cyrilzakka/clinical-trials huggingface dataset:
Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients

Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas tacrolimus should not influence colchicine disposition.

This is a prospective, controlled, open labeled study performed in renal graft recipients comparing colchicine single dose (1mg) pharmacokinetics in 14 patients treated with tacrolimus and 14 patients treated with cyclosporin.

* Renal transplantation \>= one year
* eGFR (MDRD) \> 30ml/min
* hemoglobin \>= 11g/dl
* treatment with tacrolimus or cyclosporine
* no previous muscular disease
* no drugs interfering with P-glycoprotein or CYP3A activity or expression outcomes
* colchicine AUC, Cmax, T1/2
* ABCB1C3435T, CYP3A5 and SLCO1B1 genotypes

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal graft since at least 1 year
* Patients treated with ciclosporin or tacrolimus
* Are at least 18 years old.
* Glomerular filtration rate above 30 ml / min calculated using the MDRD formula
* Among the 14 patients receiving ciclosporin:
* The genotype is not a criterion for inclusion
* Among the 14 patients with tacrolimus treatment:
* 7 genotype ABCB1 3435CC, 7 genotype ABCB1 3435TT
* Recent (1 month) residual concentration of tacrolimus between 5-10ng/ml
* Recent (1 month) residual concentration of ciclosporin between 100-200ng/ml
* For women : a negative pregnancy test (serum beta hCG)
* Realization of a medical examination.
* Informed consent and writing form.

Exclusion Criteria:

* Abnormal transaminases (AST and ALT above the ULN Laboratory).
* Underlying Liver Disease (steatosis, cirrhosis, chronic hepatitis, the virus of hepatitis C or B).
* Previous history of muscle disease (drug related especially the statin type).
* Leukopenia (WBC \<3000/mm3).
* Hemoglobin \<11g/dl.
* Patient treated by erythropoetin (whatever its hemoglobin value).
* Abnormal CPK (greater than the ULN Laboratory).
* Prior intolerance to colchicine.
* Regular intake of the following medications associated with rhabdomyolyses: antipsychotics, cholesterol lowering agents (statins or fibrates), zidovudine, antidepressants (selective inhibitor of serotonin reuptake) and lithium.
* Patient (e) can not refrain from consuming grapefruit juice.
* Patient (e) taking a tea based on St John's wort.
* Taking drugs inducers of P-gp or CYP3A4 (rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, protease inhibitors, griseofulvin).
* Taking drugs inhibitors of P-gp or CYP3A4 (quinidine, macrolide antibiotics, azole antifungals, protease inhibitors, amiodarone, diltiazem, verapamil).
* Chronic diarrhea.
* ABCB1 Genotype 3435CT for patients in the tacrolimus group.
* Participation in another concurrent trial.
* Patient (e) exclusion period of another trial.
* Patient (e) having reached the maximum annual amount of compensation provided by law.
* No affiliation to French social security scheme or without CMU.
Convalescent Plasma in the Treatment of COVID 19

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.

1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.

2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* All genders
* Age \> 18 yrs and \< 90 yrs
* Must have laboratory confirmed COVID-19
* Must provide informed consent
* Must have severe or immediately life-threatening COVID-19,

Severe disease is defined as:

* dyspnea,
* respiratory frequency ≥ 30/min,
* blood oxygen saturation ≤ 93%,
* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
* lung infiltrates \> 50% within 24 to 48 hours

Life-threatening disease is defined as:

* respiratory failure,
* septic shock
* multiple organ dysfunction or failure

Exclusion Criteria:

* No gender exclusion
* Age \< 18 yrs and \> 90 yrs
* COVID-19 negative
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia.

Secondary Objective:

* To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab administration.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration.
* To evaluate the long-term safety in participants receiving open-label alirocumab administration.

The duration of study per participant was approximately 71 weeks consisting of a run-in period (4 weeks), a screening period (3 weeks), a double-blind treatment period (12 weeks), and an open-label treatment period (52 weeks).

Eligibility Criteria:
Inclusion criteria :

Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.

Exclusion criteria:

* LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease.
* LDL-C \<120 mg/dL (\<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
* Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period.
* Fasting serum TGs \>400 mg/dL (\>4.52 mmol/L) at the screening period.
* Systolic blood pressure (BP) \>160 mmHg or diastolic BP \>100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil

Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

Analgesia is one of the pillars of anesthesia. For many years, opiates were the basic ingredient in pain relief. The effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. Some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as Remifentanil. This opiate is stronger than Morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. Therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia.

One of the severe complications following treatment with Remifentanil is the appearance of increased sensitivity to pain \[hyperalgesia\] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). In order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with Remifentanil, complementary treatments, such as Ketalar and dexmedetomidine, were offered. This study will compare the ability of Ketalar or Dexmedetomidine in alleviating increased sensitivity to pain after treatment with Remifentanil in patients who are candidates for laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

• Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Patients with sensitivity to the anesthetic
* Patients with chronic pain who are in regular treatment
* Urgent surgery
* Patients with ischemic heart disease
* Patients with known bradycardia
* Patients with a pacemaker
* Prolonged use of opiates
* Kidney/liver function problems
Molecular Mechanisms of microRNA-494 Involving in Cerebral Ischemia

We and other investigations suggested that the activation of nerve cell cycle following cerebral ischemia led to neuronal apoptosis, glial cell proliferation and the formation of glial scar.The cyclin-dependent kinases (CDKs) and cyclins jointly promoted the cell cycle progression. Our preliminary clinical trial found a new microRNA-miR-494, which involved in the occurrence of acute ischemic stroke. In our animal experiment, miR-494 could relieve cerebral ischemia injury through inhibiting cyclin-dependent kinase 6(CDK6), ubiquitin-conjugating enzyme E2L6 (UBE2L6) and histone deacetylase 3 (HDAC3), which suggested that miR-494 might play an important role in the regulation of cell cycle following cerebral ischemia. This project intends to verify the following hypothesis：①miR-494 suppresses CDK6, and/or fibroblast growth factor16(FGF16)-Ras-extracellular signal-regulated kinase(ERK)--v-myc avian myelocytomatosis viral oncogene homolog(MYC) pathway, and/or phosphatase and tensin homolog(PTEN)-/protein kinase B(AKT)-mechanistic target of rapamycin(mTOR)-S6k pathway;②miR-494 inhibits UBE2L6, upregulates the hypoxia-inducible factor 1 α(HIF-1α) expression in nerve cells, thereby increases the p21 and p27 protein levels and inhibits cyclin-dependent kinase2(CDK2)activity;③miR-494 represses HDAC3 and downregulates the cyclin-dependent kinase1(CDK1)protein level. These all mediate the cell cycle arrest of neurons and astrocytes, reduce the neuronal apoptosis and glial scar formation,promote the recovery of neurological function and provide new targets for the treatment of ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* (1）diagnosis of first ischemic stroke based on clinical information and magnetic resonance imaging; (2)presentation of subjects within 6h of the event; (3)National Institutes of Health Stroke Scale (NIHSS) score between 4 and 15.

Exclusion Criteria:

* (1）suspected cardiogenic embolism;(2）secondary stroke from cerebral hemorrhage, trauma, cancer or aneurysm and so on;(3）bleeding tendency;(4）severe cardiac,pulmonary,hepatic or renal insufficiency;(5）Vital signs are unstable to be assessed.
Assessment of Factors Involved in the Decision-making for ICU Patients' Care

A new law about the advance directives (AD) has been recently voted in France on February 2, 2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This should lead to a greater respect of the human autonomy principle. However, the interpretation of these guidelines is often difficult and may differ between doctors. Indeed, the subjectivity of these interpretations could lead to different medical decisions by physicians.

The investigators intend to assess the effect of advance directives (AD) on decision making in care by intensivists, using a simulated (hypothetical) situation.

Observational simulation (hypothetical) study of intensivist decisions for selected real patients.

Each patient writes advance directives (AD) after receiving clear information (videos and interview with an independent intensivist).

Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing the drafting conditions (information from intensivist).

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients :
* 20 patients with chronic diseases or 80 years old patient or older,
* 4 patients with chronic cardiac failure challenged in heart transplant
* 4 patients with chronic renal failure challenged in kidney transplant
* 4 COPD patients in terminal stage
* 4 patients with lung cancer challenged in surgery
* 4 patients, 80 years old or older, without cognitive impairment

Inclusion criteria for physician :

* Working in Intensive Care Unit (ICU)
* From the 10 ICUs involved in the protocol

Exclusion Criteria:

* Exclusion criteria for physician :
* Decline to participate
Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer

This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.


Eligibility Criteria:
Inclusion Criteria:

* confirmed (within last 3 months)progressive Stage IV NSCLC
* estimated life span of 3 months
* phase angle of at least 5 as measured by bioimpedance

Exclusion Criteria:

* currently taking a lipid lowering medications
* has an imminently life threatening condition
* has pre-existing liver disease
* known allergy to soybeans
* uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
* pregnant or lactating
* has a pacemaker or other implantable electronic medical device
Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study

This study examines subclinical lymphatic abnormalities in Tetralogy of Fallot patients, utilizing lymphatic magnetic resonance and near-infrared fluorescence imaging.


Eligibility Criteria:
Inclusion Criteria:

* ToF

Exclusion Criteria:

-
The efﬁcacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method

This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy.

When the WE method colonoscopy were done with the accessory channel for both infusing and suctioning of water. The water had to be suctioned or infused alternatively and increaed the insertion time.

With the new designed endoscopy that integrated a separate water jet channel for infusing water, infusing and suctioning of water can be done at the same time. Besides, water jet pumping system could provide a powerful jet to help us open the collapse lumen and keep an appropriate distance between the mucosa and the lens, thus preventing loss of visualization. It will help the colonoscopist to find the way during insertion.

Eligibility Criteria:
Inclusion Criteria:

* Underwent fully sedative colonoscopy with WE method in the outpatient department

Exclusion Criteria:

* Age \< 18 years old or \> 80 years old
* Without standard colon preparation
* Allergy to meperidine or propofol
* With a history of partial colectomy
* Refusal to provide written informed consent.
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.

STUDY PLAN

1. Only the principal investigator, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health Insurance Portability and Accountability Act ) and guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process are strictly guarded.
2. Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.
3. The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality of Life Questionnaire) forms will be completed by patients at the following time point:

   1. Within 3 weeks prior to start of radiotherapy
   2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
   3. Approximately one month after completion of radiotherapy during a follow-up visit
4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse or other healthcare provider will be available to help the patient with any questions regarding the QOL forms.
5. The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: d. Within 3 weeks prior to start of radiotherapy e. Once weekly during radiotherapy f. Approximately one month after completion of radiotherapy during a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* All of the following questions must be answered "yes" for a patient to be eligible for this protocol.

  1. Is there a working diagnosis of rectal cancer? YES NO
  2. Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
  3. Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
  4. Is the patient ≥ 18 years of age? YES NO
  5. Can the patient give informed consent? YES NO

Exclusion Criteria:

* All of the following questions must be answered "no" for a patient to be eligible for this protocol.

  1. Has there been prior radiation to the pelvis? YES NO
  2. Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

The primary aim of this study is to:

1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.

Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
* Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
* Must be able to ambulate 25 feet without an assisting device.

Exclusion Criteria:

* Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg.
* History of uncontrolled diabetes.
* Symptoms of orthostasis when standing up.
* Circulatory problems, history of vascular claudication or pitting edema.
* Unable to fully understand instructions in order to use the equipment or the process of the study.
* Body weight over 150 kg.
* Lower extremity injuries that limit range of motion or function.
* Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
* Unstable fractures.
* Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
* Chronic and ongoing alcohol or drug abuse.
* Pre-morbid, ongoing depression or psychosis.
* Ongoing physical therapy.
* Pregnancy (self-reported)
* PI's determination of inability to complete the test protocol
CT Evaluation of ACL Anatomical Reconstruction

Our research is to evaluate the position and length of femoral tunnel, and to examine whether knee stability and clinical functional outcomes are better while using two-portal or three-portal technique .

Arthroscopic anterior cruciate ligament (ACL) reconstruction is one of the most often performed orthopedic surgeries . Restoration of normal anatomy after ACL reconstruction is related to achieve better function and a satisfactory long-term outcomes. The principles for anatomical ACL reconstruction are to functionally reestablish the ACL to its native dimensions, collagen orientation and insertion sites . The basis for the completion of these principles lies in the correct identification of the insertion sites. The conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal. the 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed. The internal joint anatomy, as soft tissue remnants and bony landmarks, should guide the placement of the portals in ACL anatomical reconstruction and that each of the portals has a specific role during ACL anatomical reconstruction . So does the improved visualization through 3-portal technique compared to 2-portal technique have an impact on femoral tunnel position ?

Eligibility Criteria:
Inclusion Criteria:

1. Age ( 16 - 50 ) .
2. Isolated ACL tear with or without meniscal inj
3. Patient who have undergone ACL reconstruction in the last 5 years in Arthroscopy and sports injuries unit .

Exclusion Criteria:

* 1- Age ( \< 16 ) 2- Patient with multi ligamentous inj . 3- Revision ACL tear .
Free Iron and Out of Hospital Cardiac Arrest

Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to ICU for out of hospital cardiac arrest
* Therapeutic hypothermia

Exclusion Criteria:

* Absence of consent