cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch

The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.

Prospective, multicenter, multinational non-comparative study.

Primary Endpoint: Primary hernia recurrence\* rate at 24 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography.

Secondary Endpoints: Primary hernia recurrence\* rate at 1, 6 and 12 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography.

(\*Recurrence is defined as a clinically manifested bulge or a protrusion exacerbated by a Valsalva maneuver.)

Safety Parameters:

Deep and superficial infection (A Surgical Site Infection (SSI) will be defined in the study according to the Centers for Disease Control and Prevention (CDC) criteria for diagnosis of SSI).

Pain / Chronic pain Other post-operative complications (complications related to visceral adhesions, Ileus, seroma, hematoma...) Analgesics consumption Risk factors (severity and treatment) Efficacy Parameters: Recurrence of primary ventral hernia Operative time Time of the mesh positioning Length of Hospital Stay Ease of use (Mesh handling and manipulability, comfort of use ...) Return to daily activities/ work Patient satisfaction Patient comfort (Carolina's™ Comfort scale (CCS) - QoL questionnaire)

Visit Schedule:

Baseline visit (Preoperative) \& Operative/Discharge visit

Post-Op:

Phone call Day 10

1 month 6 months 12 months 24 months

Duration: 12 months recruitment and 24 months follow-up Up to 12 sites in Europe and the United States will be included in this study

Eligibility Criteria:
Inclusion Criteria:

* All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach
* Signed informed consent form by the patient or the legally authorized representative
* Intraoperative inclusion criteria :Size of the defect: ≤ 4 cm

Exclusion Criteria:

* Emergency procedure
* Current participation in other trials
* History of previous hernia at the same location.
* Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
* Patient \< 18 years
* BMI \> 35
* ASA score ≥ 4
* The investigator determined that the patient will not be able to comply with the required follow-up visits
Evaluation of EarlySense Home Care Tele-monitoring Device

The aims of the present study are to evaluate the information obtained by the EarlySenese monitoring system and examine correlation of the obtained data and clinical events.

The EarlySense Home Care System developed by EarlySense, Ltd., is a contact-less tele-monitoring system. The system is intended for continuous monitoring of patients' respiration rate, heart rate and patient's motion.

The system, which monitors the patient while in bed, consists of a piezoelectric sensor that produces an electrical signal in response to physiological stimulation, and a microprocessor control unit that analyzes the recorded signal and identifies respiratory and heart rates and patient motion, while patient is in bed,. In addition, the system indicates patient's in or out of bed status. The system also provides alerts if either of the physiological parameters cross predefined threshold settings (e.g., high/ low heart rate or respiratory rate, or motion or time in bed).

The system saves patient's parameters and then flags the patients, as those to have changes in their vital signs and motion, or those that do not have noteworthy changes during recent hours of monitoring. Flagging of the patients are based on changes detected in patients' baseline vital signs (heart and respiratory rates and patterns) and well as recognition of changes in patients motion and in and out of bed status in comparison to set thresholds.

The aim of this study is to evaluate relevance of the information (vital sign trends, alerts and flags) as provided by the EarlySense Home Care Tele-monitoring system to medical staff in Sheba Medical Center's Heart Rehabilitation Institute (Shelev) in order proactively monitor patients at home. The correlation between the EarlySense system alerts and flags to patient deterioration and hospital readmission will be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who resided in Shelev following a cardiac event (cardiac surgery, myocardial infarction, pacemaker implantation or other cardiac interventions )
2. Age ≥ 21 years
3. Any patient hosted in Shelev with geographically resident within 50 Km from Sheba Medical Center
4. Patients agrees to sign the consent form and able to comply with study protocol.
5. Sleeps on a mattress

Exclusion Criteria:

1. Planned readmission within 30 days of discharge from hospital
2. Discharge to hospice care.
3. Patients with cognitive disabilities
4. Patient's major treating hospital is not the Sheba Medical Center
MeDiGes Study: Metformine Use in Gestational Diabetes

Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.

Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.

The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.

Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.

Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years old.
2. Diagnosis of GD, with fasting glucose \<120 mg / dL.
3. not controlled by diet: fasting capillary blood glucose\> 95 mg / dl in at least 2-3 times or 1 hour postprandial \>140 mg / dl on, at least 2-3 times a week.
4. 2nd or 3rd trimesters of pregnancy.
5. Able to give informed consent.

Exclusion Criteria:

1. Psychopathological situations that do not guarantee proper adhesion to follow up
2. 1st trimester of pregnancy
3. gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
4. Patients who can not attend the scheduled consultation.
5. Language barrier limiting for understanding treatment settings
6. Twin pregnancy.
Exercise Prehabilitation for Locoregional Esophageal Cancer

The purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven locoregional esophageal cancer (LEC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in resistance training (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely
* Numeric pain rating scale of 7 or more out of 10
* Myopathic or rheumatologic disease that impacts physical function
Different Maxillary Sinus 3D Shapes Assessment Using CBCT Volumetric Segmentation

the study aims to assist the different 3D shapes of maxillary sinus in adult individuals among Egyptian population,The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and 3D volume will be assessed for each sinus.


Eligibility Criteria:
Inclusion Criteria:

* CBCT scans of adult Egyptian patients, males and females, with age range between 18 and 50 years old. Patients will be divided into two age groups (group 1 less than or equal 30 years old, group2 more than 30 years old).
* CBCT scans of patient without previous orthodontic treatment.
* CBCT scans without any other treatment that might interfere with the natural course of maxillomandibular growth and development.

Exclusion Criteria:

-Scans with maxillary pathologies like (tumors, odontogenic lesions, bone lesions).

* Patients with traumatic injuries or fractures affecting the maxillary sinus.
* Patients with missing upper premolar or molar teeth in one side or both sides.
* Patients with skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft.
* Images of low-resolution quality.
* Distortion of images or presence of any artifacts.
The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier

This study evaluates the impact of red meat and whole-grain intake on the colonic mucosal barrier and the dietary impact of these groups on the induced low-grade inflammation

The mucus layer in the colon is a continuous barrier separating the epithelial cells from faecal enzymes, bacteria, toxic and other components. The colonic mucus layer in patients with Crohn's Disease and Ulcerative Colitis was previously demonstrated to be thinner and more permeable compared to healthy subjects.

The colonic mucus is composed of glycoproteins held together trough unstable disulfide bridges. The digestion of red meat is associated with monosulfide production, which could bind to the disulfide molecules, make more stable trisulfide molecules, and thus destroy the mucus architecture. Moreover, different bacteria were previously linked to red meat intake and were associated with a degradation of the colonic mucus such as akkermansia muciniphila.

From the other side, the fermentation of the undigested fibres, primarily in whole-grains, is associated with the production of short-chain fatty acids, which was related to a local anti-inflammatory effect.

In this study, we hypothesise:

1. High consumption of red meat is associated with a thinner colonic mucus layer;
2. High consumption of whole-grain fibres is associated with a thicker colonic mucus layer;
3. Mucin-2 gene expression is different between patients with high red meat consumption vs low red meat consumption;
4. Mucin-2 gene expression is different between patients with high whole-grain consumption vs low whole-grain intake;
5. The level of inflammatory markers in blood "IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa is higher in subjects with high red meat and low whole-grain intake.

Eligibility Criteria:
Inclusion Criteria:

* Subjects referred to a colonoscopy in the Hospital of Southern Denmark
* Subjects able to read and understand Danish
* Mentally habile subjects
* Subjects who accept to be a part of the project

Exclusion Criteria:

* History of active cancer
* A recent colonoscopy (less than 3 months ago )
* Anamnesis of Inflammatory bowel diseases.
A Study of CP-4126 in Patients With Advanced Pancreatic Cancer

The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed advanced pancreatic cancer\*
* Not eligible for curative resection
* Performance Status (ECOG) 0-2
* Estimated life expectancy of at least 12 weeks
* Age ≥ 18 years
* Adequate haematological and biological functions:

  * Neutrophils ≥ 1.5 x 109/L
  * Platelets \> 100.0 x 109/L
  * Hb ≥ 10 g/dL
  * AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
  * AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
  * Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
  * Serum creatinine ≤ 1.5 times institutional ULN
* Signed informed consent

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Symptomatic brain metastases
* Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
* Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
* History of allergic reactions to gemcitabine or egg
* Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
* Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
* Pregnant or breastfeeding women
* Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
* Known positive status for HIV
* Any reason why, in the investigator's opinion, the patient should not participate in the study.
* Drug or alcohol abuse
* Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown. The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or without conscious sedation/analgesia.

Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to receive either placebo or midazolam (0.02 mg/kg) or 0.02 mg/kg midazolam combined with 1 mg/kg pethidine before the procedure.

Eligibility Criteria:
Inclusion Criteria:

* suspected liver disease
* known liver disease

Exclusion Criteria:

* liver transplants
* hepatocellular carcinoma
* hypersensitivity or allergy to benzodiazepines or morphinic derivatives
SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults

The goal of this randomized controlled trial is to investigate the effectiveness of a health-coaching intervention to improve physical activity in older adults with limited mobility when compared to a control, health education group.

A total of 290 older adults with limited mobility will be randomized to either a 26-week health coaching program or health education program. Outcomes will be assessed at baseline, 13-weeks, 26-weeks (end of intervention), and 52 week (6-month follow-up period).

Eligibility Criteria:
Inclusion Criteria:

* scored ≤ 9/12 on the SPPB
* are able to complete the 400-m walk in ≤ 15 minutes without sitting or physical assistance from another person or walker (use of cane is acceptable)
* scored 22/30 or higher on the Mini-Mental State Examination (MMSE)
* have no significant functional impairment as indicated by a score of 6/8 or higher on the Lawton and Brody Instrumental Activities of Daily Living Scale
* are able to safely engage in MVPA as indicated by the PAR-Q+ and by the family or study physician as necessary
* are community-dwelling
* are able to provide written informed consent.

Exclusion Criteria:

* are diagnosed with dementia or stroke
* self-report engaging in MVPA ≥ 10 minutes per week in the prior 3 months
* are unable to understand, speak, and read English proficiently
Ultrasound-Guided Versus Conventional Injection for Caudal Block

Caudal epidural block has been widely used, especially in pediatric surgery, to provide intraoperative and postoperative analgesia by affecting the region between T10 and S5 dermatomes in surgeries below the umbilical level.

In conventional single-shot caudal block, the needle is inserted through the skin with a 60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm, entering into the sacral canal.There is a risk of dural or vascular puncture when the needle is passing through sacral canal. Other complications are the soft tissue bulging, intraosseous injections and systemic toxicity.

Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore, the success rate of the classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%.

With the usage of ultrasonography in regional anesthesia, many advantages have been reported. Ultrasonography is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent within the epidural space. Therefore, this significantly increases the block success.

The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus injection and conventional sacral canal injection. Secondary objectives are; block performing time, number of needle puncture, success at first puncture and complication rate.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing phimosis and circumcision surgery

Exclusion Criteria:

* children with severe systemic disease
* previous neurological or spinal disorder,
* coagulation anomaly
* allergy against local anesthetics
* local infection at block site or
* with a history of premature birth
Educational Efficacy of VR vs. Simulator in Emergency Medical Training

It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.

In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.

After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish.

- The educational program was designed for participants to experience an emergency setting where a patient's oxygen saturation falls. The scenario starts with the decrease in the patient's oxygen saturation and the patient's condition could be changed according to the intern's management. The scenario includes various situations in which oxygen saturation could decrease, and the patient's condition changes depending on the expected responses of participants.

The scenario has been revised and supplemented through expert meetings.

* Experience two types of cases: an easy case where the patient's condition improves just by connecting an oxygen line, and a difficult case where the patient's condition does not improve even after connecting an oxygen line.
* A training program is prepared before the interns start work. The participants are divided into two groups (test group and control group). The test group wears an HMD (head-mounted display) and experiences both easy and difficult cases.
* The control group participates in simulation training using Sim-man, and the scenarios are the same for the test group (easy cases and difficult cases).
* Training on coping skills is provided through debriefing after VR and simulation.
* After completing the assigned program, participants can take the program that was not assigned to them if they wish.
* Both the test and control groups will fill out questionnaires before and after training to see changes in confidence and coping skills before and after training.

Eligibility Criteria:
Inclusion Criteria:

* the medical interns who participate in the education program for medical interns, who will work as interns at Seoul National University Hospital from March 2024
* participants who agree to the purpose of the study and consent to participation

Exclusion Criteria:

* who do not consent to participate in the study
DuoTrav® Eye Drops As Replacement Therapy Program

To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).


Eligibility Criteria:
Inclusion Criteria:

* Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction

Exclusion Criteria:

* None