cyrilzakka/clinical-trials huggingface dataset:
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes

The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.

Trial design

The DYNAMITE trial is an investigator-initiated, randomised controlled, open-labelled trial conducted in the Capital Region of Copenhagen, Denmark

The following hypothesis will be tested:

* First primary hypothesis: A treatment strategy guided by combined dynamic CT myocardial stress perfusion, FFR-CT and CT coronary angiography improves clinical outcome compared with a conventional management strategy in patients with chronic chest pain syndromes
* Second primary hypothesis: A treatment strategy guided by combined dynamic CT stress myocardial perfusion, FFR-CT and CT coronary angiography results in improved symptom relief compared with a conventional management strategy in patients with chronic chest pain syndromes

Eligibility Criteria:
Inclusion Criteria:

* Chest pain in patients with clinically suspected or confirmed ischemic heart disease
* Clinical indication for non-acute coronary evaluation
* Status of coronary revascularization

  1. With previous coronary revascularization - all patients
  2. Without previous coronary revascularization

     1. Age≥65 years - all patients with chest pain
     2. Age\>50 - \<65 years - typical angina pectoris and at least one cardiovascular risk factor and/or previous myocardial infarction

        * Typical angina requiring all 3 criteria present: a) constrictive discomfort in the front of the chest or in the neck, jaw, shoulder or arm, b) precipitated by physical exertion c) relieved by rest or nitrates within 5 min.
        * Cardiovascular risk factors: hypertension, diabetes, hypercholesterolemia, current smoking, family history of ischemic heart disease, previous stroke, peripheral artery disease

Exclusion Criteria:

* Persistent chest pain and signs of ongoing acute myocardial ischemia requiring acute coronary intervention
* Hospitalization and discharge with the confirmed diagnosis acute coronary syndrome (STEMI or NSTEMI) within the last 6 months
* Severe valvular heart disease as primary diagnosis and/or in potential need of percutaneous or surgical valve treatment
* Known severe heart failure (LVEF less than 35%)
* Language, cultural or mental factors preventing the patient from understanding the informed consent form
* Known atrial fibrillation
* Known renal impairment (estimated Glomerular Filtration Rate below \<30 ml/min)
* Known x-ray contrast allergy
* Known intolerance to adenosine infusion
Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor

Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.

Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os.

The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor


Eligibility Criteria:
Inclusion Criteria:

* Singleton gestations
* Diagnosis of arrested PTL
* 18-50 years of age
* TVU CL ≤25mm at the time of randomization

Exclusion Criteria:

* Multiple gestations
* Rupture of membranes at the time of randomization
* Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
* Fetal death at the time of randomization
* Cerclage in situ at the time of randomization
* Pessary in situ at the time of randomization
* Vaginal bleeding at the time of randomization
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years
* Placenta previa and/or accreta
* Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization
* Painful and regular uterine contractions at the time of randomization
SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable.

A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source.

An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions.

The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

A number of risk factors have been identified that increase or decrease the risk of anastomotic leak. The risk of anastomotic failure is increased by anastomosis (lower third) close to the anus, tumour size greater than 5cm in colorectal carcinoma, surgical complications, smoking, diabetes, male gender, overweight, malnutrition (protein deficiency), heart disease requiring anticoagulation, time to surgery, American Society of Anaesthesiologist score, neoadjuvant treatment, corticosteroid use. The risk of suture failure is reduced by mechanical lining, intravenous and oral non-absorbable antibiotics. The microbiome also appears to have an impact on suture failure: lower diversity of bacteria in intraoperative specimens and an increase in the number of mucin-degrading Bacteroidaceae or Lachnospiraceae strains may be associated with higher anastomotic failure.

Eligibility Criteria:
Inclusion Criteria:

* Circular stapled anastomosis
* Planned surgery with colo-colic anastomosis
* No passage disorder, as it is confirmed at the first medical examination
* Not allergic to antibiotics
* Can receive a bowel preparation
* No proximal excluded intestine, i.e., the bowel preparation may be successful (ileostomy)

Exclusion Criteria:

* treated with antibiotics within 2 weeks before randomisation
* allergic to any of the medicines used
* under 18 years of age
* have suffered from abdominal sepsis within 6 months prior to recruitment
* pregnancy or breastfeeding
* been treated with steroids
* any form of chronic immunosuppression
Secondary Prevention and Recidivism Reduction in Trauma Patients

The consumption of alcohol and other drugs is one of the main risk factors for traumatism. In addition, patients who have suffered an accident in relation to the consumption of these substances present a high risk of recidivism. In the case of alcohol, its relationship with traumatisms has been known for many years now and is still one of the main risk factors.

Secondary prevention is an important area of action and improvement in the treatment of this type of patient by considering actions, such as a brief motivational intervention, in order to avoid recidivism. The objective of motivational intervention is to make the patient aware of the relationship between the consumption of these substances and the accident, and induce them to carry out a change in habits.

The objective of the present investigation project is to determine the efficacy of secondary prevention in reducing recurrence of traumatisms. In order to this, a multicenter randomised controlled trial has been designed in which the intervention group with patients admitted for sever traumatism with positive screening for alcohol or other drugs, will be submitted to a brief motivational intervention. The main outcome will be trauma recurrence within a three year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Sever trauma patients defined as the need of assistance in a critical unit.
* Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).

Exclusion Criteria:

* Patients in treatment for abuse of alcohol and other drugs.
* Death during hospitalization.
* Non Catalonia residents.
* Not Spanish or Catalan spoken.
Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.

To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.

When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.

Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.

All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

* Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.
Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump

There will be breast tissue changes after use of a breast pump.


Eligibility Criteria:
Inclusion Criteria:

* Lactating women who were breastfeeding.

Exclusion Criteria:

* Non breastfeeding or non lactating women.
Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises in Cerebral Palsy

Thoracic mobility is the mobility of the thoracic spine, and the rib cage is often measured by the degree of thorax expansion during breathing. Thoracic mobility is affected by many reasons, such as breathing mechanics, muscle stiffness, a sedentary lifestyle, and poor posture. The risk of respiratory illness should be assessed in all individuals with Cerebral palsy. Poor mobility of the thoracic will lead to limited breathing capacity and difficulty in daily life activities. Increasing thoracic mobility enhances dynamic alignment and functional movement. Proprioceptive Neuromuscular Facilitation (PNF) of upper extremity and chest expansion exercise can improve thoracic mobility. In this method, a physiotherapeutic approach is used in muscle strengthening, lengthening, and endurance training. The study aims to analyze the effect of an upper limb training program based on PNF techniques and chest expansion exercises on the thoracic mobility of a cerebral palsy patient.

The current study will be a randomized control trial; data will be collected from the Lahore Garrison Institute of Special Education. The study will include 14 patients who are equally divided into two groups and randomly allocated. Inclusion criteria for the study will be either gender of CP patients at Gross Motor Function Classification System level I to III, who had no orthopedic surgery in the last 6 months and have a diagnosis of CP by doctors. Patients with scoliosis and any acute or current respiratory infection or other respiratory conditions, such as asthma or influenza, will be excluded from the study. One experimental group will perform upper extremity PNF combined with elastic resistance bands; the other group will perform chest expansion exercises, which are upper extremity flexion, abduction, and external rotation exercises with an elastic band. The outcomes to be analyzed will be thoracic mobility. Data collection will be done before and after the intervention. Tools used for data collection will be Brompton BPAT breathing pattern assessment tool (BPAT) and chest cirtometry. Data will be analyzed through SPSS version 23.00.

Eligibility Criteria:
Inclusion Criteria:

* Gross Motor Function Classification System level of I to III.
* BPAT score ≥ 4.
* Either gender will be included

Exclusion Criteria:

* Recent chest infection.
* Children who are hospitalized
* Scoliosis
* No orthopedic surgery in last 6 months
Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy

This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE). The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.

This study correlates the sedation level measured by entropy during DISE using propofol via a TCI pump with the local obstruction patterns of the upper airway according to the VOTE classification.

As OSAHS is a widespread disease and the DISE procedure has become a common tool for diagnosis and evaluation of further treatment, a growing number of research articles deal with this topic. These articles are available through pubmed.


Eligibility Criteria:
Inclusion Criteria:

* documented sleep apnea Syndrome with an AHI \> 5 diagnosed by polysomnography

Exclusion Criteria:

* active infection
* performed oral, head or neck surgery, pregnancy,
* ASA classification III or higher,
* chronic use of alcohol, sedatives or illicit drugs and chronic
* obstructive pulmonary disease.
Assessment of Patient Use of a New Device: RebiSmart

Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse.

Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times a week by injections under the skin. The RebiSmart device is a new injection device which has been developed to help patients with injecting their Rebif treatment.

Currently, all treatments for MS are injectable and require long term patient commitment. Patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. Using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. The RebiSmart device has been developed for patients to inject conveniently and in comfort. The device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on-screen injection guide. The aim of this study is to determine what percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study will also determine which of the device features were most useful to the patients.


Eligibility Criteria:
Inclusion Criteria:

* Have relapsing remitting multiple sclerosis
* Between 18 to 65 years old inclusive
* Have been prescribed Rebif for the first time but not yet started treatment
* Rebismart as chosen device
* Be under review by MS nurse
* Having given written informed consent to participate in the study

Exclusion Criteria:

* Injections of Rebif given by someone other than the patient
* Patients unable to use the Rebismart device due to visual or physical impairment
* Patients unwilling to give informed consent
* Contra-indications to Rebif as defined in the Summary of Product Characteristics (SPC).
* Allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors

RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may help doctors improve methods of diagnosing and treating children with brain tumors.

PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of children with brain tumors.

OBJECTIVES:

* Determine the chromosomal gains and losses by DNA ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas.
* Determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients.
* Perform a statistical analysis to determine possible associations of chromosomal abnormalities and DNA ploidy with patient age, tumor histology, tumor location, extent of disease, and event-free survival.

OUTLINE: DNA ploidy analysis will be performed to determine the overall level of aneuploidy. The results are compared to the comparative genomic hybridization (CGH) analysis, which is used to demonstrate tumor-specific losses or gains, including amplification, of specific chromosomal regions. Tumors are also screened for specific abnormalities by fluorescent in situ hybridization (FISH), which detects chromosomal rearrangements, including balanced translocations, deletions, amplifications, etc. PCR-based microsatellite polymorphism analysis may also be performed.

Primitive neuroectodermal tumors (PNETs) are screened by FISH with a distal 17p13.3 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion. Atypical teratoid/rhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q11.2. PNETs are also screened by interphase FISH with cosmids from chromosome 6 to identify tumors with deletions.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue 360 specimens.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary CNS malignancy consistent with primitive neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor
* Must be entered on CCG-9921, CCG-9931, CCG-A9961, CCG-99703 or other front-line studies developed from CCG-90024 or CCG-90025
* Retrospective specimens also obtained from CCG-921, CCG-923, CCG-9892, CCG-9921, and CCG-9931

PATIENT CHARACTERISTICS:

Age:

* Under 21

Performance status:

* See Disease Characteristics

Life expectancy:

* See Disease Characteristics

Hematopoietic:

* See Disease Characteristics

Hepatic:

* See Disease Characteristics

Renal:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility Criteria:
Main inclusion criteria:

* Patients with chronic obstructive pulmonary disease
* Current smoker or ex-smoker
* 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant

Main exclusion criteria:

* Patients with poorly controlled COPD
* Patients who need for long-term oxygen therapy
* Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation