cyrilzakka/clinical-trials huggingface dataset:
Tdap Vaccination for Infant Caregivers

This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap) vaccine to caregivers of newborn infants during pediatric well child visits increase the caregivers' vaccination rates.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* English or Spanish speaking

Exclusion Criteria:

* Do not speak English or Spanish
Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid hemorrhage (aSAH) can cause a severe headache (HA) that is famously treatment-resistant. Current pain regimens are too reliant on opioids, which results in long-term opioid dependence and can obfuscate the neurological examination, which is critical to detect vasospasm and delayed cerebral ischemia. This study will gather the initial evidence of whether the pterygopalatine fossa (PPF) regional anesthesia nerve block can treat aSAH-related HA and reduce opioid consumption in patients with aSAH.


Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage with secured aneurysm
* Age greater than or equal to 18 years
* Able to communicate pain level

Exclusion Criteria:

* Documented allergy to local anesthetics (e.g. bupivicaine)
* Patients with unsecured aneurysms
* Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc)
* Medical treatment for vasospasm including blood pressure/inotropic augmentation
* Angiographic treatment for vasospasm within 48 hours
Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol

This study investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception.
* Body mass index (BMI) must be within the range of 18 to 32.

Exclusion Criteria:

* Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
* Donation or loss of 400 mL or more of blood within two months prior to dosing.
* Significant illness (other than respiratory) within two weeks prior to dosing.
* A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.
* Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis.
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
* A known hypersensitivity to the study drug or drugs similar to the study drug.
* History of immunocompromise, including a positive HIV, Hepatitis B or C test result.
* History of drug or alcohol abuse within the 12 months prior to dosing
* Any conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.

Other protocol-defined inclusion/exclusion criteria may apply
Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters

The purpose of this study is to

I. determine several skin parameters, for example natural moisturizing factor (NMF) and cholesterol, with Raman spectroscopy in vivo and

II. compare the results with the corresponding cholesterol levels measured in venous blood.

In vivo Raman experiments will be carried out weekly on voluntary participants using a RiverDiagnostics gen2-SCA Skin Composition Analyzer (RiverDiagnostics, Rotterdam, Netherlands). All experiments will be carried out on the volar forearm. Semi-quantitative concentration profiles for several skin parameters will be determined, for example natural moisturizing factor (NMF) and cholesterol.

Additionally the total cholesterol level will be detected by venous blood sample analysis. The blood samples will be taken weekly within two weeks, similar to the Raman measurements.

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged between 18 and 65 years

Exclusion Criteria:

* Pregnancy
* Chronic skin conditions
Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS

The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.


Eligibility Criteria:
Inclusion Criteria:

* adults over the age of seventeen years

Exclusion Criteria:

* patient refuse spinal anesthesia
* spinal anesthesia is contraindicated
* pregnancy
* patient is incapable of giving consent
* diabetes
* neurological disorders
* chronic pain
* chronic use of analgesics
* spinal anesthesia within five days before the actual surgery
Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age.
* Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017.
* Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options.
* Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment.
* Sufficient kidney, liver and bone marrow function start of Stivarga treatment.
* Life expectancy ≥ 3 months at start of Stivarga treatment

Exclusion Criteria:

- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns

This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 28-42 weeks
* Birth weight between 1500 and 4200 gr
* Hospitalization for at least 3 days
* Exclusive breastfeeding (oral/ enteral)
* Feeding at 3-hour intervals
* Stable health condition
* Spontaneous breathing

Exclusion Criteria:

* Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
* 5th minute apgar score below 4 at the time of delivery
* Resuscitation requirement
* Having a congenital anomaly
* Interventional intervention in the head region
* Central nervous system dysfunction
* Postpartum medical complications
Resin Salve Versus Honey Treatment in Wound Care

In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey from manuka myrtle (Leptospermum scoparium), has successfully been used in medical context to treat both acute and chronic surgical wounds. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of surgical wounds in patients, who have undergone peripheral vascular surgery, and whose complicated wounds are candidate for topical treatment with the resin or honey. In addition, factors contributing with delayed wound healing, antimicrobial properties, safety and cost-effectiveness of the resin salve and medical honey will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Infected of non-infected acute or chronic wound after vascular surgery.
* Need for topical wound care.
* Need for wound healing follow-up at the surgical outpatient department.

Exclusion Criteria:

* Life expectancy less than 6 months.
* Advanced malignant disease.
* Need for extensive surgical wound revision or skin transplantation.
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Healthy male subjects between the ages of 40 and 55 years, inclusive
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients

Diabetic type 2 patients (DB2) has a higher prevalence of coronary artery disease (CAD) than non-diabetic persons. Presence of CAD results in murmurs arising from the filling of the arteries and can be detected by the CADScor System and can together with biological patient profile indicate the risk of presence of CAD in the patient. In the pilot study 100 asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with computed tomography (CT) cardiography and single-photon emission computed tomography (SPECT) for assessing if combination of patient profile (gender, age etc) combined with above measures may give rise to new improved risk scoring method for he DB2-patient.

The study is intended as a pilot observational study for evaluation of a new risk scoring method, CADScor System, is relevant for assessment of CAD in the DB2-patient.

The primary end point will be to document that the hypothesis of combining the CADScor System measure with other patient profile data will increase the accuracy of the method for determination of risk of presence of CAD.

The secondary endpoint will be to show that a receiver operating characteristic curve (ROC) of \> 80% for correct determination of presence of CAD will be achieved.

The further objective of the study will be to confirm the relevance of performing a large scale study with equivalent objectives.

As controls in the study will be applied CT angiography, CT-calcium and resting and drug induced CT-scintigraphy.

It is assumed that 15-20 of enrolled patients in the study will suffer from CAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from diabetes type 2
* Both sexes
* Patients between 40 and 80 years
* Patients without chest pain at rest and labor
* Patients having a normal electrocardiogram (ECG, i.e. without Q-peaks/ T-peak abnormalities in sinus rhythm)
* Patients having intact skin over sternum

Exclusion Criteria:

* Patients suffering from a heart disease
* Patients already having received heart surgery
* Patients with pacemaker or other implanted electronic device
* Patients suffering from allergy against iodine and iodine containing substances
* Patients with estimated GFR below 50 ml/min/1.73 sqm m
* Patients suffering from adenosine intolerance or known allergic asthma
* Patients not being capable of understanding the patient information of the study
* Patients who are pregnant
* Patients suffering from allergy to adhesives
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
* Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer

Exclusion Criteria:

* Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
* Brain metastases \>4 cm in any linear direction
* Intracranial or intratumoral hemorrhage
A Study of LY3532226 in Participants With Obesity

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
* Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment

Exclusion Criteria:

* Have a lifetime history of a suicide attempt
* Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
* Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
* Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
* Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
* Intend to use any weight-loss medications during study participation
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
Carolina Alcohol and Drug Resources

Substance abuse is highly prevalent among individuals with HIV and associated with negative outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this project is to address substance abuse among individuals with or at high-risk for HIV by enhancing and expanding the substance abuse services provided in the formerly Substance Abuse and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug Expansion Team (CADET) program, which offered comprehensive substance abuse care for individuals with HIV living primarily in the Durham NC area. Services will be enhanced by adding peer outreach and navigation services to improve treatment engagement and participation and expanded to replicate the enhanced CADET service model in Charlotte NC.

The target population for this project is minority individuals, primarily African-Americans, with HIV or at high-risk for HIV with a particular focus on minority men who have sex with men (MSM)s. The program will provide up to 18 months of comprehensive services for approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance treatment engagement 2) individual and group substance abuse treatment using evidence-based models 3) ongoing recovery groups for individuals who have completed the intensive substance abuse treatment phase and 4) linkage to needed services such as case management, psychiatric care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and treatment services for minority MSM of unknown HIV status to increase access and utilization of substance use services and identify HIV and Hepatitis status.

The study evaluation will involve analysis of participant survey data gathered at baseline, 6, 12, 18 months of study participation to determine the effect of the comprehensive substance abuse care services on outcomes for individuals with HIV including substance use, mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV services. The study will also determine the effect of the comprehensive substance use program on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not HIV-positive.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive or minority MSM
* substance abuse
* 18 or over

Exclusion Criteria:

* Under 18
* cognitive impairment that would preclude participation in substance abuse treatment
Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement

Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics and functional issues. This may be due to more than cause as fights, contact sports, accidents and falls.

However; implant placement might not be the treatment of choice in some situations such as: medically compromised patients with absolute contraindications for implant placement or requiring extensive augmentation procedures, growing patients, patients with financial limitations, in addition to patients living in rural areas with no access for CBCT machines.

Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a specific treatment modality, especially in patients having financial limitations.

Regarding the aforementioned conditions, surgical extrusion might be considered a cost-effective 'often overlooked' alternative compared to immediate single-tooth implant placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion may be a good alternative yielding better soft tissue results as we preserve the natural tooth with the whole periodontium.


Eligibility Criteria:
Inclusion Criteria:

1. Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients)
2. Single rooted teeth; should be single with adjacent intact or restored neighboring teeth. More than one tooth may be included in the same arch.
3. More than 1:1 crown root ratio, so that the crown to root ratio is 1:1 after extrusion and restoration

Exclusion Criteria:

1. Badly broken-down teeth with active signs of infection.
2. Teeth with vertical root fracture.
3. Teeth with severely tapered root.
4. Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
5. Potentially uncooperative patients who are not willing to go through the proposed interventions.
6. Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). 9
7. History of radiation therapy and/or chemotherapy to the head and neck, or bone augmentation to implant site.
8. Labial cortical bone fenestration diagnosed from CBCT.
9. Patients with systemic disease that may affect normal healing.
10. Psychiatric problems, emotional instability, and unrealistic esthetic demands.
11. Bruxism.
Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety

The purpose of this study is to determine the clinical efficacy and neuro-cognitive mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with treatment with SSRIs or waitlist control.

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with SSRI (Escitelopram) and a waitlist control. A secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. Outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and BOLD signals in MRI measurements. Neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.

Eligibility Criteria:
Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 65.
* Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.
* SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
* No current pharmaco-therapy.

Exclusion Criteria:

* A diagnosis of psychotic or bipolar disorders.
* A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
* Drug or alcohol abuse.
* Any current pharmacological treatment.
* Any current psychotherapeutic treatment.
* Change in treatment during the study.
* Poor judgment capacity (i.e., children under 18 and special populations).