cyrilzakka/clinical-trials huggingface dataset:
CMV Disease and IRIS in HIV-1 Infected Persons

Various diagnostic methods are available for CMV infection. But none of them could be a standard and highly valuable. Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person. By using these tools, physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study. Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS. Finally, our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage.

At present, human cytomegalovirus (HCMV) remains a major health threat in immune compromised patients. Especially HCMV will cause blind and death in HIV-1 infected person. Currently, few antiviral drugs can be chosen for treatment of HCMV infection. Besides, more and more drug resistant virus strains were reported and led failure in antiviral therapy.

Various diagnostic methods are available for CMV infection. Such as shell vial assay, CMV antigen test, pp65 antigen assay and polymerase chain reaction. But none of them could be a standard and highly valuable. Although CMV-PCR is very sensitive, it can't distinguish between active disease and asymptomatic infection or latency, can't predict symptomatic disease nor can't monitor the successful antiviral therapy.

Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person. By using these tools, physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study. Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS. Finally, our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage. We may find out new therapeutic concept and prevent virus reactivation from latency.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV-1 Disease
* Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Eligibility Criteria:
Inclusion Criteria:

* At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:

  1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
  2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion Criteria:

* None
Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.

Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.

The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.

This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

Eligibility Criteria:
Inclusion Criteria:

- age above 18

Exclusion Criteria:

- congenital glaucoma
MT10109L in the Treatment of Glabellar Lines

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.


Eligibility Criteria:
Inclusion Criteria

• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
* History of facial nerve palsy.
* Any uncontrolled systemic disease.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
* Anticipated need for surgery or overnight hospitalization during the study.
* Prior exposure to botulinum toxin of any serotype for any reason.
* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery).
* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Females who are pregnant, nursing, or planning a pregnancy during the study.
* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study

The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

Transcranial direct current stimulation (tDCS) is a novel neuromodulation method that has been observed to be promising in treatment of psychiatric disorders such as depression. Nevertheless, knowledge related to the treatment of psychological stress and its main symptom, anxiety, is very scarce. The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Naïve to tDCS
* Right-handed
* Impact of Event Scale Scores ≥ 30

Exclusion Criteria:

* Metal implants inside skull or eye
* Severe skin lesions at the electrode placement area
* History of epilepsy or previous seizures
* Pregnant or breast-feeding
* Pacemaker
* History of intracerebral bleeding during the past six months
* Major psychiatric conditions according to the Structured Clinical Interview for DSM-IV Disorders, i.e., Lifetime diagnoses of bipolar mood disorder or psychotic disorder
* DSM-IV diagnosis for one or more of the following conditions during the past six months: unipolar mood disorder, anxiety disorders, eating disorders, or substance dependence/abuse.
* Use of psychotropic medication (i.e., antipsychotic and antidepressant medications, mood stabilizers, psychostimulants, hypnotics and tranquilizers) during the past six months
EHR Nudges to Improve Quality of Care in HF

The purpose of this pilot feasibility study is to test a pharmacist-facing clinical decision support tool designed to increase adherence to guideline-directed medical therapy and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.

Heart failure (HF) is a common, morbid, and costly condition with an enormous toll on health and the health care system in the US. Unlike other HF types, for patients with HFrEF decades of high quality, randomized controlled trials have demonstrated numerous interventions-including medications, devices, and cardiac rehabilitation-that improve quality of life, lengthen survival, and reduce hospitalizations. Despite the substantial evidence, many patients with HFrEF do not receive optimal guideline-directed medical therapy (GDMT) as shown by several US quality registries dating back to 2009. Contributors to gaps in care quality have been shown to include patient-level (i.e., illness severity, race/ethnicity, socio-economic status), clinician-level (i.e., lack of knowledge, clinical inertia), and health system-level (i.e., lack of care coordination) factors.

Pharmacist-led clinics in several health systems and studies have been shown to lead to high rates of GDMT intensification. This finding is consistent with decades of research in HF and other conditions in which more resources allocated to disease management can improve quality of care. Yet, little data exist on adherence to optimal GDMT after completion of an intensive disease management program.

Northwestern Medicine is a large, integrated system that operates multiple pharmacist-led clinics to optimize GDMT in patients with HFrEF. Once patients reach the maximum level of intensification, they complete the program and are no longer actively followed by the pharmacist team. The adoption of electronic health records (EHRs) and integration of novel data sources, such as prescription fill data from third-party vendors, create the opportunity to implement strategies to monitor adherence over time and intervene when adherence declines. Clinical decision support nudges in the EHR are inexpensive strategies that have been shown in clinical areas outside of HF to increase adherence to evidence-based therapies. Studies that use pharmacy fill data to monitor adherence to evidence-based care are rare given some of the technical challenges of accessing these data and using them for clinical decision support tools.

In this pilot feasibility study, we aim to develop and test a pharmacist-facing clinical decision support tool designed to increase adherence to GDMT and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.

Eligibility Criteria:
Inclusion Criteria:

* Pharmacist at Northwestern Medicine participating in the Medication Adjusted to Target (MAT) Clinic

Exclusion Criteria:

* None
Assessment of Nutritional Status After Gastric Bypass Surgery

This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake of various common dietary protein sources 16 female patients with BMI \> 40 kg/m2 and on a waiting list for bariatric surgery will be included. The following measurements will be performed before, and 1, 3, 6, 12, and 36 months after RYGP

* body weight
* body composition (bio impedancemetry)
* basal metabolic rate (open circuit indirect calorimetry)
* 24-hour urinary urea excretion
* fasting blood chemistry
* energy and macronutrient's intake (3-day dietary recall)


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* gender: females
* body mass index \>35 kg/m2

Exclusion Criteria:

* GI tract diseases
* endocrine diseases
Development of Serologic Assays for Human Herpes Virus-8

Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to potentially measure antibody responses to HIV, other infectious agents, and human antigens, to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s sarcoma, since all those patients are almost certainly infected with HHV-8. We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would also like to examine these samples for evidence of infection with other infectious agents, such as newly identified or unknown viruses, using techniques such as PCR or deep

sequencing.

Eligibility Criteria:
* Data analysis only
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children

To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.


Eligibility Criteria:
Inclusion Criteria:

1. Parental written informed consent.
2. Age: 13≥ years ≥8 (including).
3. Gender: both male and female.
4. TOVA computerized test score ≤-1.8 at baseline.
5. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
6. Normal weight and height according to Israeli standards.
7. 21 days without any treatment for ADHD symptoms, whether medication or food supplement.

Exclusion Criteria:

1. History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
2. Pervasive developmental disorder or Non-Verbal Learning Disability
3. Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
4. History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
5. Having a sibling already included in the study.
Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care

The purpose of this study is to establish an electrocardiogram (ECG) data library to facilitate future studies on heart disease. Additionally, the study will be used to monitor changes in the patient's standard of care throughout the study period and gather patient perspectives on routine diagnostic procedures and disease monitoring and feedback on the design of heart failure trials.

Patients with heart failure with mildly reduced or preserved ejection fraction will be invited to participate in this patient observational study.

After providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ECGs will be used to contribute to establishing an ECG library for future heart disease research. Additionally, patients' perspectives on the current standard of care clinical procedures will be gathered. Patient preferences will be gathered in relation to factors around routine clinical investigations for heart failure to better design a disease monitoring tool to include clinical and patient preferences. Also, the patients may be updated on the latest therapy options.

Additionally, participants may be invited to review and provide feedback on the study design of heart failure trials under development, helping to ensure alignment with patient needs. Their input can identify potential procedure challenges and enhance the clarity of study materials, improving overall patient engagement. A follow-up call with a research physician will provide the opportunity to discuss any issues identified in the clinical baseline assessment and allow the participant to ask any additional questions.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants aged 45 to 80 years (inclusive) at the date of signing the informed consent.
2. Diagnosed with heart failure.
3. Able and willing to provide informed consent to participate.

Exclusion Criteria:

1. Diagnostic test results positive for:

   1. HIV-1 or HIV-2 infection
   2. Hepatitis B or Hepatitis C infection
2. Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator.
3. Any condition judged by the Investigator to pose an undue risk while participating in the trial
4. Diagnostic results which are inconsistent with heart failure with mildly reduced or preserved ejection fraction as judged by the Investigator.
Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Four Hospital of the Alpine Region

The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.

In France during the first wave of the pandemic, 30,230 symptomatic healthcare workers had been reported positive. Yet, the prevalence of the infection in French healthcare workers remains unknown as it mostly reflect symptomatic infections.

Also, the prevalence of infection was reported being higher in male healthcare workers, and in those having patients' facing roles. However, the impact of the level of exposure to SARS-CoV-2, the use of personal protective equipment and hospital organization to prevent infection and spread remains unclear.

Our study aims to report the seroprevalence of SARS-CoV-2 infection among French healthcare workers after the first wave of the pandemic. It also aims to explore the impact of the type of occupations and the level of exposure to the viruses on the seroprevalence of infection.

Eligibility Criteria:
Inclusion Criteria:

* Hospital staff employee
* Employed in one of the participating centers
* Volunteers to perform SARS-CoV-2 serology
* Permanent or occasional staff (temporary workers, short contracts)
* Caregivers or not (medical, paramedical, administrative, technical staff)

Exclusion Criteria:

* Staff who are not working at a participating center while participating in the study
* Person under guardianship or curatorship
* Opposition to data collection
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years

The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:

1. Proteinuria
2. Renal survival indices

This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 10 and 18 years old,
* Nephrotic resistant patients,
* No history of diabetes,
* Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
* Caregivers' acceptance to be enrolled in the study.

Exclusion Criteria:

* Uncontrolled urinary tract infection at screening,
* Blood pressure is less than 5th percentile of the same gender, age, height,
* At risk of dehydration or volume depletion,
* Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase \>2 times the upper limit of normal during screening,
* History of organ transplantation, cancer, liver disease,
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist
2. Must be at least 18 years of age or older
3. Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent to participate in the registry.
2. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial).
3. The subject is restarting the eligible medication less than 12 months since receiving the last dose.