cyrilzakka/clinical-trials huggingface dataset:
Detoxification From the Lipid Tract

Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.

It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. GABA A receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. Benzodiazepines (BZDs) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at various GABA receptors throughout the central nervous system (CNS). Alprazolam, a type of BZD, was tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process.

Even though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. The study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.

Eligibility Criteria:
Inclusion Criteria:

* People who received full doses of COVID-19 vaccines.

Exclusion Criteria:

* Women during pregnancy.
Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship

Cancer survivorship has become an important aspect of oncology research due to the risk of physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim of this research is to measure frequency and intensity of one of these issues: the fear of cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.

Indeed, in a recent work published by our team, several complication types in cancer survivorship has been identified: physical but also psychosocial disorders, which can lead to quality of life deterioration. The FCR in lymphoma pathology isn't yet documented and only a few studies concern the risk factors determination (age, sex, disease stage, treatment type, level of education, co-morbidity, isolation (familial status), financial resources, character trait in others cancers. Moreover, the FCR can be amplified by familial (young children) or professional responsibilities (self-employed profession). The consequences of FCR are poorly evaluated and are, however, potentially manifold: psychologic disorders, psychotropic consummation, delay of return to work and quality of life deterioration.

So, FCR is an innovating research project, which studies the FCR incidence in the beginning of lymphoma After-Cancer (AC) M0 and also the associated risk factors we can class in three types: 1. "Patient" factors (age, sex, habitat: rural/urban, familial status, level of education, financial resources, co-morbidity), 2. "disease" factors: histological type, disease stage, risk factor, 3. "treatment" factors : conventional versus intensified. Moreover, we will study the consequences of FCR M0 upon quality of life and if there is a need of psychotherapy from the very beginning of after-cancer phase, for high intensity FCR.

This present study is based on an interventional (with an analysis of human blood sample) prospective cohort, treated with anthracycline-containing regimens. This is a monocentric study which takes place in the Institut University du Cancer of Toulouse. The evaluation uses the scale of Fear of Cancer Recurrence Inventory (FCRI). The inclusion period lasts 2 years and patients will be followed during 2 years with a measure at M0, M12 and M24.

Eligibility Criteria:
Inclusion Criteria:

* Complete response of lymphoma (Cheson criteria 2007) after initial treatment
* Malin lymphoma (Hodgkin or not) treated with anthracyclines for at least 6 cycles : Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) or BEACOPP, Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP) et Rituximab (R-CHOP), miniCHOP et RminiCHOP, RACVBP having received or not an intensification with autologous hematopoietic stem cell transplantation in first-line
* Registered the consent to be included in this study

Exclusion Criteria:

* Person under judicial protection
Reaching and Engaging Depressed Senior Center Clients

The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years' old
* PHQ-9 Score of ≥ 10
* English or Spanish speaking
* MOCA ≥ 24 or mini-telephone MOCA ≥ 11
* Member of/attends one of the REDS Senior Centers
* Capacity to provide written consent for both research assessment and the Engage-A intervention.

Exclusion Criteria:

* Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
* Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV.
* Severe or life-threatening medical illness (e.g., end stage organ failure).
* Currently seeing an individual psychotherapist \*(if individuals are willing to go on a hiatus from their individual psychotherapist for the 15 weeks of the study, and meet all inclusion criteria, they will be considered eligible).
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants

This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion.

The evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared Spectroscopy is still controversial.

This study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with gestation age of \< 32 weeks
* birth weight \< 1500g
* \> 72 hours of age.

Exclusion Criteria:

* cardiovascular, renal, cerebral congenital defects,
* confirmed sepsis,
* no parental consent
The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)

Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a mediator stress regulation and improves social bonding. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. In two current studies that were conducted in Rambam health care we found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients.

This study will examine the effect is of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients, in a double blind (treatment/placebo) study design.

Eligibility Criteria:
Inclusion Criteria:

* PTSD patients (DSM-IV criteria)
* Ability to provide written informed consent

Exclusion Criteria:

* Suicidality
* Psychosis
* Borderline Personality
* Arrhythmia
* Cardiac disease (arrythmia, heart failure)
* Hyponatremia
* Hypertension
* Severe renal insufficiency
* Liver cirrhosis
* Lactating or pregnant women, or undergoing fertility treatment
Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

The trial is a single centre, retrospective cohort, non-interventional study to be conducted in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate the link between mean perioperative clinical heart rate and short-term composite outcomes during PCI among local CHD patients.

The study requires those data including subjects aged from 20 to 80 year-old, diagnosed as coronary heart disease with records on mean clinical heart rate during PCI from 2009.1 to 2014.5 in the database from the department of cardiology, Chinese PLA General Hospital, Beijing. All 15,000 subjects' related data from the database will be collected.Once selected, 15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean clinical resting heart rate during PCI. Group 1 will be defined as subjects' mean clinical resting heart rate ≤70 BPM, which will be set as baseline. Group 2 will be defined as subjects' mean clinical resting heart rate between 71 to 80 BPM. Group 3 will be defined as subjects' mean clinical resting heart rate between 81 to 90 BPM. Group 4 will be defined as subjects' mean clinical resting heart rate \>90 BPM. The primary endpoint is to determine the link between the mean perioperative heart rate and short-term outcomes during PCI among local CHD patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients consecutive enrolled in Chinese PLA General Hospital from January 2009 to May 2014
* Diagnosed as coronary heart disease with records on mean clinical heart rate during PCI .

Exclusion Criteria:

* Inferior wall myocardial infarction (MI) history or/and acute inferior wall MI patients;
* Dead within 3 days after admit into wards;
* LVEF\<30%;
* Install a permanent pacemaker patients.
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
* To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year.

All patients enrolled in the XIENCE V USA who have completed Study Phase I will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in Study Phase II: XIENCE V USA Long Term Follow-up (LTF) Cohort, Harvard Clinical Research Institute (HCRI) DAPT Cohort, or Abbott Vascular (AV) DAPT Cohort.

Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

Exclusion Criteria:

* The inability to obtain an informed consent.

Age limit is determined by investigator.

There are no angiographic inclusion or exclusion criteria for this study.
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 19 to 50 years, at screening
* A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\~30.0 kg/m2
* A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 28 days before the first administration of the investigational drug
* A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
* A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

Exclusion Criteria:

* A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
* A subject who has an acute illness within 28 days prior to the first dose of investigational drug
* A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
* A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
* A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
* A subject who is judged unsuitable to participate in this study by the principal investigator
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty

The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject 22 years or older.
* Scapula and proximal humerus must have reached skeletal maturity.
* Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis.
* Willing and able to comply with the protocol.
* Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject).

Exclusion Criteria:

* Active local or systemic infection, sepsis, or osteomyelitis.
* In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality.
* In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint.
* In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
* Metabolism disorders that could compromise bone formation, or Osteomalacia.
* Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection.
* Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray.
* Known allergy or suspected allergy to implant materials.
* Female subjects who are pregnant or planning to become pregnant within the study period.
* Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included).
* A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (\>5cm) will be excluded.
* Nonfunctional deltoid muscle.
* Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
* Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease.
* Currently, within the last 6 months, or planning to be on chemotherapy or radiation.
* Known alcohol or drug abuse as defined by DSM-5.
* Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
* Currently enrolled in any clinical research study that might interfere with the current study endpoints.
* Known history of renal or hepatic disease/insufficiency.
* Anatomy cannot be replicated using current available system sizes.
Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors

This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.

To evaluate the safety and in vivo dynamics of allogeneic γ9δ2 T cell in the treatment of recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation patients, and to explore the appropriate therapeutic dose.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12-65 (inclusive)；
2. Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation；
3. Basically normal liver and kidney function (as demonstrated by the following laboratory tests prior to initial γ9δ2 T cell therapy)

   * Alanine transaminase/aspartate transaminase \< 2.5×ULN；
   * serum creatinine \< 1.5×ULN；
   * total bilirubin level \< 1.5×ULN；
4. No obvious hereditary disease;
5. Normal cardiac function, cardiac ejection index above 55%;
6. Women of reproductive age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative, and use contraception during the clinical trial period and within 3 months after the last cell transfusion;
7. Sign informed consent.

Exclusion Criteria:

1. Patients with simple extramedullary recurrence;
2. Pregnant and lactating women;
3. Organ failure;

   * Heart: Ⅲ level and Ⅳ level;
   * Liver: reach the grade C Child - Turcotte liver function;
   * Kidney, renal failure and uremia period;
   * Lung: symptoms of severe respiratory failure;
   * Brain: consciousness disorder.
4. Patients with a history of solid organ transplantation;
5. Uncontrollable infectious diseases or other serious diseases, including but not limited to infections (such as HIV positive), congestive heart failure, unstable angina, arrhythmia, psychosis, or restricted social circumstances or those that the attending physician considers to pose unpredictable risks;
6. Patients with systemic autoimmune diseases or primary immunodeficiency;
7. Patients with allergic constitution;
8. Use of systemic steroid drugs;
9. Chronic diseases requiring the use of immunological agents or hormone herapy;
10. Prior treatment with any other immune cells;
11. Participated in similar clinical trials within 30 days;
12. Received radiation therapy within 4 weeks from the time of enrollment;
13. Researchers don't think clinical trials are appropriate for other reasons.
Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment

The gut microbiome has recently emerged as a major contributor to obesity, systemic inflammation, and metabolic disease. Furthermore, intestinal bacteria are crucial players in the gut-brain axis, regulating a broad range of central nervous system processes, from satiety mechanisms to anxiety and social behavior. Thus, targeting the microbiome is being actively investigated as a therapeutic strategy for a wide array of diseases, including obesity, anxiety, depression, and autism. Among all intestinal bacteria, Bifidobacterium animalis spp. lactis (BAL) has shown promise for obesity treatment in experimental animal models and human subjects, improving body composition and metabolic health, and reducing energy intake. Moreover, tryptophan metabolism, a crucial regulator of satiety mechanisms and anxiety, is a main target of BAL. Given that clinical manifestations of Prader-Willi syndrome (PWS) include hyperphagia, anxiety, altered body composition, and metabolic dysregulation, the aforementioned effects of BAL might prove highly beneficial for children with PWS. Here, the investigators will test this hypothesis by performing a randomized double-blinded placebo-controlled crossover clinical study to assess the effects of BAL supplementation on an array of clinical manifestations of PWS. Children with PWS will undergo a 3-month placebo/probiotic treatment period, a 3-month washout period, followed by a 3-month probiotic/placebo supplementation. Anthropometric, biochemical, and psychological data as well as biological samples will be obtained at the beginning of the study, and after each of the study periods, with a total of four time-points. Specifically, the investigators will determine body composition by DXA analysis; metabolic health by assessing glucose and lipid metabolic parameters as well as circulating hormonal and cytokine levels; thermoregulation by non-invasive thermal imaging; and hyperphagia and emotional and behavioral problems by applying parental-rated validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Prader-Willi Syndrome with genetic confirmation
* On a stable diet and medication regimen for at least the last two months before enrollment

Exclusion Criteria:

* Current enrollment in or discontinuation within the last 30 days from a clinical trial
* Presence of other medical problems that would preclude study participation
* Patients with a history of bariatric surgery
* Unsuitable for inclusion in the study in the opinion of the investigator
Fascia Iliaca Block Versus Intravenous Dexmedetomidine and Ketamine for Positioning Fracture Femur

Proximal femur fractures are one of the commonest fractures especially in the elderly population. Early surgical fixation is the best analgesic for associated pain. Spinal anesthesia has been favored by many anesthesiologists due to the simplicity of the technique, the better analgesic profile, and the lower incidence of complications like delirium and thromboembolic events. However, severe pain, encountered during positioning for spinal anesthesia, can complicate the technique and worsen the patient experience.

the study aim to compare the analgesic effect of intravenous dexmedetomidine and fascia iliaca block preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-60 years.
2. Hip fractures
3. Both sexes.

Exclusion Criteria:

1. Patient refusal
2. Allergy to local anesthetics
3. Bleeding diathesis or history of anticoagulant use.
4. impaired cognition or dementia
5. . Infection of the skin at the site of needle punctures area
6. multiple fractures
7. Any previous analgesic administration during the last 12 hours