cyrilzakka/clinical-trials huggingface dataset:
Digital Nerve Injury - a Case Control Study

Case control study, investigating what hand function and sensory function do patients perform 3-10 years following digital nerve injury and repair. The aim is to investigate if hand function is more limited following digital nerve injury in the thumb, index- and little finger, compared to less unburdened sensory surfaces in the fingers. Secondary aim is to investigate the long term sensory function following digital nerve injury.

Eligible patients are individuals treated at the Department of Hand surgery in Stockholm, Sweden during 2012-2018. Inclusion criteria include diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29). Exclusion criteria are concomitant flexor tendon injury and/or skeletal injury, amputations, and severe soft tissue injuries. Patients residing outside the Stockholm region and children below 18 years of age are also excluded. Initially a total number of 1330 patients have been identified. All medical records have been thoroughly scrutinized. After excluding concomitant tendon injury, a total of 606 patients remained with isolated digital nerve injury. A randomly selected sample of participants have been assigned to two groups: Patients with an injury to the digital nerve of the thumb, digit II radial side, digit V ulnar side were assigned to the "case" group and matched "controls" were randomly selected among patients with an injury to the digital nerves of either the ulnar side of digit II, either nerve of digit III and digit IV or the radial nerve of digit V. Cases and controls have been matched according to sex, year of injury and patient age.

For the purpose of this study, a clinical evaluation to investigate hand function, sensory function, strength, and ability to discriminate warm and cold and sharp and dull will be conducted. Questionnaires are used for Patient Reported Outcome Measures (PROM): Disability of the Arm Shoulder, and Hand (QuickDASH), Patient questionnaire HQ8 arm and hand (HQ8), The Hospital Anxiety and Depression Scale (HADS), Saltin-Grimby Physical Activity Level Scale (SGPALS), and in addition Douleur Neuropathique en 4 Questions (DN4) for assessment of neuropathic pain will be performed. All outcomes will be compared between groups defined as case (digital injury to the thumb, radial nerve of the index finger or ulnar nerve of the little finger) or control (all other digital nerve injuries).

Eligibility Criteria:
Inclusion Criteria:

* diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29).
* treatment completed in Södersjukhuset hospital 2012 - 2018

Exclusion Criteria:

* concomitant skeletal injury,
* amputations
* severe soft tissue injuries
* microvascular reconstruction
* residence outside the Stockholm region
* patient age below 18 years of age
Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis

Pronase is a proteolytic enzyme known for its ability to clear mucus by breaking down its main component, mucin, through enzymatic hydrolysis. This property makes it useful in gastroscopy, where it is employed to improve the visibility of the mucosal surface during endoscopic examinations. Given the same mechanism, pronase may also be beneficial in enhancing mucosal clarity during colonoscopy. This multicenter, prospective, double-blind randomized controlled trial is designed to assess the effectiveness and safety of pronase in improving mucosal visibility in patients with colitis during endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with intestinal inflammation during colonoscopy, accompanied by mucus obscuring visualization, were included, particularly those with inflammatory bowel disease (IBD), regardless of the presence or absence of clinical symptoms such as abdominal pain, diarrhea, hematochezia, or mucoid stools.
* Researchers assessed the current health status of potential participants to ensure they could tolerate colonoscopy (based on physical examination and medical history).
* Age range was 18-75 years (inclusive).
* Participants provided written informed consent to participate voluntarily.

Exclusion Criteria:

* Participants with known hypersensitivity or allergy to the study medication.
* Participants with peritonitis, intestinal obstruction, severe intestinal infection, or radiation colitis.
* Participants who did not exhibit intestinal mucus obscuring endoscopic visualization during colonoscopy.
* Participants with severe cardiovascular, pulmonary, neurological, or renal disease, or those deemed unfit for colonoscopy.
* Participants who did not provide written informed consent or lacked the capacity to do so.
* Pregnant or breastfeeding women.
* Participants who had taken antiplatelet medications (e.g., aspirin, clopidogrel) or had abnormal coagulation function within 7 days prior to colonoscopy.
* Participants currently participating in other clinical observation trials or who had participated in another clinical trial within 60 days.
Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis

we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis.

Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy. However, data with respect to its effect on non-nephrotic primary glomerular diseases are lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis. This study was thereby conducted to investigate the potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with primary glomerular diseases.

Eligibility Criteria:
Inclusion Criteria:

* glomerular diseases with subnephrotic proteinuria

Exclusion Criteria:

* DM, hepatitis, systemic immunologic renal diseases
The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver surgery

Exclusion Criteria:

* ASA IV, Cardiovascular diseases
Glutamine and Intestinal Protein Metabolism

Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated.

Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male and female, aged between 18 and 50 years, negatives for HIV1, 2 and for HVC and HVB
* BMI between 20 and 24 kg/m²,
* giving their written informed consent
* no-smokers
* no allergic and digestive antecedents

Exclusion Criteria:

* smokers
* Allergic and digestive antecedents,
* pregnancy
Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty

The purpose of this study is to compare the efficacy of 75 mg of Pregabalin and 150 mg of Pregabalin in postoperative pain control after TKA.

After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At the day before surgery date, patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to 75 mg of Pregabalin and 150 mg of Pregabalin groups.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic primary knee osteoarthritis undergoing unilateral TKA
2. Aged between 55 and 80 years old
3. Comply with protocol

Exclusion Criteria:

1. Allergy to any of the medications in this protocol (Pregabalin, Morphine, Paracetamol, Celecoxib, Tramadol, Aspirin)
2. Secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic
3. Previous surgery on the knee
4. Contraindicated to spinal anesthesia (SB) or Adductor canal block (ACB)
5. GFR \< 30ml/min, Severe Liver Function (Child-Pugh C)
6. History of seizure or cerebrovascular diseases
Assessing the Feasibility of a Whole Health Coaching Intervention for Veterans With Chronic Multisymptom Illness

This study examines the impact of a clinical whole health coaching program aimed at improving Veteran's health and well-being by promoting engagement/adherence with clinical recommendations and increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.


Eligibility Criteria:
Inclusion Criteria:

•Veterans receiving a clinical evaluation at the War Related Illness and Injury Study Centers in Washington, DC or Palo Alto, California.

Exclusion Criteria:

* Current active suicidal or homicidal ideation
* Current or lifetime history of a psychiatric disorder with primary psychotic features
* Current or lifetime bipolar disorder
* Acute or unstable psychiatric condition(s) and/or chronic illnesses that would benefit from immediate referral for treatment
* Neurological disorders such as Alzheimer's disease, advanced Parkinson's disease, and unstable epilepsy
* Pregnancy
* Current exposure to trauma, or exposure to trauma in the past 3 months
* Current or within the past 30 days substance abuse or dependence (except nicotine)
* Excessive alcohol intake defined as an AUDIT score ≥ 4 for men and an AUDIT score ≥ 3 for women.
Home-based Kidney Care in Native Americans of New Mexico (HBKC) - Enhancement: COVID-19 Study

Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) OR COVID-19 related Addition: The aim of this addition activity is to track the impact of the COVID-19 epidemic on participants with diabetes and chronic kidney disease (CKD). Investigators have modified the original HBKC Study protocol to expand data currently collected from study participants to include data in the following domains linked to the COVID-19 epidemic:

symptoms of COVID-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).

Investigators will administer a survey by phone or mail to all participants screened for diabetes and chronic kidney disease in the original HBKC study protocol. The survey will address to the following aims:

Aim 1. Develop a phone-based and or mail based survey to understand the impact of COVID19 on patient-reported outcomes for adults with diabetes and CKD.

Aim 2. Test the feasibility and acceptability of this phone-based and or mail based survey in the HBKC cohort.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the phone-based and or mail based survey.

Exclusion Criteria:

* None
Optimalization of Nephroprotection Using N-Acetylcysteine

The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a standard renoprotective management at least in patients with nondiabetic proteinuric CKD. However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the progression of CKD completely. Innovative approaches are needed to keep patients with CKD off dialysis. Additional antioxidant (N-acetylcysteine) may prove to be such beneficial therapeutic concept. To shed more light on this issue, we performed a randomised open controlled study to evaluate the influence of triple N-acetylcysteine and RAAS therapy on surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and kidney fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease
* Stable proteinuria above 300 mg/24 hours (no variations above 25% in the last 6 months)
* Normal or slightly impaired stable renal function defined as serum creatinine level below 1.7 mg/dl (eGFR \> 45 ml/min)

Exclusion Criteria:

* Nephrotic syndrome
* Steroids or other immunosuppressive treatment minimum during six months before the study
* Diabetes mellitus
* Potassium serum level \> 5.1 mEq/L
* Albumin serum level \< 2.0mg/dL
* Creatinine serum level \>2 mg/dl
* Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
* Clinically significant valvular heart disease or second or third degree heart block without a pacemaker
* History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack
* History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention
* History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
* Pregnant or nursing women
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
* History of alcohol abuse
* NSAID abuse (more than 2 doses per week)
* Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors, AT-1 receptor blockers and N-acetylcysteine
The Effect of Acceptance and Commitment Therapy-Based Intervention

Mental health is essential for students' emotional, cognitive, and social well-being. University life presents significant academic, social, and financial challenges, leading to increased stress, anxiety, and depression. These psychological difficulties negatively impact students' academic performance, relationships, and overall quality of life. Despite these challenges, many students avoid seeking professional help.

Acceptance and Commitment Therapy (ACT) is an effective approach that enhances psychological resilience and helps individuals cope with stress, anxiety, and depression. Instead of changing negative thoughts, ACT fosters psychological flexibility, encouraging individuals to develop a healthier relationship with them. Research supports ACT's effectiveness in reducing psychological distress, improving emotional regulation, and enhancing life satisfaction


Eligibility Criteria:
Inclusion Criteria:

* ust be currently enrolled as a full-time student at a university.

Exclusion Criteria:

* Individuals with significant cognitive impairments or those unable to understand the study procedures.
T-Cat Laser & Cross-linking for Keratoconus

The purpose of this study is to determine whether excimer laser corneal surface ablation (T-Cat) can be safely combined with simultaneous corneal collagen cross-linking treatment to produce an improved and stable corneal profile in the treatment of keratoconus.

Theoretical framework:

Corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape with resultant visual distortion.

Excimer laser surface ablation can be used to re-shape the corneal profile. When the corneal shape is very irregular, corneal topography data gives the best information as to how to re-shape the cornea into a normal profile, and this Topography-Computer Assisted Treatment (T-Cat) will be used to modulate the surface corneal shape.

It is known that collagen cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to prevent progressive ectasia. Corneal collagen cross-linking with riboflavin has been shown to stabilize the cornea in keratoconus, and prevents progression of the disease. If cross-linking is performed at that moment that the cornea has been re-shaped by T-Cat treatment, it should help prevent the corneal thinning resultant from the laser treatment from destabilising the cornea and causing progressive ectasia.

Purpose:

To determine whether excimer laser corneal surface ablation (T-Cat) can be safely combined with simultaneous corneal collagen cross-linking treatment to produce an improved and stable corneal profile.

Design:

Prospective, interventional trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known keratoconus or pellucid marginal degeneration.

Exclusion Criteria:

* Age \< 18 years \> 50 years.
* Minimal corneal pachymetry in eye to be treated of \< 400μ.
* Evidence of other corneal disease in the eye to be treated (e.g. Herpes simplex keratitis).
* Women who are pregnant or nursing at the time of the initial treatment.
* Presence of significant central corneal opacity.
* Patients unwilling to not wear rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post-operatively.
Non-invasive, Real-time Anesthetic Drug-monitoring System

The aim of this study is to determine efficacy of the "CorrecDose" device to continuously and non-invasively follow the changes in propofol concentrations in the participants' blood.


Eligibility Criteria:
Inclusion Criteria:

* Women who have signed Informed consent form
* Women undergoing Trans vaginal ovum retrieval (TVOR) for invitro fertilization (IVF) and will be sedated with propofol administered intravenos (IV)

Exclusion Criteria:

* Women with background diseases
* Women with chronic use of drug and medication
* Women with peripheral blood vessels problems
* Women with high blood pressure
* Women with body mass index (BMI) score over 35 or less than 18
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC

The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.

In this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by HCC. Main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form
* Obstructive jaundice caused by unresectable hepatocellular carcinoma

Exclusion Criteria:

* Patients who have previously undergone surgical biliary drainage
* Patients who need to remain percutaneous transhepatic biliary drainage
* Patients whose life expectancy is less than 3 months (BCLC stage D without a treatment plan for hepatocellular carcinoma)
* Patients who cannot undergo endoscopic procedure according to the judgment of the researcher
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.

Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.

Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.

Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.

Eligibility Criteria:
Inclusion criteria:

* Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves
* Patients who are not previously on Ranolazine
* Do not have a history of arrhythmia and are not on any antiarrhythmic therapy
* Patients with QTc on a 12 lead EKG of less than or equal to 460 ms
* Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work
* Available at least 48 hours before surgery

Exclusion criteria:

* Patients who are not undergoing above surgeries
* Patients undergoing surgery for mitral valve replacement/repair
* Patient with cirrhosis
* Pregnant patients
* Patients with chronic atrial fibrillation
* Patients who had prior adverse drug reactions or allergies to Ranolazine
* Patients who are already taking Ranolazine prior to the study
* Patient who are reported HIV Positive (as there are antiretroviral drug interactions)
* Patients who are on drugs listed in Appendix A prior to the study