cyrilzakka/clinical-trials huggingface dataset:
Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.

In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carotid stenosis.

Exclusion Criteria:

* Significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy)
* Older than 80 years
* A history of psychiatric or neurological illness
* Severe alcohol of drug abuse
* Coronary artery bypass graft (CABG) less than a year ago.
A Study of LY2090314 in Patients With Advanced or Metastatic Cancer

The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A.


Eligibility Criteria:
Inclusion Criteria:

* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have a life expectancy of greater than or equal to 12 weeks
* Males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists
* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* Have adequate hematologic, hepatic, and renal function
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.

Exclusion Criteria:

* Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
* Have serious preexisting medical conditions (left to discretion of investigator)
* Have one of the following conduction abnormalities: Corrected time between start of Q wave and end of T wave (QTc) prolongation \>450 millisecond (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long-QT-syndrome, or left bundle branch block (LBBB)
* Are taking any concomitant medication that may cause QTc prolongation, or induce Torsades de Pointes
* Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not controlled by medical therapy
* Have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher; have history of arrhythmia that is symptomatic or requires treatment
* Have chronic atrial fibrillation and/or bradycardia
* Have uncorrected electrolyte disorders including potassium \<3.4 molar equivalent per liter (mEq/L) (\<3.4 millimole per liter \[mmol/l\]), calcium \<8.4 milligram per deciliter (mg/dL) (2.1 mmol/L), or magnesium \<1.2 mg/dL (\<0.62 mmol/L)
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)
* Have a hematologic malignancy
* Females who are pregnant or lactating
A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)

This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.

This study planned to evaluate 2 cohorts: Cohort 1, up to 8 participants to receive IV doses of ALXN1830 (SYNT001 Dose 1); Cohort 2, up to 12 participants to receive IV doses of ALXN1830 (SYNT001 Dose 2).

This study was terminated after the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy were characterized in participants with WAIHA in Cohort 1 (SYNT001 Dose 1), before any participants were enrolled in Cohort 2.

Eligibility Criteria:
Inclusion Criteria:

Participants had to meet the following criteria to be included:

* Willing and able to read, understand, and sign an informed consent form
* Confirmed diagnosis of WAIHA by enrolling physician
* Must have used medically acceptable contraception

Exclusion Criteria:

Participants who met any of the following criteria were excluded:

* Participant unable or unwilling to comply with the protocol
* Active non-hematologic malignancy or history of non-hematologic malignancy in the 3 years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in situ)
* Positive for human immunodeficiency virus or hepatitis C antibody
* Positive for hepatitis B surface antigen
* Any exposure to an investigational drug or device within the 30 days prior to screening
* Intravenous immunoglobulin treatment within 30 days of screening
* Plasmapheresis or immunoadsorption within 30 days of screening
* Participant had any current medical condition that, in the opinion of the Investigator, may have compromised their safety or compliance, precluded successful conduct of the study, or interfered with interpretation of the results
Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* English reading/speaking
* Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
* Must be able bodied enough to participate in a mobile app tool for physical therapy
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Exclusion Criteria:

* Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
* Severe physical impairment:

  * Neurologic paralysis
  * Polytraumas with restrictions incompatible with anti-gravity exercises
  * Knee immobilization, bed rest
* Unstable medical conditions:

  * On ventilatory support
  * Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask \>3L/min)
  * Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
  * Neurologically instable with strokes, hemorrhages, increased intracranial pressures
* Open wounds or surgical incisions

  * Tenuous closed wounds requiring immobilization or bending restrictions
  * Open wounds that are either packed/dressed or dressed with a wound vacuum
  * Surgical wounds that are draining fluid or purulence
* Vulnerable populations

  * Incarcerated individuals
* Patients without access to a mobile phone with iOS capability
Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium

This study will investigate whether pregnant and lactating women can develop similar protective immunity as non-pregnant women against Coronavirus Infectious Disease 2019 (COVID-19) upon vaccination, without safety issues. Immunogenicity and safety of all currently licensed COVID-19 vaccines that are administered to pregnant and lactating women in Belgium will be studied.

This project will compare vaccination of pregnant women with age-matched non-pregnant women and women vaccinated in the postpartum period during lactation. The primary objectives are to assess the immune responses (humoral immunity, cellular immunity, mucosal immunity) and safety after either administration of the Comirnaty COVID-19 vaccine (mRNA, Pfizer BioNtech), the COVID-19 Moderna vaccine (mRNA, Moderna), the COVID-19 vaccine Vaxzevria (Viral Vector, Astra Zeneca) or any other vaccine that will become available for the Belgian population.

Eligibility Criteria:
Inclusion Criteria:

* Female population older than 18 years.
* Ability to provide informed consent.
* Willing to be vaccinated with a COVID-19 vaccine.
* Intend to be available for follow-up visits through one year postvaccination.
* Influenza and pertussis vaccination during pregnancy (as per Belgian recommendations) is allowed.

Exclusion Criteria:

* Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection...).
* Systemic treatment with immune suppressive medication, including chronic steroid use of \> 10 mg prednisone or equivalent.
* Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
Efficacy of an Online Self-help Program for Negative Affect and Depression

The aim of the study is to test Body, breath \& mind (BBM, internet-based self-help program) for its efficacy in reducing depressive symptoms and improving quality of life. BBM combines methods of value-oriented behavioral activation with exercises from the Chinese healing practice Qi Gong,. BBM will be compared to an active control treatment (moodgym) and a waiting list control group. We expect significant differences to the waiting list control group. In comparison to the active control treatment we expect no significant differences.


Eligibility Criteria:
Inclusion Criteria:

* All persons who suffer from depressive symptoms (subthreshold and clinical depression; PHQ-9 ≥10)
* German speaking
* Internet and email access

Exclusion Criteria:

* The DSM-defined criteria A9 acute suicidality and A5 psychomotor agitation in the context of a depressive disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* psychotic disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* major depression with psychotic features, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* eating disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* current or past schizo-affective disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* current substance use disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* inability to participate in the program due to physical, practical, or other reasons.
Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.

To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.

Eligibility Criteria:
Inclusion Criteria:

* PCOS women at Childbearing Age
* PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.

Exclusion Criteria:

* Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
* History of current or past pregnancy
* Hormonal contraceptive or metformin use within 3 months of enrollment
* Nonclassical congenital adrenal hyperplasia
Effectiveness of a Online Training Program With a Clinical Procedure Standardized in Units of Nursing (CPSUN)

This study evaluates if the implementation of an online platform with procedures and protocols, improve the knowledge of professionals and can have a health impact related to decreased contamination of blood cultures.

This is a Quasi-experimental study, with parallel groups (experimental and control).

The aim of this study is to evaluate the efficacy of an Online Learning Platform used by nurses to improve the results of a blood culture technique. The online learning tool is studied in two of four internal medicine units of a tertiary hospital in Madrid. These two units have similar characteristics of personnel, materials and structure. Both units are at a great distance, preventing a professional talk to each other.

Eligibility Criteria:
Inclusion Criteria:

* Be nurse of the nursing unit selected.
* Foreseeing to remain in service during the study.
* Acceptance of voluntary participation in the study, prior information.
* Signature of informed consent.

Exclusion Criteria:

* Those professionals who for reasons beyond their control are transferred to other services or are on leave (in any form). They can not complete the various phases of the study.
* Professionals who, for whatever reason, decide to withdraw their consent to participate in the study.
Multiple B-value Diffusion-weighted Imaging(DWI) in Evaluation of Breast Lesions

Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameter. At the same time, pathological specimens of patients will be collected. The relationship between magnetic resonance(MR) parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment. The fundamental of pathology on MR signal change will be further expounded.

Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b values diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameters. At the same time, pathological specimens of patients will be collected. The relationship between MR parameters and pathology biomarkers will be evaluated. By pre-contrast and post-contrast multi-b values diffusion weighted imaging series, patient's Apparent diffusion coefficient(ADC),tissue diffusivity (D), pseudo-diffusion coefficient (D\*), perfusion fraction (f), distributed diffusion coefficient(DDC) and alpha will be evaluated. Parameters of benign , malignant breast lesions and ipsilateral or contralateral normal breast parenchyma as a control group will be measured. Receiver operating characteristic (ROC) curve analysis is used to test the ability of different parameters in differentiating malignant from begin lesions. After Surgical operation, specimen of lesion will be collected(Not every patient's specimen will be collected. The investigators should be approved by patient themselves). The biomarkers of specimen will be detected by pathological and molecular-biological methods.Then analyze the relation between parameters of the MR imaging and pathological/molecular-biological biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with breast lesion (Breast Imaging Reporting and Data System 2,3,4,5)
* Operation is take in Tang-du hospital

Exclusion Criteria:

* Postoperative patient
* Suffer radiotherapy,chemotherapy and endocrine treatment
* Serious image artifacts
* Lesion with diameter less than 3mm
* Scan during menstrual period
* Other magnetic resonance imaging contraindications
Sternal ECG Patch Comparison Trial

This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.

The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

Exclusion Criteria:

* Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
* A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment
Labial Biopsy in Patients With Tuberculosis Disease

The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician.

The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.


Eligibility Criteria:
Inclusion Criteria:

* adults above 18 years,
* bacteriologically confirmed tuberculosis

Exclusion Criteria:

* patient not able to sign written consent
Detection and Management of Non-Compressible Hemorrhage by Vena Cava Ultrasonography

This is a study of patients admitted with major traumatic injuries. Such patients may develop inadequate circulation to the organs as a result of internal blood loss. Early detection of internal blood loss can be difficult as physical examination alone may miss patients with significant blood loss. Some patients with internal bleeding will arrive with low blood pressure; these patients are usually given 2 liters of intravenous fluid to determine if their blood pressure will recover. If the blood pressure does not rise or if it drops again later, the blood loss can be assumed to be severe, and the patient will likely need transfusions, surgery and other interventions. However, this fluid treatment method can lead to delays and complications as some patients may initially respond but then continue to bleed. The inferior vena cava (IVC) is the large vein draining blood from the lower body to the heart. The inferior vena cava is known to empty when the patient has had significant blood loss. The vena cava diameter can be seen using ultrasound. This study intends to perform ultrasound to examine the vena cava diameter on patients just after arriving with major trauma. The hypothesis of the proposed study is that an ultrasound assessment protocol of inferior vena cava diameter and collapsibility can detect and aid management of non-compressible hemorrhage in major trauma victims. After the patient has been given the 2 liter intravenous fluid treatment, the inferior vena cava diameter will be measured again. A third examination 8-24 hours after admission will determine if the inferior vena cava diameter has returned to normal. We propose that measuring the inferior vena cava in this manner can predict those patients who are likely to continue bleeding and require interventions such as surgery. Early detection in these patients may avoid delays in treatment, complications and excess mortality. Because this examination is done with handheld ultrasound machines, it could be done outside hospitals and in military combat casualty care.


Eligibility Criteria:
Inclusion Criteria:

* Major trauma patients brought to Level I Trauma Centers.
* Selected patients for the study will be those presenting with IVC collapsibility \> 50% on modified-FAST at admission and/or
* IVC diameter of \< 12mm on modified FAST at admission and/or
* A non-visualized IVC due to total collapse on modified FAST at admission (not due to body habitus or inadequate ultrasonography technique)

Exclusion Criteria:

* Pregnancy after 20 weeks gestation
* Those under 18 years of age
* Prisoners and others prohibited from participating in clinical trials
* Patients with severe traumatic brain injury who at admission are deemed by treating surgeons as having non-survivable brain injuries