cyrilzakka/clinical-trials huggingface dataset:
Stress Response in Opioid Use Disorder

Opioid use disorder is a major public health problem. Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes. People who have a strong emotional and physical response to stress are at a higher risk of relapse. The goal of this project is to test the effect of strategies to reduce response to stress in people diagnosed with opioid use disorder. Men and women diagnosed with opioid use disorder will be recruited for a one-session study. Participants will be randomly assigned to one of three brief instructional conditions followed by a brief laboratory stress test. Investigators hypothesize that, compared to education about stress, brief strategies to help people cope with negative emotions will reduce responses to stress and increase tolerance of stress. If this hypothesis is supported, it will inform the development of new treatments to improve outcome in opioid use disorder.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* primary diagnosis of opioid use disorder
* ability to read and provide informed consent

Exclusion Criteria:

* major psychiatric or medical condition that would interfere with the ability to complete study procedures
* current opioid withdrawal
* presence of another current substance use disorder at a severity requiring acute treatment
* endocrine disease or current steroid prescription
* opioid-positive urine drug screen or breath alcohol test on the data or enrollment (not including prescribed medications)
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
2. Adult males and females, 18 to 64 years of age (inclusive) at screening;
3. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Key Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.
The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment

This was a 24-month study to assess copper parameters in participants with Wilson disease (WD) treated with standard of care (SoC) medications.

After providing informed consent, participants meeting all inclusion and no exclusion criteria were enrolled into the study as outpatients. The participants' routine clinic visits were scheduled according to the standard clinical practice at the study center and at the discretion of the treating physician at approximate 6-month intervals.

At the time of enrollment, participants were receiving SoC medications for the treatment of WD, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc. If treatment was interrupted or stopped during the course of the study, participants continued in the study and biological samples and clinical data were continued to be collected for the full 24-month study period. Dosing with SoC agents was individualized and managed by the treating physician at the study center according to standard clinical practice at the site.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study.
* Male or female participants, aged 18 years or older as of signing the informed consent form.
* Receiving SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment.
* Able to understand and willing to comply with study procedures and requirements, as judged by the Investigator.
* Established diagnosis of WD.
* Adequate venous access to allow for collection of blood samples.

Exclusion Criteria:

* Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the collection or interpretation of study results.
* In the opinion of the Investigator, the participant was likely to be non-compliant or uncooperative during the study.
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

To investigate if Riociguat is effective in the treatment of systemic sclerosis


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 years and older
* Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
* dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
* Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
* ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
* FVC (forced vital capacity) ≥ 45% of predicted at screening
* DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening
* Negative serum pregnancy test in a woman of childbearing potential at the screening visit
* Women of childbearing potential must agree to use adequate contraception when sexually active. "Adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.

Exclusion Criteria:

* Limited cutaneous SSc (systemic sclerosis) at screening
* Major surgery (including joint surgery) within 8 weeks prior to screening
* Hepatic insufficiency classified as Child-Pugh C
* Patients with isolated AST or ALT \>3xULN or bilirubin \>2xULN can be included in the trial under the condition of additional monitoring during the trial
* Estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m\^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m\^2 will be undergo additional monitoring of renal function
* Any prior history of renal crisis
* Sitting SBP (systolic blood pressure) \< 95 mmHg at the screening visit
* Sitting heart rate \< 50 beats per minute (BPM) at the screening visit
* Left ventricular ejection fraction \< 40% prior to screening
* Any form of pulmonary hypertension as determined by right heart catheterization
* Pulmonary disease with FVC \< 45% of predicted or DLCO (hemoglobin-corrected) \< 40% of predicted at screening
* Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
* Not permitted prior and concomitant medication
* Pregnant or breast feeding women
* Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

The aim of this study is to evaluate influence of atorvastin on the repolarisation phase of cardiomyocytes. If there is any, it could be a part of positive "non-lipid" effect of statins in therapy of ischaemic heart disease.

Study hypothesis: atorvastin will decrease heterogeneity of repolarisation of cardiomyocytes in comparison with placebo

The group will consist of 40 healthy volunteers. The study will be mono-centric. The repolarisation phase of cardiomyocytes will be evaluated using long - term 12-lead digital ECG monitoring. There will be 3 single ECG recordings - randomly after 20 mg of atorvastin, 80 mg of atorvastatin and placebo, respectively.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age 18 - 45 years

Exclusion Criteria:

* no chronic active disease
* no concomitant pharmacotherapy, excluding hormonal contraception
* abnormal ECG, echocardiography, laboratory findings
* known hypersensitivity or myopathy due o statin
* pregnancy, lactation, breast implants
* skin disease
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization

The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term clinical outcomes of patients with critical limb ischemia (CLI).

A minimum of 50 CVA will be implanted in enrolled patients at up to 6 participating sites. The Study will include prospective evaluations on these patients at discharge, 1, 3, 6, 9, 12, 18 and 24 months following surgery. The window for follow-up visits is ± 2 weeks for each time point. All Study patients will be expected to participate in all follow-up evaluations unless precluded by patient death.

Patient status and graft performance data will be collected on all patients consented and enrolled into the Study. The primary endpoint of the Study will be limb salvage. The secondary endpoints of the Study will include primary patency, secondary patency, morbidity and mortality per the same reporting standards.

Patient attributes (age, gender, etc.) and preoperative assessments (indication for surgery, medical history) will be summarized using descriptive statistics. Graft performance will be presented as freedom from an event endpoint (patient death, graft complication, amputation, graft explant) as calculated by the Kaplan-Meier method. Log Rank and Cox Regression will be utilized for comparison between subgroups of the patient population. Statistical software will be used to compile and analyze all submitted clinical data.

The method of data reporting may include, but is not limited to, a description of the sample population, frequency distributions of patient demographics, allograft statistics, and follow-up percentages, summary of event data, correlation analysis, and actuarial analysis

Eligibility Criteria:
Inclusion Criteria:

* Patient is an acceptable candidate to receive primary open bypass on the limb receiving the CVA.
* CLI diagnosis of Rutherford Class 5 or 6.
* Tibio-peroneal trunk, Tibial or Peroneal outflow artery.
* Minimum of 1 patent run-off artery.
* Serum Creatinine \< 2.4 mg/dl.
* Life expectancy \> 2 years from consent.
* 18 years of age or older at the time of consent.
* Male or non-pregnant female.
* Ability to understand and provide written informed consent.
* Willing and able to attend and cooperate with the follow-up examinations.
* Able to follow Study required post-operative daily aspirin and/or other oral anticoagulation/antiplatelet regimen.

Exclusion Criteria:

* Patient currently receiving hemodialysis for end stage renal disease.
* Known hypercoaguable state.
* Known heparin allergy.
* Patients with any condition which, in the opinion of the investigator could preclude evaluation of response or completion of follow-up or affect patient safety.
* Currently being treated with an investigational device or drug (within 3 months prior to surgery).
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
* Male or females between ages of 18 to 75 years

Exclusion Criteria:

* Score below 10/12 on the Evaluation to Sign Consent (ESC)
Experiment Among Smokers in Which Two Variables Are Manipulated: Ostracism and Concealability

The goal of this experimental study is to learn about the effects of ostracism and concealment among adult smokers. The main aims are:

1. Determine the causal consequences of gendered stigmatization. Specifically, do women react more strongly than men to exclusion (as opposed to inclusion) especially when their gender is revealed (as opposed to concealed) for outcomes such as smoking stigma, stress, cognitive depletion, smoking attitudes, and smoking cessation intentions (Study 3)?
2. Examine the moderating roles of cultural context. Specifically, contrasting the cultural context in the US and Denmark (where gender norms are more egalitarian) do Danish smokers show fewer gender differences than US smokers in how they describe and react to their smoking stigmatization experiences (Study 1, 2, and 3)?

The proposed studies examine cross-culturally the reasons why among smokers, women feel more stigmatized than men do. An experiment with US and Danish smokers will examine how men and women differ in their reactions to being stigmatized (using a standard exclusion manipulation) when their gender is revealed instead of concealed. The outcome measures will include stress, smoking stigma, cognitive depletion, smoking attitudes, and smoking cessation intentions.

Eligibility Criteria:
Inclusion Criteria:

* daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
* speak English reside in the United States
Mental Stress and Bowel Preparation Quality

The goal of this cross-sectional study was to explore the relationship between physical and psychological stress and the quality of bowel preparation before a colonoscopy examination, in order to improve the quality of bowel preparation.

The main questions it aims to answer are:

Does physical and psychological stress affect the quality of colonoscopic bowel preparation, and delay disease detection? How can we improve the quality of colonoscopy？ Participants will be asked to complete a questionnaire containing their demographics, history of diseases and drugs, lifestyle habits, and physical and 14-item perceived stress scale(PSS-14). Quality of bowel preparation was assessed by the Boston bowel preparation scale（BPS）.

A total of 1000 patients who were to undergo colonoscopy at the Endoscopy Centre of the Department of Gastroenterology, Renji Hospital, from May 2023 to August 2023 were collected, and the general information and the physical and mental stress test scale of the patients were collected by questionnaires from random samples, and they were screened for enrolment according to the inclusion and exclusion criteria. The correlation between physical and mental stress and the quality of bowel preparation for colonoscopy was analyzed according to the Boston Rating Scale (BPS), which is used by colonoscopists to assess the quality of bowel preparation for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 75 years old with an indication for colonoscopy
* Participants signed an informed consent form for colonoscopy and underwent colonoscopy
* Participants not be with a history of digestive tumors, active inflammatory bowel disease and other conditions that significantly affect colonic motility
* Participants with good communication and comprehension skills and be able to answer assessment questions accurately

Exclusion Criteria:

* Withdrawal prior to colonoscopy
* Incomplete completion of information
PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years and older
* Patient on mechanical ventilation for more than 48 hours
* Patient with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria
* French speaking patient

Exclusion Criteria:

* Tracheostomized patient at the time of inclusion
* Limitation of therapies before inclusion in the study
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his/her data for this research
Effect of Right Lateral Position on Ventilated Preterm Neonates

Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured.

Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured. Ventilatory settings were observed before and during the intervention and neonates were followed up for development of bronchopulmpnary dysplasia (BPD).

Eligibility Criteria:
Inclusion Criteria:

* A total of 60 preterm neonates \< 35 weeks gestational age were enrolled in the study, Inclusion criteria were tracheal intubated mechanically ventilated neonates for more than 72 hours, feeding \>30ml/kg/day via nasogastric tube.

Exclusion Criteria:

* Neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4, periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedatives were excluded.
Titanium vs. PEEK Fusion Devices in 1 Level TLIF

The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.

Transforaminal lumbar interbody fusion (TLIF) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. The choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. Two of the most commonly used interbody spacers are made of polyetheretherketone (PEEK) and titanium.1 While both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. Proponents of PEEK argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. However, PEEK is a hydrophobic material that does not integrate with bone. Titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.While there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. Given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients.

Eligibility Criteria:
Inclusion Criteria

1. Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment.
2. Patients between 18-70 years of age at the time of surgery.

Exclusion Criteria

1. Patients under 18 or over 70 years of age at the time of surgery.
2. Patients undergoing more than 1 level of surgery.
3. Patients who have had prior lumbar fusion.
4. Patients requiring surgery for the management of infection, tumor, or trauma.
5. Patients who are pregnant.