cyrilzakka/clinical-trials huggingface dataset:
Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.

People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.

This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+)
* Undergoing elective total knee arthroplasty (TKA) for knee arthritis
* Can use a simple electronic (phone or tablet) device
* Provide informed consent to participate

Exclusion Criteria:

* Revision surgery
* Simultaneous bilateral arthroplasties
* Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Interest of Auriculotherapy in the Management of Chronic Insomnia

The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.

Chronic insomnia affects a significant proportion of the French population with an estimated prevalence between 15% and 20%.

This disease is mainly managed by general practitioners for whom benzodiazepines and Z-drugs (zopiclone, zolpidem) represent the first-line treatment. The french health authorities recommend limiting the consumption of these molecules to 2 to 4 weeks taking into account their possible undesirable effects (eg memory impairment, in the elderly, road accident) as well as the risk of tolerance and addiction. However, it appears that a majority of the patients concerned become chronic consumers.

The investigators propose to assess cryo-auriculotherapy in the treatment of chronic insomnia.

The population studied will consist of patients with chronic insomnia, whose diagnosis has been made according to the definition in the diagnostic and statistical manual of mental disorders (DSM-5), and followed up in an outpatient clinic at Foch Hospital or in one of the participating centers.

Half of the patients will be treated with cryo-auriculotherapy (use of a device with nitrous oxide) and compared with control patients who will have the same treatment visits involving a sham device (device without nitrous oxide).

Eligibility Criteria:
Inclusion Criteria:

* Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5)
* Score ≥ 15 on the Insomnia Severity Index (ISI) questionnaire;
* Covered by a national healthcare insurance
* Consent form signed

Exclusion Criteria:

* Pregnant woman or pregnancy planned for the duration of the study;
* Regular night work or shift work / reversal of sleep patterns;
* Trans meridian travel during the previous month or planned during the study period;
* Unstable or untreated psychiatric disorder including severe depression, severe addiction, unbalanced bipolar disorder;
* Taking insomnia-inducing drugs (eg Corticoids);
* Hypnotic treatment or antidepressant treatment with hypnotic aim introduced since less than 4 weeks or with change dating back less than 4 weeks;
* Presence of organic comorbidities which may be responsible for sleep disorders (SAS and restless legs syndrome): (STOP-BANG) score ≥ 5;
* History of central neurological disorders or progressive brain injury;
* Contraindication to the use of auriculotherapy (lesion or infection of the pinna) by cryotherapy (skin scarring disorder, risk of hypo or hyperpigmentation);
* Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
* Previous treatment with cryo-auriculotherapy
* Having started in the month preceding the first auriculotherapy session, any new treatment likely to interfere with the study: specific drug treatment (antidepressant, morphine or anticonvulsant) or complementary therapy (psychological care, physiotherapy, balneotherapy, etc.).
* Difficulty complying with the treatment, questionnaire or study protocol.
* Be deprived of liberty or under guardianship.
Next Generation X-ray Imaging System

Philips Healthcare has developed a next generation Allura investigational device. The intended purpose of the investigational device is to perform neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures on human patients. The goal of this study is to investigate the accuracy of the next generation Allura investigational device to determine the extent and localization of ischemic stroke changes in brain tissue.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has signed and dated the Informed Consent Form (ICF)
2. Age ≥ 50 years old
3. Clinical and radiological signs consistent with acute stroke I. Patient diagnosed with ischemic stroke of the anterior circulation and not eligible for thrombectomy. II. Patient diagnosed with ischemic stroke of the anterior circulation and subjected to thrombectomy. III. Patient diagnosed with hemorrhagic stroke.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Previous stroke or parenchymal damage/defects in anterior circulation territories (only applicable for subjects included by criterion 3.I or 3.II).
3. Subject participates in a potentially confounding drug or device trial during the course of the study.
4. Participation in the study exposes the subject to risk, as assessed at the discretion of the treating physician.
5. All subjects who meet an exclusion criteria according to national law.
6. Subject or subject family member is a known Philips employee.
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.

II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.

PROJECTED ACCRUAL:

A total of 70 patients will be accrued for this study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
* At least 1 metastasis for which surgery is not deemed to be a curative option
* Relapsed from or has not responded to frontline chemotherapy or biotherapy
* At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
* No history of brain metastases or visceral metastases other than lung metastases

--Prior/Concurrent Therapy--

* Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
* Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
* Endocrine therapy: No concurrent immunosuppressive drugs
* Radiotherapy: At least 4 weeks since prior radiotherapy
* Surgery: At least 2 weeks since prior major surgery
* Other: No other concurrent anticancer drug therapy, or any other experimental therapy

--Patient Characteristics--

* Age: 18 and over
* Performance status: Karnofsky 80-100%
* Life expectancy: At least 6 months
* Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
* Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal
* Renal: Creatinine no greater than 2.0 mg/dL
* Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
* Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Comparison of Marginal Fit and Internal Adaptation in All-Metal Crowns: an in Vitro Experimental Trial

The goal of this in vitro study is to compare the marginal fit and internal adaptation of all-metal crowns in polished crown preparations and non-polished crown preparations The main question it aims to answer is: are the non polished tooth preparations comparable to polished preparations? We will compare polish and non polish groups and see their effects on marginal fit and internal adaptation of all metal crown


Eligibility Criteria:
Inclusion Criteria:

1. Phantom teeth
2. Maxillary molars
3. Metal crowns with conventional lost-wax technique for crown fabrication

Exclusion Criteria:

1. Over prepared or underprepared crowns
2. Defective metal crowns
3. Ruptured silicone films upon removal
4. Defective die stone casts
Response of Psychiatric Outpatients to the Great East Japan Earthquake

Objective: Reports have described how hospitalized psychiatric patients respond to disasters; however, few reports have described the response to disaster among psychiatric outpatients, who have relatively mild disease in comparison with hospitalized, severely ill psychiatric patients. Here the investigators have analyzed the response to disaster among this under-studied population.

Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The investigators studied psychiatric change among a population of psychiatric outpatients in Tochigi prefecture, located \~160 km (\~100 miles) southeast of the Fukushima nuclear power plant, in an area that suffered moderate damage from the earthquake. A total of 328 psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2 (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4 (neurotic, stress-related, and somatoform disorders). All diagnoses were made using International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were measured as a change in psychotropic medication after the disaster.

Patient progress was determined by whether a change in medication was needed. We focused on psychotropic drug use, including the use of neuroleptics, antidepressants, and benzodiazepines, directly after the disaster on March 11, 2011. Changes in other psychotropic drugs that are prescribed less frequently, such as lithium or anticonvulsants, were not considered in this study. Changes in symptoms that did not require a need to change psychotropic medications were not considered as part of a patient's progress. Physicians rated the relationship between each change in psychotropic drug and the disaster as direct, indirect, or not relevant. Only when three physicians rated the relationship as direct did we consider the change in a patient's progress to be due to the earthquake. Worsening or improvement of symptoms was defined as a change in psychotropic medications as a result of the deterioration or improvement, respectively, of symptoms. The data were stratified by disease category and sex and analyzed using chi-square tests.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients of Ashikaga Red Cross Hospital before the Great East Japan Earthquake on March 11, 2011 who are classified as F2 (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), or F4 (neurotic, stress-related, and somatoform disorders), using International Classification of Diseases (ICD) 10 diagnostic criteria

Exclusion Criteria:

* Outpatients who did not consult with our hospital in the 2 months after the earthquake were excluded.
A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.

This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of locally or metastatic colorectal cancer
* Prior therapy with 5-FU for metastatic cancer
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Inability to interrupt aspirin therapy
* Brain metastasis
* Patients who have been treated previously with ALIMTA or irinotecan
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* History of clinical manifestation of any flavivirus infection
* History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 4 weeks prior to enrollment
* Infection with HIV, Hepatitis B or Hepatitis C
* Pregnancy, lactation or unreliable contraception in female subjects
Thigh Circumference Reduction Study

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 20 and 35
* Presence of cellulite grades II, III or IV according to GLD scale
* Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
* Subject must be able to read, understand and sign the Consent Form
* Subject must adhere to the follow-up schedule and study instructions
* Subject must adhere to the same diet and/or exercise routine throughout the study

Exclusion Criteria:

* Significant weight fluctuation (+/-10 lbs) in the past 6 months
* Taking weight-loss medications/supplements
* Participation in any other clinical study
* Cellulite treatment within 3 months of the treatment
* Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
* Prior treatment to the target area within the last 12 months
* Arteriosclerosis or weakened blood vessels
* Heart disease
* Thromboembolic disease
* Diagnosed or documented immune system disorders
* Bleeding disorders.
* Presence of uncontrolled hypertension
* Taking prescription anticoagulants
* History of keloid formation
* Malignant tumors in the target area
* Diabetes
* Any disease or condition that could impair wound healing
* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars
* Infection in the target area
* Implanted electrical device(s)
* Pregnant or lactating
Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow (BM) sampling serves as a window that represents all AML cells distributed throughout the BM, an assumption that has yet to be questioned. Simulation in mice led to inconsistent representation of the full BM, which can incorrectly suggest the absence of leukemic cells. Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the body using for instance a radioactive sugar. In one report, its use in human AML has provided proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML cells spread and home them as distinct areas rather than uniform spread as if they are distributed in liquid state.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of AML according to the WHO (World Health Organization) criteria

Exclusion Criteria:

* Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease.
* Acute promyelocytic leukemia (APL).
* ECOG (Eastern Cooperative Oncology Group) performance status of 3 or more
* Inadequate renal function (i.e., estimated GFR (glomerular filtration rate) \< 60 mL/min/1.73m2).
* Inadequate hepatic function (i.e., serum bilirubin \> 1.5×ULN; AST (aspartate aminotransferase), ALT (alanine aminotransferase) and ALP (alkaline phosphatase) \> 2.5×ULN)
* Presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy.
* Pregnancy or lactating female.
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation

The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function.

Laparoscopic gastrectomy requires a reverse-Trendelenburg position and prolonged pneumoperitoneum and it could cause significant changes in cerebral homeostasis and lead to cognitive dysfunction. We compared changes in haemodynamic variables, regional cerebral oxygen saturation, and early postoperative cognitive function in patients undergoing laparoscopic gastrectomy in the reverse Trendelenburg position with those patients that underwent conventional open gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I or II, aged 20 to 70 yrs

Exclusion Criteria:

* Patients with morbid obesity (body mass index \> 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. In the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the NRM. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. The most important cause of treatment failures were relapse and non-relpase mortality. The further analysis demonstrated that patients with higher bone marrow blast before allo-HSCT was associated with treatment failure and patients with poor perforce status or age over 45 had increased rate of NRM. To further optimization the protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect and replace idarubicin with VP-16. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days) to prevent the further reduce the relapse incidence. We anticipate LFS at 1 year should be above 50% and 1-year LFS of 20% is considered unacceptable.

Eligibility Criteria:
Inclusion Criteria:

* refractory myeloid malignancies including acute myeloid leukemia (AML) or chronic myeloid leukemia in blastic crisis (CML-BC)
* HLA matched sibling，unrelated donor, or haplo-identical donor
* Patients with bone marrow blast \>5% and positive measurable disease via flowcytometry or PCR.

Exclusion Criteria:

* patients with active infection
* liver function damage: ALT/AST above 2X normal range; and renal function damage Scr\>160µmol/L; insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%
* mental instability
* unwilling to give inform consent