cyrilzakka/clinical-trials huggingface dataset:
Macrophages Effect on Chemoresistance

Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been postulated as being involved in the progression of cancer.

Based on our preliminary findings and on published data we hypothesized that macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells during chemotherapy.

The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of Pancreatic ductal adenocarcinoma (PDA).

methods:

1. The human PDA cell line Panc1 will be grown in suitable conditions.
2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy donors in medium with M-CSF for 7 days.
3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning medium (TCCM) of PDA Cells for an additional 72 hours.
4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to macrophages CM.
5. Cell proliferation will be quantified by light microscopy and by an XTT Cell Proliferation Assay Kit.


Eligibility Criteria:
Inclusion Criteria:

* healthy people

Exclusion Criteria:

* refusal to participate
Grappler® Interference Screw Post-Market Clinical Follow-Up Study

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

This is a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).

Eligibility Criteria:
Inclusion Criteria:

* The subject must have undergone a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
* The subject must have adequate radiographic and medical records for the minimum follow-up requirement of six months

For the Prospective Data Collection:

- The subject is willing to provide written informed consent

Exclusion Criteria:

* None
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia

The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
* Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
* Patients currently treated with one antipsychotic medication

Exclusion Criteria:

* Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
* Patients currently taking clozapine
* History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
* Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
* Patients with history of renal disease or those taking medications to treat renal disease
Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy

The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.

This is an open label, multiple dose extension study to assess the ongoing efficacy, safety, and tolerability of weekly intravenous (IV) infusions of eteplirsen in DMD subjects who have successfully completed Study 4658-us 201.

Subjects will have the opportunity to enroll in this study during the last visit of Study 4658-us-201 (Week 28). Eligible subjects will receive once weekly IV infusions of eteplirsen (50 or 30 mg/kg) for an additional 212 weeks. Subjects will receive the same dose of eteplirsen they received in Study 4658-us-201. Subjects will thereafter continue to receive once weekly IV infusions of eteplirsen for up to an additional 72 week period (through week 284). If commercial eteplirsen becomes available during this additional 72 week period, participation in the study will be discontinued as subjects transition to commercial eteplirsen.

Safety, efficacy, pharmacokinetic (PK), and biomarker assessments will be performed at scheduled visits; adverse events (AEs) and concomitant medications and therapies will be continuously monitored.

If review of data from this open label study suggests that continued treatment with eteplirsen is warranted, this study may be extended by protocol amendment or subjects who successfully complete this study may have the opportunity to participate in a separate follow on, open label eteplirsen study.

Eligibility Criteria:
Inclusion Criteria:

A subject must meet all of the following criteria to be eligible for this study.

1. The subject and/or their parent/legal guardian are willing and able to provide signed informed consent.
2. The subject has successfully completed 28 weeks of treatment in Study 4658-US-201.
3. The subject has a parent(s) or legal guardian(s) who is able to understand and comply with all of the study procedure requirements.

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from this study.

1. The subject has a prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the subject or make it unlikely that the course of treatment or follow-up would be completed or impair the assessment of study results.
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(COMPLETED)

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

The duration of treatment is 10 weeks.

Eligibility Criteria:
Patients with Major Depressive Disorder
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by mutations in the MYBPC3 gene.

The study will consist of 2 escalating dose cohorts (groups). The study will enroll at least 6 and as many as 30 patients. All patients will receive active drug (TN-201 Gene Therapy). The study will follow patients for 5 years following a single dose of TN-201.

Eligibility Criteria:
Inclusion Criteria:

* MYBPC3 mutation
* Hypertrophic Cardiomyopathy (obstructive and nonobstructive)
* Left Ventricular Ejection Fraction ≥45%
* NYHA Functional Class II or III symptoms
* NT-proBNP ≥160pg/ml

Exclusion Criteria:

* High AAV9 neutralizing antibody titer
Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection

Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.

Theoretical and empirical research consistently identifies perceived burdensomeness and thwarted belongingness as suicide-specific risk factors. This proposal refines and pilots Qnnections, a novel suicide prevention intervention which aims to increase social connection and functioning through improving belongingness and reducing burdensomeness. Phase I (1.5 years) focuses on intervention refinement of Qnnections with a Veteran Advisory Board (n = 8) and expert mentors. In its current form, Qnnections is a 10-week group-based intervention intended to augment Veterans Affairs (VA) suicide prevention efforts, using a cognitive behavioral framework to target social disconnection. After refinement by mentors and Veterans with lived experience, a pilot open trial (n = 10) will engage Veterans and gather acceptability data. Following refinement from Phase 1, Phase 2 (3.5 years) includes a pilot randomized feasibility and acceptability trial (n = 48), with participants randomized to Qnnections (10 group sessions, safety plan, referrals) or an Enhanced Usual Care condition that contains elements of standard VA suicide prevention (safety plan, referrals). Veteran participants in both phases will complete quantitative assessments at baseline, mid-treatment, post-treatment, and ten-week follow-up. Qualitative data collection will occur at post-treatment. The focus is feasibility and acceptability of Qnnections and of study procedures.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who report past-month active suicidal ideation (C-SSRS \[Columbia-Suicide Severity Rating Scale\]

  -- or past-3-month suicidal behavior;
* LGBTQ+ or other minoritized gender or sexual identity;
* Have a mental health point-of-contact (e.g., Suicide Prevention Coordinator, Mental Health Treatment Coordinator);
* Willing to complete or update safety plan.

Exclusion Criteria:

* cannot provide informed consent;
* imminent psychiatric hospitalization;
* current or planned participation in residential/intensive outpatient program that would interfere study participation;
* in a conservatorship; and
* has participated in any previous parts of the study.
Brainstem Dysfunction in COVID-19 Critically Ill Patients: a Prospective Observational Study

The purpose of this study is to determine the prevalence of brainstem dysfunction in critically ill ventilated and deeply sedated patients hospitalized in the Intensive Care Unit (ICU) for a SARS-CoV-s2 infection.

The recent development of the pandemic due to the SARS-CoV-2 virus has showed that a substantial proportion of patients developed a severe condition requiring critical care, notably because of acute respiratory distress syndrome requiring mechanical ventilation and deep sedation. Outside of this coronavirus infection, this situation is classically associated with a high prevalence of brainstem dysfunction, even in the absence of brain injury. This dysfunction, either structural or functional, can be detected using appropriate clinical tools such as the BRASS score and/or using the quantitative analysis of EKG and EEG. Crucially, brainstem dysfunction is associated not only with ICU complications such as delirium, but also with a poorer survival.

Moreover, some reports of encephalitis cases and the presence of anosmia/agueusia raised the question of whether the virus could directly invade the central nervous system.

For these two reasons, it is reasonable to assume that brainstem dysfunction is particularly prevalent in critically ill patients infected with SARS-CoV-2 and that this dysfunction could be one of the major determinant of patients outcome.

Eligibility Criteria:
Inclusion Criteria:

* ICU hospitalization
* Invasive mechanical ventilation
* Deep sedation (RASS\<-3) \>12 hours
* Positive SARS-COV-2 PCR

Exclusion Criteria:

* History of neurologic disease (stroke, degenerative disease)
* Pregnant women
* Moribund patients
* Minor patient
* Major patient under guardianship or curatorship
* Prior inclusion in the study
* Patient not affiliated to a social security scheme
* Limitations and cessation of active therapies
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols


Eligibility Criteria:
Inclusion Criteria:

* Patients who understand and agree to this study.
* Adequate Oral hygiene
* One or more edentulous spaces, which are 10 weeks or longer after extractions

Exclusion Criteria:

* Pregnancy.
* Smoking of more than 5 cigarettes/day.
* History of alcoholism or drug abuse during the last 5 years.
* Uncontrolled Hypertension or diabetes.
* Patient with malignant tumor.
* Patients on daily dose of steroids.
* Patients with history of chemotherapy or radiation for the last 12 months.
Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients

The aim of this study is to determine the possible reducing effects of different concentrations of lavender oil on preoperative anxiety in orthognathic surgery patients who have high anxiety during preoperative wait.

Preoperative anxiety is a common problem. It has long been known that surgical operations, unconsciousness, the risks of the operation itself, and the pain to be encountered in the future can cause a considerable amount of anxiety. Anxiety is associated with an uncertain psychological distress, and may vary to minor disturbances to extreme stress. Depending on the severity of the anxiety, preoperative anxiety can affect how well the patient understands the information about the surgery. In addition, stress factors such as interleukins released in the body in anxiety may negatively affect both surgical and post-surgical periods. We want to help patients improve their satisfaction by reducing their anxiety levels and ensure they have a better surgical experience. In addition, anxiety can also prevent active participation in the treatment of the patient during postoperative recovery. Sedatives and other anxiolytic agents may be prescribed to prevent this condition. However, these methods can have side effects. The physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. Lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. The lavender plant belongs to the Labitae family and has been used for centuries in dried or essential oil form. Lavender obtained from flower heads and leaves with vapor distillation. Traditionally, this oil is believed to be beneficial for antibacterial, antifungal, muscle relaxant, sedative, antidepressant effects and for burn and insect bites. Nowadays it is used for aromatherapy and antibacterial and pleasant fragrance material which is used in soaps and cosmetic products. This oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various surgeries. However, the anxiolytic effect of this essential oil has not been investigated for orthognatic surgery patients and there is very few studies investigating different concentrations.

The aim of our study is to investigate whether the different concentration of lavender oil diffused in the preoperative environment of orthognathic surgery patients reduces preoperative anxiety.

Eligibility Criteria:
Inclusion Criteria:

* To undergo orthognathic surgery
* To be over 18 years old.
* Volunteering to fill pre-operative anxiety tests

Exclusion Criteria:

* Hypersensitivity to lavender and its products.
* Being on any medication.
* Being a psychiatric or psychological problem and being under treatment.
* Current upper airway infection or asthma story.
* Not want to be involved in the work.
Study of Acamprosate in Autism

Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.

Each subject with ASD will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 5-17 year-old outpatients
* Diagnosis of ASD
* General good health (determined by exam, history, and laboratory work up)
* Use of up to two concomitant psychotropic drugs (stable dosing for \>60 days) not impacting glutamate or gamma-aminobutyric acid A (GABA) neurotransmission is allowed
* Stable seizure disorder (no seizures in 6 months; on same anti-convulsant dose for \>60 days)
* Clinical Global Impression Scale Severity score (CGI-S) of 4 (Moderately III)
* Score of 13 on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW) at screen and baseline

Exclusion Criteria:

* Potential subjects with a creatinine clearance \< 50 mL/min or evidence of a previous trial of acamprosate will be excluded
Individualized Neuromodulation for the Core Clinical Features of Drug Addiction

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods.

The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive transcranial alternating current stimulation (tACS) technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 45 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
* Meet the diagnostic criteria set forth by the DSM-V concerning the severity of amphetamine-type substance addiction.
* A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
* Consent to actively cooperate in the completion of subsequent follow-up assessments.

Exclusion Criteria:

* Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
* A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
* Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
* Severe organic diseases that might compromise study participation.
* Contraindications to tACS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
Cerebrospinal Fluid Gravity Correlation Analysis

The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood levels.

Hip joint injury is one of the common injuries in the elderly, and hip arthroplasty is a treatment method that allows patients to get out of bed and return to social life as soon as possible. Currently, the common position for hip arthroplasty is the lateral position; and combined spinal and epidural anesthesia or subarachnoid anesthesia is also the common anesthesia method for hip arthroplasty. In the lateral position, the patient's affected limb is often on top and the healthy limb is on the bottom; the healthy side position is also the usual position for hip arthroplasty. In this position, it may be optimal to use a lighter specific gravity local anesthetic drug because it tends to anesthetize only the upper affected limb and does not require a return to the supine position after anesthesia due to changes in the plane of block, minimizing pain and hemodynamic fluctuations during anesthesia and position changes.

Currently, light specific gravity is more of a concept. Because in the available data, only the range of cerebrospinal fluid density of ordinary healthy adults is available, there is little literature and data to describe and analyze what the cerebrospinal fluid density of elderly patients actually is. Therefore, when we administer subarachnoid anesthesia to elderly patients, we cannot determine whether the dispensed local anesthetic drug is a light specific gravity.

In this study, we intend to collect cerebrospinal fluid from elderly patients who underwent hip arthroplasty under combined lumbar and rigid anesthesia or subarachnoid anesthesia, and measure the cerebrospinal fluid density in elderly patients, and observe whether there is a correlation between the above factors and cerebrospinal fluid density through the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and routine blood levels; thus, we can better guide the use of lighter specific gravity drugs in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA Ⅰ or Ⅱ patients No significant neurological pathology No recent history of cerebral infarction No recent history of cerebral hemorrhage No central nervous system inflammation No spinal inflammatory disease No history of spinal surgery Patients who have given pre-operative informed written consent

Exclusion Criteria:

-