cyrilzakka/clinical-trials huggingface dataset:
Airway Inflammation, Symptoms and Lung Function in COPD

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.

Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.

Eligibility Criteria:
Inclusion Criteria:

* Post-bronchodilator FEV1/FVC ratio \< 70%
* Post-bronchodilator FEV1 \< 80%
* Smokers or ex-smoker with pack/years \> 15

Exclusion Criteria:

* Atopy
* Asthma
* Concomitant lung diseases (e.g. lung cancer)
* Acute infections of the respiratory tree in the previous 2 months including COPD exacerbation.
Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection

New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been successfully introduced into the treatment of Helicobacter pylori infection. However, it was suggested that resistance to fluoroquinolones has been increasing in the Korean population and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against Gram-positive organisms, whilst retaining good activity against Gram-negative organisms. Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and other members of the quinolone class. This potent activity is believed to be due to the enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M. pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.

The purpose of this study is to compare the efficacy and the safety of using standard triple therapy and gemifloxacin-containing triple therapy as a first-line treatment for Helicobacter pylori eradication in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19-70 years with H. pylori infection
* The presence of H. pylori was defined as positive if the results of one of the following two tests were positive:

  1. Rapid urease test (CLO™, Delta West, Bentley, Western Austria)
  2. Histology. Biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of H. pylori infection by Giemsa staining.

Exclusion Criteria:

1. Patients with previous H. pylori eradication therapy
2. Patients treated with H2 receptor antagonist, PPI, and antibiotics in the previous 4 weeks, or nonsteroidal anti-inflammatory drug (NSAID) in the previous 2 weeks
3. Pregnant or lactating women
4. Patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease
5. Patients who had a drug allergy to the study drugs
6. Patients with previous gastric surgery.
The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients

The purpose of this study is to see whether a physical activity intervention improves fitness, strength and reduces sedentary behavior. The investigators are also interested in determining if changes will improve quality of life and outcomes associated with renal transplant waitlist.

Over 30 million people have chronic kidney disease (CKD) and nearly 100,000 people are awaiting renal transplant for end stage renal disease (ESRD). Renal transplant, when compared to dialysis, improves quality of life, is more cost-effective, and reduces the risk of cardiovascular disease. However, many patients who are eligible for transplant become deconditioned while waiting for organ transplantation, and may be taken off the transplant waitlist for concerns the patient will not be able to tolerate surgery. Moreover, poor physical functioning prior to transplant was associated with a 2.5-fold increased risk for delayed graft function and 2.30 fold higher risk of patient death after renal transplant. Our team has also shown that functional limitations, such as slower gait speed and poorer grip strength, were associated with not being waitlisted for transplant and decreased survival in all transplant candidates undergoing evaluation. Functional limitation may reduce the individuals' overall level of physical activity, which can increase further disability. While physical activity (PA) interventions have been shown to be effective in reducing morbidity and mortality in other chronic diseases, no study has tested the efficacy of a PA intervention in patients awaiting renal transplant. Family caregivers are integral in the care of renal transplant candidates. Decades of research has shown that family caregivers are at increased risk for cardiovascular disease (CVD) and mortality when compared to non-caregivers. Investigators propose to include the family caregivers in the PA intervention to improve patient adherence to the intervention while reducing the caregivers' risk for CVD. The proposed study addresses several of the recommendations from consensus meeting on exercise in solid organ transplant which included testing a PA intervention in a large-scale trial with both standard and surrogate markers, using a novel technology-assisted delivery of the intervention, and focusing on mechanisms linking PA with health outcomes.

Eligibility Criteria:
Inclusion criteria

* Patient:

  * Waitlisted for renal transplant
  * =\>21 years of age
* Caregiver:

  * Primary caregiver for patient
  * =\>21 years of age

Exclusion criteria:

* Patient:

  * Active suicidal ideation
  * Thought disorder
  * Delusions
  * Hallucinations
  * Recent myocardial infarction, heart attack, or stroke
  * Planned elective surgeries for joint replacement
* Caregiver:

  * Active suicidal ideation
  * Thought disorder
  * Delusions
  * Hallucinations
  * Recent myocardial infarction, heart attack, or stroke
  * Planned elective surgeries for joint replacement
Cognitive Remediation in Alcohol Disorders

The individual and societal cost of alcohol use disorders (TUAL), present in 10% of the population in France, is considerable. Despite psychotherapeutic and drug addiction treatment, the relapse rate remains very high, partly because of their very frequent cognitive disorders. In fact, more than 75% of TUAL patients present to varying degrees neuropsychological alterations that are only rarely detected and never treated. However, these cognitive disorders limit the benefit of psychotherapeutic care, reduce compliance with pharmacological treatments and hinder the patient's ability to change his behavior with respect to alcohol. An innovative way to promote the maintenance of the therapeutic contract, and therefore to reduce alcohol consumption in these patients, would be to improve their cognitive functioning. The objective of this study is to measure the efficacy of a non-drug treatment, based on a specific and personalized cognitive remediation program, compared to a standard treatment in Day Hospitalization, in order to reduce the rate of relapse very high in TUAL. It is a randomized, single-blind study with two parallel groups of patients with post-weaning neuropsychological disorders: REMED (cognitive remediation) and CONTROL (usual care).


Eligibility Criteria:
Inclusion Criteria:

* Patient male or female aged 18 to 60, French speaking and affiliated to the social security system
* Patient with TUAL (DSM-5) at the forefront of alcohol use disorders at the time of inclusion
* Patient with neuropsychological disorders objectified on BEARNI (BEARNI for Brief Evaluation of Alcohol-Related Neuropsychological Evaluation, Ritz et al., 2015 cut-off cognitive score = 13, adding a point for patients with bachelor level or lower) and confirmed at the neuropsychological checkup showing pathological performance (at least two free or total recalls of RL / RI 16 \<-1.65 and / or RBMT IGM \<-1.65 OR number of persecutory or deficit errors at MCST \<-1.65 and / or at least two BADS subtests with a score of \<or = 2 (except temporal judgment)). Evaluation (BEARNI) at least 48h after stopping benzodiazepines
* Patient weaned of alcohol, that is to say between 5 and 21 days after stopping alcohol, after disappearing signs of withdrawal (Cushman score \<2) and stopping benzodiazepines
* First hospitalization type day hospital (not necessarily first weaning)
* Patient having been informed of the study and being able to give written informed consent.

Exclusion Criteria:

* Patient with severe and long-lasting neurological complications related to alcohol (Korsakoff syndrome, fetal alcohol syndrome, ...)
* Patient with a disorder of severe use of another psychoactive substance according to DSM-5, except tobacco
* Patient with motor or sensory deficit making cognitive remediation impossible
* Patient previously included or already included in another biomedical research
* Homeless patient
Preoperative Progression of Retinal Detachment

Patients are required to position prior to retinal detachment surgery. We seek to see whether there is a correlation between the performed positioning and retinal detachment progression/regression in fovea-on retinal detachment patients.


Eligibility Criteria:
Inclusion Criteria:

* fovea-on retinal detachment
* informed consent

Exclusion Criteria:

* previous retinal detachment surgery
* \>14 days of retinal detachment symptoms
* split-fovea retinal detachment
* other retinal disease with influence on retinal biomechanics/elasticity (proliferative diabetic retinopathy, wet AMD)
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers

To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ≥18 to ≤65 years old.
* Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.

Exclusion Criteria:

* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
* Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
* Hyper- or hypocalcemia.
* Known sensitivity to mammalian-derived drug preparations and/or any biologics.
* Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

The planned total study duration per participant was approximately 1.5 to 2.5 years.

Eligibility Criteria:
Inclusion criteria:

* Body weight of \>=39 kg at screening.
* Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis, b) Polyspecific direct antiglobulin test (DAT) positive, c) Monospecific DAT strongly positive for C3d, d) Cold agglutinin titer \>= 64 at 4 degree Celsius, and e) Immunoglobulin G DAT less than or equal to (\<=) 1+, and, f) No overt malignant disease.
* Hemoglobin level \<= 10.0 g/dL.
* Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.

Exclusion criteria:

* Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy.
* History of blood transfusion within 6 months of screening, or history of more than one blood transfusion within 12 months of screening.
* Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia).
* Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms would be adjudicated on a case-by-case basis during the confirmatory review of participant eligibility.
* Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at screening.
* Positive human immunodeficiency virus antibody at screening.
* Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients

Post-Acute Care(PAC) had been inaugurated in Taiwan for almost four years and current essays revealed positive effects upon general improvements in stroke patient after PAC training. During acute phase, a stroke patient would admit to internal medicine or surgical ward and transferred to rehabilitative ward for more intensive therapeutic programs, restoring muscle power and promoting activity of daily life(ADL) ability. Under relative stable condition, the patient would transfer to PAC institution or hospitals afterwards for continuing rehabilitative program if the patient is acknowledged to have rehabilitative potentials. However, there's still lacking of investigation upon whether the length of stay in PAC correlates to general improvements. Thus, stroke patients' functional ability, such as activities of daily living (ADL) function, swallowing ability and so on, as well as their corresponding scales were assessed on the first and last day during PAC hospitalization. Statistical analysis was conducted via SPSS ver21.0 to compare the relationship of improvements in functional ability and the length of stay in PAC. We're looking forward to the final results!

Functional ability in stroke patients are evaluated by following measurements. Activity of daily life (ADL) function was estimated through modified Rankin scale(MRS) and Barthel index(BI), swallowing ability by functional oral intake scale, nutritional status via mini nutritional assessment, life quality through EuroQoL-5D, instrumental ADL function by Lawton-Brody IADL Scale(IADL), balance/coordination via Berg Balance Test, walking speed through Usual Gait Speed, cardiopulmonary capability by Six-Minute Walk Test, occupational mobility (amount use/quality) via Motor Activity Log, language through concise Chinese aphasia test, motor function of upper extremities by Fugl-Meyer Assessment and so on.

Eligibility Criteria:
Inclusion Criteria:

* \>18 y/o
* acute onset of stroke within 30 days
* Modified Rankin Scale 2\~4

Exclusion Criteria:

* patients refused to join post acute care(PAC) program
* hemodynamic unstable
* disease progression
Understanding Medication Adherence Among HIV Patients

In anticipation of a pilot study incorporating behavioral economics into the treatment of infectious diseases, we will conduct a survey with HIV/AIDS patients at the Ponce Clinic (Infectious Disease Program of Grady Memorial Hospital, Emory University School of Medicine, Atlanta, GA).

We are planning a study to improve health outcomes among patients with HIV/AIDS using insights from behavioral economics and financial incentives. We will conduct a survey with HIV/AIDS patients at Ponce Clinic (Infectious Disease Program of Grady Memorial Hospital, Emory University School of Medicine, Atlanta, GA). The patients will be low-income persons living with HIV/AIDS and possessing varying degrees of medication adherence. We want to better understand how this particular population would react to commitment devices designed to increase medication adherence. We will survey participants to see if they would prefer more commitment, in the form of a "Take-Medication-Get-Paid" plan; less commitment, in the form of an "Attend-Clinic-Get-Paid" plan; or if they would prefer to designate their own levels of commitment.

Eligibility Criteria:
Inclusion Criteria:

\* HIV/AIDS patients currently receiving treatment at the Ponce Clinic at the Infectious Disease Program of Grady Memorial Hospital (Emory University School of Medicine).
Establish Diagnostic and Prognostic Models for Preclinical AD Patients Based on Multimodal MRI, Behavioral, Genetic, and Plasma Biomarkers

To establish the diagnostic and prognostic models that could help the preclinical identification of subjects at higher risk of clinical progression to mild cognitive impairment and dementia based on combined features of baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data.

Alzheimer's disease (AD) is a global concern. Due to the lack of effective therapeutic methods targeting late-stage AD patients, it is critical to investigate brain alterations in the preclinical stage to pave the way for early diagnosis and intervention. Structural and functional magnetic resonance imaging (MRI) has been proven to be an effective and non-invasive approach to explore the neural mechanisms underlying neurological disorders. Genetic factors such as apolipoprotein E and plasma biomarkers play important roles in AD development and progression. However, the interaction effects of risk genes and different pathologic pathways implicated in the pathogenesis of AD remain unclear. Furthermore, the diagnostic and prognostic models that could predict future cognitive decline or clinical progression based on objective features derived from baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data need to be further explored.

We aim to investigate the neural basis underlying early cognitive deficits using structural and functional MRI data combined with novel analytical methods such as dynamic functional connectivity, surface-based morphometry, graph theory, multilayer network, functional-structural coupling, hidden Markov model, and connectome gradient mapping. Secondly, to explore the interaction effects of risk genes, which may help a better illustration of different biological pathways implicated in the pathogenesis of Alzheimer's disease. Thirdly, to investigate the divergent and dynamic abnormalities of multimodal imaging markers across different stages of Alzheimer's disease and their associations with plasma biomarkers, which may enhance our understanding of the neuropathological mechanisms. Fourthly, to provide scientific evidence on the potential targets for early intervention of neurodegenerative diseases. Lastly, to establish the diagnostic and prognostic models that could help the preclinical identification of subjects at higher risk of clinical progression to mild cognitive impairment and dementia based on combined features of baseline multimodal biomarkers. These studies may help a better understanding of the neural and biological basis underlying AD and pave the way for early diagnosis and intervention.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were 50-79 years old and having 8 or more years of education.

Exclusion Criteria:

* Participants with a history of stroke, other neurological disorders that could lead to cognitive impairment (Parkinson's disease, encephalitis, epilepsy, brain tumors, etc.), severe anxiety or depression, and contraindications for magnetic resonance imaging (MRI) were not enrolled.
Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes

The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.

The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.

Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with genetic mutation versus patients without mutation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Parkinson's Disease (PD)
* in use of dopaminergic medication (L-Dopa and/or dopamine agonists)
* genetic testing for mendelian forms of PD
* able to provide informed consent to participate in the study

Exclusion Criteria:

* Patients underwent Deep Brain Stimulation (DBS) treatment
Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block

The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.

Exclusion Criteria:

* Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease