cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients

Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.

Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus, willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent. Patient with childs Pugh class B or C, compensated cirrhosis may be enrolled. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of Hepatitis B virus or HIV will be excluded. Participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.

A detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team.

Compliance is assessed by counting the number of returned tablets at each visit.

A discontinuation is defined as a period with at least seven consecutive days without study drug intake.

Safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints.

Safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using MedDRA coding. Summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.

Eligibility Criteria:
Inclusion Criteria:

Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus.

willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent.

Patient with child,s Pugh class B or C, compensated cirrhosis may be enrolled.

Exclusion Criteria:

1. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml.
2. Patient with coinfection of hepatitis B virus or Human Immunodeficiency Virus will be excluded.
3. Creatinine clearance \< 50 ml/minute.
4. Albumin\<3 gm/dl.
5. aspartate aminotransferase or alanine aminotransferase \> 10 upper limit of normal.
6. Pregnant and lactating females.
7. Associated morbidity such as uncontrolled diabetes mellitus, schistosomiasis.
Minority Stress Counseling for LGBTQ+ Individuals

Lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) individuals experience a breadth of mental health disparities. Reducing these disparities is an area of key psychological research. Minority stress is theorized to be an underlying source of the disparities (Meyer, 2003). Minority stress can be conceptualized as the internalized stigma that results from experiences of social marginalization. By reducing minority stress, it is hypothesized that generalized mental illness indicators might be reduced and indicators of wellbeing increased.

Adult participants will respond to advertisements by emailing a research assistant.

A research assistant will then arrange for a pre-screening interview to ensure inclusion criteria are met.

A research assistant will review informed consent and receive a signed informed consent during the pre-screening.

Participants who are accepted into the study will then be offered up to 12 sessions of ACT or receive an unstructured treatment as usual counseling condition delivered by graduate students in the UAB medical/clinical psychology program under the supervision of Dr. Borgogna. These sessions will be 45 minutes each and delivered in Dr. Borgogna's lab. During the first sessions a survey battery will be administered on a lab secure computer administered via Qualtrics. It will be re-administered at session six, and during the last session.

The survey will include a broad base of demographic, mental health, and minority stress measures.

Participants will be assigned a random number that will link their survey responses across sessions. Identifying information will not be gathered as part of data collection.

Eligibility Criteria:
Inclusion Criteria:

* Must identify as non-heterosexual

Exclusion Criteria:

Suicide attempt within the past 12 months.

Current eating disorder.

Narcotics use within the past 3 months

Non-suicidal self-injury within the past 6 months.

Current/History of psychosis
Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD.

The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity?

Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.

This exploratory sub-study will identify psychotherapeutic processes occurring during MDMA- assisted psychotherapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in subjects enrolled in the ongoing clinical trial of MDMA-assisted psychotherapy, NCT #: NCT01211405. The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College and the New School for Social Research.

To support the clinical outcomes measured by CAPS from the MP-8 study, the sponsor is interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by heart rate variability (HRV) and fMRI. Brain activity while listening to neutral and personalized trauma-related scripts will take place at baseline and after experimental MDMA-assisted psychotherapy with low, medium, or full dose MDMA. The fMRI scan will be followed by a Diffusion Tensor Imaging (DTI) scan. After each scanning session, pulse measurements will be extracted as a digital data file from which HRV will be calculated. FMRI scans and HRV measurements will occur at baseline for participants in all conditions, one month after the second experimental session and again after a final experimental session for participants in the low or medium dose condition, and two months after the final experimental session for participants in the full dose condition.

Participants will complete the Self-Compassion Scale, a self-report measure of self-compassion at Baseline and after the final MDMA-assisted psychotherapy session. Psychotherapeutic processes will be assessed via observing psychotherapy and sorting a set of 100 therapy-related items as a means of describing the interactions. Trained coders will observe at least one pre-drug psychotherapy session, one experimental (drug-assisted psychotherapy) session and one post-drug psychotherapy session.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405

Exclusion Criteria:

* Mass brain lesion
* Have metal in their skulls,
* Having brain or heart pacemakers
* History of major head trauma
* Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)
Impairment of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparison to Patients Without Opioid Withdrawal

Main of the study is to assess the influence of high-dose opioids on the sleep architecture and patterns of breathing using non-invasive polysomnographic measurements before and after opioid withdrawal in patient who undergo opioid withdrawal independently from the present study. These data will be compared to polysomnographic data of patients under opioid treatment who do not undergo opioid withdrawal as well as to patients without opioid treatment.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 year, indication for opioid withdrawal (cohort 1), opioid intake (cohort 1 and 2)

Exclusion Criteria:

* plaster allergic reactions, opioid withdrawal (cohort 2), opioid intake (cohort 3)
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone

A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 18-50 years.
* Females should be of non-child bearing potential.
* Non-smoking for at least 12 months.
* Normal lung function.
* Subjects should be able to produce acceptable sputum samples.

Exclusion Criteria:

* Any serious medical condition.
* Hepatitis B or C and/or HIV positive.
* Currently on regular medication except paracetamol.
* Body Mass Index \<20 or \>30.
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.

Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.

Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.

However, the immune response to influenza vaccine appears to be lower in elderly than in young people.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged 65 years or over
* Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit
* Legal capacity to consent
* Subject had given written consent before his participation

Exclusion Criteria:

* Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)
* Live vaccines within 3 weeks before and after influenza vaccination
* Inactivated vaccines within 2 weeks before and after influenza vaccination
* Chronic disease non-stabilized under treatment
* Severe malnutrition in the opinion of the investigator
* Congenital immunodeficiency
* Chemotherapy or radiotherapy over the last 6 months
* Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent \>/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit
* Participation in another clinical study that could interfere with the present study
TMS-evoked Potentials During Aerobic Exercise

This study investigates the modification of the local-to-global connectivity pattern in response to a session of aerobic exercise. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity and connectivity to TMS.

Chronic musculoskeletal pain disorders rank second only to mental and behavioural disorders as a major contributor to worldwide years lived with disability. Chronic musculoskeletal pain restricts mobility, decreases cardiorespiratory capacity and musculoskeletal function, and ultimately reduces exercise capacity and quality of life. Thus, there is an urgent need for new, effective, and affordable strategies to address this growing problem, particularly in health systems around the world.

Abnormal brain connectivity patterns disrupt normal brain function in a specific neural network, causing brain circuit malfunctions and resulting in symptoms such as chronic pain. The advent of electroencephalography (EEG) compatible with transcranial magnetic stimulation (TMS-EEG) has allowed the measurement of the cortical excitability and connectivity of a single pulse of TMS in any scalp region, providing insights into cortical excitability and connectivity that were not previously possible with techniques exclusively based on MEP, create a map of activation caused by a localized pulse of stimulation. Furthermore, TMS-EEG allows recording the spread and the characteristics of the perturbations caused by a single TMS pulse across the cortex (recorded by several electrodes from an EEG cap). Physical exercise has been shown to have a positive impact on brain functioning. Regular exercise promotes the growth of new brain cells and improves the survival of existing ones. Studies have shown that regular exercise improves cognitive function, memory, and mood, and exercise has been linked to increased production of neurotransmitters, hormones, and growth factors that promote brain health. However, to date, no studies have investigated the effect of aerobic exercise on brain excitability and connectivity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Speak and understand English

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Rest PETCO2 As a Predictor of Post-operative Complications

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty and often can not undergo CPET. In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing. Moreover, inability to perform CPET has been linked with inferior outcomes following surgery.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty. Therefore, CPET as a mean of risk stratification would be of an especial interest in this group of patients. However, vascular surgery patients often present with peripheral arterial disease, which may contribute to early leg ischemia during exercise and therefore invalid cardiorespiratory reserve function measurement.

In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency in the prediction of post-operative complications in lung resection surgery patients. Whether the same parameter can be used to predict postoperative complications in a different sub-set of surgical patients (i.e. vascular surgery patients) is yet to be determined.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

Eligibility Criteria:
Inclusion Criteria:

* indication for major vascular surgery (aortobifemoral bypass surgery)

Exclusion Criteria:

* tracheostomy
Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression.

Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol
* Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for \>50% of days within 3- months)
* Depression (in at least half of participants) - must meet the criteria as outlined in the protocol
* English speaking
* Willing to use a Transcutaneous Electrical Acustimulation device

Exclusion Criteria:

* Dementia and/or severe cognitive impairment
* Unable or unwilling to provide consent
* Expected to undergo liver transplant in next 24 weeks
* No email address
* Deemed unsuitable by the study investigator
Typhoid Fever: Combined vs. Single Antibiotic Therapy

The current study goal is to examine the effect of Cephalosporins, Azithromycin and the combination of both on typhoid fever therapy in endemic population.

The investigator's hypothesize that the combination of azithromycin and ceftriaxone may prove superior to each drug, ceftriaxone or azithromycin, alone.

Typhoid Fever is a highly prevalent infection in the Indian subcontinent. Due to multidrug resistant strains in these areas, third generation cephalosporins, such as ceftriaxone, are the treatment of choice. However, the latter regimen exhibits a slow response with mean time of 5 to 7 days or even longer to defervescence, which could be attributed to poor penetration capability of the drug into cells, and thus difficulty to eradicate the bacteria from the intracellular niche.

Attempts have been made to overcome this setback by introducing alternative antibiotic regimens, such as azithromycin. However studies comparing between azithromycin and a third-generation cephalosporin for the treatment of typhoid fever in adult population in the Indian subcontinent are lacking.

Over the last few years our approach towards non-immunized travelers, who acquired typhoid fever in the Indian subcontinent, was to administer a combination therapy of intravenous ceftriaxone with oral azithromycin. The rationale of this dual regimen was its pharmacokinetic profile, which suggests a complimentary action of the two agents - ceftriaxone on the extracellular compartment and azithromycin on the intracellular compartment. Moreover, in our clinical experience, preliminary published data has proven combination therapy significantly superior to ceftriaxone alone albeit in a small group of travelers.

In the current study the investigators intend to compare the efficacy of ceftriaxone vs. azithromycin and vs. combined therapy of both agents for the treatment of uncomplicated typhoid fever in terms of time to defervescence.

4 different treatment strategies will be examined (as mentioned in the arm section). All participants will be checked for vital signs, will undergo physical examination, ECG, laboratory testing, blood, urine and stool culture and tests for susceptibility to antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Blood culture-proven typhoid fever (S. typhi or S. paratyphi)
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Allergy to ceftriaxone or macrolides
* Major typhoid fever-associated complications
* Inability to swallow oral medication
* Underlying illness
* Pregnancy
* Lactation
* Treatment within the past 4 days with an antibiotic that may be effective against typhoid fever
Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections

This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on respiratory tract infections (RTIs) in an elderly population in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 55 years of age at time of consent
* Able to eat and drink, with assistance if required
* Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study
* Signed consent obtained from subject or legally authorized representative
* Signed authorization obtained to use and/or disclose Protected Health Information

Exclusion Criteria:

* Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition
* Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation
* Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject
* Known allergy or intolerance to study products
* On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months
* Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration
* Have experienced Respiratory Tract Infection within 1 week prior to randomization
Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease

The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.

- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test


Eligibility Criteria:
Inclusion Criteria:

\[Patients with moderate-to-severe ocular dry eye\]

1. The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
2. Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value ≥ 3mm/5min)
3. Tear break-up time is 10 seconds or less
4. Screening both eyes, the corrected visual acuity is 0.2 or more
5. Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)

Exclusion Criteria:

1. Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
2. The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)

   1. Abnormal eyelid function : Disoders of the eyelids or eyelashes
   2. Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
   3. Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation
3. current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
4. The use in clinical trials of drug hypersensitivity reactions in patients