cyrilzakka/clinical-trials huggingface dataset:
A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis.

The study duration for the patients (from start of baseline to end of follow-up) is 270 days.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 60 years of age
* Patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
* Multiple sclerosis that meets the 2010 revised McDonald criteria
* Relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
* Radiologically active disease defined by at least one gadolinium-enhancing lesion on a T1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
* Disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (NOTE: Other disease modifying drugs might be added at a later date, depending on the results of current investigations)
* EDSS Score \<= 5.5
* Positive predictive test in vitro for patient's CD4+ cell reactivity to immunogenic peptide
* Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
* Fully informed written consent obtained

Exclusion Criteria:

* Positive only for the HLA DRB1\*0101, DRB1\*0102, DRB1\*0401, DRB1\*0426 alleles or for the combination of the previous alleles.
* Evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
* Therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
* Significant coexisting systemic disease including renal insufficiency
* Positive serology for hepatitis B and C, AIDS and syphilis
* Participation in another interventional clinical study, currently or during the past three months
BroadBand Light for the Treatment of Dry Eye Disease

The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.

Broadband light (BBL) is a widely used treatment for improvement of inflammatory dermatologic conditions such as acne and rosacea, and may have similar therapeutic benefits on the treatment of dry eye disease by targeting inflammation of the eyelids. The investigators propose a prospective study to determine the safety and efficacy of BBL treatment on patients with dry eye disease and meibomian gland dysfunction. Each participant will have three treatments of BBL at monthly intervals to the cheek and periorbital area with subsequent follow up. Measured endpoints will include signs and symptoms of dry eye control including full ophthalmic exam, dry eye diagnostic testing, photographs, and standardized questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I-V
* Must be diagnosed with Dry eye disease (DED) and meibomian gland dysfunction (MGD)
* Persistent dry eye signs and or symptoms after at least one prior DED treatment modality

Exclusion Criteria:

* Prior Intense pulsed light treatment for DED within the past six months
* Prior Meibomian gland treatment with a device for DED within the past three months
* History of trauma-induced ocular surface disease (thermal burns, chemical burns)
* Subject is pregnant
* History of seizures
* Having significant unprotected sun exposure within the treatment area
* Use of Accutane within the last six months
* Use of doxycycline in the last 1 month
* Allergy to proparacaine or lidocaine
* Having active herpes simplex virus infection within the treatment area
* Laser eye surgery (LASIK) within the past twelve months
* History of abnormal response to sunlight
* Having an active medical condition that may affect normal healing
* Having active infections or compromised immune system
* History of basal cell carcinoma in the treatment area within the past twelve months
* History of keloid scar formation
A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.
* First relapsed AML
* Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
* Age more than 18 years
* ECOG performance status \< 2

Exclusion Criteria:

* Prior treatment with deacetylase inhibitor
* Concurrent therapy with any other investigational agent
* Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
* Clinical symptoms suggesting CNS leukemia
* LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply
Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* (1)Age from over 19 to under 74 years
* (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
* (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
* (5)American Society of Anesthesiology (ASA) score class I, II, or III
* (6)Written informed consent

Exclusion Criteria:

* (1)Women during pregnancy or breast-feeding
* (2)Severe mental disorder
* (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
* (5)History of unstable angina or myocardial infarction within past six months
* (6)History of cerebrovascular accident within past six months
* (7)History of continuous systematic administration of corticosteroids within one month
* (8)History of previous neoadjuvant chemotherapy or radiotherapy
* (9)T4b tumors
* (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* (11)FEV1(Forced expiratory volume in one second)#50% of predicted values
Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy

The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the orthoses' impact on foot health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* haemophilia A or B, aged more than 13 years

Exclusion Criteria:

* impossibility to walk on a treadmill
* recent joint haemarthrosis or muscle haematoma
Thrombomodulin-modified Thrombin Generation Assay (TGA-TM) in Patients With Critical Infections

Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.


Eligibility Criteria:
Inclusion Criteria:

* Admission to ICU
* Clinical signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2
* Neutrophil-Lymphocyte Ratio (NLR) \>3

Exclusion Criteria:

* Intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to ICU admission
* Congenital coagulation disorder
* Treatment with Prothrombin complex concentrate (F. II, VII, IX, X) or activated Prothrombin complex within past 48 hours
* Treatment with recombinant factor VIIa (e.g. eptacog alfa) within past 48 hours
* Treatment with recombinant protein C within past 48 hours
* Active bleeding
* Acute myocardial infarction
* HIV infection
* Chronic pancreatitis
* Liver cirrhosis
Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications

The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older;
* Elective cardiac surgery under general anesthesia

Exclusion Criteria:

* Patients and their family members refused to be enrolled;
* Patients unable to communicate due to language barriers such as dementia;
* Patients admitted to ICU 24h before surgery;
* Estimated duration of surgery less than 2 hours;
* Patients died or discharged within 24 hours after surgery
Gao Bipolar Spectrum Lithium/Quetiapine Study

This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent before beginning any study-specific procedures
* Male and female patients at least 18 years of age
* Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s)
* Willing to be randomized to either Lithium or Quetiapine
* If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
* Women with reproductive potential must have a negative urine pregnancy test

Exclusion Criteria:

* Unwilling to comply with study requirements
* Patients who have had severe adverse reaction to Lithium or Quetiapine
* Patients who require inpatient care
* Drug/alcohol dependence requiring immediate acute detoxification
* Pregnancy as determined by serum pregnancy test or breastfeeding
* History of nonresponse to Lithium at doses \>900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.
Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden

The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.

The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.

Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 or more
* Confirmed MS diagnosis (McDonald 2005)
* Defined type of MS according classification of Lublin and Reingold

Exclusion Criteria:

* Subject living in an institution
* Severe cognitive dysfunction preventing to answer questionnaire
* Subject already included in other clinical study (phase 1 to 3)
Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

For a significant number of patients suffering from back pain, even basic daily activities become impossible. It is at this time that spinal surgery becomes necessary in order to improve the patient's quality of life. To combat these symptoms, surgical implants (e.g. pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of the spine, particularly after spinal decompression. Surgical navigation has a great potential to improve the accuracy of correctly implanting these devices; however, present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, fluoroscopy, etc.), require cumbersome set-ups, the physical attachment of fiducial markers, and cannot account for patient motion. Therefore, the investigators propose a real-time intraoperative optical topographical imaging based surgical guidance system capable of accurately guiding the placement of implanted devices such as pedicle screws.

The hypothesis is that optical visualization of surgically exposed bony anatomy with computerized navigation can accurately estimate subsurface anatomy and in the future, potentially guide the placement of pedicle screws during spinal surgery. The specific research aims are as follows: i) an intraoperative non-contact optical imaging system can quantify the entry point and trajectory of pedicle screws implanted by the spine surgeon; and ii) intraoperative optical imaging can predict the entry point and trajectory of pedicle screws as verified by post-operative computed tomography (CT) scans.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Able to provide consent, or have substitute decision maker available FOR SPINAL INDICATIONS
* Scheduled to undergo spinal instrumentation surgery involving pedicle screw insertion
* Scheduled for pre-operative CT scan and the surgical plan includes open exposure of the posterior bony elements of one or more level(s) of the vertebra(e)
* No contra-indication for a post-operative CT scan FOR CRANIAL INDICATIONS
* scheduled to undergo cranial surgery
* Scheduled for pre-operative CT or MRI scan
* No contra-indication for post-operative CT scan

Exclusion Criteria:

* Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation
* Previous spinal decompression with laminoplasty performed at the level intended for instrumentation
Vortioxetine for Cancer Patients With Depression: An Observational Study

The purpose of this observational antidepressant study is to determine the efficacy of vortioxetine on depression and cognitive function, and elucidate its potential effects on quality of life in patients with cancer (of any origin). We hypothesise that given its unique mechanism of action as a multimodal serotonin modulator, vortioxetine is set to achieve the above goals while maintaining a favourable side effect profile.

Cancer is always a feared illness and the diagnosis of cancer has huge psychological impact on the patients. Depression is one of the most common psychiatric sequelae and affects the disease outcome in cancer patients. Along with depression, cancer patients are also vulnerable to develop cognitive impairment. It could be related to the cancer or its treatment. Cognitive impairment that occurs among cancer patient is known as cancer related cognitive impairment (CRCI). Depression together with cognitive impairment adversely affect the quality of life of cancer patients. To date, the optimal treatment of depression in cancer is not established. The number of studies investigated the efficacy of pharmacotherapy for depression in cancer patient is limited. The evidence of treatment for cognitive impairment in depressed cancer patients is even more scarce.

Vortioxetine is one of the latest marketed antidepressants in Malaysia. It has numerous additional effects as compared to other conventional antidepressants. In addition to blockade of the serotonin transporter (SERT), vortioxetine has affinity for 5-HT1A, 5-HT1B, 5-HT3, and 5-HT7 receptors and as such, it is described as a 'multimodal serotonin modulator'. This may explain the additional benefit of vortioxetine in the treatment of depression as compared to other antidepressants. Furthermore, the unique mechanism of action of vortioxetine was also reported to improve cognitive function in patients with depression.

General Objective:

To examine the effect of vortioxetine in improving the depressive symptoms, cognitive impairment and quality of life in cancer patients who have major depressive disorder.

Specific Objectives:

1. To determine whether treatment with antidepressant vortioxetine is effective to improve depressive symptoms in patients diagnosed with cancer (of any origin) and major depressive disorder.
2. To determine whether treatment with antidepressant vortioxetine is effective to improve cognitive impairment in patients diagnosed with cancer (of any origin) and major depressive disorder.
3. To determine whether treatment with antidepressant vortioxetine is effective to improve quality of life in patients diagnosed with cancer (of any origin) and major depressive disorder.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years old
* Literate and able to understand English or Malay
* Diagnosed with Major Depressive Disorder
* Diagnosed with cancer of any origin

Exclusion Criteria:

* Medically unstable
* Delirium
* Actively psychotic
* Cognitive deficits of other causes
* Primary or secondary cerebral/cranial tumors
myDC/pDC in Stage III Melanoma Patients

This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.

Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.

Eligibility Criteria:
Inclusion Criteria:

* stage III melanoma
* WHO performance status 0-1
* radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment

Exclusion Criteria:

* irresectable disease
* any concurrent adjuvant therapy
* concomitant use of oral immunosuppressive drugs
* autoimmune diseases
Race-related Alternative Splicing: Novel Targets in Prostate Cancer

Data from evaluating prostate cancer (PCa) biopsy tissue from AA and white patients has led to the discovery of alternative splicing as a novel molecular mechanism underlying more aggressive PCa in AA men. Coded archival radical prostatectomy tissue specimens and annotated clinical data, questionnaire data, and ancestral genotyping data will be obtained from the racially diverse and federally funded North Carolina-Louisiana PCa Project (NC-LA PCaP). We will use 33 tissue specimens from each of the following 6 groups (n=198 total): white low aggressive, white intermediate aggressive, white high aggressive, AA low aggressive, AA intermediate aggressive and AA high aggressive. The aforementioned tissues will first be screened for tumor content and Gleason grade by a genitourinary pathologist. To identify race-related splice variants, RNA will be isolated for targeted sequencing of prioritized race-related alternatively spliced genes using the NimbleGen SeqCap Target Enrichment, SeqCap RNA System to capture regions of interest and the Illumina HiSeq sequencing platform to sequence these regions at a depth and coverage sufficient to accurately call alternative splicing events.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of prostate cancer.
2. Self-reported race of AA or white.
3. Availability of five unstained slides per radical prostatectomy specimen and an associated Hematoxylin and Eosin stained slide for each radical prostatectomy specimen from NC-LA PCaP.
4. Classification of prostate cancer of low, intermediate or high aggressiveness, as defined by NC-LA PCaP.

Exclusion Criteria:

1. Obtained radical prostatectomy tissue is inadequate for RNA analysis and/or is not positive for adenocarcinoma of the prostate of low, intermediate or high aggressiveness.