cyrilzakka/clinical-trials huggingface dataset:
RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

This research study will test the safety of RAD001 in combination with temozolomide.

* Participants will take RAD001 by mouth daily. They will also take temozolomide by mouth daily for one week, followed by a one-week break period. This one-week on/one week off schedule for temozolomide will continue for the duration of the treatment.
* After the first month of treatment, there will be a 7-day observation period during which no study medication will be taken to observe for any side effects.
* During all treatment cycles (1 cycle is 28 days in length) participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be experiencing. Initially, participants will come in every other week. At each of these visits, blood work will be taken to monitor the participants health.
* After every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working.

Eligibility Criteria:
Inclusion Criteria:

* Locally unresectable or metastatic pancreatic neuroendocrine tumor
* Radiologic, operative, or pathology reports should document a pancreatic location of tumor
* Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated
* 18 years of age or older
* Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
* Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine
* No Prior therapy with RAD001 or any other mTOR inhibitor
* ECOG Performance status 0,1 or 2
* Life expectancy 12 weeks or more
* Adequate bone marrow, liver and renal function as outlined in the protocol
* Negative serum pregnancy test
* Fasting serum cholesterol as outlined in protocol

Exclusion Criteria:

* Prior treatment with any investigational drug within the preceding 4 weeks
* Chronic treatment with systemic steroids or another immunosuppressive agent
* Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Women who are pregnant or breast feeding
* Patients who have received prior treatment with an mTOR inhibitor or temozolomide
* Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
* History of noncompliance to medical regimens
Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.

Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years, \< 80 years
2. Written informed consent
3. Histologically or cytologically confirmed CRC
4. Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
6. No previous chemotherapy
7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
9. Adequate hematologic and organ function

Exclusion Criteria:

1. Presence of any other active cancer
2. Presence of active infections requiring antibiotics
3. History of active autoimmune disease requiring systemic treatment
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or above age.
* 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
* Agree to use proper contraception as guided in the protocol.
* Signed for Informed Consent.

Exclusion Criteria:

* have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
* who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
* have undergone oral surgery within 6 weeks
* have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
* have undergone semi-permanent filler in lower face within 24 months
* have undergone temporary dermal filler treatment in the lower face within 12 months
* Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
* Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
* have used lip plumping products within 10 days
Recovery Housing and Drug Abuse Treatment Outcome

Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. It is meant to provide motivation for continued abstinence while enhancing social stability. In this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. Previous research had shown that RBT produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. The present study compared outcomes for patients (N = 243) randomly assigned to receive abstinence-contingent recovery housing with (full RBT) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full RBT) and without additional counseling and both these treatments were superior to usual care referral. Study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.

Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing delivered with or without intensive day treatment among individuals exiting residential opioid detoxification.

Design Random assignment to one of three conditions: recovery housing alone (RH), abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT, initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months after treatment enrollment.

Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.

Participants Patients (n = 243) who completed medication-assisted opioid detoxification.

Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.

Eligibility Criteria:
Inclusion Criteria:

* completes residential detoxification for use of opiates and/or cocaine
* willing to go to outpatient aftercare
* agrees to random assignment; signs informed consent

Exclusion Criteria:

* moving out of town
* primary substance use does not include opiates or cocaine
Multidisciplinary Care After Prostatectomy

This is a pilot, prostective, comparative, randomized, monocentric open-label study whose main objective is to determine whether appropriate psychological, nutritional and physical activity support can improve the quality of life of carrier patients. localized prostate cancer treated by prostatectomy

Pilot study to demonstrate the benefits of a multimodal intervention (psychological and nutritional support and physical activity) on the recovery of patients treated by prostatectomy for localized prostate cancer.

After inclusion of 100 patients, at week 6 will undergo a prostatectomy and then at week 9 will be randomized into two groups of 50 patients for each group.

Groupe Intervention which will benefit from multidisciplinary care over 12 weeks (one APA session per week plus 5 workshops with the psychologist and a workshop with the dietician) plus a visit with the urologist.

Then after 3 months, 6 months and 12 months, the group benefit from an evaluation with the urologist, the teacher of adapted physical activity and the dietitian.

-For the control group, it will be followed classically, a visit to the urologist, an assessment with the teacher of physical activity and the dietician, after prostatectomy, then at 3 months, 6 months and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

WHO score 0 or 1

* Adult patients with localized prostate cancer eligible for surgical treatment according to the AFU criteria following the CAPRA and d'Amico classifications: low risk or risk intermediaries. These are patients under the age of 73, with clinical stage and or MRI \< or = T3, PSA \< or = 20 ng/ml, with assessment negative extension (bone scintigraphy, thoraco-abdomino-pelvic scanner, Choline Pet-scanner)
* Informed and written consent signed by the patient
* Person affiliated with social security or beneficiary of such a scheme

Exclusion Criteria:

WHO score greater than or equal to 2

* MMSE score below 20
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to a legal protective measure)
The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC

The purpose of this study is to compare the therapy effects and clinical safety of a regulatory metabolic compound, coenzyme A (CoA) with a marketed drug, abiraterone, in Chinese patients with castration-resistant prostate cancer (CRPC) .

Prostate Cancer (PCa) has developed into the second most common cancer in men. In The United States, PCa has the highest morbidity in man. In China, the incidence rate is lower than in Europe and the US, but it is growing faster and faster. Androgen deprivation therapy (ADT) has been the most commonly used treatment for men with advanced prostate cancer for hundreds of years, effective in more than 85 percent of cases, but usually after 20 months or so, half of patients will inevitably develop castration-resistant prostate cancer (CRPC), which will become resistant to ADT, and patients will relapse. There are several treatments that are trying to address this problem. Such as the chemotherapy docetaxel, cabataxel, and the radioactive drug radium 223 dichloride; PARP inhibitor olaparib, but the efficacy is limited.

For finding some new pathways and targets to treat CRPC, a model of PCa persister cell was first been established at a cellular level in this study. In light of the new target, we first find a being used clinically drug, Coenzyme A (CoA), through prescription sieve to treat enzalutamide or abiraterone drug-fast CRPC patients. CoA functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. There is an efficient drug action at a cellular level and in animals, and we look forward to it at clinical utility.

Eligibility Criteria:
Inclusion Criteria:

- 18-100 years of age combined use with abiraterone or enzalutamide CRPC

Exclusion Criteria:

- pregnancy acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit primary hypothyroidism psychiatric patients poorly controlled hypertension, as indicated by a Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>110 mmHg using contraceptive agent using immunosuppressive drugs, prohibited medication or other non-PCa drugs long-term using CoA drug
Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional "WBS plus single-bed targeted SPECT/CT" strategy.

Images are interpreted by two nuclear medicine physicians in a 3-step procedure and by consensus. Firstly,only WBS planar images are considered. Secondly, a single-bed SPECT/CT chosen based on planar images is used if WBS demonstrated any equivocal or suspicious uptake.

Finally, WBS and double-bed SPECT/CT images are used for interpretation.

A per-lesion, a per-anatomical region and a per-patient analysis is performed. At each step, lesions, regions and diagnostic conclusions are classified using a 3-level scale, as negative for malignancy, equivocal or suspicious for metastasis

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for bone scintigraphy for initial staging of biopsy proven malignancy.

Exclusion Criteria:

* monoclonal gammapathy
* patients under 18 years of age
* Technical issues not allowing a double-bed SPECT/CT acquisition
* double bed SPECT/CT acquisition not centered from the upper cervical spine to the proximal femora
Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care

The project aims to make new technologies for locating people with dementia easier to use for the patients and those caring for them.

Objective: To systematically understand what improves the user experience of persons with dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately allow users to obtain more benefits from using these watches.

Aim: Improving the user experience of PwD and CG with locating system watches using a cross-over design and a theory-based educational session approach.

This entire research field (assistive technology in dementia care) is based on the need to address care solutions for a growing number of PwD and CG in the absence of a cure for (Alzheimer's) dementia.

Methods: A user study with two free available locating watches. In educational sessions PwD obtain a locating watch and their CG a smartphone with the application of the locating watch installed on it. By using a cross-over design each dyad (PwD and CG) obtaining both locating systems. The designed educational session hopefully ease subsequent use and make it more enjoyable. The dyads will use each system over four weeks in their real environment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of all kinds of dementia or mild cognitive impairment

Exclusion Criteria:

* not able to move outside alone
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital

The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.


Eligibility Criteria:
Inclusion Criteria:

* Must have a Traumatic Brain Injury.
* Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.

Exclusion Criteria:

* Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
* Movement disorder or spasticity affecting both upper extremities
* Patients who are ventilator-dependent.
* Patients who are on contact precautions for C.diff or other highly contagious diseases.
* Patients with neurological disorders other than TBI.
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, between the ages of 18 and 60 years
* Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
* Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
* Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI
* Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
* Contraindication to Copaxone use
* Other protocol defined exclusion criteria could apply
Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis

A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.

A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
* All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
* The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.

Exclusion Criteria:

* Allergy to tranexamic acid;
* Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
* Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
* Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
* Preoperative anemia (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males), refusal of blood products;
* Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \[\>1.4 times normal\]).
Shoulder Pacemaker for Scapular Dyskinesia

The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.

The scapula plays a key role in nearly every aspect of normal shoulder function. Shoulder dyskinesia or scapula winging effects patients as a result of nerve injury or muscle detachment or abnormal muscle recruitment. Patients with abnormal muscle recruitment often are helped the most by therapy but restoring normal firing can be difficult. Abnormal muscle recruitment is due to pain or weakness or instability of the glenohumeral joint and the muscles around the scapula attempt to compensate for the lack of normal firing patterns. In many patients, physical therapy and surgery have proven to be unsuccessful treatment options.

The Shoulder Pacemaker is a device that specifically aims at resolving functional issues that surgery and physical therapy are unable. It's a wearable electro stimulator created for patients suffering from unbalanced muscle activation in the shoulder, such as Scapular Dyskinesis. The Shoulder Pacemaker delivers "smart stimulation" through a dynamic interaction between the patient and the device. The motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. This process helps to restore normal muscle activation patterns and equilibrium. The pacemaker will hopefully assist in restoring normal muscle recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Scapular Dyskinesis
* Posterior Shoulder Instability

Exclusion Criteria:

* Rotator Cuff Tearing
* Shoulder Arthritis
* Patients with implantable electrical/electronic devices
* If participants are using wearable electrical medical devices, such as glucose sensors or infusion pumps, these devices will be turned off or the participants will be excluded from the study.