cyrilzakka/clinical-trials huggingface dataset:
Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management

This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Harnessing AI, we will extract and correlate hidden components within ECG-obtained P-wave data and echocardiographic studies with atrial fibrosis, culminating in an atrial fibrosis score (AFS). The AFS will non-invasively predict fibrosis extent and AF clinical progression, including metrics like rehospitalization, cardiac morbidity, and mortality. Ultimately, this endeavor aims to improve AF patient management, significantly reducing healthcare costs, and enhancing patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* History of paroxysmal or persistent atrial fibrillation
* Clinical indication for Atrial Fibrosis (AF) ablation according to the 2020 ESC Guidelines

Exclusion Criteria:

* Age below 18 years old
* Refusal to sign consent
* Noncompliance with the study protocol
Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.

The primary endpoint is the antiretroviral effect over 48 weeks.

The secondary endpoints are;

1. The immunologic effects from baseline at the 48th and 144th week
2. Reasons of treatment failure by 144th week
3. Adverse events and their rate of incidence by 144th week
4. Serum concentration of tenofovir in selected patients
5. Serum concentration of atazanavir in selected patients
6. Renal complication in tenofovir arm

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV infection,
* Antiretroviral initiation is recommended by current clinical guidelines,
* Treatment naïve,
* Age over 20 years old Japanese,
* Able to obtain written informed consent

Exclusion Criteria:

* Current malabsorption condition,
* Prior use of lamivudine for hepatitis B treatment,
* Positive serology of Hepatitis B surface antigen,
* Patients who have following abnormal laboratory results within 6 weeks prior enrollment;

  1. alanine aminotransferase is more than 2.5 times higher of upper normal limit
  2. estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
  3. serum phosphate level is less than 2.0mg/dl
* Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
* Patients in pregnancy or breat feeding
* Patients who are taking medications contraindicated combine use of study medicine
* Patients whose primary care physicians consider inadequate to be enroll the study
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.


Eligibility Criteria:
Inclusion Criteria:

* Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
* Patient must be previously treated with a systemic gemcitabine based regimen
* Adequate bone marrow, kidney and liver functions

Exclusion Criteria:

* ECOG performance status (PS) of 2-3-4.
* Prior locoregional radiotherapy for pancreatic cancer.
* Symptomatic brain metastases or leptomeningeal disease.
* Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
* Other concurrent malignancy
* Other protocol-defined exclusion/inclusion criteria may apply
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease

To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Primarily, Patients with chronic obstructive airways disease
* Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion

Exclusion Criteria:

- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets
Effectiveness Of The Pericapsular Nerve Group (PENG) Block In Hip Surgery

The target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Pain felt before and during surgery can cause metabolic and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce postoperative complications and mortality and accelerate post-surgical recovery. Pharmacological methods such as opioids and NSAIDs used for this may cause further deterioration and other side effects in geriatric patients with reduced renal and hepatic function, thus delaying post-surgical recovery and thus discharge. In order to avoid these side effects, regional anesthesia techniques can be preferred.

Regional anesthesia techniques are among the most effective methods of postoperative analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods. Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they provide effective analgesia, reduce the need for opioids and consequently their side effects, are effective in the treatment of dynamic pain and facilitate recovery.

Patients undergoing hip surgery have very severe pain and need additional postoperative analgesics. Mobilization of patients is delayed due to pain . Depending on this , thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis , wound infection and increased length of stay.

Alleviating the pain around the hip joint capsule is an effective analgesia method in hip surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator , and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24 hours postoperatively. PENG block is a method that is frequently used in the world and in our clinic and has a low complication rate.

In this study, the investigators aimed to show that pericapsular nerve group block performed before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients with written informed consent
* Patients over 18 years old
* Patients with ASA score I-II-III
* Patients performed spinal anesthesia for surgery

Exclusion Criteria:

* Patients without written informed consent
* Patients with ASA score IV and above
* Patients who cannot be communicated
* Patients with infection at the block site
* Patients with coagulation disorders
* Patients not suitable for spinal anesthesia
* Patients with liver and kidney failure
* Patients who are allergic to the drugs used
* Patients with major complications during the operation
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots

We propose a prospective cohort study to assess the effect of the progesterone only contraceptive pill (minipill) on coagulation parameters known to be associated with risk of thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception.

Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to starting the minipill), one and three months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S, fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio (nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This exam and the blood testing will be provided free of charge. Patients will not be prescribed the minipill after completion of the study and will be advised to consult with their primary care physician or hematologist if they wish to continue this medication.


Eligibility Criteria:
Inclusion Criteria:

* Women with a history of venous thromboembolism (VTE, blood clot in a vein) and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception.
* Blood tests which demonstrate an increased risk of thrombosis include the following:

  * Hyperhomocysteinemia/MTHFR mutation
  * Prothrombin gene mutation
  * Factor V Leiden heterozygotes
  * Factor V Leiden homozygotes, antithrombin III mutation
  * Protein S deficiency and Protein C deficiency.

Exclusion Criteria:

* Women on current anticoagulation therapy
* Women with a history of oral contraceptive related thrombotic events
* Active or history of cigarette smoking within the past 6 months
* Pregnancy
* Active lactation
* Known hypersensitivity to progestin
* Any history of malignancy
* History within the last three months of surgery or planning surgery during the study period
* Undiagnosed vaginal bleeding
* Active liver disease and history within the last 5 years of alcoholism or drug abuse.
* Additionally, women must be greater than 3 months postpartum and have had two months without contraceptive hormones (such as the birth control pill) and 6 months without Depo-Provera use prior to enrollment.
Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease

Many studies have evaluated the viability of measuring the pulmonary vascular resistance (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with an increase of PVR.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD stage II, III or IV according to the GOLD guidelines
* signed the informed consent

Exclusion Criteria:

* ischemic cardiopathy
* severe valvular disease
* atrial fibrillation
* left bundle branch block
Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed by applying a microneedle patch and as a negative control the an identical patch but without microneedles sticking out and after the topical anesthetic was applied for in one session 2 minutes and the other session 5 minutes and the investigators evaluated the pain of needle introduction and the injection of the anesthetic.

The application force of the microneedles was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), in these two different moments, introduction of the needle and injection of the anesthetic.

Eligibility Criteria:
Inclusion Criteria:

- Healthy male

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.
A Prospective Assessment of Opioid Utilization Post-operatively in Sports Orthopaedic Surgeries

There was a study titled "A prospective evaluation of opioid utilization after upper extremity surgical procedures: Identifying consumption patterns and determining prescribing guidelines" by Dr. Matzon and team from Thomas Jefferson University that came up with a simple set of opioid guidelines post-surgically. These guidelines are helping to guide surgeon's prescribing patterns and ideally limit the number of prescribed pain medicines. We plan to identify typical narcotic analgesic usage post sports orthopaedic surgery. We hope to identify the number of narcotic pain pills to prescribe to patients undergoing orthopaedic sports surgery in the future.

1, Consent patients undergoing sports orthopaedic surgery in clinic or in pre-operative holding area and also administer first questionnaire, opioid risk tool, and pain catastrophizing scale(research) 2. Sports orthopaedic surgery (standard of care) 3. Post-op pain control regimen (standard of care) 4. Call or email patient with questionnaire every day for a week followed by weekly for 7 more weeks. The children's questionnaire will be child specific and the parent will assist the child. Will also use a picture of Wong-Baker Faces to help children identify where their pain scale is which will be given to the patient the same day that the consent is obtained to use at home(research). Questionnaire should take less than 5 minutes and will include questions about how well their pain is controlled, how many analgesic medications they have taken, and if they have tried anything else for pain. (Research) 5. Patient will continue to go to post-operative appointments as scheduled. (standard of care) 6. Will store the data from the phone calls on the secured T drive. (Research)

Eligibility Criteria:
Inclusion Criteria:

* analgesics prescribed to patient

Patients that have undergone orthopaedic sports surgeries that Dr. Kaar and Dr. Kim performed with some of the examples being:

Acromioplasty Rotator cuff repair Labral repair Proximal humerus repair versus arthroplasty Elbow instability repair Elbow arthroplasty Hip arthroscopy Hip cam lesion repair Knee arthroscopy Knee ligament repair Knee meniscus repair Achilles tendon repair Cartilage preserving procedures

Exclusion Criteria:

mental retardation inmates non-english speaking pregnant on-call trauma cases
Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area

In order to find how many women continue using alcohol during their pregnancies the plan is to anonymously test routine urine samples collected during pregnancies for ethylglucuronide (ETG), a metabolite of ethanol that is detectable in urine up to several days after alcohol consumptions. Altogether 600 samples are taken in the prenatal care units and the prenatal care units dedicated for the alcohol and drug abusing mothers both in the Helsinki and Lahti areas. Test results are used to estimate and compare the prevalence of severe maternal drinking in the different populations.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant

Exclusion Criteria:

-
Nosocomial Bacteriuria in Geriatric Internal Medicine Services and Follow-up Care and Geriatric Rehabilitation of the Strasbourg University Hospitals

This thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in Strasbourg's University Hospital, between 2003 and 2017, in the follow-up of Eric de Pasquale's thesis in 2010.

This comparative study will allow to see the evolution of urinary bacterial ecology, bacterial sensitivity to antibiotics, and the part of multi-resistant bacteria, during these 14 years in geriatric services in Strasbourg.


Eligibility Criteria:
Inclusion Criteria:

* patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital
* date of hospital leaving after 1/1/17 and before 1/1/18
* patient who has a health-care urinary tract infection (occurred more than 48h after admission)
* single bacteria in the CBEU
* bacteriuria \> 105 cfu/mL regardless which clinical context or bacteria
* if a patient has several bacteriuria, they can be included if they appear after a precedent episode well treated or if the bacteria is different from the precedent

Exclusion Criteria:

* participation refusal
* Leaving of hospital out of the inclusion period
* Urinary tract infection which occurred less than 48h after admission (communitarian infection)
* bacteriuria \< 105 cfu/mL
* multiple bacteria in the CBEU
Failure Rate of GLyburide And Metformin Among Gestational Diabetics

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.

Eligibility Criteria:
Inclusion Criteria:

We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:

* 1 hour Glucose tolerance test of \>130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
* A single 1 hour Glucose tolerance test value of \> 200 mg/dl, and:
* Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria

Exclusion Criteria:

* - Known renal impairment.
* Known hepatic disease.
* Pre-gestational diabetes.
* Known allergy to glyburide, metformin or sulfa drugs.
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.

The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.

Axillary lymph node status is an extremely important prognostic factor in the assessment and treatment evaluation of patients with newly diagnosed breast cancer. Historically, axillary lymph node dissection (ALND) has been the reference standard for diagnosis and staging. However, this procedure can cause numerous postoperative problems, such as lymphedema , pain, impaired shoulder mobility and arm weakness. Furthermore, in this era of mammographic screening, axillary lymph node dissection yields negative results in 80%-85% of patients with T1 cancer.

Therefore, in recent years, sentinel lymph node biopsy (SNB) has replaced axillary dissection for lymph node staging at major medical centers. However, there are some practical issues to be resolved. For example, radiotracer distribution can be slow or faulty, valuable operating room time is expended, and pathologists must make quick decisions based on the analysis of frozen sections or there is the need to undergo two surgical interventions (i.e., removal of primary tumor and SNB, and in a next step completion ALND). If nodal positivity could be proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a decision will be made to perform axillary dissection, which is the standard of care in most node-positive patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.

Exclusion Criteria:

* Patients who had previously undergone axillary surgery.
* Patients with metastatic disease and not planned for axillary surgery.
* Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
* Patients with severe uncorrectable bleeding diathesis.
* Patients refused to sign consent.
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
* Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

Exclusion Criteria:

* Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.
Taste and Smell Impairment in Critically Ill COVID-19 Patients

Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-80
* Agree to participate in the study
* Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19

Exclusion Criteria:

* Pre-existing smell and taste impairment
* The patients have no enough cooperation to answer the questionnaire
* Having additional diseases such as dementia and Alzheimer