cyrilzakka/clinical-trials huggingface dataset:
Impact of Intensive Computerized Cognitive Training

To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.

To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.

The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patient of the Mass General Brigham Health System with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (ABI) sustained at least 12 months prior to study contact.
* Ages 25-65 years old
* Proficiency in English
* Willing and able to complete all study-related activities for 12 months, including travel to Brigham and Women's Hospital (Boston) for four in-person assessment visits and two serum and saliva sample collections.
* Access to a computer with webcam and stable internet.
* A reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points.

Exclusion Criteria:

* History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
* High likelihood of an underlying progressive neurodegenerative disorder.
* Evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the Mini-Mental Status Examination (MMSE) (Tombaugh \& McIntyre, 1992).
* Patient Health Questionnaire (PHQ)-9 (Kroenke et al., 2010) Score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction).
* Active psychotic symptoms.
* Severe sensory losses such that participants would unlikely be able to participate in the study training, even with substantial accommodations (self-report of extreme difficulty reading ordinary newspaper print or a performance-tested corrected vision test score of worse than 20/30).
* Communication difficulties that prevent the participant from effectively participating in this highly interactive study protocol (based on interviewer's rating of a person's ability to be understood and to understand others).
* Current participation in a pharmacological, or other interventional research trial.
* Life expectancy of \< 2 years.
Economic Burden in Adult Patients Diagnosed With Rheumatoid Arthritis (RA) Receiving Treatment With Biologic Disease-modifying Antirheumatic Drugs (bDMARDs)

The purpose of this study is to explore the differences in productivity loss and costs between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.

Time Perspective: Prospective with some retrospective analysis of claims data

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a bDMARD or DMARD during the identification period (01 February 2009 - 31 July 2009)
* 18 years of age or older at the index year
* At least 12 months of continuous enrollment in a large commercial US health plan affiliated with i3 Innovus, including the at least 6 months and up to 12 months prior the index date (i.e., the pre-index period) and at least 6 months following the index date (i.e., the post-index (follow-up) period)
* Diagnosis of RA (reported on baseline survey)

Exclusion Criteria:

* Diagnosis of psoriasis, plaque psoriasis, or psoriatic arthritis (ICD-9 code 696.0x, or 696.1x), ankylosing spondylitis (720.0x), Crohn's disease (555.x), non-Hodgkins lymphoma (200.xx, 202.0x-202.2x, 202.7x-202.8x), or ulcerative colitis (556.x) in any position at any time during the 18-month identification period
a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock

Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Hence, maintenance of adequate tissue perfusion is the mainstay of resuscitation of patients with septic shock.

Serum lactate is still considered the gold standard for evaluation of tissue perfusion. Thus, according to the latest definition, elevated serum lactate, as an indicator of tissue hypo-perfusion, is required for diagnosis of septic shock. However, lactate level change in response to resuscitation is slow even in survivors.

Capillary refill time (CRT) is a simple method for assessing peripheral perfusion. Monitoring CRT was found to be a good tool for guiding resuscitation and delayed CRT showed good ability in predicting mortality in patients with septic shock.

To the best of our knowledge, there is no previous report assessing the reliability of an index that include both serum lactate and CRT (lactate/CRT index) in predicting mortality in patients with septic shock.

We hypothesize that the lactate/CRT index would have good accuracy in predicting mortality in patient with septic shock.

All patients will be monitored with; non-invasive and invasive arterial blood pressure, five-lead electrocardiography (ECG), hourly urinary output, and central venous pressure (CVP). Management of the patients will be done according to the latest surviving sepsis campaign guidelines in 2016. APACHE II score will be calculated on the time of admission using MDCalc ©.

Arterial blood gases, including serum lactate (blood gas analysis device GEM premier 300, Instrumentation Laboratory, Bedford, MA, USA), will be obtained at the time of intensive care unit admission, 6 and 12 hours after admission. Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch. CRT will be recoded at the same time point as the blood sample.

The change in serum lactate (∆ Lactate), and CRT (∆ CRT) will be calculated as the difference between each two-consecutive measurement. Lactate/CRT index will be calculated as the product of multiplying the CRT and serum lactate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected septic shock, older than 18 years old

Exclusion Criteria:

* Patients less than 18 years.
* patients with evident blood loss.
* patients with metastatic cancer.
* Patients with Child B or C liver cirrhosis
* patients with estimated glomerulo filtartion rate less than 30 ml/min/m2
To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris

This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.

The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body

Eligibility Criteria:
Inclusion criteria

1. Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for \> 6 months). Patients age 16 - 21 will be considered on a case by case basis. Patients below 18 will need parental consent.
2. Extensive skin involvement.
3. Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
4. Psoriasis treated with emollients only for 2 weeks prior to treatment
5. Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
6. History of psoriasis that cannot be treated with topical agents or with previous systemic/ photo(chemo)therapy agents.

Exclusion Criteria:

1. . Positive serology for HIV, Hepatitis B, or Hepatitis C.
2. . Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
3. Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
4. Active infection or persistent fever of unknown origin. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.

6) Any history of an un-treated neoplasm
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD

The purpose of this study is to apply Avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.

Investigators hope to learn if micro-current stimulation to a chronic, non-healing wound can be lead to healing. Perfusion studies and bacterial measurements will be assessed before and after treatment on this cross-over study.

Avazzia microcurrent stimulation was applied to patients with chronic, non-healing wounds in Malaysia and was presented at the international wound conference. In 2015 a poster presentation was presented with a 10-patient case series, and in August 2016, a presentation was made by Dr. Nair, keynote speaker about his 100- patient case series showing that the treatment was safe and effective. Dr. Nair followed this study with a 5-patient study looking at perfusion images using SPY- LUNA imaging equipment. The 5-patient study looked at different methods of applying the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a chronic non-healing wound that has not healed in 30 days in their feet, legs, lower back or buttocks, but not in their hands because the hands will be used to verify equipment operation.
* Age ≥18 and ≤70 years
* Wound area is ≥0.5 cm2 and ≤22 cm2
* Willing and able to comply with weekly visits to clinic (e.g., reliable transportation)

Exclusion Criteria:

* Presence of an electrical implant such as a cardiac pacemaker or neural stimulator
* Patient is currently pregnant, possibly pregnant or breast-feeding User of any microcurrent device in the past six (6) months prior to enrollment in the study
* Patient is experiencing a medical emergency
* Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity
* Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s)
* Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency
* Patient is diagnosed with malignancies (cancers) undergoing treatment
Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma

This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 45 years of age or older
2. A visually significant cataract
3. Diagnosis of mild OAG

   * Vertical C/D ratio of less than or equal to 0.8
   * VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss)
   * Medicated IOP 25 of less than or equal to mmHg on 1-3 medications
   * If treatment naïve (before glaucoma treatment) IOP between 21 and 35 mmHg
4. Glaucoma must be judged as stable by investigator based on review of subject medical records

   * Stable VF at least 1 year prior to surgery
   * Stable nerve fiber layer at least 1 year prior to surgery
   * IOP stable on current medication regimen at least 3 months prior to surgery
5. Shaffer grade of greater than III in all quadrants
6. Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
7. Able and willing to comply with follow up visits
8. Understands and signs the informed consent

Exclusion Criteria:

1. Previous incisional glaucoma surgery or cilio-ablative surgery
2. Prior laser trabeculoplasty within 90 days of surgery
3. Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
4. Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
5. Severe and/or progressive glaucoma defined as

   * VF mean deviation worse than -12.00 dB
   * Consistent worsening of visual field on review of subject medical records
   * Consistent and progressive thinning of nerve fiber layer on review of subject medical records
   * Uncontrolled IOP on maximum glaucoma medications
   * Historically poor IOP control with medical therapy
   * Severe focal notching of the optic nerve rim
   * Expectation for future need of incisional glaucoma surgery
6. Ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period.
7. Ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e. significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc.
8. Pregnant or breastfeeding women
9. Prior refractive surgery e.g. LASIK, RK, PRK, etc.
STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.

The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:

I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).

II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).

III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).

The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years scheduled for cystectomy due to bladder cancer
* Referral to neoadjuvant chemotherapy
* Screened positive for minimum 1 SNAP factor
* Signed informed consent

Exclusion Criteria:

* Pregnancy and breastfeeding
* Allergy to pharmaceutical support (Nicotine Replacement Therapy, Disulfiram)
* Contraindications to exercise.
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.

The main objectives of this study are to determine the individual and combined effects of Raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density for which the study has been powered. Breast density is a major risk factor for breast cancer and hence it is chosen to evaluate the potential chemopreventive efficacy of our interventions. Secondary endpoints would include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling, all of which have been shown in the literature to have an influence on mammary carcinogenesis.

Study Population: Healthy, postmenopausal women between the ages of 35-70 years, undergoing yearly mammograms as part of routine screening practice.

Method of Identification of Subjects/Samples/Medical Records: Women reporting for yearly mammograms will be considered for this protocol. They will be given first a screening questionnaire to rule out any co-existing medical condition that would predispose them to thromboembolic events.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy
* Breast density greater than 25%
* No hormone replacement therapy for at least six months prior to entry into this study
* Non-smokers.

Exclusion Criteria:

* History of stroke, pulmonary embolism or deep vein thrombosis
* History of atherosclerotic heart disease
* Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)
* Diabetes mellitus
* Uncontrolled hypertension (BP ≥140/90)
* Presence of a psychiatric condition that would interfere with adherence to the protocol.
Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study

A study of the relation between genetic biomarkers and child language development in Taiwan.

The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with language disorder:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent
* Exclusion Criteria of Child with language disorder:
* Hearing Impairment

Inclusion Criteria of Adult:

* His or her child participated in this study, and gene abnormality was found.
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)

Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the cholesterol ester transfer protein (CETP), in healthy male subjects with high density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.

This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl

Exclusion Criteria:

* Clinically relevant pathological findings
Open-label Study of ASP2151 in Herpes Simplex Patients

A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria

   * Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
   * Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
   * Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles
2. Patients who can start receiving the study drug within 48 hours after onset of rash
3. Age: 16 years or older, but younger than 80 years

Exclusion Criteria:

1. Patients who are not expected to have an adequate response to oral antiviral medication.
2. Patients with two or more types of herpes simplex.
3. An extreme decline in immune function
4. Presence of serious complications
5. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

   * AST or ALT ≥ 2.5 x upper limit of normal
   * Platelet count \< lower limit of normal
   * Serum creatinine ≥ 1.5 mg/dL
   * Creatinine clearance \< 30 mL/min
6. Current or previous history of malignant tumor within 5 years before informed consent
7. Diagnosis of autoimmune disease
Perfusion CT Registry

The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 20
* Patient who has a coronary perfusion computed tomography

Exclusion Criteria:

* Unwillingness or inability to give informed consent