cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt

The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt

Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .

When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).

The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.

CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.

Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.

Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.

The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?

Eligibility Criteria:
Inclusion Criteria:

1. Both sexes will be included.
2. Age: all adult patients.
3. All diagnosed patients with operable cancer colon.
4. Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
5. Fit patients.

Exclusion Criteria:

1. Irresectable colon cancer.
2. Inoperable colon cancer.
3. Rectal cancer.
4. Unfit patients.
Intelligent Operating Room (InOR) for Orthopaedic Surgery

The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.


Eligibility Criteria:
* Inclusion Criteria:
* Adult patients 18-99 years.
* All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
* Exclusion Criteria:
* Patients/staff who are unwilling to participate in the study
* Patients/staff that withdraw from the study
* Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities,
* Single stage revision procedures with the need for special instruments and modified steps
* Patients with cognitive impairment/ special cognitive needs.
* \<18 years old
The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants

The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions.

This is a prospective (study following patients forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) observational study to examine the correlation between a sufficient blood concentration of itraconazole and disappearance of a fever (defeverscence) when itraconazole injection is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions. The recommended dose of the drug will be 200 milligram (mg), which will be administered intravenously, twice daily for 2 days (a total of 4 doses) and then 200 mg once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (which is equivalent to 20 ml) twice daily will be continued for a total of 14 days until clinically significant neutropenia is resolved.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis
* Female participants who are postmenopausal or received contraceptive operation or refrain from sexual relations and women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization) before participation and during the study
* Male participants who will not have a baby within 2 months after the completion of itraconazole therapy

Exclusion Criteria:

* Fever due to documented deep-seated fungal infection at the entry into the study, but documented candidemia will be included
* Participants with kidney function related abnormalities with calculated creatinine clearance of 30 milliliter per minute (mL/min) or lower
* Aminotransferase level 5 times or higher of normal limit and total bilirubin level 5 milliliter per deciliter (mL/dL) or higher due to hepatic dysfunction
* Participants with dementia (mental decline) related to head injury and hypoxic brain injury
* Participants with mental illness which may interfere with cooperation in treatment and monitoring condition of the clinical study
High-resolution Intra-operative PSMA PET-CT in Prostate Cancer

This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .

The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

1. Male patient, 18 years of age or older.
2. Patient is confirmed with high risk prostate cancer.
3. Patient is indicated to undergo radical prostatectomy and ePLND.
4. Patient is estimated compliant for study participation by the investigator.
5. Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria:

1. Patient has general or local contra-indications for radical prostatectomy.
2. Patient has active viral or fungal infection.
3. Patient previously received radiotherapy of the prostate.
4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.
Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation

It is an observational, descriptive, prospective, multicenter study of 8 maternity units in Lorraine and Champagne-Ardenne, aimed at comparing the percentage of "avoidable" maternal-fetal transfers (MFTs), defined as transfers in which the delivery finally meets the acceptance criteria of the sending maternity unit, according to the obstetrical indications for these MFTs.

Over the past year, an audit carried out on the Mercy maternity unit, covering 130 transfers to the Nancy regional maternity hospital, showed that patients transferred for threat of premature delivery (MAP) with a cervix \> 15 mm do not give birth at the receiving maternity unit, but return home after 48 hours' hospitalization.

When maternal-fetal transfer (MFT) is requested, numerous calls are made to private ambulance services, and in the end, many emergency rapid response units (SMUR) are called out, requiring a major human, logistical and time investment for a questionable benefit to the patient. Tensions in terms of logistics (lack of ambulance, SMUR) and human resources (lack of personnel) can, conversely, compromise good care of the parturient.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman cared for in a participating maternity unit
* Over 18 years of age
* Requested for maternal-fetal transfer (finally performed, or not)

Exclusion Criteria:

* missing data on transfer outcome
A Comparison of Chlorhexidine and Green Tea Mouthwash in Patients With Gingivitis and Their Salivary Neutrophil and TAC Levels

A Comparison of Chlorhexidine and Green Tea Mouthwash in Patients With Gingivitis and Their Salivary Neutrophil and TAC Levels.

This research was structured as a double-blind, randomized clinical trial to assess the effectiveness of CHX and green tea mouthwash on periodontal health in patients with gingivitis. 84 patients from the Department of Periodontics at Broujerd Dental School of the Islamic Azad University of Medical Sciences were chosen for the study. Before the commencement of the trial, various clinical periodontal parameters, such as plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level, were measured in six different areas of the tooth surface. Subsequently, scaling and root planning were carried out, and oral hygiene practices were enhanced for all participants. The participants were then randomly divided into three groups: Group A, CHX, and Group B, which was provided with Green tea mouthwash two times daily. After three months, the clinical periodontal parameters were reevaluated. Furthermore, to compare the total PMN and TAC levels in saliva before and after the administration of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods. The selection criteria for eligible participants in this study were also clearly defined.

Eligibility Criteria:
Inclusion Criteria:

a minimum of 20 natural teeth; a mean plaque index (PI) of at least 1.5, (10); a mean gingival index (GI) of at least 1.0 (Patients with a gingival index score of ≥1 at more than 60% of sites

Exclusion Criteria:

with systemic diseases, those who had undergone antibiotic therapy in the past three months, and anyone who had received periodontal treatment within the last six months. Participants diagnosed with aggressive periodontitis, individuals with known allergies to statin medications, and those currently undergoing statin treatment or using medications that may affect periodontal health were also not eligible. Furthermore, individuals who are immunocompromised, those who use tobacco products, and lactating or pregnant women were excluded from participation.
The HEADWIND Study - Part 4

To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns using machine learning classifiers.

Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are important prerequisites for safe driving.

Accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. Therefore, this study aims at evaluating a machine-learning based approach using in-vehicle data to detect hypoglycaemia during driving.

During controlled eu- and hypoglycaemia, participants with type 1 diabetes mellitus drive in a driving school car on a closed test-track while in-vehicle data is recorded. Based on this data, the investigators aim at building machine learning classifiers to detect hypoglycemia during driving.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Type 1 Diabetes mellitus as defined by WHO for at least 1 year or confirmed C-peptide negative (\<100pmol/l with concomitant blood glucose \>4 mmol/l)
* Age between 21-60 years
* HbA1c ≤ 9.0 %
* Functional insulin treatment with good knowledge of insulin self-management
* Passed driver's examination at least 3 years before study inclusion. Possession of a valid, definitive Swiss driver's license.
* Active driving in the last 6 months.

Exclusion Criteria:

* Contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor.
* Pregnancy or intention to become pregnant during the course of the study, lactating women or lack of safe contraception
* Other clinically significant concomitant disease states as judged by the investigator
* Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Renal failure
* Hepatic dysfunction
* Coronary heart disease
* Other cardiovascular disease
* Epilepsy
* 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
* Participation in another study with an investigational drug within the 30 days preceding and during the present study
* Total daily insulin dose \>2 IU/kg/day
* Specific concomitant therapy washout requirements prior to and/or during study participation
* Current treatment with drugs known to interfere with metabolism or driving performance
Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.

Background:

Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

Scope:

In patients with diarrhea.

Methods:

Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.

Procedure:

The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to fluorescein, acriflavin or cresyl violet
* Residing in institutions (e.g. prison)
Osteoarthritis Bedside Testing Kit

Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis

Conduct a Focus group of subjects with painful osteoarthritis of the knee to evaluate potential kit for acceptability to subjects and investigators, and usability, clarity of instructions, appropriateness of the data capture, simplicity, subject and investigator burden, and overall impressions of the procedures.

Conduct a reliability and usability study with subjects with painful osteoarthritis of the knee to determine Intra-rater reliability, Inter-rater reliability, Kit reliability.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 50 years of age or older and has osteoarthritis of the knee.
* Subject is able to communicate meaningfully in English and comply with all study procedures.
* Subject is willing to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedures.
* Subject has experienced a minimum duration of pain of at least 6 months.
* For each of the last 15 days, pain level has remained at least a 3 on a Pain Intensity Numerical Rating (P-NRS) scale from 0 to 10; 0 means "no pain" and 10 means "worst pain imaginable".
* Subject is ambulatory.
* Subject has a primary diagnosis of osteoarthritis of the knee by medical history.
* Subject must be willing to abstain from any pain medicine for 12 hours prior to the study.

Exclusion Criteria:

* • Subject is pregnant and/or breast-feeding.

  * Subject has a medical condition, other than OA, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain and other symptoms of OA.
  * Subject is not able to hold a stylus or pen.
  * Subject is not able to read a computer screen.
  * Subject has any chronic pain syndrome (e.g., fibromyalgia) that, in the investigator's opinion, would interfere with the assessment of pain and/or other symptoms of OA.
  * In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results or pose patient risk.
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
* Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);

  * Normal renal function - greater than or equal to 90 mL/min
  * Mild renal impairment - 60 - 89 (mL/min)
  * Moderate renal impairment - 30 - 59 (mL/min)
  * Severe renal impairment - less than 30 (mL/min) not requiring dialysis
  * End-stage renal disease (ESRD) - Requiring dialysis treatment
* For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Exclusion Criteria:

* Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
* Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP).
* Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).
Acute Effect of Plyometric Exercises on Musculotendinous Properties

Preventive and rehabilitation programs include plyometric exercises to promote agility, power, and muscle activation pattern during jumping. These exercises also are known to cause a high mechanical load that increases the risk of a musculoskeletal injury. The knowledge regarding the musculoskeletal damage result from this configuration of exercise can help to elaborate safer and effective training and rehabilitation programs. In this study, the investigators will conduct a clinical trial to determine the acute effect of plyometric exercises on damage caused on different portions of quadriceps and biceps femoral's muscles and tendons of quadriceps, and biceps femoral, and its effects on mechanical properties.

This is a single-arm clinical trial aiming to determine the acute effect of one session of plyometric exercises on quadriceps and biceps femoral musculotendinous properties in healthy individuals.

The sample size was determined using G\*Power software considering the application of ANOVA: Repeated measures, between factors, 90% power, alpha 0.05. Data from muscle echo intensity of the rectus femoral by Muddle et al. (2019) were considered for this calculation, with an effect size 0.44. A total of 30 individuals was required for this study.

The outcomes will include the muscle and tendon quality, and mechanical properties of the tendon. The assessments will be performed at three different moments: before exercise, immediately after, and 48 hours after exercise.

The data analysis will be performed per protocol. Generalized estimating equations will be used to identify the effects of time followed by Bonferroni posthoc. When effects are found, effect sizes will be estimated. Missing data will be estimated by statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Who practice physical activity (except jump training);
* No previous lower extremity muscle injury at least 6 months before the recruitment;
* No previous lower extremity ligament or tendon injury or surgery;
* No auditory, vestibular, visual or musculoskeletal injuries or disease that limit the execution of the exercise and assessment protocols;
* No hypertension, cardiovascular, or respiratory disease.

Exclusion Criteria:

* Body mass index greater than 30 kg/m².