cyrilzakka/clinical-trials huggingface dataset:
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.

The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：

1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
2. GT101 infusion.
3. post-infusion treatment (interleukin-2 intravenous push).


Eligibility Criteria:
Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
* 3. Arterial/venous thrombotic events within 6 months prior to surgical operation, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 5. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
* 6. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time;
* 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 8.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
The Effects of Different Lipid Emulsions on the Adipokines in Critically Ill Patients With Sepsis

Intravenous lipid emulsions contain a number of biologically active ingredients, but the most important are fatty acids. Different fatty acids can affect a number of different physiological processes in different ways in critically ill patients. Adipose tissue can play an important role in metabolic changes of critical illnesses and in adaptation to stress through structural as well as functional changes Although it is known that serum adipokine and cytokine response changes in critical sepsis patients, the factors affecting these changes and the metabolic consequences of these changes are not well defined. The aim of this study was to evaluate the effects of intravenous lipid emulsions on serum adipokine and cytokine levels in patients with sepsis. Secondly, this is to determine the adipokine and cytokine kinetics in the sepsis process and their relationship with mortality in patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sepsis within the last 24 h
* Age above 18 and below 85 years
* Indication of only parenteral nutrition therapy

Exclusion Criteria:

* Planning any different medical nutrition therapy such as enteral nutrition, immunonutrition or oral nutrition
* Hypersensitivity (fish, egg or soy protein)
* Uncontrolled hemorrhage
* Uncontrolled hyperlipidemia
* Severe primary blood coagulation diseases
* Acute pancreatitis
* Acute thromboembolic diseases
* Severe liver failure
* RIFLE stage III and IV renal failure
* Pregnancy or lactation
* Expected stay in ICU not more than 10 days
* Expected survival not more than 10 days
The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia

Adductory spasmodic dysphonia (AdSD) is a rare condition characterised by irregular and uncontrolled voice interruptions, most commonly affecting women around the age of 45. The diagnosis is clinical and usually requires evaluation by several specialists. The exact cause is not known, but a disturbance of the motor system is hypothesised, probably related to various causes such as loss of cortical inhibition or problems with sensory input.

Neuroimaging studies have shown hyperactivity in various brain regions during speech production in patients with AdSD, but it is still unclear whether this hyperactivity is due to a malfunction of auditory and somatosensory feedback or an impairment of motor programming.

Recent research indicates that patients with AdSD show excessive muscle activation during phonation, probably due to abnormal processing of auditory feedback. This suggests that intervention in the auditory system may offer new treatment opportunities.

The proposed study aims to describe the acoustic, auditory-perceptual and subjective voice and speech changes in AdSD subjects during the Quick-Lombard Test (LT), a test that assesses vocal response under noisy conditions.


Eligibility Criteria:
Inclusion Criteria:

* Native Italian-speaking patients;
* Normal hearing, hearing threshold \&lt; 20 dB HL for frequencies from 0.5 to 4 KHz;
* Age \&gt;18 years and \&lt;65 years;
* Written informed consent.

Exclusion Criteria:

* Non-Italian-speaking patients.
* Patients undergoing treatment for dystonia.
* Previous laryngeal surgery.
* Patient undergoing speech therapy.
* Patient undergoing dopaminergic therapy.
* Inability to sustain phonation of sufficient duration \&gt;3 seconds or to perform sufficient tests to assess vocal outcomes.
* Lack of written informed consent.
FLOTRAC/VIGILEO in Acute Circulatory Failure

Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Systolic arterial pressure \< 90 mmHg or Mean arterial pressure \< 60 mmHg
* Heart rate \> 100 bpm
* Norepinephrine infusion
* Urine output \< 0.5 ml/kg/h during at least two consecutive hours
* skin mottling
* Capillary refill time \> 3 sec

Exclusion Criteria:

* Acute cor pulmonale
* Ongoing renal replacement therapy
* Lack of echogenicity during transthoracic echocardiography
Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision

Background: Laparoscopic total mesorectal excision (TME) for rectal cancer is technically challenging because of the confined space within the pelvis. The robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is expensive. Transanal total mesorectal excision (TaTME) is an emerging surgical approach that allows dissection of the most difficult part of the TME plane deep down in the pelvis using a less costly transanal platform. To date, no randomized controlled trial can be found in the literature comparing TaTME and robotic TME.

Objectives: To compare the pathologic outcomes, functional outcomes, and costs between TaTME and robotic TME for mid or low rectal cancer.

Design: Prospective, randomized, controlled, superiority trial.

Subjects: One hundred and eight consecutive patients who are clinically diagnosed with cT1-3, N0-2, M0 rectal cancer located within 12 cm of the anal verge who do not require abdominoperineal resection will be recruited.

Interventions: Patients will be randomly allocated to undergo either TaTME or robotic TME.

Outcome measures: Primary outcome: composite pathologic endpoint (complete TME, clear circumferential and distal resection margins). Secondary outcomes: conversion rate, postoperative recovery, morbidity, health-related quality of life, urosexual function, and costs.

Hypothesis: Results of the present study can provide evidence-based clarification of the efficacy and safety of TaTME for patients with mid and low rectal cancer. The results of this proposed project may have a significant impact on the future treatment strategy for mid and low rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy
* Those with clinically diagnosed cT1-3, N0-2, M0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography
* Age of patients greater than or equal to 18 years
* Those with American Society of Anesthesiologists (ASA) grading I-III,
* Informed consent available

Exclusion Criteria:

* Patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy)
* Those with locally advanced T4 cancer requiring en bloc multivisceral resection
* Those with very low rectal tumor requiring abdominoperineal resection
* Those with synchronous colorectal tumors requiring multisegment resection
* Those undergoing emergency surgery
* Those with previous history of abdominal surgery precluding the robotic or laparoscopic approach;
* Those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous
* Those with psychiatric disease
* Those who are pregnant
E-Care Acceptability for Older People Undergoing Chemotherapy

The main objective of this pilot study is to evaluate the acceptability of clinical data collection using a semi-automated e-solution based on the use of text messaging among older adults undergoing chemotherapy treatment at home.

Most cancer diagnosis are made among the 70 years and over population. In this population, negative consequences of cancer treatments are of great concern, especially for those who are socially isolated or live in rural areas. International oncology societies recommend personalized treatments to reduce adverse events. However, few tools have been validated in this population to monitor compliance and risks of outpatient treatments. In addition, health professionals continue to manage unplanned patient calls which could disrupt effectiveness of their work. Our hypothesis is that the semi-automated collection of health data (text message questionnaires) during outpatient chemotherapy secures the patient's care pathway and optimizes care time, in particular for patients' education and support. Therefore, patients (and/or their caregivers) who benefit from calls follow-up (usual care), would have the possibility of receiving an additional weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data on tolerance and compliance with care plan.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of 70 years of age or older;
* Subjects undergoing chemotherapy treatment after a cancer diagnosis;
* Subjects managed by the oncogeriatrics team at the Toulouse University Hospital as part of an outpatient follow-up and followed by conventional telephone calls and CHATBOT support.

Exclusion Criteria:

* Patient's refusal to participate.
* Patient does not have sufficient equipment for downloading and using the CHATBOT tool
* Participant under guardianship, curatorship or safeguard of justice.
Heat Waves and the Elderly - Cooling Modalities

The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Such deaths are primarily cardiovascular, not hyperthermia itself, in origin. The central hypothesis of this work is that cardiovascular stress during heat wave conditions in the elderly can be reduced by applying low-energy cooling modalities. Comprehensive cardiovascular and thermal responses in the elderly will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave), very hot and dry (replicating the 2018 Los Angeles heat wave). With each of these heat wave conditions individuals will be exposed to the following cooling modalities: no cooling (control), water spray, fan use, and fan use plus water spray.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Free of any significant underlying medical problems based upon a detailed medical history and physical exam

Exclusion Criteria:

* Known heart disease
* Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc;
* Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Subject with a body mass index ≥31 kg/m2
* Pregnant individuals
Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration

Nimodipine reduces the risk of poor outcome and delayed cerebral ischemia in patients suffering aneurysmal subarachnoid haemorrhage (SAH), but its mode of action is unknown. Its beneficial effect is assumed to be due its neuroprotective effects by reducing intracellular calcium and thereby cellular apoptosis, but higher concentrations might induce marked systemic hypotension, thereby inducing cerebral ischemia. Since several dosing regimes and routes of administration with inconclusive superiority exist and since the target site concentration of nimodipine - the unbound drug concentrations beyond the blood-brain barrier - is still not known, it is reasonable to measure nimodipine concentrations within the blood, cerebrospinal fluid (CSF) and interstitial brain tissue following oral, intra-venous and intra-arterial administration and correlate intra-arterial nimodipine administration to measures of cerebral metabolism and oxygenation.

Therefore, the investigators propose to investigate in 30 patients suffering severe aneurysmal SAH and requiring cerebral microdialysis for cerebral neurochemical monitoring:

* the ability of nimodipine to penetrate into the brain of neurointensive care patients by comparing exposure in brain, CSF and plasma, dependent on the route of administration (i.e. oral, intra-venous, and intra-arterial) and dosing intra-venously (0.5 - 2mg/h)
* the impact of orally, intra-venously, and intra-arterially delivered nimodipine on cerebral metabolism, i.e. lactate/pyruvate ratio, pbtO2 and transcranial doppler flow velocities
* the effect of oral and intra-venous nimodipine on systemic hemodynamic and cardiac parameters, using continuous Pulse Contour Cardiac Output (PiCCO) monitoring
* the penetration properties of ethanol - as an excipient of nimodipine infusion - into the brain by comparing exposure in brain, CSF and plasma and quantifying the neuronal exposure to alcohol dependent on blood levels


Eligibility Criteria:
Inclusion Criteria:

* patient age \> 18 years
* aneurysmal subarachnoid hemorrhage
* sedated and mechanically ventilated
* application of brain microdialysis as standard care (due to the severity of subarachnoid haemorrhage or secondary deterioration)
* oral, intra-venous or intra-arterial administration of nimodipine due to clinical indication

Exclusion Criteria:

* contraindication for nimodipine
* no need of intensive care and bedside cerebral microdialysis as standard care
* any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast

In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.

Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods.


Eligibility Criteria:
Inclusion Criteria:

* Participants in online panel survey
* Age between 18 and 40 years
* Current resident of urban Saudi Arabia in Jeddah, Riyadh, \& Dammam

Exclusion Criteria:

N.A.
Hyperuricemia and Diabetic Nephropathy

The purpose of the study is to detect the effect of treatment of hyperuricemia on eGFR (Estimated Glomerular Filtration Rate) as an objective criterion for assessment of progression of diabetic nephropathy in patients with Type 2 Diabetes Mellitus.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry.

At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Febuxostat (80 mg, once daily) or Placebo (once daily) in patients with Type 2 Diabetes Mellitus and Stage 3 Chronic Kidney Disease (Estimated Glomerular Filtration Rate 31:59).

Eligibility Criteria:
Inclusion Criteria:

* Patient population will include both males and females above the age of 18 years with T2DM and Diabetic Nephropathy stage 3 CKD (eGFR: 31-59).

Exclusion Criteria:

* Patients with history of hypothyroidism, alcoholism, urinary tract infections, glomerulonephritis, myeloproliferative disorders and gout "as gout is a common inflammatory arthropathy characterized by painful and swollen joints resulting from precipitating uric acid crystals but hyperuricemia is commonly asymptomatic" or on drugs capable of inducing Hyperuricemia will be excluded from the study.
* Any patient will develop acute kidney injury episode at any time of the study will be excluded from the study.
* Patients with uncontrolled hypertension will be excluded from the study.
Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.

Although effective treatments for psychosocial symptoms and disorders are available, patients frequently do not receive the most appropriate and effective treatment for their symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in general practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in usual care. As a result, patients are supposed to start earlier with a treatment that fits the type and severity of their symptoms better.

The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with (suspected) psychosocial symptoms
* Aged 18 years or older and capacitated
* Adequate understanding of Dutch language
* Able to perform SGE-PsyScan at home, individually

Exclusion Criteria:

* Clear and treatable somatic causes of symptoms
* Acute distress/danger
* No written informed consent
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\<2hr)

Exclusion Criteria:

* children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection