cyrilzakka/clinical-trials huggingface dataset:
Sound Processing Changes in Babies With Opioid Exposure

The purpose of this study is to identify problems with interpreting sounds in babies that have been exposed to opioids prior to birth. Being able to identify these issues in infancy may allow us to find children who may have problems with language learning later in life so that we can try to minimize these.

This is a single center prospective study of neonates \>36 weeks' gestation prenatally exposed to psychoactive substances and gestationally age-matched controls. Evoked response potentials on EEG in response to auditory oddball paradigms will be compared between cohorts. Analyses will try to identify differences in auditory processing using ANOVAs to compare the mismatch negativity measures, amplitudes and latencies as a function of study group.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 36 weeks, confirmation of dates via ultrasound or last menstrual period
* Prenatal opioid exposure ("exposed"), confirmed via admitted use or newborn drug screen; no prenatal opioid exposure ("control") by maternal report or testing
* All races, ethnicities, sexes to be included
* Informed permission form signed by mother

Exclusion Criteria:

* Birth weight ≤ 3rd percentile or ≥ 97th percentile for gestational age
* Have comorbid medical disorders including; those associated with sensorineural hearing loss, significant congenital anomalies, congenital heart disease, known brain injury/malformations
* Infants requiring mechanical ventilation
* Infants requiring continuous sedation
Radiotherapy in Palliation of Advanced Pelvic Cancer

The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.

he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven advanced pelvic cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) \<3

Exclusion Criteria:

- prior radiotherapy to the same region
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

to compare the efficacy of HIFU treatment with standard treatment in two situations:

1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.


Eligibility Criteria:
General inclusion criteria

* Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
* classified as low or intermediate risk
* Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\].
* Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
* Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml
* Patient affiliated with health insurance or beneficiary of an equivalent plan

Inclusion criteria for the HIFU Arm

* Patients 70 years of age or older
* Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years

Inclusion Criteria for Total Prostatectomy Arm

• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.

NON-INCLUSION CRITERIA

* Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
* Included patient simultaneously participating in another research study
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:

1. Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
2. Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

More extensive description is not desired.

Eligibility Criteria:
Inclusion Criteria:

* Age 14 to 30 months
* Motor impairment that prevents functional independent mobility
* Vision and hearing adequate to use a power mobility device safely.
* Cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.
Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)

Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.

This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.


Eligibility Criteria:
Inclusion Criteria:

* Cutaneous melanoma with a tumour thickness of at least 1,00mm
* Positive sentinel node with micro metastases of max. 2mm in diameter

Exclusion Criteria:

* Mucosal or ocular melanoma
* Cutaneous melanoma located in the head/neck region
* Evidence of satellite, in transit or local metastases / recurrences
* Macro metastases of the SN or micro metastases of \>2mm in diameter
* Additional immune-suppressive therapy
* Pregnant of lactating women
Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

This is a cohort study in patients with acute ischemic stroke. The demographic characteristics, Traditional Chinese Medicine (TCM) syndromes, and other baseline information will be recorded. At the same time, baseline peripheral blood will be collected. These participants will be followed up to 90 days of onset, and 90-day modified Rankin scale (mRS) scores will be assessed. The collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke.
* Symptom onset within 72 hours.
* Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
* Male or female ≥18 years and ≤ 80 years.
* With written informed consent.

Exclusion Criteria:

* Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
* Patients has previous stroke.
* Other conditions that lead to motor dysfunction (e.g., severe osteoarthritis, rheumatoid arthritis).
* Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
* Other conditions that affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).
End Tidal Carbon Dioxide in Minimal Sedation

This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing minimal sedation for procedure.

Exclusion Criteria:

* none
Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial

RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.

OBJECTIVES:

* Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.
* Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.
* Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic myelogenous leukemia (CML)
* Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)

  * Must not have initiated study therapy
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

The purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition. The interview will last approximately 60 minutes and will be conducted by a trained interviewer, be audio-recorded (with patient consent), and all information provided by the patient will be treated confidentially and made anonymous so that it is non-identifiable. The interview may be conducted face-to-face, over the phone, or virtually via Skype, a free video conferencing program, depending upon the patient's geographic location. Patients will be compensated for their participating time.

This is not a medication-related study, and no medication will be distributed or tested during this study. Participation in this study will not affect any treatment or assistance that a patient currently receives or may receive in the future.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of one of the following conditions based upon World Health Organization (WHO) diagnostic criteria: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease (SM-AHNMD), mast cell leukemia (MCL), smoldering systemic mastocytosis (SSM), indolent systemic mastocytosis (ISM)
* Diagnosis confirmed by bone marrow biopsy
* Fluency in English
* Willingness and ability to participate in a one-hour interview

Exclusion Criteria:

* A condition or situation that would interfere with participation in an interview (e.g., cognitive impairment or disorder, alcohol or drug abuse)
* Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
* Any other prior malignancy except for the following: Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the subject is currently in complete remission, or other cancer from which the subject has been disease-free for 2 years
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training

The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.

In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI \> 25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of cardiovascular disease and diabetes in these subjects. Additionally, a British study using a very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However, the effect of LED has never been examined in overweight patients with IHD.

Several studies have shown that patients with IHD have a beneficial effect of exercise training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group has shown that aerobic interval training results in the biggest increase in maximal oxygen uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD.

In conclusion, weight loss and exercise are known strategies in preventing progression of IHD and development of type 2 diabetes in these patients, however a head-to-head comparison of the two methods has never been made and it is unknown which intervention is the most effective in improving cardiovascular risk profile. Furthermore, several mechanisms behind the known beneficial effect of these interventions are unknown.

Eligibility Criteria:
Inclusion Criteria:

* Stable Ischemic Heart Disease
* BMI 28 - 40 kg/m2

Exclusion criteria:

* Known Diabetes Mellitus
* Repeated Fasting plasma glucose ≥ 7 mmol/L or Hba1c \> 7 %
* Severe or moderate valve disease
* Main stem stenosis
* Severe heart failure, Ejection Fraction \< 35 %
* Physical or mental disability which are expected to prevent completion of intervention
* Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 \< 50 % of expected) or asthma
* Active cancer
* Severe kidney (GFR \< 40 ml/hour) or severe liver disease
* Severe ischemia or arrhythmias during exercise test
* 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker
* Organised training more than 2 times a week prior to inclusion
* Significant weight loss or weight gain (\> 5 %)3 month prior to inclusion
* Not able to comprehend written and oral informed consent
* Hormone treatment
Assessment of Inspiratory Muscles Strength and Endurance Evolution on Difficult to Wean Patients in Intensive Care Unit

Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients.

This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance.

By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.

The main objective of this study is to determinate which characteristic of inspiratory muscles between strength and endurance has more deficiency in difficult to wean patients. In a second time, the results of this study will help to choose the best IMT program to assess his impact on the weaning time.

We are going to conduct an interventional trial because of Peak Pressure measure, which is not measure in care practice. Following 18h of invasive mechanical ventilation in a controlled mode, the failure of the first single breathe trial of 2 hours and the presence of sevrability criterias defined by the European consensus conference in 2007, 80 participants will be included in the medical intensive care unit of Bordeaux's hospital. We'll perform measurements of the Maximal Inspiratory Pressure and Peak Pressure from the inclusion to the extubation.

Eligibility Criteria:
Inclusion Criteria:

* Patient ventilated more than 18h in a controlled mode;
* First single breathe trial of 2 hours failure;
* Presence of sevrability criterias definied by the European consensus conference in 2007 as usually used:

  * diminution of the sedfative agents ;
  * Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode;
  * PaO2/FiO2 ≥150;
  * Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (\<1mg/h);
  * SaO2 \> 90% with FiO2 ≤ 50%;
  * PEP ≤ 8cmH2O;
  * Corporal température between 36°C and 39°C;
  * Glasgow Score ≥ 8;
* Patient or family consent.

Exclusion Criteria:

* Age \< 18 years ;
* medically unstable;
* Poor vital pronostic at very short term;
* Cardiac arrest with a poor neurological prognostic;
* Neuromuscular disease ;
* Tracheostomy ;
* Current pregnancy ;
* Patients with guardianship or trusteeship.
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.

Eligibility Criteria:
Inclusion Criteria:

* Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
* Have signed an informed consent form (ICF).

Exclusion Criteria:

* Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
* June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.
Limus Eluted From A Durable Versus ERodable Stent Coating

The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
* Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
* No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

* Pregnancy;
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
* Inability to provide informed consent;
* Currently participating in another trial before reaching first endpoint;
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.

Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

Eligibility Criteria:
Inclusion Criteria:

* Ages 40-80 years
* Their physician agreed to participate in the study
* Seen in practice for at least one year

Exclusion Criteria:

* Prior history of prostate cancer
* Presenting for acute medical visit
* Non-skin cancer
* Lung disease requiring oxygen
* Renal failure requiring dialysis
* Intensive care visit in last 6 months
* Need assistance with activities of daily living