cyrilzakka/clinical-trials huggingface dataset:
Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation

In acute lower limb ischemia the main goal of the treatment is to restore the blood before irreversible damage to the soft tissues of the limb. Delays in identifying acute lower limb ischemia may lead to limb loss or lead to the loss of the patient. Situations in which the patient is unable to express symptoms of the acute lower limb ischemia, such as during general anesthesia, in intensive care, or immediately after vascular surgery, are challenging for medical staff to identify. A reliable, easy-to-use and non-invasive monitoring method is not yet in every day use. The aim of this study is to demonstrate that Near InfraRed Spectroscopy (NIRS) monitoring is such a monitoring method.

Tourniquet induced ischemia is often used in hallux valgus surgery because it offers a bloodless view of the anatomical structures. In our study we will measure the soft tissue perfusion (rSO2) of the lower limbs during the whole operation. The sensors based on near-infrared spectroscopy will be located to the tibial surface and will record the normal state before the start of the tourniquet, during the tourniquet and also in the recovery phase.

The hypothesis is that rSO2 decreases linearly as a function of time from the beginning of the tourniquet induced ischemia and the recovery time depends on the duration of the tourniquet. In our study the patients will be operated under a spinal anesthesia. We also hypothesise that rSO2 increases due to the induction of the spinal anesthesia. Our goal is to define the percentual decline of rSO2 that is significant for lower limb ischemia and also its time response to induction of ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Patient understands the meaning of the study and related measures.
* Patient gives his or her written informed consent.
* A tourniquet is used.
* The procedure is performed under spinal anesthesia.
* Body mass index under 40.

Exclusion Criteria:

* Patient belongs to any of the following special groups: disabled people, minor, pregnant or breast feeding women, convicts, forensic psychiatric patients.
* Previous lower limb vascular surgery.
* Previous lower limb deep vein thrombosis.
* Previously performed tibial fasciotomies.
* Any another reason why the researcher considers that the patient is not suitable for the study.
Congenital Naevi of Lower Limb in the Child

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

Eligibility Criteria:
Inclusion criteria:

- Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria:

- More than one congenital nevi in the lower limb.
Protocols Development for Single Cells Genomics and Their Implementation for Molecular Diversity Between Cells

The investigators will extract single cells and analyze the molecular composition of single cells as well as bulks using the latest protocols for single cell and bulk genomics analyses including genetic, epigenetic, transcriptomic and proteomic analyses using the latest available protocols. A broad list of such example protocols are listed below.

The samples and their molecular characterization (including sequencing \& molecular levels) will serve as the basis for development of methods for single cells analysis. The developed methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single cells and share the same structure: the measured feature will be translated to a DNA library which will represent the feature by a dedicated assay.

This library alongside with proper mathematical analysis of the sequencing results will be performed in order to conclude the desired feature. The general structure of such protocols is described in our review paper (Single-cell sequencing-based technologies will revolutionize whole-organism science, E. Shapiro, T. Biezuner \& S.Linnarsson, Nature Reviews Genetics 14, 618-630, 2013) which is attached to our proposal.

In addition, the researchers will use sequencing based methods (existing and future developed) in order to compare single cells and bulks from different tissues and/or different time points from the same donor in order to measure genetic, epigenetic, transcriptomic, and proteomic diversity.


Eligibility Criteria:
Inclusion Criteria:

Adults

Exclusion Criteria:

* Non
Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk

We are inviting you to participate in a study of how people who have had genetic counseling for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of passing increased risk onto one's children. We would also like feedback from patients who have been to our clinic in the past on the best ways to talk about PGD and PND during genetic counseling sessions. We are seeking both the opinions of people who are interested in these technologies and those who are not. It does not matter whether you have heard of PGD or PND before - you can still participate. Your past experience with genetic counseling is valuable to us in deciding how to communicate this information during sessions.


Eligibility Criteria:
Inclusion Criteria:

* Females and males who are carriers of deleterious mutations in the genes BRCA1 or BRCA2.
* Over age 18 and:

  1. For women, less than 43
  2. For men, less than 50.
* Received genetic testing and counseling for BRCA.
* Fluent in English.

Exclusion Criteria:

* Patients who are currently under treatment (chemotherapy, radiation)
* Individuals who refuse to discuss reproductive issues.
* Unable to give informed consent due to physical, cognitive, or psychiatric disability
Neuropsychological Testing Using Mobile Devices

The purpose of this studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any neurological impairment. After creating this baseline, later experiments can be proposed to compare the performance in normal subjects with those who have neurologic injury or disease.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients \> = 18 years of age
* Patient must be able to provide informed consent

Exclusion Criteria:

* Patients with score of \< 26 on Folstein Mini-Mental Status Exam
* Patients with known brain lesions
* Patients with history of stroke, neurologic disease or dementia
* Patients with acute illness or who are in imminent distress
inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion

The prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with ST-elevation acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* They include patients of both sexes, without limits of age, with a diagnosis of STEMI within 12 hours after the beginning of symptoms. ST-elevation myocardial infarction was defined in the presence of symptoms consistent, persistent elevation (\> 20 min) ST segment ≥ 1 mm in at least two contiguous leads or in the presence of left bundle branch block presumably new onset and cardiac troponin I elevation

Exclusion Criteria:

* Injury significant common core of left coronary artery (stenosis greater than or equal to 50% of the vessel lumen).
* Pre-Fibrinolysis percutaneous coronary intervention.
* Previous coronary bypass surgery.
* Thyrotoxicosis.
* Having an inflammatory systemic or local inflammatory process.
* Malignant neoplasm.
* Any disease that seriously compromise the prognosis and / or systemic inflammatory response generated.
* No thrombotic material obtained in the thrombus or insufficient for performing biochemical determinations.
Intraoperative Hyperspectral Imaging for Laparoscopic Surgery

The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.

The study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if HyperSnap Surgical System (HSS1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. In addition, we will see if it subjectively improves the identification of critical anatomical structures. In addition, the study will secondarily assess how StO2 information may be included in the surgical workflow and how surgeons may react to this additional information.

Eligibility Criteria:
Inclusion Criteria:

A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)

* Adult patients aged 18 years and over
* Common bile duct diameter \< 8mm as assessed using ultrasound
* Patients able to provide written informed consent

B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.

* Adult patients aged 18 years and over
* Patients who are scheduled for elective laparoscopic colon cancer resection
* Patients able to provide written informed consent

Exclusion Criteria:

A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)

* Patients under 18 years of age
* Patients with a history of previous abdominal surgery and multiply scarred abdomen
* Common bile duct diameter ≥ 8mm as assessed using ultrasound
* Patients unable to provide written informed consent
* Patients who are pregnant

B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.

* Patients under 18 years of age
* Patients with a history of previous abdominal surgery and multiply scarred abdomen
* Patients unable to provide written informed consent
* Patients undergoing emergency surgery
* Patients who are pregnant
Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms Trial

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.

A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-75
2. Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
8. Be able to speak and read the English language.

Exclusion Criteria:

1. Active use of narcotic pain medication
2. Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or \< 3 bowel movements per week)
3. Etiology of gastroparesis is post-surgical
4. Pregnancy or lactation
5. History of egg allergy
6. Prior surgical intervention of the stomach or gastric pylorus
7. Current parenteral nutrition
8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
Impact of Physiotherapy on Short-term Outcome After Meniscectomy

In this study we investigate whether physiotherapy offers added value in rehabilitation after meniscectomy compared with no therapy or a home program. The population consists of 180 post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients received no therapy, the next 60 patients were offered a treatment by their home physiotherapist according to our established protocol and the last 60 patients we have prepared a home program .

The physiotherapeutic treatment has been prepared based on scientific literature and own experience from the program at Ghent University and internships. It includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient. This schedule will be given to the patient along with the questionnaires at registration of the operation and will serve as a guideline for the physiotherapist for the rehabilitation of the patient after surgery. Monitoring of the evolution will take place by calling the physiotherapist on regular basis.

The home program is prepared on the basis of commonly used home exercises after arthroscopy and also includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling. The difference with the physiotherapeutic treatment is that there is no control and supervision of a physiotherapist and that the treatment is more limited. This program is given with the patient along with the questionnaires at registration of the operation.

Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an evaluation of the current condition of the patient will happen on the basis of standardized questionnaires. Based on the results of these questionnaires, collected at different times, we can determine which treatment provides the best rehabilitation after meniscectomy. The first (preoperative) questionnaire, given at registration of the operation, is completed and given to the nurse of the day hospital on the day of surgery, the other (postoperative) questionnaires are sent electronically to the patient's email address and need to be returned, after filling up.

This study spends specific attention to the speed of resumption of work / sports and daily activities and the presence or absence of complaints.


Eligibility Criteria:
Inclusion Criteria:

* Post-operative meniscectomy and surgery at Ghent University Hospital

Exclusion Criteria:
KU Alternate Meal Energy Level Study

Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.

The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.

Each intervention includes 3 months of weight loss and 3 months of weight maintenance.

Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)

Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21-65 years.
2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI \>35 may require more aggressive weight management strategies.
3. Clearance for participation from their PCP.

Exclusion Criteria:

1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
2. Participation in a regular exercise program (i.e., \> 500 kcal/wk. of planned activity as estimated by questionnaire \[34\].
3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire
4. Unwilling to be randomized to one of two diet strategies for weight loss.
5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater \[35\]. This score indicates the need for counseling outside the scope of this study.
8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
9. Medications known to significantly influence weight.
10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

Prospective monocentric study of patients with systemic sclerosis disease.

The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.

The secondary outcomes are:

* To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
* To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease


Eligibility Criteria:
Inclusion Criteria:

* Men and/or women
* With systemic sclerosis disease
* Patient willing to comply with all procedures of the study and its duration
* Social insured patients

Exclusion Criteria :

* Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis)
* Past history of sinonasal surgery
* Patient unable to receive informed information
* Refusal to sign the consent form
* Unwillingness or inability to follow the study procedures, in the opinion of the investigator
* Person deprived of the liberty
* Non-coverage by the social security insurance
* Person benefiting from a system of legal protection (guardianship...)
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants ≥6 months and ≤45 years of age at enrolment
2. Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
4. Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
5. Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.

Exclusion Criteria:

1. Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
2. Participants concomitantly enrolled or scheduled to be enrolled in another trial
3. Children and infants with a congenital abnormality
4. Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. History of uncontrolled coagulopathy or blood disorders
7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
8. History of alcohol or substance abuse
Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service

This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA) or psoriasis (Pso) according to the treating physician
* Adalimumab was started within 1 month prior to study enrollment
* Adalimumab was introduced based on current clinical practice criteria (i.e., the prescription of adalimumab was clearly separated from the decision to include the participants in this study)
* No prior record of adalimumab treatment
* Adalimumab was administered according to product label
* Naïve or previously experienced with biologic treatment
* Participant is able and willing to provide written authorization to disclose and use personal health information (informed consent), and to agree that data will be collected and provided to AbbVie

AbbVie Care 2.0 Cohort-specific inclusion criteria:

* Initiated the AbbVie care program within the first month after starting adalimumab.

Exclusion Criteria:

* Definitive discontinuation of adalimumab before being proposed to participate in the study
* Participated in any clinical experimental research within the 2 months prior to enrollment
* Pregnant or breastfeeding female participants
* Participant not able or not willing to comply with the requirements of this study protocol.