cyrilzakka/clinical-trials huggingface dataset:
WoundVac in Obese Patients Undergoing Lumbar Surgery

This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery.

Methods:

Study Design: Prospective open-label randomized clinical trial of CINPT in obese patients. Subjects will be randomized in a 1:1 to Standard of Care (SOC) and CINPT.

Study Arms: (1) Standard of Care (2) CINPT Sample Size: Based on 30% incidence of wound complications in obese patients undergoing lumbar spine surgery, a sample size of 124 (62 in each cohort) will be needed to detect a decreased incidence of 10% with an α of 0.05 and β of 0.2.

Randomization: Randomization will be done with varying blocks of 4, 6 and 8 using opaque sealed envelopes.

Procedures: All patients will receive standard pre operative prophylactic antibiotics with 2g - 3g Cefazolin or 1g Clindamycin (if patient has known penicillin allergy) based on weight 60 min before incision is made. They will be clipped if needed before being prepped. Each patient will be prepped with alcohol and then either duraprep, chloraprep, or betadine. After the procedure is complete, a subfascial and subcutaneous closed suction drain will be placed in the wound prior to closure. 1 to 3 gram of Vancomycin powder will be placed in the wound. The wound is closed with #1vicryl for the fascial layer followed by 2-0 Vicryl for the subcutaneous layer followed by 3-0 or 4-0 monocryl. In the SOC group, skin glue, Steri-strips, sterile gauze and Tegaderm will be applied to the wound. In the CINPT group, a CINPT dressing will be placed and attached to a compact portable negative pressure unit to deliver 125mmHg continuous pressure for 5 to 7 days. All patients will receive standard wound care instructions before hospital discharge. Patients will return to the clinic in 6±1 days for a wound check and removal of the CINPT.

Primary endpoint: The primary endpoint is the occurrence of a wound complication. A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥18 years old
* Patients undergoing posterior lumbar fusion with or without interbody fusion
* Body Mass Index of ≥35kg/m2
* Able to provide Informed Consent
* No prior lumbar spine surgery

Exclusion Criteria:

* Presence of skin infection or any systemic infection
* Known allergy or sensitivity to silver or acrylic adhesive
* Fragile peri-incisional skin
* Patients on anti-coagulation and/or platelet aggregation inhibitors
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Age 18 to 55 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. History of photosensitivity or recurrent rash.
5. Surgery of the gastrointestinal tract (except appendectomy)
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
7. History of relevant orthostatic hypotension, fainting spells or blackouts.
8. Chronic or relevant acute infections
9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
10. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
12. Smoker (more than 10 cigarettes)
13. Inability to refrain from smoking on trial days
14. Alcohol abuse (more than 30 g/day)
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of trial site
19. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
20. Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus
21. Vulnerable subjects (e.g. persons kept in detention)
Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study

The overarching goal for this project is to develop a service-learning program that provides students excellent hands on training and patients with an excellent service that advances their health and well-being. The aim of this study is to test the feasibility, acceptability and efficacy of an 8 week intervention on physical behaviors, cognitive function, and health outcomes compared to a control condition among sedentary, overweight and obese adults.

The overarching goal for this project is to develop and test a service-learning health promotion intervention that provides students hands on training and patients with a service that advances their health and well-being. Inactive but healthy community members and patients being treated at our local hospital will be recruited to participate. Interested volunteers will be randomized into one of two 8 week interventions. The control group will receive basic education information on physical activity, sedentary behavior, and sleep that is consistent with standard of care. These materials will be accessed via a health coaching software program called Healthie. The treatment group will receive the same education information plus health coaching and a Fitbit activity monitor to further support behavior change. Participants will be blinded to their group assignment. Major outcomes include physical activity, sedentary behavior, sleep, cognitive function, and several health outcomes. Success on whether or not the program is found to be feasible, acceptable, and effective.

Eligibility Criteria:
Inclusion Criteria:

* Physically inactive
* Overweight or obese
* Healthy enough to safely engage in regular physical activity

Exclusion Criteria:

* \<18 years or \>80 years
* Report achieving more than 75 minutes/week of moderate to vigorous intensity physical activity
* Underweight or normal weight (BMI \<25.0 mg/kg2)
* Do not intend on becoming more active in the next 3 months
* Not able to commit to a 8 week physical activity program
* No access to smartphone capable of sending and receiving text messages
* Self report mobility issues or diagnosed diseases that prevent safely engaging in regular physical activity
* Planned surgery in the next 12 weeks
* Pregnant
Effect of Cannabis on Cigarette Use Behavior

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of combustible cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on combustible tobacco use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy non-treatment seeking adults aged 21 or older
2. Report daily use of combustible tobacco cigarettes
3. Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a positive urine cotinine test at screening
4. Report current use of cannabis (at least 1 occasion per week)
5. Have experience with the inhalation route of administration for cannabis
6. Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.

Exclusion Criteria:

1. Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
3. Test positive for illicit drugs other than cannabis and tobacco
4. Positive breath alcohol test at study admission
5. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
6. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
7. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
8. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
9. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

Eligibility Criteria:
General and Angiographic Inclusion Criteria highlights:

* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 27 mm in length
* Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm

General and Angiographic Exclusion Criteria highlights:

* Within 7 days of index procedure platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; White Blood Cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or Transient Ischemic Attack (TIA) within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease
Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid.

Patients scheduled for trapeziectomy on the basis of thumb basal joint osteoarthritis will be asked to participate. Synovial fluid from the thumb basal joint is aspirated before the joint is opened. The trapezium bone and cartilage is harvested. Blood samples to evaluated lipid profile and glucose intolerance is drawn. Blood pressure and measurements of obesity is taken. Patients are also examined at baseline and 1 year postop with grip strength, pinch strength, range of thumb motion and asked to fill in patient-rated outcome measures; QuickDASH and NRS pain.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥ 25 years
* Radiologically confirmed and symptomatic thumb basal joint osteoarthritis (OA) planned for trapeziectomy

Exclusion Criteria:

* Previous surgery to the affected thumb basal joint
* Post-traumatic thumb basal joint OA
* Rheumatoid arthritis or other chronic inflammatory arthritis, history of psoriasis affecting joints, gout or pseudogout
* Ongoing infection in the hand or wrist
* Inability to co-operate with the follow-up protocol or to assimilate information about the study protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
* Systemic or intra-articular glucocorticoids or intraarticular platelet-rich plasma or hyaluronic acid injections in the affected joint within 3 months prior to enrollment
Large Overuse of Post-polypectomy Surveillance Colonoscopy

In colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking.

The aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.


Eligibility Criteria:
Inclusion Criteria:

* consecutive colonoscopy outpatients
* adults (18-80 yrs)

Exclusion Criteria:

* Subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features)
* Subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection)
* patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.
Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")

Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births in France. Studies have shown that milks enriched with protein allow to accelerate newborns growth. According to some papers, growth acceleration would have a favourable effect on psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to any benefit and even an early hyperproteinic feeding would have bad long term consequences such as appearance of several diseases in the future adult (overweight, diabetes, arterial hypertension, renal function alteration).The main objective of this clinical trial is to check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development at age of 2, compared with a milk containing same level of protein than milk proposed to newborns of normal weight. The secondary objectives of our clinical trial are to compare the effects of these two types of milk on renal function, arterial blood pressure, body composition, corpulence, food preferences, insulin resistance and intestinal integrity at age of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study will be undertaken only with neonates of Nantes Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with intra-uterine growth delay (with weight \< 10th centile)
* Aged \>34 weeks of amenorrhoea
* For neonates \>38 weeks of amenorrhoea, weight \< 2500g
* Mother's refusal of breast feeding
* Informed consent signed by the 2 parents
* Possibility to follow newborns until age of 2

Exclusion Criteria:

* Subject not fulfilling inclusion criteria
* Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)
Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematologic malignancies. Bacterial infections remain a common complication of allo-HSCT, especially in the pre-engraftment phase. Pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous HSCT but is considerably longer in allogeneic HSCT recipients who receive myeloablative conditioning regimens. This is a prospective, randomized, controlled, phase II/III clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-HSCT. All patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-HSCT, no active infection within 3 weeks before allo-HSCT, with a normal CT scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* aged above 14 years;
* diagnosis with hematological malignancies and be ready to undergo allo-HSCT;
* no active infection within 3 weeks before allo-HSCT;
* with a normal CT scan-chest before entering the transplantation cabin.

Exclusion Criteria:

* age \< 14 years;
* active and documented infection at admission;
* with a abnormal CT scan-chest before entering the transplantation cabin;
* with any conditions not suitable for the trial;
* unwilling to participate in the trial.
Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the safety and efficacy of transcatheter arterial embolization in patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA). Eligible participants will receive geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 24 months after GAE.


Eligibility Criteria:
Inclusion Criteria:

* Knee pain resistant to conservative treatment for at least 9 months post TKA performed for knee OA, and
* Moderate to severe knee pain: pain VAS ≥40 mm, and
* Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaires are validated in English.

Exclusion Criteria:

* Active systemic or local knee infection or;
* Active malignancy or;
* Life expectancy less than 6 months or;
* Prior ipsilateral knee arthroscopic surgery or repeat TKA (within 9 months of screening) or;
* Ipsilateral knee intra-articular injection in the last 3 months or;
* Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus or;
* Pregnant during the study period or;
* Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 on blood tests obtained within 30 days of procedure or;
* Body weight greater than 200 Kg or;
* Known history of severe contrast allergy to iodinated contrast resulting in anaphylaxis or;
* Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain) or;
* known avascular necrosis in the target knee or;
* Complications of TKA such as suspected or confirmed early loosening, ligamentous instability, reflex sympathetic dystrophy, polyethylene wear with or without particle disease (osteolysis), and large effusions (with or without hemarthrosis) or;
* Patient is enrolled in a different trial for treatment of knee pain post total knee arthroplasty (ipsilateral knee)
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Is hospitalized with congestive heart failure (CHF)
* Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

Exclusion Criteria:

* Has had a heart transplant
* Requires mechanical ventilation or mechanical circulatory support
Comparison of Two Radial Artery Segments Related to "Old-Fashioned" Radial and New Snuff Box Vessel Approach by US

The purpose of this study is to determine if there is a difference in the size and the depth of the radial artery at the access points for established radial and new distal radial approach for the arteries of both arms

Radial approach for coronary and peripheral procedures is now well established due to both patient and operator preference and carries a lower risk of bleeding and mortality. The most lasting consequence of transradial procedures remains radial artery occlusion, which is mainly influenced by the artery diameter and the size of the sheath. As a new, more distal approach looms on the horizon, it is plausible to determine factors that could impact its feasibility. Since the success rate for artery cannulation depends to a great extent on the size and the depth of the artery, the current study examines both parameters, as well as whether they are influenced by variables such as sex, body mass index, handedness, or comorbidities i.e. diabetes mellitus and hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old admitted to the Cardiology Department

Exclusion Criteria:

* Previous transradial procedures
* Arm AV fistula for dialysis access
* History of upper limb peripheral arterial disease
* Hemiparesis
* Hemodynamic instability