cyrilzakka/clinical-trials huggingface dataset:
The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries

This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.

Exclusion Criteria:

* Duplicated data, subjects younger than 16, patients with previous abdominal surgery, and surgically complicated cases which were converted to open surgery were excluded.
The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock

The first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

Daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). In recent years, daptomycin plays an important role in the treatment of septic shock. The pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. Although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. So the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years and ≤75 years
* confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism

Exclusion Criteria:

* known hypersensitivity to daptomycin or product excipients
* documented or suspected pneumonia caused by a grampositive organism
* infection with a daptomycin-resistant organism
* presence or history of rhabdomyolysis
* signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus

Study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. The aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
2. Patients being treated with diet and exercise therapy only at the time of eligibility test However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
3. Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
4. Patients who have given written consent to participate in this study.

Exclusion Criteria:

When consent is obtained

1. Patients with type 1 diabetes mellitus
2. Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
3. Patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less
4. Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
5. Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
6. Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
7. Patients with severe obesity (BMI 35 kg/m\^2 or more)
8. Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
9. Excessive regular drinkers
10. Patients with a previous history of lactic acidosis
11. Patients with severe cachexia, diabetic coma or precoma
12. Patients with severe infections, surgical patients and those with serious injuries
13. Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
14. Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
15. Patients who are participating in a clinical study with other interventions
16. Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing
17. Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m\^2 or less including those undergoing dialysis
18. Patients with severe hepatic disorders (Child-Pugh classification Grade C)
Study on the Relationship Between Periodontitis and Renal Disease

Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.

A total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. Fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.

Eligibility Criteria:
Inclusion Criteria:

* all participants were in general good health(except renal disease) and non-smoking

Exclusion Criteria:

* less than 20 teeth in the dentin
* hypertension
* the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease)
* a history or the symptom of any other acute or chronic infections
* systemic antibiotic treatment within previous 4 weeks
* periodontal treatment within1 month
Discharge to Home and Chronic Illness Care Pilot

The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.


Eligibility Criteria:
Inclusion Criteria:

* parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
* the parent is English speaking (to date the tools being used have been validated for English participants only)
* parent is 18 years of age or older
* patient is 17 years of age and younger.

Exclusion Criteria:

* presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
* parent and child has experienced the discharge to home transition from a previous transplant.
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study \[RUS\]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
* Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures.
* Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study.

Other inclusion applies.

Exclusion Criteria:

* Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit).
* Fracture fixation by other means (eg, plate and screw fixation).
* Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated.

Other exclusion applies.
Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor \[GM-CSF\]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Patients were stratified by whether they had no measurable disease \[NMD\] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival \[death or disease progression\], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
* ECOG Performance status of 0-2
* Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
* Age \> 16 years
* Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
* Serum pregnancy test must be negative for women of childbearing potential.

Exclusion Criteria:

* Active central nervous system metastases
* Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
* Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
* Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine \< 2.0 mg/dl, bilirubin \< 2.0 mg/dl, albumin \> 3.0 mg/dl, hematocrit \> 25, platelets \> 100,000.
* Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.
Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units

Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact.

Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. pRBCs are prepared from donated whole blood and can be stored for up to 35 days.During storage, modifications of RBCs occur and affect product quality. Among other changes, these "storage lesions" induce microparticle (MP) formation. MPs are membrane particles measuring 0.1 to 1 µm produced by stimulated or apoptotic cells through modulation of membrane lipid organization and cytoskeleton reorganization. MPs can be produced from any cell type and express antigens characteristic of their original cell. Blood contains platelet-derived MPs (PMPs), which are the most frequent; RBC (erythrocyte)-derived MPs (ERMPs), representing 4% to 8% of total blood MPs; and, more rarely, MPs produced by endothelial cells and leukocyctes. In vivo, aging RBCs release ERMPs over their whole life cycle as a preventive effect of phagocytosis by macrophages. It seems that MPs quickly spread through the body, leading to a variety of biological effects by contact and interactions with many cells. MPs are well-known bioeffectors that mediate strong procoagulant potential, mainly because of phosphatidylserine and tissue factor expression. In this way, MPs are involved in coagulation disorders associated with atherothrombosis and cardiovascular diseases.Their ability to modulate inflammatory and immune responses is increasingly being studied as well as their capacity to carry and transport RNA, DNA, major histocompatibility complex molecules, and infectious agents. Moreover, depending on the type of stimulation that induces MP production, the size and biological functions of the MP can vary.

Eligibility Criteria:
Inclusion Criteria:

* Donors who met criteria of Egyptian National Transfusion Services.
* Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab and Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).

Exclusion Criteria:

* Donors who not met criteria of Egyptian National Transfusion Services.
* Reactive serology.
Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.

Eligibility Criteria:
Inclusion Criteria:

Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18

Exclusion Criteria:

* Patient unable for follow up
* Patients with corneal or retinal disease that affects visual outcome of surgery
* Patients with previous glaucoma procedure in the eye of study
Understanding the Increased Risk of Cardiovascular Disease in People With HIV

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. Previous studies indicate that episodic use of ART is associated with increased risk of cardiovascular disease (CVD). This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

HIV is a virus that can lead to AIDS, a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Using ART treatments, people with HIV have been able to delay HIV replication and immune system deterioration and to improve quality of life. Data from the Strategies for Management of Antiretroviral Therapy (SMART) study indicate that episodic use of ART is associated with a higher risk of CVD than is continuous use of ART. The reasons behind this increased risk of CVD in the presence of HIV are not well understood. This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

This ancillary study to SMART will use relevant data and specimens from three subsamples of SMART participants and key subgroups. The three subsamples include participants randomly assigned to episodic or continuous ART, participants who had no previous use of ART prior to study entry or had ceased ART within 6 months prior to study entry, and participants who had experienced a CVD event with two matched controls for each case. The subgroups will include episodic and continuous ART participants who were taking either a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) at study entry.

This current study will use previously collected SMART data. Researchers will use data on CD4+ count and HIV-RNA levels from a prebaseline study visit and follow-up study visits that occurred at Months 1 and 2, then every 2 months for Year 1, and every 4 months thereafter during the SMART study. In addition, this study will use baseline and yearly data provided by SMART participants on CVD risk factors and treatment, including use of drug treatments for high blood pressure, diabetes history, cholesterol levels, smoking history, white blood cell count, and height and weight measurements. Last, using plasma specimens that were collected at baseline, the Month 1 follow-up, and the final follow-up, researchers will compare changes in lipoprotein particle size and numbers, as measured by nuclear magnetic resonance (NMR) spectroscopy, and changes in inflammatory and coagulation markers.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the SMART study
* CD4+ lymphocyte count greater than 350 cells/mm3

Exclusion Criteria:

* Presence of life-threatening diseases
Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments

The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future.

The study drug is designed to reduce the activity of a protein known as "heat shock protein 90", or "Hsp90". Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.

This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.

Eligibility Criteria:
Inclusion Criteria:

* recurrent cancer refractory to available systemic therapy
* 18 years old or older
* predicted life expectancy equal or greater to 8 weeks
* at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
* Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
* adequate organ function based on hematological, liver, and renal function
* LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
* wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued

Exclusion Criteria:

* pregnant or breastfeeding
* received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
* symptoms of heart failure equal or greater to Class III (by NYHA criteria)
* impaired cardiac function or clinically significant cardiac diseases
* concurrent treatment with medications that either markedly induce or inhibit CYP3A4
* concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug
High Frequency Jet Ventilation Versus Conventional Positive Pressure Ventilation for EBUS

Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. In this retrospective study, complications of 2 types of ventilation will be analyzed:

* High frequency jet ventilation (HFJV)
* Conventional intermittent positive pressure ventilation (IPPV) Descriptive statistics will be used to present the data. Both ventilation techniques will be compared after propensity score matching. For HFJV patients from 2019 will be analyzed and for IPPV patients from 2023, as the team changed its practice over time.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent EBUS at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.

Exclusion Criteria:

* Incomplete medical chart
* Patients who expressed an opposition to the use of their medical data
* Age \< 18 years
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for resection with one or more of the following

  1. Any T stage with ≥ N2 disease;
  2. T4 disease, any N stage;
  3. T3 Oral Cavity, any N stage; or
  4. Clinical evidence of extra-capsular extension on scans.
* Must be willing to undergo definitive resection with neck dissection.
* Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
* Adequate labs
* Appropriate staging imaging.

Exclusion Criteria:

* Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
* Nasopharyngeal or sinonasal carcinoma
* Confirmed metastatic disease
* Human Papillomavirus (HPV)+ disease of the oropharynx
* Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C