cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.


Eligibility Criteria:
Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery

To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.

There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years.
* Provision of signed informed consent prior to any study-specific procedure.
* Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.

Exclusion Criteria:

* Age \>80 years
* History of chronic pain or drug treatment abuse
* Depression, psychiatric morbidity or mal-adaptive coping behavior
* Neuropathy
* Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
* Chronic or acute skin infection of the lateral thorax
* Hypersensitivity to ropivacaine
* Severe hepatic or renal disease
* Refuse to participate to the study
* Pregnancy
Urotensin II and Vascular Tone in Cirrhosis

This study looks at the iontophoresis of urotensin II in chronic liver disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study

the investigators are interested in assessing the feasibility and value of brachial plexus block at the level of the humeral head in children. As a first step, the investigators propose to carry out a sono-anatomical study to describe the plexus at this level, the distribution of nerves in relation to the axillary artery, and the description of bone and muscle structures.

Brachial plexus blocks below the clavicle provide anesthesia and analgesia of the upper limb for elbow, forearm and hand surgery. Among the techniques described, axillary and costo-clavicular blocks are most frequently used.

In the axillary approach to the brachial plexus, the ulnar, median and radial nerves are in the direct vicinity of the axillary artery. However, there is considerable variability in the location of these nerves . What's more, the musculocutaneous nerve is most often distant from the other nerves of the plexus. These disadvantages are not encountered with the costo-clavicular technique, in which the nerves are brought together in the same diffusion space. On the other hand, this method does run the risk of pneumothorax and anesthesia of the phrenic nerve.

In this context, the investigators have described the brachial plexus block at the level of the humeral head in adults, which enables practicians to work on nerves gathered around the axillary artery without any risk of phrenic or pulmonary damage4.

In children, Small et al described a supra-clavicular approach, but Clayton et al, noting the high risk of pneumothorax, strongly advocated the axillary approach.

Eligibility Criteria:
Inclusion Criteria:

* patient ASA 1-2
* aged 0 to 10 years
* scheduled surgery
* parental consent obtained

Exclusion Criteria:

* Parental refusal to participate
* suspicion of local skin infection
* inability to place the limb in the position required for sonographic examination
* Upper limb malformation
* ASA III, IV
* Major surgery (cardiac, neurosurgery...)
* emergencies
Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT

This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month


Eligibility Criteria:
Inclusion Criteria:

* particepant with age rang 18-55
* particepant with non carious cervical lesion

Exclusion Criteria:

* particepant outside age rang
* particepant with periodontal problem that might affect the teeth to be treated
Violence Sexual Incidence During the First Year of Residence on Asylum Seekers

Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life.

The main objective of this study is to measure the incidence of sexual violence suffered by women in asylum proceedings during their first year of stay on French territory, in Marseille and Nice.

Introduction: One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in his life. They are exacerbated in vulnerable populations, marginalized, in post-conflict situations or population displacement.

Therefore asylum seekers women are particularly exposed to sexual violence. This is why OFPRA and the Ministry of Solidarity and Health have protected these women with regard to sexual violence, one of the priority issues for public health. Yet, the investigators do not know the proportion of women seeking asylum who have suffered violence on French soil. In addition, the investigators did not find an international study of the incidence of violence sexual abuse suffered in the host country by women seeking asylum. Objective: Determine the incidence of sexual violence that occurred in the year following the arrival on French soil of adult women in the asylum process in Marseille and Nice.

Methodology: Multicentric longitudinal observational study (Marseille and Nice) based on a historical cohort of sexual violence among women in the application process asylum. 1,800 adult women seeking asylum were registered in 2019 in Marseille and Nice. The number of subjects required is 450 women (1: 4 sample of the target population).

Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Major arrival (\> 18 years old) on French territory
* In the asylum application procedure with the GUDA in Marseille or Nice
* Having a decline of residence on French soil of twelve months over the last 2 years.
* No objection to participating in the study

Exclusion Criteria:

- Existence of cognitive disorders (dementia, mental retardation) limiting the collection of criteria for judgment
The Detection of Circulating Tumor Cells (CTCs) in Patients With Liver Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in liver cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with liver cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of liver cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except liver cancer
2. History of coagulation disorders or anemia
The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker

This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

Hypotheses of the Research H01: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the anxiety and depression levels of the patients.

H11: Training given according to Meleis's Transition Theory to patients with pacemaker implants reduces the anxiety and depression levels of patients.

H02: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the self-efficacy level of the patients.

H12: Training given to patients with pacemakers according to Meleis's Transition Theory increases the self-efficacy level of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pacemaker implantation,
* Ages 18 and over,
* The one who is literate,
* Open to communication and collaboration,
* Patients who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Not oriented to person, place and time,
* Hearing loss,
* Cannot understand and speak Turkish and
* Patients who do not want to continue the study will be excluded from the study.
Detection of Internal Tremors by Oscillometry in Parkinson's Patient

The goal of the present study is to objectively access the presence of an Internal Tremor in Parkinson's disease. Inertial sensors will be used to detect the presence of a rhythmic oscillation of 3-4 Hz. The study will be performed in both Parkinson's disease patients and healthy controls to ascertain the specificity of this type of tremor.

The interest in finding prodromal symptoms in Parkinson's disease has been growing. Internal tremor, felt subjectively by the patients, have been reported in some studies as being present on the Prodromal phases of the disease. An objective identification of this tremor has never been made. In this study we propose to objectively access the presence of Internal Tremor in Parkinson's Disease patients using accelerometers. A control population of healthy subjects will also be evaluated to confirm the specificity of tremor for a PD population.

Eligibility Criteria:
Inclusion Criteria:

(For the experimental group)

* Patient with idiopathic parkinson's disease
* Mini Mental State Evaluation score above or equal to 25
* Hoehn and Yahr scale score of ≤3 in the OFF phase, with postural stability allowing the patient to stand unaided for 1 minute.
* Able to walk unassisted
* No major osteoarticular issues
* Presence of another neurological condition that may affect gait
* Willing to undergo accelerometry in the OFF state

(For the control group)

* Healthy volunteer subjects matched for age (+/- 5 years) and sex
* Mini Mental State Evaluation score above or equal to 25

Exclusion Criteria:

(For the experimental group)

* Patients with an atypical parkinsonian syndrome
* Patients unable to walk or stand for more than one minute in the off state
* Parkinson's patients treated with deep brain stimulation, apomorphine pump, or duodopa intestinal infusion, and foslevodopa
* Pregnant patients

(For the control group)

* Participants with significant gait impairment (osteoarticular disorder)
* Those with a neurological disease that, in the investigator's judgment, may interfere with the study's outcome measure
* Participants with a clinical tremor that may interfere with the measurement of the primary outcome (e.g., essential tremor, thyroid disease, or tremors induced by medication)
* Pregnant participants
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* Male or female COPD patients between the ages of 40 and 80 years
* Smoking history of at least 10 pack years
* Not currently using (or able to wash out of) any long acting bronchodilators

Exclusion Criteria:

* Candidate on a waiting list for surgery while on study
* Using long-term oxygen therapy
* Hospitalization for COPD exacerbation
Plasma Melatonin AND Mortality After Acute Myocardial Infarction

Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and antilipaemic properties, which plays important roles in a variety of cardiovascular pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum melatonin concentrations after AMI are associated with more heart failure and cardiac death and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin secretion is associated with higher risks of MI. Early-morning blood collection is easier in clinical practice. Therefore, the investigators carried out a cohort study to evaluate the prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients of acute AMI come to department of cardiology, 301 hospital (Beijing, China),absent of cardiogenic shock, and survival for at least 24 h after percutaneous coronary intervention treatment.

Exclusion Criteria:

* patients with autoimmune diseases, collagen tissue diseases, drug addiction, radiotherapy, patients receiving immunosuppressive treatment, taking sedatives, antiepileptic drugs, tricyclic antidepressants or any medication known to influence melatonin metabolism, psychiatric sleeping disorders, shift workers, and subjects with jet-lag syndrome
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

Eligibility Criteria:
Inclusion Criteria:

* Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is \>5 years of age)
* Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Has ocular hypertension (defined as IOP of \>21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
* Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye
Microvascular Function Assessment in Healthy Subjects

Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal to 18 years old
* Healthy subjects

Exclusion Criteria:

* Aspirin allergy
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections

Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after, one and three hours after Restylane® injections in the nasolabial folds.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Subjects 30 - 65 years of age
* Subject undergoing cosmetic dermal filler injections for correction of nasolabial folds. Treatment sites should be comparable, requiring the same number of injections on each nasolabial fold
* Subjects diagnosed with moderate nasolabial folds (Wrinkle Severity Rating Scale of grade 3)

Exclusion Criteria:

* Subjects under treatment for a dermatologic condition on the face, which may interfere with the safe evaluation of the study treatment (e.g. eczema, psoriasis, severe sun-damage, dermatitis), have damaged, denuded or broken skin at the designated treatment site and/or have scarring or infection of the area to be treated
* Subjects who have taken prescription or non-prescription analgesic medication during the 24 hour period prior to the procedure
* Subjects with a history of bleeding or clotting disorders
* Subjects who have used ASA (aspirin), NSAIDs (Non-Steroidal Anti- inflammatory Drugs), anticoagulants, St. John's Wort or high doses of Vitamin E (above the recommended daily allowance) within 2 weeks prior to the procedure
Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia

In summary, there is a clear need to improve knowledge and self-management skills in adolescents with hemophilia. To date, there are no published accounts of self-management programs for this population. Evidence from other chronic diseases that affects teens suggests that by developing an interactive Internet-based program, the investigators can meet the educational needs of adolescents with hemophilia and improve their ability to manage their hemophilia. In the long-term, improved self-management should result in a smoother and more successful transition to adult care and improve patient outcomes.

The overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention that will help adolescents with hemophilia to better understand and manage their disease independently. This program is modeled after Dr. Stinson's similar successful internet self-management program developed for youth with arthritis.

This program is being developed and evaluated using a sequential, phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with hemophilia. Currently, in Phase 2A, we are developing the website with the content based on the findings from the Phase 1 needs assessment. We propose the current study to conduct usability testing (Phase 2B) to make sure it is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will enable us to determine an appropriate sample size for the future mixed controlled trial. Phases 2B and 3 are the focus of this proposal. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group. This randomized controlled trial controlled trial will include all interested pediatric hemophilia treatment centres across Canada.

We hypothesize that adolescents with hemophilia who complete the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention will demonstrate: increased hemophilia specific knowledge, increased self-efficacy, improved health-related quality of life (HRQL) and decreased stress prior to transition to adult health care.

Eligibility Criteria:
Inclusion Criteria:

* age 13-18
* diagnosis of mild, moderate or severe hemophilia A or B
* be able to speak and read English or French.
* must have access to the Internet at home

Exclusion Criteria

* cognitive impairments
* haematologist feels that they have a significant medical or psychiatric condition that will impact their participation
* don't have access to the internet.
Reconstructive Surgical Approach for Pincer Nail

A prospective design that studies the effects of a new technique for the treatment of pincer nails. The technique consists of a flattening of the bone of the distal phalanx with a frontal skin lifting that is performed in patients with a pincer nail deformity. Visual Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.


Eligibility Criteria:
Eligibility Criteria:

* Pincer nail deformity
* At least 5 years of pain in the nail
* Prior unsuccessful conservative treatments

Exclusion Criteria:

* Medical or mental conditions that contraindicate surgical treatment of the condition.
Thiol/Disulfide and Oxidative Stress

The aim of this study was to evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries


Eligibility Criteria:
Inclusion Criteria:

* 3-5 years

Exclusion Criteria:

* the children with systemic illness, using anti-inflammatory drug