cyrilzakka/clinical-trials huggingface dataset:
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

This multicentric, single blind study will enrol 160 women (18-75 years old) operated on tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 = polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine + polyamine-free diet (n = 40).

The amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer). Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months using adequate questionnaire ( analgesic scale). Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood.

Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared (isobolographic method). Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (T1, T2, T3, N0, N1, M0)
* Age : 18 - 75
* Asa 1-3
* left or right tumorectomy with complete lymphadenectomy
* left or right complete mastectomy with complete lymphadenectomy
* complete lymphadenectomy within one week following simple tumorectomy
* informed consent signed

Exclusion Criteria:

* inflammatory tumor requiring pre-operative radiotherapy
* previous history of total mastectomy or partial contralateral mastectomy
* chronic inflammatory disease treated by corticoids or NSAI
* chronic analgesic treatment
* anti-arrhythmic or anti-epileptic treatments
* morphinic treatment during the 7 days before surgery
* excessive alcohol consumption or addiction
* ketamine or neomycin contra-indication
* severe cardiovascular disease
Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching

In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.

Students seeking wellness coaching will have the option to participate in this study. The study will ask participants to:

1. Complete as many sessions of individual wellness coaching as they see fit
2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study
4. Complete an exit interview at the end of the study
5. Allow the study team to access academic records (optional)

The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.

Eligibility Criteria:
Inclusion Criteria:

1. University of Michigan students aged 18 years or older.
2. Students must either be coming to campus for the academic year or taking classes online for the academic year.
3. For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:

1. People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
2. Unwilling or unable to comply with the study procedures.
Sensory Perceptual Training on Activities of Daily Living and Hand Functions

Many risk factors can come to the fore in CP. With the new studies on CP, new risk factors are defined and existing risks are better understood. In the light of current information, general risk factors for CP are defined as premature birth, fetal growth restriction, multiple pregnancies, infections in the fetal or neonatal period, birth asphyxia, perinatal stroke, and congenital developmental disorders In addition, related risk factors are classified as prenatal, perinatal and postnatal

Children and youth with cerebral palsy face unique challenges when learning, practicing, and mastering activities of daily living (ADLs). Active participation in dressing, feeding, toileting, clothing management, and small space mobility is influenced by body structures and function and environmental and personal factors

Eligibility Criteria:
Inclusion Criteria:

* Modified Ashworth 1 and 1 +
* GMFCS level I and II
* Able to understand and follow instructions

Exclusion Criteria:

* fixed contracture or deformities in the spine or extremities
* visual or respiratory Problems,
* orthopedic surgery
Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia

Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. However, the relatively short duration of action of the currently available local anesthetics (LAs) make these advantages short-lived.

The risk for local anesthetic toxicity (LAST) increases with the trials to use higher concentrations or volumes of intrathecal local anesthetics to increase the duration of analgesia.

Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without the need for using high doses of local anesthetics and hence with decreasing the potential risk of local anesthetic, but the increased likelihood adverse effects such as short term bradycardia and prolonged duration of motor block may offset these benefits.

The aim of this study is to determine the optimal single-dose of intrathecal dexmedetomidine that prolongs the analgesic duration with the least possible side effects.

With the patients in the sitting position and the use of complete aseptic technique, 25G Whitacre spinal needles will be introduced through L2-L4 interspaces and after observing free flow of the CSF, a 3ml volume including bupivacaine 12.5mg in conjunction with dexmedetomidine (3 µg) will be injected in the first case, then the patient will be turned supine.

The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I to II.
* Patients scheduled for elective lower limb surgeries.

Exclusion Criteria:

* Morbid obese patients.
* Severe or uncompensated cardiovascular disease.
* Significant renal disease.
* Significant hepatic disease.
* Pregnancy.
* Lactating .
* Heart block.
* Bradyarrhythmias.
* Receiving adrenergic receptor antagonist medications.
* Receiving calcium channel blockers.
* Patients with pacemakers.
* Patients with implanted cardioverter defibrillator.
* Allergy to the study medications.
* Psychological disease.
* Neurological disorders.
* Communication barrier.
* Mental disorders.
* Epilepsy.
* Drug or alcohol abuse.
* Contraindications to spinal anaesthesia.
* Receiving opioid analgesic medications within 24 h before the operation.
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
* Patient able and willing to return to the implant center for follow-up visits
* Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

* Inadequate echocardiographic window for transthoracic imaging
* Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
* Evolving endocarditis or active endocarditis in the last 3 months.
* Heavily calcified annulus or leaflets.
* Congenital malformation with limited valvular tissue
* Patient requires mitral valve replacement.
* Previously implanted annuloplasty ring/band.
* Patient requires aortic or pulmonic valve replacement or repair.
* Patient is pregnant (urine HCG test result positive) or lactating.
* Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
* Life expectancy of less than twelve months.
* Patient is participating in concomitant research studies of investigational products.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients, \>/=18 years of age
* Presence of chronic kidney disease (Stage 3-4)

Exclusion Criteria:

* Participation in another clinical study
Prostate Cancer Parameters for Patients Receiving Proton Treatment

To prospectively collect data from patients treated with proton therapy for prostate cancer using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment technique.

The major purpose of this study is to analyze side effects experienced and self-reported by prostate cancer patients undergoing proton radiation therapy at IUHPTC. With the information collected, the investigators will establish pre-existing conditions before proton treatment and measure side effects after treatments that are not related to the pre-existing conditions. Also, to compare long-term side effects for patients who are treated with hormone suppression therapy along with their proton therapy to those patients who do not get treated with hormone suppression therapy. This information will help doctors better understand the side effects experienced and may help provide valuable information for future patients making decisions regarding their treatment options.

Finally, to develop a database of information regarding the treatment and outcomes for patients with prostate cancer in order to improve care of patients with this type of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate and are scheduled to receive proton radiation treatment at IUHPTC.
* Subjects with any stage or grade of tumor will be allowed including proton salvage therapy in the context of a rising PSA after surgery and a negative metastatic work-up.
* Prior use of Lupron therapy or a similar agent is allowed. Use of Lupron or similar agent must be for ≤ 6 months prior to enrollment.
* Use of Casodex and agents in the same drug class is allowed. Age is ≥ 18 years at the time of consent.
* The ability to understand and willingness to sign an informed consent and authorization for the release of health information.

Exclusion Criteria:

-Evidence of distant metastases at the time of enrollment.
Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.

The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

Eligibility Criteria:
Inclusion Criteria:

* normotensive
* good physical and mental health
* body mass index between 18 and 30
* if female, using an acceptable method of contraception and are not pregnant
* able to give voluntary informed consent

Exclusion Criteria:

* Please contact site for further details
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male subjects aged between 18 and 65 years of age inclusive.
* Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
* Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
* Subjects will have blood pressure measurements within the normal range for healthy volunteers.

Exclusion Criteria:

* The subject has a positive pre-study urine drug/ alcohol urine screen.
* A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
* Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
* Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.
Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.

Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol.

Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively.

Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
* Fair skin phototype
* Ability to understand the study goal, no dementia.
* Affiliation to the French National Healthcare System
* Voluntary patients who have signed an informed consent

Exclusion Criteria:

* Emergency surgery
* Multiple procedures, combined surgery (valvular and coronary)
* Single aortic surgery
* Patient already included in the study (second surgery)
* Patients protected by decision of law
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients with GHD who are on treatment with lonapegsomatropin
* Patients being clinically managed in Europe or the USA
* Appropriate written informed consent/assent as applicable for the age of the patient
* Patients willing to comply with follow-up requirements of the study

Exclusion Criteria:

* Patients participating in any interventional clinical trial for short stature
* Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
* Patients for whom treatment with lonapegsomatropin is contraindicated
* Patients with closed epiphyses
* Patients with active malignant tumours
* Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
* Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin
A Study Utilizing Escitalopram in Glioma Patients

This pilot study will include grade IV glioma patients treated with SSRIs during approximately a 17 week study period. Changes in cognition and evaluation of psychosocial factors from baseline to after 17 weeks of treatment with SSRI study drug will be calculated.

As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also worsens with therapy such as cranial radiation and chemotherapy, which further degrade neuronal function. Commonly, impairments in visuospatial skills and executive function are seen. There is evidence that serotonin selective reuptake inhibitors (SSRIs) such as escitalopram improve modulation and function of resting state networks, contribute to neuroplastic changes in brain regions subserving these abilities, and provide general functional support to neuronal cells. In addition to either improving cognition or preventing cognitive decline, treatment with an SSRI may also improve outcomes critical to overall survival in this vulnerable population, including functional independence, psychosocial stability, and quality of life.

We hypothesize that following treatment with escitalopram patients will experience improved cognitive and mood function over time. We will also correlate changes in mood structural MRI and electrophysiological correlates of visual pathway function. The addition of escitalopram has the potential to enhance cognitive function and hence functional independence thereby improving quality of life in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pathologically proven diagnosis of Grade IV glioma
* Patients planning to receive chemotherapy and/or radiation for newly diagnosed disease
* Performance status ECOG 0-2 or equivalent
* Patients must be age ≥19 years
* Life expectancy greater than 6 months
* Written informed consent to participate in the study.

Exclusion Criteria:

* Hemifield defects (as this obscures visual field necessary to participate in all tests)
* Inability to undergo MRI
* Severe renal impairment defined as GFR\<30 mL/minute
* Screen positive for depression or anxiety
* Already taking an anti-depressant (SSRI or NSRI)
* Have problems tolerating past treatment with SSRI or NSRIs
* Females of childbearing potential must have a negative urine pregnancy test at the study enrollment.
* Female patients must be either postmenopausal, free from menses for ≥2 years, surgically sterilized, or willing to use two adequate barrier forms of contraception
Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.

The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada

Exclusion Criteria:

* Patients with active inflammatory bowel disease
* Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
* Patients with active bowel malignancy
* Patients with diabetes mellitus or known/ suspected motility disorders of the gut
* Patients with decompensated liver disease
* Patients on ezetimibe or bile acid sequestrants
* Patients who are pregnant or breastfeeding.
* Patients with renal disease
* Patients on benzodiazepine
* Unstable cardiac or respiratory disease
* Any changes to medication in the preceding month