cyrilzakka/clinical-trials huggingface dataset:
Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.


Eligibility Criteria:
Inclusion Criteria:

* Surgical patients 60 years of age or older
* Surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)
* English speaking ability.
* Ability to give informed consent

Exclusion Criteria:

* Inmate of a correctional facility (i.e. prisoners).
* Pregnancy
* Documented or suspected family or personal history of malignant hyperthermia.
* Patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.
Prone Duration in COVID-19 ARDS

The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is:

Does the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* hospitalized for more than 48 hours
* patients diagnosed with COVID-19
* intubated patients
* underwent prone positioning for longer than 16 hours starting from the first session

Exclusion Criteria:

* Pregnant females
* Patients under the age of 18
* Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)
Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development

The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.

Women will be included in the study according to their susceptibility to develop a insulin resistance (evaluated starting from the body index of mass IMC superior to 28 kg.m-², of the waist measurement 88 cm). Once included in the study, the volunteers will receive for 4 weeks butter, dairy products and biscuits enriched in stearic, elaidic or vaccenic acid. The volunteers will undergo a measurement of the body composition by biphotonic absorptiometry as well as a complete metabolic assessment (blood and urinary samples, clamp to insulin and biopsies).

Eligibility Criteria:
Inclusion Criteria:

* female
* waist measurement \> 88 cm
* body mass index\> 28kg/m2
* Affiliated to National Health Insurance
* Subject giving his/her written informed consent
* Subject willing to comply with the study procedures
* Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

* Reported food allergies
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* Hepatic or renal impairments
* Positive serologies to HIV or HCV, determined on blood sample
* pregnant or presently attempting to get pregnant or menopause or lactating Blood donation done less than 2 months before the start of the study
* Chronic pathologies: diabetes, hypertriglyceridemia, hypertension, cardiovascular diseases, chronic inflammatory diseases
* Intestine, cardiovascular, kidney and cancer pathologies in the last 5 years
* Previous heavy intestine surgery (except appendicectomy)
* Previous medical and/or surgery judged by the investigator as incompatible with this study
* High variation (\> 5%) of body weight during the last 3 months
* Consuming nutritional supplements which could interfered with lipid metabolism (fish oil capsule, vitamins, soja lecithins,...)
* Heavy consumer of alcohol
* Smoker or ex-smoker who stopped smoking less than 1 month before V0 (more than 5 cigarettes/dy).
* Practising intensive physical exercise (\> 5 h per week)
* Vegetarian or vegan
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file
* Disliking butter, margarine, cheese, biscuits and/or vegetable oil
* Dietary habits unreliable to controlled food intake
* Being in exclusion on the National Volunteers Data file
A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia


Eligibility Criteria:
\<Inclusion Criteria\>

Screening

* Patients with essential hypertension and primary hypercholesterolemia
* If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (V1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/ antihyperlipidemic drugs during the clinical trial
* Patients who have an fasting triglyceride (TG) \< 400 mg/dL and LDL-C ≤ 250 mg/dL at Screening (V1)
* Voluntarily provided a written consent to participate in this clinical study
* Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Randomization

* Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3)

  * 140 mmHg ≤ MSSBP \< 180 mmHg
  * MSDBP \< 110 mmHg
* Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC)
* Patients who have an fasting triglyceride (TG) \< 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2)

\<Exclusion Criteria\>

* Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3)
* Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
* Patients with past history and comorbidities at screening(V1) under the following criteria:

  * Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Patients with secondary hyperlipidemia: Secondary hyperlipidemia is not limited to the following diseases; (e.g., Chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.)
  * Patients with orthostatic hypotension accompanied by symptoms
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
* Life expectancy: greater than 72 hours

Exclusion Criteria:

* Pregnant Females
* Treatment with other investigational drug(s) within 4 weeks
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.

This intervention will be randomized among patients with advanced chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR \< 30 ml/min/1.73m2)
* Age 65 years or greater or frail
* self-reported Black or White race

Exclusion Criteria:

* History of dementia
* History of legal blindness
* Listed for kidney transplantation
Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis

Inflammatory syndromes in general, and primary vasculitis specifically, present a high risk of cardiovascular involvement. Takayasu arteritis (TAK), for example, presents cardiovascular complications in up to 60% of cases. It is a systemic inflammatory disease that primarily affects large vessels, such as the aorta and its main branches. From a pathophysiological point of view, there are several causes that can lead to an exacerbated increase in cardiovascular risk in this population, including accelerated atherosclerosis, pro-inflammatory action of platelets and significant endothelial dysfunction.

In this context, the present case-control study intends to include 100 individuals (50 with TAK - case group, and 50 healthy volunteers - control group), matched by age and sex in a 1:1 ratio. The main objective of the study is to compare platelet aggregability in patients with TAK against healthy volunteers using the AggRAM® test. Among its secondary objectives is the analysis of platelet aggregability by other methods (Plateletworks, Chronolog, and PPAnalysis).

The study aims to significantly contribute to a better understanding of the potential influence of TAK on platelet aggregation and the response to antiplatelet agents, thereby contributing to a better understanding of the disease, with evident prognostic and therapeutic implications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with TAK, according to the ACR/EULAR 2022 classification criteria (score ≥ 5 out of a total of 20 points) \[17\]
* Age \> 18 years
* Using acetylsalicylic acid
* Agreement to sign the Free and Informed Consent Form (TCLE).

Exclusion Criteria:

* Previous hemorrhagic stroke

  * Use of another antiplatelet agent other than acetylsalicylic acid
  * Active infection or current use of systemic antimicrobial therapy
  * Known platelet dysfunction or platelets \<150,000/µL or \>450,000/µL
  * Severe illness with life expectancy ≤12 months
  * Known liver disease or coagulation disorder
  * Abuse of illicit drugs or alcohol
  * Dementia, psychiatric condition or any condition that, in the researcher's opinion, prevents participation and follow-up in the protocol
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).

This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR).

Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (± 2 days).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older Age 18 years or older
* ECOG performance status of 0 or 1
* Relapsed or refractory B cell ALL
* Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated
* Documented CD19 positivity within 1 month of screening
* Phase Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
* Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening
* Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
* Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central ClonoSEQ® NGS testing and \<5% blasts in the BM at screening
* Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

* Phase Ib (Cohort IA and Cohort IB) and Phase II (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease
* Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis
* History or presence of clinically relevant CNS pathology
* Presence of CNS-3 disease or CNS-2 disease with neurological changes
* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management
* Active or latent Hepatitis B virus or active Hepatitis C virus
* Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
* Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma

Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. We hypothesize that the emergence of drug resistance is responsible for this early failure of therapy and therefore intensive therapy at induction followed by high dose therapy immediately may produce a better outcome.

Subjects will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 Intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously \[IV\] over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well. Day -6: Carmustine (BCNU): 15 mg/kg (or 550 mg/m2) IV over 2 hrs. Day -4: Etoposide Day -2: Cyclophosphamide 100 mg/kg in 1 liter D5W over 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Must have biopsy proven mantle cell lymphoma confirming mantle cell lymphoma. (Flow cytometry, and cyclin D1 or t (11;14) tests of disease site should be done if available at some time in the patient's course before this therapy)
* Radiologic staging studies may be performed up to 6 weeks prior to starting therapy and not be repeated if the treating physician feels it unnecessary
* No other prior malignancy is permitted except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year.
* Age \> or = to 18 years of age
* For patients who are in first remission from a prior regimen, at least 3 weeks must elapse from a prior chemotherapy and at least 1 week from radiation or antibody therapy.

Exclusion Criteria:

* Significant medical and/or psychiatric illness which, in the opinion of the investigators, may compromise any aspect of the planned treatment.
* The patient cannot have been exposed to chemotherapy to treat any of these diseases (other than mantle cell lymphoma) for at least 3 years prior to entry on this protocol.
Enhanced Recovery in Acute Pancreatitis

Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging

Exclusion Criteria:

* • Severe acute pancreatitis defined as the presence of any of the following:

  * Organ failure (oxygen saturation\<90% on room air, mean arterial pressure\<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine\>2.0, Glasgow coma score\<15)
  * Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate

    * Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization
    * Abdominal surgery within 60 days prior to hospitalization
    * History of gastrointestinal motility disorder
    * Inflammatory bowel disease
    * Chronic comorbid illness including but not limited to \>New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission.
    * Documented allegy to any of the following medications: dilaudid, Tylenol
    * Patients transferred from an outside hospital for ongoing care
    * Non-English speaking patients for whom an appropriate language interpretor cannot be identified.
    * Pregnant women will be excluded from participation in this phase IIb trial given the limited projected sample size and rarity of this condition during pregnancy.
    * Minors (patients \<18 years of age) will not be eligible for study inclusion. The interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. However, the safety and efficacy of these treatments in the pediatric population has not been established.
Effects of Mixed Nut Consumption on Satiety and Weight Management

The first goal of the proposed study is to determine acute and long-term effects of mixed nuts (almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts) on metabolic parameters and weight management. While numerous studies have shown the beneficial effects of nuts on promoting negative energy balance and weight loss, mechanistic studies exploring how the inclusion of nuts in the diet promotes a negative energy balance and weight loss have not been conducted. The second goal is to determine the mechanisms by which mixed nut consumption regulates of food intake and body weight.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* BMI 27-40

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to nuts or gluten
Effect of Smoking Cessation on Glycemic Control in Type 2 Diabetics

The goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients The main question it aims to answer is:

Does smoking cessation lower HbA1c in type 2 diabetics on long term ? The participants will be counseled to cessate smoking and will be followed for 6 months and compared to control who will not cessate smoking .

Smoking and diabetes are both major public health issues specially in our community. They act synergistically on morbidity and mortality. Diabetic smokers have much higher rates of micro and macrovascular complications. \[Carole Clair et al., 2020\] Approximately 1.3 billion people worldwide use tobacco, most commonly in the form of tobacco smoking, and more than 7 million people die every year as a result of smoking related conditions \[Magdalena Walicka et al.,2022\] Exposure to cigarette smoke is associated with vascular damage, endothelial dysfunction, and activation of oxidative stress, inflammatory pathways, coagulation, and fibrinolysis A similar mechanism of endothelial dysfunction is described for people with diabetes. It is therefore not surprising that smoking enhances the combined harmful effects of elevated blood glucose levels, accelerating vascular damage in diabetic patients who smoke The prevalence of current smoking was 45.5% in male patients with type 2 diabetes. The levels of fasting blood glucose and HbA1c increased with number of cigarettes smoked per day compared with non-smokers Smoking and its cessation showed dose- and time-dependent relationship with glycemic control and insulin resistance in patients with type 2 diabetes mellitus. These findings may highlight the importance of smoking cessation in the clinical management of diabetes mellitus.

the effect of smoking and its cessation on glycemic control in diabetic patients has not been fully examined yet.

There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes

Eligibility Criteria:
Inclusion Criteria:

- Moderate Somking index Having been diagnosed with a type 2 diabetes Being ≥ 35 years old HbA1c \> 7

Exclusion Criteria:

Type 1 diabetes Drug induced Diabetes mellitus Type 2 diabetes on insulin treatment
Virtual Reality (VR) to Reduce Preoperative Anxiety.

Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital.
* Patients not following long-term psychotherapeutic treatment
* Patients not taking psychotropic medication
* free, informed and written consent signed by the investigator and the patient before the procedure.

Exclusion Criteria:

* patient not speaking French
* Patients with long-term psychotherapeutic treatment
* Patients taking psychotropic drugs
* patient blind and deaf