cyrilzakka/clinical-trials huggingface dataset:
Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial

The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years;
* Have a cell or landline phone and internet access;
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>1 day/previous 30 when pain made it difficult to do usual activities.
* Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities

  * Willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program
  * Able to converse comfortably in English.

Exclusion Criteria:

* Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
* Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
* Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.
Effect of a Liquid Toothpaste on Periodontal Disease

The aim of the present clinical study is to evaluate the efficacy and safety of the novel toothpaste in patients diagnosed with gingivitis and/or periodontitis.

The trial was a randomized, double-blind, placebo-controlled, parallel group, single-center(Department of periodontology, Yonsei University Dental Hospital) study.

98 patients were assessed for eligibility. Since two patients did not meet the inclusion criteria, 96 subjects were randomly assigned to either the test group.The test group was provided a liquid toothpaste and a control group received placebo. At the end of the study, results were analyzed for 87 patients : 42 in the test group and 45 in the control group .

The study protocol requested 4 visits- once every two weeks-of each subjects in the center. At the baseline, subjects were randomly allocated to the test group or the control group. Scaling and tooth brushing instruction were performed and all of the clinical parameters were evaluated. At the 2- and 4-week examinations, clinical parameters of GI, PI were evaluated and at the 6-week examination, all of the clinical parameters were evaluated.

Also, Microbiological quantitative analysis of this procedure was performed at the baseline and 6-week examinations.

Eligibility Criteria:
Inclusion Criteria:

* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of 1.1\~2.0 as determined by the use of the Loe and Silness Gingival Index.
* Signed Informed Consent Form.

Exclusion Criteria:

* initial plaque index \<1.5, gingival index \<1.0
* smoker
* Chronic disease (uncontrolled diabetes, liver disease, heart disease, kidney disease..)
* subject who had hemorrhagic medical history or who take antiplatelet agent or anticoagulant
* subject who need antibiotics for preventive administration
* subjects who had preventive treatment or treatment for periodontitis in the last three months
* Use of orthodontic appliances.
* Pregnant women or women who are breast feeding.
* Previous participation in any other clinical trial in the last 30 days
* Judged unsuitable by investigators for other reasons.
Randomized Safety Study of CVT-301 Compared to an Observational Control Group

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.

Eligibility Criteria:
Inclusion Criteria:

* Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
* Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
* Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
* Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
* Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

Exclusion Criteria:

* Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
* Pregnant or lactating females or females wishing to become pregnant.
* Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
* Patients who have had previous surgery for PD (including but not limited to deep brain stimulation \[DBS\] or cell transplantation).
* Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
Dexmedetomidine vs Fentanyl for BMT

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to be eligible for participation:

  1. The subject is 6 months to 6 years of age
  2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
  3. The subject is scheduled for elective bilateral myringotomy with tube placement
  4. The subject's parent/legally authorized guardian has given written informed consent to participate

     Exclusion Criteria:
* Subjects will be excluded from study participation if any of the following exclusion criteria exists:

  1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
  3. The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
  4. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
  5. The subject has know central nervous system disease or neurological impairment
  6. The subject is an ASA classification of 3 or greater (See Appendix 1)
  7. The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
  8. The subject refuses inhalation induction
  9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)
Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease

Children with congenital heart diseases (CHD) often show reduced health related physical fitness as well as limitations in gross and fine motor skills/development. Intervention programs in childhood are still rare and often focus just on the improvement of cardiac outcomes or exercise capacity. Web-based interventions, as a useful alternative to training manuals or supervised training, are cost effective and allow a customization of training times. Primary purpose of this study is to improve health related physical fitness in children with congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Ages 10-18 years old.
* CHD with moderate to complex severity according to the ACC criteria.
* Health-related physical fitness \<50th percentile (healthy reference).
* German speaking.
* internet availability and an internet-capable device to use the intervention app
* Informed consent of parent/guardian as well as of the child.

Exclusion Criteria:

* Severe Arrhythmias
* Severe Left Heart Failure
* Chromosomal anomalies and/or genetic syndromes.
* Severe physical and/or sensory impairments (hearing, visual, or psychomotor).
* Elective cardiac intervention within the next 6 months following enrollment.
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers who are between the ages of 20 and 65
* Experienced any of the following sleep problems, at least more than once a week for more than 2 months: 1) difficulty in falling asleep or staying asleep; 2) waking up at dusk and not being able to fall asleep again; 3) not feeling refreshed even after getting some sleep.

Exclusion Criteria:

* Diagnosed with insomnia assessed with a structured interview and sleep scale measurements
* Possibility of drug-induced sleep disorders due to current intake of medication (i.e., corticosteroid, statin, etc)
* Had taken sleeping pills (i.e., zolpidem, benzodiazepine) during the past 2 months
* Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests.
* Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument
* A history of traumatic brain injury with loss of consciousness, or any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in body)
* Had taken psychotropic drugs within the past 3 months before study participation
* Allergic to polygonatum sibiricum or experienced side effects after consumption of any product containing polygonatum sibiricum
* Participated in another clinical trial or took other medications during the period that may influence the results of this clinical trial
* Currently taking contraceptive pills
* Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients eligible for major spine surgery
* must speak and understand Danish
* must be able to give oral and written consent

Exclusion Criteria:

* alcohol or medicine abuse
* treatment with opioids \> 100 mg daily
* allergy to local anesthetics
* severe obesity
Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and hyperinflation in patients with COPD.

In this pilot study the efficacy, safety and tolerability of high dose NAC in 12 patients with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a randomized crossover design. All subjects will be followed for 28 weeks.

The effect of high dose NAC on small airways will be assessed by measuring the total and peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP, erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms will be assessed by the St George Respiratory Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented COPD based on the following criteria:

   * Smoking history of at least 10 pack-years
   * Decreased Tiffeneau index (FEV1/(FVC \< 0.70)
2. Patients aged ≥ 40 years
3. Patients who stopped smoking since more than 1 month
4. Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)
5. Patients should be treated according to GOLD guidelines

Exclusion Criteria:

1. Unstable patients who developed an exacerbation during the last 8 weeks
2. Patients who are current smokers or stopped less than 1 month
3. Patients who are allergic to acetylcysteine or to another element of the product
4. Patients with phenylketonuria or an untreated active peptic ulcer
5. Patients with any stage kidney and/or heart insufficiency or hypertension
6. Patients already treated with NAC for more than 6 months or during the last 3 months
7. Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids
8. Patients who are pregnant or are breast-feeding
9. Patients who are treated with orally administered cephalosporins
10. Patients using supplements containing antioxidants as vitamins C or E
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures

Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.


Eligibility Criteria:
Inclusion criteria

* Displaced 3- or 4-part fracture of the proximal humerus
* Age over 70 years
* Independent living
* Low energy trauma

Exclusion criteria

* Pre-existing shoulder disease
* Severe cognitive dysfunction
* More than 14 days from injury to surgery
* Comorbidity that affects shoulder rehabilitation considerably
* Concurrent injury that affect shoulder rehabilitation considerably
A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery

The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.


Eligibility Criteria:
Inclusion Criteria:

1. General Inclusion criteria:

1. 18 years old ≤ age ≤85 years old;
2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
3. Subject or guardian can understand the purpose of the experiment and sign informed consent voluntarily Book and willing to cooperate to complete the follow-up.

2. Angiographic inclusion criteria:

1. The stenosis degree of visual target lesion ≥50%;
2. 2.5mm≤ Visual target vessel diameter ≤4.0mm;
3. Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
4. Target lesions to be treated intraoperatively cannot be treated in stages.

Exclusion Criteria:

1. General exclusion criteria 1)A stroke occurred within 30 days prior to surgery; 2)Percutaneous coronary intervention was performed within 72 hours before surgery; 3)Acute myocardial infarction, cardiogenic shock, or infarction occurred within 48 hours before surgery Received CPR; 4)Other cardiac procedures (such as aortic valve placement) are scheduled within 30 days of surgery Coronary artery bypass grafting, etc.); 5)Pregnant or lactating female subjects; 6)Severe hepatic or renal insufficiency or bleeding tendency; 7)Known allergy to interventional device materials and their coatings, or allergy to contrast agents; 8)Severe stenosis, occlusion of blood vessels at the intended puncture site, or local skin infection and uncontrollable; 9)Are participating in other interventional clinical studies, and have not completed the evaluation of the primary endpoint of the relevant study; 10)Participants who had other contraindications for interventional therapy or were judged by the investigator to be unsuitable for participation in the study;
2. Angiographic exclusion criteria 1)The TIMI blood flow grade of the target lesion was \< 2; 2)Treatment requiring intrastent restenosis, or prior placement of a stent in the target vessel near both ends of the target lesion; 3)Severe tortuosity or severe calcification of blood vessels; 4)There's an intracavitary thrombus; 5)In addition to balloon forming and stent implantation, other treatments (such as atheromatectomy, rotary grinding, laser ablation, etc.) are also required at the same time; 6)The researchers determined that percutaneous coronary intervention was not suitable for robotic assistance or that there might be high risks in the process.
Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.

Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure. However, no randomized clinical trials have investigated loop diuretics versus other interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of furosemide is based in studies from the 1970s. In this study, we aim to assess the acute effect of furosemide on cardiac filling pressures and pulmonary congestion.

Hypothesis:

Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac filling pressures and pulmonary congestion before significant diuresis occurs.

Design:

A prospective, interventional study including 20 patients admitted due to a clinical diagnosis of acute heart failure with pulmonary congestion.

Intervention:

80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS\*, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.

Prospective observational study of the acute and subacute effects of furosemide in patients with acute heart failure.

After inclusion, 80 mg of furosemide is administered IV.

Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Clinical diagnosis of acute heart failure requiring hospitalization
3. Systolic blood pressure ≥100 mmHg
4. Oxygen saturation \<94% or need of oxygen
5. Confirmed pulmonary congestion on x-ray or ReDS

Exclusion Criteria:

1. More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration
2. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
3. Known chronic obstructive lung disease
4. Pacemaker or ICD on the right side
5. Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
6. Wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
7. Height less than 155 cm or higher than 200 cm
8. BMI of less than 18 or more than 38
Clinical Characteristics of Critically Ill Patients With COVID-19

Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.

Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Therefore, many patients with confirmed COVID-19 with RT-PCR and/or suspected COVID-19 were hospitalized in ICUs with a limited number of beds. This ambiguity can result in both contamination risk to uninfected patients and occupancy rate of the limited ICU beds. Hence, it may be need a new scoring system for contagious critically ill patients. The aim of this study was to describe the epidemiological and clinical features of 75 critically ill patients due to COVID-19 and to compare confirmed COVID-19 cases with suspected COVID-19 cases in our critical care units.

Eligibility Criteria:
Inclusion Criteria:

* All patients with confirmed COVID-19 and suspected COVID-19

Exclusion Criteria:

* All patients \<18 years old