cyrilzakka/clinical-trials huggingface dataset:
CryoValve® SG Aortic Human Heart Valve Combination Study

The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.

The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a CryoValve SGAV as an aortic valve replacement.
* Patients who were ≤ 21 years of age at the time of implant.

Exclusion Criteria:

* Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.
* Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.
* Patients that were ≥ 22 years of age at the time of implant.
The Relationship Between NK Cell and Graves' Disease

Graves' disease (GD) is one of organ specific autoimmune diseases, the pathogenesis is not elucidated.Natural Killer (Natural Killer, NK) cells is a kind of important immune regulator, several abnormalities of NK cell function and number in GD patients have been described in the investigators' previous study. It is remain unclear whether the NK cell disfunction is a consequence of GD.Based on the investigators' previous study, the investigators plan to monitor NK cell function in participants in the whole course of disease, analyze the association with relevant factors, such as thyroid function, immune state or treatment,to find out influences of thyroid hormones and thyroid receptor antibody affecting the function of NK cell. The investigators will reveal whether the disfunction of NK cell secondary to GD abnormal thyroid function and/or immune disorders, and realize the mechanics.


Eligibility Criteria:
Inclusion Criteria:

* New GD patients without any treatment
* Aged of 18 to 75 years old

Exclusion Criteria:

* Pregnant or lactating woman;
* Known autoimmune disease;
* Receiving psychotropic or hormonal drugs;
* Taking drugs that affect the body's immune function;
* Obviously poor compliance.
Tomosynthesis as Primary Test for Breast Cancer Screening

Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.

In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).

The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.

The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.

Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for a new round of mammographic screening
* resident in the province

Exclusion Criteria:

* previous breast cancer diagnosis
* pregnancy or suspicion of pregnancy
* presence of BRCA1/2 gene mutation
* Previous Digital Breast Tomosynthesis performed
* unable to understand informed consent
* chemotherapy in progress
* presence of breast implant
Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome

The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome.

At special education and rehabilitation centers, children diagnosed with Down syndrome will undergo initial assessment, and those meeting the inclusion criteria will be included in the study following parental voluntary consent.

Measurement assessments will be conducted three times: before therapy, after therapy (at week 8), and at a follow-up at week 12. To ensure a fair and unbiased distribution, children participating in the study will be randomly assigned to their respective groups using a sealed envelope method, a widely accepted and transparent randomization technique.

1. Grup: Routine Physiotherapy (PT) Group - Receiving routine physiotherapy treatment.

   Children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment. After 12 weeks, the control will be in the form of an evaluation.
2. Grup: Orofacial Therapy + Routine PT Group - Receiving orofacial therapy and routine physiotherapy treatment.

   For the orofacial therapy, sessions will be held twice a week for eight weeks, with each session lasting 30-45 minutes, totaling 16 sessions. This structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapy's effectiveness. Secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks.
3. Grup: Therapeutic Yoga Group + Routine PT Group - Receiving therapeutic yoga and routine physiotherapy treatments.

The therapeutic yoga group at special education centers will also meet twice weekly for eight weeks, each lasting 30-45 minutes, for 16 sessions. Secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome
* Age between 5 and 12 years old
* Scoring 4 or higher on the pEAT-10 questionnaire
* Obtained parental consent form
* Ability of the child to cooperate

Exclusion Criteria:

* Conditions that would impede assessment or communication (such as cognitive problems, psychiatric issues, etc.).
* Children who have undergone any surgery related to orofacial structures and/or received orthodontic treatment.
* Those with a history of trauma (whiplash injury, condylar trauma, fractures).
* Children who have received orofacial-related physical therapy treatment within less than 6 months.
Clinical and Psycho-social Impact of COVID-19 Related Confinement on Patients With Digestive Tumors

To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven digestive tumor
* Ongoing treatment from March,1st and April 30th

Exclusion Criteria:

* Patient refusal for enrollment in the study
* Patient not recognised legally competent
Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Stroke is one of the main causes of death and disability in Taiwan. The M1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Through regulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. Previous study had been demonstrated that priming rehabilitation program with low frequent rTMS would lead to better motor recovery in the chronic stroke patients. However, the optimal time interval between the rTMS and the rehabilitation program had not been investigated. Thus, this study will utilize low frequent rTMS, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rTMS and the rehabilitation program.

This study is designed as a randomized controlled trial. We plan to recruit 45 subacute stroke patients with hemiplegia. The patients are randomly assigned to three groups. In the Group 1, the patients receive contralateral 1 Hz rTMS stimulation and subsequent rehabilitation program. In the Group 2, the patients receive contralateral 1 Hz rTMS, but the rehabilitation will be delayed at least two hours after the rTMS stimulation. The control group receive sham rTMS and subsequent rehabilitation program. The treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. The primary outcome is upper limb Fugl-Meyer Assessment. The secondary outcomes included Medical Research Council (MRC) scale, Barthel Scale, Modified Rankin Scale (MRS), cortical excitability assessment (including bilateral maximum MEP amplitude, MEP latency, and bilateral resting motor threshold). Follow-up time points are before rTMS and at 1st, 4th, 12th weeks after the end of the treatments.

Eligibility Criteria:
Inclusion criteria

1. \>=20 years old, unilateral stroke diagnosed by CT or MRI
2. Post-stroke 1 week to 6 months
3. Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
4. No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease
5. stable medical condition and vital signs

Exclusion criteria

1. Previous stroke, traumatic brain injury, brain tumor
2. With central nervous system disease (spinal cord injury, Parkinson's disease)
3. Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker, Pregnancy...)
4. Patients unable to cooperate the treatment
Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting

A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in healthy individuals and individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs,

iii.) quantify and compare amount of UE use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and

iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (AROM) in both shoulders and elbows for their age group.
* Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (UE) injury within the last 3 months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. It does not need to be their first and only stroke.

Exclusion Criteria:

* Healthy Adults: Injury of either UE within the last 3 months and unable to follow commands related to the accelerometer use/protocol.
* Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the MoCA and Stroke Impact Scale (SIS) questions.
Genomic Landscape of EGFR Mutant NSCLC Prior to Erlotinib and at the Time of Disease Progression

The investigators propose to conduct a pilot feasibility study of single agent erlotinib in patients with metastatic EGFR mutant adenocarcinoma of the lung with up to one prior treatment with the sole purpose of characterizing the genomic landscape before erlotinib and at the time of disease progression. The logistics of obtaining adequate quality fresh tissue specimens for sequencing studies before therapy and at the time of disease progression in patients with advanced lung cancer are complex and a thorough understanding of the practical challenges in conducting a study like this is crucial.

The current proposal will include exome and transcriptome sequencing from blood collected at baseline along with tumor samples obtained prior to starting erlotinib and at the time of disease progression (a total of two tissue samples and one blood sample per patient). If carried out successfully, the proposed strategy very likely will lead to a larger and adequately powered study to understand fully evolving molecular changes due to clonal selection under treatment pressure. The pace of progress in the field of sequencing technology currently underway is only likely to accelerate in the near future yielding richer and highly content-rich information. Moreover, it is likely that genomic information from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.

The investigators plan to sequence paired tumor specimens from 20 patients with EGFR mutant adenocarcinoma of the lung before treatment with erlotinib and at the time of disease progression following treatment with erlotinib. As the investigators expect some drop off (due to unexpected clinical events precluding a second biopsy at the time of disease progression, poor specimen quality and early discontinuation of therapy for non-progression), the investigators will enroll 40 patients in this trial to get 20-paired specimens.


Eligibility Criteria:
Patient Selection

* Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma
* Presence of known sensitizing mutations in EGFR TK domain
* Consented to HRPO# 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected -Thoracic Malignancies, or Mesothelioma")
* Treatment with standard of care erlotinib
* At least 18 years of age
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction

RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.

The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ST-Segment elevation myocardial infarction \<6h
* Written informed consent

Exclusion Criteria:

* Previous Q-wave myocardial infarction or previous coronary artery bypass graft
* Cardiogenic shock
* Cardiac arrest resuscitated before angioplasty
* Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
* TIMI 2 or 3 before angioplasty
* Collateral branches Rentrop \>1
* TIMI 0 or 1 flow grade after PCI
* Any contraindications to magnetic resonance imaging
* Allergy to gadolinium
* Patient refusal / patient not having provided written informed consent
Nutritional Content of Breast Milk From Mothers of Premies

The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants with a gestational age \<=30 weeks in the NICU who are supplying their own breast milk for use by their baby
* Reasonable likelihood of survival of infant to 28 days
* Infant on/ready for oral feeding by DOL 7 days
* Willing to provide breast milk for their baby
* Able to produce at least 7mL breast milk per feeding
* Willing to abide by requirements of the study protocol
* Documentation of informed consent

Exclusion Criteria:

* Unable to provide at least 7mL breast milk per feeding
* Medically unsuitable to provide breast milk to her baby
* Maternal age \<18 years of age
Cardiac Responsiveness Assessment by CO2

The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness.

Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful.

To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity).

The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring.

Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases.

There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism.

The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output.

The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in intensive care.
* Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
* Patient with hypotension (MAP \<65 mmHg OR SAP \<90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
* Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior or inferior vena cava territory.

Exclusion Criteria :

* Patient under 18 years old
* Patient under guardianship without the possible consent of the guardian
* Pregnant woman
* Pathologies and maneuvers strongly affecting CO2 purification: Diagnosed pulmonary embolism, Prone positioning for less than 60 minutes, Exogenous intake of sodium bicarbonate less than 60 minutes ago (with the exception of an renal replacement therapy in place for more than 60 minutes)
* Recent change in respiratory quotient: Change in enteral or parenteral nutrition solution for less than 3 hours
* Pathology affecting CO2 metabolism: Fever\> 39 ° c, Intense chills.
* Patients with unstable ventilation over the hour before inclusion.
Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

The purpose of this study is to develop a questionnaire to measure patient expectations of breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will assist both surgeons and patients by helping provide valuable information to patients about what to expect during and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-75
* Patients who are scheduled to undergo lumpectomy at MSKCC as part of breast conserving therapy for invasive breast cancer OR who have completed BCT (lumpectomy and radiation) at least 6 months prior to recruitment

Exclusion Criteria:

* Inability to speak or understand English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
* Patients undergoing lumpectomy without radiation