cyrilzakka/clinical-trials huggingface dataset:
Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury.

1. Since most of these infants require ventilators (respirators) to survive, we will investigate how 2 different methods of ventilation affect brain injury. We believe that a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain blood flow and lead to less bleeding in the brain.
2. We will also examine how treatment for low blood pressure in these infants may be associated with brain injury. We believe that most very premature infants with low blood pressure actually do worse if they are treated. We think that by allowing the infants to normalize blood pressure on their own will allow them to stabilize blood flow to the brain leading to less intraventricular hemorrhage.
3. In 10 premature infants with severe brain bleeding, we have developed a simple technique to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infants are at highest risk of developing intraventricular hemorrhage and who could most benefit from interventions that would reduce disturbances of brain blood flow.


Eligibility Criteria:
Inclusion Criteria:

* ventilated ELBW (401-1000 grams) infants
* 23 to 30 weeks' gestation
* umbilical arterial catheter placed during newborn resuscitation

Exclusion Criteria:

* presence of complex congenital anomalies or chromosomal abnormality
* presence of central nervous system malformation
* infants with hydrops fetalis
* infants in extremis
* infants with early (\<3 hour of age) intraventricular hemorrhage
Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
* The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
AIT-082 Phase 1B Study

AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.

This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.


Eligibility Criteria:
Continous Positive Airway Pressure (CPAP) Compliance Study

Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.

Exclusion Criteria:

* Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder
Radial Artery Versus Saphenous Vein Patency (RSVP) Study

The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.

Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term.

The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.

Eligibility Criteria:
Inclusion Criteria:

* on waiting list for clinically-indicated myocardial revascularization surgery
* aged 40-70 years
* significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms
* negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression)
* willing to give written informed consent

Exclusion Criteria:

* poor left ventricular (LV) function (LV ejection fraction \<25%)
* severe diffuse peripheral vascular disease or bilateral varicose venous disease
* inability to comply with the angiographic follow-up at 3 months or/and 5 years
Citizen Science to Promote Sustained Physical Activity in Low-Income Communities

While low-income midlife and older adults are disproportionately affected by chronic diseases that can be alleviated by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. Those programs that are available typically do not address the recognized local environmental factors that can impact physical activity. This research aims to evaluate the added effects on two-year physical activity levels of a novel citizen science neighborhood engagement program (called Our Voice) when combined with an evidence-based, individually-focused physical activity program (Active Living Every Day), relative to the individually-focused program alone. The programs will be delivered in affordable housing settings, and represent a potentially scalable means for promoting physical activity across broader income groups in the US.

The major objective of this project is to enhance the potential scalability and sustainability of person-level physical activity (PA) interventions by leveraging the capacity of residents themselves as local data gatherers and solution generators for neighborhood environmental change. The primary aim of the group-randomized trial is to systematically compare the sustained (two-year) multi-level impacts of a lay advisor-delivered, person-level PA intervention that has demonstrated efficacy and translatability (Active Living Every Day) \[ALED Alone arm\], versus the ALED program in combination with a novel neighborhood-level intervention, called Our Voice \[ALED+Our Voice arm\]. The Our Voice program teaches residents to use a simple mobile application to individually and collectively identify neighborhood barriers to daily PA. They then convey this information to local stakeholders and decision-makers in ways that can facilitate potentially sustainable neighborhood-level improvements in support of regular PA. Up to sixteen affordable housing sites serving low-income, ethnically diverse midlife and older adults will be randomized to one of the two interventions.

Eligibility Criteria:
Inclusion Criteria:

* Lives in or around a designated housing site;
* Is insufficiently physically active based on National guidelines;
* Can engage in moderate forms of PA such as walking;
* No plans to move from the area over the 2-year period;
* Willing to engage in study assessments.

Exclusion Criteria:

* Only one eligible member of a household will be enrolled;
* Medical conditions which contraindicate participation in regular, unsupervised moderate-intensity physical activity.
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.
* Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of \<94% by pulse oximetry on room air or requiring supplemental oxygen.
* Not anticipated to require mechanical ventilation within 48 hours.

Exclusion Criteria:

* Is taking high-dose hydroxychloroquine or chloroquine.
* Is taking pimozide or strong or moderate CYP3A4 inhibitors.
* Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis.
* Has known hypersensitivity to any components of aprepitant injectable emulsion.
* Has evidence of ARDS.
* Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO.
* Has multiple organ failure.
* Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.
Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis

When there is infection in the intra-abdominal area, bacteria secrete toxins that are absorbed by the peritoneum. These toxins then bind to lipoproteins (which carry cholesterol in the blood) and are eliminated by the liver. Phospholipid transfer protein (PLTP) is a protein that facilitates the binding of bacterial toxins to lipoproteins and thus their elimination.

The objective of this study is to study the relationship between PLTP and the elimination of bacterial toxins in humans. A better understanding of the elimination of these toxins will lead to a better understanding of the disease. The ultimate objective is to improve the management of intra-abdominal infections.


Eligibility Criteria:
Inclusion Criteria:

* person who has given oral consent (patient or family member)
* pre-operative SEPSIS criteria (qSOFA \>=2) or vasopressor or mechanical ventilation treatment
* admitted to the operating room for suspected generalized secondary peritonitis

Exclusion Criteria:

* person not affiliated to national health insurance
* person under legal protection (curatorship, guardianship)
* person under court order
* pregnant, parturient or breastfeeding woman
* minor
* immunosuppression (HIV infection, corticosteroid treatment \> 0.15 mg/kg/day prednisolone equivalent \> 2 weeks, immunosuppressive treatment, primary cellular immune deficiency)
* decision to limit or stop therapy
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
* Prescribed Renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the Renvela SmPC.
* Provide signed informed consent (patient or their legally authorised representative)

Exclusion Criteria:

* N/A
A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.

On initial consultation, each study subject will be randomized by a table in the possession of investigators to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery approximately 2 weeks later and will be treated with the other treatment group:

Dexycu Group: A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.

Control Group: A total of 30 study subjects will receive topical moxifloxacin 0.5% four times per day 1 day prior to surgery and for ten days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.

Eligibility Criteria:
Inclusion Criteria:

* A male or female in good general health, greater than 18 years of age at time of screening.
* Must be able to comprehend and willing to give informed consent.
* Woman of child-bearing potential must not be pregnant or lactating.
* Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits.
* Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned.
* Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.

Exclusion Criteria:

* Subject with any signs of intraocular inflammation in either eye at screening.
* Subject with a known sensitivity to any of the study medications.
* Subject with only one eye with potentially good vision.
* Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening.
* Subject with pupil abnormalities.
* Subject with corneal abnormalities.
* Subject with a history of chronic/recurrent inflammatory eye disease in either eye.
* Subject with uncontrolled glaucoma.
* Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period.
* Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain.
* Subject with an acute or chronic disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc.
* Subject with an uncontrolled systemic disease.
* Subject with poorly-controlled diabetes.
* Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402

Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402


Eligibility Criteria:
Inclusion Criteria include:

* Males 18 to 45 years of age
* Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

* Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
* History of important bleeding episodes
* Previous allergic reaction to immunoglobulin
* Present or previous history of severe allergy, for example asthma or anaphylactic reactions
* FVIII:C \<50% or \>150% at screening
* Clinically significant out of range values for any coagulation test during screening
* Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402
Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure

Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question


Eligibility Criteria:
Inclusion Criteria:

* All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
* Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.

Exclusion Criteria:

* Missing of preoperative serum creatinine during 30 days prior surgery
* Preoperative dialysis
* Chronic kidney disease (eGFR \< 60ml/min Cockcroft-Gault equation)
* Surgical procedure lasting less than 60 min
* Planned use of permissive hypotension
* Urological procedures (including nephrectomy and renal transplantation)
* Refusal to give informed consent
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
* Aged 18\~75 years
* Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
* With at least one measurable lesion
* White blood cell count≥4×10\^9/L,platelet count≥100×10\^9/L and hemoglobin≥11g/L
* Life expectancy \>3 months
* Eastern Cooperative Oncology Group performance status of ≤1 at study entry
* Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
* Have signed informed consent

Exclusion Criteria:

* Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
* The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
* Organ transplant patients
* Patients with active bleeding or new thrombotic diseases
* Patients with body temperature \>38.5℃ for more than 3 days
* Total bilirubin \>1.5 fold of upper limit of normal (ULN), ALT/AST\>1.5 fold of ULN or serum creatine \>1.5 fold of ULN
* Patients with symptomatic brain-metastasis
* Pregnant or lactating women
* Patients with mental disorder
Cold Stored Whole Blood in Cardiothoracic Surgery

In vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days.

A challenge for implementation of Whole Blood programs in civilian health services has been an uncertainty regarding the impact of storage on the clinical effect of the whole blood transfusion, especially when it comes to platelet function which is essential to hemostasis. In vitro platelet function and post-transfusion platelet recovery decline with increasing storage time of the whole blood.

In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days. A control group receiving standard care (blood component-based transfusion) may be included.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing cardiothoracic, cardiac, or aortic surgery
2. Patients with complex surgical procedures and expected cardiopulmonary bypass (CPB) time over 120 minutes
3. Patients capable of providing informed consent to participate in the study

Exclusion Criteria:

1. Patients not capable of providing informed consent to participate or who will not provide informed consent
2. Patients with known congenital coagulopathies or hemostatic disorders (von Willebrands Disease, hemophilia etc)
3. Patients with known erythrocyte- or platelet/HLA antibodies
4. Patients with a particular increased surgical risk with expected need of ECMO
5. Patients with preoperative EuroScore II ≥ 30

5. RhD negative patient