cyrilzakka/clinical-trials huggingface dataset:
The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection

The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. The primary objective is to measure the composite rate of postoperative complications within 30 days of inguinal lymph node dissection in patients with vulvar cancer.

The aim of the study is to investigate the impact of intrawound vancomycin powder on surgical site infections. The primary objective is to measure the composite rate of postoperative complications, including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days of inguinal lymph node dissection in women with vulvar cancer.

Secondary objectives include assessing the rate of seroma or lymphocele development within 30 days of surgery. Adverse events including allergic reactions (systemic or local hypersensitivity reactions) and antibiotic resistant infections (based on wound cultures) will be described.

The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery. The investigators will identify women who are planning to undergo inguinal lymph node dissection for vulvar cancer and after consented will be randomized to either receive intrawound vancomycin powder in the operating room or to not receive intrawound vancomycin powder. Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient).

Patients will be followed post operatively at their standard postoperative visits typically at 1-3 week intervals until adequate healing of their incisions. An electronic questionnaire will be administered to all patients at the postoperative visits between 3-6 weeks to assess recovery and complications. Outcomes will be collected until six weeks postoperatively. The study will be conducted at a single institution

Eligibility Criteria:
Inclusion Criteria:

* Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
* Women with a prior lymph node dissection \>30 days before
* Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection

Exclusion Criteria:

* Known allergy to vancomycin
* Known resistance to vancomycin
Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis

Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39 years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in patients at 40 years of age or more in matched sibling allo-SCT settings might significantly decrease the incidence of acute and chronic GVHD and the incidence of late effect after transplantation.

Prophylaxis for GVHD included CSA, MTX and MMF±ATG. In the trial group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment. The dosage was adjusted to maintain a trough blood level of 200-300ng/ml. MMF was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation. The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation. ATG (Thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1. In the control group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment. The dosage was adjusted to maintain a trough blood level of 200-300ng/ml. MMF was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation. The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Standard-risk of recipients with hematological malignancies (including AML-CR1, ALL-CR1, CML-CP, MDS-RA, RARS,RCMD,RAEB-1); age from 40 to 60; having HLA-matched sibling donor; Eastern Cooperative Oncology Group (ECOG)≤1, ejection fraction (EF)≥50%; bilirubin≤35µmol/L; AST, and ALT lower than or equall to two-fold baseline;creatinie≤130µmol/L.

Exclusion Criteria:

* Active, uncontrolled infection; severe allergy to ATG, including shock or laryngeal edema; secondary stem cell transplant recipient; haplidentical recipients; matched unrelated donor recipients; non-myeloablative condioning regimen recipients; EF\<50%; bilirubin\>35µmol/L; AST, and ALT higher than two-fold baseline; creatinie\>130µmol/L.
Suture Repair vs Mesh Repair for Incisional Hernia

The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.

The main question it aims to answer are:

• Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.

This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old.
* Anticipated hernia defect 2-6cm in width
* Non-emergent case
* CDC class I
* Patients who previously underwent primary ventral hernia repair without the use of mesh
* Incisional hernia

Exclusion Criteria:

* Emergent cases
* Patients \< 18 years old
* Patients who are pregnant
* Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.
* Ventral hernia \<2cm or \> 6 cm in width
* Primary hernia
* CDC wound class II-IV
Phase 3 Study of KHK7580

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
* Mean intact PTH level of \> 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

Exclusion Criteria:

* Treatment with cinacalcet hydrochloride within 2 weeks before screening;
* Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
* Severe heart disease;
* Severe hepatic dysfunction;
* Uncontrolled hypertension and/or diabetes;
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
* Primary hyperparathyroidism;
* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
Shanghai Beixinjing Diabetic Eyes Study

In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old;
* Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.

Exclusion Criteria:

* None;
The Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients

2.1. Study Objectives

* Primary Objective(s)
* Identify the incidence and risk of CDI within one year after kidney, liver, and/or pancreas transplant
* Secondary Objective(s)
* Identify the risk factors for recurrent CDI post-transplant in patients who were diagnosed with a CDI within one year prior to Solid Organ Transplant
* Evaluate the impact of CDI on graft survival following Solid Organ Transplant

* Single center, retrospective cohort chart review study design
* Data will be collected on all liver, kidney, pancreas and combined transplant recipients who received their graft(s) from April 1, 2015 to July 31, 2018
* Will analyze outcomes from April 1, 2014 to July 31, 2019
* Patient list will be generated in Epic and Meditech
* All data will be obtained from Epic and Meditech
* All data will be collected retrospectively after the patient is discharged from the hospital

Eligibility Criteria:
Inclusion Criteria:

* Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018
* Age \>18 years old

Exclusion Criteria:

* Age \<18 years old
* Loss to early death defined as within one week from transplantation
* Patients whose primary address is in Puerto Rico
New Strategies to Enhance Smoking Cessation

The study goal is to get feedback on ways researchers can communicate complex research findings on smoking cessation to better inform patients' decisions to use medication and/or quit smoking. This will help researchers and clinicians to provide effective, easy-to-implement treatments designed to address tobacco-related health disparities in Black and other racial/ethnic subgroups. It will also help improve health literacy to change misperceptions and mistrust on uptake of varenicline and other medication for quitting smoking. A professionally made video will explain research findings relevant for varenicline's mechanisms and outcomes relative to other treatment options.

There are 2 parts to this study:

* Part 1: Focus Group to help develop the educational tool intervention
* Part 2: Randomized portion of study. In this part of the study, participants will be randomized (like flip of coin) to take part in receive the experimental educational intervention or usual methods to help stop smoking. Participants in either arm can choose to receive varenicline and it will be provided as part of study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must smoke at least 10 cigarettes/day and do not currently use a smoking cessation medication.
* Ages 18-75.
* Agree to complete surveys and measures within study.
* Ability to understand English and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who are receiving any other smoking cessation medications.
* Patients who are pregnant and/or lactating.
* Patients with psychiatric contraindications that can prevent adherence to protocol or use of intervention tools in study. For inclusivity on trial, psychiatric contraindications and ability for patient to participate in trial will be assessed on an individual basis by study investigator.
* Patients who have a contraindication with varenicline.
TREM-1 Gene Polymorphisms

Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was explored that whether or not polymorphisms detected within the TREM-1 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.

Exclusion Criteria:

* (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (\< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)

Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and treatment of ocular disorders, including diabetic retinopathy, age-related macular degeneration and glaucoma.

Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size determination has been used extensively as a valuable research tool to examine blood flow dynamics in the human retina. However, no information on the velocity profile within the vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously to imaging retinal structure.

We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity profiles in human retinal vessels in vivo.

In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by comparison with retinal blood flow measurements using a commercially available LDV system and the Zeiss retinal vessel analyzer (RVA)


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropia equal or over 3 dpt
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.


Eligibility Criteria:
Inclusion Criteria:

* Pain-related fear (score \>40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
* Musculoskeletal, neuropathic limb or back pain, or headache
* Functional limitations (score \> 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).

Exclusion Criteria:

* Significant cognitive impairment (e.g., intellectual disability)
* Serious psychopathology (e.g., active suicidality).
* Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
* Systemic disease in active inflammatory state
* Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
* Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years of age
* Written informed consent
* Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
* Former desaturation under exercise defined as Spo2-decrease \>3%
* Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

* Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) \< 6.9 Kilopascal (kPa)
* Pregnancy
* Unability or contraindications to undergo the investigated intervention
* Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake

On 29 December 2020, an earthquake struck Petrinja in Croatia. The aim of this study is to assesses prevalence of symptoms of posttraumatic stress disorder, depression, anxiety, and panic disorder among exposed inhabitants and examine the effect of family therapy on mental health as part of a public health emergency response and rapid assessment.

The strong earthquake measuring 6.4 on the Richter scale hit the area of Petrinja town in Croatia on December 29 2020, causing numerous casualties and widespread material damage. The maximum felt intensity was estimated at VIII (Heavily damaging) to IX (Destructive) on the European macroseismic scale, and it is the worst earthquake in Croatia in the last 140 years. Since the initial strong earthquake, the Petrinja area has been hit by numerous aftershocks, magnitudes ranging from 1.2 to 4.8 on the Richter scale, increasing distress of residents and contributing to further damage of houses and buildings. The earthquake and the constant aftershocks caused strong psychological and physiological reactions in children and adults directly affected as well as a large population of people living in the surrounding areas at the time when Croatia was facing a second "lockdown" during the COVID-19 pandemic.

As part of a public health emergency response, we conducted a rapid assessment among survivors in the most severely affected area by the earthquake. Findings from previous researches among survivors of natural disasters have been mixed in prevalence of mental health problems and treatments outcomes. The aim of this study is to assesses prevalence of symptoms of posttraumatic stress disorder, depression, anxiety, and panic disorder among exposed inhabitants and examine the effect of systemic family therapy on mental health during the first year following the earthquake. Qualitative methodology will be used to augment quantitative findings. The study sample consisted of 350 individuals residing in the earthquake area. Participants were selected from total number of patients requested psychological and psychiatric help during first two months after disaster. A follow up study will be conducted at 6 and 12 months to assess the change in their mental health status.

Eligibility Criteria:
Inclusion Criteria:

* People were in the earthquake area while it occured

Exclusion Criteria:

* People were not in the earthquake area while it occured