cyrilzakka/clinical-trials huggingface dataset:
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.

The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
* Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patient´s medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.
* ≥ 12 years of age at baseline visit
* ≥ 40 kg bodyweight
* Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable

Exclusion Criteria:

* Patients who have a contraindication to dupilumab according to the current EU-SmPC.
* Patients who have been treated with dupilumab for more than 7 days
* Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
* Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)
Bispectral Index and Surgical Field

This study investigates whether BIS monitor assisted anesthesia improves surgical space conditions during gynecological benign laparoscopic procedures.

Half of participants will receive BIS monitor assisted anesthesia, while the other half will receive anesthesia without BIS monitor.

General Anesthesia includes hypnosis/unconsciousness, amnesia, analgesia, muscle relaxation and autonomic and sensory blockade of responses to noxious stimulation.

Depth of anesthesia in standard practice is controlled by monitoring equipment such as blood pressure (BP), heart rate (HR), train of four ratio (TOF) and by clinical signs such as profuse sweating, tearing, cough and movements.

BIS can be used as additional tool to monitor and manage anesthesia. BIS is an empirically derived scale for measuring brain electrical activity. It computes an index between 0 and 100, whereas 0 corresponds to "no detectable brain electrical activity" (flatline EEG) and 100 to awake state. A patient is considered to be appropriately anesthetized when the BIS' value is between 40 and 60.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \> 18 years
* American Society of Anesthesiology (ASA) physical status 1 or 2
* Legally competent

Exclusion Criteria:

* Age \< 18 years
* ASA physical status ≥3
* Renal and/or lever disease
* Relevant allergies towards anesthetics
* Cancer surgery
* No informed consent or inability to give that
Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment

The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.

Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to provide written informed consent.
* Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography
* Visual Acuity between 20/25 and 5/200

Exclusion Criteria:

* Bilateral Retinal Vein Occlusion
* Vision worse than 5/200 in study eye
* History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening
* Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy
* Concurrent Exudative Age-related Macular Degeneration
* Concurrent optic neuropathy with the presence of an afferent pupillary defect
* Previous vitrectomy in the study eye
* Currently pregnant or planning to become pregnant during the duration of the study. Women currently breastfeeding are also excluded.
* Previous treatment for retinal vein occlusion in the study eye
* Any current medical condition which, in the opinion of the investigator is considered to be uncontrolled
* History of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)
Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System

AIM: To validate the tracer \[11C\]donepezil for use in the parasympathetic nervous system.

MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. PET/CT scans with \[11C\]donepezil are conducted. Six subjects will receive two PET/CT scans - once for the upper abdominal region and once for the head region two evaluate dynamic binding characteristics of the tracer in internal organ. Additionally, one single subject will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this tracer.

PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

Please see the published paper wherein all details are listed:

In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses.

Gjerløff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. J Nucl Med. 2014 Nov;55(11):1818-24.

Eligibility Criteria:
Inclusion Criteria:

* male
* 45-75 years

Exclusion Criteria:

* dementia,
* psychiatric diseases,
* serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system
Based on the Data from the Zhejiang Emergency Center, Explore the Independent and Interactive Effects of the Association Between Meteorological Factors and Air Pollution and the Number of Emergency Personnel, Identify the Relevant Vulnerable Population Characteristics, Sensitive Disease Types

Based on the health data from Zhejiang Emergency Command Center, combined with meteorological, air pollution, land use and socio-economic data of Zhejiang Province, distributional lag nonlinear models, grouped weighted quantile and regression and Bayesian spatial models were used to explore the independent and interactive effects of the association between meteorological factors and air pollution and the number of first-aiders, to identify the related characteristics of the vulnerable populations, the types of sensitive diseases and the high-risk areas, and to elucidate the driving factors of the association between meteorological factors and air pollution and the number of first-aiders. It also clarifies the drivers of the association between meteorological factors and air pollution and the number of emergencies, so as to provide a reference for the government to take targeted measures to reduce the burden of related healthcare services.


Eligibility Criteria:
Inclusion Criteria:

-Emergency data of Zhejiang Emergency Command Center in the past 5 years

Exclusion Criteria:

* Prehospital emergency information from non-Zhejiang province domains
* Emergency calls due to labor and delivery.
A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 32 kg/m2 inclusive.
* Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for \>=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the same NUC therapy for \>=3 months prior to screening.
* HBV DNA below the lower LLOQ or \< 20 IU/mL for \> 6 months prior to screening and confirmed at screening.
* Alanine transaminase (ALT) \<=1.5 x upper limit of normal (ULN) for \> 6 months prior to screening and confirmed at screening.
* Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
* Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

* Pregnant or lactating women.
* Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
* History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
* History of or suspicion of Hepatocellular Carcinoma (HCC).
* Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
* Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
* Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
* History of alcohol abuse and/or drug abuse within one year of randomization.
* History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
* Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
* Electrocardiogram (ECG) with clinically significant abnormalities.
* Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.
Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension

To explore the efficacy of Sacubitril/Valsartan in the treatment of perimenopausal hypertensive patients, as well as the difference between the antihypertensive efficacy and valsartan, the therapeutic effect of its exposure to different factors and the protection of target organs.To provide reference for the clinical treatment of perimenopausal hypertension patients with shakubactrivalsartan.

1. To evaluate the effects of Sacubitril/Valsartan on urinary microalbumin and pulse wave velocity in perimenopausal hypertension patients.
2. To evaluate the clinical application of Sacubitril/Valsartan in the treatment of perimenopausal hypertension, so as to improve the blood pressure management ability and control rate of patients with such hypertension.

A total of 264 cases of perimenopausal patients with essential hypertension who were admitted to Department of Cardiology, Second Hospital of Lanzhou University,from January, 2020 to March,2021 will be enrolled and randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan or 80-320 mg of Valsartan.The general information, menstrual history, cardiac ultrasound, urinal-renal function, PWV, baseline blood pressure, post-medication blood pressure, whether to use antihypertensive drugs and the type of antihypertensive drugs of the patients were enrolled.After 12 weeks of drug intervention, left ventricular mass indexwere measured by cardiac ultrasound, PWV, urinary microalbinin, 24-hour ambulatory blood pressure monitoring, biochemical indicators will be collected.SPSS22.0 statistical software was used for statistical analysis of PWV, urinary microalbumin, blood pressure and other results by paired data t-test, and the chi-square test was used for non-count data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with essential hypertension（SBP\>140 and \<180 mmHg, and/or DBP\>90 and \<110 mmHg)）were diagnosed according to the hypertension diagnostic criteria of the Chinese Guidelines for Hypertension (2018 Revised Edition)；
2. Female aged 45-55 years old and meeting the perimenopausal criteria in the STRAE+10;
3. No other complications, no treatment or ongoing antihypertensive therapy (SBP ≥140mmHg or Diastolic BP ≥90mmHg)；
4. Agree to participate in the study and sign the informed consent；

Exclusion Criteria:

1. Secondary hypertension；
2. History of angioedema；
3. Heart failure NYHA grade III or above (excluding grade III)；
4. Liver and kidney dysfunction (ALT or AST≥ three times the upper limit of normal value, that is, ALT≥120U/L,AST≥120U/L, creatinine clearance \< 30ml/min);
5. Hyperkalemia (serum potassium ≥5.5mmol/L);
6. Moderate or above anemia (HGB≤90g/L);
7. Bilateral renal artery stenosis;
8. History of stroke;
French Memory Support System: A Pilot Study

The purpose of this study is to develop a linguistically and culturally appropriate adaptation of the Memory Support System (MSS), an evidence-based intervention to train persons with mild cognitive impairment (MCI) to complete personal goals and instrumental activities of daily living independently. The study will involve development of the associated manual, training and patient forms, and outcome measures, and pilot testing of the intervention in a group of French-speaking individuals with MCI and their care partners

At enrollment, participants with MCI and their care partners will complete French measures evaluating cognitive and functional status. Participants and partners will also complete French measures of treatment adherence, instrumental activities of daily living, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of single or multi-domain MCI
* Clinical Dementia Rating global (CDR) score of ≤ 0.5
* Dementia Rating Scale-Second edition score of ≥ 115
* available contact with a care partner ≥ 2 times weekly
* absence or stable intake of nootropic(s) for ≥ 3 months

Exclusion Criteria:

* visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
* concurrent participation in another related clinical trial
GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.

GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia.

Although for decades there have been multiple studies on the association of asthma with factors such as weather conditions, pollution, pollen and the social condition of patients, the GeoAsma project aims to advance the study of environmental factors that influence the health of asthmatic patients by combining BigData technology and data mining analysis, Geographic Information Systems and open data provided by official sources with data from the Electronic Health Record of the Andalusian Health System, that provides healthcare services to more than 8,000,000 citizens.

This project aims to study through data mining techniques and multilevel analysis the influence of clinical and environmental factors: pollen level, air pollution, atmospheric conditions and social determinants in more than 800,000 asthmatic patients during the last 15 years in Andalusia, the southernmost region of Spain. It is expected that the results of this study will serve to define predictive models that will help professionals and patients in our region to make decisions.

After the validation of the models, a decision support system will be implemented in a web platform and in a mobile application. Its impact on the reduction of exacerbations, control, quality of life and resource consumption of asthmatic patients will be analysed. This evaluation will be carried out through a pilot with 214 patients with a follow-up period of 12 months with asthma in the hospitals participating in this proposal.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bronchial asthma in its intermittent and persistent degrees mild/moderate.
* No respiratory infections in the month prior to testing.
* Availability and/or ability to use a Smartphone.

Exclusion Criteria:

* Severe persistent asthmatics.
* Pregnant women, breastfeeding women or women who want to become pregnant during the duration of the study.
* Subjects with malignant disease, uncontrolled risk factors or any pathology that compromises the safety of the study.
* Treatment with systemic corticosteroids during the 6 months prior to or during the study.
* Subjects with problems that limit their ability to cooperate.
* Subjects unable to perform correct spirometric maneuvers.
Analysis of Non-Invasively Collected Microneedle Device Samples From Mild Plaque Psoriasis for Use in Transcriptomics Profiling

The purpose of this study is to collect skin biopsies and non-invasive microneedle device samples from participants with mild chronic plaque psoriasis vulgaris to use for transcriptomics profiling for further investigation.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a history of chronic plaque psoriasis vulgaris for at least 6 months prior to the screening visit
* Participant has had stable psoriasis conditions for at least 3 months before screening (information obtained from medical chart or participant's physician, or directly from the participant)
* Participant has plaque psoriasis covering \>= 1% but \< 10% of his total BSA on Day 1
* For Group A: Participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a target lesion severity score (TLSS) score of \>= 6 on Day 1 allowing the collection of three microneedle device samples and one biopsy sample
* For Group B: Participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a TLSS score of \>= 6 on Day 1 allowing the collection of one microneedle device sample per visit (replicating the extraction on the same area at each visit) and one biopsy sample

Exclusion Criteria:

* Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study
* Participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis
* Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the sample collection or interpretation
* Participant is known to have immune deficiency or is immunocompromised
* Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded
Impact on Nutritional Practices: SMS and Interpersonal Communication

This cluster randomized controlled study aims to add to the evidence base on mHealth interventions by assessing the main effects of delivering nutrition messages on key maternal, infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative behavior change strategies. The strategies compared will be: (i) an interpersonal communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni program, and (iii) the combination of both of these strategies (interpersonal and SMS messaging). They will be compared with the current standard of care in Tanzania. The goal will be to determine which has the greatest impact on key MIYCN and hygiene practices and care-seeking behaviors. It will be paired with a costing analysis so that these effects can be understood in the context of their costs.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of children aged 0-12 mo. or pregnant at time of enrollment
* Consent to participate in the study

Exclusion Criteria:

* Unable to consent to participate in the study