cyrilzakka/clinical-trials huggingface dataset:
Looping Whilst Restricting Carbohydrates

To investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.

Closed-loop systems combining an insulin pump, a glucose sensor and a dosing algorithm that adjusts insulin delivery in a glucose-responsive manner achieve significantly better glucose control than conventional therapy in type 1 diabetes. Achieving satisfactory postprandial glucose control, however, continues to be challenging. The main limitation is the delayed pharmacokinetics and -dynamics of subcutaneously administered insulin with peak actions between 1 and 2 hours. Conversely, glucose levels typically rise within 10minutes following carbohydrate intake. This mismatch largely explains the inability of current closed-loop systems to control postprandial glucose excursions and the increased risk of late postprandial hypoglycaemia in response to both user-derived meal bolus administration and reactive algorithm-driven insulin infusion.

Restricting carbohydrate may therefore significantly improve post-prandial glucose control whilst reducing hypoglycaemia. The efficacy of hybrid closed-loop operation in individuals with type 1 diabetes adhering to a low carbohydrate compared to a iso-caloric balanced diet has not been investigated to date.

Eligibility Criteria:
Inclusion Criteria:

* Female and male subjects aged 18 years or older
* Diabetes mellitus Type 1 as definded by WHO for at least 2 years or C-peptide negative (\<100 pmol/L with concomitant blood glucose \> 4 mmol/L)
* hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months
* HbA1c \<= 9 %
* The subject is willing and capable of adhering to the diet plan.

Exclusion Criteria:

* Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
* Excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women)
* Pregnancy, planned pregnancy or breast feeding
* Current participation in another clinical trial
* Total daily insulin dose \>2 IU/kg/day
* Nephrolithiasis
* Hereditary dyslipidemia
* Liver steatosis
Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients

Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.

The clinical determination of the intravascular volume can be extremely difficult in critically ill patients. Although hemodynamic maximization was proposed, this approach was associated with a risk of fluid overload and excessive inotropic support. Therefore, fluid optimization was seen as a significant step forward and has been shown to decrease complications. Significant effort has been devoted to defining and developing simple means for predicting fluid responsiveness, i.e. whether the patient will benefit from fluid administration. Passive leg raising (PLR), a bedside performed test, could be used to accurately predict fluid responsiveness in most conditions.

However, most parameters that provide information about fluid responsiveness during volume expansion and PLR are invasive and time-consuming. A completely noninvasive and atraumatic parameter to predict fluid responsiveness might be need urgently. Transcutaneous partial pressure of oxygen (PtcO2), a measure to detect tissue ischemia or inadequate perfusion, might reflect the change in cardiac output, thus predict fluid responsiveness. The purpose of this study was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen in the critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical signs of inadequate tissue perfusion defined as systolic blood pressure \< 90 mm Hg or a decrease \> 40 mmHg in previously hypertensive patients or the need for vasopressive drugs (dopamine \> 5 ug/kg/min or norepinephrine); urine output \< 0.5 ml/kg/hr for 2 hrs; tachycardia; presence of skin mottling.

Exclusion Criteria:

* pregnancy, age of less than 18 years, contraindication to passive leg raising test, cardiac arrhythmias, cardiogenic pulmonary edema, the presence of abdominal compartment syndrome and refusal to participate in the study
Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria have been shown to improve this type of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics.

Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* gastrointestinal symptoms
* recent (3 months) antibiotic intake
* recent (3 months) change of diet
* recent (3 months) gastroenteritis
Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
* Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:

  1. Not candidates for known curative intent therapy.
  2. Progressed following at least one prior systemic therapy.
  3. Have advanced melanoma unresectable stage III or stage IV
  4. Have advanced head and neck recurrent or metastatic disease
* Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
* Life expectancy of greater than 3 months.
* ECOG Performance Status of 0 or 1.
* Adequate organ and marrow function
* Seronegative for HIV antibody.
* Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
* More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
* Patient has stable or progressing disease after at least one prior treatment.
* Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Exclusion Criteria:

* Currently using investigational agents.
* Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
* Patient is a female of child-bearing potential who is pregnant or breastfeeding
* Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
* Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
* Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
* Patient has opportunistic infections.
* Patient has a history of coronary revascularization or ischemic symptoms.
* Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
Evaluation of Oral THC and CBD in Men and Women

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant and non-lactating females aged 21-55 years
* Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
* Not currently seeking treatment for their cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
* Any other Axis I disorder
* Report using other illicit drugs in the prior 4 weeks, other than cannabis.
* Current use of any medications that may affect study outcomes
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
* Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
* History of an allergic reaction or adverse reaction to cannabis is exclusionary.
* History of respiratory illness or current respiratory illness
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
Efficacy of PEEK Acuity Versus ETDRS Chart for Assessment of Visual Acuity and Refractive Error

Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the Peek Acuity application.

This study aims to compare the diagnostic accuracy and efficiency of the Peek acuity application (Portable Eye Examination Kit) with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in assessing visual acuity and refractive errors. The study will involve 58 participants, selected using a non-probability convenience sampling technique. A comparative cross-sectional design will be used.

Eligibility Criteria:
Inclusion Criteria:

* Males and females.
* 18 years of age or older.
* Individuals with normal vision or those with refractive error who had their corrected glasses.
* Individuals who are willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Individuals with anterior segment abnormalities such as conjunctivitis, Iritis, uveitis, keratitis, or corneal ulcers.
* Individuals with vision deprivation due to corneal opacities, cataracts, glaucoma, retinal, and optic nerve pathologies.
* Postoperative/intraoperative complications.
* Have received mydriatic drops.
* Individuals who cannot achieve normal visual acuity with corrective lenses (glasses or contact lenses).
* Individuals with neurological conditions affecting vision
* Individuals unable to cooperate with visual acuity testing due to cognitive impairments or language barriers.
* Individuals who have had refractive surgery or other eye treatments within the past 6 months.
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.

Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants.

Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations.

Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development.

The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants fed own mother's milk (or donor human milk) in need of a HMF (as decided by the investigator)
2. Gestational age \<32 weeks and birth weight \<1500 g
3. Receiving enteral feeding
4. Expected to need a HMF for minimally 21 days
5. Written informed consent from custodial parent(s)

Exclusion Criteria:

1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation;
2. Presence or history of any gastrointestinal malformation, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher);
3. No realistic prospect of survival at the discretion of the attending physician;
4. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
5. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions.
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers

This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.

A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.

Eligibility Criteria:
Key Inclusion Criteria:

1. Patients with malignant ascites requiring therapeutic ascites puncture
2. Histological confirmed diagnosis of epithelial cancer
3. Patients where standard therapy is not available or no longer feasible
4. Karnofsky index ≥60 %
5. Life expectancy \>12 weeks

Key Exclusion Criteria:

1. Concomitant treatment with other investigational product, chemo-, or radiotherapy
2. Recent exposure to an investigational product
3. Known or suspected hypersensitivity to catumaxomab or similar antibodies
4. Inadequate respiratory, renal or hepatic function
5. Inadequate blood count (platelets, neutrophils)
6. Required entirely parenteral nutrition
7. Patients with ileus or subileus within the last 30 days
8. Liver metastases with volume \>70 % of liver tissue
9. Known portal vein obstruction
10. Known Brain metastases
11. Acute or chronic infection
12. Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status
13. Albumin lower than 3 g/dL or total protein \< 6g/dL
HD-tDCS: Effects on the Somatosensory System

The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects.

The investigators aim to investigate the efficacy of different HD-tDCS electrode configurations on modulating the somatosensory/nociceptive system.

This is done to investigate the hypothesis, that different stimulation protocols can be used to modulate the somatosensory and nociceptive system, as shown in the previous studies, but that it is necessary to uncover the most efficient way to do so.

The study uses a double-blinded, sham-controlled, longitudinal design, where quantitative sensory testing will be used to assess the somatosensory function of the participants before and after a receiving a specific configuration of HD-tDCS on three consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women.
* Able to speak, read and understand English or Danish.

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Current use of opioids, antipsychotics, benzodiazepines
* Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
* Current or prior chronic pain conditions
* Lack of ability to cooperate
Nineteen Years of Modified CIMT in a Clinical Setting, to Improve Arm and Hand Function After Stroke

The goal of this observational study is to determine if clinically constraint-induced movement therapy (CIMT), when applied in a routine clinical practice, can improve arm- and hand function after stroke. Additionally, the study seeks to identify which patients experienced the greatest improvements, and to examine factors that contribute to the long-term sustainability of the treatment.

Stroke is one leading cause of disability, often resulting in difficulties using the arm and hand function on one side, making daily activities challenging. CIMT aims to enhance arm and hand function after stroke by incorporating intensive training and restraining the non-affected limb, thereby encouraging the use of the affected arm and hand. While numerous studies have demonstrated the effectiveness of CIMT, and it is recommended in national clinical guidelines, it is rarely implemented in clinical practice due to challenges in execution and sustainability. Moreover, it remains unclear which patients benefit the most from the treatment.

At a rehabilitation clinic in Sweden, CIMT has been incorporated into routine care for 19 years, which is uncommon. Participants undergo CIMT as outpatients over a three-week period, with one patient being treated at a time. By retrospectively observe outcomes from this clinically implemented and sustained model of CIMT, the study aims to address the following questions:

* Is CIMT, when conducted in a regular clinical setting, effective?
* Are there relationships between patient characteristics and outcomes?


Eligibility Criteria:
Inclusion Criteria:

* Post-acute injury (participants had completed primary rehabilitation and were living at home)
* Reduced ability to use the hemi-paretic arm
* Ability to actively extend the metacarpophalangeal and the interphalangeal joints 10°
* Ability to actively extend the wrist 20°

Exclusion Criteria:

* Unable to walk and balance safely without using the non-affected hand, with or without a mobility aid
* Unable to understand the content of the training or lack of motivation
* Serious cognitive deficit or instable medical condition believed to affect training participation
* Pain in the affected arm believed to affect training intensity
Morpho-functional Cardiac Modifications in Treated Mutated Transthyretin Cardiac Amyloidosis

Cardiac Amyloidosis (CA) is characterized by a long subclinical phase characterized by deposition of amyloid fibrils in atria, valves and walls of ventricles. Longitudinal dysfunction of the left ventricle (LV) with preserved ejection fraction (EF) is the early phase of CA.

Longitudinal dysfunction mainly involves the LV basal and middle segments with less involvement of the distal segments (apical sparing).

Strain echocardiography (STE) measures myocardial deformation. The technique has been shown to be sensitive for early detection of impaired systolic function and for the study of CA. Additionally, cardiac efficiency (myocardial work) can be derived from myocardial strain data analysis.

In the year 2018, "RNA interferences" (patisiran and inotersen) were included in the list of compassionate therapeutic use programs for exclusive use for the treatment of adult patients with hereditary amyloidosis neuropathy. The aim of our study is to evaluate the morpho-functional modifications with RNA interferences.

Transthoracic echocardiographic images are recorded in the available ultrasound units (Vivid 7 and Vivid 9, GE Ultrasound, Horten, Norways and MyLab - Esaote, Genoa, Italy). The diameters and the wall thicknesses are measured according to the insurance of the American Society of Echocardiography. The images obtained with apical view and in format 4 bedrooms with frame rates (70-80 frames / s) - stored for three cardiac cycles in cine-loop format - will be used for evaluate off-line to evaluate left ventricle deformation in the longitudinal and radial direction, basalelateral, and top segments (post processing) through software already in use and available (Suitestenza, Esaote, Florence, Italy and GE Ultrasound, Horten, Norway).

Eligibility Criteria:
Inclusion Criteria:

* presence of data obtained from historical records of patients who retrospectively met the prescriptive (neurological) criteria and received the prescription of the drugs in question (RNA interferences) having
* Cardiological evaluation (examination ECG, echocardiography) at the time of prescription
* Cardiological evaluation (examination ECG, echocardiography) evaluated six months after therapy,
* Cardiological evaluation (examination ECG, echocardiography) evaluated 12-18 months after therapy,

Exclusion Criteria:

* it wasn't possible to putatively confirm the reasonable shipment of the innovative therapy prescribed
* it wasn't possible to putatively confirm the reasonable shipment of conventional therapy prescribed (background therapy)