cyrilzakka/clinical-trials huggingface dataset:
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada

the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Eligibility Criteria:
Inclusion Criteria:

* Naïve of treatment HIV -1 infected patients
* CD4 above 100/mm3

Exclusion Criteria:

* pregnancy
* renal failure
* hepatitic disease
* ongoing opportunistic disease
* Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph \> 2.5 N
* drugs interacting with investigational drugs
Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients

The use of free Neurovascularized muscles like free latissimus and gracillis muscles for reanimation of long-standing facial palsy patients using the hypoglossal nerve for innervating these muscles

The investigators need to know which of the two muscles is better functionally and aesthetically in facial reanimation of patients with facial paralysis of more than one year duration.

Eligibility Criteria:
Inclusion Criteria:

* All patients with facial paralysis more than one year what ever the cause.

Exclusion Criteria:

* patients with uncontrolled diabetes.
Magnetic Resonance Imaging (MRI) Analysis of Coronary Artery Plaque Components

The purpose of this study is to analyze atherosclerotic vessel wall components with multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is comparable to computed tomography (CT) in showing plaque components of coronary plaques.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females 18 - 65 who are scheduled to undergo a CT scan for evaluation of coronary artery plaque.

Exclusion Criteria:

* Contraindications to having an MRI scan
* Pregnant women
Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families

Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships.

Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors.

The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.


Eligibility Criteria:
Inclusion Criteria:

Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital

* Man or woman ;
* 18 years old or older;
* Death of the accompanied patient\> 1 month;
* Number of art therapy session of the accompanied patient \> 1;
* Having agreed to participate in the study;
* Not subject to a legal protection measure.

Exclusion Criteria:

* Nobody without the physical or mental abilities to respond to the questionnaire ;
* No one reading or speaking French.
Resting Energy Expenditure in Palliative Cancer Patients

The study purpose is to measure REE by indirect calorimetry and to determine limits of agreement with confidence intervals between measured REE and predictive equations for determination of energy requirements in patients with incurable cancer. Clinical factors associated with hyper- and hypometabolism will be elucidated. Data will be obtained from patient journals in combination with measurements of REE and registration of survival. Data will be collected at one timepoint and survival will be monitored prospectively.


Eligibility Criteria:
Inclusion Criteria:

* A verified diagnosis of an incurable malignant disease
* Hospitalized at the Cancer clinic, St. Olavs Hospital
* ≥ 18 years of age
* Able to provide written informed consent
* Able to comply with all study procedures

Exclusion Criteria:

* Cognitive impairment
* In need of supplementary oxygen
* Receiving invasive or noninvasive ventilation
Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED

Renal colics are a common cause af acute intense pain in medical emergency settings requiring often the use of high level antalgics (opioid) to relief the patient.

In the other hand, Acupuncture is well known widely for its therapeutic characteristics, especially in relieving pain.

the aim of these study is to compare this two pain relieving techniques in patients consulting the emergency departement (ED) for acute onset renal colics.

acute onset pain is a frequent cause for consulting the ED (2/3 of patients). renal colics are a common cause for severe acute onset pain, we think approximatively 20% of patients consulting the ED for severe (VAS \> 70) acute onset pain have renal colics (RC).

the guidelines for the treatment of severe RC recommend the association of two drugs: a nonsteroidal anti-inflammatory agent (NSAI) typically the Ketoprofen and an antalgic typically opioid (Morphine).

but this one face many critics regarding its safety and tolerance, that's why we investigated other pain relief strategies such as acupuncture.

acupuncture is one of the five branches of the traditional chinese medicine, it has proven its efficacity and safety in many conditions and in RC.

the aim of these study is to assess the feasibility, the safety, and the tolerance of an acupuncture pain-relief strategy compared to the conventional one (intravenous opioids) in the treatment of severe acute onset RC in emergency departement settings.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years

  * has a renal colic
  * VAS over 70
  * has not got another analgesic drug before coming to emergency departement

Exclusion Criteria:

* age under 18 years

  * has not renal colic
  * VAS under 70
  * has got another analgesic treatment before coming to emergency departement
  * fever (T° \> 38.5°c)
  * cutaneous infection in the punction sites
  * anuric patient
  * contre indication of morphine
Association Between Cortisol, Cortisone, Cotinine, Nicotine, Caffeine, Melatonin Levels in Hair, Serum, Urine, Saliva and Chronic Stress

The investigators aim to investigate the association between hair, serum, urine and saliva to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.


Eligibility Criteria:
Inclusion Criteria:

* adult volunteer

Exclusion Criteria:

* students of the study host
* people who have steroid or melatonin medicine
Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2\*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.

Eligibility Criteria:
Inclusion Criteria:

* patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
* histologically verified stage IV renal cell carcinoma of clear cell type
* measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
* Karnofsky score \> 70%
* age \> 18 year.
* written informed consent

Exclusion Criteria:

* contra-indications for MRI
* contra-indications for treatment with Sunitinib
* previous systemic treatment within the last 30 days
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

* Symptoms of current depressive episode for less than 30 days or more than 2 years
* Mild depression, as measured by standard clinical research scales
* Significant suicide risk
* Lack of sexual activity (including masturbation)
* Other psychiatric conditions that would obscure the results of the study
* History of failure to respond to antidepressant treatment
* Pregnancy or breast-feeding
Registry for Chronic Obstructive Pulmonary Disease With Anxiety and Depression in China

Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria:

* Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
* Patients with tumor history during past 5 years
* Patients with COPD exacerbations during past 4 weeks
* Participants in clinical trials
* Patients in pregnancy or breastfeeding
* Patients unable to complete questionaire independently
* Patients older than 80 years old
* Patients receiving long-term domiciliary oxygen therapy
Octagam 5% Versus Comparator Post Marketing Trial

Study Design:

This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.

This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.

The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years.
2. Patients with confirmed diagnosis of Primary Humoral Immunodeficiency (PI) as stated by the World Health Organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia.
3. Patients on regular treatment (every 3 to 4 weeks) with low dose IGIV (1 g/kg) for a period of at least 6 months without changing the brand.

Exclusion Criteria:

1. Patients with a history of TEEs within the previous 24 months.
2. Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML

The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.

Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.

Eligibility Criteria:
Inclusion Criteria:

1. RR-AML
2. Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.

Exclusion Criteria:

1. Acute promyelocytic leukemia (AML subtype M3)
2. Previous exposure to the treatment of VEN-based regimen
3. Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
4. Respiratory failure (PaO2 ≤60mmHg)
5. Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[ULN\], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
6. Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate \< 30 mL/min)
7. ECOG performance status 3, 4 or 5
8. Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
9. Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
10. Patients with pregnancy
11. Uncontrolled active infection
12. Clinically significant coagulation abnormalities
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation

An assessment of the use of cold therapy to terminate atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years or older
* Male of female
* Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration
* Must be in AF at time of surgery, or inducible using manual or electrical stimulation
* Subject is willing and able to provide written informed consent
* Subject has a life expectancy of at least 1 yearExclusion Criteria:

Exclusion Criteria: • Long-standing AF (duration \> 1 year)

* Prior AF ablation
* Left main coronary artery occlusion \> 70%
* Critical aortic stenosis (gradient \> 50mm HG)
* Inability to induce patient into AF without drugs at time of surgery
* Female subjects who are pregnant at time of surgery
* Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study
* Permanent pacemaker or implantable cardioverter defibrillator
* Current cancer treatment that includes radiation of the heart
* Inability to give informed consent
* Significant intra-cardiac thrombus
* Subjects not eligible for or considered high risk for anticoagulation
Single Dose Pharmacokinetic (PK) Study

The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome (FXS) or Angelman syndrome (AS).

* The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101 following a single 5 mg dose of OV101 in adolescents with FXS or AS.
* Secondary objectives are to determine the safety and tolerability of a single 5 mg dose of OV101 in adolescents with FXS or AS.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescents with confirmed clinical and previous molecular diagnosis of FXS or AS, age between 13 to 17 years, inclusive.
2. Subjects must assent to participation in the study (if appropriate), have a parent or legal guardian/representative capable of providing informed consent on behalf of the subject, and commit to participate in all assessments described in the protocol.
3. Subjects must be receiving a stable dose of concomitant medications
4. Subjects should be able to complete study assessments.
5. Subjects who are non-sterile must agree to either remain completely abstinent or to use two effective contraceptive methods from screening until 7 days after the last dose of study treatment.
6. Subjects must have a parent or other reliable caregiver who agrees to accompany the subject at all study visits and provide information about the subject as required by the study protocol, and ensure compliance with the protocol.

Exclusion Criteria:

1. Inability to swallow a capsule.
2. Poorly controlled seizures
3. Clinically significant abnormal ECG at the time of screening.
4. Positive result on serum or urine pregnancy test for women of child-bearing potential (have experienced menarche) who are not using a dual method of contraception (e.g., condoms plus oral contraceptives), with abstinence being an accepted method.
5. Allergy to gaboxadol or any excipients
6. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study
7. History of suicidal behavior or considered a high suicidal risk by the investigator.
8. Any medical, psychological, social disorder(s), or other conditions - including seizure disorder
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

The duration of treatment is 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Known allergies to the study drug
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
2. Age ≥ 18 years and ≤ 75 years when ICF is signed;
3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
4. Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);
5. Measurable lesion according to RECIST v1.1 by IRRC;
6. ECOG score 0-1;
7. Expected survival 12 weeks.

Exclusion Criteria:

1. Has other active malignancies within 5 years before the first administration of the study drug;
2. Plan to or have previously received organ or bone marrow transplantation;
3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
4. Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;
5. Have received any research drugs within 14 days before the first use of the study drugs.
Assessment of Cognitive Functions in Patients Receiving Whole Brain Radiotherapy in Assiut University Hospitals.

Whole Brain Radiotherapy (WBRT) is widely used to manage brain metastases and primary brain tumors, but it frequently leads to cognitive decline, affecting patients' quality of life. Cognitive impairments after WBRT can manifest in various domains, including memory, attention, executive function, and processing speed. These changes are attributed to direct radiation damage to neural tissues, particularly the hippocampus and white matter tracts, as well as secondary effects such as inflammation and vascular injury. Existing literature reports that up to 30% of patients may experience significant cognitive deterioration after WBRT, with the degree of impairment influenced by factors like total radiation dose, fractionation schedule, patient age, and baseline cognitive function. Despite these concerns, there is currently no standardized protocol for assessing cognitive changes in patients undergoing WBRT. Hippocampal avoidance and neuroprotective agents like memantine have shown potential in mitigating cognitive side effects, but their implementation remains inconsistent. Furthermore, routine cognitive assessments are not yet part of standard clinical practice, leading to a reactive rather than proactive approach to managing cognitive decline. This gap in early detection and standardized cognitive monitoring highlights the need for better methods to understand and manage the cognitive consequences of WBRT. Without systematic assessment, cognitive impairments may go unrecognized until they significantly impact daily functioning, emphasizing the importance of addressing this issue to better support patients undergoing whole brain radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* • Adult patients (18 years or older)

  * Patients diagnosed with brain metastases or primary brain tumor requiring WBRT.
  * Ability to provide informed consent.

Exclusion Criteria:

* • Pre-existing severe cognitive impairments or psychiatric disorders unrelated to cancer treatment.

  * Significant neurological conditions other than brain metastases.
  * Patients unable or unwilling to provide informed consent.
Recurrence of Hepatocellular Carcinoma

analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
2. Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
3. Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
4. Patients with INR \< 1.5 or prothrombin concentration \> 50%.
5. Platelet count \> 50000 cell/mm3.

Exclusion Criteria:

1. Presence of extra-hepatic metastasis or gross vascular invasion.
2. Child class C patients.
3. Follow up period of less than 12 months.