cyrilzakka/clinical-trials huggingface dataset:
Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?

In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.

The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.

Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.

Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of \<35% is considered dyskinesia and a GBEF of \<35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 14 years of age
* food-related abdominal pain
* normal gallbladder ultrasound (US)
* GB EF 80% and greater or 35% and less on HIDA scan with CCK injection

Exclusion Criteria:

* Patients younger than 14 years old
* Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (\> 4 mm), pericholecystic fluid, sludge, or polyps
* Normal GB EF
Connecting Caregivers with Community Services: the Care Buddy Platform

The study aims to develop a mobile-app (Care Buddy) which will be a one-stop integrated source of information and technology-based solutions for caregivers of people with dementia (PWDs). Study aims to bring caregivers into closer partnerships with the wider ecosystem (e.g., healthcare practitioners, community services, peer support, and care service providers) which will ultimately improve outcomes for both PWDs and their caregivers.

This is a 5-year study with various stages: 1) proof-of-concept stage to design and develop the Care buddy intervention, 2) proof-of-value stage to assess the feasibility, acceptability and satisfaction with the Care buddy intervention among informal caregivers of PWDs, 3) test-bedding stage to assess the efficacy and cost-effectiveness of the Care buddy intervention versus usual care among informal caregivers of PWDs with help of a multi-centre 2-arm RCT and 4) deployment stage to scale up the intervention at multiple centres across Singapore, monitor its adoption and outcomes and assess any organizational and individual barriers to adoption.

By the end of the proposed five-year project, investigators aim to develop and evaluate the technology as well as achieve widespread adoption among caregivers of PWDs. Investigators want to enable easy access to information, provide decisional and social support, improve the reach and uptake of existing community service providers, and assist with coordination among multiple informal and professional caregivers through the journey of dementia caregiving and into the bereavement phase.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for patients are

  1. Singaporean/Permanent residents
  2. Age 21 years of age or older
  3. Main person or one of the main persons involved in making decisions regarding treatment patient receives or responsible for ensuring the well-being of the patient
  4. An active primary caregiver for at least 6 months, and planning to remain the primary caregiver for the next 2 years
  5. Is a family member of the patient with dementia
  6. Can read and write in English
  7. Accessible by telephone to schedule interviews
  8. Has familiarity with use of technology (e.g., computers, tablets, or internet) and is able to complete surveys, forms using digital technology
  9. Intact cognition determined through the Abbreviated Mental Test (AMT) for those who are ≥ 65 years old.
  10. Caregivers who score \>=9 on the 6-item Zarit Burden scale

Exclusion Criteria:

* Caregivers of patients staying in nursing home or other long-term care facility with no intention of being discharged will not be eligible however, if the patient is admitted to respite care for short/long term duration after being recruited, caregivers can continue to participate.
Attention Intervention Management

This is a research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.

Impairments in attention are among the symptoms most frequently reported by parents and teachers following pediatric traumatic brain injury (TBI_. These cognitive disabilities are responsible for a wide range of academic and adjustment issues. Broadly defined, attention encompasses all of the mental processes, operations, and systems requisite for acquiring and applying information. It interacts with other cognitive functions including perception, memory/learning, organization, and reasoning; attention is core to the integration of those systems. A number of different attentional subcomponents with interconnected neural systems have been identified and shown to be differentially disrupted following trauma and other brain disorders, including maintenance or sustained attention, attentional selectivity, attentional capacity, and ability to effectively shift attention. Given the prevalence of attention difficulties and secondary attention deficit hyperactivity disorder (ADHD) following TBI, it is imperative to identify treatments to effectively address attention impairments.

The study will develop and pilot the Attention Intervention and Management program (AIM). AIM focuses on direct attention training in conjunction with metacognitive strategy training. Strategies are designed to improve focus and self regulation, reduce distractions, and enhance problem solving in academic settings. Integration of attention training and metacognitive strategies will help to ensure that the student can apply the skills across settings and situations.

The Randomized Controlled Trial (RCT) in Phase 2 of this project will address two interrelated hypotheses:

Hypothesis 1: Children receiving the Attention Intervention and Management (AIM) program will evidence better performance on standardized tests of attention and executive functions (EF) than those in the wait list control (WLC) group.

Hypothesis 2: Children receiving AIM will have fewer attention and EF problems than those in the WLC on parent and teacher rating scales of attention and EF.

Participants will include children ages 10-18 with significant evidence of attentional impairments.

Eligibility Criteria:
Inclusion Criteria:

* ages 10-18
* significant evidence of attentional impairments
* moderate to severe TBI
* time since injury at least 6 months
* completion of inpatient rehabilitation (if needed
* English as the primary spoken language in the home.

Exclusion Criteria:

* Child does not live with parents or guardian
* Child or parent has history of hospitalization for psychiatric problem
* TBI is a result of child abuse
* Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
* Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Diode Laser Application With Non-Surgical Periodontal Treatment

Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. New techniques such as non-surgical or surgical methods combined with laser application are used for its treatment.

The subjects were divided into two groups as "Individuals Applied with Diode Laser in Addition to Non-Surgical Periodontal Treatment" (Laser group) and "Individuals with Non-Surgical Periodontal Treatment (SRP)" (Control group). While only non-surgical periodontal treatment was applied to individuals in the control group; In the laser group, diode laser was applied in addition to this treatment. All individuals were examined 1 and 3 months after treatment.The scaling root planing (SRP) procedure was performed mechanically with gracey curettes under local anesthesia. The diode laser applied to the study group was applied parallel to the gingival sulcus at 0.80W power, 940 nm wavelength and 0.80 J / s energy level in continuous phase. Gingival crevicular fluid (GCF) samples were taken without any procedure in order not to change the amount and content. All clinical parameters were also measured by the same investigator before SRP and in all participants. After this treatment, the participants were re-examined in the 1st and 3rd months for control purposes and GCF samples were taken from the same regions again and the clinical parameters were measured again by the same researcher. GCF samples were stored at -20 degrees Celsius until ELISA studies were performed. Clinical parameters (pocket depth, clinical attachment loss, bleeding on probing, gingival index, plaque index) and gingival crevicular fluid (GCF) sampling were obtained at each control. IL-1β, IL-10, IL-17, OPG, RANKL, TWEAK, Sclerostin levels in GCF samples were measured with ELISA method.

The aim of this study is to evaluate the effectiveness of diode laser application in addition to non-surgical treatment in periodontitis treatment clinically and biochemically and to assess the potential biomarkers for use.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of 5mm or more periodontal pockets on one or more surfaces in periodontal tissues,
2. Not having periodontal treatment in the last 3 months,
3. The informed consent form must be approved,
4. At least 18 years old.

Exclusion Criteria:

1. Presence of systemic disease,
2. Smoking,
3. Regular use of non-steroidal anti inflammatory drugs,
4. Having been treated with antibiotics in the last 3 months,
5. Individuals in need of pre-treatment antibiotic prophylaxis,
6. Pregnancy and lactation,
7. Not approving the informed consent form,
8. Patients with known allergies.
AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

Eligibility Criteria:
1. Key Inclusion Criteria:

   * Aged 18 to 80 years old
   * Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy
   * ECOG performance status 0 to 2
   * Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
   * FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension)
   * Adequate hematological function: ANC ≥ 1000/mm3, platelets

     * 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
   * Adequate liver function: total bilirubin \<1.5x ULN, AST/ALT ≤ 3xULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)
   * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min

   The above is a summary, other inclusion criteria details may apply.
2. Key Exclusion Criteria:

   * Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
   * Active CNS involvement by B-NHL
   * Leukemic presentation of B-NHL
   * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
   * Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or prior allogeneic HSCT within 24 weeks of first dose of AZD0486
   * Requires chronic immunosuppressive therapy
   * Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
   * History of major cardiac abnormalities.
   * If female, participant must not be pregnant or breastfeeding.

The above is a summary, other exclusion criteria details may apply.
Biliary Externalization After Pancreaticoduodenectomy

Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.

n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Patient age \> 18 years old;
* Elective pancreaticoduodenectomy performed for primary pancreatic disease.

Exclusion Criteria:

* Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
* Patients with peritoneal or liver metastases found during surgery.
RCT of Follow up Following Cataract Extraction

Purpose:

To examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery.

Background:

Approximately 300000 cataract extractions are performed annually in the NHS in England, requiring a similar number of post-operative visits, the majority of which result in no change in management. A conservative estimate of 70% of visits being unnecessary suggests a potential saving to the NHS of approximately £10M annually.

What's involved:

The study involves some questionnaires during the duration of the study. These include questionnaires relating to the quality of life of the patient (conducted before the operation, and at the 3 month research clinic) and a patient satisfaction questionnaire. There is also a research clinic 3 months following the operation.

What are the risks/benefits:

There are no real personal benefits to patients on the trial. The trial aims to provide very important information regarding the safety of discharging patients immediately after surgery. However the trial could potentially save many thousands of unnecessary hospital visits each year.

Method:

The method presented is based on the method employed successfully by one of the applicants in an earlier stuy of the first day postoperative review following cataract surgery which has been peer-reviewed and published in the scientific literature. An earlier draft has been presented to a patient panel and has the benefit of external review by a potential steering group.

Patients undergoing routine elective phacoemulsification cataract surgery will be randomly assigned to either a routine review at 4-6 weeks post-operatively (routine care) or to be discharged from the cataract service immediately post-operatively. All patients will be advised to see their own optometrist at 4-6 weeks for new spectacles if appropriate and will then be reviewed in a research clinic at 3 months post operatively.

Eligibility Criteria:
Inclusion Criteria:

* Adults Aged \>= 40 years
* Scheduled for day-case cataract surgery
* Able to give informed consent

Exclusion Criteria:

* Unable to provide written informed consent
* Unable to visit their optometrist post operatively
* Patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within three months of their operation (including significant diabetic retinopathy, wet age-related macular degeneration (AMD) on treatment, severe/end-stage glaucoma, previous retinal detachment or vitrectomy)
* Patients undergoing another simultaneous ophthalmic procedure
* Patients who suffer from an intra-operative complication requiring early postoperative evaluation (identified at surgery).
Heel Cushion for Plantar Fasciitis

The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of plantar fasciitis. The investigators will do a randomized controlled trial in patient with plantar fasciitis compared with stretching exercise alone. The outcome measurement include heel pain improvement, compliance, satisfaction, foot functional score at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient with plantar fasciitis

Exclusion Criteria:

* Rheumatologic problem such as rheumatoid arthritis
* Latex allergy
* Pregnancy
* Previous surgery around foot and ankle
Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP

This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (PDT) and assess if PDT can improve quality of life and prolong survival.

Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.

A prospective, randomized and controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. The improvement of survival in the randomized PDT group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).Previously, the principal investigator conducted such a study (and also conducted Endoscopic Retrograde Cholangiopancreatography with PDT) at the University of Virginia, and would continue to conduct these procedures, as well as the study at WCMC.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone ERCP (Endoscopic Retrograde Cholangiopancreatography) and Biliary stenting with or without Photodynamic Therapy.
* Biliary disorder or obstruction due to Cholangiocarcinoma.
* Above 18 years of age.

Exclusion Criteria:

* Any patient who has not undergone ERCP and biliary stenting.
* Not diagnosed with Cholangiocarcinoma.
* Below 18 years of age
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
* Subjects who require and agree to the concomitant use of a topical steroid preparation.
* Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
* Written informed consent signed and dated by subject/legal guardian
* Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Exclusion Criteria:

* Subjects with a known hypersensitivity to cetirizine or levocetirizine
* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol