cyrilzakka/clinical-trials huggingface dataset:
Telemedicine Intervention to Improve Cognitive Function

This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.

Background/Rationale:

Progressive cognitive impairment leading to dementia is an important component of Parkinson's disease (PD), contributing to significant levels of disability. The number of Veterans who will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely to increase substantially. Given the profound negative health and social consequences associated with the development of dementia, it is critical to identify interventions that effectively slow the decline of cognitive function to prolong the time to onset of dementia. Based on the results of prior studies, physical activity is one of the few nonpharmacological interventions that holds promise in slowing cognitive decline.

Objective:

The investigators hypothesize that a home-based physical activity intervention to promote walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD (PD-MCI).

Methods:

The proposed study is a randomized, controlled trial of a home-based walking intervention, evaluating effects on cognitive function. Community-dwelling Veterans with PD-MCI will be randomized to a walking intervention or a health education control intervention. Subjects will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and MCI. The interventions will last 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
* At least 2 of 3 cardinal signs of PD
* Response to dopaminergic medication
* Mild cognitive impairment

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy
Study Venetoclax Effectiveness and Real-Life Treatment Management in Participants With Chronic Lymphocytic Leukemia

This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label.
* Participants for whom the physician has decided to initiate CLL treatment with venetoclax.
* Participants the physician believes he can personally follow over all the study period.
* Participants who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control.

Exclusion Criteria:

- Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.
Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

Efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (AI) are limited. Investigators will implement AI for diabetic retinopathy screening in 13 health districts in Thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record
2. No full-time ophthalmologists in those primary hospital
3. Age more than or equal to 18 years
4. Eligible for fundus photo imaging at least 1 eye

Exclusion Criteria:

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists
2. Patients who previously diagnosed with other causes of macular edema, for example, Age-related Macular Degeneration, Radiation Retinopathy, Retinal Vein Occlusion etc.
3. History of retinal laser or surgery
4. Other ocular diseases that require referral to ophthalmologists
5. Not eligible for fundus photo imaging for both eyes (any causes)
Anogenital Wart Burden and Cost of Illnesses

The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older and has anogenital warts
* Physician confirmed clinical diagnosis of anogenital warts
* Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent
* Subject will be available for the study follow up period

Exclusion Criteria:

* Subject is unable to give informed consent
* Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI
Cognitive-behavioral Treatment for Rheumatoid Arthritis

To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* diagnosed by rheumatology consultants with RA

Exclusion Criteria:

* severe psychological difficulties
* currently receiving mental health care
* any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
* previously attended an education programme
* had a Modified Health Assessment Questionnaire score \>2 (score range 0-3), that is severe functional problems
* history of organic brain syndrome
* presence of a psychotic disorder
* presence of other uncontrolled medical disorders
* presence of a major communication disorder, illiteracy
* presence of less than an 8th grade education (due to inability to complete questionnaires)
* presence of a therapeutic dosage of an antidepressant medication, or presence of another autoimmune disease/disabling condition
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.


Eligibility Criteria:
Inclusion Criteria:

* 40% below of output of left ventricle
* tricuspid valve failure from moderate to severe
* urgent surgery required
* infectious endocarditis
Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Abstract:

Context/background: people affected by Amyotrophic Lateral Sclerosis (ALS) see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.

Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, heart rate variability (HRV), quality of life and mood in patients with ALS.

Methods: 20 volunteer patients, male and female, with ALS, bulbar or spinal will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 10) and a control group (n = 10). The Maximum Inspiratory Pressure (PIM), the HRV, the quality of life and mood will be measured. The participants of experimental group will conduct 30 inspirations per day, 15 in the morning and 15 in the evening, 5 days per week, through 8 weeks. The resistance of the training in the experimental group will be increase acording to the PIM measured at the first visit. During the first week, the resistance will be at 30% of PImax, weeks 2 and 3 at 40%, weeks 4 and 5 at 50% and the last 3 weeks at 60%. After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.


Eligibility Criteria:
Inclusion Criteria:

- Subjects with ALS

Exclusion Criteria:

* PImax more than 30mmH2O
* Score higher than 2 in GDS Reisberg scale
* Using already respiratory devices during the day (except night CPAPs support) more than 14h/day.
* Unstable medical disease for the last 3 years.
* Use of IMT contraindicated for medical reasons.
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2

The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.

We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(\>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes mellitus between 30 and 70 years of age.
2. Failure to triple OHA and on stable doses of insulin for atleast 3 months.
3. On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
4. HbA1c \< 8.5%.
5. Insulin requirement ≥0.4 IU/kg/d.
6. GAD antibody negative status.

Exclusion Criteria:

1. Patients with T1DM or secondary diabetes.
2. Patients with serum creatinine \> 1.5 mg/dl.
3. Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
4. History of cholecystitis/ cholelitiasis/ cholecystectomy
5. Seropositivity for HIV, HBsAg and HCV.
6. History of myocardial infarction or unstable angina in the previous 3 months.
7. History of malignancy
8. Patients with active infections.
Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo administer for 4 months. Patients selected for the study must have both aspirin exacerbated respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin desensitization and be taking aspirin on a daily basis for the treatment of AERD.

60 patients with Aspirin Exacerbated respiratory Disease will be screened to determine if they also have allergic respiratory tract disease as a co-morbid complication. This will involve history, allergy skin tests and a serum IgE level. They must also have been desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night.

40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections.

Monthly visits with the nurse co-ordinator will involve the following assessments: daily symptom scores, daily use of medications (particularly prednisone and rescue albuterol inhalers), lung function tests, nasal breathing test, measurement of smell and quality of life scores pre and post study.

Eligibility Criteria:
Inclusion Criteria:

aspirin exacerbated respiratory disease and allergic asthma

Exclusion Criteria:

* pregnant females,starting immunotherapy in the past 3 months, prior treatment with Xolair, negative allergy skin tests,unable to participate in lung function tests, unable to complete data forms,low platelets, serum IGE greater than 700 iu,cancer,another uncontrolled medical condition, unacceptable concomitant medication, under the age of 18 years.
Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate

The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* currently be treated at a University of MS Medical Center Internal Medicine Clinics
* currently taking metoprolol succinate for hypertension
* have their hypertension controlled (\<140/90).

Exclusion Criteria:

* uncontrolled hypertension
* severe renal or moderate hepatic impairment
* currently taking CYP 2D6 inducers/inhibitors
* recent stroke (less than 6 months)
* recent myocardial infarction (less than 6 months)
* congestive heart failure
* diagnosed obstructive sleep apnea
* atrial fibrillation
* arm circumference \>50 cm
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.

Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 \<=94%) and desaturation events requiring intervention (SpO2\<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.

Eligibility Criteria:
Inclusion Criteria:

* Weight loss surgery patients undergoing preoperative upper endoscopy
* BMI 40-60

Exclusion Criteria:

* Pregnant patients
* Previous weight loss surgery or stomach surgery
* BMI \> 60 and BMI \< 40
* Active smokers
* Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
* Lung disease, COPD asthma, cystic fibrosis, sarcoidosis
* Baseline O2 saturation less than or equal to 94%
* Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)
Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters

Chronic kidney failure in the single remaining kidney is one of the dreaded complications of nephrectomy in patients operated on for cancer-related reasons (1). Indeed, chronic kidney disease (CKD) is associated with major cardiovascular morbidity and mortality (2).

To date, there are few non-invasive methods available to predict the onset and progression of CKD in patients for whom nephrectomy is indicated. Preoperative creatinine and glomerular filtration rate are poor predictors of the subsequent risk of single kidney failure (1). Early predictive markers could help anticipate the management of CKD in patients for whom progression to end-stage renal disease is predictable. Furthermore, such markers could be used as a decision-making aid to specify the type of nephrectomy to be preferred (total versus partial nephrectomy).

The state of microcirculation, particularly retinal, is correlated with the progression of certain conditions such as diabetic nephropathy (3-5). A new technique for evaluating retinal microcirculation called OCT-A (an imaging technique in ophthalmology allowing a precise non-invasive study of the retinal microvascular network) has recently been used by our team to highlight an association between retinal vascularisation and the level of cardiovascular risk in a population of coronary patients without diabetes (6).

We hypothesize that the observation of retinal vascular abnormalities could reflect changes in kidney structure that could underlie chronic renal failure. The aim of this work is thus to evaluate whether the presence of abnormalities in the retinal microvascularisation is 1) predictive of the deterioration in renal function one year after nephrectomy for cancer-related reasons and 2) correlated with renal histological abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Indication for total nephrectomy for kidney cancer decided with a multidisciplinary oncology consultation
* Kidney scan images available
* Patient affiliated to French national health insurance
* Patient who has given oral consent

Exclusion Criteria:

* Pregnant woman
* Ophthalmologic history (macular vascular or degenerative diseases, epiretinal membranes, glaucoma)
* Cannot sit still for 60 minutes
* Metastatic cancer
* Single functional kidney before nephrectomy
* Estimated Glomerular Filtration Flow Rate (CKD-EPI formula) less than 60 mL/min/1.73m2
* Diabetes type 1 or type 2
* Proteinuria at inclusion (or in the 3 months prior to inclusion) on sample with a protein/creatinuria ratio greater than 1g/g or over 24 hours greater than 1g/day
* HIV, HCV or HBV positive serology
* Patient subject to a measure of legal protection (guardianship, curatorship, etc.)

SECONDARY EXCLUSION CRITERIA

* Patient with increased pressure during the measurement of the intraocular pressure before dilation
* Patient with histological abnormalities suggestive of nephropathy (excluding nephroangiosclerosis) or ischemic parenchymal sequelae of renal vein thrombosis in the pathological analysis of the nephrectomy sample
Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients.

Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years old
* Operative patients expected to require intensive care recovery at OHSU
* Planned or existing intra- and postoperative radial artery catheterization as part of routine care
* Palpable contralateral (to catheter) radial artery pulse
* Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total

Exclusion Criteria:

* No palpable radial artery pulse
* Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
* An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
* An AV shunt in the T-line arm
* Known sensitivity to pressure stimuli (dermatographism)
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.


Eligibility Criteria:
Inclusion criteria

Inclusion criteria (selected):

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
* Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
* Active malignant disease or current cytostatic treatment
* Known severe renal insufficiency
* Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal
* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
* Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control
* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
* Contraindications to enoxaparin
* Participation in a clinical trial during the last 30 days