cyrilzakka/clinical-trials huggingface dataset:
Resilience in East Asian Immigrants for Advance Care Planning Discussions

The purpose of the study is to develop a culturally tailored digital resilience-building intervention to help East Asian immigrants engage in advance care planning discussions with their family caregivers.

Advance care planning (ACP) is a process to facilitate decision-making for future care and document values and preferences. However, the advance directive completion rates in East Asian Americans are low, which may extend to disparities in end-of-life care, including rates of hospice use and prevalence of unwanted aggressive treatments. To address this, this study uses information technology to develop a culturally tailored digital resilience-building intervention with and for East Asian immigrants to help them engage in ACP discussions. There are two aims of this study: (1) Conduct semi-structured interviews with a total of 30 religious leaders to identify the barriers and facilitators associated with discussing ACP and death-related topics with immigrants from China/Taiwan, Japan, and Korea and (2) Develop a culturally tailored digital resilience-building intervention using think-aloud interviews with 27 pairs of East Asian immigrants with cancer and their family caregivers (9 pairs each for immigrants from China/Taiwan, Japan, and Korea).

Eligibility Criteria:
Inclusion Criteria for Patients:

* Age ≥ 18 years
* Having a cancer diagnosis documented in the electronic medical record
* Being able to read and respond to questions in English, Mandarin, Cantonese, Japanese, or Korean
* Having a family caregiver who is willing to participate in the study
* Have adequate electronic health literacy with a score of \> 30 on the electronic-Health Literacy Scale.

Exclusion Criteria for Patients:

* Having cognitive impairment per a Short Portable Mental Status Questionnaire with more than three errors
* Having completed an advance directive
* Being born in the US

Inclusion Criteria for Family Caregivers:

* Age ≥ 18 years
* Being able to read and respond to questions in English, Mandarin, Cantonese, Japanese, or Korean
* Being identified by the patient as a family caregiver
* Having adequate electronic health literacy with a score of \> 30 on the electronic-Health Literacy Scale.
Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed.

Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency).

In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period.

Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic anal fissure with spasm of anal sphincter

Exclusion Criteria:

* Inflammatory diseases of the colon
* Pectenosis
* Previous surgical interventions on the anal canal
* IV grade internal and external hemorrhoids
* Rectal fistula
* Severe somatic diseases at the decompensation stage
* Pregnancy and lactation
* Anal sphincter insufficiency
* Chronic paraproctitis
* Fibrous polyp of the anal canal, accompanied by clinical manifestations
* Individual intolerance and hypersensitivity to botulinum toxin
* Myasthenia gravis and myasthenic syndromes
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis

The study population is comprised of adult subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation and are currently receiving background treatment with tezacaftor/ivacaftor for a minimum of 1 month prior to Day 1. The planned sample size is approximately 40 subjects. 20 subjects will be assigned to PTI-428 dose level 1 or placebo and 20 subjects will be assigned to PTI-428 dose level 2 or placebo. At each dose level, subjects will be randomized at a 3:1 randomization ratio. Subjects will receive once daily oral doses of PTI-428 or placebo for 28 days, while the subjects continue to receive background treatment with tezacaftor/ivacaftor per product label. The study drug administration period will be followed by a 14-day safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF with the F508del/F508del genotype on record
* On tezacaftor/ivacaftor dosing for both label indication and per label dosing for a minimum of 1 month on Day 1
* Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive
* Clinically stable with no significant changes in health status within 14 days of Day 1
* Non-smoker and non-tobacco user for a minimum of 28 days prior to screening and for the duration of the study

Exclusion Criteria:

* Participation in another clinical trial or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Study Day 1
* History of cancer within the past 5 years (excluding cervical cancer in situ with curative therapy for at least one year prior to screening and non-melanoma skin cancer)
* History of organ transplantation
* Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness (as determined by the investigator) requiring an increase or addition of medication, such as antibiotics or corticosteroids, within 14 days of Day 1
* Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, Pulmozyme®, Cayston®, TOBI®)) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to Day 1
* History or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator
* Pregnant or nursing women
Intravascular Volumes in Hypoxia During Antarctic Confinement

This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

INTRODUCTION: Short-term space flight induces an alteration of circulating blood volumes, termed "space flight anemia" and characterized by a decrease in total red blood cell volume (RCV) and plasma volume (PV). This haematological alteration is likely to persist during a long-term space mission and impact the astronauts' health, however this question remains unexplored. During a long-term space mission, the use of hypobaric hypoxia is considered for technical reasons, however the safety of hypoxia must first be verified because this environmental condition causes substantial physiological changes, in particular changes in blood volumes that may interact with the haematological effects of microgravity.

OBJECTIVE: using the Antarctic confinement model as a high-fidelity terrestrial analogue for long-duration space missions, the investigators hypothesize that 1) sea level confinement reduces blood volume by simultaneously decreasing RCV and PV, and 2) chronic hypoxia offsets the decrease in RCV and exacerbates the decrease in PV induced by confinement.

METHODS: blood volumes will be measured via the carbon-monoxide rebreathing method, repeatedly in two groups of participants, overwintering either at Dumont d'Urville (sea level) or Concordia (altitude 3200 m). The blood viscosity will also be measured, as well as the markers of erythropoiesis and iron metabolism.

PERSPECTIVE: Documenting if some degree of hypoxia during long-duration confinement may be beneficial or unfavorable in terms of blood volume regulation is potentially relevant information for the astronauts' health and safety during long-duration space missions.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to a social security scheme
* Ability to communicate and read in English or in French
* Signed written informed consent form after visit with a MD

Exclusion Criteria:

* Pregnant, lactating or parturient women
* Cardiovascular, pulmonary or neuromuscular disease
* Vulnerable persons
A Speech Sound and Phonemic Awareness Intervention in Flemish Early Childhood Education

The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Good reading skills are an important condition for academic success.

To measure the effect of the language intervention 'Kaatje Klank', the intervention will be applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a coaching trajectory.To measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a different language intervention which focuses on vocabulary development (World-project).


Eligibility Criteria:
Inclusion Criteria:

* In eary childhood education in Flanders (2de kleuterklas)

Exclusion Criteria:

* Language or speech disorder
* Less than 1 year acquiring Dutch
Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:
* Age \> 18 years
* Patient with lung cancer of any histological type
* Initiation of ICI therapy
* Signed consent for the study

Exclusion Criteria:

* Patient with previous ICI treatment
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.

Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who have a stem cell transplant have lower than normal levels of vitamin C in their blood. Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed by oral vitamin C until six months after transplant. The effect of the Vitamin C on non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin C regimen.

Eligibility Criteria:
Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible to participate in the study:

1. Any of the following hematological malignancies:

   * Acute lymphoblastic leukemia
   * Acute myelogenous leukemia
   * Chronic myelogenous leukemia
   * Myelodysplasia
2. Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.
3. human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
4. Stem cell graft from either bone marrow or peripheral blood
5. Negative serology for HIV
6. Age ≥ 18 to \< 78 years of age
7. Karnofsky Performance Status of 70-100%
8. Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Program guidelines
9. Ability to understand and the willingness to sign a written informed consent document. Note: The consent form must be signed and dated prior to initiation of stem cell transplant (SCT) preparative treatments.

Exclusion Criteria:

* A patient who meets any of the following exclusion criteria is ineligible to participate in the study.

  1. Known allergy to vitamin C
  2. Inability to swallow oral medication
  3. Known or suspected malabsorption condition or obstruction
  4. G6PDH deficiency
  5. Uncontrolled viral, fungal, or bacterial infection
  6. Active meningeal or central nervous system disease
  7. Alternative hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants
  8. Non-myeloablative conditioning defined as total body irradiation (TBI) \< 2 centigray (cGy)
  9. Pregnancy or breastfeeding
  10. Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)

This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.

This Phase 3 study is a multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301. Patients will receive viltolarsen administered IV at weekly doses of 80 mg/kg.

Study NS-065/NCNP-01-302 will be comprised of a 96-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has completed the NS-065/NCNP-01-301 study;
2. Patient's parent(s) or legal guardian(s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act authorization, where applicable, prior to any study-related procedures; patients will be asked to give written or verbal assent according to local requirements;
3. Patient and parent(s)/guardian(s) are willing and able to comply with scheduled visits, investigational product (IP) administration plan, and study procedures.

Exclusion Criteria:

1. Patient had an adverse event in Study NS-065/NCNP-01-301 that, in the opinion of the investigator and/or the sponsor, precludes safe use of viltolarsen for the patient in this study;
2. Patient had a treatment which was made for the purpose of dystrophin or dystrophin-related protein induction after completion of Study NS-065/NCNP-01-301;
3. Patient took any other investigational drug(s) during or after completion of Study NS-065/NCNP-01-301;
4. Patient is judged by the investigator and/or the sponsor not to be appropriate to participate in the extension study for any reason.
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up

To investigate the effect of exercise or PAP prescription 3 months after completion of the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?" regarding level of physical fitness, physical activity, heart rate and health related quality of life (HR-QoL). Also if any of the investigated variables can predict the possible change in physical fitness.

Patients who have completed study will be offered a follow-up after 3 months regarding physical fitness, physical activity, heart rate and HR-QoL. Physical fitness will be measured by a symptom limited bicycle test and a muscle endurance test. Physical activity will be measured by accelerometer and the International Physical Activity Questionnaire (IPAQ) and a physical activity diary, HR-QoL will be measured by short form (SF-36).

Eligibility Criteria:
Inclusion Criteria:

* Completed the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?"

Exclusion Criteria:

* Not completed the above study or denied participation in follow up
A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.

This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
2. Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
3. Female or male aged ≧20 years
4. Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:

1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC
Evaluating Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention

This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach

Chronic pain is a burden on individuals, the health system, and society. Opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. Unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. Opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. One of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids.

Unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. Self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. Evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach. If effective, this approach could be implemented more widely. The results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain for \>3months
* On opioid medications with a dose of at least 50 milligram morphine equivalents per day
* Ability to communicate effectively using the English language, including reading and writing

Exclusion Criteria:

- Chronic pain due to cancer
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY

To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 22 years and \< 80 years
* Clinical decision to proceed with AF ablation procedure.
* Ablation procedure to be completed with General Anesthesia
* Ablation procedure to be completed with use of radiofrequency catheter ablation

Exclusion Criteria:

* History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
* Presence of a pH probe deployed in the esophagus
* Planned AF ablation procedure to be completed with laser energy or with cryo-energy
* Acute or uncontrolled psychiatric illness
* Unable to undergo upper endoscopy
* Enrollment in another FDA clinical trial
* Unstable medical condition(s) that precludes safely completing study protocol
* Subject is incarcerated
* Subject is pregnant
* Subject is unable to comprehend the details of the study
* The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements