the postpartum period. hypothesis 2: side effects for progesterone will be similar to those of placebo.

Eligibility criteria:
inclusion criteria: * gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate. * women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy. * women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. if women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. while we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine. exclusion criteria: women will be ineligible for the trial if they: 1. have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study; 2. have a known allergy to progesterone or peanuts (vehicle for micronized progesterone); 3. speak a language other than english; 4. are planning on moving out of the area in the first six months after delivery; 5. are unable to understand the study or are unable to provide informed consent; 6. are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above); 7. have pending incarceration; 8. are currently incarcerated; 9. are using another progestin; 10. are unwilling to accept randomization; 11. are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.

Keywords: cocaine abuse cocaine dependence postpartum period
a single-dose, randomised, crossover, placebo-controlled study assessing two fixed-dose combinations of inhaled long-acting beta-agonist and corticosteroid

Conditions: Asthma

Summary: the purpose of this study is to assess the the ability of a single dose of las40468 administered via genuair® and a single dose of salmeterol/fluticasone propionate (seretide®) administered via accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments

this is a phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of las40468 and a single dose of salmeterol/fluticasone propionate (seretide®) administered to adult patients with stable asthma. the study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of investigational medicinal product (imp) administration.

Eligibility criteria:
inclusion criteria: * adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both inclusive) * patients with a confirmed 6-months' history of asthma at the time of enrolment into the trial * patients treated with short-acting beta-agonists or inhaled corticosteroids at a stable dose and regimen (up to the equivalent of 1600 μg/day of beclometasone dipropionate) for at least 4 weeks prior to screening * patients whose (pre-salbutamol) forced expiratory volume in 1 second (fev1) at screening is \>60% of the predicted normal value after a washout of at least 6 hours for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if applicable * patients with a fev1 absolute increase of at least 250 ml over baseline value after inhalation of 4 puffs of 100 μg of salbutamol in one of two pulmonary function tests performed within 10-15 min exclusion criteria: * patients with clinically significant respiratory or pulmonary diseases other than asthma or history of thoracic surgery * patients with a body mass index (bmi) \ 40kg/m2 (both inclusive)
flt-pet in predicting response to chemotherapy in patients with advanced malignancies

Conditions: Malignant Neoplasm

Summary: this clinical trial studies fluorine f-18 fluorothymidine (flt)-positron emission tomography (pet) in predicting response to chemotherapy in patients with advanced malignancies. flt solution can help locate cancer cells inside the body. diagnostic procedures, such as flt-pet, may help find tumors and measure a patient's response to treatment.

primary objectives: i. to determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in flt-pet standardized uptake value which correlates with clinical response. secondary objectives: i. to determine the relationship between flt-pet and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity. outline: patients undergo fluorine f-18 fluorothymidine pet at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.

Eligibility criteria:
inclusion criteria: * patients actively enrolled and being treated on protocol 2007-0668: combination therapy with bevacizumab and temsirolimus in patients with advanced malignancy at m.d. anderson cancer center; these patients must have met the inclusion and exclusion criteria for that protocol * women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose * ability to understand and the willingness to sign a written informed consent document * patient actively enrolled and being treated on protocol 2012-0061 "a phase i trial of bevacizumab, temsirolimus alone and in combination with valproic acid or cetuximab in patients with advanced malignancy" at m.d. anderson cancer center exclusion criteria: * pregnant or breast-feeding women * history of hypersensitivity to 3'-deoxy-3'-18f-fluorothymidine (18f-flt) or any component of the formulation
oscillatory versus non-oscillatory nasal continuous airway pressure neonatal respiratory support

Conditions: Respiratory Distress Syndrome; Prematurity

Summary: this study will seek to enroll neonates requiring nasal continuous airway pressure (ncpap) respiratory support and randomize them to either oscillatory (osc-ncpap, study group) or non-oscillatory (ncpap, control group) mode. the goal of the research is to determine if osc-ncpap provides improved ventilation support compared to routine ncpap, i.e. ncpap without oscillations. this will be measured by need for change to ventilator support, improvement in pco2 values, and reduction in respiratory rate and frequency of apnea during the period of ncpap treatment. other respiratory outcomes will also be compared, including time on ncpap, time on high-flow nasal cannula support following ncpap, and time-averaged pio2 from start of study to end of respiratory treatment.


Eligibility criteria:
inclusion criteria: * newborn (0-28 days of age) admitted to neonatal intensive care unit (nicu) * ordered respiratory treatment of ncpap exclusion criteria: * major congenital defect * known or suspected chromosomal disorder
the prospective segeberg tavi registry

Conditions: Aortic Valve Stenosis

Summary: a single center registry including all patients treated with tavi at the heart center, bad segeberg, germany

a prospective single center registry including all patients treated with transcatheter aortic valve implantation (tavi) at the heart center, bad segeberg, germany. patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

Eligibility criteria:
inclusion criteria: * all patients treated with tavi exclusion criteria: * none
a study to assess the safety, tolerability and pharmacokinetics of abi-6250 in healthy participants

Conditions: Hepatitis Delta Virus; Hepatitis D

Summary: this study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (sad) and multiple-ascending doses (mad) of abi-6250 in healthy participants. effect of food will also be evaluated in part a.


Eligibility criteria:
inclusion criteria: * participant has a body mass index (bmi) between ≥18.0 and \<32.0 kg/m2 and is in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female participants must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day-1 or day 1 (predose). * participants must agree to comply with protocol-specified contraceptive requirements. exclusion criteria: * current infection of human immunodeficiency virus (hiv), hepatitis b virus, (hbv), hepatitis c virus (hcv) or acute hepatitis a virus (hav). * history of any illness that, in the opinion of the investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs. * history of any significant drug-related allergic reactions such as anaphylaxis, stevens-johnson syndrome, urticaria, or multiple drug allergies. * history of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening. * has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.
reducing risk of dementia through deprescribing

Conditions: Dementia; Alzheimer Disease, Late Onset

Summary: a cluster-randomized controlled trial (rct) called "reducing risk of dementia through deprescribing" (r2d2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.

the r2d2 study will test whether the adverse cognitive effects of anticholinergic medications are reversible by implementing a pharmacist-based deprescribing intervention for older adults within primary care practices. two groups will be recruited: providers (physicians and advanced practice providers including nurse practitioners), and patients. primary care providers of those prescribed eligible anticholinergic medications will be recruited for participation in the study, and their patients who also meet eligible criteria will be subsequently approached and recruited. participants will be randomized to one of two groups: the deprescribing intervention group or usual care; the intervention group will receive a pharmacist-based deprescribing intervention, while the usual care group will receive care as usually provided by their primary and/or specialty care providers. the intervention and follow-up data collection will occur over 24 months in order to test the long-term impact of the intervention on the planned clinical outcomes. study outcomes include cognition (primary) and safety (secondary) through validated self-reported scales.

Eligibility criteria:
inclusion criteria for participants: * age 65 and older; * at least one office visit to their primary care physician within the previous 12 months; * use of a target anticholinergic medication within the last two weeks or medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months * able to communicate in english; * access to a telephone exclusion criteria for participants: * permanent resident of an extended care facility (nursing home) * diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by international classification of diseases (icd) version 9/10 codes * diagnosis of alzheimer's disease or related dementia as determined by (a), (b), or (c) below: 1. icd-9/10 codes, or 2. current use of a medication for alzheimer's disease or a related dementia, or 3. a pattern of responses to the functional activities questionnaire (faq) that indicate dementia (i.e., ≥ 3 faq items are scored at "requires assistance," or if ≥ 1 faq item is scored at "dependent").

Keywords: deprescribing anticholinergics dementia cognition
albumin for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hypoproteinemia

Summary: the rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (hcc). therefore, many patients with hcc were with low serum albumin before and after (especially) hepatic resection. serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. however, the role of albumin infusion in patients with hepatocellular carcinoma (hcc) after resection is unknown. the present study aimed to investigate the safety and clinical necessity of albumin infusion for hcc patients after hepatic resection.


Eligibility criteria:
inclusion criteria: * body mass index \>18.5; * patients with primary hepatocellular carcinoma without any treatments for tumors before resection; * hepatocellular carcinoma should be confirmed by histopathology; * with preserved liver function (child-pugh score ≤7) before resection * ecog performance score 0 or 1; * preoperative serum albumin \>35g/l; * the level of postoperative serum albumin is between 25-30g/l in the first day after resection. exclusion criteria: * patients used albumin before liver resection (\<1 months); * plasma was used during or after liver resection; * surgery involving the extrahepatic bile duct or gastrointestinal tract.
mordified restoration of tensor veli palatini in cleft palate repair

Conditions: Cleft Palate

Summary: to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional langenbeck's repair and merely levator veli palatini restoration.

71 patients with cleft palate received surgery were divided into 3 groups. group 1: patients who received langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. group 2: patients who received palate surgery with special levator veli palatini restoration. group 3: patients who received palate surgery with modified tensor veli palatini restoration. the conductive auditory brainstem response and 226 hz tympanometry were used to test the audiological and otological status of the three groups. preoperative and postoperative results were compared intragroup and intergroup.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cleft palate. * primary palate repair. exclusion criteria: * severe general disease * confirmed hereditary hearing loss or neuropathic hearing loss. * received any kind of audiological or otological therapy before. * patients and/or his/her don't want to continue the clinical trial.
implementation of a delirium screening

Conditions: Delirium; Cancer; Bone Marrow Ablation

Summary: the purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the icu setting. the hypothesis is that patients who receive an accurate and early diagnosis of delirium coupled with a standardized intervention protocol will demonstrate improved patient outcomes as evidenced by fewer days spent in the icu, fewer days spent in the hospital (overall length of stay) and the need for less sedative medication throughout their icu stay as compared to patient data prior to the implementation of a delirium protocol.


Eligibility criteria:
inclusion criteria: * patients will be included into the study who: * are over 18 years old * speak and read english * are admitted to the sylvester comprehensive cancer center intensive care unit in the first 60 days following implementation of the delirium protocol; approximately 10 patients per month. * patient data via electronic medical record (emr) for all patients who were admitted to the sylvester comprehensive cancer center intensive care unit up to 60 days prior to the implementation of the delirium protocol. exclusion criteria: * this study will exclude: * patients who are unable to speak and read english * patients who are unable to provide written consent to participate. * patient data via emr for any patients who were admitted to the sylvester comprehensive cancer center intensive care unit prior to 60 days before to the implementation of the delirium protocol.
role of duplex doppler in accurate diagnosis of appendicitis

Conditions: Appendicitis Acute

Summary: to evaluate the role of duplex doppler in diagnosis of appendicitis compared to ct

acute appendicitis (aa) is the most common acute abdominal condition worldwide \[1\] thus far, the clinical diagnosis of (aa) remains a challenge to emergency physicians and surgeons both in the pediatric and adult populations, as the symptoms are often atypical and overlapped with various other diseases\[2\],\[3\]. the accurate diagnosis of aa depends on both clinical presentations and imaging techniques. to date, us and computed tomography (ct) remain the most common used diagnostic imaging, and ct is considered the gold standard technique to evaluate patients with suspected aa, because of its high sensitivity and specificity \[2\],\[3\]. while the associated radiation exposure remains a concern, especially, among children, the elderly and pregnant women, as radiation protection is of major importance \[2\],\[3\],\[5\],\[6\]. over recent years, research on various aspects of us imaging in the diagnosis of (aa) has gained major importance due to its radiation protection, broad availability and cost-effectiveness \[6\]. therefore,us may be valuable as an initial imaging choice for patients with suspected (aa) or with equivocal clinical presentations \[7\],\[8\]. with continuing efforts to improve the diagnostic performance of us, a variety of us findings have been described for use in the setting of suspected appendicitis, including the maximum outer diameter (mod), periappendiceal fluid, echogenic periappendiceal fat, and loss of the normally echogenic submucosal layer within the appendiceal wall \[9\] ,\[10\]. color doppler imaging has been utilized as well, with early reports describing no detectable flow in the normal appendix and later reports, with the benefit of improved instrumentation, d describing flow in normal appendices and hyperemia in inflamed appendices \[11\],\[12\]. however, objective criteria for interpreting doppler results generally have not been specifically described \[11\],\[13\],\[12\],\[14\]. .spectral doppler imaging, in contrast to color doppler imaging, provides inherently objective, quantitative data such as peak systolic velocity (psv) and resistive index (ri) values. these measurements have found utility in the assessment of the carotid arteries and, for example, both native as well as transplanted hepatic and renal vessels\[16\],\[17\]. early investigations addressed the ri in appendicitis as well, without emphasis on the psv, using instrumentation that was modern for the time \[18\],\[19\],\[20\].

Eligibility criteria:
inclusion criteria: * patients with acute abdomen and suspected appendicitis. exclusion criteria: * so obese and irritable patients whom satisfactory graded compression us can't be done. * pregnant women , children under 3 years old and adults over 60 years old for radiation hazards. * patients with renal impairment for contrast hazards.
biofeedback based virtual reality intervention to manage postoperative pain

Conditions: Pain; Pain, Postoperative; Pain, Acute; Surgery

Summary: to develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

this is a 2-phase study aimed to refine a perioperative treatment protocol for a technology-based intervention (aim 1) and to understand whether technology-based interventions can be used to help treat pain in children following surgery (aim 2). patients will participate in only one phase of the study, and when patients are enrolled will determine what phase of the study they are in. in phase 1, all patients will use the same technology, and no randomization will occur. primary and secondary outcome measures of aim 1 are assessed in phase 1. actual enrollment for phase 1 was 23 patients. in phase 2, patients will be randomized to receive 1 of 2 technology-based interventions. the perioperative treatment protocol developed in phase 1 (aim 1) will be used in phase 2 to assess the primary and secondary outcome measures of aim 2. this phase is anticipated to enroll up to 70 participants. this is not an fda-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the fda and considered "minimal risk", thus exempt from both nde and ide.

Eligibility criteria:
inclusion criteria: * ages 12 -18 years * scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay \> or = to 2 days * able to read, understand and speak english * patients requiring management by the acute pain service * possession of a mobile device/computer available for study participation exclusion criteria: * outside the age range (\ 18 years) * non-english speaking * history of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting) * history of vertigo, dizziness, seizure disorder, and/or severe motion sickness * history of chronic pain * are chronically using opioids and or benzodiazepines for the management of pain * are actively experiencing nausea or vomiting * conditions such as craniofacial abnormalities or surgeries of the head and neck * previous participation in this study
single dose of pf-06835919 escalation study in healthy adult subjects

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of pf-06835919 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy males and female of non-childbearing potential; * body mass index 21.5 to 30.5 kg/m2 (inclusive); * total body weight \>50 kg (110 lbs). exclusion criteria: -evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).