cyrilzakka/clinical-trials huggingface dataset:
Dex as Analgesic Adjuvant in OSA Patients

The purpose of this study is to assess whether intravenous peri-operative Dexmedetomidine reduces opioid requirements and or improves pain control after Uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea (OSA).

BACKGROUND/STUDY SIGNIFICANCE

Patients with OSA undergoing surgery have increased surgical risk compared to patients that do not have OSA . Perioperative medication such as benzodiazepines and opioids can decrease upper airway tone, inhibit central respiratory drive and inhibit upper airway reflexes. The supine position may also worsen the severity of the OSA. Additionally, this group of patients is more likely to have a higher incidence of complications, particularly post operative hypoxemia , difficult intubation , and complicated extubation course .

Uvulopalatopharyngoplasty (UPPP) along with other tongue base procedures are commonly performed surgical procedures used to help alleviate the symptoms of obstructive sleep apnea (OSA). Postoperative management of oropharyngeal pain is challenging since narcotic administration may compromise respiratory status in OSA patients. The Anesthesiology and Otorhinolaryngology communities have begun to rethink acceptable narcotic use in OSA patients especially following the recent FDA announcement highlighting serious adverse effects related to codeine consumption in children who had undergone tonsillectomies.

Dexmedetomidine (Precedex) is a sedative with minimal respiratory depression. Its mechanism is via alpha 2 agonism and has 8 times the affinity for the alpha 2 adrenoreceptor than clonidine. It has been shown to have sedative, analgesic, and anxiolytic effects. It produces a predictable and dose dependent decrease in heart rate and blood pressure. Dexmedetomidine undergoes extensive metabolism in the liver and is then eliminated as methyl and glucuronide conjugates mostly via the renal system. The pharmacokinetics are markedly affected by hepatic insufficiency .

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patients scheduled for UPPP
* Patients with diagnosis of OSA via polysomnography
* American Society of Anesthesiology (ASA) classification 3 or lower

Exclusion Criteria:

* Bradycardia as defined as resting heart rate \<60 Beats per min (BPM) or symptomatic
* Any degree of heart block diagnosed by ECG
* Hypotension as defined as \<20% from baseline or symptomatic
* Liver failure, (two fold rise in liver enzymes)
* Chronic Kidney Disease (CKD) III or greater
* History of allergy to opioids or dexmedetomidine
* ASA classification 4 or higher
* ICU or Step down admission
* Difficult airway as defined by previous history of difficult intubation or requiring a fiberoptic intubation.
Oxytocin Buffers Stress Response in Individuals With Impaired Coping Abilities

This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application.


Eligibility Criteria:
Inclusion Criteria:

* male

Exclusion Criteria:

* psychological disorders
* drug abuse
* cigarette smoking
* coronary diseases
* nervous system diseases
Communication in ICU During COVID-19

This study explores the actual situation of communication during the Coronavirus disease 2019 (COVID-19) pandemic in the South Asia and Middle East region. The purpose is to assess the effect of the limited visitor policy during the COVID-19 pandemic, on the pattern of interaction of critically ill patients to their kin/ guardian and doctor-family members communication.

Primary objective of this study are as follows:

1. Explore the changes in communication pattern with limited contact during the COVID-19 pandemic.
2. Assess the methods of informed consent in Intensive care units (ICUs) during the same period

An observational, cross-sectional, web-based questionnaire survey, with multi-centre involvement across hospitals in the South Asia and middle-east region. The questionnaire consists of two sections. Section one obtains information from participants regarding communication and visiting practices in ICU during pre-COVID-19 era, and the Section two obtains information regarding the policy changes if any during the COVID-19 pandemic in regards to safety of healthcare workers (HCWs) and public.

In order to obtain the largest representation of South Asia and Middle East ICUs, a network of research doctors as facilitators from each country is created. The role of the facilitators is to contact and recruit adult ICUs within their country. Each facilitator contacts the hospitals (public and private), creating a network of collaborating doctors/nurses (participants) from those hospitals who expressed their willingness to participate.

Data collection: a web based Google Forms with online access will be used Only one entry per ICU will be collected during the study. Statistic analysis: a descriptive analysis is planned for the general characteristics of the participating units and the study population.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ICUs,
2. New created COVID-19 ICUs during the pandemic

Exclusion Criteria:

1. Paediatric ICU
2. Neonatal ICU
Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior

Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. The management of psychiatric patients, including depressed subjects, faces the inability to detect those with a high risk of SB. Many studies have shown a link between low cholesterol and SB. A study has recently proposed a total cholesterol threshold below which the risk of suicide could be increased. However, a prospective study is needed to assess the predictive nature of such an indicator.

Investigators propose to assess, within a cohort of patients, the predictive value of a total cholesterol threshold in the occurrence of SB.

555 inpatients suffering from a current Major depressive disorder (MDD), hospitalized in the Department of Emergency Psychiatry and Post Acute Care will be recruited.

Each patient will attend a total of 5 visits during a follow-up period of 18 months (visits at 1, 3, 6, 12, and 18 months)

Eligibility Criteria:
Inclusion criteria:

* Major
* Meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM) criteria for a major depressive episode
* Subject who signed the non-opposition form
* Able to understand the nature, purpose and methodology of the study
* Able to understand and perform the clinical and neuropsychological evaluations.

Exclusion criteria:

* Subject whose primary psychiatric diagnosis is not a major depressive episode according to DSM-IV criteria (the existence of psychiatric comorbidity is not a criterion for non-inclusion)
* Refusal of participation
* Subject Deprived of liberty (by judicial or administrative decision)
* Subject protected by law (guardianship)
* Subject exclusion period in relation to another protocol
* Subject for which the maximum annual amount of allowances of € 4,500 has been reached
* Subject not affiliated to a social security scheme or not being the beneficiary of such a scheme.
Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?

Although immunotherapy revolutionized melanoma outcomes over the last 10 years, only 40-50% of patients respond to treatments and 25% develop acquired resistances. Natural Killer (NK) cells naturally recognize and kill tumor cells. However, the immunosuppressive micro-environment generated by the tumor decreases NK cells' killing activity. CD160 is a NK cell receptor identified and characterized in our laboratory. Engagement of the GPI isoform (CD160-GPI) initiates NK cell cytotoxic response. Upon NK cell activation, a transmembrane isoform (CD160-TM) is neo-synthesized which promotes the amplification of activated NK cell cytotoxicity.

The aim of this study is to assess the phenotypic profile of advanced stages melanoma patients' NK cells (mainly CD160-TM expression or its induction) and therefore the therapeutic potential of the use of an anti-CD160-TM agonist antibody to boost the NK-dependent mechanism leading to tumor depletion.


Eligibility Criteria:
Inclusion Criteria :

* Patients aged18-years old or over
* ECOG score between 0-2
* Inoperable stage III or stage IV melanoma
* Naïve of treatment or in progression after one or several treatment lines
* Give their written consent for the present study and be included in MelBase cohort.
* health insurance coverage.

Supplementary inclusion criteria for part II :

* skin or subcutaneous melanoma lesions
* agree and inform consent for a cutaneous biopsy or a tumor sample if presenting lymph nodes involvement if part of the usual clinical practice.

Exclusion Criteria:

* Pregnant and breastfeeding women
* Patients with psychiatric disorders
* Patients already included in another clinical trial
* Having received chemotherapy or radiotherapy during the last 4 weeks,
* Patient presenting another solid or blood cancer, chronic viral infection (e.g. HIV, HBV or HCV)
* Been treated with more than 10mg of steroids until the 4 weeks before inclusion.
* Refusal to participate to the study
* Patients under guardianship or curatorship
* Patients on state medical aid
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV

The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.

It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.

Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected for at least 6 months
* Ability to read and write English

Exclusion Criteria:

* Drug use within the past 6 months
* Cognitive impairment or dementia
* Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
* Loss of family/loved one in past 3 months
* Started a relaxation therapy in past 3 months
* History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)
* Acute infection in past month
* Change of HAART or drug regimen in past month
Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic disorder characterized by profound immune and metabolic disturbances. It emerges due to a complex interplay of genetic and environmental factors. Alteration in immune cell metabolism is another feature of SLE. Mitochondria, serving as the main regulator of cell metabolism, exhibits pronounced dysfunction in SLE patients.

Kidneys are among the most frequently affected organs in SLE, with 30-40% of patients developing lupus nephritis (LN) over the course of their disease. LN patients exhibit varying degrees of renal injury, significantly reducing their survival rate. Usually, LN originates from abnormal immune responses, resulting in the formation and deposition of immune complexes in the kidneys, triggering the release of pro-inflammatory cytokines, cell adhesion molecules, and chemokines, thereby inducing inflammation. Extensive glomerular mitochondrial damage has been reported in kidney biopsies obtained from patients with LN. So, identifying peripheral immune markers of mitochondrial dysfunction may be beneficial in assessing SLE activity and the extent of organ involvement.

Among these markers, fibroblast growth factor 21 (FGF-21) is one of the circulating immune markers which is expressed in response to mitochondrial stress. FGF-21 is known to be primarily produced in the liver, but under stress conditions, it can also be produced by the kidneys. In addition, it correlates with the degree of renal impairment in various kidney diseases.


Eligibility Criteria:
Inclusion Criteria:

- 1- Patients who will be diagnosed as SLE according to the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus.

2-SLE Patients \> 18 years old.

Exclusion Criteria:

* 1-SLE Patients \< 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.
Limb Salvage Post Venous Injury:Case Series

The venous injury diagnosis depends on history of trauma with symptoms and signs suggestive of venous injuries and color flow duplex study is of increasing value as a screen for detection of an occult venous injuries. It is associated with arterial, peripheral nerve injuries and bone fractures. Within this study of one-year duration, a seventy-five patients with acute venous injuries were included. The injured vein was either repaired or ligated according to hemodynamic state of patient and site and type of injury.

This is a retrospective cross section study of one-year duration from January 2017 and January 2019 at Najaf Teaching medical city/Iraq . The study included a Seventy-five patients with acute venous injuries. The Venous surgical interference for late complicated vascular injuries and iatrogenic venous injuries were excluded and the information was obtained from the hospital records and direct evaluation of patients.

Eligibility Criteria:
Inclusion Criteria:

All in surgical emergency departments

Exclusion Criteria:

nil
Immunoregulatory Effect of Microparticle Delivered STING Agonist in the Control of Experimental Autoimmune Encephalomyelitis (EAE) and Multiple Sclerosis (MS)

Microparticles (MPs) as a mode of therapeutic delivery can selectively deliver immunomodulatory treatment to the phagocytic cells, particularly dendritic cells (DCs), inducing their tolerogenic phenotype and function and T regulatory (Treg) cell expansion. The study will characterize the in vitro response of cGAMP immunomodulator incapsulated microparticles on the capacity of DCs and Tregs to regulate the inflammatory response.

This is a lab study only. No medication will be dispensed as a part of the study. No tests or procedures will be performed. Blood ( approximately 10 teaspoons ; 10 green top tubes) will be drawn by a qualified phlebotomist, nurse or physician in the Neurology clinic, during routine clinic visits. Proper medical procedures will be followed when collecting blood to minimize patient risk. In addition, steps will be taken to guard patient's confidentiality. Unique codes will be assigned to each sample. All identifying information will be removed from samples and clinical data before they are given to the research staff conducting the laboratory study. Only the clinic staff will have access to the consent forms, the master list (that connect the unique codes with the patient names) and subject medical records. The blood draw will coincide with the subject's regular visit to the Neurology clinic.

All records will be secured with the current PACS radiology system and computerized information systems/computerized databases which are the current methods for securing all patient information. Care will be taken to preserve the confidentiality of all patient-related information. Material with identifying information will be stored in the clinic locked data storage room. Patient names will not be used in any publications. Results of laboratory studies performed on these samples will not be shared with subjects. Laboratory results will not be incorporated into patients medical records.

The proposal states to separate dendritic cells using magnetic beads separation and use them as an antigen presenting cells to T cells.The therapeutic effect of the nanoparticle delivered phosphatidylserine (PS, PAR-PS) will be measured, using cytokine secretion and the detection of the T regulatory (Treg) cell induction. Proliferation will be determined using CFSE, cytokine secretion will be measured using ELISA and the intracellular cytokine staining for IFNg, IL-17A, IL-17F, IL-21, IL-22, TGFb, IL-10 and IL-4. The induction of Treg cells will be measured using flow cytometry and determining the percentage of CD4+ CD25+ CD127- FoxP3+ Treg cells within the CD4+ lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects meeting diagnostic criteria for relapsing remitting multiple sclerosis
2. Between the ages of 18-55
3. Not treated with immunomodulatory therapy, no other neurological diagnosis, no other inflammatory disease

Exclusion Criteria:

-
Cancer Pain Single Nucleotide Polymorphisms (SNPs)

Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.


Eligibility Criteria:
Inclusion Criteria:

* Cancer pain patients

Exclusion Criteria:

* Patients not able to provide informed consent
Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention

This research will explore the association between blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction (AMI) after primary percutaneous coronary intervention (PCI). The investigators aim to identify potential risk factors for microcirculation obstruction in AMI patients after PPCI.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. STEMI symptom onset time \< 12 hours;
3. STEMI symptom onset time 12-48 hours with persistent ischemic symptoms, hemodynamic instability, or life-threatening ventricular arrhythmias;
4. High-risk NSTEMI;
5. Emergency PCI;
6. Voluntary informed consent.

Exclusion Criteria:

1. Non-obstructive acute myocardial infarction;
2. Severe chronic kidney disease (defined as estimated glomerular filtration rate \< 20 mL/min per 1.73 m²);
3. Life expectancy \< 1 year;
4. Pregnant or planning to become pregnant;
5. Emergency PCI failure.
Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders

Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in comparison to a semi-structured interview administered by a trained interviewer.

The worldwide current gold standard for diagnosing headaches is the International Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has been problematic for accurately diagnosing patients in the clinic and as for clinical trials. To address these issues, an online instrument was developed that successfully diagnosis common primary and secondary headache disorders. In this research Investigator hopes to demonstrate an on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing different types of headaches (for example: episodic migraine vs. non episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs. non-episodic tension type, chronic tension-type headache vs. non chronic tension-type headache, medication overuse headache vs. non medication overuse headache, post traumatic headache vs. non post traumatic headache).

Participants will be screened by telephone to see if participants meet the criteria for taking part in this research study. Once participant is deemed eligible,the participants will then be randomized in a 1:1 ratio to complete either the semi-structured interview over the phone first and then complete the online questionnaire or vice versa. Study is expected to enroll 500 participants with headache and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects age between age 18-65(inclusive),
2. Subjects must agree to sign online informed consent;
3. Subject must be able to understand and willing to complete both evaluations in English
4. Willing to comply with study instructions.
5. Agree not to Rely or act on any diagnosis given to them in the study

Exclusion Criteria:

1. Presence of Disorders listed in groups 5-13 of The International Headache Society Classification of Head and Facial Pain (Headache Classification Committee of the International Headache Society, 2015 except for post traumatic headache and medication overuse headache);

1a. History of brain tumor, brain surgery

1b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis

1c. History of any significant current or previous brain dysfunction

1d. Regular use of illicit drugs.

2. Known significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.

3. Subjects with - significant cognitive impairment such as dementia, active psychiatric disease such as schizophrenia.

4. Subjects with physical limitations to participate in the on-line or phone interview impossible.

5. Non-English speaking patients