cyrilzakka/clinical-trials huggingface dataset:
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia

This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more, who are able to consent
* Singleton pregnancy
* Anatomically and chromosomally normal fetus
* Left sided diaphragmatic hernia
* Gestation at randomization prior to 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d)
* Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR \<25 %, irrespective of the liver position
* Acceptance of randomization and the consequences for the further management during pregnancy and thereafter.
* The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed.
* Intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment".
* Provide written consent to participate in this RCT

Exclusion Criteria:

* Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
* Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
* Preterm labour, cervix shortened (\<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
* Patient age less than 18 years
* Psychosocial ineligibility, precluding consent
* Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria
* Patient refusing randomization or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon
Twisted Fallopian Tubes

Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.

Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.


Eligibility Criteria:
Inclusion Criteria:

* Patient younger then 18 going through surgery for twisted fallopian tubes

Exclusion Criteria:

* Girl above 18 and tubal torsion associated with ovary torsion
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Exclusion Criteria:

1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
2. Patients with a current or past history of chronic infection
3. Patients with moderate or severe heart failure (NYHA class III/IV).
Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients Receiving Medications for Opioid Use Disorder

The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients who are already receiving treatment for opioid use disorder. The main question it aims to answer is:

Does PE+ decrease PTSD symptoms?

All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.

Participants will:

* Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
* Receive financial incentives for attending each PE+ session.
* Attend assessment visits every 4 weeks for the 12 weeks of the trial.
* Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.


Eligibility Criteria:
Inclusion Criteria:

* Female
* \>18 years old
* Gestational age ≤ 25 weeks
* Maintained on a stable methadone or buprenorphine dose for \>14 days prior to the study
* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
* Participants receiving psychotropic medications must be maintained on a stable dose for \>14 days prior to enrollment.

Exclusion Criteria:

* Male
* Under 18 years old
* Gestational age \> 25 weeks
* Not receiving medication for opioid use disorder
* No current diagnosis of PTSD
* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
* Enrolled in another ongoing evidence-based treatment for PTSD.
Cognitive Skills Training for Homeless Youth

Many young people who are homeless have cognitive deficits which impede their ability to secure and maintain employment. This study looks to see if targeting cognitive deficits can improve cognition and vocational outcome.

The aim of this research is to conduct a controlled study of cognitive remediation, to provide feasibility data on adapting an established empirically-based cognitive intervention for homeless youth to help them attain vocational goals. The ultimate purpose is that youth will improve in cognitive functioning and have better functional outcomes including jobs to sustain independent living.

The results of this study will inform a larger trial on the efficacy of cognitive remediation in homeless youth to improve cognition and vocational outcomes. Hypotheses are that, compared to those in an active control group receiving computerized work-skills training, individuals who receive cognitive remediation will show greater cognitive benefits on proximal measures of neurocognition and evidence better vocational outcome as defined by greater number of hours worked. This study will address the service gap in the use of integrated psychosocial interventions for homeless populations as the first investigation of cognitive remediation in homeless youth.

Eligibility Criteria:
Inclusion Criteria:

* have a current Diagnostic and Statistical Manual (DSM-IV) Axis I diagnosis
* residing at Covenant House New York Rights of Passage Program
* psychiatrically stable for at least 21 days
* English speaking

Exclusion Criteria:

* mental retardation (\<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
* risk for suicide or violence
* unremitted substance dependence within the past 6 weeks
Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist

The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with left ventricular hypertrophy of unknown etiology or of sarcomeric MHC pace, followed in Normandy, has given its consent to the search of Fabry disease

Criteria Exclusion:

* Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease
Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis

OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis.

II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.

PROTOCOL OUTLINE: Patients may be treated on any of three different regimens. Patients may be treated on more than one regimen, if they meet the eligibility requirements.

Patients on regimen A are adults and receive uridine triphosphate (UTP) by inhalation, followed immediately by bronchoscopy.

Patients on regimen B are children, aged 4 to 10 years. Patients receive up to 4 graded doses of UTP by inhalation on day 1. On day 2, patients receive a single dose of UTP. Patients receive amiloride followed by UTP by inhalation on day 3.

Patients on regimen C are children, aged 4 to 18 years. Patients inhale a radiolabelled (technetium 99m) monodisperse iron oxide aerosol. Radiation deposited in the patient's lungs is monitored. Patients are randomized to receive one of 4 different aerosols (vehicle; UTP; amiloride; or UTP plus amiloride), which is inhaled for 20 minutes. Patients are followed 24 hours after aerosol exposure.

Regimen D is a dose escalation study in which patients are aged 9 to 40 years. Patients receive either the vehicle or UTP by inhalation 3 times daily for 3 days. Cohorts of 4 patients each are entered at each dose level.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of mild to moderate cystic fibrosis Small production of daily airway secretions Stable pulmonary course --Prior/Concurrent Therapy-- Radiotherapy: No radiation within 12 months to cause patient to exceed annual limits Other: No chronic medication for reactive airways disease At least 12 hours since inhaled beta-adrenergic agonists At least 24 hours since systemic theophylline --Patient Characteristics-- FEV1 greater than 50% predicted Other: Not pregnant Must perform reproducible spirometry
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis

Erythropoietin is neuroprotective in animal models of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS). The aim of this study was to determine the safety and feasibility of repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 to 80
* upper motor neuron signs and lower motor neuron signs were identified in neurological examination.
* Meet the revised El Escorial Criteria for clinically possible, probable-laboratory -supported, probable, definite ALS.
* Disease duration \< 3 years (Within 3 years from symptom onset)
* ALSFRS-R score between 21 to 46
* Patient who can visit an outpatient under the aid of his or her own walking or caregivers.
* The person who have agreed in writing to participate in this clinical trial by themselves and the legal representative
* FVC over 50% at screening

Exclusion Criteria:

* Person who were not compatible with ALS
* Patient with PLS or PMA
* A group of patients who are concerned about the adverse effects of the drug administration (e.g. malignant hypertension,...)
* ALSFRS-R score below 20 at screening
* Ventilator user or Tracheostomy state patients at screening
* Gastrostomy state at screening
* FVC below 50% at screening or patient who cannot perform FVC test.
* EKG abnormality, history of coronary stent , CABG at screening
* Person who was given another clinical trial drug three months prior to screening.
* History of seizure/ epilepsy
* Abnormal renal function (serem creatinine \> 2.0mg/dl)
* Abnormal liver function(AST/ALT/bilirubin over 2 times the upper normal limit
* Pregnant
* Bleeding tendency at screening
* Infectious disease at screening
* Drug sensitivity
* Person who injected erythropoietin 6 months prior to screening
* Malignant tumor
* Other neurological disease (stroke, parkinson's disease, dementia...)
* Psychological disease
* Hb more than 16g/dL
Optimization of CRT Using an ECG Vest

Despite advancements in implant technology and various techniques of optimization, there is still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study will assess the potential benefit of a body surface mapping technology to optimize CRT devices in the chronic sub-optimal responder setting.

Cardiac resynchronization therapy (CRT) is one of the most important advances in the treatment of patients with heart failure (HF). This therapy, also known as biventricular pacing, utilizes pacemaker leads to synchronize the contraction of the walls within the left ventricle (LV) and the contraction of the left and right ventricles. Many randomized trials have conclusively demonstrated that CRT improves symptoms, LV structure and function, hospitalization rates, and survival in appropriately selected HF patients. Nonetheless, approximately 30% of CRT patients will be "non-responders" because they will not demonstrate the expected clinical and/or echocardiographic improvement following therapy. A critical component of assessing CRT efficacy during the optimization clinic will be the use of a novel method of body surface electrocardiographic mapping under development by Medtronic, called the ECG Vest. In this proposal, we describe a research study to assess the potential benefit of using the ECG Vest as part of a CRT optimization strategy on clinical and echocardiographic outcomes (heart size and function) of patients receiving standard clinical care in the UHVC CRT Optimization Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients (or their legal guardian) must be willing to provide Informed Consent and a data privacy (HIPPA) authorization
* Patient is or will be followed clinically in the UHVC CRT Optimization Clinic
* Patient has been implanted with a CRT device for at least 6 months
* Patient received an echocardiogram prior to CRT implant
* Patients must be ≥ 18 years of age

Exclusion Criteria:

* Patient's EF is currently ≥ 50%
* Patients who are pregnant
* Patient has unhealed / open wounds on the torso and/or has a history of severe allergic reactions from ECG gel / electrode glue
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)

To demonstrate a higher percent rate of achieved target lipid goals among patients at high cardiovascular risk using more potent lipid-lowering treatment options including high-potency statins and combination therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients at high cardiovascular risk according to Framingham or SCORE rates

Exclusion Criteria:

* Not eligible for lipid or statin therapy
* Intolerance to therapy
* Patients at low or intermediate CV risk
A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study

Validation of the PEFS to detect breast tumors will be performed by means of a prospective trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied for reproducibility and predictive ability. Data analysis will be iterative, moving on with each modification of the device until the final prototype is created.

Phase 2A of this study is directed primarily at prototype development, creating, testing, and modifying a 4x4 finger array device with a small footprint that is battery powered and reliable. The testing in this phase is aimed at proving that modifications did not degrade the screening sensitivity of the original lab prototype.

Target enrollment is up to 100 patients to verify that the investigators have reproducible values in the same patient. Each breast will be evaluated and compared against each other whether it is considered normal or abnormal tissue. Data from patients both normal and abnormal regions will be compared and used to determine predictive value and accuracy in this prototype. The patient population will be women and men 18 years of age or older with symptomatic breast lump either by palpation or imaging.

Symptomatic individuals scheduled to undergo diagnostic exam will be recruited from all patients presenting for breast evaluations at Dr. Brooks clinical practices who meet all the inclusion and exclusion criteria. Consent will be obtained prior to any study related activities. The PEFS evaluation will be performed by a trained individual. Subjects will be scanned in supine position without breast immobilization - similar to ultrasound testing. The PEFS data is recorded and processed by an automated software algorithm and the results are displayed topographically on a breast-map with red areas showing positive findings and black areas showing negative findings. Quantitative data will be documented and analyzed for accuracy metrics. Results will not be given to subjects nor recorded in their medical records. Because this study is not a clinical utility study, results will have no effect on clinical care decisions. The PEFS evaluation may add between 10 and 30 minutes to the clinic visit. No imaging or pathology tests are being done for research purposes.

Eligibility Criteria:
Inclusion Criteria:

18 years or older

* women or men with symptomatic breast lump by palpation or imaging

Exclusion Criteria:

* under 18 years of age
Investigation of Genetic Risk of Cardiovascular Disease in Prospective Cohort Study

Cardiovascular disease is a complex multifactorial and polygenic disorder that is thought to result from an interaction between a person's genetic make up and various environmental factors. Although many studies have revealed that several genetic variants increase the risk of cardiovascular disease, the results of these studies remain controversial. The purpose of this study is to identify polymorphisms that confer susceptibility to cardiovascular disease and to clarify the adequacy of reported susceptibility gene polymorphisms. To complete this purpose, we will prospectively study over 5,000 local residents in whom relationship between these polymorphisms and occurrence of cardiovascular disease over 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who undergo community-based annual health check in Kitanagoya city
Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Medtronic is sponsoring this Mechanical Circulatory Support (MCS) Korea Post-Market Surveillance (PMS) to evaluate the safety and performance of the HeartWare Ventricular Assist Device System (HVAD® System) when used in routine clinical care practice in Korea. The MCS Korea PMS is conducted within Medtronic's Product Surveillance Platform (PSR).

The MCS Korea PMS is an observational study conducted at two sites. This MCS Korea PMS is required by the Ministry of Food and Drug Safety (MFDS) as a condition of product approval according to Regulation on Medical Device Re-examination. The designated re-examination period is seven years after the approval date (06 Dec 2013 \~ 05 Dec 2020). All patients who require treatment of a commercially available HVAD System for approved indications between the designated re-examination period at a participating PSR site are eligible for enrollment. All enrolled patients will be followed until patient death, transplant, explant (where applicable), or the end of the study, on 05 Dec 2020.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible product
* Patient is consented within the enrollment window or waiver of consent is approved

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)