cyrilzakka/clinical-trials huggingface dataset:
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients

This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 7 to 80 years of age.
2. Has asthma
3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
4. Is willing and able to perform Vivatmo pro™ testing

Exclusion Criteria:

1. Subject has used corticosteroids prior to enrollment.
2. Subject has other current serious medical conditions
3. Subject has not been clinically stable for at least 2 weeks prior to the study
4. Subject is unwilling or unable to perform Vivatmo pro testing
A Study of LY573636-sodium in Patients With Metastatic Breast Cancer

The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.

Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Eligibility Criteria:
Inclusion Criteria:

* Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.

Exclusion Criteria:

* Serious pre-existing medical condition.
* Have active central nervous system or leptomeningeal metastasis.
* Current hematologic malignancies, acute or chronic leukemia.
* Receiving Warfarin (Coumadin).
* Have a history of radiation therapy involving more than 25% of the bone marrow.
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy

Background: Cerebral palsy (CP) is a neurodevelopmental disorder caused by damage of the developing brain and marked by impairments such as increased muscle tone. Physical therapy (PT) is an important element for spasticity management include some modalities as transcutaneous electrical nerve stimulation (TENS).

Purpose: To determine the effect of TENS on inhibition of upper limb spasticity in adult patients with spastic cerebral palsy.

Methods: Twenty-four adult spastic CP patients aged from 18 to 45 years old with grade 2 to 3 spasticity according to Modified Ashworth Scale will be randomly assigned into two equal groups: TENS group and conventional therapy group. Both groups will receive conventional therapy, while TENS group in addition will receive TENS over elbow flexors with parameter setup of (pulse frequency= 100 Hz, pulse duration= 250 μs, time=30 mints) 3 sessions per week for successive 4 weeks.

Outcome measures: Modified Ashworth scale for the spasticity and digital goniometer for elbow joint range of motion, Barthel index scale for upper limb activity of daily living. Follow-up measures will be calculated three times (preintervention, post 2 weeks, and post 4 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged from 18 to 45 years old
* Diagnosed with spastic CP (upper limb is affected)
* Elbow flexor muscles spasticity grade 2 to 3 according to Modified Ashworth Scale
* Good cognition (patient able to follow the instruction)

Exclusion Criteria:

* Patient with epilepsy
* Under antispastic medication
* Severe psychological or behavioral problem
* Sensory abnormalities
* Orthopedic surgery or severe deformities in upper limb
* Injected by botulinum toxin (botox) in the past 6 months in upper limb.
Validity and Reliability of the Turkish Form of the Knowledge Assessment Scales for Dementia and Urinary Incontinence

The primary aim of the study was to determine the Turkish version of the "Validity and Reliability of the Knowledge Assessment Scales for Dementia and Urinary Incontinence in Community Older People". The secondary aim of the study was to measure the knowledge level of dementia and urinary incontinence in the community-living elderly population.


Eligibility Criteria:
Inclusion Criteria:

1. Being 55 years of age or older
2. Knowing how to read and write
3. Being willing to participate in the study

Exclusion Criteria:

1. Having any chronic illness that would prevent urinary retention and dementia level
Change in Fascial Tension in Open Abdomens

The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with an open abdomen and plan for abdominal re-exploration

Exclusion Criteria:

* patients under the age of 18 years
* pregnant patients
* patients who have no available Legally Authorized Representative to provide consent.
* patients with a current hernia
* patients with a prior component separation
Empyema Treated With tPA & DNAse

The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.

The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.

The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients less than 18 years of age requiring an intervention for empyema by one of the following:

* Septation or loculation seen on ultrasound or computed tomography or
* Greater than 10,000 white blood cells identified on pleural tap

Exclusion Criteria:

* Immunodeficiency process
* Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
* Existing contraindications to chest tube
* Documented allergy to one of the study medications
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
* Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
* Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria
* No more than three prior systemic chemotherapy regimens
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2
* Adequate hematological, renal, metabolic and hepatic function

Exclusion Criteria:

* Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
* Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
* Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
Can the Point-Of-Care Chemistry Test (POCT) Solve the Emergency Department (ED) Crowding?

The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS).

ED crowding is one of the most serious problems in ED. POCT has shorter turn-around time compared to centralized laboratory system. If POCT introduce to ED, it may help to shorten LOS of ED patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years
* clinically required to have chemistry lab tests
* ESI 2-5
* written agreement to participate

Exclusion Criteria:

* no agreement
* ESI level 1
* no chemistry lab
Evaluation of the Right Use of Inhaled Therapeutics

Asthma and COPD have a significant impact on public health, affecting about 8 million people in France and generating health care costs of 5.5 billion euros, almost 50% of which are dedicated to long-term treatments are essentially inhaled therapies.

The good control of the disease depends on the patient's compliance, but also on the proper use of the devices used for the administration of inhaled drugs under penalty of the degradation of the control of the disease with major medical and medico-economic consequences.

Thus, education of these patients in the use of devices must be an integral part of medical care. It comes up against the complexity of the therapeutic arsenal on the one hand and on the other hand with its time-consuming nature: this makes it incompatible with a realization in consultation.

The "ARGOS" process is a telemonitoring project for the support of therapeutic education, consisting in setting up a concrete and real-time relay between prescribers and patients for the education of inhaled therapeutics.

Its objective is to provide the answer to what is currently an "unmet need" in the management of asthma and COPD, with the prospect of a positive impact on the observance of these treatments and by consequently their clinical and economic efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patient followed in Pneumology for asthma or COPD with a prescription for long-term inhaled therapies AND a home health provider (who monitors either home oxygen and / or respiratory equipment)
* The patient must have a means of telephone communication in order to be able to be contacted by a provider, an H2AD permanence or a doctor
* Patient having given his agreement after having been informed in writing of the purpose and the data collected during this study
* Age ≥ 18 years
* Beneficiary of a social security scheme

Exclusion Criteria:

* Refusal of the patient
* Patient not understanding French
* Absence of home health provider
* Absence of means of telephone communication
Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study

The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.

In this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.

A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.

The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY.

Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses

Exclusion Criteria:

* Patients who decline participation
* Patients who did not consent to being contacted about future research
* Patients who were withdrawn from the IVORY trial for any reason
Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes

The objectives of the present study are: 1) to characterize the energy-protein intake of the elderly during hospitalization; 2) to verify the influence of energy-protein intake during hospitalization on muscular (i.e., cross-sectional area of the rectus femoris and vastus lateralis muscles, muscle strength, functionality and level of independence) and clinical (i.e., length of hospital stay, hospital readmission and mortality) at the time of hospital discharge, 2 and 6 months after hospital discharge and; 3) to verify whether energy-protein intake during hospitalization is a significant predictor of loss of function and muscle mass, length of hospital stay, hospital readmission rate and mortality.


Eligibility Criteria:
Inclusion Criteria:

* both sex;
* 65 years and older;
* hospital stay less than 48 hours;

Exclusion Criteria:

* cancer in the last 5 years;
* delirium;
* cognitive deficit that impossibility the patient to read and sign the informed consent form;
* neurological disease;
* neurodegenerative muscular disease;
* patients receive nutrition via enteral and parenteral routes.
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.

Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

* previous incisional glaucoma surgery
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb

Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery.

The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons.

The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization).

This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).


Eligibility Criteria:
Inclusion Criteria:

Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2.

Age over 15 years. Minors (\<18 years) are considered to have sufficient maturity to understand the implications of the research.

Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.

Exclusion Criteria:

Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues.

Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.
Clinical Profile and Antivenom Use in Hump-nosed Pit Viper Bites in Kerala, South India: A Review.

Several controversies exist in Hypnale bite management in Kerala. Even though leading bodies like WHO recommend against using antivenom for hypnale bites, many physicians still administer antivenom for snakebites even when the culprit snake is identified. Anecdotal experience suggests that the reasons for doing so range from lack of confidence in the identification of the snake, confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification, doubts as to whether there exists para-specific neutralization capability for the available polyvalent antivenom and fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation'. To date, these domains and rationale have not been studied. It is also to be kept in mind that the evidence behind the WHO recommendation against the use of antivenom in Hypnale is based on expert opinion and case reports. The investigators intend to compare clinical manifestation and outcome amongst Hypnale hypnale bite patients who received the polyvalent antivenom to those who did not.

The investigators also intend to describe the clinical and laboratorical profile of patients with Hypnale hypnale envenomation .

Hump-nosed pit viper bites are the second most common snakebite presented to our institute as evidenced by the data in our snakebite registers. Acute kidney injury is reported in nearly 10% of the cases in our institute.

Since 2016, the participating institute maintains a snakebite register that records the patient's name, hospital number, date and time of the bite, hospital admission, and snake identification data after expert confirmation, if done. The investigators intend to review the cases with confirmed Hypnale envenomation and describe the clinical and laboratory profile of patients and their course of hospitalization.

Hump-nosed pit viper envenomation, the venom components, and the pharmacodynamics of the venom are unique to the region that it has missed the attention of many experts in the field. The current available polyvalent antivenom does not utilize the venom of Hypnale. Yet, antivenom is used by physicians for snakebites even when the culprit snake is identified, citing many reasons. The reasons range from snake misidentification to doubts as to whether para-specific neutralization capability exists for the available polyvalent antivenom. Often fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation', and confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification also comes into play.

Eligibility Criteria:
- Inclusion Criteria:

Case records of all snakebite in which the specimen brought is identified as Hump-nosed pit viper (Hypnale hypnale)

Exclusion Criteria:

* Incomplete case records from which no meaningful data can be abstracted.
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.

To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.

To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.


Eligibility Criteria:
Inclusion Criteria:

* \> 45 kg (amenable to adult dosing)
* all traumatic brain injuries NPO for at least 12 hours
* all post-operative craniotomy patients
* all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
* all carotid endarterectomy and carotid artery stenosis patients
* all endovascular patients undergoing intracranial intervention
* all post-op spine patients admitted to the NCCU

Exclusion Criteria:

* documented allergy to acetaminophen
* documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis)
* documented severe renal impairment (CrCl \< 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
* patients who are pregnant or breast feeding