cyrilzakka/clinical-trials huggingface dataset:
The MuSt-PC: a Feasibility Study on Intent to Use a Tool With Regard to Symptom Management

A study on the intent to use a tool (MuSt-PC) to manage symptoms of patients in a palliative care trajectory.

A survey study will be conducted to evaluate if GHCPs have the Intention to Use (IU) MuSt- PC in daily practice. GHCPs are recruited via the connections of the seven Centers of Expertise in Palliative Care. To invite them to participate in the study, the GHCPs are approached directly via e-mail or telephone. Participating GHCPs will be educated on how to use MuSt-PC (educational materials and instruction webinar). GHCPs will be asked to use the CDSS for five individual patients. Every time after using MuSt-PC they will be asked to answer additional questions about their experience with using MuSt-PC in that specific instance. After using MuSt-PC for five patients, they are requested to fill out a comprehensive questionnaire about their overall experiences with using the CDSS.

Eligibility Criteria:
Inclusion Criteria:

Residents (in Dutch: Arts In Opleiding tot Specialist (AIOS) or Arts Niet In Opleiding tot Specialist (ANIOS)), medical specialists and nurse practitioners working in the following disciplines are invited to participate:

* General practice
* Nursing home
* Hospital:

  * Clinical geriatrics
  * Medical oncology
  * Radiation oncology
  * Pulmonology
  * Cardiology

Exclusion Criteria:

HCPs who were formally trained in palliative care ("kaderopleiding palliatieve zorg", "Masteropleiding Palliative Medicine for Health Care Professionals at Cardiff University" or "post-HBO opleiding palliatieve zorg") and/or who have been or are currently a consultant of a palliative care consultation team are considered specialists in palliative care, are excluded from participation.

GHCPs (e.g. nurses) who cannot independently decide about CDSS recommendation adherence, including drug interventions, are excluded from participation.
Normal Values of Brain Oxygenation

New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 95 years undergoing a elective surgical procedure

Exclusion Criteria:

* History of cerebral disease
* Dependence on supplemental oxygen
Effects of a Daily Cognition Training in Older Adults Without Cognitive Impairment

To evaluate the effectiveness of a daily cognition training programme versus a traditional cognitive stimulation programme in cognitively unimpaired older adults on cognitive function, emotional state, frailty and functionality.

The present study aims to demonstrate the effectiveness of programmes that use everyday cognition for the assessment and intervention of healthy elderly people with the aim of maintaining or improving autonomy, compared to other programmes based on traditional cognitive stimulation, whose benefits do not generalise to significant improvements in everyday life. In addition, the investigators seek to relate how the presence of depression in older people impacts on everyday cognition, and therefore on the functionality of IADLs.

2. WORKING HYPOTHESIS AND MAIN OBJECTIVES TO BE ACHIEVED

1. WORKING HYPOTHESES

   * Alternative hypothesis (H1): Everyday cognition training programmes are more effective than traditional cognitive stimulation on cognitive function, emotional state, frailty and functionality in older adults without cognitive impairment.
   * Null hypothesis (Ho): Everyday cognition training programmes are not more effective than traditional cognitive stimulation on cognitive function, emotional state, frailty and functionality in older adults without cognitive impairment.

   In order to validate or disprove the main hypothesis, the following objectives have been developed:
2. OBJECTIVES:

i. MAIN OBJECTIVE: To evaluate the effectiveness of a daily cognition training programme versus a traditional cognitive stimulation programme in older adults without cognitive impairment, for cognitive function, emotional state, frailty and functionality.

ii. SPECIFIC OBJECTIVES:

* To compare the differences in the emotional state of older adults without cognitive impairment between the everyday cognition training programme and traditional cognitive stimulation.
* To contrast the differences in the cognitive function of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.
* To analyse the differences in the frailty index of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.
* To identify the differences in the functionality of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 60 years or older.
* Voluntarily sign the informed consent form about the project, authorising their participation.
* Carry out the initial assessment.
* Be admitted to the programme from the start of the programme.

Exclusion Criteria:

* No literacy skills or significant deficits in language comprehension.
* Institutionalised person.
* Have a clinical diagnosis of cognitive impairment.
* Participate in another cognitive stimulation programme during the intervention process.
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects

The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70, borh gender.
* Patient able and willing to sign informed consent and comply with study procedures.
* Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
* Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury.

Exclusion Criteria:

* Patient refusal.
* Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase.
* Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting.
* Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
* Patient has tunnels or sinus tracts that cannot be completely debrided.
* Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamicoxalacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value.
* Other clinical trial participants within 3 months.
* A random blood sugar reading \>/=450 mg/dL.
* Investigators judge other conditions not suitable for inclusion.
Long-term Study With Trazodone Once-a-Day

The aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who demonstrated an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, for up to 24 weeks.

This is an observational, prospective, single group, multicentre, international study.

The present study is planned to assess, in a real-world setting, the long-term clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who, according to the physician's judgment, have responded to the acute monotherapy (6 to 8 weeks of treatment) with Trazodone once-a-day and are eligible to continue Trazodone once-a-day monotherapy according to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Male and female patients of any ethnic origin ≥18 years old at Baseline. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 or the International Classification of Diseases (ICD)-10 criteria for MDD as their primary diagnosis and presenting with an episode of MDD.

Patients judged as responders to the acute monotherapy with TzOAD after a minimum of 6 and a maximum of 8 weeks of treatment and who are eligible to continue the assigned monotherapy according to the physician's judgement.

Patients legally capable of giving their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.

Exclusion Criteria:

Patients that meet any of the contraindications to the administration of TzOAD according to the approved SmPC.

Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, dysthymic or adjustment disorders, mental retardation, organic mental disorders or mental disorders due to a general medical condition.

Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative diseases that might compromise the participation in the study.

Patients who are, according to the physician's judgement, at serious risk of suicide.

Patients with substance abuse or dependence (except nicotine dependence), as defined by DSM-5.

Patients participating in any pharmacological or non-pharmacological interventional study.
Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

The pilot study purpose is to demonstrate that the tutorial which is a part of the device software, is giving sufficient training for the intended users.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as intermediate AMD in at least one eye
* Age \>50 years
* VA with habitual correction \>20/60 in the study eye
* Ability to speak, read and understand instructions in Hebrew
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient

Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 80 years
* Patients with subacute stroke within 2 weeks of onset
* First-ever stroke
* Supratentorial stroke
* Less than 8 SAFE (shoulder abduction, finger extension) points
* Less than 35 FMA Upper scores
* MEP (motor evoked potential) negative
* Not more than 24 K-MMSE (Korean Mini-Mental State Examination) score

Exclusion Criteria:

* Difficult to communicate due to severe language impairment.
* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
* If there are difficulties in conducting the research
* Any patients who are judged by the investigator to be difficult to participate in this study
* Patients with contraindicated MRI scans
Study of Psycho-Social Impact of Keloid

Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases, functional problem which translates to various repercussions on person's quality of life, including much stress and insecurities.

Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common condition and the investigators can make assumptions about those living with keloids, the investigators do not know the actual impact of the illness on the overall performance of patients' and how this disease, day to day, is impacting their lives. The investigators are conducting this study, aimed to investigate the psychosocial impact of keloid on daily life. Information is collected anonymously. You must be 18 years of age or older to take this survey. Parents can respond on behalf of their children who are not 18 years of age yet. The online survey will take 20-30 minutes to complete.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical Diagnosis of Keloid
2. Informed consent
3. Age above 18 to answer the survey questions
4. Parents shall respond on behalf of their minor children
The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor

Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity.

Preterm is defined as babies born alive before completing 37 weeks of pregnancy.

Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnant
2. gestational age at 18 weeks
3. previous vaginal or Cesarean section

Exclusion Criteria:

1. twins pregnancy in their second birth
2. previous preterm labor
3. diabetic during the second pregnancy
4. hypertensive during the second pregnancy
5. cigarette use during the second pregnancy
6. congenital anomalies
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.

The University of North Carolina will test the effectiveness of the Center for Disease Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies in combination, for increasing HPV vaccination coverage among adolescents in primary care clinics. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of physician educators providing feedback about clinics' current HPV vaccination coverage and in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers via remote webinar consultations. Physician educators will also use immunization registry data to provide feedback on clinics' vaccine coverage. The investigators will compare changes in HPV vaccination coverage before and after intervention for high-volume primary care clinics in four study conditions: AFIX consultations delivered in-person by state health department immunization specialists (AFIX group), physician-to-physician consultations delivered remotely by trained physician educators (P2P group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality improvement intervention (control group). In each state, 30 clinics will be randomly assigned to each study arm, for a total of 120 clinics per state, or 360 clinics overall. As a secondary endpoint, we proposed to evaluate the impact of intervention "booster" visits delivered at 12-months post-intervention. However, the CDC has recently changed the AFIX program so that the desired comparison is no longer possible. Therefore, we have eliminated booster visits. This change does not affect our primary endpoint. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the change in coverage for other vaccines, age groups and time periods.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems.

Exclusion Criteria:

* Less than 200 active records for patients between 11-17
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy.

Exclusion Criteria:

Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.
Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.

The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery.

The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CBD stone and treated by ERCP

Exclusion Criteria:

* Patient unfit for surgery,
* Pregnant patients,
* Patients with severe malnutrition,
* Patients with liver cirrhosis,
* Patients in whom endoscopic management of CBD stones failed
* Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones
* Patients who underwent previous upper abdominal surgeries
* Mentally retarded patients.
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids

Background:

Deafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant.

However, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.

Materials and methods: The unicentric, prospective cohort study included 388 patients with presbycusis aged 60-85 who were recruited in the Department of Otorhinolaryngology from March 2022 to March 2028. They were averagely divided into the control group (n = 194) and the intervention group (n = 194). The post intervention group received hearing aid intervention, and was followed up for 5 years, once every six months. Audiological assessment, cognitive function assessment, noninvasive brain imaging assessment and hearing aid effect assessment were performed at baseline and each follow-up. This thesis aim to investigate the changes of cognitive function in senile deafness under the intervention of hearing aids.

Eligibility Criteria:
Inclusion Criteria:

Age\>60yrs，≤85yrs（MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84）; Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA);

Exclusion Criteria:

Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.