cyrilzakka/clinical-trials huggingface dataset:
Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis

Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.

The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Male patients,
* Patients between 45 and 75 years of age,
* Patients undergoing major esophageal or digestive carcinological surgery,
* Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).

Exclusion Criteria:

* patients under 45 and aged 76 and over,
* female patients,
* non-carcinological or minor surgery,
* non-esophageal or non-digestive surgery,
* Gram-positive bacterial or fungal infections in the absence of associated BGN,
* patients with hematological cancer,
* immunocompromised patients,
* septic surgery (surgical site infection),
* patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study,
* patients under guardianship or curatorship,
* patients not affiliated to a social security system or equivalent in France,
* patients deprived of their liberty.
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)


Eligibility Criteria:
Inclusion Criteria:

* Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
* Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
* Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
* Hoehn and Yahr stages I-III
* Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
* Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.

Exclusion Criteria

* Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
* Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
* Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation
Pentoxifylline and Lumbar Radiculopathy

The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy

Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral lumbar radiculopathy
* Disc hernia confirming the diagnosis with radio-clinical concordance

Exclusion Criteria:

* Radicular deficit needing surgery
* Cauda equine syndrome
* Absence of radio-clinical concordance on MRI
* Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer ...)
* Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
* Pregnancy
* Follow-up not possible
* Hepatic dysfunction
* History of drug abuse
* Current use of tramadol, codeine and/or morphine and its derivative
* Antidepressant use
Computer-aided Detection During Screening Colonoscopy (Experts)

Evaluation of the colonic mucosa with a high definition colonoscope (EPKi7010 video processor).

The endoscopy images will be seen on a 27inch, flat-panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned.

The number, location, and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare.

The same patient will be submitted to a second, the same session, computed aided real-time colonoscopy using the DISCOVERY, AI-assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.

Screening colonoscopy has decreased the incidence of colorectal carcinoma in the previous decades. However, there are reports of missed polyps and interval CRC following screening colonoscopy. Several factors may affect the ADR, PDR, and missed lesions rates, such as bowel preparation, percentage of mucosal surface evaluation, and the training levels of operators.

Artificial intelligence using deep-learning algorithms has been implemented in gastrointestinal endoscopy, mainly for the detection and diagnosis of GI tract lesions such as colonic polyps and adenomas. The implementation of automated polyp detection software during screening colonoscopy may prevent the missing of polyp and adenoma during screening colonoscopy. Therefore, improving the ADR and PDR during colonoscopies. All of this, with the aim of decrease the incidence of interval colorectal carcinoma (CRC), and CRC-related morbidity and mortality.

The Discovery Artificial Intelligence assisted polyp detector (Pentax Medical, Hoya Group) was recently launched for clinical practice. This AI software was trained with 120,000 files from approximately 300 clinical cases. The visual aided detection (bounding box locating a polyp on the monitor) will alert the endoscopist if a polyp/adenoma was missed during the standard, screening procedure.

To the best of our knowledge, this may be the first study evaluating the Discovery AI-assisted polyp detector on clinical practice in the western hemisphere. The investigators aim to evaluate the real-world effectiveness of AI-assisted colonoscopy in clinical practice. The investigators will also evaluate the role of endoscopists' levels of training in the ADR, PDR, and missed lesion rate.

Eligibility Criteria:
Inclusion Criteria:

* Provided informed written consent
* Age greater than 45 years of age
* Adequate Bowel preparation

Exclusion Criteria:

* History of inflammatory bowel disease, familial polyposis syndrome
* History of colorectal carcinoma, colorectal surgery
* History of uncontrolled coagulopathy
* History of previously failed attempt colonoscopy
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.

Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria:

* 1. Out-patients, 18 year and older.
* 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
* 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
* 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion Criteria:

Main exclusion criteria:

* 1. Patients at immediate risk for suicidal behavior
* 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
* 3. The duration of the current depressive episode is greater than 2 years
* 4. Patients whose current depressive episode is secondary to a general medical condition
* 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
* 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
* 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
Ixabepilone Administered as an Enteric Coated Formulation.

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.


Eligibility Criteria:
Inclusion Criteria:

* ECOG status of 0-2.

Exclusion Criteria:

* Unable to swallow pills.
* Current or recent GI disease or GI surgery.
* Brain mets.
* Severe nerve damage.
* ANC \<1,500/mm3
* Platelets \<125K.
* Bilirubin \>=1.5 times the IULN.
* ALT/AST \>=1.5 times the IULN.
* Creatine \>1.5 times the IULN.
* Prior treatment with Ixabepilone.
* Strong use of CYPP450 drugs.
Perioperative Mental Health in Orthopedic Surgery

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.


Eligibility Criteria:
Inclusion criteria:

* Adults ≥ 60 years
* Scheduled primary hip or primary knee arthroplasty procedure
* PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

Exclusion criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.
Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for \>4 hours

Exclusion Criteria:

* None
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are:

1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.
2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.
3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.

The study pursues a randomized control trial (RCT) with persons who use pre-exposure prophylaxis (PrEP) to determine the efficacy of SBIRT (Screening, Brief Intervention, \& Referral to Treatment) in reducing the risk of alcohol drinking and associated pathogenic changes in the gut liver axis.

Participants in this study will attend visits at 3 months, 6 months,s and 12 months for about 60 to 90 minutes. These visits may include filling out a survey, participating in an interview, meeting with an SBIRT interventionist, and providing the aforementioned samples: Blood, urine, stool, saliva, oral and vaginal, if applicable.

This study will use a syndemic approach to expand the HIV/AIDS prevention toolkit among populations impacted by alcohol with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition.

Specifically, the team will execute a randomized control trial among Pre-Exposure Prophylaxis (PrEP) users demonstrating heightened alcohol use to test the effectiveness of the Screening, Brief Intervention, \& Referral to Treatment (SBIRT) intervention to reduce alcohol use and examine the subsequent impact on the gut microbiome compared to individuals receiving treatment as usual and PrEP users not demonstrating elevated alcohol use. Finally, we will employ qualitative methods (in-depth interviews) and analysis to understand decision-making factors influencing PrEP adherence and alcohol use over time.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-85 years
* Confirmation of seronegative HIV, Hep B, and Hep C status
* PrEP users
* English-speaking or Spanish speaking
* Cognitively competent to provide consent
* Attend a participating healthcare facility

Exclusion Criteria:

* Inability to consent
* Existing diagnosis of major psychiatric illness
* Unstable medical conditions (e.g., cancer)
* Taking immunosuppressants or Chemotherapy
* Taking daily antibiotics or probiotics
* Severe gastrointestinal/liver disease
* Autoimmune disease
Physical Activity, Functional Fitness and Quality of Life After Coronary Artery Bypass Grafting

The main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this population. The investigators predict physical activity and physical fitness remain limited in patients after CABG, and patients with higher physical activity levels will have higher QOL and physical fitness.

Heart diseases continue as the top 3 causes of death in Taiwan in recent ten years. Coronary artery disease (CAD) is the most prevalent fatal heart disease. Coronary artery bypass graft surgery (CABG) is now one of the most common procedures to treat CAD. It was reported that CABG intervention could prolong the life. However, outcomes of CABG have historically been measured in terms of mortality and recurrence of symptoms or complications.There is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in QOL and function activity in patients post CABG. However, the participation rate of postoperative cardiac rehabilitation is low, especially in women.Little research has been done to examine the physical activity, physical performance, and QOL in this population outside the cardiac rehabilitation setting.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CABG without valve surgery

Exclusion Criteria:

1. systemic disease, such as liver, renal disease,
2. amputation,
3. cerebrovascular disease or any others disease with limbs dysfunction,
4. lung deficit,
5. cancer,
6. cognitive disorders.
Comparison of Two Kinds of Postoperative Analgesia After Amputation

Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.

Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of American Association of anesthetists（ASA）Grade 1 or 2
2. Aged between 18 and 65 years
3. Undergoing elective total knee replacement

Exclusion Criteria:

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired
Single Site Robotic Cholecystectomy in Non Selected Patients

This is a study of new technology to allow gallbladder removal through a single small surgical incision. A surgical robot is utilized to help navigate the small space. In this study, patient characteristics are broad to assess how applicable the procedure is to everyone.


Eligibility Criteria:
Inclusion Criteria:

* presence of symptomatic gallstones

Exclusion Criteria:

* significant previous open abdominal surgery
Metabolomic Study for Localized Prostate Cancer

Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Males who are older than 18 years old,
* with clinically localized prostate cancer
* are receiving radiation therapy

Exclusion Criteria:

* none
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.


Eligibility Criteria:
Inclusion criteria:

1. 18-65 years old
2. Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
3. Plasma HCV RNA ≥ 5 log10 IU/mL
4. HCV genotype 1

Exclusion criteria:

1. Received prior antiviral treatment for hepatitis C infection
2. Subject is pregnant or breastfeeding
3. Body Mass Index (BMI) \> 32
4. Currently abusing alcohol or illicit drugs
5. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
6. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)