cyrilzakka/clinical-trials huggingface dataset:
The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy

Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

Question the necessity of routine use of drain in Laparoscopic sleeve gastrectomy surgeon

Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* - Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during Laparoscopic sleeve gastrectomy and those who had previously undergone obesity surgery (revision surgery) were excluded
Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

Study is not recruiting and using secondary data sources only

Study is not recruiting and using secondary data sources only

Eligibility Criteria:
Study is not recruiting and using secondary data sources only
Endoscopic Submucosal Dissection Registry

The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.


Eligibility Criteria:
Inclusion Criteria: Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures:

1. Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification)
2. Flat depressed lesion \< 2cm in size (llc by Paris Classification)
3. Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound
4. Upon resection, the criteria for curative ESD include:

   * Non-invasive neoplasia of differentiated carcinoma
   * No lymphovascular invasion
   * Intramucosal cancer or minute submucosal cancer \<1 mm invasion (sm1)
   * Negative deep and lateral margins.

Exclusion Criteria:

1. Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures.
2. Patients who refuse or who are unable to consent.
3. Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
4. Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.
Study on Indomethacin-responsive Headaches

Description of modalities concerning the patient care of headaches sensible to indometacine.

Description of clinical profile, treatment of crisis and background treatment

Eligibility Criteria:
Inclusion Criteria:

* patient with a diagnosis of migraine with or without aura, or trigemino-autosomic headaches or other primary headaches
* patient who are taking indometacine
* patient with written consent form

Exclusion Criteria:

* patient under 18 years
* pregnant woman or breastfeeding patient
* patient who refuses to participate
Resistance Exercise in Healthy Men

In the present study, the effects of age and dietary intake will be assessed on myocellular characteristics during 72 hours after a resistance type exercise session.


Eligibility Criteria:
Inclusion Criteria:

* healthy men between the ages of 18-30 or 70-85 years

Exclusion Criteria:

* Subjects with a recent history or current state of cardiovascular disease, COPD, Parkinson, rheumatoid arthritis, musculoskeletal/orthopaedic disorders, renal disorder, cognitive impairment.
Sun Exposure of Outdoor Workers in Mayotte and Reunion Island

The UV index in Mayotte and Reunion is greater than 14, eight months out of twelve. This index decreases linearly over the period from mid-April to mid-August where it can drop to reach an index of 8 in July. The inhabitants are therefore exposed to a maximum intensity of UV radiation according to the World Health Organization (WHO).

The WHO recommends extreme precautions for indices greater than 11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a t-shirt, sunglasses, hat and sunscreen).

Sun exposure is a major risk factor in the development of skin cancer, basal cell cancer, squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the skin. Furthermore, it causes ocular complications such as the occurrence of cataracts and this without distinction of skin phenotype.

There is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion for adults, while many risky behaviors are observed both in the professional field and during leisure activities. In order to better understand risk-taking and choose appropriate awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices (KAP) of these populations in terms of risk of sun exposure and to measure the impact of solar prevention education actions.


Eligibility Criteria:
Inclusion Criteria:

* Live in Mayotte or Reunion island
* \> 18 years old
* Work outdoors \> 2 hours a day in one of the identified professions
* Belong to the list of targeted companies

Exclusion Criteria:

* Person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators
* Person not agreeing to participate
* No one speaking any of the following languages: English / French / Shimaore / Kibushi / Creole or Comorian
* Person who cannot be followed during the 6 months of the study
* Inability to answer the questionnaire
Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.

The aim of this study is to evaluate and compare the effectiveness of assisted sit-up exercise and swiss ball pikes on the treatment of pain and disability of postpartum low back pain. The current study will compare the use of assisted sit-up exercise and swiss ball pikes. The current study is novel in a way that there is limited literature about treating postpartum low back pain with physical strengthening exercises. These two methods will be employed to see if they improve ranges along with accompanying pain and disability.

This study will be a randomized clinical trial. Subjects with postpartum low back pain meeting the predetermined inclusion and exclusion criteria will divide into two groups. Pre-assessment will be done using the Numeric Pain Rating Scale \& Roland-Morris Questionnaire as subjective measurements. Subjects in one group will be treated with assisted sit-up exercise and the other will be treated with swiss ball pikes. Each subject will receive a total of 12 treatment sessions, with 2 treatment sessions per week. Post-treatment reading for numeric pain rating scale and Roland-Morris questionnaire will be recorded after the end of the 4th, 8th, and 12th treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 40 years.
* Back pain without leg pain for at least three months postpartum period.
* Pain intensity of numeric pain rating scale ranges between 6 to 10.
* Intensity of pain limited daily work activities.

Exclusion Criteria:

* Any kind of infection, malignancy, inflammation, and structural deformity present in the lumbar and pelvic region.
* Neurologic signs
* Trauma history of the lumbar and pelvic region
* Any lumber or abdominal surgery
* Pregnancy.
Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults

High blood pressure is the leading risk factor for heart disease and stroke. Approximately 12% of the population have a particular genetic factor (known as the TT genotype) which increases the risk of high blood pressure. Previous studies conducted at this centre have shown that taking the B-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the TT genotype. It is currently not known how riboflavin lowers blood pressure in those with the TT genotype but it could be as a result of altering blood levels of nitric oxide. Nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. However, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. Furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. Therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. It is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 60 years and below
* Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)

Exclusion Criteria:

* Consumer of B-vitamin supplements
* Consuming medication that interferes with B-vitamin metabolism
Multidisciplinary Management of HCC in Elderly Patients

Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).

Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).

Eligibility Criteria:
Inclusion Criteria:

* HCC patient
* eligible for surgery

Exclusion Criteria:

* non eligible for surgery at first HCC diagnosis
Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students

The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone.

The transition to college is associated with worsening mental health symptoms. This study tested whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone. Participants were 130 first-year students. The investigators randomly assigned 88 students to a mindfulness-plus-mood-monitoring or a mood-monitoring-only group and asked them to use an app 3 times a day for 3 weeks. They, along with an assessment-only control group (n=42), completed self-report questionnaires at baseline, post-intervention, and 6 and 12 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* enrolled first-year student at university

Exclusion Criteria:

* serious suicidal concerns
A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers

Individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. This study evaluates in 40 healthy and fasted participants whether the postprandial glucose response upon a standardized breakfast is dependent on gut microbial richness. Gastric emptying rate, intestinal transit time, insulin, appetite hormones and measures of the intestinal microbiome and fermentation will also be analyzed in the context of postprandial glucose metabolism.

Elevated blood glucose levels constitute a major risk factor for pre-diabetic and diabetic patients. Postprandial glucose tests have been used for decades to monitor and compare glucose responses. Yet, individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. A recent landmark study showed that the inter-individual variation of postprandial glucose responses was associated with multiple person-specific factors including faecal microbiome factors. Gut microbial richness has for a long time been considered a hallmark of gut health and stability. Furthermore, microbial richness has been associated with colonic transit time, which together with the gastric emptying rate appear to be major determinants of the initial glycaemic response to carbohydrate-containing meals. Therefore, the aim of the study is to investigate whether postprandial glucose responses are associated with gut microbial richness, as well as secondary measures including gastric emptying rate, intestinal transit time and gut microbial composition and fermentation.

In an acute-meal study, 40 healthy fasted participants will consume a standardized breakfast including one tablet of paracetamol (for estimating gastric emptying rate) and 300 mL of juice.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 27
* Willing to eat lentils, tomatoes, spaghetti, bread, butter, strawberry jam, and drink juice
* Known ability to tolerate paracetamol
* No current use of medication (oral contraceptive pill and mild antidepressants is allowed)
* Did not take antibiotics, diarrhoea inhibitors and laxatives in the 6 previous months
* Willing to collect and deliver a faecal sample on the intervention day
* Willing to eat corn and fill out a self-reported corn-intestinal transit time questionnaire
* Willing to consume a paracetamol tablet (500 mg paracetamol)

Exclusion Criteria:

* Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
* Pregnant or lactating women
* Suffering from irritable bowel disease (IBS), small intestine bacterial overgrowth (SIBO) or inflammatory bowel disease (IBD)
* Current chronic or infectious disease
* Current diagnosis of diabetes
* Blood donations within 3 months before participating in the current trial or participation in other scientific experiments
* Frequent intake of painkillers (paracetamol)
Safe Use of Medication At Home by Caregivers. Experimental Study

Experimental study to test the effectiveness of a psychoeducational intervention using virtual reality, aimed at caregivers of multi-pathological and polypharmacy persons to promote safer medication use at home. Experimental design with two groups (experimental and control), pre-post measures, and participants assignment to groups by simple randomization.

Null hypothesis. There will be no differences in the frequency of medication errors at home, the severity of the consequences of medication errors, perceived self-efficacy, and health literacy between caregivers using a dosing device (control group) and caregivers using a dosing device with the reinforcement of a psychoeducational intervention designed ad hoc (experimental group).

Background. Population aging is leading to an increase in the number of multi-pathological and polymedicated patients. These patients are at increased risk of suffering adverse events due to medication errors (ME), especially if Barthel≤55. The management of their medication places an added burden of stress on those who assume responsibility for their care. This task, due to the existing gender gap, falls more often on women.

Objective. To promote the safe use of medication in the home by those who assume the role of caregivers of these patients.

Method. Mixed research study. First: Nominal groups (N=128) and survey (N=1255) to design a psychoeducational intervention aimed at caregivers based on the identification of ME, its causes and consequences, and risk factors that contribute to ME. Second: Single-subject experimental design (two groups, experimental and control, with pre-post measures) to determine the effectiveness of the psycho-educational intervention (n=432).

Setting. Primary care centers and caregivers' associations and training schools in Alicante, Granada, Madrid, Pamplona, Seville, and Zaragoza.

Expected results. Identify critical elements for medication risk management in the home by caregivers. Low-cost psycho-educational intervention for safer use of medication adjusted to the possible different needs of male and female caregivers. The transfer of results will be mainly oriented to reinforce the action carried out by nursing and caregivers' training schools.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or less than 55).
* Residence in Alicante, Granada, Madrid, Pamplona, Seville, or Zaragoza (in the patient's home or the family member's home).
* At patient's charge for at least six months during the year.

Exclusion Criteria:

* Caregivers of patients who are institutionalized a minimum of 3 months per year.
* Caregivers with experience of more than six months in the use of medication dosing devices.
* Health education/profession.
* Filing of a property claim in the last 5 years.
Pharmacist-led Perioperative Medicines Optimisation

Patients attend pre-assessment clinics (POAC) who require an elective operation and who are having a general anaesthetic. At POAC patients are asked about their health, and past medical conditions to assess their fitness for anaesthetic, a list of medicines taken is documented. Patients can then be given a date for surgery. During their stay in hospital patients will see a pharmacist who confirms what medicines are being taken, and ensures those medicines are prescribed and available during the patients stay.

This study is aimed at improving the care of patients who are admitted for elective surgery. The study will review two different interventions made prior to a patient's admission for surgery. One will look at a group of patients taking a high risk medicine and the other a group of patients with a high risk disease. The high risk medicine chosen is warfarin, and the high risk disease is Parkinson's disease. It is known that inappropriate or lack of medicines management in these groups can result in delayed surgery, poorer surgical outcomes and can affect a patient's recovery after surgery. Due to patient numbers and the variability between patients being too great, and a lack of research in this area a controlled trial cannot be performed. This complex intervention will review the interventions made, to understand how and why the interventions change care and what it is specifically within the interventions that are exerting a positive effect to improve care. All elective surgical patients who attend POAC at St James' University Hospital who are either, taking warfarin or who have Parkinson's disease will be seen by a pharmacist. An accurate drug history will be taken and if changes are required to medications these will be resolved at the POAC appointment. Patients will be provided with an individualised perioperative medication plan.


Eligibility Criteria:
Inclusion Criteria:

* Participant has capacity.
* Participants must be attending the POAC at St James' University Hospital
* Scheduled elective surgery or other procedures requiring general anaesthesia
* Male or Female, aged 18 years or above.
* Diagnosed with Parkinson's Disease or taking warfarin
* In the Investigator's opinion, is able and willing to comply with all requirements of the intervention.

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the intervention.
* Under 17years of age
* Participants who are having a local anaesthetic
* Any who are having emergency surgery
* Participants who are unable to provide consent
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk or may influence the result, or the participant's ability to participate in the intervention.
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

Safety: To evaluate the incidence and type of adverse events and serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
* Is ≥ 22 and ≤ 65 years of age.
* Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.

Exclusion Criteria:

* Has an acute inflammatory process or active infection at the injection site.
* Has received mid- and/or lower-facial region treatments with any dermal fillers.
* Has received facial dermal therapies.
* Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.
Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.

Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.

The aim of this study is to investigate if specific biological markers can predict exercise capacity in advanced heart failure patients supported with continuous-flow left ventricular assist device patients.

Eligibility Criteria:
Inclusion Criteria:

* Stable CF-LVAD patients.

Exclusion Criteria:

* Unstable CF-LVAD patients.