cyrilzakka/clinical-trials huggingface dataset:
Individualized Versus Conventional Perioperative Blood Pressure Management

Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).

This study, aiming to reflect real clinical scenarios as much as possible, does not impose specific restrictions on perioperative management other than the target blood pressure. It allows discretion to each participating institution or physician. For the same reason, there are no restrictions on method for blood pressure measurement (invasive, non-invasive, or both), site of blood pressure measurement, fluid therapy, and vasopressors use for maintaining target blood pressure in each group.

Through random allocation, the conventional group targets a mean arterial pressure (MAP) of 65 mmHg or higher and a systolic blood pressure (SBP) of 90 mmHg or higher during surgery. The individualized group targets no less than a -20% of the baseline MAP and SBP. The baseline MAP and SBP are defined as the average values of all MAP and SBP measured between one day before surgery and the morning of the surgery.

The two blood pressure management strategies are applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the blood pressure management strategies are applied until the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥65 or,
* those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure,
* undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours.

Exclusion Criteria:

* Emergency surgery
* Organ transplantation surgery
* Brain/carotid artery surgery
* American Society of Anesthesiologists physical status 5 or 6
* Pregnancy
* Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
* Estimated glomerular filtration rate \<30 ml/min/1.73m2
* Renal replacement therapy
* Acute decompensated heart failure
* Sepsis
* Shock
* Use of inotropes/vasopressor infusion (dopamine, norepinephrine, vasopressin, etc.)
Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression

Study TRD subjects' resistance to at least 2 different antidepressants, we hypothesize that because of their significant depression and treatment resistant status they are most likely to exhibit BSMN pathway abnormalities.

Potential subjects will be identified during clinical visits. If a patient qualifies to participate in the study they will have to stop any antidepressants that they are taking to prepare for the use of MAOIs. After a two week washout period, subjects will have an fMRI and will be started on a MAOI. They will then be followed up for 8 weeks, which is routine and considered standard care.

Eligibility Criteria:
Inclusion Criteria - TRD:

1. age: 18 - 65 yrs.;
2. satisfy criteria for DSM-IV major depressive disorder (MDD);
3. 17-item Hamilton Depression Rating Scale (17-item HDRS) score \> 18;
4. treatment resistance depression as defined as report of inadequate response (patient report of minimal improvement or nonresponse) despite past treatment with at least 2 different classes of antidepressants acting on the 5-HT and/or DA monoamine systems(except MAOIs) (as determined with the Antidepressant Treatment History Form (ATHF)20 with score of \>3 on each of the items and verified by medical records if available);
5. able to give informed consent;
6. no use of alcohol in the past 1 week and negative urine toxicology screen;
7. MAOI treatment indicated as assessed by an independent psychiatrist not affiliated with the study;
8. voluntary consent to treatment with an MAOI after reviewing all other options and agree to follow safeguards and precautions during treatment.

Inclusion criteria for healthy subjects

1. ages 18-65 years and ability to give voluntary informed consent;
2. no history of psychiatric illness or substance abuse or dependence;
3. no significant family history of psychiatric or neurological illness;
4. not currently taking any prescription or centrally acting medications; no use of alcohol in the past 1 week;
5. and no serious medical or neurological illness.

Exclusion Criteria - TRD:

1. schizophrenia, schizoaffective or primary anxiety disorder;
2. serious medical or neurological illness;
3. history of significant head injury;
4. on fluoxetine treatment;
5. on lithium or have received ECT or rTMS in the last 3 months to avoid long-term effects of such medications;
6. substance or alcohol dependence in the past 6 months or substance abuse in the past 3 months;
7. unable to give informed consent.

Exclusion criteria for both groups:

1. pregnant or breast-feeding;
2. metallic implants or other contraindication to MRI.
Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir

The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with VIH-1, documented with a positive HIV-1 antibody test and/or positive PCR, confirmed for HIV-1 RNA.
* Patients treated with a HAART that should contain AZT+3TC+ABC (Trizivir®)
* Patients with an indetectable viral load, which will be defined \<40 copies/mL within the last six months.
* Patients with a lipoatrophy clinical evidence (which will be defined as moderate or severe, according to the Lipodystrophy Severity Grading Scale).
* Men or women aged ≥ 18.
* For women of childbearing potential, negative urine pregnancy test during the Screening visit.
* Patients that have signed and dated the Informed consent Form prior to any Study-specific procedure.

Exclusion Criteria:

* Patients with evidence of protease inhibitors failure, and/or documented evidence of protease gene resistance mutation. This evidence could be prior or during the inclusion period in the Study.
* Patients who, for any reason could not be treated with LPV/r.
* Cachexia, defined as an Body Mass Index \<17 Kg/m2.
* Pregnant or breastfeeding women, or women of childbearing potential who do not use the appropriate contraceptive method, according to the Investigator judgment.
* Clinically relevant disease or condition, according to the Investigator judgment, three months prior to the patient inclusion in the Study.
* Patients taking the following concomitant medication that could affect the adipocyte function or morphology, such as: insulin, steroids, anabolic steroid, anti-inflammatory medication for more than three months.
A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which can be broadly categorized as patient-related or procedure-related. It has been shown that split-dose regimen or some modified educational strategies can improve the quality of bowel preparation. For the patients with possible IBP before the performing of colonoscopy, it may be better to repeat bowel preparation with modified or enhanced strategies in case of failed intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a model to predict the quality of bowel preparation individually.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 years old who undergoing colonoscopy

Exclusion Criteria:

* failed colonoscopy because of technical chanllenge or poor tolerance of patients
* history of colorectal surgery
* prior finding of severe colonic stricture or obstructing tumor
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileum
* known or suspected bowel obstruction or perforation
* pregnancy
* unable to give informed consent
Hypoglycemia and Cardiac Arrhythmias in Type 1 Diabetes

The investigators hypothesise that following episodes of hypoglycemia, rebound hyperglycemia may result in a prolonged period of increased QTc and, thereby, increased susceptibility to serious cardiac arrhythmias in patients with type - 1 diabetes.

In this study, changes in cardiac rhythm, haemodynamic regulation, and hormonal response will be evaluated during insulin-induced hypoglycemia followed by hyperglycemia and euglycemia, respectively, on two separate experimental days. Twenty-four patients with type-1 diabetes are included. Patients are randomised 1:1 to start with either the combined hypo- and hyperglycemic or the hypo- and euglycemic clamp. After an overnight 10 hour fast, participants are admitted for a 255 minute clamp. An individualised insulin infusion will be initiated targeting a plasma glucose level of 5.0-8.0 mmol/l. When the targeted plasma glucose level is achieved, the hyperinsulinemic euglycemic clamp will be initiated at time 0. The insulin infusion will be fixed at an infusion rate 80 mU/m2/min and a 20% glucose infusion will be initiated in order to regulate plasma glucose levels. After 45 min of monitoring at euglycemic plasma glucose level, plasma glucose will be decreased over a period of 30 minutes, targeting 2.5 mmol/l for a period of 60 min in a hyperinsulinemic hypoglycemic clamp. From 135 min to 195 min, plasma glucose levels will be increased to either hyperglycemic level or euglycemic level and will be kept constant for 105 minutes. Echocardiography is performed at baseline, at hypoglycemic level and at hyper-or normoglycemic level. Blood samples are taken every 15 minutes throughout the entire clamp, however bedside plasma glucose is analysed every fifth minute. A Holter-ECG is obtained throughout the entire clamp.

Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent
* Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
* Age 18-70 years
* Insulin treatment for ≥3 years

Exclusion Criteria:

* Arrhythmia diagnosed prior to the screening visit
* Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
* Severe heart failure (left ventricular ejection fraction \<25%)
* Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
* Thyroid dysfunction (except for well-regulated eltroxin substituted myxoedema)
* Anemia (male: hemoglobin \<8.0; female: hemoglobin \<7.0 mmol/l)
Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.

OBJECTIVES:

* Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
* Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.

OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.

Patients' enzyme expression levels are compared with their clinical data.

Eligibility Criteria:
\<Inclusion criteria\>

* Pathologically confirmed stage III colon adenocarcinoma
* Curatively resected (R0)
* Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
* Provided written informed consent

\<Exclusion criteria\>

* Synchronous or metachronous multiple cancers
* Contraindications for fluorouracil-based chemotherapy
* Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
* Ineligible patients according to the investigator's judgement
The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD

MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.

The investigators will randomize 180 PAD patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. They are also planning to recruit 50 non-PAD healthy control subjects.

The goal is to answer the main hypothesis that miR-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. male or female 30 years or older,
2. Infrainguinal PAD,
3. critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent,
4. candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons,
5. absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms,
6. willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion Criteria:

1. life expectancy of less than 2 years due to reasons other than PAD,
2. acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
3. current chemotherapy or radiation therapy
Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes

Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients with Parkinson's disease (PD), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of these symptoms are still not fully understood. Gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. The aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients able to walk without assistance
* Patients with Parkinson's disease or other degenerative parkinsonian syndromes (progressive supranuclear palsy \[PSP\], multiple system atrophy \[MSA\], corticobasal degeneration \[CBD\], etc.)

Exclusion Criteria:

* Other parkinsonian syndromes
* Dementia
* Neuroleptic treatment
Online Mindful & Resiliency Program Intimate Partner Violence

The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women.

The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women. Investigators will recruit participants via email and social media flyers to local community sites as well as approved Loma Linda University affiliated sites. Participants who consent will then complete a Demographic Questionnaire(before initial session of program), Pre and Post Stress Surveys (at the start and end of each session), Five-Facet Mindfulness Questionnaire(before and after completion of the program), and a semi-structured interview after the completion of the program. The program will be done be 20-minutes sessions for 3x/week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women who self-identify as having or who are currently experiencing intimate partner violence
* English or Spanish speaking
* Between 18 and 85 years old.

Exclusion Criteria:

* Males
* No experience of partner violence
* Not fluent in either English or Spanish \<18 and \>85 years of age
Latino Teen Depression Treatment Study

Despite experiencing higher rates of depressive symptoms (Center for Disease Control and Prevention, 2020) and similar rates of Major Depressive Disorder (MDD; Substance Abuse and Mental Health Services Administration (SAMHSA), 2019), Latino adolescents in the U.S. are significantly less likely than their non-Latino White peers to receive treatment for MDD (SAMHSA, 2019). The purpose of this study is to identify a stakeholder-preferred implementation strategy that may improve psychotherapy attendance among Latino adolescents. Latino adolescent-parent dyads and healthcare providers will be recruited from healthcare settings and social media. Focus groups will be conducted with healthcare providers (n=5), and individual interviews will be conducted with Latino adolescents with a diagnosis of depression (n=15) and their parents (n=15).


Eligibility Criteria:
Inclusion Criteria for Teens:

* Male gender
* Aged 13-17 years
* Diagnosed with Major Depressive Disorder or Persistent Depressive Disorder
* Referred to psychotherapy and/or prescribed antidepressant medications for depression

Exclusion Criteria for Teens:

* Experiencing imminent thoughts of self-harm or suicide
* Experiencing acute psychological distress (e.g., uncontrolled crying)

Inclusion Criteria for Parents:

* Parent or legal guardian of teen
* Able to read and speak English or Spanish

Exclusion Criteria for Parents:

* Unable to read/speak English or Spanish

Inclusion Criteria for Healthcare Providers:

* Self-identification as regularly providing clinical care to Latino adolescents with depression
* Be in a role in which they can provide or refer patients to depression treatment

Exclusion Criteria for Healthcare Providers

* Unable to provide or refer to depression treatment
A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP

Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.

This french Registry "France LEADLESS" is a national registry designed to confirm the safety and efficacy of the AVEIR VR LP System in a patient population indicated for the implantation of a VVI(R) pacemaker in France and the AVEIR AR LP System in a population of patients indicated for the implantation of an AAI(R) pacemaker or both systems used in conjunction in a population of patients indicated for the implantation of a DDD(R) pacemaker. This registry will also make it possible to collect the characteristics and indications of patients under normal conditions of use.

Observational national multicentric registry. Retrospective and Prospective, non-randomized, single-arm allowing exhaustive follow up of all AVEIR VR and AR LP implants in France.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with an AVEIR VR LP device and/or an AR LP device
* Patient over 18 years old
* Patient informed of the nature of the study, agrees to participate in the study

Exclusion Criteria:

* Patient under 18 years of age
* Patient refusing to participate in the study
Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant at time of enrollment
* Planning to undergo a scheduled cesarean delivery
* Desires to use the LNG-IUS for contraception
* Willing and able to sign an informed consent in English
* Willing to comply with the study protocol
* Age greater than or equal to 18 years
* English speaking

Exclusion Criteria:

* Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
* Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
* Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
* Uterine anomaly which would not allow placement of the LNG-IUS
* Current cervical cancer or carcinoma in-situ
* Desire for repeat pregnancy in less than 12 months
* History of postabortal or postpartum sepsis
Study to Measure Relaxation From Different Types of Focused Breathing Exercises

Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow breathing techniques to induce physiological and mental relaxation. Medical research suggests that slow breathing techniques induce physiological relaxation. This 6 week study will compare the effects of different types of breathing. The hypothesis is that different breathing techniques produce different physiological and mental changes.


Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 50 years
* English speaking

Exclusion Criteria:

* Hypertension
* Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
* Diabetes
* Renal Disease
* Anxiety Disorder
* Depression
* Other psychiatric conditions including schizophrenia or bipolar disorder
* Attention-deficit-disorder or Attention-deficit-hyperactivity disorder
* Musculoskeletal condition limiting capacity to perform yoga such as chronic lower back pain, chronic neck pain
* Asthma
* Chronic Obstructive Lung Disease
* Obstructive Sleep Apnea
* Smoker
* Currently taking blood pressure medications, oral diabetic medication or insulin
* Current participation in a mind-body practice/program
* Current cancer other than non-melanoma skin cancer
* Regular swimmer
* Plays wind or brass musical instruments