cyrilzakka/clinical-trials huggingface dataset:
Dermal Phototoxicity Study

Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female volunteers age 18 years or older
2. Has uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II, or III

Exclusion Criteria:

1. Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
2. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study
Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

Recent data suggests that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF.

This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.

This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Antiretroviral treatment naive
* Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
* Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.

Exclusion Criteria:

* Received HIV-specific immunizations within 6 months prior to study entry
* Received immunizations within 6 months prior to study entry
* Known allergy or sensitivity to study drugs
* Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
* Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
* Evidence of HIV seroconversion within 6 months prior to study entry
* Illness requiring systemic treatment and/or hospitalization
* Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
* Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
* Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
* Abnormal laboratory values. More information on this criterion can be found in the protocol.
* Pregnant or breastfeeding
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers. New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them. These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of persons with dementia
* Caregivers must either live with the care recipient (person with dementia) or be the identified primary support
* Caregiver relationship must have been present for the prior 6 months
* Caregivers must have telephone access
* Caregivers must speak English or Spanish
* Care recipients must have a prior dementia diagnosis
* Care recipients must be living in the community other than a nursing facility

Exclusion Criteria:

* Persons with dementia, lacking an informal caregiver who can communicate in Spanish or English, or living in a long term care facility
* Caregiver lacks the capacity to consent to study participation
Synaptic Density and Progression of Parkinson's Disease.

AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.

DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.


Eligibility Criteria:
Inclusion Criteria:

* PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease
* Less than 5 years disease duration since motor symptom onset according to the patient
* Hoehn-Yahr stage 1 or 2 in medication ON state
* Capacity to understand the informed consent form

Exclusion Criteria:

* Neuropsychiatric diseases other than PD
* Major internal medical diseases
* Relevant abnormalities on MR brain
* History of alcohol or drug abuse
* Contraindications for MR
* Pregnancy
* Previous participation in other research studies involving ionizing radiation with \> 1 mSv over past 12 months.
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.

Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Women of childbearing potential (WOCBP) who are using acceptable method of contraception
* Women who are not nursing

Exclusion Criteria:

* History of Gastrointestinal (GI) disease
* Any GI surgery that could impact study drug absorption
* History of allergy to drug class or related compounds
* History of allergy to metformin or other similar acting agents.
* History of any significant drug allergy.
* Estimated creatinine clearance (ClCr) \< 80 mL/min using Cockcroft-Gault formula
The Neurobiology of Expectancy and Pain Perception

This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.


Eligibility Criteria:
Inclusion Criteria:

* a) Healthy male and female adults aged 21-50
* b) No contraindications to fMRI scanning
* c) Right handed

Exclusion Criteria:

* a) Current or past history of major medical, neurological, or psychiatric illness
* b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)
* c) Claustrophobia
* d) History of head trauma
* e) History of impaired elimination
* f) Instability of responses to experimental pain (see Study Procedures Section)
* g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
* h) Non-fluent speaker of English
Adaptive Radiation Treatment for Head and Neck Cancer

This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.


Eligibility Criteria:
Inclusion Criteria:

* biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
* stage III/IV, T3-4, Nx M0
* \< 70 yrs
* glomerular filtration rate (GFR) \>60
* WHO 0-1
* no previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* adequate bone marrow function, adequate hepatic function,informed consent
* \>18 years

Exclusion Criteria:

* expected failure from follow-up
* previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* expected inability to complete either one of the treatment arms
* pregnancy or lactation
* patients (m/f) with reproductive potential not implementing adequate contraceptive measures
* prior surgery, radiotherapy or chemotherapy for this tumor
* contraindications or serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or are likely to interfere with the study assessments
* known active symptomatic fungal, bacterial and/or viral infections including HIV
* concomitant (or with 4 weeks before randomisation) administration of any other experimental drug
* concurrent treatment with any other anti-cancer therapy
* prior treatment with one or more of the active compounds
Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.


Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
* BMI between 30 kg/m2 and 50 kg/m2
* Not taking anti-depressant medications
* Read English proficiently enough to read study assessments
* Available for duration of treatment plus follow-up period
* Able to travel to study location (New Haven, CT) for monthly visits
* Agree to study procedures

Exclusion Criteria:

* Medical status judged by study physician as contraindication
* History of seizures
* Past or current anorexia nervosa, bulimia nervosa
* Current medications that influence eating/weight
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
* Pregnant or breastfeeding
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
* Fasting triglyceride levels \>140 and \< 400 mg/dl and values varying less than 35% between two screening measurements
* Normal liver function tests and white blood cell count

Exclusion Criteria:

* Type 2 Diabetes for \> 3 years or HbA1c ≥ 7.5
* Known or suspected Type 1 Diabetes
* Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
* Creatinine \> 2.0 mg/dl or other evidence of active kidney disease
* Hepatic enzyme elevation \> 2x normal
* Known Nonalcoholic Fatty Liver Disease
* Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems
* Recent history of nausea or vomiting
* Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
* A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
* Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (\>1 g/day)
* Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
The Impact Of Text Message (SMS) Reminders On Helmet Use Among Motorcycle Drivers In Dar Es Salaam, Tanzania

This study seeks to evaluate the impact of a text-message (SMS) program delivered to motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this study, the investigators will conduct a randomized controlled trial to see if this program leads to increased helmet use over time. The investigators will recruit between 350-400 motorcycle drivers to receive the text program. The investigators will obtain each of their cell phone numbers, and the participants will be split into three groups. The first group will receive reminders framed as social norming (ie "Most of your peers wear helmets"). The second group will receive reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). The third group will act as the control and receive texts that relate to general road safety, but not helmet use. All groups will receive the same general road safety information being delivered to the control arm. The purpose of sending different types of reminders is to assess which type of messages are more likely to cause a motorcycle driver to regularly wear their helmet. The investigators will survey the participants at the initiation of the study and after weeks 3 and 6 during the study, asking about their helmet use. This will be a short survey, and any personal information gathered during the study (ie, phone numbers), will be securely stored so as to protect their privacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Must own a cell phone with text-message features
* Must demonstrate ability to retrieve and read text-messages
* Must have access to a helmet.

Exclusion Criteria:
Smartphone Application for Smoking Cessation

The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.

In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Eligibility Criteria:
Inclusion Criteria:

* Smoke 5+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone
* Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener \& Abrams, 1991)

Exclusion Criteria:

* None
Cardiac Amyloidosis Registry of University Hospital Leipzig

This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.

Cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. There is evidence from clinical trials about warning signs ("red flags"), diagnostic algorithms, and evidence for specific treatment. However, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. Furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities.

Clinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. Furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures.

The cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care University Hospital Leipzig. In particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed cardiac amyloidosis according to current standards

Exclusion Criteria:

* refusal to participate
Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions

This randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 50 years
* Good general health
* Dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (EVA)
* Presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe)
* Exposed root surface caused by abrasion, erosion or gum recession

Exclusion Criteria:

* Volunteers using analgesic medication
* Presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease
* Patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months
* Patient with fixed orthodontic appliances
* Drug users or pregnant women were also excluded.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)\^2 to 30 kg/m\^2, inclusive, at screening
* Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
* Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
* Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
* A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -2

Exclusion Criteria:

* History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
* History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
* Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
* Has a history of or is infected with human immunodeficiency virus (HIV \[positive serology for HIV antibody\]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening
Diagnostic Value of the Biofire®in Community Acquired Pneumonia

This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.

the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.

This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU with community acquired pneumonia

Exclusion Criteria:

* Age less than 18 years old.
* End stage malignant patients,
* Patients admitted to the ICU with Acute Lung Injury (ALI).
* Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).
* Patients with radiological findings suggesting atypical pneumonia.
* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other immunosuppressants.
* Solid organ or bone marrow transplant patients, cystic fibrosis.
* Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.