cyrilzakka/clinical-trials huggingface dataset:
Melatonin for Sleep in MS

Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration.

To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20-70 with a diagnosis of MS by 2010 McDonald Criteria or CIS (clinically isolated syndrome), who report sleep disturbance as measured by a score \>=5 on the Pittsburgh Sleep Quality Index, or more specific insomnia symptoms (a score of \>14 on the Insomnia Severity Index) over the past month.
* Participants must be able to read and write English

Exclusion Criteria:

* Individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (DMTs) in prior month.
* Non-English speaking individuals
* Individuals with hypertension, impaired liver function, or seizure disorder
* Individuals with untreated depression, as determined by a score greater than or equal to 8 points on the HADS (Hospital Anxiety and Depression Scale)
More Individualized Care: Assessment and Recovery Through Engagement

The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time. The study tests whether offering nurse support to the patient and their primary care team that addresses these things and related issues can improve patients' health and well-being. Eligible subjects are identified automatically using health system data and randomly assigned 50:50 to either a no-contact usual care arm or to the arm offered the MI-CARE program.


Eligibility Criteria:
INCLUSION CRITERIA

Eligible patients must meet all 4 criteria:

1. ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date);
2. Age ≥18 years at the pull date;
3. ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date.
4. Evidence of potential OUD in the 365 days prior to and including the date of the qualifying PHQ-9 score. Any 1 of the following qualifies as evidence of potential OUD:

   1. ≥1 active OUD ICD-10 diagnosis code in any setting except labs;
   2. ≥1 prescription (orders or dispensed) for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
   3. ≥1 procedure code for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
   4. ≥1 ICD-10 codes for opioid overdose;
   5. ≥1 OUD ICD-10 code, including remission, and prescription (orders or dispensed) or procedure code for injectable naltrexone.

EXCLUSION CRITERIA

Patients are ineligible who meet any of the criteria below:

1. The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2;
2. The patient has already been randomized to the trial or was outreached in the pilot study (including outreach to the primary care provider only);
3. English interpreter required (per health system records).
4. Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ:

   1. Alzheimer's disease or dementia diagnosis.
   2. Medication to treat Alzheimer's or dementia.

   (b) Severe cognitive limitations.
5. Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers).
6. Previously requested to not participate in research studies at the health system;
7. Documentation of hospice care in the 2 years prior to and including the date of the qualifying PHQ score;
8. Patient is actively being outreached for (or is participating in) depression care management (Kaiser Permanente Washington only)
Advanced MR Imaging of Osteoarthritis

The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:

1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult.
2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.

Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.

This study aims to help address these issues by:

1. Calculating effect sizes for MR measurements to inform sample size calculations for future studies.
2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.

The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.

Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.

This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.


Eligibility Criteria:
Group 1 Inclusion Criteria:

* Meets American College of Rheumatology (ACR) criteria for OA
* Kellgren-Lawrence grade 2-3 OA on knee radiograph
* Medial compartment predominant disease
* Neutral alignment
* Aged 40-60
* Body Mass Index (BMI) \< 35 kg per square meter
* Ambulatory and in good general health

Group 2 Inclusion Criteria:

* No current symptoms of knee pain or stiffness or other clinical features of OA
* Aged 40-60
* BMI \< 35 kg per square meter
* Ambulatory and in good general health

Exclusion Criteria (both groups):

* History of ipsilateral lower limb fracture
* History of ipsilateral lower limb surgery (including arthroscopy)
* Metabolic bone disease
* Inflammatory arthritis
* Haematological malignancy
* Paget's disease
* Bone metastases
* Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
* Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)
* Unable to consent
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients

The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Hemoglobin A1c levels \>=7.5% and \<=10.5%;
* Body mass index (BMI) 25 to 45 kg/m2;
* Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
The Nash-wo-Numa (Childhood Growth & Development) Study

The proposed study will be a cross-sectional study in the District of Matiari, Pakistan. Children ages 9-15 years will be identified from a Matiari District household census scheduled being conducted from December 2016- to May 2017 by the Department of Pediatrics and Child Health, Aga Khan University. Anthropometric measures, Tanner Stage, Hemoglobin concentration, blood draw as well as questionnaires will be assessed in all participants.


Eligibility Criteria:
Inclusion Criteria:

* All girls between 9.0-14.9 years of age and boys between 10.0-15.9 years of age at the time of enrollment who are permanent residents of Matiari are eligible to participate in the Nash-wo-Numa Study.
* The participant's birth mother must also be available to participate in the study and be cognitively able to answer questions since they will be able to provide more accurate information about the birth characteristics of the participant as well as household information like dietary intake

Exclusion Criteria:

* Children not meeting the age criteria will not be invited to participate in the study. Female participants who are pregnant or have been pregnant will be excluded from the study.
* Participants must not be participating in any other nutrition trials. Participants with known chronic or genetic diseases that impact growth will be excluded.
* An illustrative list of conditions include: congenital heart disease, metabolic disorders (e.g. diabetes), cancer, genetic disorders (Down's syndrome, Turner's syndrome), blood disorders (symptomatic thalassemia, sickle cell anaemia), chronic disorders (kidney i.e. nephrotic syndrome, gastrointestinal i.e. Crohn's, bone dysplasia, immunodeficiency disorders).
Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study

Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.

The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).


Eligibility Criteria:
Please note: Only individuals who receive primary care at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA, are eligible for this study.

Inclusion Criteria:

* Age between 18 and 80 years old
* Obese based on World Health Organization criteria (BMI\>30kg/m2)
* Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
* Able to understand and sign an informed consent document
* Able to communicate with the investigator and understand the requirements of this study

Exclusion Criteria

* Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
* Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
* Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
* Women who are breastfeeding
* Prisoners
* Children
* Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years
* Individuals with uncontrolled hypertension (systolic blood pressure (SBP) \>165, diastolic blood pressure (DBP) \>100)
* Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),
* Individuals already using weight loss therapy
* Individuals with an inability to learn adequately from English language audio-taped materials
* Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)
* Individuals without access to a scale
* Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.


Eligibility Criteria:
Inclusion:

* Remain on present anti-HIV drugs during screening until a new regimen is started.
* Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
* Have an HIV which shows reduced susceptibility to lopinavir.
* Are at least 18 years old.
* Are not presently ill.
* Have not been treated for an opportunistic infection within 30 days of screening.
* Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
* Agree to use an accepted barrier method of birth control.

Exclusion:

* Female subject is pregnant or lactating.
* Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
* Are taking chemotherapy.
* Have a medical problem with their pancreas.
* Have been screened for this study within the past 12 weeks.
* Appear to be unsuitable in the opinion of the doctor.
A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators

The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a valid driver's license with a minimum of 3 years of driving experience.
2. Subject reports daily driving activity.
3. Subject is fluent in English.
4. Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
5. Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria

Exclusion criteria:

1. Subject is significantly underweight or morbidly obese.
2. Subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining Physician, will contraindicate SPD465 treatment or confound efficacy or safety assessments.
3. Subject with a lifetime history of psychosis or bipolar disorder.
4. Subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated.
5. Subject with a history of mental retardation or a severe learning disability.
6. Subject is naïve to ADHD treatment with methylphenidate or amphetamine.
7. Subject has a history of glaucoma or narrow angle glaucoma.
8. Subject has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
9. Subject has known cardiac structural abnormalities as well as any other condition that may affect cardiac performance.
10. Subject has clinically significant ECG or laboratory abnormalities at Screening or Baseline.
11. Subject has a history of hypertension or has a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg10.
12. Subject has used any psychoactive prescription medication or over-the-counter (OTC) medication requiring more than a 28-day washout. Hormonal contraceptives are acceptable.
13. Subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine.
14. Subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine).
15. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
16. Female subject is pregnant or lactating.
A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.

The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.

Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.

Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.

The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.

The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.

Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.

Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone.

Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure.

The data is then taken from the video and analyzed by a blinded operator.

Eligibility Criteria:
Inclusion Criteria:

* ASA status 1-2
* BMI \< 35
* Elective surgery
* General Anesthesia

Exclusion Criteria:

* Difficult intubation
* Indication for rapid sequence intubation
* Contraindication for cervical collar
Radiodiagnostic Properties of Maxillary Antroliths

Background: To evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography.

Materials and Methods: A review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. The relationship between antroliths and sex, location, dental treatment status, and sinus inflammation was evaluated. The shape, size, and volume of the antroliths were also analyzed. Significance was set at p=0.05 for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* DPR and CBCT and also had a maximum of 3 months
* Image quality was sufficient
* No artifacts CBCT images

Exclusion Criteria:

* Tomographic images that contained pathologies such as cysts/tumors in the
* Insufficient diagnostic quality
* History of maxillofacial trauma or surgery, any syndrome/bone-related disease/metabolic disease
* Insufficient diagnostic quality or patient position-related artifacts
Pharmacokinetics and Safety of Moxifloxacin

The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg) of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX in a higher dosage in TB patients.

Moxifloxacin (MFX) is a fluoroquinolone with a high in vitro and in vivo bactericidal activity against Mycobacterium tuberculosis. A daily dose of 600-800 mg MFX should be considered for optimal killing of the involved mycobacteria and suppression of drug resistance, which is higher than the currently used dose of 400 mg once daily. In general, safety data to support switching to the suggested higher dose are limited.

For this purpose, twenty tuberculosis patients will start on a standard dose of MFX 400 mg once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede the dose escalation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture
* Starting treatment with MFX in a dose of 400 mg as part of their TB treatment

Exclusion Criteria:

* Contra-indication for MFX
* Baseline QTc-interval \> 450 msec
* History of resuscitation
* History of ventricular tachycardia (including Torsades de Pointes)
* Family history of sudden cardiac death or Torsades de Pointes
* Additional risk factors for Torsades de Pointes (including known heart failure, Left ventricular hypertrophy)
* Use of concomitant treatment with QT/QTc prolonging drugs (including anti-dysrhythmics class IA and III, antipsychotics, tricyclic antidepressants or the antihistaminic drug terfenadine)
* Abnormal electrolytes (K, Mg, Na, Ca)
* Abnormal cardiac repolarisation on screening/baseline ECG
* History of adverse events to fluoroquinolones
* HIV co-infection
* RIF treatment during last 3 weeks before start of the study. After a washout period of 3 weeks the patient can be included.