cyrilzakka/clinical-trials huggingface dataset:
Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes

To investigate how platelets recover to normal function in subjects who have symptoms of a heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for planned coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 to \<80 years of age who present with any one of the following:
* symptoms of Acute Coronary Syndromes (ACS)
* clinical symptoms of angina, or a positive stress test or who return for routine follow up angiography post stent placement in whom co-administration of aspirin and a thienopyridine (that is, clopidogrel, ticlopidine, or prasugrel) is not contraindicated

Exclusion Criteria:

* Those presenting with ST-elevation MI (STEMI)
* histories of refractory ventricular arrhythmias
* an implanted defibrillator device
* congestive heart failure (NYHA Class III or above) within 6 months prior to screening
* significant hypertension
* subjects with a history or clinical suspicion of cerebral vascular malformations, transient ischaemic attack, or stroke
* bleeding disorders
* women known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding
Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects

This study will compare the effect of guided tissue regeneration using a mixture of autograft and PRF covered with a collagen membrane as compared to the membrane alone in the healing of apicomarginal defects. Healing of the lesions will be compared 2 dimensionaly and 3 dimensionaly using CBCT.

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups -in test group 1 -the defects will be filled with a mixture of autograft(which will be obtained from the surrounding buccal cortical plate by using a trephine bur) and prf(will be prepared by Choukron's method) and the defects and denuded root surface will be covered with a collagen membrane and in test group 2 -the defects will be filled with a blood clot and over that the collagen membrane will be placed. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) and will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.. The criteria for a successful outcome included the absence of clinical signs and/or symptoms and radiographic evidence of complete or incomplete healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age 16 years to 55 years
* Periapical defects with periodontal communication.
* Apicomarginal defects with probing depth \> 6mm on mid-buccal and interproximal surfaces

Exclusion criteria

* Presence of buccal bone on flap elevation.
* Fractured /perforated roots.
* smokers.
* pregnant females and lactating mothers
Time Efficiency Comparison of Two IntraVitreal Injection Techniques

Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.

Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.

The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral thinning, history of previous glaucoma surgery, history of pars plana vitrectomy, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.

The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.

Eligibility Criteria:
Inclusion Criteria:

\* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications

Exclusion Criteria:

* History of extraocular or intraocular infection within 3 months of the scheduled IVI date
* Scleral thinning
* History of previous glaucoma surgery
* History of pars plana vitrectomy
* Hypersensitivity to the IVI drug, proparacaine or povidone iodine
* Inability to understand the informed consent form
Physical Exercise for Treatment of Depression and Anxiety - RCT

In a 12 week randomly controlled open trial 102 participants with symptoms of depression and/or anxiety will be exposed to either aerobic high intensity training (HIT) or relaxation therapy. Cognitive functions, biomarkers, psychiatric symptom scales and physical status will be collected at baseline, after 12 weeks and after a year. Depression and anxiety will be measured twice during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Score ≥12 on MADRS or score ≥16 on BAI
* Inhabitant i Örebro County, Sweden
* BMI ≥18 kg/m\^2

Exclusion Criteria:

* Diagnosis of chronic psychotic disease or ongoing psychotic episode.
* Ongoing manic state of bipolar disorder
* Severe somatic disease or condition where high intensity exercise is contraindicated
* Difficulty with reading, hearing or understanding the Swedish language
Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma Gait Parameters Study

This purpose of this study it to characterize the walking patterns of children diagnosed with Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the treatment protocol and after completion of treatment. Their walking patterns will be compared to children without ALL or LL to see if their walking patterns are different at specific times in their treatment program or up to 10 years after completion of their treatment. The investigators will gather data by observing how the child walks, runs, hops on one foot and climbs stairs and by recording walking patterns on a pressure sensitive mat. The investigators will compare this data to children without ALL and LL.

Cases will be identified and referred by the primary oncologist or by the Childhood Cancer Survivorship team. When a possible subject has been identified they will be contacted via telephone or during a routine clinic visit to determine their interest in the study. Two hundred subjects will be recruited for participation with the goal of 5-10 subjects at each of the 14 times points across the treatment protocol and survivorship. These time points to include: at diagnosis, the start of consolidation therapy, the start of interim maintenance therapy, the start of delayed intensification therapy, Day 29 of delayed intensification therapy, the start of interim maintenance II therapy (if applicable), Day 1 of cycle 1,3,5 of maintenance therapy, end of therapy, and 1, 3, 5, and 10 years off therapy ( +/-1 year).

Clinical data will be collected from the medical record, roadmaps documenting cancer-directed therapy, direct patient interview and examination by the physical therapist during the study evaluation. Clinical data will include: Date of birth (to calculate age at diagnosis and current age); Gender; Race and Ethnicity; Primary cancer diagnosis; Date of Primary Cancer Diagnosis; Chemotherapeutic agents received (agent name, cumulative dose and date received); Radiation therapy (date received, site radiated, and dose delivered); Any other clinical conditions affecting musculoskeletal performance; Dates of previous PT; Pain score at the time of study participation. Height, weight, shoe size and leg length will be collected at time of study participation.

Subjects will complete a self report of the PedsQL™ Generic Core Scale and the parents will complete the parental report.

Observation gait assessment will include hopping on one foot, running and walking 30' and ascending/descending stairs.

Temporal spatial gait parameters will be recorded on the GaitRite mat

Eligibility Criteria:
Inclusion Criteria:

1. Age 2-27 years of age
2. Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
3. Currently undergoing treatment for ALL or LL or completed treatment for ALL or LL in the last 10 years.

Exclusion Criteria

1. Relapsed ALL or LL
2. Received a stem cell transplant, either autologous or allogeneic
3. Non ambulatory status prior to diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities

This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.

Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been signed prior to or at Screening Visit
* Caucasian male and female patients
* Age ≥ 18 years
* Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on the upper extremities
* Selected AK study lesions have clearly defined margins and are mild to severe (grades I to III):
* Mild grade (I): Slight palpability, better felt than seen
* Moderate grade (II): Moderately thick AK, easily felt
* Severe grade (III): Very thick and/or obvious AK
* Skin sun sensitivity type I to IV according to Fitzpatrick

Exclusion Criteria:

* PDT Non-responder
* Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT (e.g. antineoplastic topical formulations as e.g. Metvix®, Ameluz®, Luxerm®, Solaraze®, Aldara®, Picato®, Actikerall®, 5-FU or vitamin A acid containing formulations)
* Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
* Pre-treatment with hypericin during the 2 weeks preceding PDT
* Treatment with systemic retinoids during the 3 months preceding PDT
* Treatment with cytostatics or radiation during the 3 months preceding PDT
* Female patients of childbearing potential (A female is considered of childbearing potential unless she has had tubal ligation, hysterectomy or has been postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months.)
* Patients with clinically relevant suppression of the immune system
* Diagnosis of Porphyria
* Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematosus or pemphigus erythematosus
* Concomitant use of medicinal products with known phototoxic or photoallergic potential such as hypericin, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines
* Skin diseases that might interfere with response evaluation of study PDT
* Skin sun sensitivity type V or VI according to Fitzpatrick
* Known intolerance to one or more of the ingredients of the study medication
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
* Suspected lack of compliance
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda

In this mixed methods study, the investigators assessed feasibility of use of the PATH bCPAP kit on neonatal patients as well as the usability and acceptability of the device by healthcare workers.The study took place in a rural Ugandan special care nursery with experience in bCPAP. Neonates with respiratory failure were consented and treated with the PATH bCPAP kit and blenders. The investigators conducted prospective data collection of the device use through observation as well as collected qualitative data via interviews with nurses, which were analyzed using a rapid qualitative analytical method.

Preterm birth is responsible for 1/3 of deaths under age five- the majority which occur in resource-constrained settings. Many of these deaths are due to respiratory failure which can be treated with bubble continuous positive airway pressure (bCPAP). Commercialized bCPAP devices are expensive, leading resource-constrained settings to make and use improvised devices. These improvised devices have not been tested for performance and run on 100% oxygen. WHO guidelines strongly advise against the use of 100% oxygen-particularly with preterm newborns where it can cause blindness, lung and brain injury.

To address this need, PATH has developed a low-cost bCPAP kit which includes oxygen blenders that do not require electricity nor a source of pressurized air to blend oxygen with air. The objectives of this early feasibility study are to:

1. assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and
2. assess the usability and acceptability of the PATH bCPAP kit with oxygen blenders by healthcare workers.

Newborns will be treated with the PATH bCPAP kit and a subset of these will also be treated with the PATH blender as needed to provide blended oxygen. Results from this study will be used to identify appropriate modification to the use procedures and/or the device as needed. Once testing is completed and product revision finalized, the PATH kit and blenders will allow resource-constrained settings to provide rigorously tested bCPAP therapy and blended oxygen to patients with reduced risk of morbidity from oxygen toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Newborns \<44 weeks post menstrual age with respiratory failure requiring treatment with bCPAP therapy during the period of study
* Parent or legal guardian consented to participation in the study within 24 hours of bCPAP initiation.

Exclusion criteria:

\* No parental nor legal guardian consent for participation in the study.
A Study of the Effect of a Nurse Navigator Program on High Risk Patients

The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.


Eligibility Criteria:
Inclusion Criteria:

- Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI.

Exclusion Criteria:

- Decrease cognitive capacity to consent to the study.
Proportional Assist Ventilation vs Pressure Support Ventilation

In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are:

1. Pressure support ventilation; the standard ventilation that we use for the patients in the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant air pressure to assist patients with their breathing.
2. Proportional assist ventilation; a newer way of helping people with their breathing. The air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.


Eligibility Criteria:
Inclusion Criteria:

* Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
* Age 18 years or older.

Exclusion Criteria:

* Patients who are weaned from ventilatory support within the first 72 hours of transfer to the RACU. Even though these patients had been randomized, they will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
* High spinal cord injury
* Immunosuppressed patients receiving chemotherapy or radiation therapy (\< 2 months after chemotherapy or radiation therapy).
* Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
* High risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease).
* Patients unable to trigger the ventilator for any reason.
* Any patient who is not considered a candidate for weaning from ventilatory support
* Patients consented for another interventional study.
* Patients requiring more than 30 days to wean once randomized will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.

This study is conducted over two phases.

Pilot Phase: This study will enroll approximately 12 patients, up to 20 in total in the Pilot Phase and 30 patients in the Expansion Phase. The first three patients that are enrolled in the Pilot Phase can have any solid tumor type; however subsequent patients must have Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Triple negative breast cancer (TNBC), Estrogen Receptor/Progesterone Receptor (ER/PR) positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastro-oesophageal junction adenocarcinoma or head and neck cancer. No more than three patients with ER/PR positive breast cancer can be enrolled in the Pilot Phase and similar restrictions may be placed on other tumor types to ensure a heterogeneous population.

Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts of 10 patients each depending on sub-type of breast cancer:

Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis

Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Pathologically confirmed diagnosis of solid tumors
* Metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
* Adequate bone marrow, hepatic and renal function
* Normal Electrocardiogram (ECG)
* 18 years of age or above
* Able to understand and sign informed consent

Pilot study only:

- CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer

Expansion Phase Additional Criteria:

* Locally advanced or metastatic breast cancer
* Received at least one cytotoxic therapy in the locally advanced and metastatic setting
* Received ≤ 5 prior lines of chemotherapy in the metastatic setting
* Candidate for chemotherapy

Expansion Phase Cohort 3 additional inclusion criteria:

* Breast cancer with active brain metastasis
* Neurologically stable

Exclusion Criteria:

* Active Central nervous system (CNS) metastasis (applies to pilot phase and expansion phase cohort 1 and 2 only)
* Clinically significant GI disorders
* Prior irinotecan or bevacizumab therapy within last 6 months and for Expansion Phase patients, have received any prior treatment with Topol inhibitor
* Known hypersensitivity to MM-398 or ferumoxytol
* Inability to undergo MRI
* Active infection
* Pregnant or breast feeding
* Prior chemotherapy administered within 3 weeks, or within a time interval less than at least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day of dosing in this study
* Received radiation therapy in the last 14 days
* Treated with parenteral iron in the previous 4 weeks
TRIAGE: TRIage of Sepsis At emerGency dEpartment

Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.

Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged over 18 years
* Patient with a single acute infection site suspected or confirmed by the clinician on clinical or paraclinical manifestations.
* Patient admitted to ED with at least two systemic inflammatory response syndrome (SIRS) criteria
* Patient with symptoms for less than 72 hours upon arrival to the emergency department.
* Patient requiring according to physician judgment of hospitalization for at least 48 hours for his septic episode
* Patient having been informed of the conditions of the study and having signed the informed consent form

Exclusion Criteria:

* Patient arrived in an emergency room for over 6 hours.
* Patient with septic shock upon arrival to the ED Patient with acute organ failure on arrival at emergencies other than septic.
* Patient hospitalized in the week before inclusion.
* Patient immunocompromised (HIV, transplanted, patients undergoing chemotherapy, patients receiving treatment\> 20 mg / day of prednisolone or equivalent).
* Patient with known pathology among non-infectious pathologies potentially associated with SIRS
* Patient diagnosed with sepsis within 30 days before the date of inclusion.
* Patient has already been included in the study.
* Minor Person.
* Person refusing to sign the written consent form.
* Pregnant woman parturient or nursing.
* Patient with no social security insurance, with restricted liberty or under legal protection