cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.

In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed.

The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* 18 years or older
* Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS)

Exclusion Criteria:

* Individuals with a comorbid disorder that may confound the diagnosis of IBS, including:
* celiac disease
* inflammatory bowel disease
* autoimmune disorders that affect the GI system
* history of bowel resection
* HIV/AIDS ( human immunodeficiency virus/acquired immunodeficiency syndrome)
* diabetes with HgA1c\>7.0
* neuroendocrine tumors
* microscopic colitis
* lactase deficiency
* eosinophilic bowel disease
* acute intermittent porphyria
* any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude
* Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
* No WiFi at home
* Any history of seizure
* Ongoing treatment for a GI cancer
* Major audiovisual impairment (complete blindness, deafness)
* Inability to understand English at 6th grade level
* Any events planned over the 8 weeks of the study that could end your ability to participate in the study, such as a medical procedure, vacation, or change in residence (Note: the study team can always delay enrollment)
The Effects of Progressive Relaxation Exercise

Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.

Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.


Eligibility Criteria:
Inclusion Criteria:

* Those who scored 111 points or more on the Premenstrual Syndrome Scale,
* were married or single at the time of the research,
* did not have children.

Exclusion Criteria:

* those who were pregnant or postpartum,
* those who were diagnosed with any psychiatric disease according to the records,
* those who did not perform relaxation exercises outside of the training.
A Novel ACT-based Video Game

A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility.


Eligibility Criteria:
Inclusion Criteria:

* Adults reporting some existing form of anxiety, depression or ongoing stress.
* Need ability to read and write English.
* Need internet access to play the videogame.

Exclusion Criteria:

* Those who are under 18
Group Intervention on Vaccine Confidence

This study has one primary objective and two secondary objectives, with an overall goal of understanding barriers to vaccination and vaccination confidence, so that effective interventional strategies can be further developed and tested to improve vaccination outcomes in a community healthcare setting.

The study will use a mixed methods approach, combining focus group discussion, virtual interviews with healthcare professionals, cross-sectional survey on vaccination attitude, and clinic-based intervention with a cluster randomized controlled trial design for the quantitative stage. They study will also follow up patients with interviews after the quantitative stage completes.

Eligibility Criteria:
Qualitative study standards:

Inclusion Criteria:

* having used MultiCare's services in the past 12 months or whose minor child(ren) has/have used MultiCare's services in the past 12 months, and who have been involved in the child(ren)'s immunization decision-making as a caregiver
* current residential location in Washington State
* willing to participate

Exclusion Criteria:

* terminal disease (to be decided)
* cognitive impairment
* main immune deficiency conditions

Quantitative study standards:

We will randomly (and) equally select clinics from 1) Puget Sound and 2) Eastern Washington areas. Since the intervention is on facility level (group intervention), instead of at patient level, blinding will also be impractical. We plan to use stratified random allocation within the pediatric (n1 = 2) or adult stratum (n2 = 4), to decide which sites will get the intervention.
Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma

Primary Objective:

1. To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial.

Secondary Objectives:

1. To describe additional outcomes (duration of response \[DOR\], progression-free survival \[PFS\], overall survival \[OS\], and time to next treatment \[TTNT\]) in the same Benchmark Cohort population described in the primary objective.
2. To describe distribution of treatment regimens, ORR, DOR, PFS, OS, and to compare ORR, PFS, OS, and TTNT in an Analysis Cohort consisting of real-world patients derived from the Benchmark Cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Comparative analyses of PFS and OS will be performed conditional on sufficient maturity of survival data in the R5458-ONC-1826 (NCT03761108) trial at the time of analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at baseline
2. Confirmed diagnosis of active MM by IMWG diagnostic criteria
3. Have myeloma that is response-evaluable with measurable disease by M-protein in serum or urine as specified in the IMWG response criteria.
4. Triple-class exposed or refractory

Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (POEMS) changes syndrome
2. Known MM brain lesions or meningeal involvement
3. History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
4. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy)
5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
6. Live or live attenuated vaccines
7. Treated with B-cell maturation antigen (BCMA)-directed immunotherapies (BCMA antibody-drug conjugates are not excluded).

Note: Other protocol-defined Inclusion/Exclusion criteria apply
Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.

Primary Objective(s): Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robotic-assisted radical prostatectomy.

Secondary Objective(s)

* To determine the opioid usage in the opioid and non-opioid group from the start of the pain treatment administration until discharge in patients following robotic-assisted radical prostatectomy.
* Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following robotic-assisted radical prostatectomy.
* Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following robotic-assisted radical prostatectomy using a standardized scale for common post-operative adverse effects including bodily functions.

Eligibility Criteria:
Inclusion Criteria:

* All men ages 40-75 undergoing robot assisted radical prostatectomy (RARP) with or without bilateral lymph node dissection with low, intermediate, or high-risk prostate cancer.
* Patients must have normal organ function as defined below:
* AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
* Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* Participants with known allergies to any medication involved in the study or its excipients,
* Participants who are incarcerated persons,
* Participants with a chronic narcotic dependence,
* Participants with any prescription for narcotics in the past 30 days,
* Participants who have had only major pelvic or abdominal surgeries as bowel, rectal colon, bladder, liver, gallbladder, kidney, etc. in the past 6 months.
* Patients may not be receiving any other investigational agents.
* Patients with known metastatic disease or brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
The Effect of Menopause on Sexual Life and Depression: a Case-control Study.

work completed but not yet published

work completed but not yet published

Eligibility Criteria:
Inclusion Criteria:

* Case group: Women between the ages of 45-65, who are in the postmenopausal period, who are literate, who do not have communication difficulties / mental disabilities, and who volunteer to participate in the study were included.

Control Group: Women between the ages of 45-55, who were not menopausal, who were literate, who had no communication difficulties / mental disabilities and who volunteered to participate in the study were included.

Exclusion Criteria:

* For case group: Women with premature menopause (before the age of 40), chronic systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.

For control group: Women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.

The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).


Eligibility Criteria:
Inclusion Criteria:

* age over 50
* screening colonoscopy

Exclusion Criteria:

* History of colorectal surgery
* History of hereditary colorectal cancers or polyposis syndrome
* Gastrointestinal bleeding
* Inflammatory bowel diseases
* Inability to provide informed consent
* Pregnancy
Resolving Grief After Spinal Cord Injury

The purpose of this study is to examine the usefulness of the Grief Recovery Method in assisting persons with spinal cord injuries to achieve as complete a recovery as possible, thereby allowing for fuller participation in life.


Eligibility Criteria:
Inclusion Criteria:

\* Persons with a spinal cord injury who are willing to participate in the program.

Exclusion Criteria:

\* Unable or unwilling to participate.
Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

The current study investigates the effect of different doses of pulses ultrasound therapy on different nerve conduction parameters of the median nerve in healthy volunteering subjects.

In the current study, we apply pulsed ultrasound therapy on median nerves of healthy volunteer subjects, at 1 W/cm2 10% duty cycle, 3 W/cm2 10% duty cycle, 1 W/cm2 50% duty cycle, and 3 w/cm2 50% duty cycle. Parameters of median nerve conduction study, Latency, amplitude, area, duration and forearm NCV are recorded before and after application of ultrasound therapy.

Eligibility Criteria:
Inclusion Criteria:

1. 120 hands of 60 subjects of both genders with age range 18: 24 years.
2. Subjects assigned will be apparently healthy subjects with no neurological or neuromuscular history affecting the upper limb.

Exclusion Criteria:

1. Peripheral polyneuropathy.
2. Diabetes mellitus.
3. Previous surgeries or median and/or ulnar nerve release.
4. Cervical radiculopathy.
5. Median or ulnar entrapment neuropathies.
6. Previous or current pregnancies.
Does Maternal Instruction Prevent Kernicterus in Nigeria?

This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared with those who did not received instruction (concurrent opportunistic controls in phase 2).

This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE) among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and identifies social/behavioral/medical factors associated with ABE. Information gained in phase 1 identified high risk sub-populations and guided selection of instructional materials for phase 2. Core data sheets submitted monthly by participating centers included clinical data, demographic information, number of antenatal clinic visits, birth place (hospital, clinic, home) and attendant, distance from care centers and reasons for delay, if any, in seeking care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000 subjects in each phase are required to demonstrate a 20% decrease in disease prevalence (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infant receiving treatment for neonatal jaundice

Exclusion Criteria:

* Non-viable premature infants
* Severe congenital defects.
* Postnatal age greater than 21 days
Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression

The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.

Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.

Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder

Exclusion Criteria:

* Serious comorbid psychiatric disorder
* Unstable medical illness
* Prior use of any omega-3 fatty acid product
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

This is an open label, Phase 1b/2 study with multiple treatment arms evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of rucaparib in combination with a second anticancer therapy in participants with an advanced/metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific participant populations in an expansion phase (Phase 2 cohorts).


Eligibility Criteria:
Inclusion Criteria Phase 1b (all arms):

* Solid tumor, advanced or metastatic, progressed on standard treatment participants in Arm B must have either triple negative breast cancer OR urothelial carcinoma OR ovarian cancer OR have a solid tumor with a deleterious mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D
* Measurable disease per RECIST v1.1
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

* Known history of myelodysplastic syndrome (MDS)
* Symptomatic and/or untreated central nervous system (CNS) metastases

Inclusion Criteria Phase 2 (all arms):

* Histologically or cytologically confirmed solid tumor, previously treated and measurable per RECIST v1.1, as follows:
* Arm A: ovarian cancer with gBRCAwt disease, either platinum-sensitive OR platinum-resistant
* Arm B: Metastatic triple negative breast cancer OR advanced/ metastatic urothelial carcinoma OR relapsed ovarian cancer
* At least 1 prior line of standard therapy for advanced disease
* Adequate organ function
* ECOG 0 or 1
* Tumor tissue for genomic analysis

Exclusion Criteria Phase 2 (all arms):

* Prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor treatment allowed for participants with ovarian cancer
* Known history of MDS
* Symptomatic and/or untreated CNS metastases
Telephone Enhancement Procedure for Continuing Care - 1

The purpose of this study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities.


Eligibility Criteria:
Inclusion Criteria:

* Residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge.
* Voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.
Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤80
* Clinical signs consistent with the diagnosis of an acute ischemic stroke
* Baseline NIHSS score obtained prior to randomization ≥8
* Intracranial arterial occlusion of the distal intracranial carotid artery or
* Middle (M1/M2), demonstrated with CTA, MRA, DSA
* The possibility to start treatment (artery puncture) within 6 hours from onset
* Regional hypothermia is expected to start within 15 minutes after recanalization
* Informed consent given

Exclusion Criteria:

* mTICI\<2b after endovascular treatment
* No significant pre-stroke disability (mRS ≤1)
* Previous NYHA grade \> 1
* Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
* Baseline platelet count \< 50000/µL
* Baseline blood glucose of \< 50mg/dL or \>400mg/dl
* Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg). NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
* Seizures at stroke onset which would preclude obtaining a baseline NIHSS
* Subjects who have received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
* Renal insufficiency with creatinine ≥ 3 mg/dl
* Woman of childbearing potential who is known to be pregnant or lactating
* Subject participating in a study involving an investigational drug or device that would impact this study
* Cerebral vasculitis
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
* Unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas).
* CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
* ASPECT\<6
* Subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation)
* Evidence of intracranial tumor (except small meningioma)