cyrilzakka/clinical-trials huggingface dataset:
Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency Department

The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.

Clinical trial aimed to assess the impact of a pharmaceutical care program initiated in the Emergency Department vs standard care in patients with heart failure and/or COPD, conducted at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) between Jan12-Feb13.

The researchers hypothesize that a systematic, standardized pharmaceutical care program may be related to a lower frequency of drug related problems (DRP). Moreover, the investigators also hypothesize that 6-month mortality, the average length of the hospital stay, and its related cost may also be decreased.

This study was approved by the Hospital de la Santa Creu i Sant Pau Ethics Committee. Written informed consent will be obtained from the participants .

The study will include 100 patients who fulfill all the inclusion criteria, described in the Eligibility Section.

Eligibility Criteria:
Inclusion Criteria:

* Age: 65 years and over
* Admission in the Emergency Department for a period equal to or higher than 12 hours;
* Number of home medication equal to or higher than four;
* Diagnose in the Emergency Department episode: decompensated heart failure and/or decompensated COPD.

Exclusion Criteria:

* Suffering from dementia, severe mental disorders and living in nursing homes.
The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy

Objective: To evaluate the application effect of continuous nursing intervention in type 2 diabetic retinopathy (DR), and to explore its clinical application value. Methods：Patients with type 2 DR admitted to our Hospital from June 2019 to June 2022 were selected as the research objects and divided into intervention group and control group by random number table method. The control group received routine nursing intervention, and the intervention group received continuous nursing intervention on the basis of the control group. The related effect evaluation indexes such as fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin and visual acuity were collected and compared between the two groups at discharge, 1 year and 2 years after discharge. The readmission rate of the two groups was counted to evaluate the effect of continuous nursing intervention.


Eligibility Criteria:
Inclusion Criteria:

* (1) DR diagnosis and classification criteria in line with the latest version of the 2017 Clinical Guidelines for Diabetic Retinopathy developed by the American Eye Association \[9\];
* (2) Type 2 diabetes course of more than 5 years, with varying degrees of retinopathy;
* (3) Monocular disease, no blindness;
* (4) Education level above primary school; - (5) Patients informed consent for this study and signed a consent form.

Exclusion Criteria:

* (1) with severe cerebral hemorrhage or cerebral infarction, severe nephrotic syndrome, senile dementia, cardiovascular and cerebrovascular diseases;
* (2) Patients with macular edema, severe corneal (and) or lens opacity affect the observation of the fundus, angle-closure glaucoma can not mydriasis, other fundus diseases, and nursing interventions for other chronic diseases. This study was approved by the ethics committee of our hospital.
Deep Phenotyping of Rosacea and Migraine

This study aims to deep phenotype patients with rosacea and migraine

Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated.

The purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis with either rosacea and/or migraine

Exclusion Criteria:

* does not want to participate
* cannot co-operate to investigation
Early Incentive and Mobilization During COPD Exacerbation

To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both groups, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.

Prospective randomized study in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients for COPD exacerbation

Exclusion Criteria:

* Hospitalization within the previous 14 days,
* current participation in rehabilitation program,
* locomotor or neurological condition or disability limiting the ability to perform exercise,
* lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.

Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD.

ADHD is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention .ADHD is more often a complex disorder with a high rate of associated co-morbid conditions. Co-morbid conditions are prevalent among people with ADHD and increase its burden and complexity of management.Children with ADHD are at a higher risk than children without ADHD for developing other psychiatric disorders .Motor skill problems and Neurological soft signs are found in many neuropsychiatric conditions .NSS have been associated with inattention and behaviour difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD .

Eligibility Criteria:
Inclusion Criteria:

* Age: 6-17 years.
* Sex: both sexes will be included in the study.
* IQ≥70.

Exclusion Criteria:

* Age: less than 6 years or more than 17 years.
* IQ\<70.
* Patients with major neurological deficits, cerebral palsy and uncontrolled epilepsy.
* Patients with major psychiatric disorders e.g schizophrenia spectrum disorder.
* Patient who refusing to participate in the study or their caregiver refusing to give informed consent.
Acute Effects of Benzbromaron on the Pulmonary Circulation

Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known inhibitor of the TMEM16A channel and is used in patients with gout.

In this pilot study the investigators plan to investigate if Benzbromarone has an acute effect on the pulmonary arteries in humans. This will be investigated within the frame of a right heart catheterization performed in patients with known PAH due to clinical reasons. The investigators hypothesize that the application of Benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes upon NO and Benzbromarone may be compared.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* known pulmonary arterial hypertension
* right heart catheterization indicated due to clinical reasons

Exclusion Criteria:

* known allergy against Benzbromaron, Gelborange S or other ingredient of the used drug (Benzbromarone AL) or a drug with similar chemical structure
* severe renal insufficiency (GFR\<30ml/min/kg)
* renal diathesis
* severe hepatic disease (Bilirubin \>1.6 mg% or AST or ALT \> 3x Norm)
* known pregnancy
* uncontrolled systemic arterial hypertension (\>150 mmHg systolic or 95 mmHg diastolic)
* uncontrolled ventricular arrythmia
* uncontrolled bradycardic or tachycardic supraventricular arrythmia
* myocardiac infarction within the last 12 months
* pulmonary embolism within the last 6 months
* ongoing iv. or sc. Prostanoid therapy for PAH
* Pulmonary hypertension other than PAH
SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

The gastrointestinal tract has many functions; it provides nutrition, produces hormones, performs a barrier function, maintains a stable gastrointestinal micro flora and plays an important role in the inflammatory process as it is the largest producer of cytokines (proteins associated with inflammation). This gut function is impaired after colorectal (bowel) surgery. There is evidence to suggest that impaired gut function is associated with increased complications. Hence if gut function is preserved, it should equate with better outcomes. As a result, there has been increasing interest in treatments called Gut Specific Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a conditionally essential amino acid and preferred fuel source for intestinal cells. Research has shown that glutamine promotes cell growth, increases clearance of harmful organisms from the blood, and reduces the surgical stress response. In other words, glutamine has a favourable influence on gut function.

Recent studies from our unit using intravenous glutamine in critically ill patients have shown an early return of gut function, which in turn is associated with attenuation of the inflammatory response and improved outcomes. It is not known whether oral glutamine is associated with a similar outcome. A recent pilot study at our unit suggests an association between oral glutamine and early return of gut function. The aim of this research is to determine if giving oral glutamine results in an early return of gut function and whether this is associated with an attenuation of the systemic inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing elective colorectal surgery (both open or keyhole) will be eligible for the study.

Exclusion Criteria:

* Allergy to glutamine/placebo
* Failure to obtain informed consent.
* Patients with existing infections.
* Pregnant women and children under the age of 18 years will be excluded from the study.
* Patients on antibiotics in the previous 2 weeks.
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)

The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.

It is planned to enroll 105 patients into AMI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio.

Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues.

The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with AMI. There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction successfully treated by infarct related artery (IRA) successful revascularization
* Male and female patients, aged 18-80 years
* Large myocardial injury as demonstrated by LVEF ≤45% and/or infarct size (IS) ≥10% of the LV muscle on cMRI 2-5 days after pPCI
* Signed informed consent

Exclusion Criteria:

* Pacemaker or other contraindications to cardiac MRI
* Malignancy
* Moderate or severe immunodeficiency
* Acute or chronic bacterial or viral infectious disease
* Soft tissue disease or local infection in a place of required artery puncture
* Pregnancy or breastfeeding
* Any objective or subjective reason for inability to attend follow-up visits
* Females of childbearing potential, who does not want to use a highly effective method of contraception
* Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
* Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
* Life expectancy \< 1 year
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* The participant must answer Yes to the question ''Do you think your memory is not as good as it was?''
* Have a MoCA Score between 20/30 and 26/30
* Have a QAF score of less than 9/30
* Understand, read and talk French
* Having good visual and hearing acuity

Exclusion Criteria:

* Major cognitive decline or neurodegenerative disease.
* Already consuming a daily medium chain triglyceride or ketone supplement.
* Soy, milk, gluten or allergy to the study product
* Controlled or uncontrolled diabetes
* Uncontrolled chronic disease
* Vitamin B12 deficit
* Clinical anomaly in the blood chemistry profile
* QSP-9 score over 19/27
* Taking an anti-cholinergic drugs
* Recent change in medication
* Active cancer in the last 2 years
* General anesthesia in the last 6 months
* history of alcohol abuse or dependence in the last 2 years
* Participation in other interventional or PET research project
* Unable to undergo an MRI or PET scan
* History of kidney stones or hypercalcemia
* History of cardiovascular events or insufficiency
* Renal failure and / or creatinine \<58 umol or\> 110 umol for men and \<46 umol or\> 92 umol for women or if the GFR (glomerular filtration rate) \<60 ml / min / 1.73 m2
* Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.)
* Body mass index \<20 or voluntary weight loss of more than 5% in the last 6 months.
Effect of Bright Light Treatment On Elders In a Long Term Care Environment

The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will:

1. improve sleep quality
2. improve cognitive scores
3. improve depression scores
4. improve quality of life scores.

Bright light therapy has been shown to improve depression and insomnia in multiple studies. These are common conditions among elders, particularly those residing in long term care environments. Bright light therapy has been inadequately studied in the geriatric population. We will show that a groups of twenty elders can simultaneous be exposed to bright light and that it will result in improvements in multiple realms of behavior and quality of life. Elders will be tested with a number of neuropsychological test batteries prior to exposure to bright light and again at the end of a four week exposure. Some subjects will have daytime and night time activity levels monitored with actigraphy. Cortisol and melatonin levels will be obtained prior to and at the end of the exposure period.

Eligibility Criteria:
Inclusion Criteria:

* residents in Masonic Villages, Elizabethtown, PA long term care
* ability to give informed consent and complete the neuropsychological tests

Exclusion Criteria:

* blindness
* severe illness expected to preclude the ability to complete treatment
* moderate to severe dementia that precludes the ability to complete testing
* light sensitivity making treatment to light therapy uncomfortable
Study in Chronic Kidney Disease (CKD) Not on Dialysis

The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 20 years or above at the time of informed consent
* Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis
* Patients who had been in the care of a physician for Chronic Kidney Disease for \>2 months and was not expected to begin dialysis for at least 4 months
* Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)

Exclusion Criteria:

* Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of \< 7.0 mg/dL or \>/- 11.0 mg/dL) at Week -2 (Visit 2).
* Significant renal impairments
* Had acute renal failure within 3 months of Run-in period
COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes

The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.

The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression. The investigators approach will combine practice-based medical and cognitive behavioral treatment with strong community-based support to immediately place the patient at the right level of intervention based on disease and severity and to step-up treatment intensity and follow-up if the initial response is inadequate. The practice-based component will use a care manager linked to medical, pharmacologic, and behavioral colleagues. The community based component will utilize community health workers to provide support and facilitate access to resources. Goals include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining the impact of this approach on psychological mediators of improved glycosylated hemoglobin (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical Diagnosis of Type 2 diabetes mellitus
2. Glycosylated Hemoglobin (HbA1c) \> 7.0 = Uncontrolled
3. Positive score on diabetes related distress 2 question screener and/or
4. Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener

Exclusion Criteria: a diagnosis \[from billing records using International Classification of Disease, 9th Edition (ICD-9) codes\] of:

1. advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or
2. alcoholism or
3. cognitive impairment, or
4. major psychiatric disease or
5. any type of physical or mental impairment that would preclude active participation
Transbronchial Ablation for Peripheral Lung Tumor

The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.

The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable malignant lung tumor. The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 year-old.
2. Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis.
3. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.
4. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation.
5. Patients have good compliance and sign the informed consent.

Exclusion Criteria:

1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
2. Patients have contraindications of general anesthesia.
3. Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion.
4. There are large blood vessels or important structures adjacent to peripheral lung lesion.
5. Researchers consider the patient do not fit for the study due to other reasons.