cyrilzakka/clinical-trials huggingface dataset:
Closed-Loop Fluid Administration System Using Hemodynamic Monitors

The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid administration system to deliver fluids using feedback from standard operating room hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the patient is determined by the anesthesiologist caring for the patient. In this study protocol, the rate of fluid administration will be determined instead by the closed-loop (automated) control system under the supervision of the anesthesiologist. The system will independently decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the system to ensure appropriate volumes are being delivered and to intervene if necessary.

In our protocol we will test the hypothesis that closed-loop fluid administration can maintain higher cardiac stroke volume (shown to improve patient outcomes after surgery) than anesthesiologist management. We have shown this to be the case in multiple simulation studies and in-vivo animal studies, but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require cardiac output monitoring undergoing surgery and require mechanical ventilation and consent to participate in the study will be included in the study. They will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of fluid administration. Fluids are usually given to a patient based on the physician's discretion. As part of the study patients will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors at UCI). Data from this study will be retrospectively compared to subjects case matched to evaluate differences in cardiac output, total fluid given, and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (over the age of 18)
* Subjects undergoing elective major, abdominal surgery
* Subjects requiring general anesthesia and mechanical ventilation
* Subjects requiring cardiac output monitoring and an arterial line

Exclusion Criteria:

* Subjects under 18 years of age
* Subjects not undergoing surgery
* Subjects not requiring general anesthesia or mechanical ventilation
* Subjects not requiring cardiac output monitoring or an arterial line
* Subjects who are pregnant
* Subjects without the capacity to give informed consent
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity

The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.

This post-market registry is intended to assess the clinical use and safety of the Lutonix® Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (AEs) as well as outcomes in subpopulations defined by subject and lesion characteristics. All subjects will be followed for 1 year.

This registry is performed with marketed devices within the indications for use. There are no additional treatments or exams that will take place within this registry.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age;
2. Rutherford Clinical Category ≤ 5;
3. Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow up;
4. Stenotic or obstructive vascular lesions in artery(s) of the lower extremity;
5. Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current country-specific IFU.

Exclusion Criteria:

1. Patient is currently participating in an active phase of another investigational drug or device study;
2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast.
The Natural History of Recovery After Stroke

The goal of this longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.

This study constitutes the first step in the RESTRO project: Evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. In this study, we will monitor sensorimotor and cognitive functions of Stroke patients along the first 6 to 12 month following their stroke. Data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Independent in all activities of daily living before the stroke.
* In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in ADL before the second stroke).
* Medically stable
* Able to provide informed consent.

Exclusion Criteria:

* The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
* Traumatic brain injury and/or extra-cerebral hemorrhage.
* Significant psychiatric condition, including alcoholism and drug abuse.
* Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
* Participation in another interventional study.
R115777 in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors.
* Assess the toxicity of this drug in these patients.
* Determine, preliminarily, the efficacy of this drug in these patients.
* Determine the potential predictors of response in patients treated with drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy

  * Advanced, recurrent, or metastatic disease
* Previously treated with at least 1 chemotherapy regimen
* Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm3
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 75,000/mm3

Hepatic:

* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN

Renal:

* Creatinine clearance at least 60 mL/min OR
* Creatinine no greater than 1.6 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

* See Disease Characteristics
* No concurrent hormonal therapy

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present
* No concurrent radiotherapy to measurable lesions

Surgery:

* See Disease Characteristics
* At least 3 weeks since prior major surgery and recovered

Other:

* At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)
* Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors

For prepubertal patients, cryopreservation of testicular tissue is the only option available to preserve their fertility before cancer treatment. But testicular autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the testicular tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of testicular tissue cryopreservation.

Some solid tumors have high risk of metastatic localization including in testis. There is concern over the possible presence of malignant cells in testicular tissue that could cause a recurrence of the primary disease after reimplantation. Thus, the possibility of testicular tissue involvement needs to be evaluated with sensitive molecular methods.

Based on our experience in detection by RT-PCR of minimal residual disease (MRD) in neuroblastoma since 1994 \[Tchirkov et al. 2003\] and in testicular tissue cryopreservation since 2012, we want to develop a specific and sensitive method for residual disease detection by RT-PCR in order to evaluate the tumor contamination of testicular harvested tissue.

Study population: We chose 3 models of pediatric solid tumors with high risk of metastases and which often require sterilizing treatments (chemo and/or radiotherapy): neuroblastoma, Ewing tumor and alveolar rhabdosarcoma. We will use four tumor cells lines: IMR32 and SK-NSH for neuroblastoma; RD-ES for Ewing tumor; RH-30 for rhabdosarcoma. We plan to use 20 fragments per line.

Study duration: 12 months Study design: Testicular tissue without known malignancy but with a condition warranting a biopsy (fertility assessment) will be harvested.

The harvested testicular cortex will be treated to recover all viable sperm and then, we use remaining tissue to be contaminated with tumor cells lines. Then, detection of the specific transcript will be done by RT-PCR in fresh tissue and after freeze/thaw. Total RNA will be extracted with the TRI-reagent and qRT-PCR will be performed using the "TaqMan" technology.

Primary endpoint: to reach a sensitivity about 1/106 cells.

Eligibility Criteria:
Inclusion Criteria:

* Men in childbearing age whose fertility assessment require a testicular biopsy may be included

Exclusion Criteria:

-
Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.

OCD is an anxiety disorder characterized by intrusive thoughts or images (obsessions), which increase anxiety, commonly accompanied by repetitive or ritualistic actions (compulsions), which decrease anxiety. The most frequent symptoms are contamination concerns with consequent washing or concerns about harm to self or others with consequent checking.

Although many OCD patients benefit from pharmacotherapy or CBT, between 7% and 10% of OCD patients fail to benefit from these standard treatments and may be considered treatment-resistant with a chronic deteriorating course. The most severely afflicted and disabled of these patients may be indicated for neurosurgical treatments, often considered as a therapy of last resort.

Neurosurgical procedures currently used in the treatment of severe, treatment-resistant OCD include anterior cingulotomy, subcaudate tractotomy, limbic leucotomy (which is a combination of the first two procedures) and anterior capsulotomy. The commonality between the different neurosurgical procedures is the irreversible lesioning of bilateral neuroanatomical structures and/or interconnecting pathways that are believed to be involved in the control of affect and limbic function.

An alternative neurosurgical treatment option to the standard lesioning procedures is Reclaim® Deep Brain Stimulation (DBS) Therapy for OCD, which received CE mark in July 2009.

Eligibility Criteria:
Inclusion Criteria:

* signing and dating of Informed Consent
* male and female patients at least 18 years of age
* diagnosis of Obsessive Compulsive Disorder
* meeting the definition of treatment resistance

Exclusion Criteria:

* Axis-I disorder primary to OCD
* contraindication to implantation
* suicide risk
* risk of non-compliance
Physiotherapist in the Emergency Department

This study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 75 and over
2. Patients admitted to emergency for falls.
3. Clinically stable patient who may benefit from a gait assessment or fall risk assessment
4. Patients able to understand the protocol and not verbally object to participation.

Exclusion Criteria:

1. Patients with limb fractures requiring surgical treatment
2. Patients under guardianship or curatorship.
3. Patients already included in an interventional research protocol.
The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases

The goal of this monocentric double blinded cross over trial is to evaluate safety and tolerability of inhaled furosemide in patients with pulmonary diseases and dyspnea.

The main question\[s\] it aims to answer are:

* is inhaled furosemide safe and well tolerated?
* is inhaled furosemide capable of dyspnea suppression and is there any additive effect of levodropropizine

Participants will be given:

* inhaled furosemide or placebo in double blinded cross over manner. Dyspnea severity and vital functions will be measured, adverse reactions monitored
* all participants will receive levodropropizine open label. Dyspnea severity and vital functions will be measured, adverse reactions monitored

102 subjects from the pool of patients hospitalized in our pulmonary clinics will be randomized in 1:1 ratio to 2 arms in double blinded manner. Subjects in both arms will inhale first vial of study medication - furosemide 40 mg or placebo (saline). Dyspnea severity and vital functions will be measured, adverse reactions will be monitored. After an hour the subjects will inhale the second vial of study medication followed by the same procedure as earlier. Neither subjects, nor investigators will know which vial contains furosemide and which contains placebo. At last all subjects will receive levodropropizine open label and the dyspnea severity, vital signs and adverse reaction will be monitored for another hour. The measured values will be statistically evaluated a results published.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand and sing written consent
* ability to use visual analogue (VAS) and Borg dyspnea scale
* presence of lung disease (asthma, chronic obstructive pulmonary disease, interstitial pulmonary disease, tumour affecting lungs, Coronavirus Disease 2019 (COVID19), drug induced dyspnea, lung infection)
* dyspnea at least 50 points in VAS and at least 5 point in Borg dyspnea scale
* women of childbearing age consent ot avoid sexual intercourse during the study participation

Exclusion Criteria:

* hypersensitivity to furosemide, levodropropizine or any additives in studied drugs
* mucociliary disorder (kartegener syndrome, ciliary dyskinesis)
* severe liver disease - cirrhosis Child Pugh B or C
* renal failure, creatinine clearance less than 35 ml/min
* unstable patient requiring frequent treatment changes
* patients with continual intravenous medication requiring modification of their therapy more often than ever 4 hours
* unability to participate in all study procedures
* pregnancy, breast feeding
* participation in other clinical trial with administration of study drug in last 28 days or 5 half times of studied drug (the longer period is taken into account) before screening
Linkage Study in Familial Pulmonary Fibrosis

To map the gene (or genes) for familial pulmonary fibrosis.

BACKGROUND:

Familial pulmonary fibrosis (FPF) is a rare, progressive, life-threatening disease. Although far from definitive, several lines of evidence suggest that it could involve genetic susceptibility and that its expression may be modified gene-environment interactions involving exposure to fibrogenic dusts. If the specific gene loci involved can be identified and their functions characterized, these studies could lead to a better understanding of the etiology of the disease and effective intervention strategies among families at increased risk. It is conceivable that the genetically influenced pathologic mechanisms involved may be shared with other, more common forms of pulmonary fibrosis such as idiopathic pulmonary fibrosis (IPF) or asbestosis. Thus, these studies could lead to the early identification of individuals susceptible to reversible interstitial lung disease and to the development of novel therapeutic approaches.

Familial pulmonary fibrosis is indistinguishable pathologically from idiopathic pulmonary fibrosis and appears to be inherited as an autosomal dominant trait with variable penetrance; pulmonary fibrosis is associated with pleiotropic genetic disorders, such as Hermansky-Pudlak syndrome, neurofibromatosis, tuberous sclerosis, Neimann-Pick disease, Gaucher's disease, and familial hypocalciuric hypercalcemia; pulmonary fibrosis is frequently observed in autoimmune disease, including rheumatoid arthritis and systemic sclerosis; variable susceptibility is evident among workers who are reported to be exposed occupationally to similar concentrations of fibrogenic dusts; and inbred strains of mice differ in their susceptibility to fibrogenic dust.

DESIGN NARRATIVE:

The study uses standard genetic methodology (linkage analysis) to investigate the distribution of polymorphisms for anonymous genetic markers in families with familial pulmonary fibrosis. The comprehensive genome-wide study, using standard genetic markers, will allow identification of loci which subsequently may prove to contain novel genes that play a role in the pathogenesis of pulmonary fibrosis. Once genetic loci are defined in familial pulmonary fibrosis, candidate genes can be identified on the basis of both positional and functional criteria. Moreover, this approach will provide basic information on high priority loci that will be applicable to the rapidly evolving dense human transcript map for pulmonary fibrosis in families with two or more cases of pulmonary fibrosis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Induction Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy

The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing tumor metabolic heterogeneity and predicting prognosis for patients with locally advanced, unresectable non-small cell lung cancer (stage III) treated by neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures;
* Patients aged 18\~75 years old;
* had histologically or cytologically confirmed non-small cell lung cancer;
* Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
* Life expectancy ≥12 weeks;
* World Health Organization (WHO) Performance Status of 0 or 1;
* had unresectable stage III disease according to the 8th edition of the American Joint Committee on Cancer staging system;
* Women should be non-breast feeding during the study period;
* Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study treatment and for a period of 5 months following the last administration of the study treatment;
* Men who have sex with WOCBP must agree to comply with the contraceptive method during the study treatment and for 7 months after the last administration of the study treatment;
* Absolute neutrophil count ≥1500/uL, hemoglobin ≥9.0mg/dL, platelet ≥100000/uL;
* Serum creatinine clearance \>50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976);
* Serum bilirubin ≤1.5 x upper limit of normal (ULN), Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN;
* Forced expiratory volume in 1 second (FEV1) ≥800ml;

Exclusion Criteria:

* Concurrent enrollment in another clinical study, unless it is an observational(non-interventional) clinical study;
* Mixed small cell and non-small cell lung cancer histology;
* Prior exposure to any anti-programmed cell death protein(PD)-1 or anti- PD-L1 antibody;
* Active or prior documented autoimmune disease within the past 2 years;
* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
* History of primary immunodeficiency;
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses;
* History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
* Any situation not suitable for this study judged by researchers;