cyrilzakka/clinical-trials huggingface dataset:
Epidemiological Study on the Relationship Between Respiratory Health and Air Pollution From Industrial Sources

The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation to the one recovered in the Urban Community of Lille (CUDL) less industrialized.

Airflow obstruction include Pulmonary Disease, Chronic Obstruction and asthma. Identification of Airflow obstruction is through Functional Tests Lung. In the 1950s, high pollution levels were associated with increased mortality. Despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. The Urban Community of Dunkirk (CUD) focuses many large pollutant emitters. The long term effects of industrial pollution on TVO are unknown.

The main objective of the project is to compare the prevalence of Airflow obstruction in the Urban Community of Dunkirk affected by industrial pollution compared to that found in the Urban Community of Lille (CUDL) less industrialized. Secondary objectives are: 1) To assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) To assess the prevalence of TVO general population in French populations 3) Establish a baseline epidemiological and biological bank.

Eligibility Criteria:
Inclusion Criteria:

* had lived for at least 5 years in the same city or its surrounding urban area (either Lille or Dunkirk) in the northern of France
* Agreed to participate and signed contentment

Exclusion Criteria:

* The detainees
* People under legal protection
* Individuals unable to consent
Blood Biomarkers for Screening of Alzheimer's Disease

The goal of this observational study is to estimate the screen performance of blood biomarkers of interest (Aβ40 and Aβ42, P-Tau181, P-Tau217, GFAP and NfL) in patients with Alzheimer's disease (AD), mild cognitive impairment due to AD, and cognitively normal individuals. The main questions it aims to answer are:

* to identify core blood biomarker suitable for early screening of AD.
* to establish a comprehensive model for the early identification of AD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years;
* AD (meets the 2011 NIA-AA AD diagnostic criteria), or MCI (meets the 2004 Peterson MCI diagnostic criteria), or cognitively normal subjects;
* Signed informed consent form.

Exclusion Criteria:

* The presence of other disorders that can cause cognitive impairment;
* Unable to cooperate with the completion of cognitive assessment;
* Refusal to draw blood.
Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)

The purpose of the study is to determine the influence of preoperative co-morbidity in relation to increased length of stay and postoperative complications in patients receiving fast-track hip or knee replacement.

Preoperative risk assessment is well established and repeatedly demonstrated to be related to adverse postoperative outcomes regarding all organ functions. However, all evidence is based upon conventional care programs and none has been done on fast-track surgery, neither in total hip arthroplasty (THA) or total knee arthroplasty (TKA).

The purpose of this study series is therefore to evaluate the importance of conventional risk factors in an optimised fast-track TKA and THA set-up. These studies will be performed in the Lundbeck Foundation Center for fast-track THA and TKA, based on an established database, but with additional detailed risk information to be included in studies of certain types co-morbidity.

The Lundbeck Foundation Center Database prospectively registers patient characteristics and co-morbidity in all patients receiving hip and knee arthroplasty. This is done using a questionaire and with dedicated staff available to help in case of doubt regarding specific questions. Additional information is collected by scrutinizing the patients medical charts. Completeness of data has been shown to be about 95%.

Eligibility Criteria:
Inclusion Criteria:

* Standardized elective fast-track THA or TKA

Exclusion Criteria:

* Elective THA or TKA not in regular fast-track setup
* not a Danish citizen
A Mobile App Based Cognitive Dissonance Intervention for Smoking Cessation

This research study aims to develop a cognitive dissonance-based mobile app for smoking cessation (CoQuit) and test the efficacy of the app with 500 adult smokers who express a desire to quit smoking.

This research project will evaluate the CoQuit mobile app for smoking cessation by having 500 daily adult smokers recruited through social media and randomized to either the CoQuit app or an app that has similar content but no tasks for inducing cognitive dissonance among participants. Outcomes will be measured at 1- and 3-months post-baseline and will include quit attempts, number of days without smoking (smokefree days), and changes in smoking attitudes and behavior, and smoking abstinence. Usability data, system log data on program use, and participant satisfaction data will also be analyzed.

The researchers hypothesize that individuals using the cognitive dissonance intervention (CDI) will show greater increases in quit attempts, smoke free days, quit rates, and positive smoking attitudes and behaviors than individuals in the active comparison condition. The researchers will test whether gender, smoking dependence, readiness to quit, previous quit attempts, age of smoking initiation, and socio-economic status moderate intervention effects on smoking outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Self-reported daily smoking
* Having a valid home mailing address in the United States
* English-speaking
* Access to a smart phone with video capability for the duration of the project
* Expressed desire to quit smoking

Exclusion criteria:

• Currently participating in a tobacco cessation program
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age \>/=18 years
* Diagnosis of chronic renal anemia
* Not on dialysis
* Hemoglobin concentration \<10 g/dl
* No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
* Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min
* Adequate iron status

Exclusion Criteria:

* Transfusion of red blood cells during the previous 2 months
* Poorly controlled hypertension
* Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)
* Hemolysis
* Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Study of the AFB and Stenting of the Iliac Arteries

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia
* Rutherford classification category 3-5 chronic limb ischemia,
* age: 45-75 years old.
* Patients who consented to participate in this study.

Exclusion Criteria:

* Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;
* Flush occlusion of the common iliac artery;
* Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis \>50%);
* Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis \>50%);
* Refusal to participate in the study;
* Stroke or myocardial infarction within the past 3 months;
* Ischemic heart disease with New York Heart Association functional class IV;
* Malignant tumor with an estimated life span of under 6 months;
* Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting);
* Hepatic or renal insufficiency (bilirubin\> 35 mmol/l, glomerular filtration rate \<60 ml/min/1.73 m2);
* Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12
* unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.
Virtual Reality Cognitive Training in Alcohol Use Disorder

This study aims to test the feasibility of using exercises in virtual reality for cognitive training of patients with alcohol use disorder undergoing residential treatment.

Alcohol use disorder has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed, with improvements in specific cognitive and executive domains, with behavioral approaches consisting in cognitive training. The advent of computer-based interventions may leverage these improvements, but RCTs on the use of digital interactive-based intervention are still scarce.

The aim consists in exploring whether a cognitive training approach using virtual reality exercises based on activities of daily living is feasible for improving cognitive function in patients with alcohol use disorder undergoing residential treatment.

The method consists in a two-arm randomized controlled trial with individuals recovering from alcohol use disorder in a therapeutic community that will be assigned to an experimental and a control group. The experimental group consists of virtual reality-based cognitive training whereas the control group of treatment-as-usual. A comprehensive neuropsychological battery of tests will be used consisting in tests for global cognition, executive functions, and specific tests form memory, attention and cognitive flexibility. The AB design will involve a baseline assessment before intervention and post-intervention assessment.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Without history of psychiatric or neurological disorders
* Attending the inpatient program for rehabilitation of alcohol use disorder

Exclusion Criteria:

* Psychosis episode during the intervention
* Withdrawal from the inpatient program for rehabilitation of alcohol use disorder
Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis

The effect of comprehensive respiratory physiotherapy applications on respiratory function, functional capacity and peripheral muscle strength in children with cystic fibrosis and non-cystic fibrosis will be compared.

Bronchiectasis may be a congenital cause such as cystic fibrosis (CF) or non-cystic fibrosis such as primary ciliary dyskinesia, post-infectious conditions, aspiration and immunodeficiency; It is a disease characterized by irreversible dilatation of airways. Symptoms; purulent sputum production, chronic cough, hemoptysis, recurrent fever and pleurisy. Mucociliary clearance disorder secondary to inflammation and involvement of exocrine glands in CF plays a major role in the development of symptoms; In non-cystic fibrosis bronchiectasis (NCFB), the development of similar symptoms may occur regardless of these reasons. However, in the examinations of CF, proximal airways; In NCFB, distal airways have been affected more intensively. As part of pulmonary rehabilitation, comprehensive respiratory physiotherapy (CRP) has an important role in the treatment and management of bronchiectasis. Airway cleaning techniques, approaches to reducing respiratory work, and patient education form the basis of CRP and play an active role in the treatment and management of the disease. In the literature, there are studies in which the effects of CRP are given in both CF and NCFB patients and studies comparing evaluation results in both groups without treatment. However, no study was found to compare the efficacy of CRP in these two groups of diseases. Therefore, in this study, the investigators aimed to investigate the differences between the efficacy of CRP among the groups in children with CF and NCFB.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6-18 years old
* Clinically diagnosed as cystic fibrosis or non-cystic fibrosis bronchiectasis

Exclusion Criteria:

* Previous history of lung or liver transplantation
* Have had an acute exacerbation in the last month and / or have a history of hospitalization
* Having a diagnosis of orthopedic problems affecting mobility or a history of musculoskelatal surgery
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours. The primary outcomes include the rate of conversion to open, rate of intra-operative adverse events, the rate of post-operative adverse events relating to the cholecystectomy within 30 days, and re-admissions and re-operations relating to the cholecystectomy within 30 days. In addition, operative time, the rate of use of intra-operative imaging, and the hospital length of stay will be collected as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subject between 18 and 80 years of age at the time of surgery.
* Subject underwent a robotic-assisted cholecystectomy during the study time period.

Exclusion Criteria:

* Cholecystectomy was performed as a secondary procedure.
The Correlation Between Blood omega3 and ADHD

Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions.

Aim: Study the relationship between omega3 blood values and ADHD clinical status.

Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.

The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6 months, all children will undergo clinical examination and blood tests will be taken for omega3 index analysis. Blind frozen samples of isolated red blood cell (RBC) will be analyzed according to the omega3 index methodology.

Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions.

Aim: To investigate influence effects of omega3 dietary supplementation on ADHD symptoms and the measured blood values.

Methods: The study will be authorized by the Ziv Helsinki Committee and the Ministry of Health. Written Informed consent will obtained from parents. The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.

Eligibility Criteria:
Inclusion Criteria:

- ADHD group: Children diagnosed with ADHD aged 6-14; children who have not received a dietary supplement of omega3 in the last month

Control group inclusion criteria: Children without ADHD and related neuropsychiatric syndromes aged 6-14, Children who have not received a dietary supplement of omega3 in the last month.

Exclusion Criteria:

- Children with severe chronic or autoimmune disorders, children who received a dietary supplement of omega3 in the last month
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in Combination With JS001,a PD-1 monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Expected survival ≥12 weeks.
* Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.
* Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:

Participants that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence \>6 months from completion of therapy are permitted.

* At least one measurable lesion based on RECIST version 1.1
* HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
* ECOG performance status score: 0 or 1.
* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.

Exclusion Criteria:

* Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Toxicity from a previous treatment has not returned to Grade 0-1.
* Prior ADCs or PD-1/PD-L1 inhibitor therapy.
* Active central nervous system (CNS) metastases.
* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
* History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
* Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Effects of Exhalation Valve on the Lack of Air and Exercise Tolerance in Patients With COPD

The purpose of this study is to evaluate the effects of the application of Expiratory Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD).

Initially will be collected clinical and anthropometric data of the participants, and they are packaged in self-evaluation form. The evaluation of pulmonary function at rest (spirometry, body plethysmography and lung diffusion capacity for carbon monoxide) will be rescued from patient charts. When carried out for over six months, will be repeated by the researchers. Patients will conduct incremental CPET of 5-10W / min limited by symptoms (FEV1 \<1L - 5W or FEV1\> 1L - 10W) (Visit 1). After a period of 2-7 days the CPET will be performed submaximal with 75% of the peak load reached in the incremental CPET (visits 2 and 3). The application of EPAP (10cmH2O) via face mask (Vital RHDSON Signs®, New Jersey, USA) will be randomized with the help of opaque envelopes to be given in one visit. During the visit without EPAP will be maintained using the facial mask applied without resistance. IC serial measurements will be carried out before, during and immediately after the exercise. Participants will be instructed to maintain the use of long-acting bronchodilator as prescribed by the medical assistant usually before the methodological stages of the study.

Eligibility Criteria:
Inclusion Criteria:

* clinically stable patients without exacerbation of signs in the eight weeks preceding the study
* making use of drug therapy (long-acting bronchodilators)
* able to perform the exercise on the bike
* without other comorbidities that compromise the results exercise
* sign the Informed Consent

Exclusion Criteria:

* associated heart diseases
* diagnosis of asthma
* Oxygen therapy use
* SpO2 \<85% at rest
* use of oral corticosteroids or antihistamines
* use of artificial airway
* musculoskeletal dysfunction
Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout

To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.

1. To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.
2. to measure the level of uric acid in feces.

Eligibility Criteria:
gout

Inclusion Criteria:

1. age:year of 25\~60;
2. Be consistent with the 2015 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) gout diagnostic criteria ,and serum uric acid \>420 μmol/L;
3. The patient are willing to take part in our study.

Exclusion Criteria:

1. abronia, surgery, postoperative, dehydration within 2 weeks, acute or chronic infectious diseases, severe trauma, malnutrition, diabetes, malignant tumors;
2. diagnosed as cardiovascular and cerebrovascular diseases within 3 months;
3. heart failure (New York Heart Academy，grade IV);
4. hepatic insufficiency ( Alanine transaminase or Aspartate aminotransferase ≥3×upper limit)；
5. chronic kidney disease or abnormal renal function( serum creatinine ≥1.5×upper limit)；
6. excessive drinking；
7. The investigators considered the patients unsuitable for inclusion in this study.

hyperuricemia:

Inclusion Criteria:

1. age:year of 25\~60;
2. A medical record in our hospital showed that the person is healthy, without key disease;
3. serum uric acid \>420μmol/L without gout flares. Exclusion Criteria:Same as the group of gout.

healthy controls:

Inclusion Criteria:

age:year of 25\~60; A medical record in our hospital showed that the person is healthy, without key disease; serum uric acid ≤420μmol/L. Exclusion Criteria:Same as the group of gout.