cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.

Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.

There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.

Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
* Locoregional anesthesia
* Age equal to or greater than 18 years
* Consent to participate in the study

Exclusion Criteria:

* Age under 18 years old
* General anesthesia
* Allergy to local anesthetics
* Severe kidney failure (Cr ≥ 2mg / dL)
* Chronic opioid use (over 3 months)
* Chronic pregabalin / gabapentin use (more than 3 months)
* Psychiatric illness that may interfere with the evaluation or follow-up
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
2. Are not candidates for a surgically curative procedure.
3. Have progressed despite, are intolerant of, or are not appropriate for current therapies.

Exclusion Criteria:

1. Have an active, uncontrolled infection.
2. Have known or suspected cerebral metastasis.
3. Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
5. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

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iFR Guided Coronary Artery Bypass Grafting Surgery

The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.

To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.

It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.

Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.

Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.

Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.

Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.

Eligibility Criteria:
INCLUSION CRITERIA

1. Age of 25 to 80 years of age
2. Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery
3. Undergoing isolated first-time elective CABG surgery
4. Available pre-operative angiography data with iFR measurements done during the pre-operative angiography

EXCLUSION CRITERIA

1. Emergency CABG surgery
2. Ejection Fraction≤ 40%
3. Severe valvular heart disease
Combined Package of Interventions for Environmental Enteropathy

Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.


Eligibility Criteria:
Inclusion Criteria:

* children residing in catchment area of Limela, Machinga District, Malawi
* aged 12-35 months
* youngest eligible child in each household

Exclusion Criteria:

* severe acute malnutrition
* severe chronic illness
* children unable to drink 20 mL of dual sugar solution
* children in need of acute medical treatment for illness or injury at time of enrollment
Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors

To validate the outcome measures and the tolerability of Kuvan treatment in the improvement of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without mental retardation.


Eligibility Criteria:
Inclusion Criteria:

* Biochemical confirmation of PKU,
* Measurable maladaptive behavior at baseline,
* Signed informed consent,
* Not pregnant or lactating,
* Females on birth control if applicable,
* Willing to comply.

Exclusion Criteria:

* Subjects or care provider unreliable, use of investigational products within 30 days prior to enrollment,
* Pregnant or lactating,
* Concurrent disease or condition that would interfere with study participation or safety, ie multiple psychotropic meds, any condition the PI renders the subject at high risk, on drugs that inhibit folate synthesis,
* Concurrent use of levodopa.
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.

This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C with HCV genotype 1 infection
* Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

Exclusion Criteria:

* Presence or history of non-HCV chronic liver disease
* Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
* Decompensated liver disease
Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The investigators try to observe the efficacy and safety of application of vedolizumab, anti-CD25 monoclonal antibody and rapid reduction of glucocorticoids in the treatment of grade 3-4 steroid-refractory aGVHD(SR-aGVHD) with lower gastrointestinal involvement.

Sample size: According to Simon optimal two-stage design, P0=60%, P1=80%, α=0.05, β=0.2, a sample size of 45 was chosen.

Objects: Adults ages 18-65 diagnosed with grade 3-4 SR-aGVHD with lower gastrointestinal involvement.

Design

Participants with grade 3-4 SR-aGVHD with lower gastrointestinal involvement(progression after 3 days or lack of improvement after 5 days of 1-2 mg/kg/d systemic steroids) receive combined therapy of vedolizumab and anti-CD25 monoclonal antibody, with methylprednisolone terminated in 7-10 days.

Vedolizumab is given 300mg, day 1/15/43, and then once every 8 weeks until gastrointestinal GVHD reaches grade 1 (1 episodes for minimum).

Basiliximab is given 20mg twice a week for week 1, and then once a week until GVHD of the participants reaches grade 2(3 episodes for minimum). If basiliximab is not available, it can be replaced by recombinant humanized anti-CD25 monoclonal antibody injection, 50mg once with the same frequency.

Methylprednisolone is reduced to 1mg/kg/d at day 1 and is aborted in 7-10 days. If chronic GVHD or overlap syndrome is considered later during treatment, steroids (ie. methylprednisolone 0.5mg/kg/d) can be administered again.

Intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range.

Best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion.

The investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. Then the investigators access the hematological disease status, aGVHD, cGVHD, infection state once a month.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids) with gastrointestinal involvement.
* Age 18-65.
* ECOG score≤3.
* Must be able to understand and willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Refractory/secondary graft-versus-host disease.
* Severe complications such as myocardial infarction, chronic cardiac insufficiency,
* hepatic failure, renal insufficiency, etc.
* Clinically uncontrolled active infections.
* Other Malignant tumors with progression.
* Heart failure: EF\<30%, NYHA≥grade III.
* Pregnant or lactating women.
* Expected survival \<60 days.
* Undergoing other drug clinical trials.
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

The following two dose levels will be tested sequentially:

* 4.1E11 total vg/cochlea
* 8.1E11 total vg/cochlea

Eligibility Criteria:
Criteria for Inclusion:

1. Participants may be of any age, based on Cohort Criteria
2. At least two mutations in the otoferlin gene
3. Clinical presentation of Profound bilateral sensorineural hearing loss as assessed by ABR
4. Preserved distortion product otoacoustic emissions (DPOAEs)
5. Able and willing to comply with all study requirements, including willingness to participate in a separate long term follow-up study after completion of this trial

Criteria for Exclusion:

1. Persistent ear infections, anatomic or other abnormalities of the ear, and/or medical conditions that would contraindicate undergoing surgery, anesthesia, and/or administration of investigational gene therapy
2. Bilateral cochlear implants
3. Prior participation in a clinical trial with an investigational drug, within six months prior to administration, or any prior participation in a gene therapy clinical trial
EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.


Eligibility Criteria:
Inclusion Criteria:

* consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.

Exclusion Criteria:

* severe cardiovascular diseases, liver and kidney dysfunction;
* platelet and coagulation dysfunction (PLT \< 50\*109/L, INR \> 2);
* cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
* cases unavailable for follow-up.
Neck Pain in Danish Military Pilots and Flight Crew

The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.


Eligibility Criteria:
Inclusion Criteria:

* Military fighter and helicopter pilots and crew
* Active flying 2006 or later

Exclusion Criteria:

* Pilots and crew not active since 2005 or earlier
* Pilots and crew with other nationality than Danish
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants

The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.

In this long-term follow-up study, participants who enrolled in SHP607-202 (NCT03253263) will be followed from 12 months corrected age (CA) through 60 months CA. Participants will not receive any investigational product in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were randomized into Study SHP607-202 (NCT03253263). Participants who were randomized, but did not complete Study SHP607-202 (NCT03253263) must be at least 12 months CA.
* Written informed consents (and assents, if applicable) must be signed and dated by the participant's parent(s)/legally authorized representative(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).

Exclusion Criteria:

- Participants are excluded from the study if the participant or participant's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.
Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

The purpose of this clinical trial is to assess the safety and efficacy of SDX-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by investigating a vibration pattern of SDX-3101 compared to a control

Chronic rhinosinusitis (CRS) is a common disease (e.g. 11% of adults in the UK report symptoms of CRS) leading to substantial health and socioeconomic burden with estimated healthcare costs in the USA of $772/patient/year (2011).

CRS is characterised by the long-term presence of multiple symptoms including facial pain/pressure in about 80% of CRS patients. Factors contributing to the pathophysiology of adult CRS include allergies, bacterial biofilms, asthma and exposure to various environmental pollutants. Computed tomography (CT) scans are often used to identify mucosal thickening and to identify any comorbid factors such as anatomic abnormalities.

It is known from the literature that low vibration frequency can improve blood flow, significantly reduce inflammation, and increase the fibroblast activity \[13\]. Therefore, SynDermix AG created the innovative high-technology, portable medical device SDX-3101 targeting a disease with high unmet medical need. The device offers a drug-free or eventually an add on treatment complying with the maximum demands of safety for the patients potentially avoiding undesirable drug effects or surgery. SDX-3101 is indicated for treatment of CRSsNP in adults

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female subjects between 18 and 70 years old
* Diagnosed history of chronic rhinosinusitis without nasal polyps (CRSsNP) defined as per EPOS Guidelines.
* Moderate to severe baseline SNOT-20 GAV score (\> 20)
* Willingness to stop nasal saline irrigation and drug therapy for CRSsNP (restart later on possible)

Exclusion Criteria:

* Subjects with local pathology that would compromise the ability to either administer the device or assess the benefits/risks (e.g. mucocele, antrochoanal polyp, facial trauma, radiation injury, or birth defect)
* Systemic corticosteroids if not stop for 14 days before study enrolment
* Subjects suffering from insufficiently controlled asthma
* Subjects suffering from insufficiently controlled allergic rhinitis (AR)
* Subjects with prior sinus operations within the last 4 months
* Subjects with known primary ciliary dyskinesia/cystic fibrosis
* Subjects with serious underlying medical condition
* Ongoing oncological treatments
* Known hypersensitivity to materials in direct contact with the skin
* Metal or metal-like implant (incl. ceramic) located in the head or neck area. Unremovable hearing aids
* Patients with implanted cardiac pace-maker
* Women who are pregnant or breast feeding
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Renal Tolerance of Amoxicillin and Cloxacillin Combination

2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.

The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
* Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice
Clinical Safety of a Novel Milk Protein Peptide

Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide positively influence blood markers, metabolism and improve quality of life.

The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with body mass index between 27-40.

Exclusion Criteria:

* have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;
* have milk allergies
Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.

This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=40
* Planning to have a trabeculectomy

Exclusion Criteria:

* Life threatening or debilitating disease
* Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
* Pseudophakic lens
* Contralateral eye already enrolled in study