cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Thoracotomy

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-thoracotomy pain syndrome (PTPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after thoracotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PTPS .

Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.

Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PTPS

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 75 years.
2. patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
3. American Society of Anesthesiologists classification of physical status \< IV.

Exclusion Criteria:

1. emergency surgery.
2. off-pump surgery.
3. redo surgery.
4. ejection fraction less than 35%.
5. refusal of the patient.
6. known hypersensitivity to LA.
7. chronic opioid use or chronic pain patient.
8. psychiatric problems or communication difficulties.
9. liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
10. renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
11. obstructive sleep apnea syndrom.
12. coexisting hematologic disorders.
13. pregnancy or breastfeeding.
SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs

This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
* The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC.
* The patient receives 3rd generation EGFR-TKI in the first line setting.
* The patient is ≥18 years of age and ≤75 years of age at the time of screening.
* The patient's Karnofsky performance score (KPS) is ≥70 at study entry.
* The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI.
* The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
* The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator.
* The patient has signed informed consent.
* EGFR Exon19 deletion or Exon21 L858R mutation

Exclusion Criteria:

* History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible.
* The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
* Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator.
* Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.
Lipid Variability--Influence of Stress

To investigate the variability of lipids and specifically the effects of stress on serum triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.

BACKGROUND:

While researchers had documented some of the behavioral contributors to fluctuation in individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention had been given to psychosocial stress. Early reports utilizing accountants, race car drivers, and air traffic controllers provided some uncontrolled data associating stress with cholesterol increases. Yet, no empirical research on stress that concomitantly examined other related influences was available. This paucity of data was probably due to lack of objective measures of stress and difficulty in measuring lipid subfractions.

DESIGN NARRATIVE:

Based on the results of their pilot study, and their research observations, the investigators predicted significant positive associations between stress level and triglycerides. A total of 228 public accountants (148 men and 80 women to provide comparable power between the sexes) were recruited from the greater Birmingham, Alabama area. Participants were evaluated monthly for 18 months, across three stressful and non-stressful work intervals (i.e., tax seasons). The investigators also collected data (during this same time frame) to closely monitor the following variables that affect lipids: dietary intake (including alcohol, caffeine, total calories, total fat, saturated fat, and dietary cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status and menstrual stage among the women. Additionally, a substudy presented a unique opportunity for them to investigate the relation between stress and triglyceride-rich lipoproteins in the formation of foam cells.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Surface Nerve Stimulation Treatment for OAB in Children

The purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.

Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.

The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.

When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment of OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. In the non-responding cases behavioural modifying regimes can be coupled with anticholinergic medication. However, poor compliance of the child or parents, or dose limiting side effects often influences the efficacy of this intervention. Also a considerable number of children experience no or only limited effect from the treatment even though all instructions are complied with. This has let to research into new treatment modalities and the use of low frequency electrical current to inhibit detrusor overactivity in adults has become common. Pilot studies have indicated a significant effect of TENS on urinary incontinence in children with OAB.

Hypothesis:

* Sacral TENS is an effective treatment of urinary incontinence in children with OAB refractory to anticholinergic medication coupled with bladder training and voiding reeducation.
* The acute effect of sacral TENS can be identified by urodynamics
* It is possible to predict the outcome of sacral TENS treatment in these children.

  30 children (age 5-14 years) with functional daytime incontinence refractory to anticholinergic medication coupled with bladder training. The study protocol consists of 1 week of basic home registrations and a 4 day in-patient phase succeeded by a 4 week home training period. The participants will be randomized to treatment with either active or inactive TENS.

Eligibility Criteria:
Inclusion Criteria:

* Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
* Incontinence refractory to treatment
* Informed consent

Exclusion Criteria:

* Severe diseases of the kidneys or urinary tract besides OAB
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study in patients with unresectable, locally-advanced or metastatic New York esophageal squamous cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.

Eligibility Criteria:
Selected Inclusion Criteria:

* Histological diagnosis of synovial sarcoma
* Immunohistochemistry (IHC) results from tumor biopsy for New York esophageal squamous cell carcinoma 1 (NY-ESO-1) are positive
* Participants have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide-containing systemic anti-cancer therapy regimen
* Must have documentation of no evidence of disease progression of the tumor during or after completion of first line systemic anti-cancer therapy
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
* Age \>/= 12 years
* Life expectancy of at least 6 months

Selected Exclusion Criteria:

* Have received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy \>28 days prior to day 1
* Have received prior anti-NY-ESO-1 therapy
* Have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide
* Have received treatment with systemic immunomodulatory agents within 28 days prior to administration of the first dose of CMB305, or 5 half-lives of the drug, whichever occurs sooner.
* Have significant immunosuppression from concurrent, recent, or anticipated need for chronic treatment with systemic immunosuppressive dose of corticosteroids or immunosuppressive medications.
* Have psychiatric or other medical illness, or any other condition that in the opinion of the investigator prevents compliance with the study procedures or ability to provide valid informed consent.
* Have history of uncontrolled autoimmune disease.
* Have a significant electrocardiogram finding or cardiovascular disease
* have inadequate organ function per protocol
* History of other cancer within 3 years
* Evidence of active tuberculosis or recent clinically-significant infection requiring systemic therapy.
* Evidence of active Hepatitis B, Hepatitis C, or Human Immunodeficiency virus (HIV) infection
* Have a history of brain metastasis
* Have received cancer therapies including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 weeks prior ot the first scheduled dose of CMB305
* Female of child bearing potential who is pregnant, is planning to become pregnant, or is breast feeding; or male who is sexually active with a female of child bearing potential who is planning to become pregnant.
B7-H3 NIR Imaging for Osteosarcoma Surgery

Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Besides, intraoperative frozen-section analysis of resection margins of OS is often restricted by the hard tissues around OS, which makes it impossible to know whether a negative margin is achieved. Herein, based on the high expression of B7-H3 in OS, a targeted probe B7H3-IRDye800CW is synthesized by conjugating anti-B7H3 antibody and IRDye800CW. This trial is aimed to investigate R0-resection rate and 2-y local recurrence rate after using this probe in Musculoskeletal tumor surgery for osteosarcoma as well as the safety parameters of this probe in human.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with histologically confirmed osteosarcoma of the limbs.
* 2. the patients has not undergone tumor resection.
* 3. Age between 18 and 60 years old.
* 4. No prior systemic treatment for osteosarcoma.
* 5. Measurable disease as assessed by imaging studies (e.g., MRI, CT).
* 6. Adequate bone marrow, liver, and renal function.
* 7. Written informed consent obtained from the patient.

Exclusion Criteria:

* 1. History of other malignancies within the past 5 years.
* 2. Pregnancy or lactation.
* 3. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
* 4. Uncontrolled intercurrent illness that would preclude safe study participation.
* 5. Prior radiation therapy to the target lesion.
* 6. Any medical condition that would compromise the patient's ability to undergo surgery or comply with study procedures.
* 7.Patients not able to sign the Informed Consent.
OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration

Smartphone apps have the potential to measure standard metrics of visual function. In addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. Smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. While there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy.

The OKKO Health app (www.okkohealth.com) is a smartphone app available on Apple iOS and Android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. The app has one game per function, each on average 1-2 minutes. There are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. This study will aim to validate these measures of visual function against gold standard clinical tests.


Eligibility Criteria:
Inclusion Criteria:

* Participants with AMD in at least one eye
* Willing to travel to the clinic in Exmouth/Bristol
* Able to hold and use a smartphone

Exclusion Criteria:

* Significant ocular pathology other than AMD
* Unable to provide written informed consent
Vienna Hypothermic Oxygenated Machine Perfusion Study

In this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at Medical University of Vienna will be prospectively recorded. Investigation of short- and long-term outcome in this cohort will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
* age ≥ 18 years

Exclusion Criteria:

* pregnancy
* partial grafts
* the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible
Use of MRI for Assessing Stomach Relaxation in Response to a Meal

This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).


Eligibility Criteria:
Inclusion criteria for Dyspeptic patients (30 required)

* One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
* Patients fulfilling the ROME-II criteria for functional dyspepsia,
* AND no symptom improvement after standard dose PPI treatment,
* AND normal upper gastrointestinal endoscopy within six months prior to the study

Inclusion Criteria for Healthy Controls (20 required)

• Absence of current abdominal symptoms or depression

Exclusion Criteria for all Participants

* Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy);
* Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair;
* Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted;
* Pregnant or breast-feeding females;
* Known claustrophobia;
* Any metal objects in the body (e.g. metal implants, pacemaker, AICD)
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI).

The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and was examined its feasibility and efficacy in the elderly individuals with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 55-90
* Educational level above 1 year and confirmed literacy
* Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
* Clinical Dementia Rating (CDR) of 0 or 0.5

Exclusion Criteria:

* Diagnosed to dementia by DSM-IV
* Evidence of delirium, confusion
* Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
* Evidence of severe cerebrovascular pathology
* History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
* History of substance abuse or dependence such as alcohol
* Presence of depressive symptoms that could influence cognitive function
* Presence of medical comorbidities that could result in cognitive decline
* Use of medication that could influence cognitive function seriously
Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19

COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Cases of myocarditis have also been reported with COVID-19.

Cardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.We will also assess predictive factors for transfer in Intensive Care Unit or death.


Eligibility Criteria:
Inclusion Criteria:

- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples

Exclusion Criteria:

- Patients who refused the use of their routine care data after information by investigators.
Depression Treatment in General Medical Settings

The purpose of this study was to examine the effect of a new disease management model for depression, the Collaborative Depression Management Program (CDMP), designed to improve clinical outcomes and increase depression treatment in general medical settings.

Clinically depressed individuals that could benefit from newer treatments for depression often do not receive care. Low treatment rates are of particular concern since depression is projected to be the second leading cause of disability worldwide by 2010. Major depression has been the focus of numerous intervention studies with primary care patients during recent years. However, despite advances in the development and testing of quality intervention models for depression treatment, very little is known about the effectiveness of interventions with Latinos. This is important because Latinos are less likely than whites to receive depression treatment, even though the rates of depression are similar for both groups. A major public health challenge is to make available the benefits of intervention developments in depression treatment for all groups in society. As a first step, we examined the impact of a quality depression intervention with Puerto Ricans. The specific aims were:

1. To examine the effect of a Collaborative Depression Management Program in reducing depressive symptoms, improving quality of life, and decreasing health-related functional impairment among Puerto Rican patients in general medical settings.
2. To determine whether a Collaborative Depression Management Program is effective in improving satisfaction with care and reducing barriers to depression treatment among Puerto Rican patients in general medical settings.

This study employed a randomized experimental design. Depressed patients receiving general medical care were assigned to one of two conditions: 80 to the Depression Management Program and 80 to treatment as usual. All subjects completed assessments at baseline, week 8, week 16 and week 24. Our overall programmatic goals were to increase the likelihood that depressed patients receive care and to make available for the Puerto Rican community advances in the treatment of major depression.

Eligibility Criteria:
Inclusion Criteria:

* patients ages 18 or older that meet the clinical criteria for major depression.

Exclusion Criteria:

* pregnancy, planning a pregnancy, breastfeeding or less than 3 months post-partum
* severe cognitive impairment
* ongoing psychiatric treatment
* do not plan to use the study clinic as a main source of medical care during the next six months
* a history of bipolar disorder or psychosis
* those clinically judged to have a high acute suicidal risk
* unstable or life-threatening medical condition