cyrilzakka/clinical-trials huggingface dataset:
STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)

The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.

Participants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy/progression) and diagnosis (astrocytoma/oligodendroglioma and grade).

Critical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.


Eligibility Criteria:
Prospective Metabolic Cohort:

Inclusion Criteria:

* Radiological diagnosis of brain tumor compatible with lower grade glioma
* Full clinical history

Exclusion Criteria:

* Current pregnancy or lactation
* Patients not able to provide informed consent

Retrospective Cohort of FFPE samples:

Inclusion Criteria:

* Confirmed diagnosis of lower grade glioma
* Full clinical and radiological history
Effect of Preoperative Diet on Perioperative Gut Microbiome

The aim of the study is to evaluate the gut microbiome (i.e. bacteria, viruses, and fungi that reside in the gut) of people undergoing abdominal surgery, evaluate whether specific diets can change the gut microbiome, and, if so, whether those changes translate into better surgical outcomes.

Standard of care: patients undergoing major abdominal colorectal surgery are sometimes advised to eat healthfully prior to surgery, but without more specific recommendations regarding their diet.

Research Activities:

1. Screening: eligible patients will be identified through screening the clinic schedules.
2. Enrollment: in person or remotely, after the patient is determined to require major abdominal surgery, they will be invited to participate in the study. If they consent to participate, they will be randomized to receive either low-fat/high-fiber diet, high-fermented diet, or continue with their normal diet for 10-14 days prior to the surgery.
3. Intervention: at baseline, data will be collected regarding clinical information of the patients (age, body mass index, comorbidities, medications or supplements, physical activity levels, antibiotic or probiotic use in the past six months), and baseline dietary pattern, which will be evaluated through application of a validated Food Frequency Questionnaire (DHQ III). Patients in the intervention arms (low- fat/high-fiber diet or high-fermented diet) will receive meal samples during the 10-14 days preceding surgery. Patients in the control arm will receive a $25 grocery voucher. Adherence to the diet will be assessed through regular check ins with the patients.

   Stool samples will be collected in five timepoints: at the beginning of the study, after the dietary intervention, during surgery, in the first week after the surgery, and between 21-30 days after surgery. The stool samples will be sent for analysis of the microbiome.

   A fragment of the resected bowel will also be sent for analysis of the mucosal-associated microbiome.
4. Closeout: After surgery, all patients will receive the same standard dietary protocol and care, and will be followed for 30 days without any further intervention.

Eligibility Criteria:
Inclusion Criteria:

* undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks

Exclusion Criteria:

* patients who do not speak English or Spanish
* houseless patients
* decisionally impaired patients
* presence of ileostomy prior to the surgical procedure
* surgery without intestinal resection
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
* Subject should start treatment no later than 10 weeks postsurgery.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Acceptable hematology parameters:

  * Absolute neutrophil count ≥1500 cell/mm3
  * Platelet count ≥100,000/mm3
  * Hemoglobin (Hgb) ≥8.0 g/dL
* Acceptable blood chemistry levels:

  * Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
  * Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
  * Serum creatinine within upper limits of normal.
* Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
* No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
* Signed informed consent.

Exclusion Criteria:

* R2 resection or presence of metastatic disease.
* Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
* Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
* Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
* Severe, active co-morbidity, defined as follows:

  * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  * Transmural myocardial infarction within the 6 months of study registration
  * Uncontrolled hypertension, diabetes or arrhythmia.
  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
* Not able to take medicine orally.
Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients

Skin diseases, despite low mortality, significantly impair quality of life. This randomised controlled trial evaluates the efficacy of a digital toolkit comprising psychotherapeutic strategies in reducing QoL burden in patients with chronic inflammatory skin conditions. This toolkit is hosted on a mobile application and will be used by study participants randomised to the intervention arm over the 32 week study period.

Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life. Up to 80% of dermatological patients experience severe itch and poor sleep, and related such mental health challenges as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics such as Mindfulness training, Cognitive Behavioural Therapy, and Acceptance and Commitment Therapy are widely used and effective in the treatment of mental health illness. However, there is limited evidence on the application of such interventions in dermatology and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis, eczema or chronic urticaria diagnosed by a dermatologist
* Aged 16 or older
* Peak pruritus intensity of 4 or more on a 11-point numerical rating scale (0-10, with 10 representing worst itch)
* Able to engage with a mobile application in the English language

Exclusion Criteria:

* Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
* Patients with unstable psychiatric condition, characterized by

  o Hospital inpatient admission for a psychiatric condition or initiation of a psychotropic medication in the prior 3 months
* Patients with unstable dermatological condition, characterized by

  * Recent flare of the skin condition within the last 2 weeks, including diagnosis of a flare by a doctor, use of systemic steroids, oral antibiotics, wet wrap rescue therapy, oral antivirals, or increase in frequency of phototherapy or dose of systemic medications for the dermatological condition within the last 2 weeks OR
  * Any of the following within 3 months

    * inpatient admission for a dermatological condition
    * Initiation of phototherapy
    * Initiation of systemic therapy (conventional immunosuppressive agent, biologics, JAK inhibitors) within the last 3 months.
The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD

Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Recent studies have shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.

Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of lower limbs）at 0 days, 3 days, 3months ,6months.

Purpose：

1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.


Eligibility Criteria:
Inclusion Criteria:Genetic analysis of DMD; from 2 to 6 years old ;without other diseases .

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Exclusion Criteria: other congenital diseases;upper respiratory infection, gastroenteritis, vaccination, trauma.

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Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans

The evaluation of the impact of environment on the incidence of cancer is a major public health issue. Increased knowledge in this area is necessary for the implementation of primary prevention means with appropriate preventive measures but also to the implementation of secondary prevention measures with targeted screening actions.

Among the environmental exposures that may lead to cancer, mutagenic environments are of major importance, and the causal link between environmental genotoxicity and cancer has been established for a long time. It is also well established that susceptibility to mutation is highly variable among individuals. This is explained by genetic polymorphisms of genes involved in metabolism and in genome stability.

The identification of biomarkers of exposure to mutagenic environments is necessary for assessing the impact of an environment in humans. Some studies in animals have shown that the PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated efficiently and reliably.

The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells , spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements). Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma membrane is easily achievable by flow cytometry.


Eligibility Criteria:
Inclusion Criteria:

* Major patients,
* The patients achieving a breast cancer
* Patients who have benefited from a breast surgery
* Patients to have an external adjuvant radiotherapy.
* Patients being able to read and understand French.
* Patients beneficiaries of a social security scheme.
* Pregnant women can not participate in this study. A pregnancy test should only be prescribed when clinically indicated, regardless of the course of the study.
* Patients who received information and signed informed consent

Exclusion Criteria:

Patients who received chemotherapy before radiation therapy.

* Minor patients
* Patients who do not speak French and / or unable to read and understand French.
* Patients who have had radiotherapy history
* Patients who have had a history of chemotherapy
* Patients who have not received the information and had not signed informed consent for participation
Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility

During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.

HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 50 who are admitted to a skilled nursing facility following hospitalization
* Qualify to receive at least physical therapy services
* Ambulatory prior to hospitalization

Exclusion Criteria:

1. Patients with neurological disorders such as acute stroke or acute traumatic brain injury
2. Patients on hospice care
3. Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):

   1. Recent unstable fracture
   2. Advanced congestive heart failure
   3. Bone metastasis sites
   4. Tumors in strengthening target areas
   5. Acute Illness
   6. Recent myocardial infarction (within 3-6 weeks)
   7. Weight bearing restrictions on graft or fracture sites
   8. Exposed tendon or muscle
   9. Absence of pedal pulses
   10. Presence of fistula
   11. Platelet levels \<50,000/μL
4. Weight-bearing precautions and inability to ambulate prior to hospitalization
Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.

Eligibility Criteria:
Inclusion Criteria:

* All otherwise healthy babies who need casting for congenital clubfeet

Exclusion Criteria:

* All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.
fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

This study will examine the impact of functional near-infrared spectroscopy-based neurofeedback to a region within the brain's prefrontal cortex involved with self-regulation of resisting craving in alcohol use and prescription opioid use disorder patients. Participants will be asked to complete two cue reactivity tasks, six sessions of neurofeedback training as well as craving visual analog scales and self-efficacy questionnaires throughout a two-week period of their time in residential treatment at the Caron Treatment Center. They will be followed for 90 days after treatment completion at Caron to assess the impact neurofeedback had on their ability to remain sober once patients are living back in the "real world".


Eligibility Criteria:
Inclusion Criteria:

* sex: male or female
* Age: greater than or equal to 18 years
* Caron Treatment Center residential patients with alcohol use disorder, moderate to severe (equivalent to Alcohol Dependence in DSM-IV-TR), or prescription opioid use disorder (pOUD)
* Fluent in written and spoken English
* Patients who are right-handed
* Valid email address and reliable internet access after leaving the Caron Treatment Center

Exclusion Criteria:

* Patients who are concurrently receiving a psychoactive drug for the treatment of an Axis I disorder.
* Patients with current major depressive disorder or schizophrenia, bipolar disorder, post-traumatic stress disorder, or a history of traumatic brain injury.
* Decisional impairment
* Adults unable to consent
* Women who are pregnant
* Prisoners
* Patients who are left-handed
* No reliable email addresses
Effectiveness and Safety of Implantable Neurostimulation Systems for Chronic Pain: A Spanish Multicenter Study (STIM-RENASED)

Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of implantable stimulation systems for chronic pain treatment in Spain.

All Spanish hospitals that implant neurostimulation systems for pain treatment will be invited to participate in the study. Patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. Demographic data related to the pathology and procedure will be collected. Follow-up will be conducted at six and twelve months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
* Accept to participate in the study and sign informed consent.

Exclusion Criteria:

* Patients in whom it would be difficult to complete follow-up.
* Insufficient understanding of the Spanish language.
* Pregnancy.
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

The treatment groups are:

A. Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.

B. Group B will be randomized to a 12 week supervised exercise program and placebo.

After the 12 week supervised exercise program, all participants will undergo a second randomization to ranolazine or placebo for an additional 12 weeks, during which independent walking will be encouraged.

Both groups will participate in a two week lead-in period after each randomization of the trial, allowing for the stabilization of their medications and dosing of ranolazine. Medications such as cilostazol, calcium channel blockers and nitrates will be discontinued during the lead-in period, unless their use is for management for high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* Males or females greater than 40 years of age.
* Documented peripheral arterial disease
* Stable lower extremity intermittent claudication (Rutherford class 1-3) for 3 months.

Exclusion Criteria:

* Critical limb ischemia (Rutherford class 4-6).
* Percutaneous or surgical lower extremity revascularization within last 12 months.
* Myocardial infarction within the last 6 months.
* cardiac surgery within the last 6 months.
* Unstable angina
* Stable chronic angina
* New York Heart Association Class II-IV heart failure
* Left ventricular ejection fraction less than or equal to 35%
* Venous thromboembolism within the last 6 months.
* Uncontrolled high blood pressure, defined as systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg.
* Allergy to ranolazine.
* corrected QT interval (QTc) greater than or equal to 440 ms in males or 460 ms in females.
* Pregnant or nursing females.
* Chronic dialysis therapy.
* Significant liver impairment (defined as transaminases greater than or equal to 3 times the upper limit of normal) within the last 6 months.
* Concomitant use of Cytochrome P450-3A (CYP3A) inhibitors
* Concomitant use of CYP3A inducers
* QTc prolonging agents
* Orthopedic or neurologic disorders that prevent treadmill walking.
* Current participation in a structured exercise program.