cyrilzakka/clinical-trials huggingface dataset:
Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis

This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection.

Exclusion Criteria:

* Patients expected to be on CRRT for \< 5 days,
* Patients with Child-Pugh C cirrhosis, and
* Patients who are pregnant.
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin

A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
* Hemoglobin A1c of 7-10% at screening.
* Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

* Compliant with study drug administration during the run-in period and throughout the trial.
* Patients with fasting triglycerides greater than 500 mg/dL at screening.
* History of certain diabetic complications or cardiac problems.
Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration

The purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered

Sick leave due to low back pain (LBP) is costly and compromises workforce productivity. Sick leave itself, fears and believes regarding return to work, and a low self-esteem have been identified as independent predictors of extended sick leave. Previous data suggested that multidisciplinary rehabilitation programs, including physical activities and psychobehavioral management, should decrease sick leave duration in chronic LBP. However these programs are heavy (at least 4 weeks long), and are often proposed to patients at the end of the management (over 6 months after the beginning of symptoms). Another approach could be to propose a shorter multidisciplinary program (for example 5 days long), earlier in the history of LBP to break the vicious circle as soon as possible. The target population could be people suffering from subacute LBP with sick leave duration between 4 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 18 to 60 years (included)
* Low back pain (or back and radicular pain with back pain the most painful)
* Sick leave between 4 and 24 weeks duration, without expected return to work
* A prior medical evaluation is made and the results will be communicated to the patient
* Patient giving his informed consent to participate in the study
* Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

* Cognition or behavioral disorders making it impossible to assess
* Inability to speak and write French
* Contra-indication to perform a short spa therapy
Probiotics and Examination-related Stress in Healthy Medical Students

Probiotics are live microorganisms exhibiting multiple properties beneficial to health. An increasing body of evidence indicates that probiotics may support healthy brain function and may relieve stress. Recent research in this area has examined lactic acid bacteria in detail, but little is known about the stress-relieving effects of Saccharomyces, a yeast with probiotic properties.

Psychological stress is a factor that allows people to successfully cope with various daily life situations. On the other hand, excessive stress may lead to bodily harm and decrease performance, e.g. academic achievements. Probiotics may help manage stress, but little is known whether probiotics improve performance under stress.

The aim of this trial is to examine whether the healthy medical students may demonstrate better performance in academic examinations when supplementing their diet with a yeast probiotic strain Saccharomyces boulardii (CNCM I-1079) or bacterial probiotic strain Lactobacillus rhamnosus GG (ATCC 53103). The secondary aim of the trial is to evaluate the potential effects of this supplementation on state anxiety as well as on biochemical and physiological stress markers.


Eligibility Criteria:
Inclusion Criteria:

* Being a third year medical student of the Faculty of Medicine or Faculty of Military Medicine, Medical University of Lodz

Exclusion Criteria:

* formal inability to sit the first attempt of the final examination of Basic Medical Pharmacology
* chronic diseases: neurological, psychiatric, cardiological, gastroenterological, immunological, endocrine or infectious
* state of immunosuppression
* history of hospitalization (\< 3 months before entrance to the study)
* presence of central venous catheter
* parenteral nutrition
* current pregnancy or intention to become pregnant within 3 months from the entrance to the study
* current lactation
* allergic reaction (\< 3 months before entrance to the study)
* hypersensitivity to yeast, maltodextrins, potato starch, magnesium stearate, hypromellose, gelatin, glycerol or titanium dioxide
* body mass index over 30
* chronic medication use (current or \< 3 months before entrance to the study)
* systemic antibacterial or antifungal medication use (current or \< 3 months before entrance to the study)
* overuse of alcohol or psychoactive substances (current or \< 3 months before entrance to the study)
* tobacco smoking - more than 5 cigarettes (or equivalents) a day (currently or \< 3 months before entrance to the study)
* pro- or prebiotic preparations intake (\< 3 months before entrance to the study)
* vegan or other atypical diet
* doing professional or extreme sports
Internet Mindfulness Meditation Intervention

Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase meditation practice as compared to another meditation program. The study will last six weeks for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will receive learning materials and guided meditations, but the implementation will be self-paced. Participants in the IMMI group will receive weekly learning sessions and be required to practice meditation every day. IMMI group participants will also receive a weekly reminder call from a member of the study staff and have access to technical support in the event of trouble with the online program. All subjects will complete online self-report questionnaires that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress at baseline and at the end of the six-week intervention. Subjects will also be given a questionnaire at the end of the study gauging their satisfaction with the mindfulness program they participated in.

Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to participants and demographic information about IMMI users. The study will be the same as noted above, but all subjects will be entered in the IMMI program.

Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing time or frequency of meditation sessions), and improve quality of life will be examined as well.

Participants will undergo the following: Week 0 - Telephone screening; Week 1 - Baseline Assessment; Week 2-Week 7 - Internet Mindfulness Meditation Intervention (or Access in Phase 1); Week 8 - Endpoint Assessment

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years old
* Access to Computer and Internet
* Can hear and understand instructions
* Willing to accept randomization scheme and agrees to follow the study protocol

Exclusion Criteria:

* Significant acute medical illness that would decrease likelihood of study completion (self-report)
* Significant, untreated depression, as assessed by CESD-5 \>20 during screening
* Current daily meditation practice (≥ 5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)
The Effect of Mindfulness Training on Postoperative Pain - a Solomon Four Group Design

The goal of this clinical trial is to learn if mindfulness education works to reduce pain after inguinal hernia operation in adults. The main questions it aims to answer are:

Does mindfulness education reduce the pain level after inguinal hernia operation? Does mindfulness education reduce the pain intrusion level after inguinal hernia operation? Does mindfulness education reduce the fear of pain level after inguinal hernia operation?

Participants will:

Pain level, pain intrusion and fear of pain levels will be determined 24 hours before surgery.

Awareness training will be given before surgery. Pain level, pain intrusion and fear of pain levels will be determined 24 hours after surgery.

Cognitive behavioral therapy and mindfulness-based therapies are successful practices in reducing anxiety and psychological distress (Ghielen et al. 2019). Mindfulness training includes teaching a range of meditation techniques as well as how to focus on the present moment in daily activities (Monshat, K., \&amp; Castle, D. J., 2012). Mindfulness training given to patients undergoing hip replacement surgery has been shown to reduce postoperative pain and improve their physical functioning (Dowsey et al., 2019). Similarly, it has been reported that mindfulness training given to patients who will undergo knee and hip replacement before surgery can prevent postoperative pain and opioid use (Hanley et al., 2021). In a study, mindfulness training used in the management of pain after lumbar disc herniation surgery was found to be useful in managing postoperative pain (Juneyoung et al., 2019). Aromatherapy with lavender oil was found to be effective in reducing pain after inguinal hernia surgery (Bagheri et al., 2020). This suggests that in addition to pharmacological pain management, non-pharmacological methods are also effective in pain management and can be used. In a meta-analysis evaluating the effectiveness of mindfulness-based interventions in acute pain, it was found that there was a lack of good quality evidence for the effectiveness of mindfulness-based interventions in reducing pain severity in clinical or experimental settings (Shires et al., 2020). It is stated that more rigorous large-scale studies conducted with pain populations are needed before cognitive behavioral therapies can be definitively recommended as first-line treatment for acute or chronic pain (McClintock et al., 2021). Therefore, our study was planned to determine the effect of preoperative awareness training on postoperative pain in patients undergoing inguinal hernia repair surgery.

Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in research
* planned inguinal hernia surgery with mash
* to be able to read and understand Turkish
* ASA I-III

Exclusion Criteria:

* bilateral or revision inguinal hernia surgery planned
* having a mental illness
* use of opioid-derived medication in the last month
* wanting to leave at any stage of the study
Telehealth-Filter Ventilation ( COMET2P1 )

The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette.

The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.

This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples.

Subjects (N=184; N=92 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial with one week of baseline; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes.

Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed.

Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers) will be collected remotely and dropped off at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

* Unstable health
* Unstable medications
* Pregnant or nursing
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis

This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.
Biological Collection of Neurocognitive Disorders

The development of biological biomarkers reflecting neuropathology has enhanced the diagnostic precision of Alzheimer's disease over the past decade, compared to the clinical diagnosis that suffers from low specificity. Patients undergoing evaluation in specialized memory clinics suspected of major or minor neurocognitive disorder are notably examined through a lumbar puncture to measure beta-amyloid 42, beta-amyloid 40, total tau, and phosphorylated tau in the cerebrospinal fluid (CSF). The purpose of this clinico-biological collection is to better characterize the existing biomarkers used in clinical practice, as well as the development of new diagnostic or prognostic biomarkers for neurodegenerative diseases causing neurocognitive disorder (Alzheimer's disease, Lewy body disease, frontotemporal lobar degeneration, in particular).

The primary objective is to gain a better understanding of conventional biomarkers and to develop new diagnostic and prognostic biomarkers for neurocognitive diseases: establishing a prospective clinico-biological collection of patients evaluated in clinical practice for a neurocognitive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Not under legal guardianship
* Clinical indication for blood and cerebrospinal fluid (CSF) biomarkers measurement during a day hospital stay for Alzheimer's disease (beta-amyloid peptide, tau protein).
* Signature of the research consent form.

Exclusion Criteria:

* Not affiliated with a social security scheme.
* Patient under State Medical Aid (AME).
Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?

Mitral regurgitation (MR) is a disease affecting the mitral valve that it causes a volumetric and pressure overload in the left chambers due to the leak of the unidirectionality normally guaranteed by the heart valve system.

The gold standard for severe mitral regurgitation is currently surgical mitral valve repair (PLM) using longitudinal median sternotomy to expose the heart Since the mid-1990s, the right mini-thoracotomy, ie a surgical access with cut in the 3rd or 4th intercostal space that would allow to reduce the size of the surgical site making it less traumatic and more aesthetic, addressing mainly a young target population.

Since the 2000s this method has spread more and more, expanding all over the world and spreading especially in the United States and Germany. This method has been progressively used in the treatment of the whole mitral valve surgery starting from valve repair up to prosthetic replacements.

Mitral valve repair through minimally invasive access in degenerative pathology has made it possible to obtain excellent long-term results, with low recurrence rates of regurgitation. In our center the results on the first 48 patients have been published in 2005 by Lapenna et al. Over the years this method has been adopted in thousands of patients worldwide, however the data present in the literature they stop at a follow-up of about 10 years. In 2017 De Bonis et al. of the San Raffaele Hospital have published the outcome of a particular subgroup of patients (bileaflet prolapse) treated with minimally invasive access, comparing them with as many subjects subjected to the same method of mitral repair ("edge-to-edge technique or Alfieri stitch"), obtaining superimposable long-term results (about 14 years old).

The goal of the present study is to analyze very long-lasting results in patients treated with mitral valve surgery with access in right mini-thoractotomy.


Eligibility Criteria:
Inclusion Criteria:

* patients with degenerative mitral regurgitation
* patients treated with mitral valve repair in right minithoracotomy

Exclusion Criteria:

* median sternotomy
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth

Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.

Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

Eligibility Criteria:
Inclusion Criteria:

1. Adult healthy patients , Male and female, Age range: 16-26 years.
2. Severe crowding ≤ 7 (Little's irregularity index)
3. Permanent occlusion.
4. Exist all the Mandibular teeth (except third molars).
5. Good oral and periodontal health:

   * Probing depth\<4 mm
   * No radiographic evidence of bone loss .
   * Gingival index≤ 1
   * Plaque index ≤ 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, ...)
2. Patients have anti indication for oral surgery ( medical - social - psycho)
3. Presence of primary teeth in the mandibular arch
4. Missing permanent mandibular teeth (except third molars).
5. Poor oral hygiene or Current periodontal disease:

   * Probing depth ≥ 4 mm
   * radiographic evidence of bone loss
   * Gingival index \> 1
   * Plaque index \> 1
6. Patient had previous orthodontic treatment
SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.

OBJECTIVES: I. Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia. II. Assess the toxicity of fenretinide in these patients.

OUTLINE: Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses. After 6 courses, patients receive a post-treatment biopsy. Patients exhibiting disease progression or unacceptable toxicities are removed from the study. Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 51 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven oral mucosal intraepithelial neoplasia Stage II: moderate dysplasia, keratosis with atypia Stage III: severe keratinizing or nonkeratinizing dysplasia No myelodysplastic syndrome No retinopathies

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: Prior surgical ablation of prior dysplastic sites allowed Other: At least 2 months since prior therapy toxicities Patient Characteristics-- Age: Not specified Performance Status: SWOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study