cyrilzakka/clinical-trials huggingface dataset:
A Study for Patient With Chronic Low Back Pain

The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients with chronic low back pain

Exclusion Criteria:

* Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer

HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.

A nurse will meet the patient and present the study, then the patient will be invited to participate. If the patient is interested, an information note will be given and the non-opposition of the patient will be collected.

Patients will be registered via a registration form and an inclusion number will be attributed at each patient.

Eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8.

Modalities of refrigerant helmet use will be set according to the habits of the Oscar Lambret center with the following rules :

* Placement of a single-use non-woven hygiene cap on the scalp
* T-15 minutes: placement of the refrigerant helmet
* T0: begin of eribulin infusion (duration: 2-5 minutes)
* T+15 minutes: rinse of the line
* T+30 minutes: withdrawal of the helmet

Efficacy will be evaluated before treatment and at each eribulin cycle.

Eligibility Criteria:
Inclusion Criteria:

* Female patient who has a locally advanced or metastatic breast cancer
* Indication of Halaven treatment :

patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage

* Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia.
* Aged ≥ 18 years
* Non-opposition of the patient must have been collected

Exclusion Criteria:

* Skin metastasis of the scalp
* Sensitivity to cold, cold agglutinin disease or cryoglobulinemia
* Impossibility to submit at the study procedures due to geographic, social or mental reasons
Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma

Liver transplantation (LT) is the only curative option for a selection of patients with hepatocellular carcinoma (HCC) based on clinical selection criteria known as the Milan criteria. Nevertheless, 15% of these patients still show tumour recurrence after LT. In a monocentric pilot study, we have demonstrated that specific changes in N-glycan profiles (measured before LT) occur in HCC patients receiving LT1. These specific changes proved to be strongly associated with the risk of HCC recurrence and overall death after LT, independent of the criteria used for stringent patient selection. Pathophysiologically, it is known that abberations in protein glycosylation are involved in the onset en development of HCC. As such, a prognostic biomarker was developed that can clearly differentiate between patients with and without increased risk of HCC recurrence.

The primary goal of this research study is to set up a prospective, multicentre study in order to validate the prognostic value of this glycomics-based serum biomarker. As such, the risk of tumour recurrence in patients undergoing LT for HCC will be estimated independent from the Milan criteria and the French alpha-fetoprotein model as the current standard. The secondary goal is to explore the potential of serum glycomics as markers of early recurrence after LT for HCC. More specifically, we aim to investigate whether serial glycomics determination at fixed time points after LT could allow early detection of recurrent HCC even before it is visible on conventional imaging. Consequently, a diagnostic biomarker for monitoring early recurrence after LT could be developed with the potential of redirecting treatment strategies already in an early disease stage.

In case the promising data from the pilot study will be confirmed, the prognostic biomarker could be implemented in daily clinical practice leading to optimization of patient selection using a simple blood test before LT. More specifically, this marker could improve organ allocation thus preventing unnessecary treatment toxicity for the patient and reducing the costs of treatment for society. Moreover, it should be emphasized that a patent application was already submitted and accepted in collaboration with TechTranfer of Ghent University (PCT/EP2021/057788-Prognostic markers of disease recurrence in liver transplant recipients with hepatocellular carcinoma).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated patient informed consent document
* Diagnosis of hepatocellular carcinoma
* Age ≥ 18 years
* Ability to comply with protocol-specified evaluations and scheduled visits
* Eligible for liver transplantation and/or active on the waiting list for liver transplantation
* Consulted the department of Gastroenterology and Hepatology

Exclusion Criteria:

* Diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)
Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia

Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients

Site of study:

This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals.

Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.

Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-38 years old.
* Mild and moderate preeclampsia parturient.
* American Society of AnesthesiologistPhysical status II.
* Body Mass Index (BMI) (25-35kg/m²).
* Type of operations: elective cesarean section under spinal anesthesia.
* Written informed consent from the parturient.

Exclusion Criteria:

* Altered mental state.
* Women with known history of allergy to study drugs.
* Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
* Patients receiving anticonvulsants or antidepressants.
* Sever preeclampsia, intrauterine growth restriction or fetal compromise.
Glycosylated Hemoglobin and Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization (HbA1c)

Glycosylated Hemoglobin (HbA1c) is considered as one of the best markers to assess the glycaemia treatment over a period of 3 to 4 months, and is considered as predictive marker for perioperative mortality and morbidity. The impact of the elevated HbA1c on the risk of perioperative major cardiovascular events in patients undergoing coronary bypass revascularization (by retrospective analysis of perioperative cardiovascular events and preoperative HbA1c) is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012

Exclusion Criteria:

* disapproval of use of data for research purposes
Correlations of Epigenetic Changes With POCD in Surgical Patients

Postoperative cognitive dysfunction (POCD) is a subtle cognitive dysfunction, especially postoperative memory impairment lasting for weeks or months. The underlying pathophysiological mechanism of POCD remain unclear. The aim of this study is to explore the epigenetic changes during perioperative period and its correlation with POCD in surgical patients.

The incidence of postoperative cognitive dysfunction (POCD) in elderly patients ranges widely from 16% to 21% and is associated with adverse outcomes. The exact cause of POCD remains unknown. Extensive studies report that epigenetic modification, including the alteration of DNA methylation and chromatin structure, plays an important part in the regulation of memory and learning. The present study thus hypothesize that epigenetic modification may increase the risk for POCD. The present study will enrolled the elderly patients (aged≥65) and young and middle-aged patents (aged 20-50) who are planning to undergo elective noncardiac surgery under general anesthesia. Perioperative clinical characteristics of all patients will be recorded. Participants enrolled will be evaluated for POCD with Mini-Mental State Examination (MMSE) on preoperative day, postoperative days 1. Postoperative pain will be evaluated by the numerical rating scale (NRS). The patients' blood will be collected in the morning on the day before surgery and after surgery when they recover consciousness for the detection of concentration of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) by enzyme-linked immunosorbent assays (ELISA).

The present study may help to find whether epigenetic changes will occur after surgical and anesthesia stress and will be an important factor for POCD in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

•ASA Grade I to III Age \>65 BMI 18-28kg/m2 Patients undergoing abdominal surgery,orthopedic surgery and spinal surgery

Exclusion Criteria:

* Exclusion Criteria:

  * do not consent, Patients with mini mental state examination (MMSE)score of ≤20 at screening severe heart,kidney or lung disfunction;unstable angina undergoing abdominal operation previously refuse to use PCA unexpected surgical complication such as bleeding; psychiatric disorders; drug or alcohol abuse
Ostom-i Alert Sensor Quality of Life Validation

The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.

Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse).

An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* use of an ostomy bag for at least six months
* must own an iPhone, iPod Touch, or Android

Exclusion Criteria:

* use of large urostomy bags
Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.


Eligibility Criteria:
Inclusion Criteria:

* ECOG ≤ 1
* Willing to undergo tumor biopsies from injected and distal lesions
* Must have two biopsy accessible lesions:

  * \* one lesion must be ≥10 mm and \<100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.

    * a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
    * tumors encasing major vascular structures (i.e., carotid artery or tumors close to other vital organs), are not considered appropriate

Exclusion Criteria:

* Patients who require local palliative measures such as XRT or surgery
* Symptomatic or untreated leptomeningeal disease.
* Presence of symptomatic central nervous system (CNS) metastases
* Impaired cardiac function or clinically significant cardiac disease
* Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
* Active infection requiring systemic antibiotic therapy.
* Known history of Human Immunodeficiency Virus (HIV) infection.
* Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Malignant disease, other than that being treated in this study.
A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential (i.e., postmenopausal).
* Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests.
* Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.

Exclusion Criteria:

* Pregnant or lactating women.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
* Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
* Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
* History or clinical evidence of alcoholism or drug abuse.
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females).
* Individuals of Asian descent or other individuals reporting ethanol intolerance.
* Modified Swiss Narcolepsy Scale total score \< 0 at screening or history of narcolepsy or cataplexy.
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A

The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Subject is less than 6 years of age
* Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis)
* Documented medical history of at least 50 exposure days for treatment with all other factor VIII products
* Subject's parent or legally authorized representative has provided informed consent

Exclusion Criteria:

* Detectable inhibitor to factor VIII measured in the screening sample by the local or central hemostasis laboratory
* History of inhibitor to factor VIII at any time prior to screening
* Subject has any one of the following laboratory abnormalities at the time of screening:

  1. platelet count \< 100,000/mm3
  2. hemoglobin concentration \< 10 g/dL (100 g/L)
  3. serum creatinine \> 1.5 times the ULN for age
  4. total bilirubin \> 2 times the ULN for age
* Subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., platelet dysfunction secondary to uremia, liver failure, von Willebrand's Disease)
* Subject has known hypersensitivity to RECOMBINATE rAHF
* Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry
* Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels. Nine subjects will be enrolled and administered with three different doses of KL001. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL001. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL001 for a total 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male ≥12 years of age.
2. Moderate/severe or severe hemophilia B (baseline FIX activity ≤2% of normal or documented history of FIX activity ≤2%).
3. At least 3 bleeding episodes per year that require on-demand treatment with FIX OR are treated with a prophylactic regimen of FIX.
4. At least 100 days exposure history to recombinant or plasma-derived FIX protein products.
5. No neutralizing antibodies to exogenous FIX protein products.
6. Willing and able to comply with study procedures and requirements.

Exclusion Criteria:

1. Suffering from chronic inflammatory muscle disease.
2. Positive in Hepatitis B or Hepatitis C.
3. Infection with HIV-1 or HIV-2 and CD4+T cell count ≤ 200/ μ L.
4. History of thrombosis or susceptibility to thrombosis.
5. Current or previous participation in another gene therapy study.
6. Has any other significant medical condition that the investigator feels would be a risk to the subject or would impede the study.
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Major surgical procedure requiring arterial access

Exclusion Criteria:

* Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.
Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 19\~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
2. ASA PS 1-3

Exclusion Criteria:

1. Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
2. Previous hepatectomy or liver transplant
3. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
4. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
5. Uncontrolled hypertension (systolic blood pressure \> 160mmHg)
6. Acute narrow angle glaucoma
7. Myasthesia gravis
8. Known allergy to the drugs included in the study
9. Cardiac arrhthmia (non-sinus rhythm)
10. Taking drugs that affect the autonomic nervous system of diabetes
11. Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
12. History of drug or alcohol abuse
Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes.

Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patients, aged 18 years or older, with non-healing foot ulcers

Exclusion Criteria:

* Patients with macrovascular disease amenable for revascularization with more than 70% obstruction in femoral artery (evaluated by US doppler) were excluded from the study. Similarly, patients with a documented allergy to NAC, liver cirrhosis or those receiving NAC for other indications were excluded. Finally, patients with chest pathology incompatible with pressure changes, patients with inner ear disease, or those suffering from claustrophobia were excluded.