cyrilzakka/clinical-trials huggingface dataset:
The Multi-Media Social Skills Project for Adults

This study is investigating the development of a social skills training program for adults with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal Investigator for this study is Dr. Michael Murray, the director of the Autism Studies Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a social skills training program to address and enhance the social skills of adults with Asperger's Syndrome and high-functioning autism.

During group study visits, a group of six young adults with Asperger's Syndrome or high-functioning autism will meet weekly for about 90 minutes. The purpose of the group sessions is to work on everyday social skills such as initiating and maintaining conversations, establishing friendships, and dealing with situations such as job interviews and dating.

A generalization session will be held every week after the group therapy session with same-age peers who have been screened to participate in the study. The purpose of including peers in the class is to give young adults with Asperger's syndrome and high-functioning autism a chance to practice the social skills learned in the group study visit with a peer group. Study participants will be paired with a typically developing peer for an outing in the community to a nearby restaurant or shop or an in-class exercise such as a mock job interview.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 35 years of age
* Must be a Pennsylvania resident
* A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the SRS-2
* A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition
* English as primary language spoken
* Ability to fluently speak in full sentences

Exclusion Criteria:

* A significant language delay
* Difficulty with aggression directed at peers
* A primary thought disorder
* A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
* A current high school student at start of intervention
* Low social motivation demonstrated through formalized assessment and/or by responses given to screening interview
A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)

This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.


Eligibility Criteria:
Inclusion Criteria for All Participants

* Males and females
* Availability of a parent or other reliable caregiver. The same person must agree to accompany the participant to all clinic visits and provide information about the participant's behavior and symptoms

Inclusion Criteria for Participants with Autism Spectrum Disorders (ASD)(Diagnostic evaluations will be completed at study site by research staff and supervised by a licensed psychologist)

* Age: 5-45 years
* Diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and the Autism Diagnostic Observation Schedule (ADOS-2).
* Children's Yale-Brown Obsessive Compulsive Scale modified for ASD (CY-BOCS-ASD) total score of at least 12
* Clinical Global Impression-Severity (CGI-S) scale of at least 4 about participant's current autism severity
* Intelligence quotient (IQ) score of 50 or above as assessed by the Abbreviated Intelligence Quotient (ABIQ) SB5 scale
* All medications and treatments are expected to be stable for the duration of the study

Inclusion Criteria for Typically Developing (TD) Healthy Participants

-TD participants aged 5-45 years

Exclusion Criteria for All Participants

* Participation in an in investigational drug or device study within 4 weeks or 5 times the half-life of the investigational molecule prior to screening, and participant is not expected to enroll in any other trial during the study
* Co-occurring disease, condition, or treatment that might interfere with the conduct of the study or pose an unacceptable risk to the participant
* Unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with study objectives

Exclusion Criteria for Participants with ASD -Known "syndromic" ASD (e.g. Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome) History of alcohol misuse and/or illicit drug use during the last 12 months of the study

Exclusion Criteria for TD Healthy Participants

-TD healthy participants with a first-degree relative with ASD
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus
Artificial Intelligence in Large-scale Breast Cancer Screening

This is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (AI) computer-aided detection (CAD) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. Since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.


Eligibility Criteria:
Inclusion Criteria:

* Participants in regular population-based breast cancer screening at Capio St Göran Hospital

Exclusion Criteria:

* Incomplete exam (complete exam: mediolateral oblique and craniocaudal images of Left and Right breast)
* Breast implant
* Complete mastectomy (excluded from screening positive group)
* Participant in surveillance program for prior breast cancer
Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence

Opiate dependence is a serious problem, and oxytocin has many properties which make it attractive as a treatment for this type of substance dependence. This experiment will test the effects of oxytocin on a variety of brain-based processes in patients with opiate dependence. The investigators hypothesize that intranasal oxytocin in these conditions will enhance emotional processing and will have beneficial effects on stress responses in opiate-dependent patients.


Eligibility Criteria:
Inclusion Criteria:

* adult men 18 years or older
* meet DSM-IV criteria for opiate dependence, and no other active substance dependence disorder save nicotine dependence
* clinically stable, and low risk for suicide as determined by principal investigator and screening questionnaire
* abstinent from non-prescribed opiate use for at least two weeks from Baseline 1 and free from opiate withdrawal symptoms. If on agonist therapy, dose must be stable for 2 weeks before study visit.
* must be able to use nasal spray
* negative salivary drug screen, save for opiates

Exclusion Criteria:

* any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
* any active, severe mental illness, neurological disorder, including schizophrenia, autism, Asperger's syndrome
* are unsuitable in any way to participate in this study, in the opinion of the investigator
* hospitalizations due to complications of an Axis 1 disorder for the past 12 months, excluding drug or alcohol rehabilitation
* any clinically significant chronic pain condition, as determined by the principal investigator
* positive salivary drug screen at the time of the visit, for any substance other than opiates or another prescribed medication
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion Criteria:

* Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.

Other protocol defined inclusion/exclusion criteria apply
Pain Managment in Chronic Shoulder Pain

The purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores

Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain .

The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient .

An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) .

Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged from 21-60 years.
* Patients with American Society of Anesthesiologists (ASA) physical status I and II.
* Chronic shoulder pain (\>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments.

Exclusion Criteria:

* Refusal of procedure or participation in the study by patients.
* History of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied.
* Patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury).
* Uncontrolled diabetes mellitus patients with glycated hemoglobin (HbA1C) levels of more than 7%.
* Patients with known history of allergy to the study drugs.
* Infection at site of injection.
* Cognitive or psychiatric illness that will lead to inability to cooperate, speak, or provide informed consent.
A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants

This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
* Agree to abstain from strenuous physical activity outside of daily norm, until end of study.
* Body mass index between 16 and 32 kg/m2 (inclusive) at screening; weight should be \<= 100 kg at screening.
* Male and/or female using protocol defined and regulatory approved contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.
Role of Alprazolam in the Management of Acute Coronary Syndrome

Cardiovascular disease has always been one of the most concerning ailments of all times considering mortality. On one end due to the emergence of pharmaceutical technology, there is a reduction in mortality, on the other hand owing to a sedentary lifestyle the incidence of this disease is increasing. Hence leading to up slopping trend in cardiovascular prevalence. Acute coronary syndrome is one of the most deadly and acute presentations of cardiology requiring immediate intervention to dampen the frequency of complications. One of the fundamental goals in the treatment of ACS is to lower the heart rate so that load on myocardial tissue can be reduced. In order to do so, we already have multiple options like beta-blockers, calcium channel blockers, and new generation ivabradine (not affecting blood pressure unlike others).

World has studied the increased prevalence of anxiety as a concomitant factor in ACS patients causing detrimental effects on cardiovascular outcomes being anxiety as one of the first responses to chest pain and hospital admission causing tachycardia. This study is designed to achieve the goals of lowering the heart using the anxiolytic property of alprazolam. This randomized, parallel group, close label, placebo-controlled, event driven, interventional clinical superiority study will be conducted in Cardiology department of Shaikh Zayed Hospital with a sample size of 48 allocating using lottery method in both experimental and control group. Heart Rate at baseline and after 6 hours will be monitored in both groups to establish the fall of heart rate in both patients. Data will be collected by using pre-designed performa and will be entered and analyzed via SAS 9.4. Statistical analysis will be done using T-test and p value \<0.05 will be considered significant.

Significance of the study is to lower the required dosage of beta-blockers in order to achieve optimum beta-blockade using an anxiolytic while not affecting the blood pressure.

Eligibility Criteria:
Inclusion Criteria:

Systolic BP\>100mm Hg Age between 18-80 years Sinus Rhythm

Exclusion Criteria:

* Cardiogenic Shock / Hypotension
* Known Asthma/COPD
* Bradycardia (HR \< 60)
* Already on Beta blockers/ Anxiolytics
* Sick sinus syndrome
* Second or third-degree heart block (in the absence of pacemaker)
* Decompensated heart failure
* With documented hypersensitivity to the drug or components
* Valvular Heart Diseases
* Congenital Heart Diseases
* Status post CABG
* Any co-morbidities except Diabetes Mellitus and Hypertension
Biomarkers and Choroidal Neovascularization

The aim of the study is to find biomarkers in the blood and aqueous humor of patients with type 1 choroidal neovascularization and correlate them with the response to anti-VEGF treatment.

Age-related macular degeneration (AMD) is the most frequent cause of blindness in industrialized countries. Multiple molecular pathways have been implicated in the pathogenesis of choroidal neovascularization (CNV). Currently, the treatment relies on neutralization of VEGF (Vascular Endothelial Growth Factor). However some patients have an incomplete response to anti-VEGF treatment. A recent study suggested the implication of the mineralocorticoid receptor pathway in the formation of CNV.

The study (of investigators) aim is to evaluate the concentation of metabolites of MR pathway in the blood and aqueous humor of patients with CNV and compared them with patients without CNV in order to increase our understanding of CNV pathogenesis and find potential biomarker of response to anti-VEGF treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients of group 1:

* Patients with type 1 choroidal neovascularization in a context of central serous chorioretinoathy or age related macular degeneration
* Patients without intravitreal injection or last intravitreal injection \> 3 months
* Informed signed consent

Patients of group 2:

* Patients without choroidal neovascularization
* Patients with intraocular surgery (cataract or vitrectomy surgery)
* Signed consent

Exclusion Criteria:

* Myocardial infarction \< 12 months
* Chronic renal failure
* Inflammatory disease
* Infectious disease :HIV, viral hepatitis, tuberculosis
* Type 1 or 2 Diabetes
* Patients treated by mineralocorticoid antagonist treatment.
* Type 2 or 3 choroidal neovascularization
* Pregnant woman
Evaluation of a Virtual Home Dialysis Mentoring Program (Home)

The Investigator plans to establish a virtual platform for home dialysis physician mentoring with the intent to:

1. Formulate a practical, interactive, virtual curriculum in home dialysis
2. Provide dedicated video conferences in home dialysis mentorship
3. Measure knowledge awareness and attitudes towards home dialysis

Home-based kidney replacement therapy offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Globally, there is an increased awareness of home dialysis. However, there is a lack of mentoring centers to support new programs and/or nephrologists to initiate and grow home dialysis.1, 2 Critical prerequisites for a successful mentoring relationship include:

* Established excellence in home dialysis in the mentor center
* Willingness from both mentors and mentees to participate in the program
* Engaging, high quality clinical content, including sharing of best practices
* Lack of system barriers to establish home dialysis
* Dedicated metrics to measure success of the program

The Investigator plans to establish a virtual platform with the intent to:

1. Formulate a practical, interactive, virtual curriculum in home dialysis
2. Provide dedicated video conferences in home dialysis mentorship
3. Measure knowledge awareness and attitudes towards home dialysis

The Investigator hypothesizes that an effective, sustained mentorship program will increase knowledge and awareness of home dialysis and will ultimately enhance overall home dialysis adoption.

Eligibility Criteria:
Inclusion Criteria:

* Credentialed physicians at Satellite Healthcare
* Nephrology fellows at nephrology training program affiliated with Satellite Healthcare credentialed physician

Exclusion Criteria:

* Any person who does not meet the inclusion criteria
The Doppler Feasibility Study

The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been referred for a cardio-respiratory polygraphy sleep study.
* Patients aged one month up to one year old.

Exclusion Criteria:

* Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
* Child anticipated to become distressed with additional sensor.
* Child too clinically unwell to take part (as decided by clinical staff).
Treatment of Upper Extremity Deep-Vein Thrombosis

The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.

Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.

The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.

All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.

All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.

All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram

Exclusion Criteria:

* Active, clinically significant bleeding
* Known hypersensitivity to heparin or low-molecular weight heparin
* Currently pregnant or less than 1 week post-partum
* Acquired bleeding diathesis
* Known inherited bleeding disorder
* Renal failure
* Extremes of weight
* Poor performance status
* Unable to return for repeat diagnostic testing or follow-up visits
Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or myelodysplastic syndrome.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of dolastatin 10 in patients with chronic myelogenous leukemia in blast phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes. II. Assess the possible antileukemia effect of this treatment in these patients.

OUTLINE: This is a dose escalation study. Patients receive dolastatin 10 intravenous (IV) bolus once every 3 weeks. Patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients, subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10. If DLT occurs in 2 of 3 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are followed until death.

PROJECTED ACCRUAL: This study will accrue up to 25 patients within 8 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed chronic myelogenous leukemia in blastic phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes (refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered (unless evidence of rapid disease progression) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified