cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients

This study will assess the efficacy of periodontal treatment in diabetic patient. Patients will be randomized in the periodontal group or in the control group. The control group will received a periodontal treatment after the study.


Eligibility Criteria:
Inclusion Criteria:

* patient suffering from a periodontitis
* patient with : 7,0% \< Hemoglobin A1c \< 9,5%

Exclusion Criteria:

* If an hospitalization is planned within the next 4 months
* Patient suffering from chronic infectious pathology (HIV, hepatitis C virus, hepatitis B virus, mononucleosis)
* Renal insufficiency
* Contra indication for amoxicilline or clindamycin
* Antithrombotic treatment
* Liver disease
The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.

The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at \<12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at \<12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* \<12 weeks pregnant at first prenatal check up

Exclusion Criteria:

* Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.

This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Age≥65 years
* Expected operation time≥ 2 hours
* Postoperative hospital stay≥ 4 days
* Sign the informed consent form

Exclusion Criteria:

* Neurosurgery or cardiac surgery
* Emergency surgery within 6 hours of admission
* End-stage disease with an expected survival of \< 3 months
* Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
* Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
Feasibility Clinical Evaluation of the Calibreye System

To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Open angle, pseudoexfoliative or pigmentary glaucoma
* IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
* Visual field mean deviation score of -3dB or worse
* Area of healthy, free and mobile conjunctiva in the target quadrant
* Shaffer angle grade ≥ 3 in the target quadrant

Exclusion Criteria:

* Angle closure glaucoma
* Congenital, neovascular or other secondary glaucomas
* Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring \> 3 months prior to the preoperative visit)
* Previous glaucoma shunt/valve in the target quadrant
* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
* History of corneal surgery, corneal opacities or corneal disease
* Active diabetic retinopathy
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen

The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent from subject or family member
2. Subjects with open abdomen suitable for temporary closure with NPWT therapy
3. Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)
4. Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit
5. Male or female, 18 years and above

Exclusion Criteria:

1. Synthetic mesh inserted in the abdomen
2. Non-enteric fistulae or unexplored fistulas
3. Untreated osteomyelitis
4. Malignant wounds
5. Abdominal wall hernia
6. Subjects previously treated with an NPWT abdominal dressing
7. Known allergy or hypersensitivity to any of the components in the dressing
8. Pregnancy
9. Subjects not suitable for the investigation according to the investigator's judgement
10. Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.

Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients who require an endotracheal tube during general anaesthesia.
* Informed consent.
* Legally competent.
* Be able to understand Danish and be able to read the given information in Danish.

Exclusion Criteria:

* Planned or former operation in or around the pharynx or the larynx.
* Cancer, infection or sequelae in or around the pharynx or the larynx.
* Use of a stomach tube before or during surgery.
* Suspected difficult intubation.
Perception of Female Hormonal Contraception by the Main Prescribers

The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment.

Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.


Eligibility Criteria:
Inclusion criteria:

* Any health care professional in general medicine, gynecology and midwifery
* graduate or in progress
* in practice (any practice modality in metropolitan France)
* agreeing to participate in the survey by completing the questionnaire anonymously, after having read the information and non-objection notice attached to the questionnaire.

Exclusion criteria:

- Any other health profession

Inclusion criteria:

- Any health care professional in general medicine, gynecology and midwifery
Primary Care Pathway for Childhood Asthma

At least half of children with asthma have poor disease control, which can result in complications requiring emergency treatment and hospitalization. As asthma is one of the most common reasons for children to visit emergency departments (ED) and be hospitalized, this disease places a heavy burden on the health care system and families. While there is strong evidence that timely treatment with preventative therapies can substantially improve asthma control, reduce sudden worsening of symptoms, and lower rates of ED visits and hospitalizations, a significant proportion of children do not receive these therapies.

The purpose of this study is to improve the prescription and use of evidenced-based preventative therapies for children with asthma with the goal to significantly improve their disease control and quality of life, while reducing unnecessary ED visits and hospitalizations. The investigators will achieve this by: i) installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic disease management (CDM) health professionals to provide targeted and timely asthma education to parents and children with asthma. The investigators will test this pathway and education project in a representative sample of 22 Alberta primary care practices, using a pragmatic cluster controlled trial methodology.


Eligibility Criteria:
Inclusion Criteria:

* Validated diagnosis of asthma according to CPCSSN validated definition

Exclusion Criteria:

* Children under 1 and over 17 years of age
* Children of parents who have opted out of CPCSSN data collection
* Children with validated asthma who have not attended practices in the last 2 years, or have not received bronchodilator therapy in the last 12 months
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. The objective of this randomized controlled trial (RCT) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

With increased interest in quality of life after thyroidectomy, preservation of proper vocal cord function and voice quality is an important issue in thyroid surgery. External branch of the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs for innervation and integration of laryngeal muscular system. The EBSLN innervates the cricothyroid muscle (CTM), which is important in adjusting the tension and length of the vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high pitch phonation and decreased pitch range and reduced voice projection, which are important for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive and objective tool to confirm the nerve presence and integrity, application of the intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle function. However, it remains unclear whether there is any intraoperative neuromonitoring techniques-added value to the clinical outcome of thyroidectomy in terms of identification of EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of the application of the intraoperative neuromonitoring during thyroid surgery to identify and preserve EBSLN function.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo thyroid surgery
* Patients who understand and agree to take part in this study

Exclusion Criteria:

* If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.)
* Patients who are required with lateral compartment neck dissection
* Patients with recurrent thyroid cancer
* Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present
* Patients with a history of vocal cord and larynx disease
* History of hyperthyroidism (e.g., Graves' disease)
* Taking anticoagulants (aspirin, warfarin, etc.) before surgery
* Disorders of coagulation
* In the case of women, pregnant women and breastfeeding patients
* Patients judged inappropriate by clinical trial researcher
Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers

This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
* Locally advanced or metastatic NSCLC diagnosed by histology or cytology
* The major organs are functioning well；
* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.

Exclusion Criteria:

* Current concomitant presence of other malignancies within 5 years prior to the first dose;
* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
* Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
* Long-term unhealed wounds or fractures;
* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
* Subjects with any severe and/or uncontrolled disease;
* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
* Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;
* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography

The study investigates the influence of a clinically indicated fluid challenge on end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data will be collected before, during and after infusion of 500 ml of crystalloid solution in mechanically ventilated patients on an operative intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* patients on mechanical ventilation
* clincial decision to monitor regional ventilation with electrical impedance tomography
* clinical indication for fluid challenge
* established cardiac output monitoring with transpulmonary thermodilution

Exclusion Criteria:

* age \< 18 years
* open lung injuries
* instable injury of spine or cranium
* thoracic metal implants
* body mass index \> 35
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity

To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.


Eligibility Criteria:
For healthy volunteers

Inclusion Criteria:

* good health
* normal ECG
* cardiac ejection fraction \> 50%

Exclusion Criteria:

* with chronic disease or treatment
* under law protection
* not affiliated to the national health insurance

For patients with heart failure

Inclusion Criteria:

* clinically sable
* with sinusal heart rhythm
* without sign of neuropathy
* cardiac ejection fraction \< 50%

Exclusion Criteria:

* with pace maker
* under law protection
* not affiliated to the national health insurance
* skin lesion or severe allergia
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD

This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).

This study will enroll individuals diagnosed with Parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). Outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by H reflex) and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
3. Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).

Exclusion Criteria:

1. Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
3. Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
4. Subjects with a history of head injury.
5. Subjects with a history of seizures or epilepsy.
6. Subjects who are currently pregnant.
7. Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
8. Individuals with skull abnormalities, fractures or unexplained, recurring headaches.