cyrilzakka/clinical-trials huggingface dataset:
The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. For elective surgery that is not associated with higher blood loss and a long period of preoperative fasting, including fluids IFT is dosed to cover the basal daily need for fluids. However, it is not clear whether this fluid dose is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG). EG binds a significant amount of plasma, which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected. However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. IFT is tailored to the surgical performance, blood loss, and patient (comorbidities, length of preoperative fasting, hydration level, volemia status). For elective surgery that is not associated with higher blood loss (\< 200 ml) and a long period of preoperative fasting, including fluids (fluids per os \< 2 hours before the procedure), IFT is dosed to cover the basal daily need for fluids (approx. 1-2 ml) /kg.hour-1). However, it is not clear whether this fluid intake is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG), which is a thin carbohydrate layer on the endoluminal side of endothelial cells, which is of fundamental importance for the physiology of microcirculation and tissue metabolism. EG also binds a significant amount of plasma (estimated up to 1.7 liters), which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected (e.g. cardiac surgery using an extracorporeal circuit or vascular surgery). However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* elective recumbent and laparoscopic surgery
* informed consent

Exclusion Criteria:

* blood loss over 250 ml
* hemodynamic instability requiring noradrenaline infusion
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation

This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explored. Also, the investigators will assess the potential usefulness of vitamin D supplementation in a randomized control trial.

Statins are a class of drugs that are widely prescribed to lower blood cholesterol levels. Although they have few side effects, many patients report muscle pain, cramps, and weakness when using these drugs. We know very little on the real impact of these muscle symptoms on patient quality of life, especially in relation to muscle strength and endurance.

Patients under statin therapy will stop medication for 2 months. Results from blood sample, muscle function and muscle biopsy (in some participants) will be compared with baseline. Participants will then take vitamin D supplementation or placebo for one month. Thereafter, statin will be reintroduced for two months while continuing vitamin D or placebo supplementation. At the end of that time, measures from blood sample, muscle function and muscle biopsy will be compared with other visits.

Eligibility Criteria:
Inclusion Criteria:

* statin therapy
* healthy and sedentary or moderately physical active

Exclusion Criteria:

* Current treatment with other lipid-lowering drugs
* Natural medicine affecting lipid metabolism
* CK levels above the normal range
* Clinical vitamin D deficiency
* Impaired liver or kidney function
* Untreated hypo- or hyperthyroidism
* Treatment with other medications known to increase risk of myopathy
* Existing infection requiring antibiotic therapy
* Consumption of greater than 60 ml of grapefruit juice per day
* Inherited muscle disorders or myopathy
* Polymyositis or inflammatory myopathy
* Use of corticosteroids
* Comorbidities resulting in muscle or bone pain
* History of elevated CK
* Unexplained cramps
* Known sickle cell trait
* Cancer within the 5 years prior to study entry
* Diabetes
* Stroke, coronary artery or peripheral vascular disease
* Physical disability or previous injury interfering with exercise testing
* Pregnant or breastfeeding
* Depression (in last 3 years) or treatment with antidepressants
* Use of anti-psychotic drugs
* Alcohol abuse
Semaglutide in Auto-HSCT

The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.

Study design:

The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.

Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up.

Study population:

A planned total number of 40 patients will be randomized.


Eligibility Criteria:
Inclusion Criteria:

* Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
* Age ≥ 18 years
* BMI ≥ 18.5
* ECOG performance status\* ≤ 2
* Literate in Danish and/or English

Exclusion Criteria:

* Diabetes
* Inflammatory bowel disease
* Previous or current gastrointestinal malignancy
* Personal or family history of medullary thyroid carcinoma or MEN syndrome
* Genetic disorders with defective tissue repair (e.g., Fanconi anaemia)
* History of pancreatitis (acute or chronic)
* Renal impairment measured as eGFR value of \< 30 ml/min/1.73 m2
* Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times upper normal limit at screening
* Known or suspected hypersensitivity to semaglutide or other GLP-1RA
* Pregnant or nursing females
IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia.

Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death.

As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Attending for an elective procedure requiring general anaesthesia
* Prior radiotherapy to the neck

Exclusion Criteria:

* General anaesthesia is not the primary airway plan
* Previously known difficult intubation
* Patient refusal
Pivot Breath Sensor Performance Study

A clinical study enrolling 70 subjects to:

* evaluate the user performance of the Pivot Breath Sensor
* compare measurements from the Pivot Breath Sensor to a similar device
* assess user documentation comprehension
* obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.

The objectives of this performance study are to:

* Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
* We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.
* assess user documentation comprehension
* obtain feedback on the Pivot Breath Sensor via rating scales.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Owns and uses a smartphone
* Willing to sign the Informed Consent Form
* Resident of the United States
* Able to read and comprehend English

Exclusion Criteria:

* Prior experience with a study sponsored by Carrot Inc.
* Pregnancy
Better Memory With Literacy Acquisition Later in Life

This study aims to discover whether acquiring basic-literacy in adulthood can improve episodic memory and brain structural and functional connectivity. In a collaborative project between Brazil and USA, the investigators will use a randomized controlled trial approach to leverage the level of evidence of the benefits of basic adult-education as a possible cognitive reserve builder. If successful, the study's findings will be important in shaping policies targeting increasing access to late-life education to reduce dementia risk.


Eligibility Criteria:
Inclusion Criteria:

Being illiterate (TOFHLA score \<53) and availability to participate in the study for at least 12 months

Exclusion Criteria:

A) Presence of remarkable cognitive complains and/or decompensated psychiatric illness (depression and anxiety) and/or current substance abuse such as alcohol and illicit drugs use.

B) Objective cognitive impairment: score of 2 standard deviations or bellow for age and education on the Mini-Mental State Evaluation (MMSE) and/or score of 6 or lower on the delayed recall task from the Brief Cognitive Battery.

C) History of previously diagnosed dyslexia D) Formal MRI contraindications including metal or claustrophobia. E) Severe structural lesions detected by MRI.
Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.

This is a 48-week matched, prospective, observational, cohort study of HIV-infected adults on antiretroviral therapy who actively use heroin or who have never used heroin. The overarching goals are 1) to define the extent and specifics of immune activation in HIV-infected IV heroin users; 2) to define the effect of IV heroin on gut integrity and permeability, and the relationship of gut integrity alteration and immune activation; 3) importantly, to study the reversibility of immune activation, inflammation, and gut dysfunction after cessation of IV heroin, and to that effect, compare strategies for medication assisted treatment-buprenorphine/naloxone versus methadone or vivitrol maintenance; 4) to study if heightened immune activation associated with active intravenous drug use (IVDU) is associated with higher cardiovascular disease risk, including endothelial dysfunction and arterial inflammation, and if these effects are reversible with buprenorphine/naloxone or methadone.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection or no HIV infection
* 18 years or older
* HIV-1 RNA \< 400 if HIV-infected and on antiretroviral therapy
* On stable antiretroviral therapy at least 12 weeks with cumulative duration of at least a year for HIV-infected if on antiretroviral therapy
* Currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past for active heroin group
* Initiating medication assisted treatment for active heroin use initiating medication assisted treatment groups

Exclusion Criteria:

* Active infection, malignancy or other inflammatory condition
* Uncontrolled diabetes or hypothyroidism
* Known cardiovascular disease
* Pregnancy
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects

This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin alone and in combination with multiple doses of FG-4592, and will evaluate the effect of multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.

The study consists of 2 periods, separated by a washout period (a minimum of 14 days after warfarin dosing on Day 1, Period 1). Screening takes place from Day -22 to Day -2.

Subjects are admitted to the clinical unit on Day -1 of Period 1. On Day 1 of the first period, subjects receive a single oral dose of warfarin. After completion of all assessments on Day 8, subjects are discharged from the clinical unit on the condition that there are no medical reasons for a prolonged stay. They return to the clinical unit on Day -1 of the second period, after the washout period.

In Period 2, the subjects receive multiple doses of FG 4592. On Day 7 of Period 2, FG 4592 is given concomitantly with warfarin. After completion of all assessments on Day 16 of Period 2, subjects are discharged from the clinic on the condition that there are no medical reasons for a prolonged stay. The subjects return for an End of Study Visit (ESV) 5 to 9 days after the last assessment of Period 2 (or after early withdrawal).

Safety assessments are performed throughout the study. Blood and urine samples are collected for PK and PD assessments.

Eligibility Criteria:
Inclusion Criteria:

* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control.
* Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
* Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -1 and must use two forms of birth control.
* Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.

Exclusion Criteria:

* Subject has a known or suspected hypersensitivity to FG 4592, warfarin, or any components of the formulations used.
* Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit \[Day -1\].
* Subject is lactose intolerant.
Pink Esthetic Score Around Immediate Implants Using PDDM as Jumping Gap Filling Material.

Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft?

This study aims to evaluate the soft tissue changes as well as hard tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix in comparison to xenograft.

Because xenogeneic bone is so readily available in substantial quantities, it has been the subject of notable research. However, because they contain organic material from a foreign species, xenogeneic bones are inherently very antigenic.

According to experimental results, PDDM encourages bone regeneration in a manner like autogenous bone. Both cortical bone and autogenous tooth grafts share similar physical and chemical characteristics, including optimal biodegradability, not requiring a separate surgery to harvest the graft and space maintenance capabilities. PDDM is a valuable comparator to autogenous bone in ARP and around dental implants in guided bone regeneration procedures

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years of age; with non-restorable teeth requiring replacement with immediate implants in the maxillary esthetic zone.
* Absence of active infection at the surgical site.
* Adequate primary stability following immediate implant placement.
* Intact socket walls following the extraction.
* Class I dental socket based on a preoperative CBCT scan
* Buccal plate thickness more than 1 mm and thick biotype.
* Compliant patients who will sign an informed consent and agree to the follow up period.

Exclusion criteria

* Poor oral hygiene or the lack of regular maintenance.
* Individuals with compromised immune system or debilitating systemic disease.
* The presence of parafunctional habits (bruxism or clenching).
* External root resorption.
A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis

Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).


Eligibility Criteria:
Inclusion Criteria (main):

* mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;

  * female volunteers of childbearing potential\* must agree to use appropriate and reliable methods of contraception
  * written informed consent obtained.

Exclusion Criteria (main):

* severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
* treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
* treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
* treatment with vitamin A supplements;
* treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
* treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
* known allergic reactions, irritations or hypersensitivity to the active ingredients
* contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;
Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis

The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients

The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients.

To date, there is no conclusive evidence on the "best treatment" for patients presenting with IAD. This has led to current clinical practices tend to select IAD products based on its cost and availability, which can be heavily influenced by marketing and commercialisation efforts.

This study allows investigation of the effectiveness of IAD products to ensure the provision of optimal care.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years and above at point of recruitment
* Diagnosed with IAD
* At regular risk of exposure to urine and faeces over their hospitalization

Exclusion Criteria:

* Having a known allergy to the treatment products
* Haemodynamically unstable at point of assessment for study
* Unable to tolerate lateral positioning for skin cleansing and treatment application
* Pregnancy
* Having an existing skin disease at point of study that might lead to inaccurate IAD assessment, such as herpes or scabies.