Kornimate/medical-research-clean huggingface dataset:
assessing neuropsychiatric symptoms including depression, anxiety, irritability, and suicidal thoughts or behavior in subjects quitting smoking on varenicline tartrate or placebo

Conditions: Smoking Cessation

Summary: study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.


Eligibility criteria:
inclusion criteria: * smokers who smoke \>10 cigarettes/day and who have at least a moderate level of addiction as measured by the fagerstrom test for nicotine dependence (score \>5) exclusion criteria: * any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder. * any unstable medical condition

Keywords: nicotine withdrawal, smoking cessation, varenicline
treatment in patients with suspected or confirmed covid-19 with early moderate or severe disease

Conditions: COVID-19

Summary: this study proposes to evaluate clinical outcomes and viral load in covid-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. patients will be randomized to supportive care, or hydroxychloroquine alone, or hydroxychloroquine and azithromycin.

this is a phase 3 study. primary objective: • to evaluate clinical outcomes in patients with suspected or confirmed covid-19 with early moderate to severe disease in a randomized controlled trial. secondary objectives: * to evaluate quantitative viral load over time * to evaluate length of hospital stay and days in icu * to evaluate toxicity of the treatment options * to evaluate rate of readmission after hospital discharge * to evaluate duration of clinical symptoms arm a: control arm - supportive care only arm b: hydroxychloroquine 400 mg po bid on day 1 hydroxychloroquine 200 mg po bid days 2 through 5 arm c: hydroxychloroquine as in arm b and azithromycin 500 mg po on day 1 azithromycin 250 mg po days 2 through 5

Eligibility criteria:
inclusion criteria: * age greater than 18 years * positive sars-cov-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (puis). * onset of symptoms \< 7 days from date of enrollment * oxygen saturation of \>94% on room air with defined risk factors (table 1) consistent with moderate disease or oxygen saturation of \< 94% on room air consistent with severe disease * ability and willingness to comply with study procedures exclusion criteria: * qtc greater than 450 milliseconds on screening ekg * pregnant or lactating women * inability to take oral pills or inability to use a feeding tube * inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. for the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals. * patients requiring icu level care * use of azithromycin or hydroxychloroquine within 30 days prior to admission
mobile support to improve recovery and treatment court outcomes

Conditions: Substance Use

Summary: this study will fully develop and implement an interactive text messaging intervention system for individuals sentenced to dtc. upon completion of programming and testing of messages the investigators will enroll 40 participants and randomize participant to a control condition (tau group) or the intervention condition (txs group). assessments will occur at enrollment, and day 30 follow up.

this study builds on pilot work in which live inspired llc and research partners, have a history of collaboration in the development, revision, and evaluation of web-based and mobile phone technologies to promote behavior change. for this project the investigators will fully develop and implement an interactive text messaging intervention system for individuals sentenced to dtc who are entering the program, at which time participants are expected to begin addressing underlying issues related to their addiction, and during which time participants are highly vulnerable to relapse and noncompliance with mandated activities. outcomes will include participation in and compliance with court-mandated appointments, abstinence from drug use (measured by urine testing), participation in substance abuse treatment, participation in education/employment training programs, and participation in related programs and workshops as directed by the court. data will be collected directly from court records using a database established by the participating courts for this study.

Eligibility criteria:
inclusion criteria: to be eligible, participants must be 1. age \>18; 2. newly enrolled in the drug court program \[within 1 month\]; 3. own a mobile phone and use text messaging; 4. have a phone plan that allows unlimited texting; 5. agree to participate in the study protocol and be available for all assessments through the final 30-day assessment; and 6. speak and read english. exclusion criteria: we will exclude anyone who is not able to participate in the intervention or assessments (e.g., deaf, blind, or otherwise impaired and unable to participate in computerized assessment).

Keywords: text messaging
closed-loop oxygen control for high flow nasal therapy

Conditions: High Flow Nasal Cannula; Oxygen Therapy; Hypoxemia; Hyperoxemia; Acute Respiratory Failure; Respiratory Insufficiency

Summary: in patients with acute hypoxemic respiratory failure (ahrf), high flow nasal therapy (hfnt) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (spo2) in the target range and avoid hypoxemia and hyperoxemia. the hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted spo2 ranges and decreases the time spent outside clinical target spo2 ranges as compared to manual oxygen control in icu patients treated with hfnt.


Eligibility criteria:
inclusion criteria: * adult (\>17yo) patients admitted to the icu treated with hfnt for at least 8h * requiring fio2 ≥ 30% to keep spo2 in the target ranges defined by the clinician * written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation. exclusion criteria: * patient with indication for immediate continuous positive airway pressure (cpap), noninvasive ventilation (niv), or invasive mechanical ventilation * hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * low quality on the spo2 measurement using finger and ear sensor (quality index below 60% on the massimo spo2 sensor, which is displayed by a red or orange colour bar) * severe acidosis (ph ≤ 7.30) * pregnant woman * patients deemed at high risk for need of mechanical ventilation within the next 8 hours * chronic or acute dyshemoglobinemia: methemoglobin, carbon monoxide (co) poisoning, sickle cell disease * tracheotomised patient * formalized ethical decision to withhold or withdraw life support * patient under guardianship * patient deprived of liberties * patient included in another interventional research study under consent * patient already enrolled in the present study in a previous episode of acute respiratory failure

Keywords: high flow nasal cannula nasal high flow oxygen close-loop hypoxemia hyperoxemia
study of adecatumumab relative to folfox after r0 resection of colorectal liver metastases

Conditions: Liver Metastases; Colorectal Cancer

Summary: the purpose of this study is to determine the effect of adecatumumab alone or following folfox in patients with r0 resected liver metastases from crc (colorectal carcinoma) and to compare the effect to folfox alone.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed complete resection (r0) of liver metastases from colorectal adenocarcinoma * age ≥18 years * ecog performance status ≤ 2 * patient was informed, has read and understood the patient information / informed consent form and has given written informed consent exclusion criteria: * extra-hepatic distant metastases or locally recurrent disease at time of enrolment * neoadjuvant chemotherapy of liver metastases prior to surgery * any anticancer chemotherapy within 4 weeks prior to study entry * start of oxaliplatin-based chemotherapy within 9 months prior to study entry * any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry * any radiotherapy or radio frequency ablation (rfa) to the liver prior to surgery * treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry * acute or chronic pancreatitis or history of alcohol induced pancreatitis * liver cirrhosis, acute hepatitis or chronic hepatic disease * any unresolved complications from prior surgery * persistent neuropathy * history of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and ductal carcinoma in situ (dcis) * history of inflammatory bowel disease * active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator * use of immune-suppressive agents such as the regular use of systemic corticosteroids * hiv positivity * known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, folinic acid, 5-fluorouracil, oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (dpd) deficiency * pregnant or nursing women * women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter * not willing or incapable to comply with all study visits and assessments * placed into an institution due to juridical or regulatory ruling

Keywords: colorectal carcinoma liver metastases (only) r0 resection r0 resection of liver metastases from colorectal cancer
comparative study between single and double limb hip spica cast in fracture femur in young children

Conditions: Femur Fracture

Summary: we performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. they were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). the primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications.

femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. conservative management is associated with good results, whether by single or double-limb cast fixations. we aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification.

Eligibility criteria:
inclusion criteria: * children aged 2 to 6 years * children with femur shaft fractures exclusion criteria: * children younger than 2 years or older than 6 years * articular fractures or fractures that cant be managed with a cast * old fractures older than 3 weeks
parietex progrip study

Conditions: Hernia, Inguinal

Summary: the objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia progrip mesh repair compared to lichtenstein repair with lightweight polypropylene mesh.

* patients in progrip group will be treated with self-gripping lightweight polyester and polylactic acid meshes providing a sutureless fixation. * patients in lichtenstein group will be treated with lightweight polypropylene meshes requiring fixation by sutures. * study participation will start at signature of informed consent and each patient will be assessed before surgery. a close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study. * 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. patients will be stratified by center.

Eligibility criteria:
inclusion criteria: * all male patients at participating centers with a primary, uncomplicated inguinal hernia. * collar of the defect ≤ 4 cm * signed informed consent exclusion criteria: * 30 years ≥ age ≥ 75 years * emergency procedure * inclusion in other trials * bilateral inguinal hernia * recurrence

Keywords: uncomplicated primary inguinal hernias
intensive versus standard treatment for hypotension on maternal hemodynamics in preeclamptic patients

Conditions: Adverse Effect

Summary: the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics in preeclamptic patients following cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. the 2018 international consensus in the united kingdom and northern ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics in preeclamptic patients following cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification i to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥160 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly
effectiveness study of pramlintide to treat post-transplant diabetes mellitus

Conditions: Diabetes Mellitus

Summary: post-transplant diabetes mellitus (ptdm) develops in up to 30% of patients undergoing solid organ transplantation. this disease is difficult to treat as the levels of glycemia fluctuate in response to variations in doses of steroid and other immunosuppressive agents. at the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections. the investigators hypothesize that the addition of pramlintide (symlin) to the management of patients with ptdm would help patients with post-transplant diabetes attain better control at the critical time of titration of immunosuppressive regimens. the primary objective of this proposal is to improve glycemic control of diabetes with pramlintide in patients with post-transplant diabetes at 3 and 6 months of therapy.


Eligibility criteria:
inclusion criteria: * post-transplant diabetes (ptmd) * aged 20-70 * diagnosis of diabetes within the last 6-18 months * stable medications * stable weight for 3 months * serum creatinine \< 1.5 mg/dl exclusion criteria: * pre-transplant diabetes * major postoperative complications following transplant * pregnancy * significant gi discomfort with nausea or vomiting * inability to learn continuous glucose monitoring * development of diabetes more than 4 years after transplant * omen of child-bearing potential who use birth control pills and have fasting triglycerides of \> 400 mg/dl

Keywords: post transplant diabetes mellitus
integrated dual exercise and lexiscan positron emission tomography: idealpet

Conditions: Coronary Artery Disease

Summary: this is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. we will also include 10 healthy subjects without known heart disease. we would like to study stress testing of the heart using exercise and a medication called regadenoson. imaging of the heart will be performed.

regadenoson is stress agent approved by the fda for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (spect) in patients that are unable to exercise adequately. we would like to study regadenoson in conjunction with exercise rubidium-82 positron emission tomography myocardial perfusion imaging (pet mpi). regadenoson is not approved by fda for use with rubidium-82 pet mpi. also, we would like to study a novel stress protocol of regadenoson combined with symptom limited exercise stress (not fda approved). the objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with lexiscan (lexercise pet) compared to lexiscan alone (lexiscan pet), to assess image quality of lexercise compared to lexiscan pet and to compare relative and absolute myocardial perfusion imaging with lexercise compared to lexiscan pet to identify cad.

Eligibility criteria:
inclusion criteria: * age \> 18 years * clinically indicated n-13 ammonia pet study or ten healthy volunteers * known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or q wave mi on ecg) or intermediate to high pretest likelihood of cad * able to exercise on a treadmill * able and willing to provide informed consent to participate in the study exclusion criteria: * contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure \ 200 mmhg, respectively), or \> 1st degree atrioventricular block in the absence of a functioning pacemaker. * subject requires emergent cardiac medical intervention or catheterization after the clinical study. * documented myocardial infarction (mi) ≤ 30 days prior to enrollment. * history of percutaneous coronary intervention (pci) ≤ 4weeks prior to enrollment. * history of coronary artery bypass graft (cabg) ≤ 8 weeks prior to enrollment. * history of heart transplantation. * allergy or intolerance to aminophylline or regadenoson * known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease \[e.g., asthma, wheezing, chronic obstructive pulmonary disease (copd), etc.\]. * severe lv dysfunction, with ejection fraction of \< 30% * serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline pet study) or a social situation which will preclude research study participation * history of seizures.

Keywords: coronary artery disease exercise regadenoson positron emission tomography
clinical decision support for women with a history of gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: the investigators hypothesize that computer-assisted decision support will increase the percentage of women with a history of gestational diabetes who receive appropriate follow-up screening. specific aim 1: develop an algorithm to identify cases of gestational diabetes among patients in the partners health care system using administrative and laboratory data. specific aim 2: assess primary care provider knowledge, attitudes, beliefs, and barriers to compliance regarding screening guidelines for women with a history of gestational diabetes. specific aim 3: test whether a computer-assisted decision support tool to identify patients with a gdm history and prompt screening will increase compliance with guidelines. the investigators hypothesize that decision support will significantly increase in the percentage of women screened.

approximately 5 percent of women are diagnosed with gestational diabetes (gdm) during pregnancy. these women face an increased risk of progression to type 2 diabetes1 and may benefit from lifestyle interventions and screening to detect early disease. however, studies have shown that less than half of women are screened appropriately in the postpartum period. this performance gap may reflect both lack of communication between obstetric and primary care providers and lack of knowledge of appropriate screening guidelines. the investigators plan to assess a quality improvement initiative, using administrative and clinical data, to identify women with a history of gdm and implement decision support to enhance quality of care.

Eligibility criteria:
inclusion: * primary care clinic (gynecology, internal medicine, community health center) * use longitudinal medical record (lmr) program for documentation * previously participated in rct of decision support intervention exclusion: * none

Keywords: screening gestational diabetes mellitus