cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Class II Restorations

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. proximal caries that are similar in size to premolar and molar teeth
4. vital teeth
5. teeth in contact with the opposing tooth and subjected to normal occlusal forces
6. attend follow-up appointments

Exclusion Criteria:

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. exposure of the pulp during cavity preparation
7. systemically unhealthy
8. pregnant and lactating women
Single Ascending Dose Trial in Patients With Type 2 Diabetes

The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent
* Men and women between the ages of 18 and 65, inclusive at the time of randomization
* Women must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
* Diagnosed with type 2 diabetes
* HbA1c ≥ 6.5% and ≤ 10%
* Fasting C-peptide value ≥ 0.8 ng/mL
* Men must agree for the duration of the study and continuing for 4 weeks after the dose of study drug, to practice a highly effective method of birth control. Highly effective methods of birth control include sexual abstinence, vasectomy or a condom with spermicide (men) in combination with either barrier methods, hormonal birth control or IUD (women).
* Men must agree to not donate sperm for the duration of the study and continuing for 4 weeks after the dose of study drug.
* Body mass index between ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 at screening
* Negative screening test for alcohol and potential drugs of abuse at screening and day -2, unless medication is prescribed by a physician and approved by the principal investigator and Amgen medical monitor

Exclusion Criteria:

* Men with partners who are pregnant at the time of screening or men with partners who plan to become pregnant during the study
* Women who are pregnant or breastfeeding History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance \< 60 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula), or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness
* Significant cardiac disease, including but not limited to evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia
* Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (Hbs Ag), or hepatitis C virus antibodies
* An unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator (eg, risk of complications or adverse events unrelated to study participation)
Cancer Stem Cells in Acute Leukemia

Descriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or relapsed acute leukemia (AML or ALL)
* Plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. WBC\>50,000 and bone marrow contraindicated)
* Age 1 month to 30 years
* Understand and provide informed consent (subject if\>18, legal guardian if\<18)

Exclusion Criteria:

* Age 0 to 4 weeks
* Treatment related leukemia or leukemia secondary to MDS
* Situations that would limit compliance with study requirements or ability to willingly give consent
Epicardial Stimulation of the Cardiac Autonomic Nervous System

The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery.

Proof of concept study

Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure.

Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al.

The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective cardiac surgery for valvular or coronary surgery
* Having received written and oral information about the protocol and having signed a written informed consent
* Affiliated or beneficiary of a social security plan

Exclusion Criteria:

* Patient with an indication for cardiac surgery:
* Urgent or semi-urgent
* Aortic surgery
* Heart transplantation
* Mechanical circulatory assistance
* Patients who have already undergone cardiac surgery
* Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason
Effect of BIBW 2948 BS in COPD

Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis


Eligibility Criteria:
Inclusion Criteria:

* COPD smokers
* ages between 40 and 70

Exclusion Criteria:

* Significant other diseases
* abnormal hematology
* abnormal liver function
* psychiatric disorders
* pulmonary obstruction
* asthma, allergic rhinitis
* dependance on oxygen
* patients with history of myocardial infarction
* patients with history of cancer
* women of child bearing potential
* antiplatelet or anticoagulation therapy
Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 40 years or older.
2. Patient has a documented diagnosis of COPD.
3. Patient qualifies for continuous (24/7) long-term oxygen therapy.
4. Patient is prescribed oxygen at ≤ 5 L/min.
5. Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.
6. Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.
7. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.

Exclusion Criteria:

1. Patient's condition is contraindicated for the use of a POC.
2. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
3. Patient is unable to complete the 6-minute walk test.
4. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids.
5. Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
6. Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
7. Patient has a life expectancy \< 1 year.
8. Patient has non-COPD lung disease that may affect oxygenation or survival.
9. Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
10. Patient is pregnant or planning to become pregnant.
11. Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
12. Patient, in the opinion of the investigator, should be excluded from the study.
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery

During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~III

Exclusion Criteria:

* ASA classification IV
* New York Heart Association (NYHA) class III\~IV
* Severe obstructive lung disease / restrictive lung disease
* Pulmonary hypertension
* End-stage organ disease (i.e. hepatic failure, renal failure)
* Arrhythmia
* Previous history of thoracic surgery
Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways

A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation.

These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2 with cryotherapy (CRYO).

The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.

This is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) or cryotherapy.

Thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (EPS), referred to percutaneous catheter ablation, will be enrolled in this trial.

After informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. Group I: electrophysiological mapping and ablation with radiofrequency (RF) focal lesion formation.

Group II: electrophysiological mapping and ablation with cryotherapy (CRYO) focal lesion formation.

The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.

Eligibility Criteria:
Inclusion Criteria:

* Patients with para-hisian accessory pathways, diagnosed by electrophysiological study (EPS), with indication of invasive treatment according to current guidelines. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.

Exclusion Criteria:

* Previous cryotherapy ablation;
* Previous extensive radiofrequency ablation (including aortic cusp mapping);
* Age below twelve years;
* Severe coagulation disorder;
* Pregnancy;
* Refusal to participate in the study.
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway

This project is based on the assumption that the nurse coordinators of the centres have common missions at each of the key stages of patient care. These missions make the care plan more fluid and improve the quality and safety of care as well as the patient's prognosis.

The Hypothesis is that co-follow-up by a doctor and a nurse coordinator reduces time between referral to treatment, average lengths of stay, unscheduled readmissions or early emergency visits, compared to follow-up that does not involve a nurse coordinator.

Main objective:

Describe the roles and missions of professionals dedicated to the coordination of care pathways for patients with HCC

Secondary objectives:

Compare the indicators of quality of care in HCC centres with a nurse coordinator:

1. Timeframe in treatment:

   * timeframe between the first contact with the HCC centre and the first interventional radiology treatment.
   * timeframe between the first contact with the centre and the first presentation at a multidisciplinary team meeting (MDT)
   * time between the first contact with the centre and the diagnostic consultation
   * timeframe between the first contact with the centre and discharge from the hospital
   * timeframe between the first interventional radiology procedure and the next for the subgroup of patients who have multiple procedures during the follow-up period
   * timeframe between the first contact with the nurse coordinator of the centre and discharge from the hospital.
2. The average length of stay of hospitalization
3. The number of visits to the emergency unit during the first month following the radiology intervention
4. The number of unscheduled readmissions during the first month following the intervention.

Assess the feasibility of collecting the above-mentioned timeframe and variables and the patients and carers feedback on the coordination of the care pathway Describe the organization of care pathways for patients with HCC in centres with or without a nurse coordinator.

Research method: This is a retrospective descriptive pilot study. It aims to describe the organization of care.

Population: Patient with a diagnosis of localized hepatocellular carcinoma.

Data processing:

* Feasibility questionnaires will be sent by email.
* The interviews will be transcribed and coded with NVivo® software
* Patient data will be collected in the ecrf
* Data processing from anonymized files by the authors of the research only. All data will be centralized at Bichat Hospital (URC Paris Nord) for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Centre with interventional radiology treatment
* Active list of patients followed for a HCC of at least 70 / year
* Reply to the feasibility questionnaire within 60 days from receipt of the email

Exclusion Criteria:

* Patient with a localized HCC diagnosis (BCLC A or B)
* Hospitalised for a first interventional radiology treatment (radioembolisation, transarterial chemoembolization or percutaneous ablation) in one of the centres included in the study between July 1, 2017 and December 31, 2017
Long-term Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Phantom Limb Pain (PLP)

* Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes.
* The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain.

This is a Crossover sham control.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* Limb amputation from at least 6 months before study enrollment
* Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study
* Written informed consent

Exclusion Criteria:

* Coexistence of major neurological or psychiatric diseases
* Being actively enrolled in a separate study targeting pain relief
* Post traumatic stress disorder (PTSD) diagnosed patients
* Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure
* Pregnant women
* Within the traumatic amputees group - subjects diagnosed with diabetes
Social Media Use in Adolescent Diabetes Care

The goal of this clinical trial is to evaluate the feasibility of a social media intervention to support diabetes management in adolescents with type 1 diabetes.

Adolescent participants will be randomized to receive diabetes education and peer support over Instagram or to usual outpatient diabetes care. Researchers will assess whether the social media intervention is feasible. In addition, the study team will also explore and compare changes in glucose levels and person-reported outcomes between the two groups.

The majority of adolescents with type 1 diabetes do not meet recommended glycemic targets, placing them at risk for acute and chronic diabetes-related complications. Strategies that improve adolescent diabetes self-management are needed. Social media offers new opportunities to provide diabetes education and peer support through communication in a digital environment.

As part of a randomized controlled trial, adolescent participants will be randomized to receive diabetes education and peer support over Instagram in addition to usual care or to standard outpatient diabetes care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes ≥12 months
* Most recent hemoglobin A1c (HbA1c) level is \> 7.0%
* Currently use Dexcom continuous glucose monitoring (CGM) system
* Speak English fluently
* Cognitively able to participate in program on Instagram and complete surveys
* Have access to a personal Instagram account
* Found to be eligible on the Social Media Preference Screener

Exclusion Criteria:

* Patient is a ward of the state
* Patient is pregnant as diabetes standard of care is different during pregnancy (i.e., different glycemic targets and frequency of clinic visits)
* Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata

This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design".


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily sign the informed consent form.
* Patients who participated in ZGJAK018.

Exclusion Criteria:

* Subjects who are unsuitable to the trial, as identified by the investigator.
Different Anesthetic Technique For ERCP

Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.

ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.

Previous studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years old
* Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)
* Coagulation function tests in normal range

Exclusion Criteria:

* Potentially difficult airways
* Administration of sedative or narcotic drugs in the previous 24 hours
* Severe renal or hepatic impairment
* Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)
* Contraindications to a nasotracheal intubation
* Coagulopathy
* History of frequent episodes of epistaxis
* Emergent ERCP
* At risk for reflux and aspiration