cyrilzakka/clinical-trials huggingface dataset:
Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength

This is a sub-study parallel to ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery (NCT03888768).

Only female participants of ProPBM will be included in this sub-study.

Association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of ProPBM protocol within female participants is elucidated in this study.

BACKGROUND:

Maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin.

Handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. To our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron.

METHODS:

At recruitment of ProPBM study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed.

After randomization, those within the ProPBM protocol will receive IV iron therapy as indicated. Participants who are randomized to standard care will follow usual medical management.

Participants will be admitted 1 day prior to surgery. On admission, preoperative bloods and handgrip strength will be repeated for patients who were randomized into the ProPBM arm.

Eligibility Criteria:
Inclusion Criteria:

* Female patients participating in the ProPBM study
* Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery
* The patient must be willing and able to provide informed consent for the study

Exclusion Criteria:

* Patients with known muscle weakness eg myasthenia gravis
* Patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function
* Patients in which IV iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron
* Patients with iron overload
Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: a Multicenter, Randomized, Double-blind, Controlled Clinical Trial

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.

Eligibility Criteria:
Inclusion Criteria:

* Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
* Participants were 18 years or older.
* 18 kg/m2≤BMI≤30 kg/m2
* Participants with American Society of Anesthesiology (ASA) physical status I-III.
* Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.

Exclusion Criteria:

* with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
* with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
* with sensory disorders such as hyperalgesia.
* with other bodily pain.
* allergy to amide-type local anesthetics or any of the trial drugs
* taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(NSAIDs),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h.
* with a history of alcohol or opioid abuse.
* who were pregnant or lactating.
* who were currently included in another clinical study within 3 months.
Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye

The aim of the study is to gain more insight into the potential impact of a vitrectomy (removal of the vitreous) on postoperative effective position of the intraocular lens (IOL). Moreover, this study can provide very useful information for the optimal lens calculation in patients undergoing lens extraction with IOL implantation (whether or not combined with a vitrectomy) should undergo.

* Comparison ELP post phaco VTX (pucker / floaters) versus post phaco and use this information to develop a customized IOL calculation for eyes undergoing phacoVTX.
* Evidence for recording lens thickness (LT) parameter in the IOL strength calculation in KWS (in the calculation of the ELP in the light of the Olsen formula, using the C-constant) in order to be able to make an even more accurate prediction of the post-operative diopter target of the patient.

Eligibility Criteria:
Inclusion Criteria:

* age \> 50 yrs
* macular pucker wherefore vitrectomy is necessary

Exclusion Criteria:

* macular pathology other than macular pucker
* Corneal pathology
* Other ocular pathology that could affect the biometrics or ELP
* Previous vitrectomy in one of the eyes
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test

The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.

Neonatal hyperbilirubinemia or newborn jaundice impacts over 85% of all newborns \[1\]. Regardless of the mechanism, excessive hyperbilirubinemia has been traditionally treated with phototherapy to minimize any probable risk of developing bilirubin-induced neurotoxicity. However, earlier and more recent data suggest that pre-discharge bilirubin screening for risk of significant hyperbilirubinemia, whether due to a rapid bilirubin production or an earlier age of onset, has impacted the guidelines for clinical use of phototherapy \[1, 2\]. In this study, we plan to test the performance of a novel transcutaneous device (BiliCareTM) first for screening for bilirubin levels at postnatal age of 6 to 48 hrs; and possibly also, to substitute the use of this measurement for total plasma/serum bilirubin (TB). This device applies a novel light transmission technology that has the potential to measure bilirubin as a point-of-care test in the subcutaneous tissue, and then uses an internal algorithm to calculate bilirubin levels in the skin. In this proposalstudy, we will to assess the clinical performance of the BiliCare by correlating measurements made by this device to near-concurrent measure of total plasma/serum bilirubin at normative ranges (mean, median, range and inter-quartile ranges ) for all term and late-preterm newborns (including those who are at-risk for jaundice and / or being administered with phototherapy) born to families of diverse race and ethnic backgrounds.

Eligibility Criteria:
Inclusion Criteria:

1. Signed parental informed consent
2. Gestational Age \>=24 weeks

Exclusion Criteria:

1. Less than 24 weeks of pregnancy at delivery
2. Bruising at the point of measurement on both ears
3. Birthmarks at the point of measurement on both ears
4. Hematomas at the point of measurement on both ears
5. Excessive Hairiness at the point of measurement on both ears
6. Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours
Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases

Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients

Cerebral autoregulation (CA) is the ability of cerebral vascular system to contract or diastole with the change of perfusion pressure, and to maintain the stability of cerebral blood flow. It has been found that there are different degrees of CA damage in patients with traumatic brain injury, ischemic stroke, hemorrhagic stroke, aneurysmal subarachnoid hemorrhage, ischemic hypoxic encephalopathy and sepsis. At the same time, studies have shown that CA damage or loss is related to brain dysfunction and poor prognosis in patients with neurocritical diseases. Therefore, early assessment and intervention of CA can help identify individuals with high risk of complications and improve outcome.

Targeted temperature management (TTM) is a kind of body temperature management started when the core temperature of patients is higher than 37.5 ℃, including achieve hypothermia (TTMhypo) and maintain normal temperature (TTMnorm). TTMhypo has been widely considered as one of the neuroprotective therapies for a variety of brain diseases and injuries, including ischemic stroke, traumatic brain injury, hypoxic brain injury caused by out-of-hospital cardiac arrest and neonatal hypoxic ischemic encephalopathy. Its neuroprotective effects in reducing brain edema, reducing intracranial pressure, reducing brain metabolism and inhibiting apoptosis have been recognized. However, the existing studies mainly focus on the effect of TTMhypo on the mortality and neurological outcome of patients with severe neurological diseases in ICU. There is no large clinical study on the effect of targeted temperature management (TTM) on cerebral autoregulation in patients with severe neurological diseases. Due to the controversy of TTMhypo on mortality and neurological outcome, this study aime to reduce the patient's core temperature to normal. Patients with severe neurological disorders who still had cerebral autoregulation dysfunction, had fever, and needed to reduce the core temperature to normal. Therefore, the effect of TTMnorm on cerebral autoregulation before and during cooling was observed.The main measures were the THRR, Mx and TOx during cooling.

Eligibility Criteria:
Inclusion Criteria:

- Aneurysmal subarachnoid hemorrhage (aSAH), Traumatic brain injury (TBI), Acute ischemic stroke (AIS), Intracerebral hemorrhage (ICH), Ischemic hypoxic encephalopathy (HIE), sepsis-associated encephalopathy (SAE) who need to reduce the core temperature to normal.

Exclusion Criteria:

* Age \< 18 years old;
* Pregnancy;
* The temporal window was limited and the image could not be obtained;
* Patients with bradycardia induced by common carotid artery compression and intolerant of THRT
* Patients with severe carotid artery disease;
* Uncorrected severe coagulation disorders and active bleeding;
* Patients without informed consent;
* Patients who had been treated with hypothermia before inclusion
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.

The primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving Humira continuously.

All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week 13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and SB5 or continue on Humira.

Eligibility Criteria:
Inclusion Criteria:

* Have no history of Adalimumab and cell-depleting biologics
* Have no history of any other biologics use within 6 months prior to Week 0
* Have plaque psoriasis diagnosed at least 6 months, with or without psoriatic arthritis
* Have plaque psoriasis with the involvement and severity of total affected BSA ≥ 10%, PASI score of ≥ 12 and PGA score of ≥ 3 (moderate)
* Considered to be a candidate for phototherapy or systemic therapy for psoriasis
* Adequate hematological, renal, and hepatic function by central lab
* Non-childbearing potential female, or childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from Screening until 5 months after the last dose of IP

Exclusion Criteria:

* Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis
* Have other skin disease than psoriasis that requires topical, phototherapy or systemic therapy
* Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of SB5 or Humira
* Have received phototherapy or conventional systemic therapy within 4 weeks prior to Week 0
* Have received topical therapy for psoriasis within 2 weeks prior to Week 0, however class 6/7 corticosteroids are allowed on face and groin
* Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP
* Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to Week 0. Non-live COVID-19 vaccines are allowed
* Have active or latent tuberculosis
* History of ongoing infection or a positive test of HBV, HCV, or HIV infection
* History of sepsis, chronic or recurrent infection
* History of lymphoproliferative disease or leukaemia
* History of malignancy within the last 5 years
Improving Household Air Quality in Homes With Children

The purpose of this study is to determine if real-time feedback (lights/sounds) from small smoke particle monitors and brief coaching will encourage parents to reduce young children's secondhand tobacco smoke exposure in their home.

The purpose of this efficacy study is to test whether children's home secondhand tobacco smoke exposure (measured by cotinine \& nicotine assays, fine particulates and reports of smoking in the home and/or home smoking bans) can be reduced by using custom particle monitors to provide real-time feedback to household residents plus brief advice/praise.

Eligibility Criteria:
Inclusion Criteria:

* Families with at least one parent or guardian (18 years of age or older),
* Household resident who smokes tobacco,
* Child under fourteen years old exposed to tobacco smoking in the home
* Plans to live in San Diego County for at least three months.
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)

The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).

Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow down AD without altering its natural evolution. The development of new therapies has primarily focused on preventing the progression of AD. This therapeutic strategy involves being interested in patients with an early stage of AD such as a mild cognitive impairment (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can slow or even improve cognitive decline, particularly executive functions.

The primary objective of this trial is to compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance obtained in the TMT B in the older adults with a MCI.

The secondary objectives of the study are as follows:

* To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in executive performance in patients with a MCI.
* To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in variability of stride time in patients with a MCI.
* To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in executive performance in patients with a MCI.
* To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in variability of stride time in patients with a MCI.
* To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3 in patients with a MCI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Memory complaints
* No dementia (DSM-IV, NINCDS-ADRDA negative)
* No depression (Geriatric Depression score ≤ 5/15)
* Ability to walk a distance of 15 meters unaided
* Diagnosis of MCI
* To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D \[25OHD\]concentration ≤ 30ng/mL)
* To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)
* To have given and signed an informed consent to participate in the trial
* To be affiliated to French Social Security

Exclusion Criteria:

* Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression score \> 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at the time of inclusion)
* Vitamin D supplementation during inclusion
* Contraindications to vitamin D
* Unstable medical condition
* Enrollment in another simultaneous clinical trial
* Civil defense measures underway
Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.

This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC.

Participants were enrolled into the Panitumumab + Paclitaxel + Carboplatin + Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unresectable stage IIIB or IV non-small cell lung cancer (NSCLC)
* No more than one prior chemotherapy
* Adequate hematologic, renal and hepatic function
* Measurable disease or evaluable disease on CAT scan or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Able to fast for 10 hrs twice during the study - Able to tolerate oral medications
* Life expectancy of at least 3 months

Exclusion Criteria:

* Symptomatic or untreated central nervous system metastases requiring current treatment
* History of arterial thrombosis within 1 year prior to enrollment
* Anticoagulant therapy, except for warfarin of less than 2mg per day
* Symptomatic peripheral neuropathy
* History of pulmonary hemorrhage or hemoptysis
* Myocardial infarction within 1 year before enrollment
* Uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\]
* History of other cancer, unless treated with no known active disease for longer than 3 years
* Previous treatment with AMG 706 or panitumumab, previous treatment with inhibitors of VEGF or EGF
* No antibody treatment for 6 weeks prior to enrollment
* Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive
Caffeine and Resistance Training in Young Adults

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, little is known about the prolonged effect of this supplement on neuromuscular adaptations to strength training.

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training.

Objectives: The present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as on fatigue resistance during repeated sprints, fatigue perception, mood state, reaction time, diet, and potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 18 and ≤ 35 years.
* Body mass index (BMI) \&lt; 25 kg/m².
* Physically active subjects (\&gt;150 min/week of moderate exercise).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise.
* Participants capable of performing the tests.

Exclusion Criteria:

* History of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism.
* Use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study.
* Body mass index (BMI) \&gt; 25 kg/m².
* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
* Performing strenuous exercise within 48 hours prior to the tests.
* Failing to replicate the same food intake on the two experimental days.
* Consuming caffeine after 6 PM on the day prior to training or testing.