Kornimate/medical-research-clean huggingface dataset:
ptsd clinical team research clinic (pct research clinic)

Conditions: PTSD

Summary: part of the irb_00136053 study was to look at the effectiveness of warrior renew and warrior renew+eal interventions. furthermore, demographic information on veteran participants will be analyzed.

eal is one of a group of equine-assisted services (eas), which are aimed at providing benefits for humans, including addressing emotional, mental and social components of functioning. in recent years, the use of eas has grown rapidly in europe and the united states in general and is being increasingly used for active-duty military and veteran veteran populations. as we have previously reviewed, there is evidence that eas, such as eal, can contribute to reduction of ptsd and other psychological symptoms as well as enhancing well-being via improvements in resilience, life satisfaction, trust, self-image, and self-control, as well as quality of life.

Eligibility criteria:
inclusion criteria: * referred to ptsd team exclusion criteria: * none

Keywords: ptsd
study of pha-848125ac in adult patients with advanced/metastatic solid tumors

Conditions: Solid Tumour

Summary: the purpose of this open-label, multi center, phase i study was to determine the safety profile of the oral compound pha-848125ac administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. objectives of the study were to determine the maximum tolerated dose and the dose that can be recommended for phase ii investigations.


Eligibility criteria:
inclusion criteria: * signed, written irb-approved informed consent * histologically or cytologically confirmed relapsed or refractory solid tumors for which no standard therapy exists * ecog (who) performance status 0-1 * life expectancy of at least 3 months * age \>=18 years * a negative pregnancy test (if female in reproductive years) * acceptable liver and renal function * acceptable hematologic status * 10. previous cancer therapy is allowed with the exclusion of experimental cdk2 inhibitors. treatment with radiation therapy, surgery, chemotherapy, or investigational therapy must be completed within one month prior to study entry * use of effective contraceptive methods if men and women of child producing potential * capability to swallow capsules intact * grade \<=1 retinopathy exclusion criteria: * in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * known brain metastases * major surgery, other than diagnostic surgery, within 4 weeks prior to day 1 * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * pregnant or breast feeding women * unwillingness or inability to comply with procedures required in this protocol * known infection with hiv, active hepatitis b or hepatitis c * diabetes mellitus uncontrolled, or with clinical evidence of diabetic retinopathy, severe peripheral vascular disease or diabetic ulcers * current enrollment in another clinical trial * patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (lactose intolerance) * previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), parkinson's disease, multiple sclerosis, stroke and cerebellar injury * gastrointestinal disease (e.g. crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption * chronic/intensive use of antacid or h2 receptor antagonists * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.

Keywords: advanced/metastatic solid tumors
911 nurse triage line

Conditions: Emergencies

Summary: each year, millions of americans call 911 for time-sensitive issues that don't require emergency medical services (ems). in need of medical help, these callers may treat 911 as an entry point into the healthcare system, yet an ambulance to the emergency department can harm both their own long-term health and the health of others. in a field experiment in washington, dc, the investigators randomly assign nurses directly into 911 calls in order to triage low-acuity calls. while other 911 reforms have denied callers access to alternative resources, this effort reforms 911 by offering appropriate care.


Eligibility criteria:
inclusion criteria: * low-acuity call exclusion criteria: * incarcerated
increasing atrial base rate pacing to reduce atrial fibrillation

Conditions: Sick Sinus Syndrome; Paroxysmal Atrial Fibrillation

Summary: this study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.


Eligibility criteria:
inclusion criteria: * sick sinus syndrome patients having dual-chamber pacemaker * having paroxysmal af defined as at least 2 episodes of ahr/ams \>190 b/min lasting \>6 minutes * having normal atrioventricular conduction exclusion criteria: * other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome) * history of acute coronary syndrome * significant heart valve disease * chronic af before randomization * overt heart failure * malignancy * any reasons for antiarrhythmic medication use * inability to follow patients every 3 months

Keywords: sick sinus syndrome paroxysmal atrial fibrillation atrial pacing high atrial base rate pacing
study of troxatyl™ administered by continuous infusion to subjects with refractory acute myelogenous leukemia (aml)

Conditions: Acute Myelogenous Leukemia

Summary: this is a phase i, single-arm, open-label, multi-center study of rising doses of troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of troxatyl™.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of acute myelogenous leukemia (aml) refractory to prior therapy and/or unlikely to benefit from known therapies. * subjects must have adequate organ and immune function as indicated by the following laboratory values: \*creatinine clearance ≥5 l/hr (83ml/min), \*total bilirubin ≤2.0 mg/dl (≤34.2 µmol/l), \*ast(sgot) and alt(sgpt) ≤3 x uln exclusion criteria: * clinical evidence of active central nervous system (cns) leukemic involvement * active and uncontrolled infection * uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment * neurologic or psychiatric disorders that would interfere with informed consent or study follow-up * known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse. * also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment. * females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.

Keywords: single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia acute myelogenous leukemia (aml) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies
piloting clinical bacteriology in the ebola virus disease care response

Conditions: Sepsis Bacterial; Ebola Virus Disease; Bloodstream Infection

Summary: despite access to experimental ebola virus disease (evd)-specific treatments, about 30% of patients still die in the ebola treatment centers (etc) in drc. there is limited study done about the potential contribution of bacterial co-infections (in particular bloodstream infections) to this adverse outcome, as blood cultures were so far rarely available in epidemic areas. findings from patients treated in europe and the usa, and case discussions in the field call for further investigation. building further on an ongoing microbiological surveillance project of itm and inrb in drc, we are able to set up a research project which will pilot in a standardized manner clinical bacteriology tools (bacterial blood cultures, biomarkers as crp, procalcitonin and white blood cell differential count, and clinical early warning scores) to study bacterial bloodstream infection in evd patients in the n-kivu/ituri outbreak. this project will add evidence on 1) frequency, causative pathogen and antibiotic resistance profiles of bacterial bloodstream infections, as well as 2) the predictive value of biomarkers and early warning scores, in evd patients at different timepoints during hospitalization in an etc in drc. the results will inform appropriate antibiotic treatment in an evd setting and improve patient outcomes.


Eligibility criteria:
inclusion criteria: * patient admitted in an ebola treatment center (etc) or ebola transit center (tc) * laboratory-confirmed (ebola rt-pcr positive result) evd diagnosis, or, evd suspect patient requiring instant intravenous antibiotic treatment * willing and able to provide written informed consent personally or by a legally acceptable representative if the patient is unable to do so exclusion criteria: * we do not exclude certain patient groups, but whenever harm is expected from the additional blood sampling needed for this study, the clinician can opt not to enroll the patient

Keywords: ebola virus disease evd bacterial infections bacteriology blood cultures crp dr congo antibiotic resistance bacterial bloodstream infection
transcutaneous raman spectroscope (trs) analyses of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the primary translational research objective of the study is to demonstrate feasibility of using the transcutaneous raman spectroscopy technology in a point-of-care environment. this study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. we will be evaluating safety, device design and certain human engineering factors associated with point of care use of the trs. we anticipate the data we collect in this study will form the basis of later medical device studies.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * diagnosis of diabetes mellitus * full thickness or superficial foot and ankle ulcers based on clinical assessment (e.g., university of texas (ut) grades 1-3, stages a-d). for reference, see appendix 1 for the ut classification table exclusion criteria: * age less than 18 or greater than 80 years old * subject has a psychological or sociological condition or an addictive disorder that would preclude informed consent * completely epithelialized ulcer based on clinical assessment with no ischemia or infection (ut classification 0a) * current or previous use of anti-resorptive bisphosphonate drugs (e.g., risedronate (actonel) and alendronate (fosamax))

Keywords: foot ulcer, diabetic spectrum analysis, raman
assisted hatching versus endometrial scratch in recurrent implantation failure

Conditions: Recurrent Implantation Failure

Summary: 300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group

group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation\& assisted hatching group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation

Eligibility criteria:
inclusion criteria: * recurrent implantation failure * normal uterine cavity by transvaginal ultrasound exclusion criteria: * endometrial polyp or fibroid distorting the endometrium * hydrosalpinx * preimplantation genetic diagnosis * severe male factor
safety/efficacy study of levodopa-carbidopa intestinal gel in parkinson's subjects

Conditions: Dyskinesias; Parkinson's Disease; Severe Motor Fluctuations

Summary: long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

study s187.3.003 (nct00360568) is a phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (lcig) in the treatment of participants with levodopa-responsive parkinson's disease (pd) with persistent motor fluctuations despite optimized treatment with available pd medications. all participants received lcig. only participants who completed 12 weeks of double-blind, double-dummy treatment in study s187.3.001 or s187.3.002 (nct00357994/ nct00660387) qualified for enrollment in this 12-month continuation treatment study.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) according to united kingdon parkinson's disease society (ukpds) brain bank criteria * levodopa-responsive with severe motor fluctuations * completion of protocol s187.3.001 (nct00357994) or s187.3.002 (nct00660387) and continue to meet the inclusion criteria for the preceding study exclusion criteria: * patients with medically relevant abnormal findings (labs, electrocardiogram \[ecg\], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (week 12) of study s187.3.001 (nct00357994) or study s187.3.002 (nct00660387)

Keywords: carbidopa severe motor fluctuations intestinal gel levodopa efficacy levodopa carbidopa intestinal gel dyskinesia parkinson's disease duodopa levodopa-carbidopa duopa
b vitamins in mthfr positive patients with major depression: a post hoc analysis of findings

Conditions: Depression

Summary: a randomized double-blind placebo controlled study of reduced b vitamins in patients with major depression who were positive for one or both of the common mthfr polymorphisms was conducted between 8/1/2014 and 4/3/2015. homocysteine levels and madrs scores were used as primary measures. the study was designed to test safety and efficacy of reduced b vitamins in mdd associated with mthfr. this study examines the data from the trial to see effects, effect sizes, and further, if demographic factors and other patient characteristics correlated with findings.

this original study was designed to evaluate the efficacy and safety of reduced b vitamins as monotherapy in adults with major depressive disorder (mdd) who were also positive for at least 1 methylenetetrahydrofolate reductase (mthfr) polymorphism associated with depression, and further test the hypothesis that reduced (metabolized) b vitamins will lower homocysteine (hcy) in a majority of clinically responding patients. 330 adult patients with mdd (dsm-5), and positive for mthfr c677t and/or a1298c polymorphisms were enrolled in a trial conducted between august 1, 2014, and april 3, 2015. 160 patients received placebo, while 170 received a capsule containing a combination of reduced b vitamins. plasma homocysteine levels were measured at baseline and week 8. the montgomery-asberg depression rating scale (madrs) was used to evaluate efficacy for mdd. this further analysis is conducted on the resultant data, with patient names withheld. it is an extensive look at the findings to determine if response is correlated with hcy reduction and if other factors may be associated with response or non-response.

Eligibility criteria:
inclusion criteria: * major depression with mthfr positive status exclusion criteria: * dementia, bipolar, active substance abuse

Keywords: mthfr depression vitamins homocysteine
impact of eras in lsg

Conditions: Laparoscopic Sleeve Gastrectomy; Enhanced Recovery After Surgery; Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative

Summary: patients with bmi \>35 and chronic diseases or bmi \>40 will be scheduled to receive laparoscopic sleeve gastrectomy (lsg). two groups are planned according to receive enhance recovery after surgery (eras) protocol or not. all participants will receive standard lsg. participants of eras will receive anesthesia and post-surgical nutrition protocol which are determined for eras. all patients will be checked for status of pain with vas score, nausea and vomiting with ponv score at postoperative 2nd hour, 12th hour. in eras group liquid oral intake will be started between postoperative 2nd and 4th hours. in no eras group liquid oral intake will be started in the morning of postoperative first day. the patients who provides discharge criterias will be discahrged. these criterias are; to provide adequate pain relief with paracetamol and nonsteroidal painkillers, no wound problem, no complications after surgery, pulse rate \<90 beats / min, temperature ≤ 37 · 5 ° c, respiratory rate, \<20 breaths / minute, to be able to mobilize easily, to be able to drink 1 liter of water after surgery. emergency admissions of the participants within a month after surgery will be recorded.


Eligibility criteria:
inclusion criteria: * must be performed laparoscopic sleeve gastrectomy * body mass index \> 35 with a comorbidıty or ,body mass index \> 40 exclusion criteria: * surgery with peroperative complication * revision surgery applications
drug-coated balloon in combination with new generation drug-eluting stent for de novo diffuse disease treatment

Conditions: Coronary Artery Disease

Summary: a pilot observational study to evaluate safety and efficacy of the hybrid approach des/dcb in treating de-novo diffuse lesions

this is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is to assess the feasibility and the clinical outcomes of using the restore dcb (cardionovum gmbh, bonn, germany) in combination ("hybrid approach") with a new generation des (type at operator's discretion) for the treatment of diffuse cad encountered in daily clinical practice. the rationale of the proposed strategy derives from the characteristics of dcb in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse cad -avoiding a long metallic, permanent cage within extended coronary segments

Eligibility criteria:
inclusion criteria: * patients presenting with stable or unstable cad eligible for pci (according to the international guidelines) because of diffuse cad involving segments suitable for a hybrid approach; * signed patient informed consent/data release form exclusion criteria: 1. age \<18 years; 2. cardiogenic shock; 3. pregnancy or breastfeeding; 4. infarct-artery max diameter (within planned device deployment segment) \ 5.0 mm; 5. comorbidities with life expectancy \<6 months; 6. severe calcification or/tortuosity proximally or at the dcb target segment;

Keywords: drug coated balloons drug eluting stent diffuse disease
nimotuzumab plus nab-paclitaxel and cisplatin in treating patients with advanced esophageal carcinoma

Conditions: Stage IV Esophageal Squamous Cell Carcinoma

Summary: there have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.and,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.so,the objective of this single-arm phase ii trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.

in the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. in eastern countries, chemotherapy became one of the treatment strategies for advanced esophageal cancer. in an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of nimotuzumab plus nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: * patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology. * males or females aged ≥18 years, \< 75 years. * eastern cooperative oncology group (ecog) performance status 0-2. * life expectancy ≥12 weeks. * adequate bone marrow, renal, and liver function are required. * able to comply with the required protocol and follow-up procedures, and able to receive oral medications. exclusion criteria: * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * allergy to anti-egfr antibody. * female subjects should not be pregnant or breast-feeding. * adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin \< 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. * patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Keywords: nimotuzumab nab-paclitaxel carcinoma of esophagus