cyrilzakka/clinical-trials huggingface dataset:
Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas

The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.

Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.

The purpose of the phase I portion of the study is to determine the maximum tolerated dose (MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.

The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.

Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
* Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
* All ages are eligible. Pediatric patients (\<15 years of age) are eligible to be treated at a dose level previously tested in adults.
* Adequate liver and renal function.
* Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
* Negative pregnancy test within 72 hours of study treatment in females of childbearing potential.
* Life expectancy of at least 2 months.

Exclusion:

* Active serious infection not controlled by oral or intravenous antibiotics.
* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
* Concurrent treatment with other anti-cancer agents.
* Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
* Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

The goal of this observational substudy is to evaluate the feasibility, performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue perfusion device using urethral photoplethysmography in patients undergoing major abdominal surgery and in whom an advanced hemodynamic monitoring is placed.

Continuous monitoring of tissue perfusion in patients undergoing major surgery remains challenging because of the lack of tools available. Through using urethral photoplethysmography, the urethral perfusion index (uPI) could allow tissue perfusion monitoring through a modified urinary catheter. The goal of this observational study is to evaluate the feasibility , performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new device in the field. We aimed to assess its performance (duration and signal quality), the uPI variations during hemodynamic events (fluid challenge) in patients undergoing major abdominal surgery and equipped with an advanced hemodynamic monitoring.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing major abdominal surgeries and equipped with an advanced hemodynamic monitoring for goal directed therapy

Exclusion Criteria:

* Atrial fibrillation
* Ejection fraction \< 30%
Gene - Exercise Research Study

The investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* free from CV disease
* ability to undergo exercise training

Exclusion Criteria:

* previous history of CV disease
Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA)

Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* less than 55 years old
* occlusion of FOP after cryptogenic CVA

Exclusion Criteria:

* characterized thromboembolic event
* patients who have a surgery after transitory ischemic accident
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
* Has a Mini-Mental State Examination total score of 16 to 26;
* Has a Modified Hachinski Ischemia Scale score of ≤ 4;
* Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
* Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
* With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.

Exclusion Criteria:

* Positive screen for drugs of abuse, alcohol or cotinine;
* Females must not have positive results for pregnancy;
* Focal neurological signs on examination;
* Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
* History of any significant neurologic disease other than AD;
* History of head trauma, motor vehicle accident, concussion.
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients

This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.

This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.

Eligibility Criteria:
Inclusion Criteria:

- The trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (AIS) chest score ≥3) admitted to the ICU

Exclusion Criteria:

1. had intubation and used the mechanical ventilation within 2 hours
2. had the emergency surgerys within 2 hours
3. patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax
4. the Glasgow Coma Scale \<8
MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

This study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).

Caregivers of infants with CHD are at high-risk of anxiety and distress due to the complex daily caregiving demands. Previous research has demonstrated decreased parental stress and more optimal infant developmental outcomes with a psychosocial intervention delivered to caregivers of infants with CHD prior to hospital discharge as well as reduced healthcare use in caregivers who received medical video-consultations during the interstage surgical palliation period. This study will implement a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs. The program is delivered via video chat over the Internet and caregivers will complete questionnaires about general family information, stress, and feeding their infant.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver's infant is less than 45 days of age at time of study enrollment.
* Caregiver of infant with high-risk, shunt dependent physiology (one or two-ventricle circulation) having just received neonatal surgery for CHD.
* English is a primary language for caregiver of infant.

Exclusion Criteria:

* Caregiver's infant is greater than 45 days of age at time of study enrollment.
* Not a caregiver of infant with high-risk, shunt dependent physiology having just received neonatal surgery for CHD.
* English is not a primary language for caregiver of infant.
A Follow-up Study in Patients With Inherited Metabolic Disorders (IMD) Who Underwent Hematopoietic Stem Cell Transplantation (HSCT) With MGTA-456

A follow-up study to evaluate the safety and clinical outcomes of patients with inherited metabolic disorders (IMD) who have undergone hematopoietic stem cell transplantation (HSCT) with MGTA-456

This is a follow-up study to evaluate the long-term safety and efficacy outcomes of patients with inherited metabolic disorders (IMDs) who received MGTA-456 for HSCT in the core study. MGTA-456 is an expanded CD34+ cell therapy product candidate given after myeloablative conditioning to induce rapid and sustained hematopoietic engraftment. In patients with selected IMDs, transplant is expected to replace defective or missing protein, and preserve neurodevelopment. Patients with Hurler syndrome (also referred to as mucopolysaccharidosis-1H (MPS-1H)), cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) enrolled in the core study will be eligible to participate in this follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board (IRB)/Independent Ethics Committee-approved written informed consent form must be signed and dated by the patient or legal guardian. Study assents will also be prepared for children and adolescents to review when applicable.
* Patient completed an IMD study in the MGTA-456 program and was administered MGTA-456 for HSCT.

Exclusion Criteria:

•Patients enrolled in an IMD study in the MGTA-456 program who did not receive MGTA-456 or were withdrawn from the core study.
Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy

Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO expression in the skin correlates with cell proliferation and differentiation. Many studies have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon cancer, and others, was also found to correlate with more aggressive cancer behavior. Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in solid malignancies as compared to normal tissues. It is assumed that this aberration can be found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in malignancies in general. Methods: The study will be carried out on surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of the surgical routine treatment. The excision will be made in elliptic shape including the lesion and a part of normal skin surrounding it. A sample will be taken from the central part of the lesion and from the external extremity of the normal tissue. Western Blot will be conducted to detect the expression of TSPO. Binding activity with the TSPO specific ligandwill also be determined. Expected Results: We expect to observe either (a) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue. Importance: Until today, only a very small number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO expression. Our study will also measure the binding activity of TSPO in cutaneous malignant tissues compared to normal tissues


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Exclusion Criteria:

* Non-compliance with inclusion criteria
Comparation of Different Devices to Measure Corneal Thickness

Comparison of different methods for measuring peoples corneal thickness

Volunteers with healthy corneas will be measured by different instruments to detect their corneal thickness. First interindividual difference between the instruments will be reviewed. People will be measured again two times on two different days to examine an interindividual difference in all instruments.

Eligibility Criteria:
Inclusion Criteria:

* healthy cornea

Exclusion Criteria:

* myopia or astigmatism over 1,5 dpt
* corneal surgery
* acute ocular inflammation
* lost of vision
Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients

The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that occurs at a time when the patient's white blood cell count is low. White blood cells aid the body's normal defenses against infection, so a fever during this period might make it difficult for the patient to fight infections.

This study is a multi-center, open-label, prospective and observational study enrolling approximately 440 patients. The primary objective of this study is to examine the fever response rate after itraconazole IV (directly into the vein) is administered for more than 3 days to patients with neutropenic fever based on investigator's discretion. Follow-up will be performed before and after administration and for 7 days after administration. Study population consists of the patients who visit a study center during the study period and are judged to have neutropenic fever associated with hematologic malignancy such as acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma. The decision to treat patients with itraconazole is as per physician discretion and doses are determined based upon approved labeling recommendations and physician discretion. The safety and efficacy of itraconazole administered beyond 29 days is not yet been established in the treatment of fever in neutropenic patients suspected of systemic fungal infection. Itraconazole 200 mg IV twice daily for 2 days, for a total of 4 doses, then 200 mg IV once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (20 ml) twice daily should be continued for a total of 14 days

Eligibility Criteria:
Inclusion Criteria:

* Patients with neutropenic fever who receive antineoplastic therapy or stem cell transplantation for acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma
* Patients who are recommended to receive itraconazole injection for treatment of acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma

Exclusion Criteria:

* Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
* Fever due to documented deep-seated fungal infection at the entry into the study (documented candidemia will be included)
* Significant hepatic and renal dysfunction
* Patients who, at the discretion of the investigator, are not eligible for the study participation based on warnings, precautions and contraindicated medications as listed in the package insert of the drug
Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction

The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase III)


Eligibility Criteria:
Main Inclusion Criteria:

* History of Erectile Dysfunction (ED) of at least 1 month duration.
* Anticipate having the same adult female sexual partner during the study.
* Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.
* Sign the informed consent form

Main Exclusion Criteria:

* ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity
* ED caused by untreated or inadequately treated endocrine disease
* Current treatment with doxazocin, nitrates, cancer chemotherapy, or anti-androgens
* Severe renal or hepatic impairment, history of malignant hypertension
* Presence or history of specific heart conditions
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-60 years old
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Pathologically confirmed invasive breast cancer
* A pathological T1-2N0M0 tumor
* Tumor bed is labeled with Titanium clips
* Negative surgical margins
* Written informed consent.

Exclusion Criteria:

* KPS\<70
* Treated with neoadjuvant chemotherapy
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing
Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing.

Children with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents.

The mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate.

Using Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following:

1. The airway microbiome composition in children with cleft palates.
2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.


Eligibility Criteria:
Inclusion Criteria:

* cleft palate \& lip (uni/bilateral) or cleft palate
* No syndromal disorders

Exclusion Criteria:

* syndromal disorder
* history of ventilation tube placement
Primary Palliative Care for Emergency Medicine (PRIM-ER)

This proposal builds upon the evaluation of Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine (PRIM-ER) implemented in 33 Emergency Departments (EDs). This is a retrospective cohort study that seeks to measure the effect of PRIM-ER on older adults with serious illness on aspects of: 1) ED disposition to an acute setting; 2) healthcare utilization in the 6 months following the index ED visit; 3) survival following the index ED visit; and 4) determine site, provider, and patient-level characteristics that are associated with variation in impact of PRIM-ER across sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients must demonstrate one-year mortality of at least 30 percent (score \> 6) according to the Gagne Index, a validated instrument used to measure all cause one-year mortality in community-dwelling older adults, calculated based on their prior 12 months before the index ED visit of Medicare claims.

Exclusion Criteria:

* ED patients transferred from a nursing home on the index ED visit will be excluded since prediction of mortality and disposition of such patients differs from community-dwelling adults.
* Patients currently receiving hospice at the time of the index ED visit will also be excluded since they have already received services.