cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder

This research study evaluates the effects of anFDA-approved medication NAC in individuals with Bipolar Disorder. Participants in the study will will be assigned to two medication conditions and will take both NAC and a matched placebo. The order in which they take each medication will be random. Study medication will be taken for 14 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-60 years
2. Meet DSM-5 criteria for bipolar I or II disorder
3. Able to provide informed consent and read, understand, and accurately complete assessment instruments
4. Willing to commit to medication treatment and follow-up assessments
5. Meets DSM-5 criteria for any mood episode (i.e., Major Depressive, Hypomanic, Manic), Current or In Partial Remission
6. Prescribed daily use of at least one FDA-approved mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic)
7. Willing to abstain from antioxidant supplements (e.g., coenzyme Q-10, vitamin E) for the duration of the study.

Exclusion Criteria:

1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
2. Meet DSM-5 criteria for substance use disorder (other than Tobacco Use Disorder) within the past 6 months.
3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
4. Any history of brain injury with loss of consciousness greater than 5 minutes
5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
9. Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be hazardous if taken with N-Acetylcysteine (NAC).
10. Medication dose changes of ≥ 20% ≤ 2 weeks prior to testing
11. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
12. Current suicidal or homicidal risk
13. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
14. Has taken NAC in the last month or experienced adverse effects/allergic reaction from it at any time
15. Significant claustrophobia and/or past negative experiences with MRI
16. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
Research on the Application and Mechanism of New Biological Probes in Biomedicine

Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form voluntarily.
* Age 18-70 years old.
* High expression (positive) group: The results of multiple laboratory tests indicate that the marker is higher than the normal range.
* Low expression (negative) healthy volunteer group: those with no underlying diseases and no abnormalities in the physical examination.
* Have routine examination to check the remaining body fluid samples, and the body fluid samples are not contaminated.

Exclusion Criteria:

* Accompanied by other inflammations.
* The data of the subject is not complete, or the collection of cases is incomplete due to other reasons.
* The researcher judged that it was not suitable to participate in this research.
Prilocaine for Spinal Anesthesia in Ambulatory Setting

The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.

We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings.

Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

* General Anesthesia
* Procedures lasting longer than 2 hours
Improving Medical Decision Making for Older Patients With End Stage Renal Disease

The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.

The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet. The video will be shared with their nephrologist. The patient will have a copy of the video to take with them and share with their loved ones.

Patients will answer survey questions about their preferences, knowledge, decisional conflict, and ACP engagement. They will be surveyed every two months for one year or death (if they die before one year).

Potential participants will be recruited from 10 nephrology clinics: Massachusetts General Hospital (n=75), Brigham and Women's Hospital (n=75), University of Pittsburgh (n=75), University of Pennsylvania, Stanford University, Palo Alto Veterans Institute for Research, University of Washington, Renal \& Transplant Associates of New England, University of New Mexico and Boston Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥70 are eligible if they have EITHER Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 in the past 12 months NOT determined to be a result of AKI OR Have a diagnosis of CKD and less than a two-year prognosis from any cause, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")
* Patients age 65-69 are eligible if they have BOTH Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 NOT determined to be a result of AKI AND Have less than a two-year prognosis, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")
* Patients who have not had a nephrology visit in the past 12 months can be recruited from non-Nephrology Clinics per the above eligibility criteria

Exclusion Criteria:

* listed for kidney transplantation or previous transplant recipient
* already on or previously on dialysis (including emergent dialysis)
* new patient visit
* visually impaired beyond 20/200 corrected
* psychological state not appropriate for ACP discussions as determined by the primary nephrologist
* cognitive impairment
Efficacy of Home-Based Posture Exercises As an Addition to Pharmacological Treatment in Fibromyalgia

This interventional study aimed to evaluate the effects of home exercise in addition to pharmacological treatment on pain threshold and spinal mobility in fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants were between the ages of 18 and 65,
* No diagnosis of rheumatic disease,
* No diagnosis of chronic comorbid disease,
* Participants diagnosed with fibromyalgia syndrome according to the European League Against Rheumatism (EULAR) criteria will be included as volunteers.

Exclusion Criteria:

* Patients under 18, over 65 years of age
* Those diagnosed with chronic comorbid diseases
* Those with a history of rheumatic disease
Implementing Pathways to Improve Pediatric Asthma Care

Background:

Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care.

Primary Objective:

To evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings.

Primary Endpoints:

1. Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
2. Inpatient/Hospital: Mean length of hospital stay

Study Design:

This project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.


Eligibility Criteria:
Participant/Local champion Eligibility Criteria:

Inclusion Criteria:

* Working as a physician at the study site

Exclusion Criteria:

* None

Patient/child eligibility criteria:

Inclusion Criteria:

* Age 2-17 years
* Primary diagnosis of asthma

Exclusion Criteria:

* Transferred in from another inpatient facility
* Presence of a chronic medical condition that precludes pathway use
Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

Trial protocol intended the optimization of induction treatment with:

1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.
2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration
3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making.

For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy.

Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second.

Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions


Eligibility Criteria:
Inclusion Criteria:

* ALL de novo high-risk criteria
* Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)
* No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome
* General condition suitable scale (ECOG 0-2), or\> 2 if due to ALL
* Negative pregnancy test for women of childbearing age
* Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them

Exclusion Criteria:

* L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.
* LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).
* Lymphoid blast crisis of chronic myeloid leukemia
* Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group
* Undifferentiated acute leukemias
* Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines
* Patients with chronic phase of activity
* Patients with severe chronic respiratory failure
* Kidney failure due to ALL
* Serious neurological disorder not due to the LAL
* History of pancreatitis
* Pregnancy or breastfeeding
* Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study
* General condition affected, not attributable to the ALL
The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

Intraocular surgery could induce vitreous degeneration and then abnormal posterior vitreous detachment (PVD) could occur including vitreoschisis and partial-thickness PVD. Vitreomacular interface (VMI) abnormalities such as epimacular membrane were observed following many intraocular surgeries. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.

The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, and then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months.

Tsukahara et al introduced wide-field OCT-based PVD classification. The advance OCT device will be useful in detection of abnormal PVD and it's sequelae. If the risk factors of post-phacoemulsification PVD were explored, the prevention of abnormal PVD and VMI disorders could be done.

Eligibility Criteria:
Inclusion Criteria:

* Cataract patients who was scheduled for phacoemulsification
* Age \>50 years
* No complete PVD was detected by OCT
* Can be taken the wide-field OCT images
* Written informed consent

Exclusion Criteria:

* Secondary cataract)
* History of ocular trauma or head trauma
* Systemic diseases that can cause the intraocular problems such as connective tissue disease
* History of other ocular diseases such as glaucoma, uveitis and vitreoretinal disorders
* History of intraocular laser treatment
* History of intraocular surgery such as intravitreal drug injection

Withdrawal Criteria:

* Intraoperative complications such as posterior capsular rupture and zonule dialysis
* Postoperative complications such as vitreous hemorrhage and postoperative endophthalmitis
* Undergo the intraocular surgery during the follow-up period
* Receiving the intraocular laser treatment during the follow-up period such as laser capsulotomy and panretinal photocoagulation
* Having the ocular trauma or head trauma during the follow-up period
A Trial of CM-AT in Children With Autism- Open Label Extension Study

The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.

Autism is currently a significant cause of disability in the pediatric population. CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a powder taken three times a day. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.

Eligibility Criteria:
Inclusion Criteria:

* Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
* Ongoing 00102 Protocol required completion of 00101 Protocol
* Now recruiting subjects directly into 00102 Protocol

Exclusion Criteria:

* Ongoing study required patients to be 3-8 years old weighing \< 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing \< 22kg (48.4 lbs.).
* Newly recruited subjects must be between ages 9 - 12 years old weighing \< 22kgs (48.4 lbs.)
* Demonstrated previous allergy to porcine (pork) products
* Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
* Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
* Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
* Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance
Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic.
* Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications.
* Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.

Exclusion Criteria:

* Subjects who are pregnant.
* Subjects who have significant obesity.
* Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
* Subjects with active viral disease, i.e. hepatitis, HIV.
A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy

The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and / or after RP) over 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have histologically confirmed adenocarcinoma of the prostate
* Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
* Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (\>) 20 nanograms per milliliter (ng/mL)
* Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
* Participants must have received at least one perioperative hormonal therapy pattern as listed below:

  1. greater than or equal to (\>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be less than or equal to (\<=) 2 months; and/or
  2. \>= 6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery

     Exclusion Criteria:
* Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

This trial is an open, national, multi-centre trial. The trial will be initiated after olive pollen season 2012 and subjects will receive treatment for 6 weeks.

The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The frequency of patients with adverse reactions will be the primary endpoint.

Frequency of patients with systemic reactions according to EAACI classification, increase in IgG4 and in IgE and reduction in immediate skin reactivity.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18-65 years of age.
2. A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
3. Positive SPT to olive pollen (wheal diameter ≥ 3 mm).
4. A positive specific IgE against olive pollen (≥Class 2; ≥0.70 KU/L) documented in the last 5 y

Exclusion Criteria:

1. FEV1 \< 70% of predicted value at screening after adequate pharmacologic treatment.
2. Uncontrolled or severe asthma.
3. A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized.
4. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
5. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
6. Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
7. Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
8. Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
9. History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
10. History of severe and recurrent angioedema.
11. Any contraindication according to the Investigator Brochure (IB).
12. Use of an investigational drug within 30 days prior to screening.