cyrilzakka/clinical-trials huggingface dataset:
Prediction of Atherosclerotic Plaque Progression

To predict coronary atherosclerosis progression in patients with acute coronary syndrome by the use of intracoronary imaging methods.

To investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA To study the influence of gene polymorphisms (in genes playing role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes

The fundamental aim of this study is to investigate the ability of intracoronary imaging to predict progression of coronary atherosclerosis in patients with acute coronary syndrome. In patients who are indicated for acute coronary angiography and have at least one non-culprit lesion (not indicated for revascularization) identical segment of non-culprit vessel will be analysed and several parameters will be detected by OCT (optical coherence tomography) and NIRS (near-infrared spectroscopy) including the presence of TCFA (thin-cap fibroatheroma) and plaque lipid content quantified by LCBI (lipid core burden index). During follow up visits (1Y, 2Y, 5Y and 10Y) major cardiovascular events will be monitored and the progression of coronary involvement will be estimated at 1Y and 2Y by CCTA (coronary computed angiography).

The second part of the trial is to investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA.

A further target is to study the influence of gene polymorphisms (in genes playing a role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes. Patient DNA will be isolated from peripheral blood leucocytes, and polymorphisms in genes for Hemoxygenase-1 and endothelial Nitric Oxide Synthase will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome diagnosis
* Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)

Exclusion Criteria:

* Contraindication for OCT or IVUS
* Circulatory instability
* Renal insufficiency (creatinine level \>200umol/l)
* Pregnant or of childbirth age and not using reliable contraception
* Life expectancy of less than one year
Effectiveness of Creatine on Pain, Fatigue, and Muscle Architectural Variables in Patients Witg Fibromyalgia.

Creatine, a non-protein organic amino acid, is synthesized from arginine, glycine, and methionine. The use of creatine has been shown to be effective in healthy subjects, providing benefits primarily in terms of strength, which has been the main factor studied. In patients with various conditions, including pain, creatine supplementation has demonstrated a reduction in pain and even cognitive improvements.

Due to creatine's general improvement in muscular endurance and fatigue.

Through this study, we aim to analyze whether creatine supplementation can be beneficial in reducing symptoms in patients with Fibromyalgia. Previous studies have demonstrated its benefits, and therefore, we want to evaluate if these benefits can manifest in a shorter time compared to previous studies in patients with Fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with FM
* aged between 18 and 75 years
* agree to participate and sign the informed consent

Exclusion Criteria:

* who do not have recent surgeries
* patients with reduced mobility
* adequate level of comprehension to be able to answer the questionnaires that will be provided in the study
* If they are taking antihypertensive medications
Breast Cancer Registry Platform

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with breast cancer will be evaluated for up to five years.

Eligibility Criteria:
Inclusion Criteria:

EBC cohort:

* Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes)
* Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant thera-py or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, what-ever was given first

ABC cohort:

* Female and male patients with advanced breast cancer (stage IV defined as synchronous or metachronous diagnosis of distant metastases at inclusion)
* Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first

All cohorts:

* Written informed consent

  * Patients participating in the PRO module: signing of informed consent form and completion of baseline questionnaire before start of initial systemic treatment for EBC or systemic first-line treatment for ABC
  * Patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC
* Age ≥ 18 years

Exclusion Criteria:

* Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or ABC
* Patients who do not receive any systemic therapy for EBC or ABC
Phase II Study of the Enzyme Inhibitor NTBC for Tyrosinemia Type I

OBJECTIVES:

Assess whether 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) at 0.6 mg/kg per day prevents liver failure in at least 1 patient with tyrosinemia type I.

PROTOCOL OUTLINE: Only 2 patients with tyrosinemia type I are known to this research team; others will be treated if found and if clinical conditions permit.

The enzyme inhibitor 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) is administered orally, in 2 divided doses daily with meals.

Patients will be followed closely for side effects attributable to NTBC.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Tyrosinemia type I No cirrhosis No hepatocellular carcinoma
The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells Harvested From Umbilical Cords

The aim of this study is to obtain and test endothelial cells (EC's) from umbilical cords to examine specific properties of these cells which make up the inner lining of blood vessels.

Mechanical testing will be performed on the Ec's to see how the cells reacts and ultimately how the blood vessel is affected.

A central role in the mechanism that defines the nature of vessel remodelling is played by endothelial cells. EC's are extremely sensitive to the frictional forces exerted on a unit of the endothelial area by blood flow. This mechanical stimulus is known as wall shear stress (WSS). WSS experienced by EC's in-vivo is unsteady due to the unsteady nature of blood flow produced during the cardiac cycle and due to the complex nature of the vascular tree.

The extent to which this applies to venous cells and tissue remains unknown and it is the focus of this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are attending the Maternity Services who are pregnant and due for routine delivery.
* Aged 18- 40 years.
* Are willing and capable to voluntarily sign a statement of informed consent to take part in this investigation.
* Patients due to give birth to twins will be included in this study. Women having both "normal" delivery and caesarean section delivery will be included in this study.

Exclusion Criteria:

* Patients unable to provide informed consent.
* Patients who are under the age of 18 and over the age of 40 years.
* Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the Consultant.
* Patients with a Blood Borne Virus (HIV Type 1, HIV Type 2, Hepatitis B, Hepatitis C) will be excluded from the study.
* Patients with diabetes that is not gestational in nature will be excluded from this study.
* Patients due to deliver triplets or more will be excluded from this study.
* Patients who deliver their baby before 37 weeks gestation will not have umbilical cord tissue retained for study purposes.
Comparison of Obesity Alleles Among Diverse Demographic Patients

This proposal is designed to (1) establish the feasibility of a research strategy for discovering ethnic differences in the frequency of genotypes in patients after bariatric surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to identify genetic factors that may influence the success of various surgical weight loss interventions and determine whether these factors are associated with specific patient populations.

Goals:

1. Establish feasibility of obtaining research consent on patients to collect clinical data, family history, and blood samples.
2. Complete comprehensive genetic analyses on a diverse group of severely obese patients who have undergone bariatric surgery, specifically the primarily non-Caucasian Bellevue population and the Caucasian population of Geisinger Health Systems and NYU Langone Weight Management Program, to help define genetic factors that influence which surgical interventions work best for which patients. The ultimate aim is to rapidly translate these discoveries into practical solutions.

Methods and Procedures: The participants of this study are all patients who have undergone bariatric surgery at Bellevue Hospital, NYU Langone Weight Management Program, and Geisinger Health System. The investigators have already completed this in 200 patients and plan to increase enrollment for a total of 2500 patients. The investigators will collect blood samples on bariatric surgery patients and send the blood to Geisinger for genotyping and analysis. An extra sample of venous blood (about 4 tablespoons or 40ml) will be collected at the time of routine postoperative visits. In addition, the investigators will use information that has routinely been and will be collected during postoperative visits as part of the care that bariatric patients receive. The investigators will look at the electronic medical record to obtain the preoperative weights. This includes questionnaires patients complete and the results of the laboratory tests and other studies.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone any type of bariatric surgery

Exclusion Criteria:

* Patients who have not had bariatric surgery
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer

Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.

The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)


Eligibility Criteria:
Inclusion Criteria:

* 20 years and older
* Person who agreed to participate in this study and signed voluntarily on the written informed consent form
* Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen
* Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception
* Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires
* Life expectancy more than 6 months
* Performance status of ECOG grade 0\~1
* Hb ≥ 9g/dL
* Person with moderate liver function (AST, ALT ≤ 2.5 × ULN)
* Person with moderate renal function (Cr ≤ 1.5 × ULN)

Exclusion Criteria:

* Pregnant or nursing women
* Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma
* No controlled pain despite the use if analgesics.
* Person showing hypothyroidism despite the hormone treatment
* Person with insomnia despite an appropriate treatment
* No controlled hypertension (DBP \>100mmHg or SBP \>160mmHg)
* Person who has experience of hypersensitivity to the trial drug (ginseng) components
* Person with autoimmune disorders (Multiple sclerosis, Lupus, rheumarthritis etc.)
* Person who is alcoholic dependent or has psychiatric disorder
* Person who has cognitive or psychiatric problems
* Person who has an experience of chemotherapy agents use 6 months before a screening visit
* Person who had a surgery 2 weeks before a screening visit
* Person who had taken herbal medicinal product (including Chinese medicine) 4 weeks before the screening visit
* Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician
Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy

Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT are non-responders. In this study the investigators will use a previously validated method to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and blood pressure. Furthermore, cardiac magnetic resonance imaging (CMR) with late gadolinium enhancement (LGE) will be performed in feasible subjects. The main purpose of the study is to determine if myocardial work by echocardiography in combination with viability assessment by LGE-CMR can predict response to CRT.


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated for CRT device according to European Society of Cardiology (ESC) guidelines from 2013.
* Subject is willing to sign informed consent form and is 18 years or older.

Exclusion Criteria:

* Right bundle branch block.
* Recent myocardial infarction, within 40 days prior to enrollment.
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
* Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
* Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
* Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period).
* Complex and uncorrected congenital heart disease.
* Breastfeeding women or women of child bearing potential.
* Enrolled in one or more concurrent studies that would confound the results of this study.
* Impossible to obtain LV volumes by echocardiography
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.

The purpose of this research study is to investigate whether or not increasing or decreasing duration of sleep over one night will change the concentration of amyloid-beta in cerebral spinal fluid (CSF).

Eligibility Criteria:
Inclusion Criteria:

* cognitively normal or CDR 0
* negative for amyloid deposition by PET Pittsburgh Compound-B (PIB) imaging or CSF amyloid-beta-42 concentration
* Age 18-60
* Average reported sleep time 6-10hrs

Exclusion Criteria:

* diagnosis of a sleep disorder such as sleep apnea, narcolepsy, or restless leg syndrome
* positive ambulatory sleep study for obstructive sleep apnea (AHI \> 5 respiratory events per hour) that will be performed as part of initial screening prior to enrollment
* Clinical Dementia Rating (CDR) \> 0
* tremor or other neurologic injury in the non-dominant upper extremity (such as stroke or tremor) that would prevent the use of actigraphy
* current sleep walking or other sleep parasomnia
* diagnosis and treatment of stroke, myocardial infarction or heart attack,
* coronary artery disease, atrial fibrillation, or congestive heart failure
* diagnosis and treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD)
* diagnosis and treatment of bipolar disorder, major depression, or Schizophrenia
* current urinary or fecal incontinence
* currently on a low salt diet
* diagnosis and treatment of a neurologic disorder such as Parkinson's disease, epilepsy, multiple sclerosis
* currently taking any blood thinner medications such as warfarin, Plavix, or Aspirin
* kidney disease resulting in renal impairment
* liver disease resulting in hepatic dysfunction
* Pregnancy
* currently taking sedating medications such as benzodiazepines
* alcohol use at bedtime
* tobacco use
* BMI \>40
* contraindication to lumbar puncture
* diabetes
* sleep schedule outside the range of bedtime: 8pm-12am and waketime 4am-8am
* self reported difficulty sleeping in an unfamiliar environment
* use of sedative-hypnotic medications
* inability to get in and out of bed
* history or presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or patient report
* history of drug abuse within the past 6 months
* positive score on 2 or more categories on the Berlin questionnaire
* participation in another investigational medicinal product or investigational device within the last 30 days
Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty

About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.

Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.

Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO™ (Smith\&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.

To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO™ for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO™ system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient for whom a total ankle arthroplasty has been scheduled
* Patient affiliated to a national health insurance scheme or similar
* Patient who have signed an informed consent form for its participation in the study

Exclusion Criteria:

* Patient with contraindication to use of the PICO™ device
* Patient participating in another study including an exclusion period in progress
* Patient participating in another interventional study that may interfere with this research
* Adult patient protected by law, under guardianship or tutorship ;
* Pregnant or breastfeeding women.
Effects of Preparing Parents To Participate In Their Child's Care In The Recovery Room

The objectives of this study were to evaluate the effect of a preoperative educational DVD on parents' knowledge acquisition, participation and anxiety related to their child's care in the recovery room (RR). It also aimed at evaluating the DVD in terms of children's postoperative distress, pain, analgesic requirements and length of recovery.

Following the development of a validated preoperative educational Digital Versatile Disc (DVD) for parents, a randomized clinical trial, with a pre-test-post-test control group, was conducted on 123 French or English speaking parent-child dyads whose child was aged from 3 to 10 years and underwent an ear-nose-throat (ENT) or dental same day surgery at a Canadian pediatric hospital. The parents in the control group received the standard preoperative preparation (verbal and written information about hospital procedures and the hospital's surgical virtual tour). The parents in the experimental group viewed the DVD and received the standard preoperative preparation. Parents and children were videotaped in the recovery room; parental participation and children's distress were measured using observational scales. A validated multiple choice questionnaire was used to measure parents' knowledge acquisition, whereas a visual analogue scale allowed parents to report their anxiety level prior to, during and after their stay in the recovery room. A chart review was conducted to collect data on children's postoperative pain, analgesic requirements and length of recovery. In order to assess the effect of the DVD on parents and their child, T-test, chi-square analyses and repeated measures ANOVAs were conducted among 105 dyads.

Eligibility Criteria:
Inclusion Criteria:

* Parents speaking, reading and communicating to their child in english or french
* Parents who consented to participating in the study
* Parents who had a child aged 3 to 10 years who underwent a day surgery of the ENT type (an adenoidectomy or an amygdalectomy or a combination of both) or of the dental type (a dental exam under general anesthesia or an extraction or a dental repair under general anesthesia) were part of the sampling

Exclusion Criteria:

* The parents and the children who did not fit the eligibility criterias were excluded from the study.
* The parents who completed the consent form and questionnaires before the day of the surgery and who did the pre-surgical preparation, but who did not accompany the child in the recovery room were not part of the study.
* Also excluded, children who presented post-anesthetic complications (ex.: respiratory distress, hemorrhage, severe emotional distress, etc.).
* Children presenting surgical complications (ex.: cardio-respiratory distress and hemorrhage) were also excluded from the study.