cyrilzakka/clinical-trials huggingface dataset:
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy elderly subjects.

Primary:

* To determine whether low does of the α2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated working memory and executive control functions, in healthy elderly subjects. Subjects will be randomly assigned to receive placebo or guanfacine at one of two dose levels: 0.1 mg, or 0.5 mg daily at bedtime in double-blind fashion for twelve weeks.

Secondary:

* To determine whether guanfacine can favorably influence global status and quality of life (QOL) in healthy elderly subjects.
* To determine whether low-dose guanfacine is safe and well-tolerated in healthy elderly subjects.

Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled will be nondemented, male and female individuals who meet the following inclusion criteria:

* 75 years of age or older
* Fluent in English
* Stable medical condition for at least 4 weeks prior to Screening visit
* Stable dose of non-excluded medications for at least 4 weeks prior to Screening visit

Exclusion Criteria:

* Dementia
* Mild Cognitive Impairment (Amnestic MCI)
* Clinically significant neurologic disease
* Clinically significant or unstable medical conditions that would interfere with participation in the trial
* Known hypersensitivity to guanfacine
* History of alcohol or substance abuse or dependence within the past 5 years
* Active major psychiatric disorders, including major depression
* History of mental retardation
* Significant abnormalities on clinical laboratories, ECG, or physical examination
* Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
* Education level \< 6 years
Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial.

The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA

A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis patient (KL classification gr 2-4)
* Primary TKA
* Varus deformity \< 20 degree
* Flexion contracture \< 20 degree

Exclusion Criteria:

* Coagulopathy
* Platelet dysfunction
* Inflammatory arthritis
* Revision TKA
Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis

A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis

"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.

Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).

Eligibility Criteria:
Inclusion Criteria:

* Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015)
* Must have AD affecting \>5% total body surface area (TBSA) at Baseline
* History of AD for at least 3 months prior to Baseline
* Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures

Exclusion Criteria:

* Use of topical corticosteroids within 7 days prior to Baseline
* Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
* Subjects that require systemic therapy for the treatment of AD
* Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
* Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
* Any clinically significant skin disease other than AD
* Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
* History of severe anxiety and/or depression; any history of suicide attempt
* Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
* Subjects who, in the opinion of the Investigator(s), would be non-compliant with the visit schedule or study procedures
* Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
* Chronic condition(s) which are either unstable or not adequately controlled
* Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
* Any medical condition that may, in the opinion of the Investigator(s), preclude the safe administration of test article or safe participation in the study
Primary Prevention of Peristomial Hernias Via Parietal Prostheses

The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.

Eligibility Criteria:
Inclusion Criteria:

* The patient has given informed consent
* The patient must be affiliated with a health insurance programme
* The patient must be available for 24 months of follow-up
* The patient requires a colostomy (primo-event, ie first colostomies only)

Exclusion Criteria:

* The patient is currently participating in another interventional study
* The patient is in an exclusion period determined by a previous study
* The patient is under guardianship
* The patient refuses to sign the consent
* It is impossible to communicate information to the patient (does not read French)
* The patient is pregnant
* The patient is breastfeeding
* There is a contra-indication for any treatment used in this study
* The subject has already had a colostomy
* The subject has peritonitis
* The subject needs a colostomy for infectious reasons
Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

To maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Eligibility Criteria:
Inclusion Criteria:

* PD greater than 3 years
* Stable dose L-dopa but symptoms not adequately controlled and have "off" time
* Able and willing to complete diary on specific days

Exclusion Criteria:

* Previous use of rotigotine or Neupro
* Atypical Parkinson's syndrome
* Pallidotomy
* Thalamotomy
* Deep brain stimulation
* Fetal tissue transplant
* Dementia
* Psychosis
* Hallucinations
* Epilepsy
* Renal or hepatic dysfunction
* Clinically relevant cardiac dysfunction
* Symptomatic orthostatic hypotension
* Skin sensitivity to adhesives or unresolved contact dermatitis
* History of chronic alcohol or drug abuse
* Pregnant or of child-bearing potential
* Impulse control disorder
"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome

The aim of the study is the evaluation of the effect of metformin among the patients without diabetes, on the incidence of reintervention, unplanned revascularization, after full percutaneous coronary revascularization as a result of the first episode of the acute coronary syndrome (ACS).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* ACS, according to the current definition of the European Society of Cardiology, treated with percutaneous coronary intervention with drug eluting stent implantation
* Occupation and place of residence not causing difficulties in participating in control visits
* Uncomplicated course of the disease (ACS) as assessed by the treating physician
* Negative history of diabetes
* Not taking any hypoglycaemic drugs prior to hospitalization immediately or within the last 6 months
* HbA1c\< 6,5% (assessment during hospitalization)
* Written consent to participate in the study

Exclusion Criteria:

* Significant valve disease confirmed by ECHO
* Previous CABG
* NYHA IV during hospitalization
* Chronic kidney disease with GFR \<60 ml / min / 1.73 m2 according to MDRD
* ALT three times above normal according to laboratory criteria
* Serious co-morbidities and estimated survival less than 2.5 years, as assessed by the treating physician
* Known gastrointestinal disease that may potentially be responsible for the intolerance to metformin (e.g. inflammatory bowel disease, gastro-oesophageal reflux disease)
* Known potential difficulties in cooperation with patients (dementia, mental disorders, distance from the place of residence, if considered potentially problematic, alcoholism)
* Hypersensitivity to metformin
* Pregnancy and breastfeeding
* Patient participation in another clinical trial
ALBI and PALBI Scores and HCC Prognosis

To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores.

To investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and overall survival among different modalities of treatment.


Eligibility Criteria:
Inclusion Criteria:

• The diagnosis of HCC will be based on the presence of an arterial hypervascular focal lesion \> 2 cm with rapid wash-out with a single imaging modality (triphasic computed tomography (CT), or dynamic magnetic resonance imaging (MRI)) or two imaging modalities demonstrating the before mentioned feature for lesions \< 2 cm with or without elevated serum alpha-fetoprotein (AFP) levels.

Exclusion Criteria:

* Patients below 18 years old.
* Patients with pre-existing other malignancies.
* Patients with pre-existing gall bladder stones, benign strictures, or other biliary diseases.
* Patients with pre-existing haematologic disorders.
* Patients with proteinuria.
* Missed follow-up.
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles

To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.


Eligibility Criteria:
Inclusion Criteria:

* Female between ≥18 and ≤65 years old.
* Décolleté wrinkles with a rating of moderate to severe (grade 2 to 3) on the MAS Décolleté Wrinkles-At Rest as determined by the blinded live rater and confirmed by the treating investigator afterwards.

Exclusion Criteria:

* Any previous treatment with fat injections, poly L-lactic acid or permanent dermal fillers (e.g., silicone, polymethyl methacrylate) in the décolleté.
* Any previous surgery, including plastic surgery, or surgical permanent implant in the décolleté or in the breasts that could interfere with effectiveness and safety.
* Any previous thread lifting in the décolleté.
* Previous treatment with collagen fillers, calcium hydroxylapatite (CaHa), and/or long-lasting hyaluronic acid (HA) fillers (e.g., Belotero® Intense/Volume, Juvéderm® Volift/Volbella) in the décolleté within the past 24 months before baseline.
* Previous treatment with other HA fillers in the décolleté within the past 12 months before baseline.
* Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non-invasive skin tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment) in the décolleté within the past 6 months before baseline.
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. For institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required.

Exclusion Criteria:

* Patient will not sign the Informed Consent
Manage Macular Cystoid Edema with Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab

The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.

Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.

Eligibility Criteria:
Inclusion Criteria:

* Foveal center-involved macular edema (ME) lasting less than 9 months
* Central Macular Thickness (CMT) greater than or equal to 250 μm
* Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
* Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections

Exclusion Criteria:

* Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
* Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
* Concerns or doubts regarding treatment
* Known allergies to the ingredients of the medication.
Influence of Oxytocin on the Startle Reflex and on Its Modulation

Oxytocin (OXT) is currently regarded as a crucial neuropeptide in the mediation of various human social behaviors, e.g. social affiliation, social recognition, and the modulation of anxiety, mood, and aggression. An impairment of social behavior, emotional regulation as well as increased stress reactions are characteristic of several psychiatric conditions, including schizophrenia, social anxiety and PTSD, in which there is also some evidence for OXT dysfunction. The startle reflex is a basic defensive reaction that can be modulated by emotional stimuli. The investigation of the startle reflex and of its modulation is a well-validated method to test stress reactions and emotional regulation. These processes are impaired in the same psychiatric diseases, in which OXT dysfunction was evidenced. Although previous animal studies showed that the dysfunction of brain OXT systems might be implicated in startle reflex and in its modulation, no study has been performed yet in human that investigated the influence of OXT administration on the startle response and on its affective modulation. A first aim of this study is to investigate the influence of OXT on stress reactivity and emotional modulation in healthy humans. A second aim is to develop a method for the investigation of anxiety disorders. Fifty male healthy participants will be tested using a randomized double-blind placebo-controlled cross-over design in two occasions; once with administration of 24 IU OXT, and once with placebo using nasal sprays while performing a computer-based experiment, in which emotional pictures and auditory startle probes are presented. We will measure the subject's subjective ratings of the pictures as well as the facial EMG activation, heart rate and electrodermal activation throughout the study. This project offers a unique opportunity to study the relationship between the OXT system and basic motivational and emotional behaviors. The investigation of these mechanisms is in turn greatly worthwhile, not only for understanding of the neurochemical and physiological processes involved in emotional regulation, but also for the comprehension of the neuroendocrine and neurophysiological mechanismsunderlying anxiety disorders. In the long term, it could open the possibilities of OXT as a psychobiological therapeutics of psychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* gender: male
* age \> 18 years
* good command of German
* non-smoker

Exclusion Criteria:

* impaired cognitive abilities
* past or current psychiatric or neurological disorder
* other relevant somatic disease (including liver, kidney or heart diseases - -- allergy to preserving agents (Paraben contained in nasal spray)
* other medication including hormonal and herbal medication
* participation in other clinical studies within one month
* impaired hearing
Exploring the Association of Imaging and Tumor Microenvironment in Urologic Cancer Using Radiogenomic Approach（Radiogenomics-Urinary）

This is the prospective, observational cohort study (Radiogenomics-Urinary), which aims to explore the relationship between the imaging information of urologic cancer patients, tumor microenvironment and the prognosis of urologic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated for urologic cancer in Wuhan Union Hospital from August 2024 to August 2027;
2. Aged \> 18 years old;
3. At least one CT scan or MRI scan before treatment;
4. Tissue biopsy pathological examination confirmed the diagnosis of the above tumors.

Exclusion criteria：

1. Poor image quality;
2. Incomplete clinical data or loss of follow-up;
3. Presence of another primary malignancy other than urologic cancer;
4. Unclear pathological diagnosis。
The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers

Pilot study to test the acceptability and feasibility of an intervention aimed to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition and cardiorespiratory fitness.

The evolution of the MOVI studies, conducted by the research group, has led to create the last project (MOVI-HIIT; ClinicalTrials.gov Identifier: NCT04863040).

This pilot study will include children aged 4-6 years from 2 public schools of the province of Ciudad Real, Spain, with 2 arms (intervention and control) and the intervention will last 8 weeks.

The intervention proposed in the study is implemented through an online platform developed to achieved the intensities required for the age-range of participants, but this platform has never been tested accurately in the classroom.

Thus, it seems necessary to pilot the intervention to evaluate the acceptability and feasibility of the intervention, in order to improve facts, if necessary, to achieved proposed objectives.

Eligibility Criteria:
Inclusion Criteria:

* The participating schoolchildren must belong to the 2nd and 3rd year of preschool education, not have any malformation that prevents them from learning the Spanish language (or Spanish sign language), not have any type of physical or mental disorder that parents and/or teachers have identified that prevents the performance of physical activities, not suffer from any chronic disease such as heart disease, diabetes or asthma that, according to the criteria of their pediatrician - after analysis of the program of activities - prevents their participation in the measurements and/or the intervention.
* As this is an intervention in the classroom, the school faculty will include the active breaks proposed in the center's programming, for which reason the intervention will be received by all the children in the intervention group school. However, the investigators will consider school participants to be those who have the consent of the parent or guardian for participation in the study. In addition, schoolchildren must verbally express their willingness to participate in the baseline and final physical examinations.

Exclusion Criteria:

* Children with severe Spanish language learning difficulties.
* Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
* Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-HIIT)
Characterizing the Association Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18+
2. Planning to undergo surgery
3. English speaking
4. Ability and willingness to complete questionnaires and assessments

Exclusion Criteria:

1. Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
2. Known Pregnancy
3. Elevated Suicidality
4. Enrollment in a conflicting perioperative trial