cyrilzakka/clinical-trials huggingface dataset:
The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department

Actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (eFAST) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination.

However, there are no data with regard to in-hospital effects of a positive prehospital eFAST.

The main objective of this study was to evaluate the effects of prehospital eFAST driven decisions on in hospital time-to-definitive diagnostics or time-to definitive treatment, whichever came first, in a level 1 trauma center.

The goal is to define if this information could have a role in prioritizing patients' access to care in a population of abdominal trauma patients with A-AIS \> 1 and a documented liver or spleen injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to emergency department with a ICD-9-CM diagnosis of traumatic liver or spleen injury (codes 8640x, 8641x, 8650x, 8651x)
* Abdominal AIS ≥ 2
* CT scan or operating theatre admission performed within 180 minutes from ED admission

Exclusion Criteria:

* Death before CT scan or OR/Angio suite admission (missing primary outcome measure)
* Transferred to other hospitals before CT scan or operating room admission
* Missing data
The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery

A nursing visit is a method used for psychological preparation and information of patients. During nursing visits, the operating room nurse visits the patient before the surgery, informs the patient about the surgical process and nursing care practices and gives education. The study was conducted to determine the effect of nursing visit before laparoscopic surgery on the anxiety and pain level of the patient in the postoperative period.

In this study, a structured education program was created, the visiting nurse was ensured to be the nurse who is involved in the patient's surgery, and the levels of anxiety and pain were evaluated according to objective criteria in the postoperative period on the patient group planned for laparoscopic surgery.

The study was conducted with 135 patients, 72 in the experimental group and 63 in the control group. The website https://www.randomlists.com/random-letters was used during the randomization of the patients. The patients were randomly assigned to the experimental and control groups according to their sequence numbers.

For the standardization of patient education, an education booklet was prepared in line with the literature, and the final version was prepared by consulting experts. The experimental group was educated by visits of the operating room nurse. The control group was educated by the service nurse. Data were collected with state-trait anxiety inventory and visual analog scale.

Visual analog scale (VAS)- The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points Spielberger State-Trait Anxiety Inventory - Anxiety inventory was developed by Spielberg et al. in 1970 and adapted into Turkish by Oner and Le Compte in 1977. This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level The State-Trait Anxiety Inventory was applied before the patient education and the State Anxiety Inventory after the education. The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively, and the State Anxiety Inventory was applied again 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were 18 years old and above
* who could speak Turkish and who were able to communicate
* underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) were included in the study.

Exclusion Criteria:

* Emergency and unplanned cases,
* patients transferred to the intensive care unit after surgery,
* patients with neurological or psychological problems were excluded from the research.
Cardiovascular Risk After Preeclampsia

Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Women
* 18-60 years
* 5-15 years postpartum

Exclusion Criteria:

* Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
* Pregnancy and/or active breastfeeding
* Glaucoma disease, epilepsy
* In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR \< 30 ml/min)
Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of MS by McDonald criteria
* Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
* Receive MS care at the Mandell MS center
* Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
* 18 years of age or older

Exclusion Criteria:

* Already began to take drug prior to baseline research visit
* Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
* Unwilling or unable to complete assessments
Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action

A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID).

Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated.

From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment.

Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
2. Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study

Exclusion Criteria:

1. Inability to provide consent
2. An adverse event during Study SPM-008 which precludes participation in this study
3. Any condition per the investigator's clinical judgement that precludes participation in the study
NeuroPathways Intervention for Brain Tumor Patients

This goal of this study is to test an information and support intervention for patients with malignant (or "high-grade") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit interviews.

This study will be a prospective pilot randomized controlled trial to examine the feasibility and acceptability of a novel, population-specific intervention designed to help patients with recently-diagnosed malignant brain tumors process and cope with their illness.

The specific aims are to 1) refine the NeuroPathways intervention based on feedback from an open pilot study (n=up to 10) with exit interviews, 2) evaluate the feasibility and acceptability of NeuroPathways in a pilot randomized controlled trial (n=40), and 3) explore preliminary effects of the intervention on psychological, behavioral, and cognitive outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Massachusetts General Hospital Cancer Center patient
* Within 6 weeks of diagnosis with a primary malignant brain tumor
* Able to speak and read in English

Exclusion Criteria:

* Inability to provide informed consent as assessed by the study team (e.g., due to neurological impairment such as severe cognitive impairment/dementia or moderate-to-severe receptive aphasia)
* Deemed inappropriate to approach by patient's oncologist or study PI
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.

Participants will be asked to keep a pill diary.

The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.

Eligibility Criteria:
Inclusion Criteria:

* Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
* Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis
* May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy
* Performance status of 0-1
* Measurable disease
* Adequate liver, renal, and bone marrow function
* Must be able to give written informed consent
* Women able to become pregnant must have a negative pregnancy test
* Must be 18 or over
* Must be able to swallow pills

Exclusion Criteria:

* Prior treatment with sorafenib or m-TOR inhibitors
* History of acute MI within the last 6 months
* Active brain metastasis or patients with meningeal metastases
* Prior treatment for another cancer in the last 5 years
* Prior bleeding problems; coughing up or vomiting blood
* Non-healing wounds, ulcer, or long bone fracture
* Chronic use of systemic steroids or immunosuppressive agents
* Uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects

To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
* Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2

  * BMI = Weight(kg)/ Height(m)2
* Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
* Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial

Exclusion Criteria:

* History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
* Any medical history that may affect drug absorption, distribution, metabolism and excretion.
* Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
* Any clinically significant chronic medical illness.
* Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Individuals with one of the following laboratory test results in screening.

  * AST, ALT \> UNL (upper normal limit) x 1.5
  * Creatinine clearance ≤ 60 mL/min
  * Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
* Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
* Individuals who cannot eat standard meal provided from clinical trial center.
* Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
* Individuals who had received a blood transfusion within 60 days prior to study drug administration.
* Exposure to any investigational drug within 6 months prior to the first IP administration.
* Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
* Individuals who had drinking (alcohol \> 21unit/week) within 14 days prior to screening.
* Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
* Subjects having been deemed inappropriate for the trial as determined by the investigator.
Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS)

Patients : 20 patients with symptomatic apical periodontitis related to mandibular premolars were selected.after proper anathesia, Access cavity was ppreformed.The working length measured using apex locator.chemomechanical preparation was done .for trunatomy file group ,using file sequence according to manufacture's instructions until medium one .for edgeendo group ,using file sequence also according to manufacture's instructions until file size 35 taper4.Apical fluid samples was collected by paper point from the both preoperatively and before obturation and also pain was assessed pre and post opertively.finally,the root canal were filled by gutta-percha and resin based sealer.the access cavity was restored by glass ionomer restoration.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnoses of apical periodontitis related to single-rooted mandibular premolars
* no evidence of excessive mobility

Exclusion Criteria:

* presence of any systemic disease or allergic reaction
* Incompletely formed root
* Previously Endodontically treated teeth
A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures

This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single Anti-Epileptic Drug (AED) with marketing approval in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and ≥16 years of age
* Subject has a diagnosis of epilepsy, having experienced unprovoked partial-onset seizures (IA, IB, or IC with clear focal origin) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981
* Subject experiences partial-onset seizures despite appropriately chosen and adequately tried treatment with 1 antiepileptic drug (AED)
* Subject has been treated for epilepsy with a stable dose of 1 marketed AED The use of benzodiazepines is permitted as rescue therapy for epilepsy. Benzodiazepines may have been used as needed but not more frequently than once per week.

Exclusion Criteria:

* Subject has a history or presence of seizures of other types than partial onset (IA, IB, or IC with clear focal origin)
* Subject is taking benzodiazepines for a nonepilepsy indication (Exception: Concomitant use of benzodiazepines is allowed if the subject is taking them on a regular basis, has been on a stable dose for at least 1 month prior to Visit 1, and does not require changes in the dosage and administration throughout the study period. However, concomitant use of benzodiazepines on an as needed basis is not permitted.)
* Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception, unless sexually abstinent, for the duration of the study
* Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (EI-AEDs: CBZ, phenytoin, barbiturates, primidone, topiramate) who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception according to the World Health Organization (WHO) recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI-AEDs or does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
* Subject has sick sinus syndrome without a pacemaker, or a second or third degree atrioventricular (AV) block, or subject has any other clinically relevant electrocardiogram (ECG) abnormalities
* Subject has a history of convulsive status epilepticus within the last 12 months prior to Visit 1
Diagnosis of Acute Obstructive Renal Failure by Clinical Ultrasound Performed by the Emergency Physician.

Acute renal failure is frequently diagnosed in the emergency room during a biological assessment. Its discovery requires determining the cause, which may be either functional, or obstructive. The obstructive cause is responsible for 10% of acute renal failure. It is recommended to start the exploration of this pathology with an ultrasound in search of an obstructive cause. However, ultrasound from the radiologist is not always available.

The realization of this ultrasound by the emergency physician would reduce the time to obtain the diagnosis and therefore the time of passage to the emergency room.

No study has yet been carried out to validate the performance of this ultrasound by the emergency physician in the case of acute renal failure.

This study would validate the diagnostic performance of this ultrasound technique in order to identify as quickly as possible patients with acute renal failure whose cause is obstructive.

Acute renal failure is frequently diagnosed in the emergency room during a biological assessment. Its discovery requires determining the cause, which may be either functional, i.e. kidney dysfunction, or obstructive. The obstructive cause is responsible for 10% of acute renal failure. It is recommended to start the exploration of this pathology with an ultrasound in search of an obstructive cause. However, ultrasound from the radiologist is not always available.

The realization of this ultrasound by the emergency physician would reduce the time to obtain the diagnosis and therefore the time of passage to the emergency room.

No study has yet been carried out to validate the performance of this ultrasound by the emergency physician in the case of acute renal failure.

The aim of this research is to evaluate the performance of clinical ultrasound in the diagnosis of an obstructive cause of acute renal failure by the emergency physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an emergency structure
* Patients with acute renal failure (defined by an increase of 1.5 x the baseline serum creatinine value (known or expected according to age and sex))

Exclusion Criteria:

* Patients unable to express their non-objection
* Patients who have undergone a kidney transplant
* Dialysis patients
* Pregnant women