cyrilzakka/clinical-trials huggingface dataset:
The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation

The purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. In clinical practice, dexamethasone is always diluted with glucose in many cases, but diluted dexamethasone in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dilution with glucose on dexamethasone induced perineal irritation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* ASA physical status I-II

Exclusion Criteria:

* On regular use of analgesic
* Contraindication or allergy to steroid or glucose
* Drug or alcohol abuse
* Diagnosed with paresthesia or mental diseases
* Communication disorders
* Pregnancy or nursing
Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.

The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Have been exposed to HIV, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs PEP
* that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails

Exclusion Criteria:

* pregnant women, lactating, or those intend become pregnant during the study period.
* subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study
* contraindicated treatment with the study drugs, or products under investigation
Association Between Telomere Length and Cardiac Dysfunction

Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.


Eligibility Criteria:
Inclusion Criteria:

* 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are either inpatients or outpatients
2. Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial
3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode" or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks
4. Patients with a HAM-D17 total score of 18 or more

Exclusion Criteria:

1. Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
2. Female patients who are pregnant, possibly pregnant, or breast feeding
3. Patients judged to be unable to tolerate any type of antidpressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date
4. Patients who have previously received electro-convulsive therapy
5. Patients who have participated in clinical studies on medical devices or other drugs within the past month
6. Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history
7. Patients with a history or a complication of diabetes
8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
10. Patients with a history of seizure disorder (epilepsy etc.)
Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis

The goal of this clinical study is to compare the dosing of an antibiotic in overweight patients having surgery. The main question\[s\] it aims to answer are:

* Are the antibiotic concentrations in blood and fat tissue in patients that are overweight sufficient to prevent the chance of infection?
* Can dosing using body composition rather than body weight improve the chance of achieving good antibiotic concentrations in overweight patients? Participants will allow us to collect small amounts of blood and fat tissue during their regularly scheduled surgery.

Researchers will compare differences in antibiotic concentrations based on dosing by standard of care (body weight based) versus body composition.

The risk of surgical site infections are higher in patients with obesity compared to non-obese adults. Our group has previously demonstrated that radiologic measures of abdominal subcutaneous fat are associated with surgical site infection risk in patients undergoing colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients. Therefore, we hypothesized that measures of abdominal size and composition in patients undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in this tissue compartment than the current standards of body weight and BMI. We confirmed this hypothesis and identified kidney function and body depth (by morphomics) to be predictive of cefazolin exposure in target tissue. Morphomics is a technology that transforms existing computed tomography data into body measures and composition. This study is a head-to-head comparison of this new proposed morphomic test regimen to the standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Accessible abdominal computed tomography scan prior to surgery
2. Adult patients \> 18 years of age
3. Body Mass Index ≥ 25 kg/m\^2
4. Expected to receive cefazolin prior to surgical incision
5. Estimated creatinine clearance ≥90 mL/min

Exclusion Criteria:

1. History of a hypersensitivity reaction to penicillin or cephalosporin
2. Pregnancy
The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants

In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.


Eligibility Criteria:
Inclusion Criteria:

* \<32 gestational week and/or \<1500 g birth weight

Exclusion Criteria:

* Major congenital anomalies, hemodynamic instability
Protective Effects of Normobaric Hyperoxia on Blood Brain Barrier in Patients With Acute Ischemic Stroke

The purpose of this study is to find out a serum marker for the evaluation of blood brain barrier damage based on animal experiments and investigate the effect of NBO（Normobaric hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA thrombolytic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female with age from 18 to 85;
2. Acute ischemic stroke;
3. National Institutes of Health Stroke Scale (NIHSS) score of 4-25
4. mRS score less than 1 before onset of stroke symptom;
5. Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy;
6. Informed consent obtained

Exclusion Criteria:

1. Stroke or serious head trauma within the previous 3 months
2. Major surgery or severe trauma with in the preceding 3 months
3. Intracranial hemorrhage
4. Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
5. Symptoms rapidly improving
6. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
8. Arterial puncture at a noncompressible site within the previous 7 days
9. Seizure at the onset of stroke
10. Platelet count of less than 100,000 per cubic millimeter
11. Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
12. Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
13. CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
14. severe hepatic or renal dysfunction
15. active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
16. \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)﹥95% as per current stroke management guidelines; 17 medically unstable;

18. inability to obtain informed consent. 19. Life expectancy\<1 years 20. Pregnant or breast-feeding women 21. Unwilling to be followed up or poor compliance for treatment 22. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.

Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

This pragmatic clinical trial will (1) assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program (IOP) and at a 6-month follow-up comparing service members and veterans (SM/Vs) with mild traumatic brain injury (mTBI) + substance use (SU) and a TBI -control group; and (2) assess SU-related outcomes at the end of IOP treatment and durability of SU outcomes at 6-months follow-up among SM/Vs with co-occurring SU. Analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders, will be used to refine and disseminate a scalable approach to treating individuals with mTBI and co-occurring SU.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* US military service member or veteran
* Diagnosis of mild traumatic brain injury (mTBI) and/or repetitive head impact/blast exposures
* Participating in the SHARE Military Initiative intensive outpatient program

Exclusion Criteria:

* History of brain injury other than mTBI or progressive neurological disorder
* Active psychosis
* Not able to provide consent
Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease

In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study. Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home. They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Aged between 18-35 years old
* Agree to provide blood samples
* Healthy adults who weigh at least 110 pounds
* Agree to devote 40 minutes daily to this study for a week

Exclusion Criteria:

* Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia)
* Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week
Resilience Reminders

The purpose of this study is to evaluate the feasibility and acceptability of the Resilience Reminders™ (RR™) program in managing psychological distress and resiliency in adolescent and young adult cancer survivors.

Study participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT check in within the app. Participants will also be asked to complete an online survey at the time of enrollment and at 4 and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 19-25 years of age
* Prior AYA cancer diagnosis
* Completed primary treatment for their cancer
* Score of 3 or above on the Distress Thermometer at the time of recruitment

Exclusion Criteria:

* Individuals without legal capacity to give consent
* Individuals who are not fluent in reading, writing, and speaking English
Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application

The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Adults (18+)
* Both elective and non-elective procedures
* Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
* Able to understand and read the English language
* Signed informed consent

Exclusion Criteria:

* Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
* Known allergies to chlorhexidine gluconate or isopropyl alcohol
* Multiple planned lower extremity surgeries
* Local skin disease
* Pre-existing or known infection at surgical site
* Open wounds or local abrasions
* Unable to or unwilling to follow through with study requirements
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes

This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
* Type 1 diabetes
* Time since diabetes diagnosed at least 5 years
* Followed for diabetes at consultation for at least 12 months

Exclusion Criteria:

* Patient previously included in this study
* Secondary diabetes
* Pregnant patient
* Patient consulting for an emergency
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
* Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
* Documented local or central assay-positive for tumor BRAF V600E/K mutation.
* Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
* Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
* Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.

Exclusion Criteria:

* Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
* More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
* Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.
Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients

This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
* Confirmed diagnosis of brain metastases or suspected brain metastases
* Iruplinalib is proposed for treatment
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
* Adequate organ and marrow function

Exclusion Criteria:

* Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
* The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
* The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
* Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes

The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.

The main questions it aims to answer are:

* Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?
* Do athletes with high sports specialization will sustain injury in one-year follow-up?
* Does sports specialization have a relationship with sports performance tests, and quality of life?
* Does sport specialisation, training volume, geographical factor relate to injury history?
* Does sports specialisation, injury history differ between sports (individual and team sports)?
* Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?

Recruited young healthy athletes (8-16 years-old) from sports schools, clubs, teams will invited to study. There will be performed assessment, which included:

* participant characteristics (age, biological age, gender, height, weight, body mass index, sports experience, training workload, sports specialization, history of injuries)
* sports performance (value of dynamic balance, isometric strength of lower limbs, functional movement patterns)
* quality of life and health assessment (EQ-5D-Y)
* geographical factor (Rural, Urban)
* Sports (Individual, Team)
* History of Injuries (Localization, Type)

One-year after meetings, there will be send questionaire and phone-call to participants and their coaches/parents in order to obtain information about injuries (location, type, time-loss, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Healthy (without injury, pain, or symptoms)
* Participation in sports activities (minimum 6 months)
* Age of 8 to 16 years-old
* Agreement to participation from parent/guardian

Exclusion Criteria:

* pain or other symptoms related during study
* lower extremity or trunk surgery in the last 6 months
* lack of medical approval for participation in sports games
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns

Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.


Eligibility Criteria:
Inclusion Criteria:

* inborn full-term neonate
* social security affiliation
* informed consent form signed by parents

Exclusion Criteria:

* prematurity \< 35GW
* gemellary pregnancy
* Birth weight \< 2200 g
* neonatal respiratory distress syndrome (nasal oxygenotherapy \> 24 hours, invasive or noninvasive ventilation)
* neonatal malformation with conséquences on lung function
* neonatal liver or renal failure
* high risk of heritable lung disease
* contra-indication to saccharose or paracetamol antalgic use
* language barrier,
* mother refusal to declare or precise her tobacco consumption
* no social security cover
* informed consent form not signed