cyrilzakka/clinical-trials huggingface dataset:
Decision-Aid for Renal Therapy Pilot Trial

Successful communication between patients, caregivers, and physicians can improve how patients feel about their treatment. Our recent studies of older dialysis patients find, however, that many patients do not engage in this type of communication about treatment options. This study aims to determine whether the Decision-Aid for Renal Therapy (DART), a web-based program, can improve shared decision-making (decisions where patients are actively engaged) among patients, caregivers, and physicians, and improve certainty and satisfaction in treatment decisions.

Successful end-of-life communication between patients, caregivers, and physicians is associated with superior psychosocial outcomes, less intensive treatment, greater satisfaction, and higher likelihood of death at home. The Decision-Aid for Renal Therapy (DART) is an interactive web-based decision-aid that can empower patients and caregivers to select the treatment choice for chronic kidney disease that best suits them. DART was developed using a rigorous, validated, patient-engaged process and helps clarify decision-points and tradeoffs by providing individualized information about outcomes that matter most to patients. DART is designed to promote shared decision-making between patients, caregivers, and physicians and align preferences with treatment received.

Although proven effective and in current use in the general population, DART's effectiveness in an older population is unclear. The purpose of this project is to conduct a pilot study of DART's feasibility and effectiveness to improve end-of-life planning and shared decision-making among older end-stage renal disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stages 4 or 5, not currently on dialysis
* Age \>=70
* English-speaking
* Willingness to be randomized to DART
* Able to sign informed consent
* 5-year kidney failure risk probability \> 15% using \[www.kidneyfailurerisk.com\]
* Glomerular filtration rate (GFR) \< 30

Exclusion Criteria:

* Non-English speaking
A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery

This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Adenocarcinoma confirmed by pathology
3. Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope.
4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).
5. The operation is estimated to be sphincter-preserving.
6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2.
7. The estimated life time is not less than one year.
8. The patient agree to sign the informed consent.

Exclusion Criteria:

1. The patient refuse to follow research plan.
2. Emergency case
3. Pregnant and lactating female patient
4. The patient did not accept radical resection.
5. The patient did not accept first stage resection and anastomosis.
6. The patient has experienced anal-rectal surgery.
7. The patient has experienced left colon surgery.
8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.
9. The patient was diagnosed with cognitive or communicative obstacles.
10. The patient was diagnosed with serious repeated infection or other concomitance diseases.
11. The patient has participated other medical research which may affect his/her bowel function.
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents and pre-adolescents with no prior sexual history
* Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts
Mentor Integration Study

Mentor Integration Project

This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.

Primary Aims:

* Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
* Determine which of the above conditions is most effective
* Determine which of the above conditions is most cost efficient


Eligibility Criteria:
Inclusion Criteria:

Eligibility for this protocol is as follows:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age,
* All subjects must be able to read and write English at the 6th-grade level
* Not homeless
Twins and the Risk of Parkinson's Disease: A Clinical and Imaging Study

The purpose of this study is to examine the role of genetic and environmental factors in the cause of Parkinson's disease.

Parkinson's disease (PD) is a growing health problem in the elderly, and genetic factors may provide substantial clues toward eventual treatment and/or prevention of the disorder. The National Academy of Sciences/National Resource Council (NAS/NRC) World War II (WWII) Veteran Twins Cohort Registry is one of the few population-based groups of elderly twins. Previous studies in this group indicated that genetic factors were involved only in early-onset PD, however there was no follow-up to these studies.

The purpose of the "Twins and the Risk of PD" study is to follow-up previous studies and confirm the initial findings. In this study, investigators will use the NAS/NRC WWII Veteran Twin Cohort Registry to compare the concordance rates for PD in monozygotic and dizygotic twins-at least one of whom has PD.

The overall goal of this research is determine the contributions of genetic and environmental factors in the cause of PD.

The study will involve traditional clinical research methods, such as a clinical examination, as well as innovative imaging techniques, such as single photon emission computed tomography (SPECT). SPECT-a nuclear imaging test involving blood flow to tissue-is used to evaluate certain brain functions.

Findings from this study may help to set research priorities in PD, and to develop tools for early detection of the disorder.

Eligibility Criteria:
Inclusion:

* Participants will be recruited from a closed cohort-the National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort
Preventing Medication Dispensing Errors in Pharmacy Practice with Interpretable Machine Intelligence: Wave 2

Pharmacists currently perform an independent double-check to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. This research is being conducted to examine the effectiveness machine intelligence (MI) advice on to determine if its impact on pharmacists' work performance and cognitive demand.


Eligibility Criteria:
Inclusion Criteria:

1. Licensed pharmacist in the United States
2. Age 18 years and older at screening
3. PC/Laptop with Microsoft Windows 10 or Mac (Macbook, iMac) with MacOS with Google Chrome or Firefox web browser installed on the device
4. Screen resolution of 1024x968 pixels or more
5. A laptop integrated webcam or USB webcam is also required for the eye tracking purpose.

Exclusion Criteria:

1. Eyeglasses with more than one power (bifocals, trifocals, progressives, layered lenses, or regression lenses)
2. Cataracts, intraocular implants, glaucoma, or permanently dilated pupil
3. Require a screen reader/magnifier or other assistive technology to use the computer
4. Eye surgery (e.g., corneal)
5. Eye movement or alignment abnormalities (lazy eye, strabismus, nystagmus)
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, male and female
* Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
* Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy.
* Centrally confirmed CLDN18.2-positive
* HER2 negative
* At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1)
* ECOG: 0-1
* Expected survival ≥12 weeks;
* Good blood reserve and liver, kidney and coagulation function
* Willing to provide informed consent for study participation.

Exclusion Criteria:

* Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment
* Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation
* Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g
* Individuals with a history of severe cardiovascular and cerebrovascular diseases
* Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening
* Current peripheral sensory or motor neuropathy ≥ grade 2
* Uncontrollable third space effusion in clinical practice
* Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization
* The researcher determined that there are other situations that are not suitable for participation in this study
Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Fluent in English
* Diagnosed with Cystic Fibrosis
* Colorado resident
* Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
* Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
* Access to private email to complete surveys
* Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))

Exclusion Criteria:

* Currently receiving therapy or counseling with an outside provider for a mental health condition
* Currently in treatment for alcohol or substance abuse
* Unstable medical condition (not including cystic fibrosis)
* Neurological disease
* Pregnant women
* Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)

The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).


Eligibility Criteria:
Inclusion Criteria:

* Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.
* Adequate Karnofsky performance status, liver function, and renal function.

Exclusion Criteria:

* Pregnant or nursing.
* Has had a liver transplant.
* Has a New York Heart Association heart failure classification \>2.
* Has unstable angina.
* Has uncontrolled clinically significant cardiac arrhythmia.
Personality Change Study for Borderline Personality Disorder

Participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment. After the baseline period, participants will receive six weekly 50-60-minute treatment sessions. After the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.


Eligibility Criteria:
Inclusion Criteria:

* Speak English fluently
* Diagnosis of Borderline Personality Disorder

Exclusion Criteria:

* diagnosed psychological conditions that would be better addressed by alternative treatments
* concurrent psychotherapy
* medication instability
* substance use disorder
Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children

A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months


Eligibility Criteria:
Inclusion Criteria:

* • Patients with good general health.

  * Adequate oral hygiene,
  * Patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste.

Exclusion Criteria:

* Uncooperative child.
* Active carious lesion.
* Labial surface restoration.
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

The study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was not manageable with metformin.

This was a Phase IV, multi-center, randomized, open-label study. Eligible patients started pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for Acromegaly.

Participants being treated with pasireotide s.c or LAR at screening were eligible as long as they met protocol criteria during the screening period. If previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.

Participants who continued to receive clinical benefit after completing the Core Phase could enter an optional Extension Phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. Patients continued in the Extension Phase until the last participant randomized in the Core Phase completed 16 weeks of treatment post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years old
* Confirmed diagnosis of Cushing's disease or acromegaly

Exclusion Criteria:

* Patients who require surgical intervention
* Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry
* HbA1c \> 10 % at screening
* Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.
Outcomes and Cosmesis With Whole Breast Irradiation and Boost

This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

The study population will consist of 50 participants with non-metastatic, early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). Eligible patients will include those with a biopsy proven invasive breast cancer or DCIS, greater than or equal to 18 years of age, undergoing breast conserving surgery and adjuvant radiation therapy at UW Health with an indication for WBI with tumor bed boost. Selection need for boost and radiation treatment field design and pre-tx imaging are at the discretion of the treating provider.

Accrual will occur over 5 years at UW Health. Participants will complete 5 treatment visits and 7 study visits over the course of approximately 5.5 years. Research-related outcome measures - MD assessments (e.g., cosmesis) PROMs, and AEs -- will be assessed prior to treatment start, at the 6-week follow-up visit, as well as at 12-, 24-, 36-, 48- and 60-month follow-up visits. Study participation ends after completion of the 60-month follow-up visit.

Objective

• To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB.

Secondary Objectives

* To assess PROMs via BREAST-Q in patients treated with ultra-short WBI with SIB.
* To assess acute toxicities in patients treated with ultra-short WBI with SIB.
* To assess late toxicities in patients treated with ultra-short WBI with SIB.
* To assess ipsilateral breast tumor recurrence in patients treated with ultra-short WBI with SIB.
* To assess overall survival (OS) in patients treated with ultra-short WBI with SIB.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS
* Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx
* Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
* Treatment plan includes breast tumor bed boost
* Willingness to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Mastectomy of ipsilateral breast
* Lack of histologic diagnosis
* Histologic involvement of the axillary or regional nodes or metastatic disease
* Accelerated partial breast irradiation treatment plan
* Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin
* Previous history of chest radiation therapy
* Previous history of ipsilateral breast cancer
* Concurrent cytotoxic chemotherapy
* Active connective tissue disease including scleroderma
* Inability or unwillingness to return for required follow up visit
Preventing Falls Among Older Fallers to Test the Effect of LIVE-LiFE, a Home-Based, Tailored Fall Prevention Program

Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for older adults with a high risk for falling.

Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.

Safe-LiFE Group: Individually tailored intervention at the participant's home spaced across 12 weeks including:

* Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
* Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
* Medication review and feedback concerning medications with increased fall risk

Control Group:

• An individualized fall risk assessment provided to participant and their primary care provider

Sample: 40 community-dwelling older adults in Baltimore City or County


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 70 or older
* Self-report of 2 or more falls in the past 12 months OR 1 fall causing injury in the past 12 months

Exclusion Criteria:

* Moderate-severe memory problems
* No conversational English
* Not able to stand
* Resident in a nursing home or assisted living facility
* Hospitalized \> 3 times in the last year
* Terminally ill (\<1 year expected survival)
* Receiving active cancer treatment
Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients

The restless leg syndrome (RLS) is among the most common problems for the individuals undergoing hemodialysis (HD) therapy. This randomized controlled trial was conducted to determine the effect of the massage, applied with 5% lavender oil for the individuals receiving HD therapy, in the first half of HD session three times a week for four weeks on both legs for 10 minutes in each leg, on severity of RLS and quality of life. The study was completed with 58 patients including 31 people in the intervention group and 27 people in the placebo control group, in 7 hemodialysis centers located in a city center. The ethics committee approval, informed consent of the individuals and the institutional permission were obtained. The data were collected using the patient information form, RLS Severity Rating Scale, Kidney Disease Quality of Life Questionnaire (KDQOLTM-36) and patient follow-up charts. In accordance with the massage application protocol, those in the intervention group were massaged with lavender oil and those in the placebo group were massaged with baby oil. Chi-square test, t test, repeated measures one-way analysis of variance, and Pearson correlation analysis tests were used to assess the data. In the comparisons, the value of p\<0.05 was accepted as significant.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* were not pregnant or did not plan pregnancy
* were diagnosed with RLS by a physician
* had at least mild RLS based on the RLS Severity Rating Scale
* had received HD treatment in the HD units for at least 3 months and three sessions per week
* had continued the dialysis treatment at the same institution
* had not changed the treatment schedule before the massage therapy and throughout the study
* could understand and communicate in Turkish

Exclusion Criteria:

* Patients with an allergy to lavender oil
* had an open wound that would hinder the massage therapy
* had lower leg problems such as neuropathy
* had a neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis
* had a history of other CIT methods applied