cyrilzakka/clinical-trials huggingface dataset:
Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease

ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics." ALT-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes.

The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype

Subjects will be male and female, 18 to 75 years old, with Type 2 diabetes mellitus, a documented or suspected history of coronary artery disease, and a Haptoglobin type 2-2 (Hp 2-2) genotype. Subjects on prescribed anti-diabetic and coronary artery disease medications may continue to take their medications throughout the study.

Subjects who qualify will receive active drug (ALT-2074 20 mg, 40 mg or 80 mg) or placebo every 8 hours for 28 days. There will be three sequential cohorts of increasing doses of active drug. There will be 2 follow-up visits (Days 35 and 42). Blood and urine tests for safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure inflammation and oxidative stress will be performed throughout the study. Electrocardiograms and 24-hour Holter monitoring will also be performed at various time points during the study.

Eligibility Criteria:
Inclusion criteria:

1. Male or female, 18 to 75 years of age.
2. Diagnosis of Type 2 diabetes mellitus
3. Stable coronary artery disease (CAD) documented or suspected, not requiring adjustment for ≥2 months, as determined by: a. A history of myocardial infarction verified by Q-wave electrocardiogram and/or medical records, occurring greater than 6 months before the screening Visit; OR b. A coronary angiogram and/or stress test; OR c. A ankle brachial pressure index less than 0.9; OR d. Age greater than 60 years of age
4. Hp 2-2 genotype.
5. Ability to communicate and comply with all study requirements.

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Microvascular and Fibrosis Imaging Study

In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess differences in microvascular function and density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD) compared to healthy subjects. The microvascular changes will be compared to overall treatment response in patients with scleroderma and chronic GVHD as assessments will be made before and after the patients start treatment for their diseases and determine if these imaging techniques provide valuable and reproducible data when assessing a patient's response to treatment for those diseases. In addition, the application of Acoustic Radiation Force Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will be evaluated.

The investigators hypothesize that the vascular and dermal structures are altered in patients with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations and can be used to 1) detect early disease activity, 2) quantify and assess response to therapy and 3) quantify and correlate with overall disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Subjects above the age of 18 who are capable of giving informed consent with one of the following conditions: Scleroderma, Graft vs Host Disease, Sickle Cell Disease, Morphea, Connective Tissue Disease with cutaneous manifestations: cutaneous lupus, dermatomyositis, vasculitis, patients who are undergoing HSCT, or patients with a diagnosis of hematologic and non-hematologic malignancies without GVHD
* Control patients include normal healthy controls above the age of 18 who are capable of giving informed consent.

Exclusion Criteria:

* Patients who experience discomfort, will be prone to experience discomfort or cannot tolerate the position required for the imaging studies.
* Subjects unable to provide informed consent.
* Smokers, patients unable to tolerate caffeine avoidance for the day of the study.
Satisfaction With Care and Quality of Life

Investigating the predictive value of patient satisfaction with care on 6 months and 1-year quality of life.

Background: Evaluating the impact of complex procedures of patient care for chronic disease patients is one of the objectives and priorities defined in the French framework of the Public Health Act of August 2004. The relevant indicators that predict the impact of the medium-term hospitalization on the quality of life remain to be explored.

Preliminary data showed that care satisfaction, usual indicator of quality of care, was associated with quality of life away from the hospital, especially in the field of orthopedics (prosthetic surgery). Satisfaction is an indicator currently collected in routine periodic surveys in all establishments. This project will test the hypothesis of the prognostic role of this satisfaction after a medical or a surgical treatment in people hospitalized for chronic disease.

Objective: The objective of this research is to investigate the prognostic value of satisfaction with care on the quality of life of patients with chronic disease hospital, at 6 months and 1 year of discharge.

Patients and methods: A multicenter cohort of 1520 patients hospitalized in medical and surgical units for chronic disease (in the field of cardiovascular, musculoskeletal, nephrology, urology, digestive, pulmonary or endocrine). Patients will respond to PJHQ satisfaction questionnaire at the waning of their hospital stay. The quality of life (SF-36) will be measured at 6 months and 1 year after hospitalization.

The socio-demographic characteristics, diagnosis, anxiety state (HAD), optimistic / pessimistic personality (LOT-R), comorbidities (Charlson and Functional comorbidity index), major health events (rehospitalization, death ) and the characteristics of the stays and care structure (cluster services) who welcomed them will be saved.

The number of subjects required was calculated based on a cluster sampling (13 poles or services between institutions) to highlight with a power of 80% a difference of 5 points of quality of life among the satisfied and less satisfied subjects.

Statistical analysis will study the relationship of satisfaction scores with QoL dimensions at 6 months and 1 year, in hierarchical regression multilevel models adjusted for confounding variables.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40-75 years
* Patients hospitalized for treatment of chronic disease, defined as a disease lasting for more than 6 months, and confirmed by a validation committee
* Hospitalization motivation is:

  * A care of an acute episode of a chronic disease
  * A car of a worsening of chronic disease
  * A new therapeutic of a chronic disease

Exclusion Criteria:

* Patients who did not have a therapeutic intervention during their hospitalization (i.e., diagnostic analysis or medical follow-up without change of their treatment)
* Patients with more than 5 hospitalizations during the previous 5 years (more than 1 per year)
Microcurrent Stimulation to Treat Macular Degeneration

Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

This is an observational study in which data will be collected from a group of patients with retinal diseases such as Dry Macular Degeneration, RetinitisPigmentosa, and Stargardt's Disease, who have opted to receive Microcurrent Stimulation Therapy as an alternative treatment for their retinal condition.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent and comply with follow up visits
* Age 40 years or older
* ETDRS best corrected visual acuity better than 5 letters
* History of Dry Age Relted Macular Degeneration; Retinitis Pigmentosa; Stargardt's disease
* No Anti-VEGF treatments for at least 3 months prior to study
* No new antioxidant/vitamin supplementation for at least 3 months prior to study

Exclusion Criteria:

* History of Non-Compliance with regular medical visits
* Significant media opacities (exclude NS 4+) that may interfere with assessing visual acuity
* Presence of pigment epithelial tears or rips
* Known serious allergies to fluorescein dye
* Presence of retinal neovascularization
* Any treatment with an investigation agent in the past 30 days
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Outpatients
* History of GERD-related symptoms for at least 6 months prior to study inclusion
* Endoscopically confirmed erosive GERD or non-erosive GERD

Main Exclusion Criteria:

* Acute peptic ulcer and/or ulcer complications
* PPIs during last 7 days prior to study start
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
* Intake of PPIs in combination with antibiotics for eradication of H. pylori
Blood-borne Infection Screening in an Afghan Antenatal Population

Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize hospitals to assess the following aims:

Aim 1: To determine whether the re-training and assignment of health care providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.

Aim 2: To assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling.

Aim 3: To investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptable to both men and women in Kabul, Afghanistan.

Outcomes are assessed through questionnaire responses and inspection of vaccination cards at six month intervals by trained study staff through one year total study time. Differences between groups will be assessed with generalized linear mixed modeling. Information obtained to address Aim 3 will be gathered at the 12 month follow-up and analyzed with simple proportions and Chi-square test to assess differences between sexes and other socioeconomic indicators.

Eligibility Criteria:
Inclusion Criteria:

* admitted for obstetric care
* Dari or Pashto speaking
* not previously participated in the study
* in medically stable condition
* accompanied by and have approval of a spouse
* able to provide informed consent

Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.

Exclusion Criteria:

* medically unstable or imminently delivering (complete cervical dilation)
* husband unavailable or does not approve participation
* unable to provide consent
Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt

This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.

50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 18-65 years
2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC

Exclusion Criteria:

1. Tumor progression on the waiting list
2. Vascular invasion by imaging studies
3. Extrahepatic or lymph node metastasis
Women Empowered to Live With Lupus Study

The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based self-management education program that has been shown to help people with chronic conditions to take control of their health problems. This study focuses on African American women with SLE because the CDSMP has not been widely studied in this population.

The CDSMP is an evidence-based, community-based, generic self-management program that consists of 6 weekly classes of two and a half hours each one, for six weeks. CDSMP classes are facilitated by certified peer leaders. Because the CDSMP is widely disseminated and available to the adult U.S. population through community centers, it may be a suitable and accessible option for African Americans with SLE, even though it is not specifically tailored to SLE or to African Americans. As the CDSMP has been primarily evaluated in predominantly white middle-class seniors with more common diseases (e.g. osteoarthritis, diabetes), the effectiveness of the CDSMP in helping African American women to self-manage SLE is unknown.

This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with lupus. Using a two-group longitudinal cohort design with participants sampled from a parent population-based SLE cohort in Georgia, investigators will examine behaviors, health and healthcare outcomes, and the extent to which individual characteristics modify the effectiveness of the CDSMP.

The Georgians Organized Against Lupus (GOAL), a longitudinal cohort of patients with a validated diagnosis of SLE, will be used to enroll participants into the intervention. A random sample of African American women with SLE selected from the parent GOAL cohort will be recruited into the WELL (Women Empowered to Live with Lupus) cohort. WELL participants will attend the CDSMP classes in the community, along with people with other chronic illnesses. WELL participants will be asked to attend the CDSMP in the community and answer questionnaires at 4 select time periods before and after the program. Investigators will follow participant's progress for up to 18 months after they attend the CDSMP.

African American women from the GOAL cohort non-selected to be assigned to the intervention will comprise the usual care group. Participants will continue their longitudinal assessments as part of the GOAL cohort data collection efforts. Changes in outcomes for up to 18 months will be compared between WELL participants and the usual care group.

Eligibility Criteria:
Inclusion Criteria:

* Currently participating in the GOAL study

Exclusion Criteria:

* Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
* Significant cognitive impairment
Patient's Perception of Exercise After Bone Tumor Resection-A Qualitative Study

The aim of this study is to investigate the opinions of patients who have undergone bone tumor resection surgery about post-op exercises.

Semi-structured in-depth individual interviews will be conducted with patients who have undergone bone tumor surgery. In in-depth individual interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. Thematic analysis method will be used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 65,
* Individuals without communication problems,
* Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery
* Patients who have previously received therapeutic exercises

Exclusion Criteria:

* Uncontrollable arrhythmia and/or hypertension
* Presence of advanced sensory deficit
* Visual and hearing problems
* Not having sufficient communication skills (Mini-Mental Test score below 24 points)
* Patients undergoing head and neck bone resection
Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD

THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.

This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CNV secondary to AMD
* No other ocular disease
* No history of kerato-refractive surgery
* No epilepsy
* Ability to perform electrophysiologic study

Exclusion Criteria:

* Pregnancy
* Minority
* Epilepsy
* History of kerato-refractive surgery
Validation of the 3D-CAM and the UB-CAM in French

Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.

The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.

Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (\> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.

The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Adults hospitalized in acute geriatric units
* Aged 65 or older
* Patient (or relative) not objecting to participating in the study

Exclusion Criteria:

- Legal protection regimes (guardianship, curatorship)
Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street

Acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma.

The worsening asthma is accompanied by increased oxidative stress and inflammation in the lungs.

The investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity. They will be exposed to Oxford St. or to Hyde Park for 2 hours each, at a walking pace. Real time exposure to PM2.5, carbon monoxide and nitrogen dioxide will be made each time. Health outcome measurements will be made before and after exposure to each street. Statistical analyses will be made to examine the effect of diesel exposure on changes in health outcome measures.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be selected according to the current severity of their asthma; thirty from Steps 1 and 2 and thirty from Step 3 of the World Health Organization (WHO) Global Initiative for Asthma (GINA) asthma guidelines. These will include mild and moderate asthmatic states. Depending on baseline FEV1, subjects will undergo either a methacholine bronchial hyperresponsiveness assessment or airways reversibility testing. Subjects with normal FEV1 (\>80% predicted) or normal FEV1/FVC ratio will undergo methacholine challenge. Subjects with FEV1 \<80% predicted will undergo airways reversibility testing. Subjects must have either a PC20 of less than 8mg/ml methacholine, or improvement in FEV1 of 12% or more, following inhalation of short acting β-agonist (salbutamol 200μg from metered dose inhaler \[MDI\]). Skin prick testing will be conducted for common allergens (house dust mite, grass pollen, aspergillus fumigatus and cat hair). The results will only be for descriptive purposes, not as subject inclusion/exclusion criteria. Subjects may be atopic or non-atopic (according to history and allergy testing).
FemaSeed LOCAL Artificial Insemination Trial

Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.

314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).

Eligibility Criteria:
Inclusion Criteria:

1. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)

Exclusion Criteria:

1. Greater than three prior intrauterine insemination (IUI) cycles
2. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes)
3. Prior history of ectopic pregnancy or tubal surgery