cyrilzakka/clinical-trials huggingface dataset:
Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation

This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.

PRIMARY OBJECTIVES:

I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Eligibility Criteria:
Inclusion Criteria:

* Human leukocyte antigen (HLA)-identical sibling donor
* Myeloablative preparative regimen (i.e., \>= TBI 12.0 Gy, \>= busulfan (BU) 8.0 mg/kg PO, \>= BU 6.4 mg/kg intravenously (IV), \>= treosulfan 42 g/m\^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
* Transplantation of PBSC
* Cyclosporine (CSP)-based postgrafting immunosuppression
* Willingness to give informed consent
* DONOR: Age \>= 18 years
* DONOR: HLA genotypically identical sibling
* DONOR: Willingness to give informed consent

Exclusion Criteria:

* Nonmyeloablative preparative regimen
* Participation in an investigational study that has acute GVHD as the primary endpoint
* The allogeneic PBSC donor has a contraindication to statin treatment
* DONOR: Age \< 18 years
* DONOR: Active liver disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels \> 2 times the upper limit of normal \[ULN\])
* DONOR: History of myopathy
* DONOR: Hypersensitivity to atorvastatin
* DONOR: Pregnancy
* DONOR: Nursing mother
* DONOR: Current serious systemic illness
* DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
* DONOR: Current use of statin drug
* DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
* DONOR: Total creatinine kinase \> 2 times the ULN
The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes

The primary aim of this study is to assess and quantify the longitudinal impact of a mobile App-based module - FYA-003 - which is a gamified health education module for children promoting nutrition, physical activity, health hygiene, and infectious disease risk reduction within the clinically proven app fooya!, on the dietary and physical activity habits, hygiene practices, clinical outcome measures, and related knowledge of children and their caregivers. The app will be delivered in the classroom setting through school-based health education.

A 2-arm cluster randomized controlled trial with pre-, during- and post-treatment measurements will be conducted in a school in Chennai (India) - Panchayat Union Middle School (PUMS), Katchipedu - to assess and quantify the longitudinal impact of a proposed Digital Vaccine candidate, called FYA-003®, on students' knowledge, behaviors and outcomes related to diet, physical activity and health hygiene. After following the protocol for recruitment and informed consent, the investigators will pair up grades in the school (site) in consecutive order, such as grades 1-2, 3-4, 5-6, and 7-8, and randomly assign one grade in the pair to Group 1 and the other to Group 2. These pairs are assumed to be close to each other in age, maturity levels, health related knowledge, and exposure to mobile apps, hence appropriate for pairing up for the study.

A team of research staff located in Chennai will coordinate the execution of the experiment. After following the protocol for participation by the school administrator and staff, and the protocol for student recruitment and informed consent, the investigators will adopt a cluster-randomized trial design, where treatment assignment will be done at the grade level. Actual food choice, clinical measurements, survey data, and food logs will be collected by the site PI with support from a research project coordinator during weekly visits to the school. Game play data will be collected automatically whenever the mobile device is connected to the internet and will be downloaded to a secure server after the school visits. The research team will coordinate the gameplay timing with the school officials.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-14
* Parents willing to participate (fill out parent surveys)

Exclusion Criteria:

* Children physically unable to use a device
* Children with special needs
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).

This is a Phase 1/2 study of VT-464 in chemotherapy-naïve CRPC patients who are treatment-naive or who have failed prior therapy with abiraterone and/or enzalutamide. The study will examine several parallel QD dosing regimens of VT-464 using a traditional modified "3+3" Fibonacci study design. Approximately 3 dose-levels of VT-464 will be examined in each dosing regimen that is fully enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
* Patients must have a minimum serum PSA level of \>2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
* Patients must have castrate levels of testosterone (\<50 ng/dl \[1.74 nmol/l\]).
* Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
* Patients must have an ECOG Performance Score of 0 or 1.

Key Exclusion Criteria:

* Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
* Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
* Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
* Patients who have received TOK-001 (Galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
* Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for \> 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for \< 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
* Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
* Patients who have received palliative radiotherapy within 4 weeks of study entry.
* Patients with a history within the last 3 years of another invasive malignancy.
Virtually Supervised Exercise for Kidney Transplant Candidates

This study is examining whether a virtually supervised exercise program can improve physical function in persons who are awaiting kidney transplant. The investigators will compare the results to a similar group of persons who receive a health education program.

This study is examining if a virtually supervised exercise program can improve physical function in persons awaiting kidney transplant. A double-blind, parallel group randomized controlled clinical trial, this study will enroll 80 persons for 24 weeks. Our primary outcome is performance on the 30 second sit to stand test, and our secondary outcomes are changes in the Fatigue Severity Scale and the Beck Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Listed for kidney transplant
* Positive answers (e.g. yes) to one of the following:

  * current difficulty with climbing up 10 stairs,
  * has changed in the past year how they climb 10 stairs
  * current difficulty with walking a 0.5 mile (5-6 blocks)
  * has changed in past year in how they walk 0.5 mile (5-6 blocks)
  * documented performance of 430 meters or less on the six minute walk test in the past 12 months
  * documented performance of 9 points or less on the Short Physical Performance Battery in the past 24 months
  * documented performance of less than 3 points or less on the five times sit to stand test in the past 24 months
* Demonstrated ability to stand up independently from a seated position and then sit back down without using their arms or an assistive device in the past 24 months

Exclusion Criteria:

* Does not speak English
* Nursing home resident
* Severe low vision (≥20/200 with corrective lens)
* Severe hearing loss even with use of amplification preventing communication
* Unstable angina or uncontrolled arrhythmia
* Supplemental oxygen therapy
* Myocardial infarction, major heart surgery, stroke, venous thromboembolism, hip fracture, hip or knee replacement in past six months (temporary exclusion)
* ≥ 3 errors on the Six Item Screener
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values \> 4.0 ng/ml.


Eligibility Criteria:
Inclusion Criteria:

* PSA \> 4.0 ng/ml
* written informed consent
* age \>18

Exclusion Criteria:

* patients with prostate cancer
* patients with prior prostate biopsy
* patients with contraindications against MRI or biopsy
Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM?

Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset of regular uterine contractions.

PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to 80% of cases occurring at term. Approximately 90% of patients' experience PROM enter spontaneous labor within 24 hours, but disagreement exists among health care providers on the optimal management of women with PROM, particularly the need for and timing of inductions.

Nipple stimulation is a non-medical natural method for induction of labor. Previous studies demonstrated its effectiveness for initiating labor within 72 hours in women with favorable cervices. The actual mechanism by which such a technique results in cervical ripening is not well understood.

In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with term PROM choosing expectant management.

The participants in the study will be randomized into two groups of expectant management (patients desire an active approach will be excluded).

All eligible participants will be randomly allocated to either intervention or control group. They will be followed from the time of presentation with rupture of membranes at the ER and until the time of delivery. Prophylactic antibiotics will be administered after 18 hours from rupture of membranes as per departmental policy.

On admission, and after validating inclusion criteria, women will be offered to join the study. For the intervention group women will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.

For both groups maternal surveillance will include obstetrician assessment every 6 hours or per maternal request if painful contractions. Every assessment will include documenting maternal vital signs, sense of contraction, fetal cardiotocographic assessment and vaginal examination if painful contractions. After delivery,all participants will be requested to fill a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Primagravidas at term (\>37) weeks having PROM
* Singleton pregnancies
* Cephalic presentation
* Unfavorable cervix (Bishop score \<7)
* Desire an expectant management

Exclusion Criteria:

* Prior cesarean section/ uterine rupture / transmural uterine incision
* Non reassuring fetal heart rate monitoring (Category III)
* Signs of fetal or maternal infection
* Time elapsed since PROM \> 6 hours
* Meconium or blood-stained amniotic fluid
* Any contraindication for vaginal birth
Why Still in Hospital After Hip Fracture Surgery?

At our institution, hip fracture patients are admitted and treated according to a fast track patient pathway. The aim of this study is to identify areas of this patient pathway that can be improved. To achieve this, the study will investigate the underlying reasons for the continued need for hospitalization on the consecutive days after hip fracture surgery.

The study will be conducted at the orthopedic department, Akershus University Hospital, as a prospective observational study and will include approximately 200 consecutive hip fracture patients. The patients will be evaluated once daily for the fulfillment of predefined discharge criteria. If the discharge criteria are not met or if the criteria are met but the patient is not discharged in spite of this the underlying reason(s) are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Operated at the orthopedic department, Akershus University Hospital, for a hip fracture

Exclusion Criteria:

* Lack of written informed consent
Hellenic Registry for cIAIs (HERCO-II)

Complicated Intra-Abdominal Infections (cIAIs) represent an emergent surgical situation which lead to important non trauma-related mortality in several Emergency Surgical Centers worldwide. Their prevalence seemed to be unrelated to age, gender, health status and socioeconomic condition. Early diagnosis, timely septic source control, wide-spectrum antibiotic delivery and resuscitation with fluids and vasoactive agents in critically ill patients are fundamentals for successful cIAIs management. Moreover, septic shock, antibiotic resistant multi-pathogens and comorbidities have been associated with increased morbidity and mortality of cIAIs.

Several international health associations announce updated guidelines for cIAIs management. Nevertheless, such guidelines could not be widely implemented, because of specific features of several healthcare systems worldwide. The aim of the present study is to investigate the prevalence of cIAIs among the Greek health system and the potential association of time interval of septic source control, preoperative resuscitation and multidrug resistant pathogens with morbidity, mortality, ICU stay and length of stay in patients with cIAIs.

Registry of patients with complicated intra-abdominal infections including:

* Patient demographics (gender, age, Carlson Comorbidity Index, cancer history/chemotherapy during the last 6 months, health unit stay during the last 6 months)
* Management (conservative, minimally invasive, surgical)
* Minimally invasive procedure - type (CT-guided drainage, endoscopic)
* Surgical procedure - type (open or laparoscopic, day or night, procedure description)
* Cultures (blood, peritoneal fluid, tissue)
* Time of diagnosis (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, white cell count, CRP)
* Just before procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, vasoactive agent delivery, intubation)
* Intraoperative parameters (time interval between diagnosis and intervention, WSES score, operative time, open abdomen, VAC)
* After procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, vasoactive agent delivery, intubation)
* Empirical wide-spectrum antibiotics (type and time interval from diagnosis)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Signed consent from patient or authorized representative
3. Complicated Intra-Abdominal Infection

   * Acute appendicitis with localized or diffuse peritonitis
   * Grade II or Grade III acute cholecystitis (Tokyo guidelines)
   * Visceral organ perforation with peritonitis
   * Bowel perforation after colonoscopy
   * Complicated diverticulitis (WSES classification)
   * Anastomotic leaks with abscess, localized or diffuse peritonitis

Exclusion Criteria:

1. Age \< 18 years old
2. No signed consent from patient or authorized representative
Protecting Home Healthcare Workers: An Interactive Video-based App to Coach Workers Through Challenging Health and Safety-related Situations

This project will create a video-based app that empowers home healthcare workers to communicate with clients and their families about managing health and safety hazards in client homes. Using a participatory approach, home healthcare workers will 1) review and revise video scripts and recordings that demonstrate effective and less effective communication strategies when talking to clients, families, and other stakeholders about health and safety hazards and 2) contribute to the creation and review of an interactive app that they perceive to be useful, usable, and desirable.

This project includes two of three original aims. The first aim (Aim 1), already completed, created scripts based on real-world scenarios regarding speaking with clients and families about health and safety hazards in their homes.

Based on the data from Aim 1, the research team has prepared scripts describing each scenario. Each scenario includes two to three different approaches that represent successful, less successful, and/or unsuccessful examples of communicating about solving difficult or complex health and safety challenges. Each scenario includes a short introductory statement about the context of the scenario and two to three subsequent scripts and/or recordings that demonstrate the different communication approaches. Scenarios with successful communication strategies present the approach and outcomes that are consistent with best practices for HHW's in a given situation.

In Aims 2 and 3, participants will participate in either an individual or group interview using Zoom, Teams, or similar. They will review scripted scenarios and, as they are developed, video recordings based on the scripted scenarios. They will answer questions about the relevance of the information, how realistic the dialogue is, the usefulness of the information, and changes/improvements they would make. In addition, participants will review an app designed to allow users to select the videos they wish to view, and view successful, less successful, and unsuccessful communication approaches and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Home healthcare worker (including clinical, professional, and administrative staff)
* 18+ years of age
* 6 months of home healthcare experience
* access to computer/tablet/smartphone

Exclusion Criteria:

* none
Omega-3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3

The National Register of Nephrology in 2007 shows, similarly to the European data, a problem of a high mortality rate among Polish dialysis patients.

The main reason of death among chronically dialysis patients are cardio - vascular system diseases. According to "The Report on the Condition of Renal Replacement Therapy in Poland in 2007", these diseases are the cause of 53% deaths in Poland. The patients with chronic kidney disease (PChN) are particularly at risk of cardio - vascular complications. These complications occur on average 30 times more often than in the whole population, and among young dialysis people, these complications occur 300 times more often. In the development of cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is responsible for antiplatelet effect.

This project is aiming at defining and elaborating on the connection between Omega-3 acids, and cardiovascular complications, their influence on the functioning of the cardiovascular system, and moreover, a better understanding of the effects of therapeutic and pharmacological therapies in patients at different stages of chronic kidney disease. Carrying out this project will be a good start to shape an international project in this area.

The survey will cover 90 patients from chronic kidney disease at different stages of the disease(I-III) and 30 healthy subjects as a comparison group.

At the beginning and at the end of the observation period, besides the clinical test, some other tests will be carried out: echocardiography, pulse wave velocity (PWV), ambulatory blood pressure monitoring (ABPM). Blood will be collected for laboratory tests such as: lipid profile, uric acid, C reactive protein (CRP), blood urea nitrogen (BUN), creatinine, morphology, calcium (Ca),phosphorus (P), Ca x P, ionogram, xanthine oxidase, monocyte chemoattractant protein (MPC1),Omega-3 acids, resolvin and protectins - the metabolites of Omega-3 acids, creatinine excretion, MPC1 excretion and excretion of uric acid. The patients will be treated with Omega-3 acids as a Gold Omega 3 preparation (2x1 capsule where 1 capsule = 1000 mg) for 6 months.

Eligibility Criteria:
Inclusion Criteria:

- chronic kidney disease (CKD) stage 1-3

Exclusion Criteria:

* without diabetes
* without Immunosuppressive therapy