cyrilzakka/clinical-trials huggingface dataset:
Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

Pre-existing pain and severe postoperative pain are predictors of persistent pain after surgery, but a complete understanding on the development of persistent pain is still lacking. The study aims to identify clinically relevant and genetic risk factors for persistent postsurgical pain that can be reliably distinguished statistically.

The study will focus on: (i) risk factors representing biopsychosocial processes that influence chronic pain, such as pain and psychological vulnerability; (ii) genetic factors relating to mechanistic pathways to persistent pain generation. Patients will be recruited from those undergoing breast cancer surgery at the mentioned site. Pain and anxiety assessment will be conducted via visual analogue scoring, mechanical temporal summation assessment and a series of questionnaires. After the surgery, all patients will be given appropriate analgesia, and the pain score and analgesia usage will be recorded. Phone survey will be conducted 4 and 6 months, respectively, after surgery to determine the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 21 - 80 year old;
* Healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (ASA 1-3);
* Undergoing breast cancer surgery.

Exclusion Criteria:

* History of intravenous drug or opioid abuse;
* Current chronic daily treatment with corticosteroids (excluding inhaled steroids);
* Previous history of chronic pain syndrome;
* Obstetric patients.
Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults

The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. The purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training \[CCPT\], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in Hong Kong. The study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.

The study design is a cluster randomized controlled trial. Twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. A total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. Each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. Each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. Assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.

Eligibility Criteria:
Inclusion Criteria:

1. Age 60 or above
2. Both gender
3. Willingness and capability to participate in this study and training
4. Willingness and capability to give informed consent to participate in this study
5. Pass the cutting-point of referenced screening tests (cognitive and emotional)

Screening tools:

* MOCA score above 19 (satisfactory basic function)
* Positive and Negative Syndrome Scale (PANSS) with scores \< 19 in positive scale, \< 22 in negative scale, and \< 38 in general psychopathology scale

Exclusion Criteria:

1. A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease
2. Early stages of Alzheimer's Disease, or the use of psychoactive drugs
3. Complicated conditions that preclude regular attendance of the training
4. Currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer ).
The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement

"This study investigates the feasibility of tele-rehabilitation combined with targeted training for cognitive enhancement in individuals with Multiple Sclerosis (MS). Multiple sclerosis (MS) is a chronic illness that affects the central nervous system, often resulting in cognitive impairments that significantly impact quality of life. Tele-restoration provides an accessible and effective method for delivering therapeutic interventions, particularly beneficial for those with mobility limitations.

The study was a randomized controlled trial with multiple sclerosis patients divided into two groups: one receiving tele-rehabilitation-based task-specific training and the other receiving conventional care. The mediation group participated in structured cognitive training sessions conducted using a tele-rehabilitation platform, focusing on tasks designed to enhance memory, attention, and executive functions. Psychological assessments were conducted during the mediation period to measure improvements.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of MS confirmed by a neurologist.
* Between 18 and 65 years of age.
* Presence of psychosis confirmed by standardized psychometric testing.
* A stable treatment environment that allows intervention.
* Internet access with camera and computer/tablet.
* Ability to understand and follow course directions.
* Willingness to give informed consent.

Exclusion Criteria:

* Severe psychiatric co-morbidities affecting cognitive function.
* Concurrent intervention with other psychological rehabilitation programs.
* Lack of availability or use of technology necessary for tele-rehabilitation.
* Further research interventions.
* Unstable medical condition
Clinical Characteristics and Prognostic Factors of Atrial Fibrillation at a Tertiary Center of Pakistan - From a South-Asian Lens - a Retrospective Study.

To evaluate the clinical characteristics and management purseued for atrial fibrillation in a tertiary care center of Pakistan. We aimed at looking baseline characteristics and associated co-morbid conditions and primary diagnosis associated with atrial fibrillation.

It is a retrospective observational study done at Aga Khan University Hospital, Karachi, Pakistan, which is a tertiary care teaching hospital with a cardiology and cardiac surgery center. Aga Khan Hospital is one of the main referral health centers in Pakistan.

This study was approved by Aga Khan University ethical review committee (ERC No. # 2019-1008-2905).We reviewed hospital record files of 651 patients including both males and females, admitted in Aga Khan University Hospital from 1st July 2018 to 31st December 2018, who were found to have atrial fibrillation as a primary or associated diagnosis. Diagnosis of atrial fibrillation was confirmed on a 12 lead ECG. Fifteen patients were excluded who did not have electrocardiographic evidence of atrial fibrillation.

For all patient, demographic information including age and gender, reason of admission and duration of arrhythmia were noted from the written medical records. Comorbidities were tabulated including: diabetes mellitus, hypertension, coronary artery disease, heart failure, cardiomyopathy, valvular heart disease, chronic obstructive pulmonary disease, and hyperthyroidism. Echocardiographic data were reviewed for left atrial (LA) dimension, LA volume index and left ventricular (LV) systolic function.

Patients were labeled as Diabetic if they had HbA1c of \>6.5gm/dl or they were already on treatment for diabetes mellitus. Hypertension was defined as average of two readings of systolic blood pressure of ≥140mmHg or diastolic blood pressure of ≥90mmHg or patients already taking antihypertensive medications. Coronary artery disease was defined as ≥50% stenosis in at least one of the epicardial coronary arteries. Cardiomyopathy was defined as left ventricular ejection fraction of ≤50% Chronic obstructive pulmonary disease was defined as forced expiratory volume in 1st second to forced vital capacity ratio of \<70% of the predicted value. Patients were labeled hyperthyroid if they have low serum TSH and high serum concentration of free T4 or T3 as per laboratory reference range.

All patients were followed from the time of inclusion to the time of discharge or till inpatient death. Hemodynamic parameters including heart rate and blood pressure were recorded at the time of inclusion for patients with known atrial fibrillation and at the time of onset of arrhythmia for those with new onset atrial fibrillation. Patients' treatment record were reviewed for medications. Complications related to atrial fibrillation or its treatment were recorded.

Eligibility Criteria:
Inclusion Criteria:

* inpatients
* Age \>/= 18 years
* Having atrial fibrillation on 12 lead surface EKG.
* Both males and females.

Exclusion Criteria:

* Age \<18 years.
* Non-availability of 12 lead EKG.
Mindfulness Training for Older Adult Canadian Immigrants

This study will evaluate whether mindfulness-based stress reduction (MBSR) is a viable community program for enhancing wellbeing among older adult immigrants from low income neighborhoods. Half of the sample will be randomized to receive the 9-week mindfulness program and the other half will be randomized to a wait list control condition. Primary outcomes of interest will include perceived stress and self-report depressive symptoms. Secondary outcomes will include trait mindfulness and self-care, self-compassion, emotion regulations, and attentional skills. Participants will also be invited to engage in a 30-minute interview to discuss their lived experience as an immigrant in Canada and their experience in the MBSR program. Due to COVID-19, all sessions will be held virtually.

Adults aged 65 years and older are the fastest growing segment of the Canadian population. In the 2006 Census, 43% of older adults in Ontario identified as being a Canadian immigrant, a statistic which continues to grow in the context of an aging population. Aging is commonly associated with declines in physical and cognitive capacity, which is significantly accelerated by chronic perceived stress. Lower income older adults are particularly vulnerable to accelerated aging and disease onset due to the stress of economic insecurity. In 2012, the highest low-income rates in Canada were reported among immigrants 65 years of age and older. Accordingly, it is important to investigate programs that can support the wellbeing of aging Canadian immigrants.

The principal investigator (PI) and her research team will conduct a one-factor between-subjects design with two conditions - a mindfulness-based intervention and a waitlist control - to examine the benefits of mindfulness training on indices of wellbeing, including perceived stress, depressive symptoms, emotion regulation, self-compassion and self care. It is hypothesized that mindfulness training will enhance indices of wellbeing compared to a wait-list control. Employing a mixed-methods approach, participants will also engage in a qualitative interviews to provide insight into the lived experience and how mindfulness may serve Canadian immigrants.

Eligibility Criteria:
Inclusion Criteria:

* 60+ years of age; Canadian immigrant; low socioeconomic status; immigrated to Canada within last 15 years; reports experiencing stress in their daily life.

Exclusion Criteria:

* existing contemplative practice; currently enrolled in a research study; non-fluency in English; neurological disorder that prevents participation in the 9-week program or testing procedures; plans to vacation during the study period/unable to attend 9 program sessions and 2 testing sessions; existing substance abuse (last 6 months); psychiatric disorder that may prevent participation in 9-week program or testing procedure.
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)

Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody titer level and T cell response level (spot formation cell counting).

Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.

In selected communities or assigned clinical trial institutions, participants who had completed two doses of SARS-CoV-2 vaccination will be invited in this study. Informed consent form will give to potential participants with well explained of trial contents during baseline. Participants who gave their signed informed consent form will be blocked randomized in a 1:1 ratio to intervention group or placebo control group.

Eligibility Criteria:
Inclusion Criteria:

1. 18 ≤age ≤59 years;
2. Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (≥6 months from the time of vaccination).
3. Not vaccinated third dose vaccination;
4. Voluntarily participate in the study with signed informed consent form.

Exclusion criteria:

1. Pregnancy or lactation period;
2. Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
3. Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
4. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
5. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
6. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
7. End-stage cancer or other terminal diseases with life expectancy \<6 month;
8. History of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia,or history of myocardial or cerebral infarction within past six months;
9. Participating in other clinical trials.
Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with chronic phase chronic myelogenous leukemia.

OBJECTIVES:

* Determine the antileukemic effects of tumor-specific Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) junction specific peptide vaccine, as measured by a decrease in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR), that persist for at least 3 months, in patients with chronic phase chronic myelogenous leukemia.
* Determine the percentage of patients treated with this vaccine who become RT-PCR-negative for BCR-ABL transcripts.
* Compare response in patients with B3A2 junctions vs B2A2 junctions when treated with this vaccine.
* Determine the immunologic response over 1 year in patients treated with this vaccine.
* Correlate response with specific HLA types in these patients.
* Determine the safety of this vaccine in these patients.

OUTLINE: This is a pilot, multicenter study.

Patients receive BCR-ABL junction-specific peptide vaccine subcutaneously in weeks 2, 4, 6, 8, and 11 and then once monthly for 10 months.

BCR-ABL transcript levels are assessed by quantitative reverse-transcriptase polymerase chain reaction at baseline, weeks 2, 4, and 6, every 3 months during treatment, and then 2 weeks after completion of study treatment.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML)

  * In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart
  * Minimal residual disease
* Detectable BCR-ABL transcript levels obtained \< 6 months apart AND ≤ 0.5-log lower than the lowest value obtained within the past 6 months

PATIENT CHARACTERISTICS:

* Karnofsky performance status 80-100%
* Bilirubin \< 2 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* ALT and AST \< 2.5 times ULN

PRIOR CONCURRENT THERAPY:

* Recovered from prior therapy
* No major surgery within the past 4 weeks
* No prior chemotherapy
* No prior immunosuppressive therapy
* No prior corticosteroids
* No prior stem cell transplantation
* No radiotherapy within the past 4 weeks
* No other concurrent investigational agents
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial

The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.

Recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be reproduced laparoscopically. However, many controversies exist due to no evidence and no long-term results. There was no prospective multi-center large-scale randomized controlled trial in the world on the long-term outcome of laparoscopic gastric cancer surgery.

Korean Laparoscopic Gastrointestinal Surgery Study Group, therefore, proposed a multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus open distal gastrectomy for gastric cancer (KLASS Trial) after the feasibility and validity of these procedures had been evaluated by analyzing retrospective multi-center large series.

This KLASS trial is supported by a grant for 2005 from the National R\&D Program for Cancer Control, Ministry of Health \& Welfare, Republic of Korea. Nine surgeons from 9 centers are participating in this trial. All the participants performed more than 50 cases of open and laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of gastric cancer surgeries per year. Primary endpoint of this trial is to elucidate that there is no difference of overall and disease-free survivals between laparoscopic and open groups. The KLASS trial consists of 5 major subjects: comparison of 5-year overall and disease-free survivals, standardization of preoperative diagnosis, assessment of the quality of life, evaluation of postoperative inflammatory response and immune function, and cost-effectiveness. The KLASS trial will be able to validate and verify laparoscopic gastric cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically proven gastric adenocarcinoma
2. age: 20 \~ 80 years
3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0
4. no history of other cancer
5. no history of chemotherapy or radiotherapy
6. written informed consent

Exclusion Criteria:

1. ASA \>3
2. combined resection
3. total gastrectomy
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven rectal adenocarcinoma
* inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy
* diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision
* T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy
* no evidence of distant metastases
* tumor size \<6cm
* sufficient organ function
* no contraindication to laparoscopic surgery
* without other malignancies in medical history

Exclusion Criteria:

* concurrent or previous diagnosis of invasive cancer within 5 years
* locally advanced cancers requiring en bloc multivisceral resection
* intestinal obstruction
* intestinal perforation
* history of colorectal surgery
* American Society of Anesthesiologists(ASA) class 4 or 5
* pregnant or breast-feeding women
* history of mental disorder
* participation in another rectal cancer clinical trial relating to surgical technique
Mirror Neuron Network Based Motor Imagery Training to Improve Brain Computer Interface Performance in Spinal Cord Injury Patients

The overall vision of this proposal is to demonstrate that a virtual reality based motor imagery training program will improve brain computer interface (BCI) performance and motor function in quadriplegic subjects. The ultimate goal is to increase the independence of subjects with spinal cord injury by training to safely control BCI assistive devices and to enhance motor recovery.

Intend to train subjects in motor imagery techniques using an advanced virtual reality based platform. Hypothesize that this will enhance the cortical signals necessary for operating a non-invasive EEG-based BCI. Specifically, designed training paradigms will activate "mirror neurons" associated with performance of movement, observation of movement, and motor imagery. Mirror neuron network (MNN) activation induces cortical plasticity, and may therefore enhance cortical signals generated during BCI use. Plan to assess the effect of training paradigm on cortical signals generated during motor imagery, using EEG. Also, investigate neuropsychological factors that play a role in a subject's ability to generate vivid motor imagery.

Eight subjects with spinal cord injury (SCI) will be recruited during the sub-acute phase (3-6 months following injury). Four participants will immediately undergo motor imagery training in an immersive virtual reality environment at NASA. EEG assessments and motor function testing will be performed at intervals during the 3-4 week motor imagery training period to assess improvement in cortical signature generation and motor recovery. The other four participants will undergo the same protocol after a 6 week delay, in order to assess the effect of training timing after injury in both cortical signature generation and motor function recovery.

Eligibility Criteria:
Inclusion Criteria:

* sustained incomplete Spinal Cord Injury (American Spinal Injury Impairment Scale) at a level of C5-7 within three to six months prior to enrollment

Exclusion Criteria:

* unstable or acute medical or psychiatric illness; pregnancy; epilepsy; diabetes; autism spectrum disorder, history of severe traumatic brain injury or stroke, and those taking medications that may interfere with EEG readings, including beta blockers and sedatives.
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators

Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators


Eligibility Criteria:
Inclusion Criteria:

* Patients with dual-chamber pacemakers or defibrillators

Exclusion Criteria:

* Recent acute ischemic events
* Recent atrial or ventricular arrhythmias
* Uncompensated heart failure
* Amiodarone use within last year
* Women of childbearing potential
* QTc \<430 msec males
* QTc \<450 msec females