cyrilzakka/clinical-trials huggingface dataset:
Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Dry eye disease for \> 3 months meeting specific sign and symptom criteria
* Best correct visual acuity of +0.6 logMAR or better
* Willing to sign informed consent and attend study visits
* Willing to comply with contraception requirements

Exclusion Criteria:

* Unable to meet specific sign and symptom criteria
* Signs of ophthalmic allergic, inflammatory or infectious conditions
* Use of contact lenses
* Anatomic abnormalities preventing accurate study assessments
* Use of medications that influence eye dryness
* Recent ophthalmic surgery
* Unwilling to suspend current treatments for dry eye disease
ACT-MBC: a Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)

ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
2. ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy
3. Measurable and/or non-measurable disease is allowed
4. Male or female breast cancer is allowed
5. Age \> 18 years
6. Willingness to provide mandatory blood specimens
7. Willing to return to enrolling institution for follow up imaging at least once

Exclusion Criteria:

1. Life expectancy of ≤ 6 months
2. Inability to provide blood samples based on the judgment of the treating provider
Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin + Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This molecular genetic study will be performed in patients presenting with dyspepsia, who had an indication for gastroscopic examination, to explore the incidence of antibiotic resistant Helicobacter pylori in Rajavithi Hospital, Thailand.

Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Eligibility Criteria:
Inclusion Criteria:

* male or female with dyspepsia
* age \> 15 years
* fulfil indication for gastroscopic examination
* able to give informed consent

Exclusion Criteria:

* contraindication for gastroscopic examination and biopsy
A Study of Tocilizumab in Patients With Rheumatoid Arthritis

This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Moderately to severely active rheumatoid arthritis
* Inadequate response to previous treatment with an anti-TNF agent
* Receiving methotrexate for at least 12 wks before study

Exclusion Criteria:

* Previous treatment with tocilizumab
* Previous treatment with other IL-6 receptor inhibitors
* Treatment with corticosteroids (oral prednisone \>10 mg/day or equivalent) within 4 wks
* Conditions noted in the tocilizumab prescribing information
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well as its risk factors.


Eligibility Criteria:
Inclusion Criteria:

* men and women between the ages of 18 and 60
* recently diagnosed Diabetes Type II (within the last 12 months)

Exclusion Criteria:

* no orally-taken medication up to present
* no insulin therapy
* no diseases resulting from diabetes like Nephropathy, Neuropathy, Angiopathy or Retinopathy
* fasting blood sugar values in the morning under 200mmol
* sufficient production of insulin
Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation

Introduction: Renal transplantation represents the therapeutic mode with more durable treatment, greater cost-effectiveness, survival benefits and quality of life of the patients, however, with high cardiovascular mortality.

Objectives: To evaluate the acute and chronic effects on heart rate variability and the impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients following a full-body Vibration training program.

Methods: It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one year before and present a stable transplant function through the level Of creatinine

It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the inclusion criteria

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 59 years
* who underwent transplantation at least one year before
* present a stable transplantation function through the creatinine level \<1.8 mg / dL
* No drug use with ability to modify the autonomic nervous system, such as sympatholytic drugs

Exclusion Criteria:

* unstable hypertension;
* Amyloidosis;
* Congestive heart failure, recent myocardial infarction, unstable angina;
* Musculoskeletal abnormality that impairs the performance of the exercises;
* Have a metal implant or cardiac pacemaker.
Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults

This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. Participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. It is hypothesized that there will be a significant improvement in brain function.

1. Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults.
2. Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample.
3. Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes.
4. Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

Eligibility Criteria:
Inclusion Criteria:

* Adult Day Program Participants with early dementia able to consent or assent with surrogate permission
* Control participants (55-100+ yo) able to participate at location with doctor permission

Exclusion Criteria:

* history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care

The aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

This study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being under surveillance in the coronary intensive care unit

Exclusion Criteria:

* Presence of neurological disease that may affect the cognitive status
* Not being clinically stable
* Not to cooperate
A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma

This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.

Primary study endpoints:

Overall Survival Rate (OS Rate) at 24 months after infusion：Survival rate from the start of cell infusion to 24 months after infusion.

Secondary study endpoints:

Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment

Other efficacy endpoints of zevor-cel:

Overall response rate (ORR)：Proportion of subjects with a partial response (PR) or above.

Complete response or stringent complete response rate (CR/sCR) ：The proportion of subjects with the best response of CR/sCR.

Duration of Response (DOR)：The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.

Progression Free Survival (PFS) Overall survival (OS)： The time from the start of cell infusion to death due to any cause.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
3. Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.

Exclusion Criteria:

1. There were no specific exclusion criteria for this study。
Virtual Reality and Fear of Falling in Parkinson's Disease

Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. The fear of falling (FoF), a natural response to unstable balance, can exacerbate postural control problems. However, evaluating FoF relies primarily on subjective self-reports due to a lack of objective assessment methods.

Objectives: This mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. This protocol examines a range of FoF-related responses, including cognitive, neuromuscular, and postural stability factors.

Methods: Individuals without and with Parkinson's disease will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where FoF can be elicited using virtual reality (VR) technology. Data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. Semi-structured interviews will gather participants' and researchers' experiences of the protocol.

Discussion: This method may allow accurate assessment of how FoF impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. Virtual environments reproduce real-life scenarios that trigger FoF. Rigorously assessing FoF with this approach could demonstrate its ability to quantify the effects of FoF on movement.

Conclusions: This protocol aims to improve FoF assessment by evaluating multiple responses during movement in virtual environments. It addresses current measures' limitations. A feasibility study will identify areas for improvement specific to Parkinson's disease. Successful validation could transform how FoF is evaluated and managed.


Eligibility Criteria:
Inclusion Criteria:

* People ≥ 40 years old.
* Participants diagnosed with Parkinson's disease by a neurologist, regardless the type.
* Modified Hoehn and Yahr stages I to III.
* Able to follow instructions and understand questions.
* Able to walk independently and without walking aids.
* People who experience excessive fear of falling and fear of movement.
* Able to communicate verbally.
* Stable use of Parkinson's Disease or other comorbidities medications.

Exclusion Criteria:

* Impaired vision and hearing.
* Unstable medical condition.
* Co-existing neurological or orthopedic conditions that may limit mobility and affect participation.
* Dizziness, vertigo, headache, and motion-sickness.
* Cognition impairments.
* Pregnancy.
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility:

Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy.

The contraindications are:

* Bilateral carotid bifurcations located above the level of the mandible
* Baroreflex failure or autonomic neuropathy
* Uncontrolled, symptomatic cardiac bradyarrhythmias
* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Objectives:

To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:

* New York Heart Association (NYHA) Class
* Six Minute Hall Walk
* Echocardiogram measures
* Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).

Evaluate health care utilization over follow-up, such as heart failure hospitalizations.

Describe device programming and utilization

Eligibility Criteria:
Inclusion Criteria:

* Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
* Subject has been implanted with the BAROSTIM NEO System in the past 30 days
* Subject has signed an Ethics Committee approved informed consent form

Exclusion Criteria:

* Bilateral carotid bifurcations located above the level of the mandible
* Baroreflex failure or autonomic neuropathy
* Uncontrolled, symptomatic cardiac bradyarrhythmias
* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population

HPV infection has been recognized as the most prevalent sexual transmitted infection worldwide. Burden of many HPV related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated HPV types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention.

Objectives:

1. To determine the HPV genotypes distribution in genital warts in the study population.
2. To assess the knowledge about transmission \& prevention of HPV infection related diseases
3. To determine the direct medical costs of genital warts attention.

Study population

Female and male between 18 - 45 years of age living in Bogota, Colombia

Sample frame

Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)

Analysis

Analysis of the information will be exhaustive. We will calculate prevalence of HPV genotypes in the GW in both sexes separately. Analyses of the survey will include simple frequencies, percentages, and comparison of results related to HPV knowledge with sociodemographic and clinical information. Explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. We will calculate the medical cost of patients enrolled in the study. The treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. We will use national reference cost list (SOAT) to determine the cost of procedures included.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-45 years.
* Lesions suspicious of being HPV related.
* The main manifestations of anogenital warts include:

  * Cauliflower-like condylomata acuminata lesions that usually involve moist surfaces
  * keratotic and smooth papular warts, usually on dry surfaces
  * subclinical "flat" warts, that can be found on any mucosal or cutaneous surface and, which are probably overseen in the majority of cases.
* Lesions other than the described above, are not to be biopsied, according to the investigator criteria.

Exclusion Criteria:

* Not willing to participate
* To be a participant in any HPV vaccine clinical trial study
* Known immune suppressive disease.
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy.

Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.


Eligibility Criteria:
Inclusion Criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Subject is willing and able to provide written informed consent to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.
2. Age ≥ 18 years at the time of consent.
3. Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma.
4. Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study.

Exclusion Criteria

All subjects meeting any exclusion criteria at baseline will be excluded from study participation.

1. Inability or unwillingness to provide informed consent
2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment
Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study

This longitudinal follow-up study aims to analyze how surgical and patient characteristics affect clinical outcomes in the subjects received total hip arthroplasty (THA) or hemiarthroplasty (HA).

Clinical assessments in this research include visual analogue scale (VAS), Harris Hip Score (HHS), Oxford Hip Score (OHS), forgotten joint score (FJS-12) and X-ray imaging applied to examine the stability of implants. Through analyzing surgical information, functional measures and self-reported questionnaires, this study intends to gain insights into the correlations between various clinical aspects.

Eligibility Criteria:
Inclusion Criteria:

1. 20 years old at least.
2. Osteoarthritis (OA)
3. Avascular necrosis
4. Rheumatoid arthritis (RA)
5. Previous failure of hemiarthroplasty
6. Femoral head or neck or trochanteric fractures
7. Developmental dysplasia of the hip

Exclusion Criteria:

1. Being unable or unwilling to participate in
2. Subjects having cognitive impairment cannot fill out survey
3. Other complication causing severe deficiency in function and motion