cyrilzakka/clinical-trials huggingface dataset:
Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty

The objective of this randomised controlled feasibility trial is to evaluate the feasibility of the Smart Taiko Drum-playing intervention embedding the cognitive-motor dual-task training concept for older adults with cognitive frailty, and identify the preliminary efficacy of the intervention on cognitive and physical functions and frailty status.

1. Study design:

   - Randomized Control Trial
2. Participants:

   - Community-dwelling older adults with cognitive frailty
3. Setting:

   - Community centres for seniors
4. Intervention

   * Playing Smart Taiko three times/weeks x 16 weeks for 30 - 45 minutes each session
   * A Smart Taiko Drumming system has been developed for older adults to play the drumming game with their preferred music genres.
5. Waitlist-control group

   - Will receive usual care
6. Health outcomes that will be assessed three times at baseline, during (8th week) and immediate post-intervention (16th week)

   * cognitive functions
   * physical functions
   * mental health
   * physical frailty status
   * body composition
7. Feasibility evaluation

   * recruitment
   * retention
   * satisfactory survey
   * compliance with the survey
   * safety
   * focus group intervention with participants

Eligibility Criteria:
Inclusion Criteria:

* with cognitive frailty
* without a diagnosis of a neurological or psychiatric condition that could affect cognitive function
* live independently or with partial assistance
* with pre-frailty

Exclusion Criteria:

* with a significant sensory or motor impairment that would preclude participation in the intervention
* are unable to understand or follow instructions due to language or hearing impairment
* have already been in another cognitive or physical intervention programme within the past three months
* are taking medications that could significantly affect cognitive or physical functions
* with any medical condition or treatment that would contraindicate participation in the study.
The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)

The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)
* must be able to complete a 1 week wash-out of current anti-diabetic medications
* Age 30-70 years
* HbA1c (Hemoglobin A1c) ≤11% at screening
* Body mass index (BMI) \<40 kg/m2
* Patients with type 2 diabetes mellitus (T2DM): Must have a fasting blood glucose of ≤12.2 mmol/L (240 mg/dL) at screening
* Able to provide written informed consent prior to study participation
* Able to communicate well with the investigator and comply with the requirements of the study

Exclusion Criteria:

* Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
* Need for insulin within the previous 3 months
* Use of Thiazolidinediones in the previous 4 weeks
* Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
* Treatment with systemic steroids and thyroid hormone (unstable dosage).
* Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* Significant illness within the two weeks prior to dosing.
* Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
* history or clinical evidence of pancreatic injury or pancreatitis;
* history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);
* evidence of urinary obstruction or difficulty in voiding at screening;
* Polymorphonuclears \<1500/µL at inclusion or platelet count \< 100,000/μL at screening and baseline.
* History of immunocompromise.
* Evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
Different Doses of Sevoflurane During Induction of Anesthesia on Emergence Delirium in Children

The investigators aim to reduce the incidence of emergence delirium in children aged 2-7 years old by using two different doses of sevoflurane during inhalatory induction of anesthesia.

Sevoflurane is an inhalational agent widely used in general anesthesia, both for induction and maintenance of anesthesia. It is not irritative on the airways and has a pleasant smell. Within their properties are: low partition coefficient blood / gas (rapid induction and awakening), low heart, liver and kidney toxicity. Inhalational induction in pediatric anesthesia with this agent is frequent to avoid vein puncture in awake patients and is generally done with maximum doses available to obtain a fast loss of consciousness.

Emergence delirium (ED) is frequent in children. It is defined as a mental disorder during recovery from general anesthesia that may include hallucinations, delusions and confusion expressed by crying, restlessness and involuntary physical activity. It usually lasts for 30 minutes and is not necessarily related to pain. During this episodes, children can hurt themselves or others, lose vascular catheters or other invasive devices. ED can generate anxiety and stress in caretakers, delay transfer from Post-Anesthesia Care Units (PACU), increase costs of medical attention and increase use of opioids or other sedatives.

Many interventions have been used to decrease the appearance of ED such as dexmedetomidine, clonidine, benzodiazepines, propofol among others but with no consistent results. The use of sevoflurane has been linked with ED in children and it can induce seizures in high doses (over 2 MAC).

The aim of this study is to test whether using a lower dose of sevoflurane (5%) during induction of anesthesia in children results in less ED than using higher doses (8%).

Eligibility Criteria:
Inclusion Criteria:

* Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
* American Society of Anesthesiologists (ASA) classification of I or II

Exclusion Criteria:

* Use of Total Intravenous Anesthesia (TIVA)
* Familiar or personal history of Malignant Hyperthermia
* Contraindication to caudal block
* Parents or legal guardians do not sign informed consent
Dermacyd Delicata Breeze - Photo Evaluation

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.
Anal Fistula Repair With Platelet-rich Plasma

Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate.

The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.


Eligibility Criteria:
Inclusion Criteria:

* complicated anal fistula with patient fit for surgical treatment
* minimum 6 weeks after
* written informed consent

Exclusion Criteria:

* age \<18
* pregnancy
* drug abuse, drug substitution program
* homeless (follow-up difficult)
* restricted in legal capacity
* simple fistulas requiring fistulotomy
* complicated fistulas requiring an anus praeter naturalis
SmartManage Stress Management for HIV+ Cancer Survivors

The purpose of this study is to design and refine a web-based platform developed for managing symptom burden in men who have sex who are HIV+ cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years or older
2. Fluent in English
3. Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
4. Be at least 30 days post active primary cancer treatment
5. Self identify as a sexual minority cisgender man
6. Self-report having been diagnosed with HIV
7. Have reliable access to a computer/device with internet accessibility

Exclusion Criteria:

1. Have had one of the following exclusionary cancer types: Non-melanoma skin cancer, brain cancer, eye cancer, history of some form of pediatric cancer (if that is participant's only cancer diagnosis)
2. History of advanced (metastatic) cancer of any type
3. Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
4. Appears actively intoxicated or otherwise unable to provide full informed consent
5. Have any other medical condition resulting in predicted live expectancy of less than 12 months
Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

Testing the effect of Virtual Reality - guided imagery acupuncture

The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers 18-75 years of age.
* Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
* At least 4/10 clinical pain on the 11-point LBP intensity scale.
* Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of back pain (e.g. cancer, fractures, infections),
* Complicated back problems (e.g. prior back surgery, medico legal issues),
* Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
* Conditions making study participation difficult (eg, paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
* The intent to undergo surgery during the time of involvement in the study.
* Unresolved medical legal/disability/workers compensation claims in connection with low back pain.
* Lacking the capacity to consent for oneself
* Do not have access to zoom or other software regularly to complete the study.
Near Infrared Spectroscopy in Thyroidectomy

Thyroidectomy operations have traditionally been performed as open surgery. However, the scarring that occurs in the patient leads to cosmetic problems, especially in young women. Today, as a result of the development of minimally invasive surgical techniques, the number of natural orifice transluminal endoscopic surgeries (NOTES) is increasing. Surgical scars are avoided by using natural pathways such as the mouth, urethra, vagina or anus. Transoral endoscopic thyroidectomy (TOETVA) with vestibular approach, a form of NOTES, was first performed in 2011. In this method, the operation is performed through three ports entered near the gingiva-buccal sulcus. TOETVA surgeries are performed with an insufflation pressure of 6 mmHg in the neck region. No studies are examining the effects of this pressure on the blood vessels in the neck region on the blood supply to the brain tissue. Therefore, the investigators aim to compare cases operated using open thyroidectomy or TOETVA method by measuring cerebral regional tissue saturation.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* Patients with neck surgery.
* Patients who received radiotherapy to the neck region.
* Patients with cerebrovascular or neurological disease.
* Patients who underwent open surgery during the operation.
New Treatments for Actinic Keratoses of the Scalp

This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.

Actinic keratoses are premalign skin lesions with increasing prevalence, causing a rising burden on the health care system. In this blinded controlled study we assess the efficacy of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy to daylight photodynamic therapy. It is a prospective, randomized and blinded split-head comparative study during the years 2016- 2024. 120 patients are recruited based on referral or from patients attending the clinic, with 2 or more actinic keratoses on the head, 60 to the pulsed dye-laser study and 60 to the fractional laser study. Follow-up appointments are 6 months, 1 year and 2 years post treatment. Patient reported maximal pain during treatment is documented.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)

Exclusion Criteria:

* pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, subjects must meet all of the following criteria:

* Has previously undergone primary TKA for any of the following:
* non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
* inflammatory degenerative joint disease including rheumatoid arthritis
* correction of functional deformity.
* Subject was implanted with the specified combination of components
* Subject is willing and able to complete required study visits and assessments
* Subject plans to be available through the 10 year postoperative follow-up visit
* Subject is willing to sign the approved Informed Consent document
* Subject must be at least 2 years post TKA prior to informed consent.

Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* Subject was skeletally immature (less than 21 years of age) at time of implantation
* Subject is currently enrolled in another clinical investigation
* Subject is unwilling or unable to sign the Informed Consent document
* Subject has documented substance abuse issues
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject has a body mass index (BMI) of greater than 40
* Subject is currently incarcerated or has impending incarceration
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.


Eligibility Criteria:
Inclusion Criteria:

* Have diagnosis of T2D according to the World Health Organization Criteria
* Have an HbA1c of 7.0% - 10.5% inclusive, at screening
* Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study
* These antihyperglycemic medications are accepted in the study

  * DPP-4 inhibitors
  * SGLT2 inhibitors
  * biguanides, such as metformin
  * alpha-glucosidase inhibitors
  * GLP-1 receptor agonists, oral or injectable
  * Sulfonylureas, or
  * Thiazolidinediones.
* Are insulin naïve.

Exceptions:

* short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes

  * Have a body mass index of ≤45 kg/m².

Exclusion Criteria:

* Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
* Have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
* Have had severe hypoglycemia episodes within 6 months prior to screening.
* Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening

  * acute myocardial infarction
  * cerebrovascular accident (stroke), or
  * coronary bypass surgery.
* Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
* Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.