cyrilzakka/clinical-trials huggingface dataset:
A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells

Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Total body surface area (TBSA) ≥ 5%.
* Full-thickness burn requiring operative procedures.
* Admitted ≤ 120 hours following burn.
* Injury location includes a contralateral area.

Exclusion Criteria:

All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:

* Patients who are moribund.
* Known infection with any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Human T-lymphotropic Virus (HTLV), Syphilis, or West Nile Virus.
* Injury location limited to face and/or hands.
* Pregnancy.
* Active cancer and currently undergoing treatment.
Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

This study adopts a combination of retrospective and prospective cohort research methods to explore the composition of preoperative oropharyngeal and gut microbiota in elderly patients undergoing elective upper abdominal surgery, aiming to analyze the correlation between preoperative oropharyngeal and intestinal microbiota composition and metabolite levels and the occurrence of postoperative pulmonary complications (PPCs). The research subjects of the retrospective cohort study were participants (ClinicalTrials.gov No. NCT05679661) included in the prospective RCT on the effects of perioperative immune nutrition intervention and oral hygiene on postoperative complications in elderly patients, which was conducted at Peking Union Medical College Hospital from January 2023 to present. The prospective cohort study plans to continue enrolling elderly patients aged ≥ 65 who underwent elective upper abdominal surgery.

This study collects preoperative oropharyngeal and fecal samples, as well as preoperative plasma from patients for microbial sequencing and untargeted metabolomics analysis. The main outcome measurement is PPCs, which include pneumonia, atelectasis, and hypoxemia within 7 days after surgery. Inflammatory cells and cytokines in peripheral blood are secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 65 years old;
2. Surgery: Upper abdominal surgery (expected duration ≥ 2 hours);
3. Anesthesia methods: general anesthesia, tracheal intubation;
4. ASA classification: I-IV levels;
5. Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
6. Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent

Exclusion Criteria:

1. Emergency surgery;
2. This is the second surgery within the past month;
3. Preoperative presence of pulmonary infection or other serious pulmonary complications
4. Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery
Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients

The purpose of this study is to better understand the impact that Indwelling Pleural Catheters have on patients with malignant pleural effusions from a psychosocial point of view.

After being informed about the study, all patients giving written informed consent will undergo a baseline assessment including disease and social characteristics on the day of their Indwelling Pleural Catheter (IPC) insertion. At 2 weeks and 6-8 weeks post insertion, they will be contacted via telephone for a semi-structured interview focusing on the psychosocial impact that the IPC has had on their lives. Data surrounding the medical care of the IPC will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Aged 18 years or above
* Diagnosis of malignant pleural effusion
* Will be undergoing IPC insertion for management of their malignant pleural effusion
* Have the means to be contacted and be able to conduct an interview in English via telephone within the study timeframe

Exclusion Criteria:

* Inability to consent
* Estimated life expectancy of \<4 weeks
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.

Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.

Eligibility Criteria:
Inclusion Criteria:

* Intracranial surgery will be performed
* Age 25-75
* ASA in the I-II-III risk group

Exclusion Criteria:

* Under GKS 15
* heart failure,
* renal insufficiency,
* liver failure,
* congenital neurological deficits
Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements

The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.

Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

* Patients who die during or after operation
Fetuin A in Hashimoto Thyroiditis

Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis

Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the eligibility criteria will be included in the study. Approval of the local ethics committee and informed consent of the participants will be received for the study. The study is conducted in accordance with the Declaration of Helsinki. Demographic characteristics, concomitant diseases, smoking and alcohol drinking habits, concomitant medication usage, anthropometric and biochemistry data of the eligible patients will be recorded. Patient group will consist of patients with newly diagnosed Hashimoto thyroiditis and the control group will consist of healthy volunteers.

Groups will be compared according to their demographic, an¬thropometric and biochemistry data and serum fetuin-A levels. In order to detect the relationship between the serum fetuin-A levels and clinical features, correlation analyses will be done.

Eligibility Criteria:
Inclusion Criteria:

* patients newly diagnosed with Hashimoto thyroiditis

Exclusion Criteria:

* Acute infection
* Acute or chronic inflammatory disease
* Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.)
* Hypoxic situations (chronic obstructive pulmonary disease etc.)
* Severe heart, kidney and liver disease
* Pregnancy
* Endocrine disorders
* Malignancy
* Usage of drug that affects thyroid hormone levels
Abnormally High Parathyroid Hormone Levels Worsens Outcomes in Vitamin D Depleted Critical Care Patients

This study aims to investigate the impacts of abnormally elevated PTH levels on clinical outcomes among critically ill patients with vitamin D depletion.

This study is a secondary analysis of data from a previous multicentre, prospective, observational cohort study (REC No: 201805087RINB) examining vitamin D deficiency prevalence and outcomes in critical care. From the previously enrolled 651 critically ill patients admitted to medical and surgical intensive care units (ICUs), those enrolled within 48 hours of admission are analyzed. Vitamin D depletion is defined as a serum 25-hydroxyvitamin D (25(OH)D) level \<30 ng/mL. Patients are categorized as PTH non-responders (PTH levels of 15-68.3 pg/mL) or PTH responders (PTH levels \> 68.3 pg/mL). The primary endpoints include the rate of survival to day 28 and the rate of survival to hospital discharge. Secondary endpoints include the length of ICU stay at day 28 and day 90, Acute Physiology and Chronic Health Evaluation (APACHE) II score, Sequential Organ Failure Assessment (SOFA) score, and blood clinical laboratory variables.

Eligibility Criteria:
Inclusion criteria:

1. Critically ill patients within 48 hours of ICU admission

Exclusion criteria:

1. Less than 20 years old
2. Severe malnutrition (BMI\<18kg/m2)
3. Severe anemia (hemoglobin concentration \<7g/dL)
4. Receiving high-dose vitamin D treatment (\> 3000 IU/day) within four weeks
5. Have been admitted to the ICU within three months
6. Suffering from diseases that affect vitamin D concentration, calcium metabolism or bone metabolism (for example: parathyroid disease, rickets, chirtosis, and severe cirrhosis \[Child C\])
7. Patients and family members who do not speak the native language
Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo

The study aims at evaluating skin wrinkling, puffiness and fatigue and dark circle appearance on asian and african-american healthy volunteer cohorts receiving a cosmetic formulation containing NMN (2%). The product will be evaluated after 28 and 56 days of twice-daily application in comparison with a reference cosmetic formulation using clinical scoring under dermatological control. Cosmetic acceptability and future use will also be subjectively evaluated by analysis of the subjects answers to an evaluation questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Subject having given her free informed, written consent
* Subject willing to adhere to the protocol and study procedures
* Subject with normal frontal temperature lower than 37.5°c/100.4°F
* Subject has read and understood the information given by the investigator related to protection against Novel Coronavirus 19 and necessity to contact the investigator in case of any suspicion of COVID related manifestation (increase of frontal temperature, cough, sore muscles, weakness...) during the study

Exclusion Criteria:

* Pregnant or nursing woman or woman planning to get pregnant during the study
* Start, stop or change in hormonal treatment (including contraceptive pill) \<1.5 months
* Cutaneous pathology on the study zone (face)
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous efficacy of the study product
* Subject having undergone a surgery under general anesthesia within the previous month
* Know allergy to certain cosmetic or dermato-pharmaceutic products
* Subject having done injections on face and/or a lifting
* Excessive exposure to sunlight or UV-rays within the month preceding the study
More Than Body Appearance (MBA) Intervention

The promotion of a positive body image is crucial to increase the efficacy of psychological interventions targeting body image. Recent studies indicated that positive body image also acts as a protective factor against the onset of ED symptoms. However, in the last decades, research has predominantly focused on reducing body dissatisfaction, with most available psychological interventions for body image adopting a disease reduction perspective while neglecting positive aspects of psychological functioning. This approach has shown limited efficacy in improving body image. Consequently, it is crucial to develop new psychological interventions including both perspectives (i.e., disease reduction and health promotion perspectives) to improve body image and to test their efficacy in different contexts and populations.

The aim of this study was to investigate the efficacy of a 2-week online psychological intervention (More than Body Appearance; MBA) designed to improve body image in young women at both high and low risk of developing Body Image Disorders and in female athletes practicing aesthetic sports.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above

Exclusion Criteria:

* Presence of a full-blown Body Image Disorder (BID);
* Current treatment for a BID.
The Psychobiological Effects of Participation in a One-Month Insight Meditation Retreat

The purpose of this study was to examine how participation in a 1 month intensive Insight (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social affiliation, and inflammation, which are important for physical health, longevity, and behavior, and (b) to relate observed biological changes to baseline levels and changes in psychological traits, which may underlie improvements in personal adaptive functioning.

The investigators are specifically assessing the effects of retreat on telomere length and telomerase levels in participants' white blood cells, as well as plasma levels of interlukin-6 (IL-6), to assess how the retreat experience impacts these markers of cellular aging and inflammation. The hypotheses are that retreat participation will increase both telomere length and telomerase activity, but decrease IL-6 levels. The investigators will also assess the impact of retreat participation on oxytocin-a hormone involved in a number of physiological and behavioral processes, including affiliative bonds and stress responses-the hypothesis being that participation in the retreat will increase plasma oxytocin levels. The investigators will then explore how these and other biomarkers relate to psychological processes and personality traits, which may also be altered by participation in the meditation retreat.

Eligibility Criteria:
Inclusion Criteria:

* Previous meditation experience equivalent to two 5-10 day residential meditation retreats

Exclusion Criteria:

* Disclosure of potentially contagious blood-borne illness (e.g., HIV, Hepatitis, etc.) or other illnesses that might interfere with telomere or telomerase measurement
Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
* The criteria for receiving secukinumab were according to standard clinical practice.

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
* Pregnant women and women during breastfeeding
The Brain Metabolic Change in Chronic Cancer Pain Patient: FDG PET Image Study

Cancer pain deteriorated in quality of life and related with numerous psychosocial problems. Over the one third of cancer patient suffered from moderate to severe cancer pain, even under adequate pain management.

The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology. As a functional neuroimaging, the PET evidently provided anatomical activated regions, size, and spatial extent information. In this study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain. Therefore, we may provide useful information to treatment target in cancer pain patients.

Overall, cancer incidence has decreased and the rate of cancer deaths in both men and women has also significantly declined among both men and women in all site.However, the prevalence of chronic pain is 28.2%, ranging from 22.5% to 35.4%, depending on the location of the primary tumor, and neuropathic characteristics were observed in 19.9% of patients with chronic cancer pain.

Despite numerous studies on cancer pathogenesis and diagnosis, few reports have demonstrated the brain mechanism underlying cancer pain. One study used resting functional magnetic resonance imaging (fMRI) to identify the changes in the functional brain network of chronic bone cancer pain mice under anesthesia. Cancer-induced bone pain (CIBP) might alter resting state activity of the cingulate cortex, prefrontal cortex (PFC) and ventral striatum, indicating a strong affective component of the CIBP mice.In imaging studies of human patients with cancer, patients with chronic cancer pain exhibited activation in the PFC.

The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology.Owing to the higher glucose metabolic rate in the brain, brain FDG-PET images are not routinely used in the clinical setting. However, several studies have demonstrated functional brain changes in human pain condition.In this study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients who scheduled whole body FDG-PET image scan for clinically indicated.
2. Age \> 20

Exclusion Criteria:

1. Unable to complete questionnaires.
2. Prior evidence of brain metastases.
Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL

A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign hand pigmentation who wish to improve their skin appearance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Female/Male.
* Age= 21-70 (Adults).
* Fitzpatrick skin phototype = I-V
* Congenital or acquired benign pigmentation on hands.
* Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
* Able to read, understand and provide written Informed Consent.
* Able and willing to comply with the treatment/follow-up schedule and requirements.
* Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.

Exclusion Criteria:

* History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
* Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
* Excessive underlying vascular conditions (e.g. dense network of capillaries).
* Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding.
* Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.
* Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
* Prior treatment with medium-depth or deeper, chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study.
* Any other surgery in treated area within 9 months of initial treatment or during the course of the study.
* Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated.
* Multiple dysplastic nevi or suspicious pigmentation in area to be treated.
* Presence of underlying tattoo in the treatment area.
* Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process.
Effect of Root Planing on Surface Topography.

In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing with piezoelectric ultrasonic scraper \[PU\]; or 4) root planing with vertically oscillating ultrasonic device \[VOU\]. Post-treatment, the teeth will be extracted and their topography analyzed in 124 observations with white light confocal microscopy, measuring the roughness parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing programmed tooth extraction for chronic advanced periodontitis.

Exclusion Criteria:

* Patients with no advanced periodontitis or patients that refused the treatment.