cyrilzakka/clinical-trials huggingface dataset:
Predictors Associated With Maintaining Driving in Old Age

The goal of this observational study is to learn about predictors associated with maintaining driving in old age. The main questions it aims to answer are :

* which and how medical factors can influence stopping or maintaining driving (quantitative research)
* how social environment can influence stopping or maintaining driving (quantitative research)
* what are the needs of all the actors in the field (qualitative research)
* know about the opinions and practices of all the actors in the field (qualitative research) Participants will be ask to answer questions in an interview taking about an hour. Quantitative research will ask participants to fill out a questionnaire about social environment.

FAMACO is a project led by Gérontopôle Auvergne Rhône-Alpes (AURA) and Chaire Santé des Ainés of the Jean Monet University, supported by the Observatoire National Interministériel de la Sécurité Routière (ONISR), that aims prevent the loss of autonomy of the elderly population by identifying predictors associated with maintaining driving in old age. This is a mixed quantitative and qualitative prospective study.

Quantitative study identify medical factors linked to stopping driving by analysis data from "PROnostic of factors OF cardiovascular or neurovascular disease" (PROOF) cohort. In addition, a questionnaire on the social environment was addressed to participants.

Qualitative study focus on identifying the expectations and needs of all concern populations : elderly divers, elderly former drivers, general practitioner, geriatrician, certified driver's license physician, law enforcement, driving instructors and emergency services. This qualitative study will be carried out on three different sites : Saint-Etienne, Marseille, and Lille.

Eligibility Criteria:
Inclusion criteria :

* being part of one of the population studied (older 65 people ; attending physicians ; law enforcement ; certified driver's license ; physicians ; geriatricians ; driving instructors ; personal assistance services)
* live in Saint-Etienne, Marseille or Lille

Exclusion criteria :

None
Comparison of the Efficiency of Two Different Methods in Managing Early Postoperative Thirst

Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Although different methods have been applied in the management of thirst in the existing literature and positive results have been obtained, studies with high evidence value are very limited. The aim of this study was to compare the effectiveness of two different methods in thirst management.

In this study, the investigators compared the effectiveness of two of the methods proposed in the literature for the relief of postoperative thirst.

These methods are ice application and wet gauze. A numerical comparison scale was used to assess and monitor thirst (0=no thirst, 10=worst perceived thirst).

In patients with a thirst score of 4 and above in the early postoperative period, the duration of thirst severity and the method of quenching thirst with oral ice or wet gauze impregnation were compared. In addition, a control group without any intervention was included. The thirst conditions of these three groups were compared.

A total of 240 patients, 80 in each group, were included in the study. Oral ice was applied in one group, wet gauze in the second group and no intervention was applied in the third group.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* undergoing elective surgery
* Patients undergoing surgery other than gastrointestinal system surgery
* Patients in class I, II, III according to the American anesthesiologists' association classification (ASA)
* Patients who have completed a minimum of 6 hours of strict fasting and 3 hours of thirst
* Patients who can verbally express a thirst level of 4 points or more according to visual benchmark scale in the early postoperative period
* Patients who comply with the safety protocol in the early postoperative period
* Patients who can express their thirst in the early postoperative period/recovery unit
* Patients with a duration of surgical anesthesia ≥1 hour and taken to the recovery unit at the end of surgery will be included in the study.

Exclusion Criteria:

* Emergency planned surgeries
* Patients who had a second surgical intervention during the hospitalization period
* Patients who need intensive care after surgery
* Patients with problems in the extubation process after surgery
* Patients with altered state of consciousness after surgery
* Patients with fluid electrolyte imbalance (hypovolemia and sodium imbalance)
* Patients with swallowing difficulties and fluid intake restriction
* Foreign patients with language barriers
* Patients with menthol allergy
* Patients with problems in the head, neck, throat and mouth will be excluded from the sample.
* Women who have just given birth and are breastfeeding.
The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery

Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2) will be recorded in several steps in coronary artery bypass graft and valvular cardiac operations. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.

Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II elective coronary artery and valvular cardiac surgery patients. Intraoperative delta PCO2, lactate, ScVO2 will be recorded in several steps. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery, stable cardiac function

Exclusion Criteria:

* Clinical signs of heart failure, symptomatic cerebral or peripheral failure, uncontrolled diabetes mellitus
Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine

The purpose of this research study is to better understand how people respond to cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these chemicals as harmless agents while others suffer damage to their cells that can ultimately result in cancer. We hope to develop a better understanding of how we can identify the people who are in danger of getting cancer. Participants will complete questionnaires regarding their health and smoking history. We will take blood samples to look at genes which determine how the body breaks down some tobacco-related toxins. Participants will be given a small amount of liquid to drink, containing alcohol, water, and a compound called deuterated phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is non-toxic and does not cause cancer, but this compound is broken down by the body in the same way as cancer-causing agents. We will follow the pathway of this compound as it is broken down in the body.

Forty apparently healthy smokers and non smokers (20 male, 20 female) will be recruited by advertising in the Twin Cities area. This will be done by the Tobacco Use Research Center. They will be screened in a phone call, then invited to come in for an orientation session at which consent will be obtained. Pregnant smokers will be excluded. They will visit the clinic weekly for 2 months and once monthly for 4 months for a total of 6 months participation.

At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug \[D10\]phenanthrene. They will then collect their 24h urine and return it to the clinic. The urine will be analyzed for \[D10\]phenanthrene tetraol. The goal of the study is to determine the longitudinal stability of the amount of \[D10\]phenanthrene-tetraol in urine.

Eligibility Criteria:
Inclusion Criteria:

* smokers and non-smokers
* smoking at least 10 cigarettes daily for the past year (for smokers)
* in good physical health (no unstable medical condition)
* stable, good mental health (not currently, within past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

* subjects who have, within the past 6 months, experienced unstable or untreated psychiatric diagnoses, including substance abuse, as determined by the DSM-IV criteria.
* subjects using any other tobacco or nicotine products.
* female subjects who are pregnant or nursing.
* subjects with an unstable medical condition.
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men

The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented.

Up to this date, there was a lack of qualitative research on vaccine acceptability among men and theory-based interventions that promote HPV vaccination among men. A few studies have been conducted with parents and physicians regarding HPV vaccination with girls, and a few regarding women's awareness and acceptability. Results indicated increasing awareness of HPV, informing costs and benefits associated with the vaccine, and perceived susceptibility. Based on this information, it is crucial to obtain a further understanding of knowledge, awareness, and predictors related to HPV and its vaccination in men. Information obtained can be utilized in developing an intervention to increase intentions of taking the HPV vaccine. Refining results will lead to a standardization of an intervention that can be implemented across college campuses.

Eligibility Criteria:
Inclusion Criteria:

* Males
* English speaking
* 18-25 years
* Undergraduate or graduate student at the University of Cincinnati

Exclusion Criteria:

* Females
* Under 18 years, or above 25 years
* Non- English speaking individuals
* Non-university attending students
* If already received HPV vaccination
An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)

An open-label, single-arm, multicenter, Expanded Access Protocol \[EAP\] designed to provide treatment access to setmelanotide (3 mg, administered subcutaneously \[SC\], once daily) for eligible patients with BBS who have no alternative treatment options. All patients will continue to receive setmelanotide at the discretion of the Treating Physician and while they are deriving clinical benefit.

This is an open-label, multicenter, EAP, designed to provide treatment access to setmelanotide for eligible patients who have BBS and who have no alternative treatment options.

Patients will undergo clinical and safety assessments before setmelanotide initiation, and then at 3 monthly intervals - or more frequently if clinically indicated - following initiation of setmelanotide and until treatment is completed or discontinued. All patients must have a 4 week (30 day) follow up safety evaluation after treatment is stopped.

The end of the program is defined as the last expected evaluation of the last patient or the date of reimbursement and commercialization of setmelanotide in these indications, whichever comes first.

Eligibility Criteria:
Patients who have not taken part in any previous setmelanotide clinical trial must fulfill all of the following study's eligibility criteria:

Inclusion Criteria:

1. Clinical diagnosis of BBS
2. Males and females aged ≥6 years
3. Obesity (≥30 kg/m2) for patients ≥18 years old or weight \>97th percentile for age and sex on growth chart assessment for patients aged 6 to 17 years
4. Female participants of child-bearing potential must be confirmed as non-pregnant
5. Patients with significant neuropsychiatric disorders such as depression should be carefully evaluated regarding the benefit/risk ratio for the use of setmelanotide
6. Patients unable to enroll in another clinical trial with setmelanotide as determined by the treating physician

Exclusion Criteria:

1. Moderate to severe renal dysfunction defined as a glomerular filtration rate (GFR) \<60 mL/min/1.73m2
2. History or close family history (parents or siblings) of skin cancer (excluding non-invasive basal or squamous cell lesion) melanoma, or patient history of ocular cutaneous albinism
3. Inability to comply with a daily injection regimen

Patients who have taken part in any previous setmelanotide clinical trial, have met all of the study's eligibility criteria, and have shown meaningful clinical benefit, defined as at least a 5% reduction in body weight for patients aged ≥18 years or a 5% reduction in BMI in patients aged \<18 years from baseline through the end of the preceding study, will be eligible.
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population.

Hypotheses

H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen.

H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.


Eligibility Criteria:
Inclusion Criteria:

* Child must be scheduled to undergo tonsillectomy (with or without adenoidectomy).
* Child must be between the ages of 4 and 15 at the time of enrollment.
* Child and caregiver must be English-speaking.
* The same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency.

Exclusion Criteria:

* Child cannot self-assess pain due to conditions such as developmental delays, chromosomal abnormalities, and other syndromes.
* Child had significant adverse effects to codeine, tramadol, or acetaminophen in the past.
* Child has a known underlying seizure disorder (not febrile seizure).
* Child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase \[AST\]/amino alanine transferase \[ALT\], above normal value for age, respectively).
* Child or caregiver is not English-speaking.
* The same caregiver (e.g., mother) is unable to complete all follow-up assessments.
Biomarkers and Perfusion - Training-Induced Changes After Stroke

The purpose of this observational study is to examine the effects of 4-weeks of physical fitness training in patients with subacute ischemic stroke on cerebral imaging and blood-derived biomarkers.

This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled trial "Physical Fitness Training in Subacute Stroke" (PHYS-STROKE). In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4-weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4-weeks of relaxation sessions (5 times a week, for 50 minutes). A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and blood tests before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion and vessel size imaging. Blood tests will determine several parameters such as immunity, inflammation (including neopterin, MMP-9), metabolism (including ApoCIII, oxidized LDL, HOMA-index, uric acid, CK-MB, cystatin c, and leptin), cytokines (osteopontin, adiponectin), and endothelial function (SDF1-alpha, ADMA, sICAM, sVCAM, E-selectin, P-selectin). Additionally, we will assess the association between functional outcomes (co-primary outcome measures of PHYS-STROKE) and biomarkers including imaging results.

Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years
* Diagnosis of subacute ischemic stroke (within 5-45 days after stroke onset)as determined by initial MRI/CT scan of the brain
* Cortical, sub-cortical, or brainstem affection
* Barthel Index (BI) \<65 at inclusion
* Able to sit for at least 30 seconds (unsupported or supported, i.e., holding onto supports such as the edge of the bed)
* Ability to perform aerobic exercise, determined by by responsible physician
* Provision of written informed consent

Exclusion Criteria:

* Lacking ability to comply with study requirements
* Stroke due to intracranial haemorrhage
* Previous subarachnoid hemorrhage or other hemorrhagic stroke
* Progressive stroke
* Not able to receive magnetic resonance imaging scans, including perfusion imaging
* Unable to perform the required exercises due to medical, musculoskeletal, or neurological problems
* Required help of at least 1 person to walk before stroke due to neurological (e. g., advanced Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis) or non-neurological co-morbidities (e. g. heart failure, orthopaedic problems)
* Life expectancy \< 1 year as determined by responsible physician
* Drug or alcohol addiction within the last six months
* Significant current psychiatric illness defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
* Current participation in another interventional trial
Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2

The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.

Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patient
* Able to realize 4 couples Biopsy/MRI within 12 months after the transplant
* Mandatory enrolment in a social security plan
* Patient having signed an informed consent.

Exclusion Criteria:

* Contraindication to MRI: pacemaker, ferromagnetic foreign body, etc
* Impossibility to undergo MRI: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia
* Pregnancy
* Patients under a measure of legal protection
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
* \>=1 measurable lesion;
* ECOG performance status of \<=1.

Exclusion Criteria:

* prior systemic therapy for advanced or metastatic disease;
* adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
* other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* clinically significant cardiovascular disease in past 6 months.
A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different Products

Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to comply with the informed consent procedures
* Subject's wound is on the body or scalp
* Subject will be able to come to the clinic for suture removal on day 14

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject's wound was not closed with 4-0 nylon sutures
* Subject's wound is on the face
* Subject plans to apply other topicals to the area under study
* Subject's suture is removed before or after day 14