cyrilzakka/clinical-trials huggingface dataset:
Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities

The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia.

Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.


Eligibility Criteria:
Inclusion Criteria:

* Works at a participating long-term care facility that has more than 50 staff members, has a staff COVID-19 booster vaccination rate of ≤60% as of December 1, 2021, and is located in Washington state or Georgia.
* 18 years or older

Exclusion Criteria:

* Does not work at an enrolled long-term care facility
* 17 years or younger
Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.


Eligibility Criteria:
Inclusion Criteria:

* Has been or will be implanted with the ACUITY Spiral Lead within 29 days
* Plans to remain in the long-term care of his/her enrolling physician
* Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
* Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Exclusion Criteria:

* Is unable or unwilling to comply with the protocol requirements
Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study

Exclusion Criteria:

* pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate \< 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within \< 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months
Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients

To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients

Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* age-related cataract patients

  * Eye axis length ≤22.5mm and refraction ≥ +0.5D
  * Predicted postoperative corneal astigmatism ≤0.75D
  * mesopic pupil size between 3.0mm to 5.5 mm
  * Preoperative angle kappa ≤ 0.5 mm
  * Preoperative corneal spherical aberration \<0.5μm, high order aberration \<0.5μm

Exclusion Criteria:

* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* Preoperative visual acuity of worse than 0.2 logMAR in any eye.
A Digimed Oncology PharmacoTherapy Registry

DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.

The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor.

The actual doses of DigiMeds™ will be based on standard of care as prescribed by treating physician. Patients will be instructed in the use of the DigiMeds™ and the DMP based on standard of care plus use of the DMP system.

Every effort should be made to take the DigiMeds™ as prescribed.

Patients in this study will be given the option to use their personal smartphone or will be provided a provisioned iPad to use for the duration of the study. Each patient will receive a Starter Kit comprised of two wearable sensor pods, adhesive strips, and instructions. Additionally, some kits may contain the provisional iPad Mini and charger for those without an approved smart device. Should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. Broken pods should be returned to Proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Prescribed treatment with DigiMeds™
* Have an Android or iOS-enabled device (e.g., iPhone, iPad, Samsung) or be willing to use a Proteus issued iOS device
* Signed consent form

Exclusion Criteria:

* Receiving palliative or hospice care services (i.e., proxy for \<12 months life expectancy)
* Not proficient in the English language
* Have impaired cognitive ability
* For women: current pregnancy
* Have skin sensitivity to adhesives or active/chronic dermatitis
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality

The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .

Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .

Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.


Eligibility Criteria:
Inclusion Criteria:

1. Unexplained infertility.
2. Tubal factor. Included treated hydrosalpinx and pyosalpinx
3. first cycle .
4. Body mass index: 18-29.
5. Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone \>1.
6. Antral follicular count: more than 5 follicles in one ovary.
7. combined factors .
8. Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.

Exclusion Criteria:

1. Patients with Endometriosis.
2. Azoospermic male.
3. Body mass index more than 29.
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens

Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery
* Clear intraocular media
* Signed informed consent and data protection documentation
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
* Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided

Exclusion Criteria:

* Subjects with ongoing adverse events that might impact outcomes during the study
* Use of systemic or ocular medication that may affect vision
* Acute or chronic disease or condition, ocular trauma or surgery that may confound results
* Patients with amblyopia, strabismus, nystagmus
* Concurrent participation in another clinical trial
Quality End-of-Life Care in Nursing Homes

The purpose of this study is to examine key organizational structures and processes (leadership, teamwork, communication, palliative care) and their impact on the quality of end-of-life care for dying residents and their family members.

As the American population ages, nursing homes are rapidly becoming a dominant site for death. Currently, 25% of all deaths occur in nursing homes and 35% of all elders over the age of 85 die in nursing homes. By 2020, 40% of those over 65 will die in nursing homes. Nursing home residents die in pain with undue psychosocial suffering. For all permanently placed residents, death is inevitable. Nonetheless, how residents die, is not.

There have been long standing concerns about the quality of care and quality of life in nursing homes. Although there is some evidence that the quality of care for nursing home residents has improved, serious problems continue in areas that potentially affect end-of-life such as dehydration, pressure ulcers, and pain. Efforts to improve care have rarely considered the dynamic nature of nursing home structure and process factors, such as staffing levels, leadership of the director of nursing, or communication and teamwork among staff that facilitate or impede the organization's ability to improve care processes. Findings from our preliminary studies in nursing homes indicate that organizational structure and process factors make a difference in end-of-life care for residents and their family members. More specifically, staff education, staffing levels, leadership of the Director of Nursing (DON) and administrator, teamwork and communication among direct care staff, and incorporating palliative care clinical practices into day-to-day care had a profound impact on outcomes such as the honoring of end-of-life preferences, symptom management, and satisfaction with care. A more generalizable understanding of key structure and process factors and their relationship to resident care and outcomes at the end-of-life will provide a foundation for future intervention studies aimed at improving care.

Eligibility Criteria:
Inclusion Criteria (Nursing Homes):

* 60 beds or greater

Exclusion Criteria (Nursing Homes):

* less than 60 beds

Inclusion Criteria (Nursing Home Staff):

* 19 years of age or older
* trained to provide resident care

Exclusion Criteria (Nursing Homes):

* less than 19 years of age
* staff on units exclusively Medicare or average length of stay less than 30 days

Inclusion Criteria (Family Member/Significant Other):

* 19 years of age or older
* somewhat to very involved in resident's care and decision-making

Exclusion Criteria (Family Member/Significant Other):

* not involved in resident's care and decision-making
* resident was in the nursing home less than 31 days
* resident was less than 65 years old
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib

The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.

Protocol was amended in November 2021, after the recent FDA approval of abemaciclib in the adjuvant setting. On October 12, 2021, FDA approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%. Our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well. 2-negative advanced breast cancer. Patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform (CARE ACROSS platform) where they can register their side-effects of cancer and the treatment received at frequent intervals. Patients will be randomized in the platform in two arms with an allocation 1:1(automatically by the platform). After every report of their side-effects, patients in Arm A will receive an acknowledgement and suggestion to stay in contact with their clinician. After every report of their side- effects, patients in Arm B will receive an acknowledgment and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported. Clinicians involved in the trial will refer patients (upon enrollment or to those already enrolled) to a dedicated online platform. Patients will sign up by entering their patient ID and their email address (and picking their password for security).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HR-positive, HER2-negative breast cancer
* Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
* 18 years or older
* Any menopausal status
* Treatment with abemaciclib in combination with endocrine therapy
* Any endocrine therapy
* At least two months of treatment with abemaciclib
Study to Identify Biomarkers for Protein Intake

Results from observational studies suggest a small beneficial association between protein and blood pressure that may be mainly attributable to the intake of protein from plant sources. In epidemiological studies biomarkers of dietary intake are useful to estimate intake more reliably. Dietary studies using biomarkers of protein intake generally show stronger associations with health outcomes. However, data on biomarkers for specific types of protein (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition the secondary purpose is to investigate whether intake of protein from these sources influences kidney filtration rate and urinary acid excretion differentially.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* BMI between 18.5 and 30 kg/m2
* Healthy (As judged by the participant)
* Written informed consent obtained

Exclusion Criteria:

* Unable or unwilling to comply with study procedures.
* Unusual dietary patterns, including high alcohol intakes (≥ 2 glasses/day) and a vegetarian diet
* Recent (\< 4 weeks) or current participation in a study with any investigational drug or dietary intervention
* Usage of an energy restricted diet during the last two months
* Weight loss or weight gain of 5 kg or more during the last two months
* Smoking
* Stomach or bowel diseases
* Kidney disorders
* Diabetes, thyroid disease, other endocrine disorders
* Prevalent cardiovascular disease
* Extreme sports (\>8h/ wk)
* Usage of any prescribed medication except for oral contraceptives
* Use of systemic antibiotics in the period of 3 month prior to the study
* For women: pregnant or lactating
* For women: not using oral contraceptives
* For women: Unwilling to use oral contraceptives for consecutively for at least the total study duration
* Liver function parameters (ALAT, ASAT, and γ-GT) and renal function parameters (Serum creatinin) outside the normal range
Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers

Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female volunteers.

The study was designed to compare the bioavailability of nifedipine new formulation specially designed to be used in pre-term labour management instead of anti-hypertensive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 45.
* Body weight within the normal range (Quetelet index between 19 and 26) expressed as weight (kg) / height (m2) .
* Medical history , physical examination within normal appliances .
* No evidence of significant organic or psychiatric disease based on history, physical examination and laboratory tests .
* Laboratory tests (hematology and biochemistry) within the normal range , according to normal reference values of the Biochemistry laboratory of Hospital de la Santa Creu i Sant Pau. Variations may be allowed based on clinical judgment of the Centre d' Investigacio Medicament (CIM ) .
* Vital signs: blood pressure (Systolic Blood Pressure (SBP) \> 90 \<140 mm Hg / Diastolic Blood Pressure (DBP) \> 50 \<90 mm Hg ), heart rate (\> 50 \<90 ) , temperature and ECG record within normal range.
* Not having participated in another clinical trial during the previous three months at the beginning of the current study .
* Not having donated blood in the previous four weeks.
* Free acceptance to participate in the trial. Written informed consent signed.
* Use of effective contraception different from oral contraceptives.

Exclusion Criteria:

* Previous history of alcohol or drug use or abuse during the previous month to the selection process.
* High consumption of stimulant beverages (\> 5 coffee, tea, cola drinks daily).
* Previous history of allergy, drug hypersensitivity or idiosyncrasy.
* Taking any medication in the 4 weeks preceding the trial, including non-prescription medicines and herbal remedies.
* Positive serology for hepatitis B, C or HIV.
* History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological or other chronic diseases.
* Having had surgery during the previous 6 months.
* Having donated blood in the month before the study began.
* Smokers.
* Positive pregnancy test at any monitoring during the study.
Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab as compared to current culture media standard, bedside inoculation with blood culture bottles.

The purpose of this study is to validate the principal study that recommends inoculation with blood culture bottles at bedside versus lab inoculation (delayed inoculation) of ascitic fluid in the diagnosis of spontaneous bacterial peritonitis. This study had a small sample size (29) and goal is to validate results with a larger sample size. The aim of current proposed study is to assess for non inferiority of lab inoculation of ascitic fluid culture versus current standard of blood culture bottles. To achieve 90% power and true sensitivity 95%, goal is to enroll 460 patients within the course of a year or until number of samples is reached, with plan to compare the sensitivity of bedside inoculation of blood culture bottles versus the lab using sterile plate techniques as per current lab culture technique. Unlike previous study, all comers for ascitic fluid collected will be analyzed that are to undergo diagnostic paracentesis.

Eligibility Criteria:
Inclusion Criteria:

* Ascites on ultrasound

Exclusion Criteria:

* Consent declined
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced.

The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* Celiac patients on gluten free diet since 1 year
* iron deficiency (ferritin \<15 ng/L or ferritin 15-20 + transferrin saturation \<15%)

Exclusion Criteria:

* allergy to iron supplementation
* anemia
* pregnancy or breastfeeding
* menopause
* organic or psychiatric diseases