cyrilzakka/clinical-trials huggingface dataset:
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

Pharmacological, single-center, non-profit observational study.

The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).

Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.

The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Ability to understand and sign the informed consent
* Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.

Exclusion Criteria:

* Co-infection with other viruses (HCV, HIV)
* Treatment with immunosuppressive/immunomodulatory drugs
* Other congenital and/or acquired immunodeficiency conditions
Staying Healthy With Follow-up Care: A Mobile Chatbot Feasibility Study for AYA Cancer Survivors

The purpose of this project is to identify effective strategies to assist survivors of childhood and young adult cancers (diagnosed between birth and age 39) who have not returned for follow-up cancer care for 3 or more years, to reengage with the health care system. The investigator will evaluate the effect of a novel, bidirectional conversational agent ("Penny"), compared to usual care, to assist patients with scheduling appointments, lab work as well as scans and specialty appointments as needed.

To achieve this, the investigator will use a two-arm randomized controlled trial to explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from patients. Penny is a conversational agent ("chatbot") that engages patients in real time via text messaging, allowing for bidirectional communication and motivational cues to promote adherence. The chatbot will assist patients who have not been see for cancer follow-up care, with scheduling follow-up appointments, labs, scans, specialty appointments, and monitor compliance with the appointments made.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \> 18 years), male or female, diagnosed with cancer as a child or as a young adult, between birth and 39 years of age
* Patient possession of a mobile device that can receive SMS texts
* Ability to respond to questions and engage with "Penny" in English
* Ability to provide informed consent to participate in the study
* Approval of the patient's oncology care team for the patient to be involved in the study

Exclusion Criteria:

* Anyone who does not meet the inclusion criteria
* Patients with a history of thyroid cancer or skin cancers
Comparison of Standard Versus Low Bicarbonate Hemodialysis

This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.


Eligibility Criteria:
Inclusion Criteria:

* Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
* Age \> 18 years

Exclusion Criteria:

* Use of oral alkali within the previous month
* Hospitalization within the previous month
* Inability to provide written informed consent
* Pregnancy
City of Rochester Teen Outreach Program (TOP™) Evaluation

As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.


Eligibility Criteria:
Inclusion Criteria:

* must be registered at a participating RC
* age 11 through 14 years
* participants must assent and parent(s) or legal guardian(s) provide permission to participate
* basic understanding of the English language

Exclusion Criteria:

* age at enrollment of less than 11 or greater than 14 years
* for facilitators, age less than 21 is an exclusion criterion
The Effect of the MedSentry System on Medication Adherence

The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.

We hypothesize that:

1. The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
2. The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
3. The improvement in adherence correlates with better health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed the Partners Connected Cardiac Care Program (CCCP)
* Take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat Heart Failure (HF) and other comorbid disorders.
* Take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime).
* The patient must be able to open a pill bottle independently.
* The patient must be able to sort and manage their own medications.
* Hospitalization within the last 24 months.
* Have a telephone or cell phone.
* Live in the greater Boston area.
* The patients must speak, read and write English.
* The patients must not be either vision or hearing impaired (i.e., unable to hear an alarm similar to a clock alarm or oven alarm).
* Patient must have an Massachusetts General Hospital (MGH) affiliated care provider.

Exclusion Criteria:

* Dementia or other conditions precluding the participant from providing informed consent or from learning to use the MedSentry pillbox.
* Home environment unsuitable for the MedSentry pillbox and other installed equipment.
* Awaiting revascularization, cardiac resynchronization or heart transplant.
* Patients with a coexisting terminal illness like cancer or Chronic Renal Failure (CRF) requiring dialysis.
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine

This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged from 19 to 70
* Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.

Exclusion Criteria:

* Those who will apply other intrauterine device rather than investigational device during the study period.
Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults

With the onset of the sixth decade in life, degenerative processes affect the neuromuscular system in terms of losses in muscle strength (dynapenia) and muscle mass (sarcopenia). Neural (e.g., numerical loss of alpha motoneurons) and morphological factors. Borde et al. 123 number and size of particularly type-II muscle fibers), as well as their interaction, are responsible for age-related declines in muscle strength and mass. There is evidence that muscular weakness is highly associated with impaired mobility and an increased risk for falls. Moreover, lower extremity muscle weakness was identified as the dominant intrinsic fall-risk factor with a five-fold increase in the risk of falling. An anti-gravity treadmill allows users to walk or run in a reduced body weight environment. The user walks or runs on a treadmill belt surrounded by an enclosed, air-filled chamber. When air pressure increases, an upward force offloads the weight of the runner and decreases the percentage of body weight (BW%) experienced upon foot impact. So, a research question was developed in our mind after the literature review. Is there any effect of AGT training on fall risk of older adults?


Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling adults aged 55 years and above.
2. Berg balance score should be from 46 to 54.
3. Able to follow instructions in Urdu.
4. No neurological conditions, and no musculoskeletal injuries within the past year.
5. Both male and female.

Exclusion Criteria:

1. Pain with ambulation or dizziness when standing or walking.
2. Contraindications to treadmill walking and LBPP such as cardiovascular conditions.
3. Severe osteoporosis, fractures, when loading of the abdominal region, hip or pelvis is contraindicated (such as groin infections, skin graft in the groin region, gastrointestinal tubes, colostomy, compromised skin integrity), orthopedic conditions in the past year or neurological conditions.
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.

This study is a multicenter, non-blinded, non-comparative study. Patients who meet the eligible criteria will undergo one week observation period followed by four week treatment period. In treatment period, patients will receive gabapentin enacarbil orally one daily after dinner. After the four-week treatment period with gabapentin enacarbil, a one-week post-observation period will be undertaken.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with restless legs syndrome (RLS) according to the international RLS Study Group Diagnostic Criteria
* Patients whose score is 15 or greater on the International RLS (IRLS) Rating Scale on the first day of the pre-observation period.
* Patients whose creatinine clearance level at the first day of pre-observation period is ≥30 mL/min to \<60mL/min estimated by Cockcroft-Gaul t equation
* Patients who provide written consent

Exclusion Criteria:

* Patients with sleep disorder such as sleep apnea syndrome, which affects the RLS evaluation
* Patients with history of augmentation and treatment rebound of RLS symptoms when using dopamine agonis
* Patients with neuropathy and movement disorder (diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesia, rheumatoid arthritis etc)
* Patients with uncontrolled diabetes \[HbA1c\>7.5% (NGSP value), in the past six months\], iron deficiency anemia, or drug administration of hypnotic sedatives.
* Patients who attempted suicide within six months prior to the consent obtained, or who have been diagnosed as a suicide risk by investigator or sub-investigator
* Patients with moderate or severe depression
* Patients with alcohol dependence or drug intoxication or who have a history of abuse or drug dependence in the past one year
* Patients whose job is shift work, professional driver, or engaging in hazardous activities such as operating machinery
* Patients with history of hypersensitivity to gabapentin
* Patients who have experience to participate in other post-marketing clinical studies or clinical trials within 12 weeks prior to the start of pre-observation
* Others: patients who are concluded to be ineligible by an investigator or sub-investigator as ineligible
A Study of LY3471851 in Healthy Participants

The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy males or females, as determined by medical history and physical examination
* Are first generation Japanese or are Caucasian
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening

Exclusion Criteria:

* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have an abnormal blood pressure and/or pulse rate as determined by the investigator
* Regularly use known drugs of abuse and/or show positive findings on drug screening
* Are immunocompromised per investigator judgment
Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department

The COVID-19 pandemic has disrupted traditional clinical teaching, depriving medical students of valuable clinical engagement with patients who required an aerosol-generating procedure (AGP) in the emergency department (ED). Because of the infection control restrictions, medical students are not allowed to enter resuscitation room where AGPs takes place, even in the aftermath of the pandemic.

The Microsoft HoloLens 2 is an augmented reality (AR) head-mounted device (HMD) which enables a single clinical teacher to facilitate real-time distant immersive learning by medical students on critically ill ED patients while insulating them from infection risks. Our team has successfully developed an AR HMD prototype based on HoloLens for clinical teaching and conducted 10 pilot teaching sessions. Overall, the audio-visual quality of the video-laryngoscope image captured by the HoloLens were rated satisfactorily by the students. Cybersickness symptoms such as dizziness, nausea, and eye strain were infrequent among the viewers.

The investigators conduct a pilot randomised controlled trial (RCT) which aims to evaluate the feasibility of conducting a full-scale RCT. The investigators collect data of the impact of AR learning and bedside learning on student knowledge gain, cognitive load, motivation and adverse effects. The investigators invite 33 Year 5 or 6 medical students to participate in this study during the Emergency Medicine Specialty Clerkship rotation at the Accident and Emergency Department (A\&E) of Queen Mary Hospital (QMH). Consented medical students are randomly assigned in clusters based on their existing student group assignment (around 10 students per each small group) in a 1:1 to two arms: AR clinical learning arm and the control arm (bedside clinical learning).

Randomisation is performed by a research assistant not directly involved in the study using sequentially numbered opaque, sealed envelopes. Given the first-person perspective through the HoloLens, it is not possible to blind the medical students.

To standardise the teaching content of all study sessions, all such sessions are delivered by the principal investigator (PI) of this study during the study period and the pre-reading materials are the same for both groups. The PI will demonstrate endotracheal intubation using video laryngoscope and other AGPs on a manikin in the resuscitation room.


Eligibility Criteria:
Inclusion Criteria:

* Year 5 or 6 medical students during the Emergency Medicine Specialty Clerkship

Exclusion Criteria:

* refusal to consent
The Effects of Functional Action-Observation Training on Gait Ability in Patients With Chronic Stroke

This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago.
2. determination not to have cognitive disability, based on the score(\>24 point) of mini mental state examination-Korea version.
3. determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(MVPT)
4. ability to independently gait longer than 10m in the room and to keep standing up without help.

Exclusion Criteria:

1. surgery in the last three months
2. participating any other research
Travacom Post Marketing Surveillance Study

The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (IOP) medication and when use of Travacom is considered appropriate.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Open-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (IOP) agents and when the use of Travacom is considered appropriate.
* Discontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Mean IOP not greater than 36 mmHG in either eye.
* Read, sign, and date (or legal representative) the Informed Consent prior to the start of any study-related procedures.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at Screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study.
* Chronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis.
* History of clinically significant or progressive retinal disease.
* Best corrected visual acuity (BCVA) score worse than 20/80 Snellen.
* Bronchial asthma or related history that would preclude safe administration of a topical beta-blocker.
* Severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent.
* History of spontaneous or current hypoglycemia or uncontrolled diabetes.
* Known medical allergy, hypersensitivity, or poor tolerance to any component of Travacom deemed clinically significant in the opinion of the Principal Investigator.
* Use of any additional topical or system ocular hypotensive medication during the study.
* Participation in any other investigational study within 30 days prior to Screening visit.
* Other protocol-defined exclusion criteria may apply.
Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)

The main objective of this study is to determine if oral supplementation of Citrulline, when combined with HIIT, can produce significant changes in body composition, muscle quality, muscle metabolism and functional capacity in older obese men and women .

The investigators hypothesize that Citrulline combined with HIIT will be more beneficial than HIIT alone which will be more beneficial than citrulline alone which will be more beneficial than placebo alone in obese elderly men and women .

Citrulline is a non-protein amino acid, isolated from watermelon, involved in the urea cycle and an arginine precursor. Participants will take 10g/d of citrulline or placebo (isocaloric).

High intensity interval training (HIIT) is a high intensity aerobic training (30 sec at 85% and up of HRmax + 1min30 at 65-70% of HRmax). they HIIT duration is 30 min/session. HIIT is recognized as beneficial to improve health in human such as Vo2max, body fat or .

Then intervention will be follow during 12 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

1. autonomous (being able to follow the exercise program) and without cognitive impairment (MOCA test ≥21) ;
2. obese status (BMI between 30 and 40 kg / m2 or a waist circumference greater than 102 cm for men and 88 cm for women or fat mass (%; total or androïd or gynoïd) equal or superior to 27% in men and 40% in women;
3. stable weight (± 5 kg) for 6 months;
4. non-smoking and moderate drinkers (max: 15 g/day of alcohol) ;
5. without stroke or history of stroke ;
6. sedentary (less than 2 hours of structured physical activity per week);
7. not being involved in a vigorous exercise program for at least 12 months;
8. can understand French
9. postmenopausal women (without menses since 60 consecutively months).

Exclusion Criteria:

1. to have a metal implant (pacemaker);
2. asthma requiring oral steroid treatment;
3. taking other medication that could affect metabolism or cardiovascular function;
4. taking anticoagulant medication.
5. taking hormonal-replacement therapy (only for women)
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive

The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection

This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28.

Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product
* Subjects must test positive for HIV infection
* Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.
* Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control
* subjects must be clinically stable for 6 months prior to study enrollment.

Exclusion Criteria:

* Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection)
* Subjects with history or prior exposure to a vaccinia-containing product
* subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)
* Subjects with concomitant illnesses associated with impairment of immunologic function.
* subjects with dementia
* Subjects with malignancy.
* Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities
* Current or past history of eczema
* known allergies to any component of MVA, including eggs or egg products, or allergies to blood products
* females must not be pregnant and using approved contraceptives.
* Morbid obesity