cyrilzakka/clinical-trials huggingface dataset:
Acute Stress Response in Migraine Sufferers

This study will examine the influence of stress and fasting on headache activity. Participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits.

Stress and headache are intricately interrelated. Stress is thought to contribute to headache disorder onset in predisposed individuals, trigger or worsen individual headache episodes in those with headache, and exacerbate the progression of a headache disorder. In exacerbating headache disorder progression, stress is believed to be a major factor in headache transformation from an episodic to a chronic condition.

Broadly stated, stress is conceptualized as an imbalance between a demand, whether actual or perceived, and resources to handle the demand, resulting in a strain on the system. A stressor is any challenge or threat, whether objectively verified or not, to normal functioning. The stress response is the body's activation of physiological systems to protect and restore functioning.

This study is 2 x 2 experiment using male and female migraine sufferers. Participants will be randomized to a fasting or not fasting condition for the visits. Thus, the experiment is a 2 (control versus stress) x 2 (fasting versus not). During the approximately 4 weeks of participation (ranging from 9 to a maximum of 28 days), a participant also will complete a twice-daily diary.

Eligibility Criteria:
Inclusion Criteria:

* Women and men 18-65 years of age
* A provisional diagnosis of migraine (with or without aura).
* Headache frequency of 2 to 15 attacks/month

Exclusion Criteria:

* Presence of a secondary headache disorder (e.g., brain tumor)
* Chronic daily headache (\> 15 headache days/month) or medication over-use headache (\> 8 abortive medication doses/month)
* Recent change in nature of headache symptoms over last 6 weeks
* Not being able to read or speak English at a 6th grade level
* Any condition that would preclude the safe experience of a benign laboratory stressor including seizure disorder, Axis-I psychotic disorder, unstable cardiac conditions
* An active substance dependence issue (e.g., alcohol, marijuana) that interferes with data collection and headache activity.
The Effect of Laser Hair Removal on Permanent Hair Reduction

The purpose of this study is to learn more about how hair removal with lasers achieves, what appears to be, permanent hair reduction. Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about how the permanent reduction in the treated areas occurs. Recently, it has been discovered that certain cells in the hair follicle must be destroyed in order to achieve permanent hair reduction. A marker of these types of cells known as keratin 15 has been identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to gain a better understanding of how lasers cause hair reduction on a biochemical level.

Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about the mechanisms involved in achieving what clinically appears to be permanent reduction in hair density in treated areas. We postulate that in order to achieve permanent hair reduction, stem cells located in the bulge region of the follicle must be destroyed. Recently, a marker of follicular stem cells (keratin 15) has been identified and noted to be detectable using immunohistochemical techniques. In addition, several other immunohistochemical markers for various components of the hair follicle are available.

We propose to quantitatively measure the effects of laser hair removal on the immunohistochemical staining properties of treated follicles with respect to keratin 15 and other follicular markers. We hypothesize that the degree of such staining will be greatly reduced following laser therapy, thus providing, to our knowledge, the first biochemical evidence to support permanence of the treatment's effects.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older of either gender.
2. At least moderately dense axillary (armpit) hair that is dark (not blonde or white) in color.
3. Subjects must understand and sign the informed consent documents prior to participation.
4. Subjects must be in generally good health.
5. Subjects must be willing and able to comply with the requirements of the protocol
6. You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

1. Oral retinoid use within one year of study entry.
2. History of prior laser therapy or electrolysis of the axillae.
3. Subjects who do not desire permanent reduction in axillary hair.
4. Non-compliant subjects.
5. Pregnant or nursing subjects.
6. Subjects with a significant medical history or concurrent illness/condition that the investigator(s) feel is not safe for study participation.
7. Active infection of the site to be treated or a history of herpes simplex or zoster infection at the site to be treated.
8. History of keloid scar formation.
9. Known history of allergy or sensitivity to lidocaine.
10. History of waxing, plucking, or bleaching of the hair for 6 weeks prior to the treatment.
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PAH, WHO GROUP I
* Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH
* Willing and able to provide written informed consent

Exclusion Criteria:

* Previous initiation and permanent discontinuation of Tyvaso
* Participation in an investigational clinical drug or device trial within 30 days of enrollment
* Current or past diagnosis of lung neoplasm
* Active gastrointestinal or pulmonary bleed at enrollment
* Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment

This study examines whether an integrated alcohol/substance abuse, suicide, and HIV prevention protocol is associated with lower onset and frequency of alcohol and other drug use, suicidal behavior, and high risk sexual behavior among adolescents receiving community based mental health care.

The purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and HIV prevention program to an assessment only control condition in a randomized clinical trial. This prevention protocol is designed as an "add-on" intervention to standard mental health care. We will examine the extent to which the addition of this prevention protocol is associated with lower rates of alcohol use and drug use, suicidal behavior, and HIV related risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* ages 13-18
* English speaking adolescent and at least one English speaking parent
* receiving mental health treatment
* living with a parent or guardian willing to participate

Exclusion Criteria:

* Active Alcohol or Marijuana Dependence Diagnosis
* HIV infection
* Pregnant
* Current psychosis
* Cognitively unable to give assent
Emotional Freedom Technique (EFT) Effect on Nurses

Background: Infectious disease outbreaks have a psychological effect on the general population, and especially on health workers. Nurses who care for COVID-19 patients feel negative emotions, fear, and anxiety due to fatigue, discomfort, and helplessness due to high-intensity work.

Objective: The study aims to evaluate the effect of EFT in the prevention of stress, anxiety, and burnout of nurses who have an important position in the fight against COVID-19.

Design: Randomized controlled trial. Setting: COVID-19 department of a university hospital in Istanbul Province, Turkey.

Participants: The sample of the study consisted of nurses working on 80 COVID-19 cases.

Methods: The investigators will recruit nurses who care for the patient infected with COVID-19 randomly allocated them to the intervention (n = 40) and control (n = 40) groups. EFT will apply to the experimental group with online access. Data will collect using the Introductory Characteristics Form, the Subjective Discomfort Unit Scale, the State-Trait Anxiety Inventory, and the Burnout Scale.

With the onset of the COVID-19 epidemic, healthcare workers have assumed important responsibilities in the control, prevention, care, and treatment of its spread. In this period, they provided the necessary health practices for suspicious or confirmed COVID-19 patients in the front lines and under harsh conditions, which are generally long and tiring. It is clear that infectious disease outbreaks have a psychological effect on the general population, and especially on health workers. The social distance required to prevent outbreaks is a key factor in disease management while causing social and psychological effects.

2.1. Design A randomized controlled experimental research design. The study complied with the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) checklist.

2.2. Participants This study will conduct with nurses working in a university hospital located in Istanbul between May 2020 and June 2020, working in the care of COVID-19 patients.

2.5. Measures The data will be collected with the Introductory Characteristics Form, the positive units of distress scale, the State-Trait Anxiety Inventory, and the Burnout Inventory. The investigators created our data collection forms using Survey Monkey, which provides electronic self-access and prevents data from multiple entries from the same person, making it easier to collect and track data. Confidentiality will be guaranteed by completely disabling electronic and IP address records to obtain anonymous replies.

Eligibility Criteria:
Inclusion Criteria:

* Not taking any courses about coping with anxiety and stress,
* Volunteering to participate in the study.

Exclusion Criteria:

* Having any psychiatric diagnoses
Vascular Occlusion in Patients With Osteoarthritis

Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone. The investigators speculate this training strategy could be beneficial in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* BMI \<39
* Knee Ostearthritis type II and III
* VAS (visual analogue scale) between 2 and 8

Exclusion Criteria:

* Hip osteoarthritis
* Use of NSAID
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy

Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.

The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.

The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.


Eligibility Criteria:
Inclusion Criteria:

* SpA
* Planning to start anti-TNF alpha treatment

Exclusion Criteria:

* Patients not being able to communicate in Norwegian or not being able to fill in questionnaires
* Surgery in more than 5 of the joints/entheses to be examined by US
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children

Folic acid as a appetizer in primary malnutrition


Eligibility Criteria:
Inclusion Criteria:

Primary malnourished children

Exclusion Criteria:

* previous folic supplementation in the past 3 months
HIV, Equity, and Addiction Training (HEAT) Program

This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama.

The contemporary drug crisis and the COVID-19 pandemic have exposed the complex syndemics of addiction and infectious diseases: rising rates of substance use disorder (SUD) have outpaced our ability to respond with a limited healthcare workforce and public health capacity. SUD is increasing in those living with and at risk for HIV, and infectious consequences of SUD, like hepatitis C, have continued, unmitigated, in rural parts of the U.S. where many states lack Medicaid expansion, syringe service programs, and public health infrastructure to respond to the drug crisis and comorbid infections. Systemic racism and regressive policies in the Deep South criminalize people who use drugs, creating additional barriers to care, HIV prevention, and addiction treatment. As a result, people who use drugs rarely receive comprehensive addiction and HIV treatment. Yet telemedicine has the potential to overcome these barriers and bypass the constraints of a brick-and-mortar clinic to link vulnerable people, including those with HIV, to care. Although telemedicine has become mainstream in recent years, few studies have evaluated telemedicine for SUD in the Deep South from the perspective of patients and providers.

Eligibility Criteria:
Inclusion Criteria:

* Receiving services at HIV clinics in Alabama
* Reported opioid and/or stimulant misuse
* 18 years of age or older

Exclusion Criteria:

* Receipt of SUD clinical care other than through HIV provider/clinic in the last 3 months
* Inability to engage in interviews independently without support (e.g., cognitive impairment)
* Currently psychotic
* Actively suicidal: presents with a suicide attempt or suicidal ideation
Improving Outcomes in Peritoneal Dialysis

The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and the best way to collect data regarding their function in England, Wales and Northern Ireland.

Phase 1: We will carry out a detailed examination of existing returned pilot data with emphasis on data fields with poor data completeness and perform root cause analysis, and assess deficiencies in data field definition to identify improvements to be implemented. We will construct and disseminate electronic survey material to all study centres with targeted visits by the Principle Investigator undertaken. These visits will facilitate insight into local organization of data collection including interaction with designated individuals responsible for data returns. PD training days will be organized with emphasis on clinical practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics will be linked to existing acquired PD patient information to ensure the accuracy of collected data. An online data acquisition system will be developed to allow direct data entry from centres.

Phase 2: On-going and sustained data acquisition performed on a prospective basis.

Phase 3: Primary data analysis including clinical practice variation in England, Wales and Northern Ireland to identify site specific PD catheter functionality variation. Additionally, patient and site specific characteristics that predict clinical outcomes in PD will be identified and characterised.

Phase 4: Clinical guidelines will be developed.


Eligibility Criteria:
Inclusion Criteria:

* Any adult (16 years or over) patient requiring first PD catheter placement

Exclusion Criteria:

* Patient less than 16 years
Dynamic Respiratory Muscle Function in Late-Onset Pompe Disease

This study intends to evaluate dynamic respiratory motor performance as a valuable measure of pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a strategy that includes comprehensive evaluations of respiratory volume, flow, and timing parameters during resting and loaded breathing. These evaluations will then be associated to the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease will be contrasted to the function of age- and gender-matched control subjects. This approach will enable the investigators to evaluate the relationship between dynamic diaphragmatic function and respiratory motor function.

The following tests will be completed over a two-day period: Respiratory pressure tests, breathing test, magnetic resonance imaging and magnetic resonance spectroscopy (MRI and MRS).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Pompe disease OR
* Be an age and gender-matched unaffected control subject

Exclusion Criteria:

* Pre-existing obstructive lung disease or asthma
* Forced vital capacity (FVC) \<30% or \>80% of age/gender predicted values
* Inability to travel to the study site
* Requirement for positive pressure ventilator support when awake and upright
* Participation in longitudinal studies that may independently alter lung function
* Presence of any other chronic medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study
ALI in Cancer Patients

The aim of the study is to describe and evaluate the outcomes of cancer patients presenting with and treated for ALI at our center .

Acute limb ischemia (ALI) is a vascular emergency and is associated with significant morbidity and mortality. Peripheral arterial embolism or thrombosis from malignant disease is uncommon and a rare cause of acute limb ischemia. Limb ischemia can be caused by emboli from the tumor itself, from metastatic deposits within large vessels, as well as the tumors of adjacent organs such as the lung, which invade the left or right atrium of the heart and then disseminate to the main arteries of the body. This acute event may be the first indication of malignant disease in the patient.

Eligibility Criteria:
Inclusion Criteria:

* All cancer patient presented to Vascular and Endovascular surgery departement with ALI.

Exclusion Criteria:

* Patients with benign tumors or without active malignancy.
* Patients with iatrogenic limb ischemia related to a tumor chemoembolization procedure.
Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn

This study aims to determine how maternal Fe status influences placental and neonatal Fe status in pregnant adolescents and to assess the impact of the Fe endowment of birth on functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in neonates born to these adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis).

Exclusion Criteria:

* Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (\>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study.
* Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures.