cyrilzakka/clinical-trials huggingface dataset:
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging

MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of retinoblastoma
* brain MRI available

Exclusion Criteria:

* insufficient quality of brain MRI
Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis

Self-management is critical for patients with chronic conditions such as rheumatoid arthritis. Such management requires that patients understand what to do to best manage their condition. This study will use a randomized controlled study design to evaluate the impact of a new educational intervention consisting of an educational digital video disc (DVD) and a self-management support session/teleconference with a multidisciplinary team of health care providers for patients (n=150) with active rheumatoid arthritis (RA) starting on or changing biologic agents. This study aims to test whether this intervention improves behavioural intentions, knowledge, and medication adherence three months post-intervention and whether acquired knowledge is retained six months after the intervention. This project will allow to quantify the impact of the educational intervention on patients' behavioural intentions in practical situations using an existing validated questionnaire called BioSecure. The impact of the educational intervention on disease-specific knowledge and on medication adherence will be evaluated using validated questionnaires.

The primary objective of this study was to determine whether patients with active RA starting or changing biological agents demonstrate better self-care safety skills in practical situations using the BioSecure questionnaire three months after receiving a multidisciplinary educational intervention, as compared to patients who received usual care. The secondary objectives were to assess the impact of the educational intervention on behavioral intentions and beliefs and adherence to RA medications in patients receiving the intervention compared to usual care.

Trial design This was a pilot, unblinded, randomized study. Participants in group 1 received the usual care plus the multidisciplinary educational intervention at baseline. Participants in group 2 first received usual care, and after 3 months were offered the intervention. The patients' self-care safety skills was measured using the BioSecure questionnaire, and the behavioral intentions and beliefs with respect to medications was assessed using structured questionnaires at baseline, 3 and 6 months. With the participant authorization, data on RA medication adherence, i.e. biological agents and other non-biologic Disease-modifying anti-rheumatic drugs (nbDMARDs) was obtained for the 3 months preceding enrollment and up to 6 months afterwards using their pharmacy records.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and had a diagnosis of RA,
* with active disease as per rheumatologist evaluation,
* having received a trial of two traditional nbDMARDs therapy, and
* who requires the addition or change of a biological agent

Exclusion Criteria:

* patient unable to consent,
* patient unable to answer questionnaires,
* patient unable to view a DVD at home
* patient unable to participate in a teleconference
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).


Eligibility Criteria:
Inclusion criteria:

1. Completion of the double-blind trial 248.524 or 248.636
2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).

Exclusion criteria:

1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
2. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.History of psychosis, except history of drug induced hallucinations.

5. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.

10. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin \> 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance \< 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.

14. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline.

17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.

19. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
Multi-joint Muscle Fatigability and Gait Performance in People With Multiple Sclerosis

The purpose of this study is to compare walking to leg strength and endurance in people with multiple sclerosis (PwMS). Using these findings, we hope to be better understand what causes PwMS to have problems walking.

The purposes of the research are to determine the association of gait performance with lower extremity muscle fatigability and strength measures, and create a preliminary model that can better explain the variance in gait performance based on these muscle performance values. Objective criterion-based measures of physical fatigue (i.e., fatigability) and muscle weakness have been associated with impaired task performance in people with multiple sclerosis (MS). MS-related deficits in muscle capacity result in higher fall risks and a loss of function. However, it is unclear if lower extremity fatigability tests add clinical value to objective strength testing in the rehabilitation and clinical management of MS. Better understanding how patterns of lower extremity (LE) fatigability and strength affect mobility in people with MS could improve outcome measure development and inform rehabilitation strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years
* History of multiple sclerosis
* Expanded Disability Status Scale \< 7.0
* Receives care at the Washington DC Veteran's Affairs Medical Center Neurology Service and Multiple Sclerosis Center of Excellence - East
Serum Amyloid A in Women With Unexplained Infertility

High follicular fluid amyloid A level is associated with reduced pregnancy rate.

The aim of this study was to find an association between serum level of amyloid A and unexplained infertility.


Eligibility Criteria:
Inclusion Criteria:

1. women with unexplained infertility (unprotected, regular intercourse for at least 2 years).
2. Nulligravida ,Regular mensturation.
3. Age less than 40 years .
4. Normal parameters (in the study group):

   * hormonal profile (day 2 FSH,LH), midluteal phase progesterone, Prolactin, TSH
   * transvaginal ultrasound
   * hysterosalpingography
   * detailed semen analysis

Exclusion Criteria:

1. Age above 40
2. Smoking females
3. Obesity (BMI\>30)
4. Women with any systemic or medical diseases leads to elevation of SAA as:

   1. Systemic lupus erythematosis
   2. Rheumatoid arthritis
   3. Sarcoidosis
   4. Diabetes Mellitus
5. Using hormonal contraception (for control group)
Telephone Counseling and the Distribution of Nicotine Patches to Smokers

The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:

1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
2. Test if sending placebo patches directly will also lead to a higher quit rate.
3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* Daily smoker
* \>=6 cigarettes per day
* Ready to quit within one month
* First time quitline caller
* Valid phone number
* Valid address (no P.O. boxes)
* California resident
* Agree to participate in study and evaluation
* English or Spanish speaking

Exclusion Criteria:

* Uses other form of tobacco
* Use of Zyban or Chantix
* One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
Telehealth Intervention in Cirrhotics

This study is a randomized controlled trial comparing a simple telehealth intervention implemented after hospital discharge to standard of care, specifically looking at the number of hospital readmissions throughout the course of the study. All cirrhotic patients admitted to the Hepatology service at The Hospital of the University of Pennsylvania will be approached and consenting patients will be randomized to one of the two arms as outlined below. Patients will be followed for 90 days with daily texts and weekly phone calls. The rates of 30 and 90 day readmission as well as the days to readmission will be compared between the two study groups.

Patients with cirrhosis and ascites comprise a large percentage of hospital admissions. As a large transplant center, the University of Pennsylvania sees an average of 54-65 cirrhotic patients admitted to the hepatology service every month. Many of these admissions are preventable and can be attributed to poor medication adherence and late detection of clinical deterioration. By introducing a telehealth intervention following hospital discharge, investigators seek to decrease the number of readmissions for these patients by encouraging and assisting with improved adherence and by regularly tracking the progression of symptoms.

This interventional study will serve a dual purpose of helping both the patient and their provider. Patients will obtain an extra line of communication to their providers that eases their ability to access resources and alert their providers to new symptoms. Similarly, by instituting a triaged system of communication with the patient, their health team is able to offer more individualized treatment while also providing more immediate attention at the first signs of clinical deterioration. This study will determine rates of 30 and 90-day readmissions in both cohorts as a way to examine the impact of a simple telehealth intervention compared to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cirrhosis of the liver
* Admitted to the Hospital of the University of Pennsylvania
* Ability to read and provide informed consent in English
* Ability to read and provide informed consent or surrogate present who can provide consent
* Possess a cell phone and willing to receive text messages.
* Has a surrogate who with a cell phone who is willing to receive and sent text messages for patient

Exclusion Criteria:

* Inability to provide informed consent in English
* Inability to provide informed consent or lack of surrogate who can provide consent
* Non-Cirrhotic
* Has received a liver transplant
* Discharged to hospice or has a disease process other than cirrhosis (i.e. severe heart disease or cancer) accounting for a high chance of mortality in the next 6 months.
* Advance symptoms of other disease process or too medically complex
* Actively using illicit substances or alcohol
* No access to cell phone with texting capability
* Not followed at the Hospital of the University of Pennsylvania
Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger

Despite conscious intentions to remain abstinent, persons with substance use disorders often find that negative emotions and environmental cues automatically "trigger" drinking and other substance use. This study aims to test whether activating the baroreflex mechanism can be used "in the moment" to help resist drinking triggers. It consists of 3 phases (Recruitment, Intervention, Follow-up).

Stage 1: Trained research staff conduct a comprehensive clinical interview and questionnaires to assess participant's mood, substance use, and triggers. Participants are paired with a Primary Research Clinician (PRC) who will work with them during the intervention.

Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway, NJ. Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers University Brain Imaging Center, Newark, NJ). Participants are randomized into an active intervention or control group after the pre-intervention lab session. They are given an iPhone and trained to use a paced breathing app that is pre-loaded onto the phone. Participants in both groups use their app any time they anticipate or experience a trigger to drink or use drugs. Participants are compensated for their use of the app and the time for participation. To ensure that participants are correctly performing the paced breathing task, their PRC visit with them weekly to provide coaching sessions using a computer-based biofeedback program. During the 4th week, ECG and respiration data are collected. Participants also complete questionnaires about mood and triggers, and provide feedback on the usefulness of the app.

During the lab sessions, participants complete a series of questionnaires and ECG, blood pressure and respiration are collected during four 5-minute tasks (resting baseline, non-resonance breathing, resonance breathing, and visual processing/attention). During the neuroimaging sessions, participants are placed in the scanner for structural scans and four 5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded.

Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete questionnaires about their quality of life across multiple domains and the usefulness of the app.


Eligibility Criteria:
Inclusion Criteria:

* Women over age 18
* Women diagnosed with substance use disorder
* Women participating in IOP at Center for Great Expectations, New Brunswick, NJ

Exclusion Criteria:

* Pregnancy
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

To investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

This investigation will be conducted to investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI Intravenous Infusion 120mg, 500mg in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Among the safety specifications defined in the Japan Risk Management Plan of IMFINZI, the following items are set as the safety specifications for this study.

Interstitial lung disease, Colitis/Severe diarrhoea, Hepatic function disorder/Hepatis/Cholangitis Sclerosing, Endocrine disorders (Dysfunction thyroid, Dysfunction adrenal, Pituitary dysfunction), Type 1 diabetes mellitus, Renal disorder (interstitial nephritis, etc), Myositis, Myocarditis, Myasthenia gravis, Immune thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including guillain-barre syndrome), Infusion reaction, Pancreatitis, Gastrointestinal perforation, Rhabdomyolysis, Meningitis, Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal toxicity and Use in patients with a history of organ transplant (including haematopoietic stem cell transplant).

Eligibility Criteria:
Inclusion Criteria:

* Patients with curatively unresectable biliary tract cancer who receive IMFINZI for the first time in combination with gemcitabine hydrochloride and cisplatin.

Exclusion Criteria:

-
Gene Therapy Study in Severe Haemophilia A Patients (270-201)

This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, dose escalation study in order to determine the safety and efficacy of valoctocogene roxaparvovec (an Adenovirus-Associated Virus based gene therapy vector in participants with severe haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

1. Males 18 years or older with established severe Haemophilia A (endogenous FVIII level ≤1 IU/dL) as evidenced by their medical history.
2. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days (EDs)
3. Greater than or equal to 12 bleeding episodes for patients on on-demand FVIII replacement therapy over the previous 12 months. Does not apply to patients on prophylaxis
4. No history of inhibitor, and results from a modified Nijmegen Bethesda assay of less than 0.6 Bethesda Units (BU) 2 consecutive occasions at least one week apart within the past 12 months
5. Sexually active patients must be willing to use an acceptable method of contraception.

Exclusion Criteria:

1. Detectable pre-existing immunity to the AAV5 capsid as measured by adeno-associated virus 5 (AAV5) transduction inhibition (TI) or AAV5 total antibodies
2. Any evidence of immunosuppressive disorder or active chronic infection including hepatis B, hepatitis C, HIV
3. Significant liver dysfunction as defined by abnormal elevation ofliver function tests, or for patients who have undergone liver imaging or biopsy and found to have evidence of grade 3 or higher fibrosis
4. Evidence of any bleeding disorder not related to haemophilia A
5. 12. Treatment with any investigational product within 30 days prior to the end of the screening period, or any previous exposure to any gene transfer therapy
6. Any disease or condition that per the physician's discretion would prevent the patient from fully complying with the requirements of the study including possible corticosteroid treatment outlined in the protocol. The physician may exclude patients unwilling or unable to agree on not using alcohol for the 16-week period following the viral infusion.