cyrilzakka/clinical-trials huggingface dataset:
Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation

The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation

In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
4. Patients in the subject group vulnerable to clinical study
5. Patients who had undergone a prior catheter ablation for atrial fibrillation
Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

Alcohol use is increasingly prevalent in modern society and is known to cause cognitive impairment and dysregulation of inflammatory responses. In the present study, the investigators want to perform a randomised controlled trials to test whether nitrate could change the oral microbiota and benefit the cognitive impairment in alcohol dependence patients. The investigators survey the oral bacterial communities in saliva samples of 70 alcohol dependent patients following 14 days of dietary inorganic nitrate (nitrate-rich beetroot juice, \~750 mg NO3- /d) and placebo (nitrate-depleted beetroot juice, \~1 mg NO3- /d) supplementation.


Eligibility Criteria:
Inclusion Criteria:

1. Han nationality
2. Montreal Cognitive Assessment(MoCA) score \>11
3. Diagnosis of alcohol dependence

Exclusion Criteria:

1. Past or current infectious disease
2. Past or current heart, brain, liver, kidney, and other severe diseases
3. Past or current metabolic diseases that can lead to abnormalities of the immune system, such as obesity (Body Mass Index \> 30 kg/m2), diabetes, or rheumatoid arthritis
4. Past or current neurodegenerative diseases, such as Parkinson's disease
5. Use of steroidal and non-steroidal anti-inflammatory drugs, antibiotics, antioxidants, and immunosuppressive agents within two months of enrollment
6. Use of probiotics and probiotics every day for the first two months before enrollment
7. Previous or current DSM-IV diagnosis of schizophrenia, depression, anxiety disorder, bipolar disorder, mental retardation, dementia (excluding mild cognitive impairment, MCI), or substance dependence other than alcohol and nicotine
8. Irregular eating habits that affect the oral flora (except alcohol) in the previous two months
9. Current oral disease
Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A

The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .

The main question\[s\]it aims to answer are:

•\[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?\] •\[is there any effect of Prior Anterior Chamber Paracentesis?\] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . \]


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type II.
* Patients with visual acuity \> 0.1, able to fixate and with clear visual media.
* Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.

Exclusion Criteria:

* Age under 40 years.
* Poorly controlled diabetics (HbA1C greater than 9.0%)
* Proliferative diabetic retinopathy.
* OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
* Neovascular AMD in the study eye.
* History of glaucoma.
* Tilted disc and optic disc anomalies.
* One-eyed patients.
* Usage of systemic or topical corticosteroids.
* Patients with a history of intraocular surgery other than cataract surgery.
* Systemc diseases rather than hypertension and diabetes mellitus.
* Corneal opacities that might hinder acquisition of good quality OCT images.
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial

The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years,
* Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria
* Severe MDE (HDRS-17\> 20)
* Drug resistance to at least two well-conducted antidepressant treatment lines
* With stable antidepressant treatment for at least 4 weeks before inclusion
* Benefiting from a social security scheme
* Having given their consent to participate

Exclusion Criteria:

* Psychiatric history other than a mood disorder
* Neurological history, including epilepsy and intracerebral calcifications
* History of substance use disorder other than tobacco
* Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, ...)
* Compulsory psychiatric care
* Protected adults, people under legal safeguard
* Pregnant or breastfeeding woman
* Women of childbearing age who do not have a negative pregnancy test and are not using contraception
Biomarkers For Immune Checkpoint Inhibitors

This is a laboratory, non-treatment study. Immune checkpoint inhibitors are a type of immunotherapy that stimulates a patients immune system to fight their cancer. Immune checkpoint inhibitors are standard, FDA approved treatment for certain types of cancers such as melanoma, lung cancer, kidney cancer and bladder cancer. The laboratories of Dr. Jack Elias and Dr. Chun Geun Lee at Brown University are studying how immune checkpoint inhibitors work.Kintai Therapeutics is a biotech company in Cambridge Massachusetts that will focus on the molecules present in the GI tract, including the stomach, small intestine and colon.

Patients who are receiving immune checkpoint inhibitors for their cancer treatment are eligible. Patients will sign informed consent. Ten cc of blood will be drawn before beginning immune checkpoint inhibitors and 10 cc of blood will be drawn 1-4 months after treatment is initiated. Deidentitified blood samples will be sent to the lab of Dr. Jack Elias and Dr. Chun Geul Lee and analyzed for biomarkers. The blood samples will be linked to the patient by a research number. Response to treatment will be correlated to potential biomarkers. The stool samples will be linked to the patient by a research number. Bacterial DNA and RNA may be sequenced and data used to identify bacterial taxa and genes within the stool. In compliance with NIH guidelines, all human DNA data would be removed computationally, and will not be used in any analyses. Small molecules may be profiled with metabolomics. Bacteria may also be isolated from the stool into in vitro culture, and efficacy of single-strains or communities and/or their DNA, RNA, and metabolites on disease models may be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumors initiating treatment with an immune checkpoint inhibitor.
* No prior immune checkpoint inhibitors
* Age \>18.
* Signed informed consent

Exclusion Criteria:

* The patient is unwilling or unable to provide informed consent
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests

Most prevention efforts focus on promoting services (e.g. vaccination, screening tests). While some of these services have clear net benefit, many instead have possible or clear net harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are delivered in healthcare settings at higher rates than what might be expected based on their potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to deliver more quality care. An important issue in delivering prevention messages is how to shift toward a focus on the appropriateness of prevention: encouraging services with clear net benefit and either discouraging or reducing demand for services with possible or clear net harm. Unfortunately, little is known about what drives overuse of potentially harmful screening services or how to make harms relevant to patients.

This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1) assess factors associated with intent to receive possibly or clearly harmful screening services and 2) determine whether and how patients' plans to get screened change with various presentations of information about harms (e.g. qualitative, quantitative, narrative, framed). The investigators will focus on three types of screening services: osteoporosis screening (previous C recommendation and now no recommendation for women \< 65 years old with no fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).


Eligibility Criteria:
Inclusion Criteria:

* Women between ages 50 to 85
* Men between ages 50 to 85
* Eligible for exemplar service of interest (see below for specifics of inclusion/exclusion for specific services)

Exclusion Criteria:

* Current treatment of psychosis
* History of alcohol or substance abuse within the last 2 years
* Dementia or other severe cognitive dysfunction
* serious medical illnesses with a life expectancy of less than 2 years (e.g., metastatic cancer)
* inability to speak and understand English
* blindness
* presentation for an acute medical visit
* no telephone number

Osteoporosis Screening (women aged 50-64)

Exclusion Criteria:

* a personal history of osteoporosis
* a personal history of moderate or severe osteopenia
* BMI (body mass index) \< 18.5
* personal history of non-traumatic fracture
* family history of hip fracture
* current smoking
* current use of prednisone (\>30 consecutive days)
* alcohol use of 3 or more drinks/day.

Prostate Cancer screening (men aged 50-69)

Exclusion Criteria:

* a prior history of prostate cancer

Colorectal Cancer Screening (men and women aged 76-85)

Exclusion Criteria:

* prior history of colorectal cancer
* adenomatous colon polyps \> 6mm (or 2 or more \< 6mm)
* symptoms referable to colorectal cancer
Design of an Intervention to Equip Middle Managers and Managers in Healthcare Institutions with Tools to Increase the Resilience of Their Teams

The main objective of this preparatory action (experimental study without control group, before and after measurements) is to develop and test the feasibility of the e-Resilience tool in a relevant environment (TRL6). This web-based tool has been designed to facilitate the work of the top and middle management of healthcare institutions to strengthen the resilience of their teams to face critical situations inherent to healthcare activity.

The main questions it aims to answer are:

1. Which components of the e-Resilience intervention need to be improved?
2. Does the e-Resilience tool improve the knowledge of middle managers in healthcare institutions on specific techniques and strategies to strengthen the resilience of the professionals and teams under their care?
3. Is the e-Resilience tool helpful and applicable to clinical settings in the opinion of middle managers in healthcare institutions?

Participants in the study are middle management and healthcare professionals from primary care centres and hospitals in the Valencian Community (Spain). A group of experts review the components of the intervention/tool to improve its adaptability to clinical settings. Subsequently, a sample of healthcare professionals and middle managers complete the intervention by answering a knowledge questionnaire before and after the intervention and a survey to evaluate the tool.

There is no control group.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals and middle management in active healthcare institutions.

Exclusion Criteria:

* Inability to complete the web-based intervention due to access difficulties or lack of digital literacy.
Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking

After entering the OR; the patient will be cannulated and fully monitored with basic monitors (pulse oximeter, NIBP \& ECG), a nasal cannula is connected to the patient to deliver oxygen.

We gave the patient 5 ml of propofol to decrease the discomfort felt by the patient during injection of local anesthesia. Benox eye drops is applied to the operative eye in both groups.

Patients were allocated into 2 groups; each group is 25 patients Group 1: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid, 0.5ml below the inferior punctum in the lower lid medial margin.

Group 2: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection

During surgery, we will assess the pain degree during probing using Verbal Rating Scale (0 to 10 scale where 0 is no pain an 10 is unbearable pain), to assess the efficiency of this single low volume injection.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing lacrimal duct intubation surgery
* Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III.
* Age between 18-70, both sexes.
* Axial lengths ranging between 22-28mm.

Exclusion Criteria:

* ASA IV.
* Patient age less than 18 or more than 70 years.
* Coagulation disorders (e.g. patients on warfarin (INR\<1.5)
* Communication difficulties preventing reliable assessment.
* High myopia (axial length more than 28mm) and medial staphylomas.
Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers

The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
2. Age ≥21 and ≤50 years
3. BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
8. Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomization
10. Participation in another trial with an investigational drug within 2 months prior to randomization
11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (more than 60 g alcohol a day)
14. Drug abuse
15. Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during the trial)
16. Excessive physical activities within 1 week prior to randomization or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of the study centre

    The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
19. Asthma or history of pulmonary hyperreactivity
20. Hyperthyrosis
21. Allergic rhinitis in need of treatment
22. Clinically relevant cardiac arrhythmia
23. Paroxysmal tachycardia (\>100 beats per minute)
Study on the Induction of Food Tolerance in Babies

This general population based, randomized controled trial aims at answering two major hypotheses: First, systematic early introduction of solid foods decreases the incidence of food allergy and dietary restrictions by the age of one year. Second, stimulation with the symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe allergic symptoms.

All new born babies living in the city of Oulu are recruited to the study (n=1380) at their first health nurse visit (at or before 1 month of age) in the local primary care child health clinics. Families in the intervention group will get an instruction booklet including information on early systematic introduction of solid foods starting at the age of 4 months, with foodstuff from all major groups in diet by the age of 6 months (vegetables and fruits, wheat and other grains, meat, fish, egg, dairy products). Furthermore, the booklet includes information and instructions on food related symptoms and atopic eczema. Babies with mild symptoms are encouraged to continue the symptom-eliciting food. All families fill out monthly internet-based questionnaires on food diary, symptoms, diagnoses and health care visits until the age of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* All newborn babies attending local Child Health Clinics

Exclusion Criteria:

* Parents unable to communicate with Finnish language (questionnaires in Finnish)
Retinal Function in Diabetic Patients Without Retinopathy

The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.

Type 1 and type 2 diabetic patients with no diabetic retinopathy and no hypertension were compared with sex and age-matched control subjects. Color vision was tested with the desaturated LANTHONY 15-Hue test. Contrast sensitivity was assessed with the Pelli-Robson contrast sensitivity test. Pattern-electroretinogram, Ganzfeld full-field electroretinogram and multifocal electroretinogram were recorded according to the International Society for Clinical Electrophysiology of Vision (ISCEV). Flicker-induced vasodilatation in retinal arteries and veins was assessed using the Dynamic Vessel Analyzer.

Eligibility Criteria:
Inclusion Criteria:

* For diabetic patients :

  * age between 20 and 55
  * type 1 or type 2 diabetes mellitus
  * diabetes duration of more than 5 years
  * no diabetic retinopathy on fundus examination or fundus photographs
* For control subjects :

  * sex and age matching with the diabetic patients
  * no diabetes, no familial or personal history of elevated blood sugar

Exclusion Criteria:

\*For both diabetic patients and control subjects :

* presence of cataract or history of cataract surgery
* intraocular pressure of more than 21 mmHg
* abnormal score on the Ishihara test
* other ocular disease
* ametropia more than 3 diopters, anisometropia more than 1 diopter, astigmatism more than 1 diopter
* systemic hypertension (defined as systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
* treatment with vasoactive drugs
* tobacco consumption of more than 20 cigarettes a day
Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy

This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of pharmaco-resistant focal epilepsy
* Patient candidate for surgery to resect the epileptogenic zone
* Patients affiliated to a social security scheme or beneficiaries of such a scheme
* Patients with French as their mother tongue
* Patients who have given signed informed consent before performing any procedure related to the study.

Exclusion Criteria:

* Contraindication to performing an MRI:
* Intellectual disability objectified by a Mini Mental Score (MMS) score \<24 in the year preceding inclusion,
* Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,
* Participation in other research protocols underway with exclusion period or in the previous week,
* Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.