cyrilzakka/clinical-trials huggingface dataset:
Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training

Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation. The "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with Fontan physiology. Inspiratory muscle training can improve the performance of competitive athletes across a range of sports and can improve quality of life and functional capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and possibly by improving peripheral blood flow during exercise. One could surmise that the effects of these changes would be particularly important in the Fontan population. The investigators propose to study the effects of inspiratory muscle training on exercise and pulmonary function parameters in a cohort of adult Fontan patients.

The investigators hypothesize that a 12-week program of inspiratory muscle training with an inspiratory impedance threshold device will improve inspiratory muscle strength and endurance, and that this will translate into improved exercise performance in patients with Fontan physiology.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Fontan physiology
* Undergoing cardiopulmonary stress testing
* Able to complete a previous cardiopulmonary stress test in the preceding 24 months
* Ability to comply with the inspiratory muscle training protocol
* Ability to return for repeat stress testing and pulmonary function testing 12 weeks after enrollment
* Ability to provide informed consent

Exclusion Criteria:

* Status post cardiac transplantation
* Current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential)
* Active respiratory infection
* Active cigarette smoker
* Baseline oxygen saturation \<90% at the previous clinic visit or exercise test
* Forced expired volume in 1 s and/or vital capacity \<60% of predicted at the previous exercise test
* Cardiac surgery or catheter-based procedure in the preceding 18 months or planned surgery or catheter-based procedure within the next 3 months
Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants of 25-32 weeks of gestation
* Birth in one of the two maternity hospitals of Amiens agglomeration (CGO or clinic of Europe )
* Arrived in the Neonatal Medicine unit \< 2 hours of life
* Necessitated a care in an incubator

Exclusion Criteria:

* Preterm infants \> 32 weeks of gestation
* Birth outside the Amiens metropolitan area
* Arrived in the Neonatal Medicine unit after 2 hours of life
* Present a malformation syndrome or severe heart disease
* Pathology requiring support within the first 7 days of life
* Apgar score \< 5 to 10 minutes of life
* Need for initial management in open incubator
* Unavailability of a type of incubator " Caleo® "
9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histopathological diagnosed of advanced gynecological tumors.
5. Subjects must submit tumor tissues for test.
6. Life expectancy of ≥ 12 weeks.
7. Subjects must have measurable disease according to RECIST (version 1.1).
8. Adequate organ functions.
9. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 180 days after termination of study therapy.
10. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. History of another malignancy within 3 years before the first dose of study drug.
2. Patients with ongoing clinically significant toxicities related to prior treatment.
3. Presence of Grade ≥ 2 peripheral neuropathy.
4. Exclusion of prior diseases and prior treatments as specified in the protocol.
5. Comorbidities: a. Hemoglobin A1C ≥ 8%; b. Ocular diseases or symptoms present prior to the first dose of study medication; c. Severe respiratory diseases; d. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study medication; e. Active autoimmune diseases within 2 years prior to the first dose of study medication, or a history of autoimmune diseases with potential for recurrence; f. Active infections; g. Severe arterial or venous thromboembolic events.
6. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.
7. Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis.
8. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.
9. Prior Treatments: a. Major surgical procedures within 28 days prior to the first dose of study medication; b. Administration of other investigational drugs or experimental medical devices within 28 days prior to the first dose of study medication; c. Use of P-glycoprotein inhibitors or inducers, or potent CYP3A4 inhibitors within 14 days prior to the first dose of study medication; d. Receipt of live vaccines within 28 days prior to the first dose of study medication or planned administration of any live vaccine during the study period; e. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;.
10. Subjects with a history of drug abuse or psychiatric disorders, or suspected allergy, intolerance, or severe infusion reactions to the investigational drug or any of its components.
11. Pregnant or lactating women.
12. Not suitable to receive study treatment for other conditions as per investigator.
Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging

With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.

Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.

Eligibility Criteria:
Inclusion Criteria:

* First stroke episode
* More than six months after stroke
* Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
* Capacity to understand and complete simple tasks
* Know how to read and write
* Motivation to participate

Exclusion Criteria:

* Hemi spatial neglect
* Depressive symptoms, moderate to severe
* Presence of other neurological or orthopaedic problems
* Severe eyesight problems
* Claustrophobia
* Presence of ferromagnetic materials
Ruxolitinib and Decitabine for High Risk Hematological Malignancies

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Allogeneic hematopoietic stem cell transplantation should be offered to eligible patients with high risk hematological malignancies whenever feasible. To further improve the outcome of transplantation patients with high risk hematological malignancies, the investigators developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine. In this study, the investigators tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine in Patients with high risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; High risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation;
2. Medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, Chronic myelomonocytic leukemia;
3. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors
4. All patients should aged 12 to 65 years;
5. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
6. Renal function: creatinine ≤the upper limit of normal;
7. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
9. Have signed informed consent.

Exclusion Criteria:

1. pregnant women;
2. Patients with mental illness or other states unable to comply with the protocol;
3. AML patients with t (15;17);
PlayFit Pilot: Encouraging Social Physical Play in the Community

The investigator is pilot testing the feasibility and impact of a low-cost intervention that uses existing gymnasiums, and therefore has the potential to be replicated across the United States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key components, intended to overcome the major barriers to physical activity. First, it will assist people in finding others to play with, using the Pick-Up model of designating times to play and making those times known in the community. Second, it will overcome a lack of confidence in physical activity by including games of lower intensity for relatively unfit adults, then building up to moderate and vigorous games. Third, it will require team members of varying ages and genders to encourage intergenerational play. Fourth, it will use modified equipment (e.g., softer, lighter balls) and smaller game space to require less running, so that even relatively unfit people can feel confident participating. Fifth, it will be designed to be led by community volunteers, which will increase its disseminability.

AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will come up with a list of games to play and pilot the games at a gymnasium. The investigators will observe the participants playing the games and have them complete a brief survey.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-50
* Fluently read and speak English
* Current member of Hershey Medical Center's University Fitness Center OR willing to become a member
* Currently exercises \< 150 minutes per week

Exclusion Criteria:

* Has been told by a doctor they a heart condition and should only do exercise recommended by a doctor
* Currently pregnant or planning to become pregnant in the next 6 months
* Planning to move out of the area in the next 6 months
* Has pain in chest, neck, jaw, or arms at rest, during daily activities of living
* Has experienced a forceful or rapid heart rate
* Has experience unreasonable breathlessness
* Has experienced dizziness fainting or blackouts
* Has experienced ankle swelling
* Has burning or cramping sensation in lower legs when walking short distances
* Has been told by a health professional not to exercise OR exercise only when supervised by a professional
* Has been diagnosed with diabetes
* Has been told by a doctor, nurse or health professional that they have (1) Weak or failing kidneys, (2) A heart attack/ myocardial infarction, (3) Angina or coronary heart disease, (4) A stroke, or (5) Any other kind of heart condition or heart disease - e.g. heart valve problem/aortic regurgitation (do not include heart murmur)
ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Pancreatic duct stones can cause obstruction of the main pancreatic duct leading to abdominal pain, exocrine pancreatic insufficiency, and recurrent acute pancreatitis. By removing pancreatic duct stones, the obstruction can be relieved, and this can improve symptoms. Small stones can be removed with standard endoscopic retrograde cholangiopancreatography (ERCP) and stone removal, but larger stones may require lithotripsy to break up the stone before removal. The two current methods of lithotripsy include extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL).

ESWL is based on concentrating shock wave energy to the stone through an external device. SOPIL is a newer technique based on direct visualization of the stone during ERCP and targeting the stone with a shock wave catheter. There are currently no studies directly comparing ESWL to SOPIL for breaking apart stones in the pancreatic duct, so this study is designed to compare the two techniques.

Objective #1: Obtain pilot data to determine the optimal method of clearing large MPDS Objective #2: Obtain pilot data to assess how effective large MPDS clearance is in improving long term patient centered outcomes Objective #3: Obtain pilot data to measure the cost effectiveness of large MPDS clearance


Eligibility Criteria:
Inclusion Criteria:

* MPDS located in the head, neck, or neck/body junction of the pancreas
* MPDS \> 5 mm in size
* Abdominal CT scan, Endoscopic ultrasound, or prior ERCP demonstrating MPDS
* Abdominal pain related to MPDS
* Previously failed ERCP performed with intent to clear MPDS, OR MPDS determined by treating physicians to not be amenable to clearance by standard ERCP techniques

Exclusion Criteria:

* MPDS predominantly located in the body and tail of pancreas
* Any obstructing MPDS \> 5 mm located in the body and tail of pancreas
* Known pancreatic head stricture precluding passage of the pancreatoscope with endoscopic stone extraction based on prior imaging or prior ERCP
* Pancreatic head mass
* Impacted MPDS located at the pancreatic duct orifice
* Prior attempts at ESWL or SOPIL for MPDS
* Walled off pancreatic necrosis
* Active alcohol use, defined as any alcohol use within 2 months
* Surgically altered anatomy (see text)
* Gastric outlet obstruction or obstruction precluding passage of the endoscope
* Standard contraindications to ERCP
* Implanted cardiac pacemakers or defibrillators
* Known calcified aneurysms in the path of the shockwave
* Age \< 18 years, pregnancy, incarceration, unwillingness/inability to provide informed consent, or anticipated inability to follow protocol
Management of Sub-Clinical Bacteriuria in Pregnancy

The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.
* Urine culture of less than 100,000 CFU

Exclusion Criteria:

* Less than 18 years of age
* Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit)
* Use of immunosuppressant drugs
* Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures)
* History of renal disease including renal failure and transplants
* Urine culture \> 100,000 CFU of any organism
DHA Supplementation in Patients With STGD3

We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.


Eligibility Criteria:
Inclusion Criteria:

* All Moran Eye Center patients with STGD3

Exclusion Criteria:

* All others
Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-PSMA-1007.

\[18F\]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-PSMA-1007 PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.
Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma

To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.

This is a phase II multicenter study designed in two phases. A total of 32 patients will be included in 10 hospitals belonging to the Spanish Group for Research in Sarcomas (GEIS). Selection criteria are: patients with localized soft tissue sarcoma from the extremities or trunk with high-risk features (\>5 cm and grade 2-3), or recurrences after prior inadequate surgery. The treatment schedule will be: initial biopsy, 3 cycles of high-dose Ifosfamide, 12 gr/m2 in 5 days, concurrent with Radiotherapy 50 Gy, and subsequent wide surgery. To assess the predictive factors of response to the combination therapy, DNA and RNA extraction will be performed on the pretreatment biopsies. DNA will be used to hybridize Affymetrix GeneChip® Human Mapping 500K Array, which allows for the study of 500000 SNPs throughout the genome. The expression of 39000 RNA transcripts will be evaluated employing the Affymetrix Genechip Human Genome HG-U133 Plus 2.0, and validated by real-time RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Advanced Soft Tissue Sarcoma histological proven, potentially resected, located in extremities and trunk for one of the following histological subtypes: leiomyosarcoma, undifferentiated pleomorphic sarcoma, Synovial Sarcoma, Liposarcoma and malignant tumour of peripheral nerve sheath.
2. Primary tumour:

   1. Size ³ 5 cm of diameter
   2. Histological grade 2-3
   3. Deep location
3. No distant metastases
4. Patients must have not been previously treated with Chemotherapy or Radiotherapy on the tumour area.
5. However patients are eligible with local relapse after previous surgery.
6. Patients must be £18 and ³ 65 years old.
7. Patients must have ECOG performance status 0 to 1
8. Patients must have measurable disease by Recist Criteria.
9. Absolute neutrophil count ³1,500/mm3, platelet count ³ 100,060 ml/min, creatinine, total bilirubin, ALT and AST £ 1.5 times the upper limit of normal
10. Signed informed consent prior to any study specific procedures

Exclusion Criteria:

1. Patients with cerebral metastasis
2. Pregnant or breast feeding patients.
3. Active infection or other concomitant severe illness.
4. Severe psychiatric illness which would not make possible the obtention of the informed consent
5. Concurrent treatment with other experimental drugs within 30 days prior to study entry.
6. History of previous treated or diagnosed cancer in the past 5 years, excepting basocellular cell skin cancer, cervix cancer in situ or superficial bladder carcinoma.