cyrilzakka/clinical-trials huggingface dataset:
SCED - Wisdom Enhancement for Post-Stroke Depression

One-third of stroke survivors experience post-stroke depression, but there are currently no official guidelines for supporting them. Researchers aim to investigate whether the wisdom enhancement timeline technique can reduce depression in stroke survivors. The investigators also want to understand how this technique positively impacts mood, identity, self-esteem, and wisdom. The study will involve nine stroke survivors from the National Health Service (NHS) to gain insights into effective ways to support those with post-stroke depression.

One-third of stroke survivors have post-stroke depression. Finding ways to help them feel more positive after such a challenging event can be tricky. Right now, there are no official guidelines on the best way to support post-stroke depression, and research into this is still growing. That is why the investigators want to see if the wisdom enhancement timeline can improve the mood and overall well-being of people who have had a stroke.

In this study, the investigators have two goals. First, the investigators want to see if the wisdom enhancement timeline technique can reduce depression in stroke survivors. Second, the investigators aim to discover how this technique brings positive mood changes.

The main question the investigators want to answer

1. Does enhancing wisdom through the timeline technique improve psychological outcomes (mood, identity, self-esteem) in post-stroke depressed individuals?
2. In post-stroke depressed individuals, is the improvement in wisdom the first indicator of subsequent improvements in identity, self-esteem, and mood?

It is hypothesised that wisdom will improve first following the session where wisdom is applied. This will then be followed by either identity or self-esteem, with mood improving last.

To carry out this study, the investigators will work with three stroke survivors receiving care from the National Health Service (NHS). By focusing on this smaller group, the investigators hope to gain insights into the effectiveness of the technique in reducing depression and enhancing the lives of stroke survivors. This study is essential as it could help the investigators understand the best way to support those with post-stroke depression.

Eligibility Criteria:
Inclusion Criteria:

* Had a stroke.
* Those who self-report as having difficulties with depression to a clinician.
* Have sufficient cognitive and communication abilities for informed consent and active engagement

Exclusion Criteria:

* Under the age of 18. Because this is the age when they are treated as an adult by UK law.
* Severe cognitive impairments or mental health difficulties that would hinder task engagement or provide informed consent.
* Medical instability jeopardising consistent participation or well-being.
* Significant risk concerns regarding safety to themselves or others.
* Substance use/dependency impacting adherence.
* Prescribed psychotropic medication less than 3 months ago.
* Currently involved in research.
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

This is an open-label, Phase 2 study that will investigate the incidence and severity of diarrhea in early-stage HER2+ breast cancer patients receiving neratinib with loperamide, alone and in combination with an anti-inflammatory treatment or a bile acid sequestrant treatment, or neratinib dose escalation, who have previously undergone a course of trastuzumab therapy in the adjuvant setting.

Patients will receive:

* Neratinib 240 mg orally once daily with food for thirteen 28-day cycles.
* Loperamide daily for two 28-day cycles and then as needed.
* Amendment 3, an anti-inflammatory treatment for one cycle and loperamide to be administered daily for two 28-day cycles and then as needed. Closed to enrollment.
* Amendment 4, colestipol for one cycle and loperamide to be administered one cycle and then as needed. Closed to enrollment.
* Amendment 5, colestipol for one cycle and loperamide as needed. Closed to enrollment.
* Amendment 6/6.1, 120 mg neratinib for Week 1 (C1D1-C1D7), followed by 160 mg neratinib for Week 2 (C1D8-C1D14), followed by 240 mg neratinib for Week 3 and thereafter (C1D15 to end of treatment). Loperamide as needed. Closed to enrollment.
* Amendment 7/7.1, 160 mg neratinib for the first 2 weeks (C1D1 - C1D14), followed by 200 mg neratinib for the next 2 weeks (C1D15 - C1D28), followed by 240 mg neratinib thereafter (C2D1 to end of treatment). Loperamide as needed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18; male or female
* Early breast cancer (stage I-3c)
* Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+
* Prior course of adjuvant trastuzumab given \>2 weeks and ≤1 year from enrollment
* No evidence of local/regional recurrence or metastatic disease
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception
* Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO

Exclusion Criteria:

* Major surgery \< 30 days
* Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) \< 14 days
* Corrected QT Interval (QTc) \>0.450 seconds (males) or \>0.470 (females) or other active cardiac disease
* Significant chronic GI disorder with diarrhea as a major symptom
* Active, unresolved infections
* Currently pregnant or breast-feeding
Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
* Seeking spectacle independence after surgery
* IOL power between +5.0D y +34.0D
* Transparent ocular media, except for the cataract prior to surgery.
* Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

Exclusion Criteria:

* Preoperatory corneal astigmatism greater than 1.0D
* Previous corneal surgery or trauma
* Irregular cornea (e.g. keratoconus)
* Choroidal hemorrhage
* Microftalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Severe concomitant ocular condition
* Cataract not age-related
* Severe optic nerve atrophy
* Diabetic retinopathy
* Ambyopia
* Extremely shallow anterior chamber
* Severe chronic uveitis
* Pregnancy or lactating
* Rubella
* Mature/dense cataract difficulting preoperatory eye fundus assessment
* Previous retinal detachment
* Concurrent participation in another investigation involving drugs or medical devices
Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).

There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2.

Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* New diagnosis of HCC within the last three months
* Clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis
* Ability to complete study procedures English

Exclusion Criteria:

* Significant uncontrolled hepatic encephalopathy
* Cognitive impairment, or psychiatric disorder which will interfere with study participation
* Patients near the end of life for whom hospice is recommended
A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China

Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.


Eligibility Criteria:
Inclusion Criteria:

* patient with previously or undiagnosed chronic liver disease/cirrhosis;
* serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT\>10ULN（male 300 U/L; female 200 U/L)

Exclusion Criteria:

* those who had or been diagnosed hepatocellular carcinoma or other types of malignancies;
* pregnancy;
* obstructive biliary diseases or other disease lead to bilirubin evaluation;
* using steroid or immunosuppressant in 4 weeks;
* prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver transplantation.
* combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2\<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS\<8)
A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC

The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage IV squamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed squamous NSCLC.
* Have stage IV disease at the time of study entry (American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th edition).
* Have measurable disease at the time of study enrollment as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
* Have tumor tissue available for biomarker analysis.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Have adequate organ functions.

Exclusion Criteria:

* Are currently enrolled in another clinical trial.
* Have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor.
* Have received previous chemotherapy for advanced NSCLC. Participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
* Have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
* Have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required).
* Have a history of arterial or venous embolism within 6 months prior to study entry.
* Have clinical evidence of concomitant infectious conditions.
* Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
* Are pregnant or breastfeeding.
* Have a known history of drug abuse.
* Have a concurrent active malignancy. Participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: Participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and Lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
* Have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.
Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.

Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.

This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing.

Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound.

Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients age \> 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.
* Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV \> 125 cm/sec) or occlusion of one or both ICAs
* Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.

Exclusion Criteria:

* Age \< 18 years.
* Hospitalized inpatients.
* Inability to provide informed consent.
* Prior history of carotid endarterectomy or carotid artery stent.
* Prior neck surgery
* Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.
Effects of Yoga and Relaxation on Stress and Quality of Life

The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.


Eligibility Criteria:
Inclusion Criteria:

- stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems

Exclusion Criteria:

* serious acute or chronic diseases
* pregnancy or lactation
* known serious mental illness
* immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
* participation in another study
R-wave Optimisation in Cardiac Resynchronisation Therapy Study

The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. More specifically it is to investigate whether using the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.


Eligibility Criteria:
Inclusion Criteria

* The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function.
* Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of \<35% and either

  * a QRS duration of \>150ms or
  * a QRS duration of 120 - 149ms with further evidence of dyssynchrony confirmed by echocardiography.
* Participants must have \>95% true biventricular pacing over the 1 month before enrolment and throughout the observation period.
* The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of \< 1mm or \<20% of the total QRS deflection with standard LV offset settings applied.
* The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing.
* The participant must be willing to comply with the protocol requirements including travelling to the Royal Bournemouth Hospital for the attendances required for the study and intend to have their long term device follow up at the Royal Bournemouth Hospital at the time of enrolment.
* Provision of informed consent Exclusion criteria
* Hypertrophic or restrictive cardiomyopathy
* Suspected acute myocarditis
* Correctable Valvulopathy
* An Acute Coronary Syndrome within the last 3 months
* Recent (within the last 3 months) or scheduled coronary revascularisation
* Treatment resistant hypertension
* Severe obstructive lung disease
* Pregnancy at the time of enrolment or a desire to become pregnant during the study period
* An inability to walk
* Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
* Unable to provide informed consent
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects

This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve.

The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase.

Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:

* Arm A: Peg-IFN plus AL-3778 (N=20)
* Arm B: Peg-IFN plus matching placebo (N=10)


Eligibility Criteria:
Inclusion Criteria:

1. A female subject must be of non-childbearing potential
2. Subjects must have CHB infection, documented by serologic profile consistent for CHB infection at screening:

   1. serum HBsAg positive (for \>6 months)
   2. serum IgM anti-HBc negative
3. Subjects are treatment-naïve and are serum HBeAg positive with:

   1. serum HBV DNA \>=20,000 IU /mL at screening
   2. HBsAg \>250 IU/mL at screening
   3. ≥2× upper limit of normal (ULN) ALT and ≤5× ULN at screening

Exclusion Criteria:

1. Positive test for hepatitis A virus immunoglobulin, hepatitis delta antibody (Ab), hepatitis C Ab, human immunodeficiency virus (HIV) Ab and/or evidence of clinically relevant active infection that would interfere with study conduct or its interpretation would also lead to exclusion.
2. Positive test for anti-HBs antibodies and anti-HBe antibodies.
3. Subjects must have low levels of liver fibrosis that is classified as Metavir F0-F2
4. Any history or current evidence of hepatic decompensation
5. Subjects must have absence of hepatocellular carcinoma
6. Subject with evidence of retinopathy on retinal fundus photographs
7. Exclusions related to interferon use for the purposes of this study
8. Subjects with one or more of the following laboratory abnormalities at screening

   1. serum creatinine elevation \>1.0× ULN
   2. hemoglobin \<11 g/dL \[males\], \<10.5 g/dL \[females\]
   3. platelet count \<125× 109 cells/L
   4. absolute neutrophil count \<1.0× 109 cells/L
   5. total bilirubin \>1.0× ULN; unless known Gilbert's Disease or Dubin-Johnson Syndrome
9. Subjects having received an investigational agent or investigational vaccine, or having received a biological product within 12 weeks or 5 half-lives (whichever is longer) prior to baseline (first intake of study drugs).
the Effect of Universal Salt Iodization on Thyroid Diseases

1. acquire the environmental iodine status of Hangzhou
2. acquire the iodine status of population in Hangzhou
3. acquire the prevalence of thyroid diseases in Hangzhou
4. explore the association between iodized salt and thyroid disease


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 6 years old;
2. living for above 5 years at present residence.

Exclusion Criteria:

1. resident with coronary angiography (CAG) or endoscopic retrograde cholangiopancreatography (ERCP) in 6 months;
2. resident taking amiodarone drug;
3. resident with abnormal kidney function or serious illness