cyrilzakka/clinical-trials huggingface dataset:
Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults

The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults.

Cognitive stimulating activities are often recommended for older adults; however, little is known regarding the effects of these activities on cognition, motivation and quality of life in this population. The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults. Eighty-eight older adults were enrolled in an open-label controlled clinical trial to evaluate the effects of this training program on cognition, motivation and quality of life. Training had a significant effect over time; the training group maintained their level of performance on verbal learning and memory tasks, whereas the control group exhibited a significant decrease in performance from baseline to post-intervention. The subjects in the training group were more motivated to learn at study entry; however, the training had no significant effect on motivation or quality of life. Abacus training associated with other activities may benefit verbal learning and memory in older adults. Additional studies with longer follow-ups are necessary to determine whether the results of this training will have a positive effect on the lives of older adults.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Score ≥ 26 on the Mini-Mental State Examination
* Portuguese as a native language.

Exclusion Criteria:

* A neurological or serious medical condition that would prevent participation in the study.
P3 Ghana Cookstove Study

Background:

Despite their potential health and social benefits, adoption and use of improved cookstoves has been low throughout much of the world. Explanations for low adoption rates of these technologies include prices that are not affordable for the target populations, limited opportunities for households to learn about cookstoves through peers, and perceptions that these technologies are not appropriate for local cooking needs. The P3 project employs a novel experimental design to explore each of these factors and their interactive effects on cookstove demand, adoption, use and exposure outcomes.

Methods:

The P3 study is being conducted in the Kassena-Nankana Districts of Northern Ghana. Leveraging an earlier improved cookstove study that was conducted in this area, the central design of the P3 biomass stove experiment involves offering stoves at randomly varying prices to peers and non-peers of households that had previously received stoves for free. Using household surveys, electronic stove use monitors, and low-cost, portable monitoring equipment, we measure how prices and peers' experience affect perceptions of stove quality, the decision to purchase a stove, use of improved and traditional stoves over time, and personal exposure to air pollutants from the stoves.

Discussion:

The challenges that public health and development communities have faced in spreading adoption of potentially welfare-enhancing technologies, like improved cookstoves, have highlighted the need for interdisciplinary, multisectoral approaches. The design of the P3 project draws on economic theory, public health practice, engineering, and environmental sciences, to more fully grasp the drivers and barriers to expanding access to and uptake of cleaner stoves. Our partnership between academic institutions, in the US and Ghana, and a local environmental non-governmental organization creates unique opportunities to disseminate and scale up lessons learned.


Eligibility Criteria:
Inclusion Criteria:

* Classified as "rural"
* Uses biofuel as main cooking fuel source
* Has women in household aged 18-55 and at least one child under five

Exclusion Criteria:

* Clusters that are close to the S1 clusters, creating a set of clusters far enough from the original R group that will create the S2 cluster.
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient must sign informed consent prior to the index-procedure
* Patient must be older than 18 years
* Patient must be compliant with follow-up dates at 1 month and 12 months
* Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
* Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
* Reference vessel diameter ≥4.5 and ≤6.5 mm (visual estimate)
* Patients with a TASC A, B or C lesion
* Diameter stenosis of target lesion \>50% or chronic occlusions
* Inflow arteries are free of hemodynamically significant obstruction (i.e. ≥50%)
* The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. ≥50%)
* At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography

Exclusion Criteria:

* Patients with Rutherford 1 and 6
* Patiens with Serum creatinine \> 2.0 mg/dL or renal dialysis
* Patient takes esomeprazole or omeprazole
* Patient is pregnant
* Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
* Target lesion cannot be crossed with a guidewire
* Target lesion is located in the popliteal artery
* Patients with a nickel-titanium allergy
* Patients with an aneurysm in the superficial femoral artery and popliteal artery
* Patients with a TASC D lesion
* Patients with a life expectancy \<1 year
* Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted
* Patients with previous bypass surgery in the SFA
* Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)
* Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure
* Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients

Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Stable COPD without an exacerbation within 3 months prior to study entry
* mild, moderate and severe COPD with or without treatments, regardless of COPD medications

Exclusion Criteria:

* Concomitant other chronic lung diseases including with TB and malignancy
* HIV
* Being on immunosuppressive drugs and systemic corticosteroids
* Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
* Cognitive impairment
* Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.


Eligibility Criteria:
Inclusion:

* age: \> 18 years of age
* admitted following cardiac surgery
* stay in the ICU expected to be \> 20 h
* blood glucose \> 6.7 mmol/l within 4 hours of ICU admission or patient already on insulin treatment

Exclusion:

* patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* known or suspected allergy to insulin
* any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* patients participating in another study
* moribund patients likely to die within 24 hours
* patients after organ transplantation within the last three months
* patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent doses of hydrocortisol)
Overall Diet Quality and Breast Cancer Risk

The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.

This study examined the role of overall diet quality on the risk of developing invasive breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow for the assessment of overall diet quality. Specifically, diet quality was characterized by the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010), Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations between diet quality and the risk of developing breast cancer were examined using multivariate Cox proportional hazard regression models to provide hazard ratios and corresponding 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

* Participants with no history of cancer diagnosis prior to baseline.
* Participants with no history of myocardial infarction prior to baseline.
* Participants with no history of stroke prior to baseline.
* Participants with no history of diabetes prior to baseline.
* Participants who are not missing excessive dietary data.
* Participants with energy intake values at ≥1% and ≤99% of the population distribution.
The Blood Pressure Analysis on Critically Ill Patients

The study is to explore the relationship between coefficient of variation of harmonic magnitude (HCV) and different organ failures among those critically ill patients. In the future, we can act as a warning system on patients with multiple organ failures or terminal illness, also as an indicator of treatment effect.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients in the 20-to-99 age range
* Subjects agree to sign the Informed Consent Form and are willing to cooperate with Arterial pulse measurement

Exclusion Criteria:

* Subject has severe arrhythmia
COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension

This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of hypertension
* Triglycerides of 120-400 mg/mL
* LDLc levels not requiring lipid lowering medication.

Exclusion Criteria:

* Has known contraindication to alpha- or beta-blocker therapy.
* Has taken any non-ocular beta-blockers within three months before screening.
* Has Type I or II diabetes.
* Taking lipid lowering medications.
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?

Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. The World Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. In fact, worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis are estimated to be at 9.6% and 18.0% respectively. In Hong Kong, the latest census revealed that 514,000 people suffer from degenerative arthritis, representing 0.7% of the population. Although these values are much lower than the international figures reported by the WHO, it is inevitable that the prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging population in Hong Kong. Similar to any other chronic disease with wide prevalence, the impact of osteoarthritis translates to a substantial socioeconomic burden on a societal level.

Total knee arthroplasty has become the gold standard to manage the pain and disability associated with end-stage arthritis who have exhausted all conservative measures. Although contemporary advances in prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient's recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid rehabilitation regimes.

Knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide proprioceptive feedbacks for those with knee injuries or knee pain. There are four categories of knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. This study will mainly be focusing on the effects of the unloader/off-loader brace. Previous studies have demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), speed of walking (p\<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis as a part of the conservative management protocol. However, there have few studies that investigated whether proprioceptive knee bracing has any role in functional recovery post total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (age over 18 years old) underwent Total Knee Arthroplasty within 2 to 4 weeks;
2. Adult who is able to provide written consent and compliance with treatment and assessment regime

Exclusion Criteria:

1. Patients with disabilities, wheelchair dependence for mobility;
2. Underwent revision Total Knee Arthroplasty;
3. Found with complication wounds following surgery;
4. Diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that might affect their compliance to treatment;
5. Do not fit to the sizes of knee braces;
6. Not to given written consent and be non-compliance with the treatment and assessment regime
The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.

Eligibility Criteria:
Inclusion Criteria:

1. chronic hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
2. more than 60 years of age or 60 years;
3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
4. patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
5. receive burr hole drainage;
6. sign informed consent voluntarily.

Exclusion Criteria:

1. pregnancy or lactation;
2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy
3. have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up;
4. patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity);
5. CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery;
6. have CSDH for more than 1 year or organized hematoma;
7. CSDH caused by over V-P shunting;
8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
9. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly;
10. have venous thrombosis of lower extremity or pulmonary embolism;
11. cannot regular reexamine within 1 year for any reason;
12. life expectancy less than 1 year;
13. participating other ongoing clinical trial;
14. patients are not qualified for other reason evaluated by two neurosurgeons;
15. have bile reflux gastritis and esophageal diseases.
Comparing the Stanford Letter Project Form to Traditional Advance Directives

Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for patients.

Step1: Any adult participant who is interested in completing advance directives and able to read and write in English and or Spanish will be eligible to participate in the study

Step 2:

Online Stanford consent form will be presented before the participants. Only after they read the consent and click on the participation link will they be able to enter the study.Those who are willing to participate will be randomly assigned to either the letter or traditional advance directives in Spanish and study measures. They will also answer questions as to how much they liked and understood the documents.

Step 4: The investigators will collect data until the investigators reach an n=1000

Step 5: The investigators will analyze the results and submit for publication.

In this protocol, we are assessing whether patients prefer the traditional advance directives or the letter directive. As it is just an questionnaire based study, there no risk for patients.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Under 18
The Effect of Audio Based Nutrition Education on Dietary Intake Practice, and Egg-based Diet Intervention on Nutrient Adequacy, and Gestational Weight Gain Among Pregnant Women and Newborn's Birth Weights in the North Sidama Zone, Ethiopia.

Background: Inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight. Likewise, majority of Ethiopian pregnant women have inadequate nutrient intakes. These may be due to their poor dietary habits. Nutrition education is well-established intervention to enhance optimal dietary practices and is crucial to design appropriate diet interventions like multiple micronutrient and protein-energy supplements to optimize pregnancy outcomes.

However, in this country, integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied. Therefore, this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women, and newborn's birth weight in North Sidama Zone.

Materials and methods: These studies will employee mixed study designs sequentially to address each specific objective. Baseline survey: A mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of North Sidama Zone in February 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women.

Following the baseline survey, four-arm cluster- randomized controlled trial (cRCT) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight from March to August 2024. A total of 300 pregnant women will be selected randomly from participants of the baseline survey, and enrolled in four arms in a 1:1:1:1 allocation ratios: A multi-level mixed-effect logistic regression model will be used for quantitative data analysis, and a paired and independent t-test will be employed to measure the mean change in dietary intake practice, gestational weight gain and nutrient density between intervention and control groups. The qualitative data will be analyzed using Atlas-Ti software according to the inductive thematic content analysis approach.

Budget and work plan: For this study 1,102,200 ETB will be required. The study will be funded by Norad Project, Hawassa University, Sidama Regional Government and other possible grants in future. The study period will be March to August 2024.


Eligibility Criteria:
Inclusion Criteria:- .Pregnant women less and equal 12 weeks of pregnancy.

.Exclusion Criteria: Pregnant women who had been diagnosed with:-

* Confirmed hypertension
* Diabetes mellitus