cyrilzakka/clinical-trials huggingface dataset:
JIT: Effect of Pain on DT in TMD

Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. However, few systematic examinations of modifiable and non-modifiable risk factors, including orofacial pain status, have been conducted. This project addresses this gap in knowledge by determining the effect of pain on drinking topography in heavy drinkers with and without chronic TMD pain in both the laboratory and daily life.


Eligibility Criteria:
Inclusion Criteria:

* Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
* Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedures.
* Participants in this study must report regular drinking exceeding NIAAA guidelines for (≥ 2 (men) or ≥ 1 (women) drinks per day on average) over the past six months, as well as drinking on ≥ 2 days/week.
* Meet Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myalgia (masticatory muscle pain), arthralgia (TMJ pain), or a combination (Schiffman et al., 2014) (TMD group only).
* Own a smartphone with internet access.
* Use of prescription medications will be allowed, provided they do not contraindicate alcohol use.

Exclusion Criteria:

* Use of opioid analgesics within the past month;
* Current major depression;
* History of any psychotic disorder;
* Under-controlled hypertension or diabetes (as reflected by self-report); neurological disease (e.g., multiple sclerosis, epilepsy, amyotrophic lateral sclerosis, Parkinson's disease);
* Serious medical illness (e.g., hepatitis, HIV/AIDS);
* Impaired cognitive function;
* History of substance use disorder (including nicotine/tobacco);
* Alcohol naïve
* Alcohol use disorder, or currently attempting to quit or cut down on using alcohol
* Positive pregnancy test
* Breastfeeding or intending to become pregnant
* Loss of sensation in the lower leg
* Inability to complete study tasks due to weakness, immobilization, or loss of limbs
* Chronic pain (Control group only)
* A urine-based drug screen for tetrahydrocannabinol, cocaine, benzodiazepines, morphine, and methamphetamine (Innovacon, Inc., San Diego, CA) will be performed. Participants testing positive for any substance will be discontinued.
* Medications that contraindicate alcohol use
Neurologic Injuries in Adults With Urea Cycle Disorders

Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose of this study is to evaluate how UCD-related neurologic injuries affect adults with one of the most common types of UCD.

UCDs are a group of rare genetic diseases that affect how protein is broken down in the body. The cause of UCDs is a deficiency in one of eight enzymes responsible for removing ammonia, a waste product of protein metabolism, from the bloodstream. Normally, ammonia is converted into urea and then removed from the body in the form of urine. However, in people with UCDs, ammonia accumulates unchecked and is not removed from the body. Toxic levels of ammonia can build up and cause irreversible neurologic damage that can affect metabolism, cognition, sensation, and movement. This study will focus on the most common enzyme disorder among UCDs, ornithine transcarbamylase deficiency (OTCD), a disorder inherited from mothers. Using different types of magnetic resonance imaging (MRI), this study will evaluate how UCD-related neurologic injuries affect metabolism, cognition, sensation, and movement in adults with OTCD.

Participants in this study will attend an initial study visit that will include a review of medical history, current symptoms, impairments, and diet history; urine and blood collection; a physical exam; a full neurological exam; and cognitive and motor testing. During this visit, participants will undergo imaging studies and additional cognitive and motor testing over a 2- to 3-day period. This will include standard MRI studies and four sessions consisting of functional MRI (fMRI), diffusion tensor imaging, and 1H magnetic resonance spectroscopy. For the fMRI study, participants perform various motor and behavioral tasks while in the imaging scanner. Magnetic resonance spectroscopy (MRS) is used to study and evaluate the chemical makeup of specific brain areas. Diffusion tensor imaging is used to assess myelination of major brain pathways and their alteration in disease states. This study will involve one-time participation. There will be no follow-up visits for this study.

Eligibility Criteria:
Inclusion Criteria for Participants with OTCD:

* Diagnosis of OTCD or heterozygote state of OTCD by metabolic or molecular means. Female participants must be clinically stable and heterozygous for OTCD. Male participants must be hemizygous for late onset OTCD.

Inclusion Criteria for Healthy Controls:

* No known medical or metabolic disorder

Inclusion Criteria for All Participants:

* IQ of at least 80
* Willing to travel to study site
* English-speaking
* Age between 18 and 60 years

Exclusion Criteria for All Participants:

* Currently being treated for an acute illness
* History of neuropsychiatric drug use
* Unable to undergo MRI scanning without being sedated
* Unable to participate in neurocognitive and/or motor testing
* Metal device in body that might interfere with MRI scanning
* Pregnancy or breastfeeding
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .

Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age.
* Patients infected with Human Immunodeficiency Virus (HIV)
* Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.
* Provision of informed consent.

Exclusion Criteria:

* Proven Hepatitis B virus infection (acute or chronic).
* Proven hypersensitivity to the vaccine or any of its components.
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
* Other protocol-defined exclusion criteria may apply.
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

Primary Objective:

Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months

Secondary Objectives:

* Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months
* Insulin glargine dose at 3 and 6 months
* Hypoglycemic episodes (all types)


Eligibility Criteria:
Inclusion criteria:

* Patients with a diagnosis of type 2 diabetes for more than 6 months
* Patients treated with Oral AntiDiabetics (OADs monotherapy or combination) with an HbA1c \>7% and \<10% and/or treated with NPH insulin with HbA1c \>7% and \<10% or treated with NPH insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months.
* Ability to perform SMBS and insulin self-titration under the physicians guidance.
* Body Mass Index (BMI) \>21 kg/ m2.
* Signature of informed consent.

Exclusion criteria:

* Hospitalized patients.
* Pregnant women or with the intention of becoming pregnant.
* Unexplained weight loss of more than 10% in the last 6 months.
* Women with child bearing potential not using effective contraceptive methods.
* Women in breast feeding period.
* Patients on chronic treatment with systemic corticosteroids or protease inhibitors.
* History of drug or alcohol abuse.
* Diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry.
* Major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator.
* Renal failure known as creatinine \> 1.4 mg/dl in women and \> 1.5 mg/dl in men.
* Known hypersensitivity to glargine or any of its excipients.
* Patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Topical Itraconazole in Treating Patients With Basal Cell Cancer

This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.

PRIMARY OBJECTIVES:

I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).

SECONDARY OBJECTIVES:

I. To determine if topical itraconazole gel will decrease BCC size.

OUTLINE:

Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.

After completion of study treatment, patients are followed up for up to 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
* The subject must be willing to apply the medications twice daily for 1 month
* The subjects must have at least four BCCs in non-cosmetically sensitive sites
* For women of child-bearing potential, a negative urine pregnancy test
* Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
* For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose

Exclusion Criteria:

* Pregnancy or breast-feeding
* History of congestive heart failure or other findings of ventricular dysfunction
* History of current evidence of malabsorption or liver disease
* Current immunosuppression or taking immunosuppressive drugs
* Taking oral itraconazole
* Taking any medication known to affect hedgehog (HH) signaling pathway
* The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone

The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use.

This is an Observational, retrospective study on the use of Risperidone long-acting injectable. The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone. Patient outcomes will be evaluated based on pre-existing risk or disease factors and past medication use. Data will be collected from medical charts and other available medical records from one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. The study will compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. Information about past use of anti-psychotic medications will be collected. The occurrence and frequency of adverse events \[Extra-Pyramidal Symptoms (EPS) - the abnormal body movements sometimes associated with antipsychotic medications, body weight changes, drowsiness, sexual problems\] and the dose or change in dose of Risperidone long-acting injectable will also be collected. The study will also investigate the relapse rate and the hospitalization rate before and after treatment. It is a chart review type of study. No study drug has been used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria
* Patients who used to be treated with Risperidone long-acting injectable regularly for at least 3 months
* Patients whose medical charts or other medical records are available

Exclusion Criteria:

* None
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid

This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. It may also help doctors understand how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by RT-PCR) for change in response to ZA.

SECONDARY OBJECTIVES:

I. To evaluate 30 measures of immunologic function (by Luminex panel) for change in response to ZA a) after 48-72 hours and b) after 10-23 days.

II. To explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for change in response to ZA.

OUTLINE: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.

After completion of study treatment, patients are followed up at 40-44 days.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
* Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or
* Biopsy proven ER/PR positive tumor
* Ability to provide informed consent

Exclusion Criteria:

* Tumor that lacks both estrogen and progesterone receptors
* Patients who will receive neoadjuvant therapy prior to definitive surgery
* Bisphosphonate therapy currently or within the past 12 months
* Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
* Renal impairment as determined by a creatinine clearance \< 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

The purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation.

The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood.

This 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 to 79
* White or Black
* Community-dwelling in Memphis, TN or Pittsburgh, PA vicinity
* Well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting)

Exclusion Criteria:

* Any difficulty with activities of daily living
* Clinical dementia
* Inability to communicate with interviewer
* Intention of moving out of vicinity in the next year
* Active treatment for cancer in the previous 3 years
* Participation in a trial involving a lifestyle intervention
Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers

In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.

In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The healthy volunteers receive 1. furosemide and 2. aminohippurate sodium "PAH" as single dose. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer for medical history and physical examination findings
* 18 years, \<40 years
* Written informed consent is given
* No clinically relevant changes in laboratory parameters
* Inconspicuous current ECG
* taking medication under a different drug trial within the last 30 days

Exclusion Criteria:

* concomitant medication at study days or a week before
* allergies or known hypersensitivity reactions to furosemide or aminohippurate sodium
* decreased creatinine clearance by Cockcroft-Gault (\<100 ml / min)
* current drug abuses
* opiate addiction within the last 10 years
* smoking within the last year
* pregnancy and 6 months postpartum, lactation
* deprivation of legal capacity
* Cooperation inability
A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning - Nelli

Nelli is a video-based non-EEG physiological seizure monitoring system. This study is a blinded comparison of Nelli's identified events to gold-standard video EEG review in at-rest pediatric subjects with suspected motor seizures.

Automated analysis of video recordings to detect seizures, assisted by modern methods of machine learning, holds great promise to address this issue. Increased computational power has made it possible to implement complex image recognition tasks and machine learning in everyday use. Nelli® software is designed to use computer vision and machine learning-based algorithms to automatically detect seizure events. This study will provide evidence that Nelli software can identify seizure events and deliver objective data to clinicians for evaluation of seizure management.

This study is being conducted to validate the Nelli Software's ability to identify periods of audio

/video data that contain recordings of patients experiencing seizures (or seizure-like events) during periods of rest. The software's performance will be compared to the gold standard, expert review of video EEG data.

Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of \>70% (lower 95% CI) and with a false discovery rate (FDR) comparable to similar devices on the market.

Eligibility Criteria:
Inclusion Criteria:

* Subject shall sign informed consent.
* Subject is between 6 and 21 years.
* Subjects shall be undergoing video-EEG monitoring for routine clinical purposes.
* Subjects shall have a suspected history of motor seizures.
* Subject shall be able to understand and sign written informed consent or have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.

Exclusion Criteria:

* None identified.