cyrilzakka/clinical-trials huggingface dataset:
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy

The sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal and masseter muscle. The regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. The mandibular block is a simple and reliable technique but little used. Yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the V3 block ropivacaine is not evaluated in the maxillofacial surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult patients and patients from 15 to 18 years old
* with mandibular trauma or orthognathic surgery
* Affiliated to a national insurance scheme
* to have signed the informed consent of this study
* Physical status score 1-3

Exclusion Criteria:

* allergy to local anesthetics
* severe coagulopathy
* hypovolemic patient
* Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
* Pregnant or breast-feeding women according to the article L1121-5 of the Code of the Health Public.
* Vulnerable People.
Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

This study will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this study are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
* Morning (pre-glucocorticoid \[GC\] replacement dose) blood concentrations of 17-OHP \>4-times upper limit of normal (ULN).
* Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) (minimum 50 kg) and ≤35 kg/m\^2.
* Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
* For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥3 months prior to the Screening Visit.
* Apart from CAH, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ECGs, and the results of the safety laboratory tests.

Exclusion Criteria:

* The participant is pregnant or breastfeeding.
* The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety findings at the Screening Visit that indicate a potential risk for the participant if enrolled, in the opinion of the investigator.
* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.

Other inclusion and exclusion criteria may apply.
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. Up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as HbA1c levels). The main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in PWT1D, and to address the role of CFTR variants as potential contributors to pancreatic insufficiency.

In this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes.

Patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (EPI). EPI will be defined based on the levels of pancreatic enzymes (Amylase; lipase; and trypsinogen). As the prevalence of EPI in people living with type 1 diabetes (PWT1D) is \~50%, we expect roughly the same number of individuals into both groups (with or without EPI).

Variables :

Subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected.

Glucose variation will be assessed with a continuous glucose monitoring system for 1 month. Briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc..

From collected peripheral blood mononuclear cells (PBMCs) we will quantify CFTR function and level of expression, as well as identify CFTR variants by next generation sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Living in Montreal

Exclusion Criteria:

* Pregnancy,
* Use of corticosteroid
* Use of medication known to have a relevant impact on glycemic control.
A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis

RESYZE was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in Spain, assessing secondary progressive multiple sclerosis (SPMS) patients in a real-world setting. Patients underwent clinical assessments and received their standard routine medical care, as determined by their treating physicians. The study used secondary data i.e., electronic medical records (EMR) from hospitals. Patients who met the eligibility criteria were selected from the EMR of each of the sites, to include adult SPMS diagnosed patients who received at least one dose of siponimod during the start of treatment period between April 2021 and 01 September 2022, with a 12-month observation period, regardless of whether or not they continued the treatment. The study compiled data that was available in the hospital EMR from each patient up to 24 months before the first siponimod dose, and 12 months after the first siponimod dose. Data were collected for each patient at regular intervals of 6/12 months and within a window period of ±45 days, as available.


Eligibility Criteria:
Inclusion criteria:

* Patients with SPMS, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from April 2021 to September 2022), regardless of whether they continued treatment or they did not.
* Patients who received at least 1 dose of siponimod treatment for SPMS with a 12-month observation period.
* Availability of the data for at least 12 months after siponimod initiation.

Exclusion criteria:

* Patients with any contraindication to siponimod, according to applicable Summary of Product Characteristics (SmPC).
* Patients included in any clinical trial at any moment of the study period.
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.

See Eligibility Criteria section

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Weigh at least 40 kg
* Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure
* Willing and able to provide informed consent
* Able to communicate and read in English

Exclusion Criteria:

* Emergency procedure such that informed consent may not be obtained
* Known cognitive impairment, history of delirium or dementia
* Known hemodialysis or fistula graft
* Delirium Observation Score (DOS) Score of \>6 prior to surgery
* Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis)
* Any known contraindication or sensitivity to the cerebral oximeter sensor
Effects of Normobaric Hypoxia Exercise Program on Bone Turnover Markers and Metabolism in Premenopausal Women

The impact of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women falls within the realm of physical culture for an active and healthy society. Within this context, the implementation of a project is supported aiming to:

1. Monitor, support, and promote physical development, fitness, and physical activity in society, by assessing the effects of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
2. Develop and implement innovative methods, forms, and means of physical activation and training for individuals of various ages, by formulating general assumptions of an endurance-strength training concept under normobaric hypoxia conditions, concerning changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
3. Prevent injuries in physical education and sports, by designing a useful training program for osteoporosis prevention as well as for managing carbohydrate and lipid metabolism disorders in premenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* No significant cardiovascular, respiratory system diseases and musculoskeletal system,
* No contraindications to physical activity. ECG, baseline urinalysis, morphology are required.
* T-score within normal limits (+1.0 to -1.0).
* Informed consent of the patient to participate in the study.

Exclusion Criteria:

* Use of hormone replacement therapy (HRT).
* Use of substances (cigarettes, alcohol).
* Any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
* Any other factors determined by the study investigators as unsuitable for participation.
MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

The aim of the randomized-controlled, single-center MEDPass trial is to assess the effects of MEDPass versus conventional administration of oral nutritional supplements (ONS) on energy and protein intake in medical and geriatric inpatients.

Disease related malnutrition (DRM) in hospitalized patients is a common problem.The oral nutritional support with ONS is one of the first and most common treatment approach in the patients at nutritional risk. Treatment with ONS may reduce mortality and complications in hospitalized patients.

There are no standards on the type of administration of ONS in terms of timing throughout the day leading to individual approaches. ONS are conventionally served as snacks by nurses, nursing aids or gastronomy personnel between the main meals. The MEDPass-mode offers a different approach by serving ONS together with the medication, three or four times per day, in unusually small portions. Preliminary trials suggest that compliance and cost effectiveness may be improved with the MEDPass-mode.

Enhancing compliance to ONS may not consequently lead to improved total energy and protein intake throughout the day. There has never been a large trial in which total energy- and protein intake of the subjects was studied consequently and systematically throughout the hospitalization. Therefore, this trial will bridge this gap by studying total energy- and protein intake as primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Nutritional risk screening (NRS-2002) total score ≥3 points according to routine screening at admission within 72 hours
* Expected hospital LOS ≥3 days after screening (as estimated by the treating physician)
* Patient qualifies for ONS and approves prescription
* Age \>18 years
* Willingness and ability to provide informed consent

Exclusion Criteria:

* Initially admitted to critical care unit
* Immediate post-operative phase (\<7 days post-surgery)
* Dysphagia with the inability to swallow liquids
* Supplemental enteral and/or parenteral nutrition
* Admitted with, or scheduled for, total parenteral nutrition or tube feeding
* Mini Mental State examination \< 16 points
* hospitalized due to anorexia nervosa
* hospitalized due to acute pancreatitis
* hospitalized due to acute liver failure
* cystic fibrosis
* patients after gastric bypass surgery
* patients with short bowel syndrome
* terminal condition (end of life situation)
* poor skills in German language (study language)
High-flow Nasal Cannula and Exercise Tolerance in COPD

Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. The objective was to evaluate and compare the acute effects of HFNT and NIV during exercise on cardiorespiratory parameters, dyspnea, exercise tolerance and comfort in patients with moderate to severe COPD.

The patients underwent an initial clinical examination, with anthropometric evaluation, blood gas analysis, pulmonary function tests and measurement of maximum respiratory pressures. The exercise protocol started in the sector of Ergometry and Cardiopulmonary Exercise Testing. After completing the maximum incremental cardiopulmonary exercise test, two additional visits were scheduled for the three constant load tests. All patients studied underwent an evaluation of cardiopulmonary exercise testing (CPET). During maximum-incremental CPET, breath by breath: oxygen consumption (V̇O2, mL/min), carbon dioxide production (V̇CO2, mL/min), respiratory exchange rate (RER), minute ventilation VE (L/min), respiratory rate (bpm), equivalent ventilation for O2 and CO2 (V̇E/V̇O2 and V̇E/V̇CO2). In addition, cardiac monitoring was performed by 12-lead electrocardiogram (ECG) throughout the procedure. On the day of the experiment, the patients underwent two cardiopulmonary exercises with constant-load at 90% of the previously determined peak, separated by an interval of at least 1 hour.

The NIV parameters were adjusted for each patient with Trilogy 100 (Philips™). Spontaneous ventilation mode was set before the protocol for all patients, and a previous period of NIV adaptation was performed to titrate the inspiratory and expiratory pressures. The adaptation period started with the minimum Inspiratory Positive Airway Pressure (IPAP) value of 15cmH2O, and, every 2 minutes, increasing the pressure every 2 cmH2O according to the patient's tolerance.16 The Expiratory Positive Airway Pressure (EPAP) was programmed to vary between 4 and 6 cmH2O. Before the start of the examination, an adaptation was performed with the selected mask and initial ventilator settings for 20 min. No additional oxygen was offered.

The high flow system used was Optiflow® (Fisher \& Paykel Healthcare, Auckland, New Zealand). Before the test, flow titration was performed for the patient, which started with the administration of a minimum gas flow of 30L/min and, every 2 minutes, the flow was increased by 5L/min according to patient tolerance. The test only started after 20 minutes of adaptation.

Eligibility Criteria:
Inclusion Criteria:

* Previous COPD
* FEV1 ≤ 50%
* Optimized medication

Exclusion Criteria:

* COPD Exacerbation
* Cardiac disease
* Previous neurologic disorders
* Unable to complete all protocol
Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis

Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain.

This study has the aim to test the effectiveness of hypnoanalgesia, performed by a specialised nurse, for peri-and post-procedual pain reduction.


Eligibility Criteria:
Inclusion Criteria:

* patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
* Age of 18 and over

Exclusion Criteria:

* NA
The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have hypertension and uncontrolled SBP on monotherapy.
* Patients who have read, signed and received a copy of the informed consent prior to any study procedures

Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.

Exclusion Criteria:

* Any history of secondary hypertension
* History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care

This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch repair deficiency in patients with endometrial cancer, mutations in the genes responsible for Lynch syndrome (inherited forms of endometrial cancers) and other DNA changes that could help guide treatment strategies. Universal tumor DNA sequencing may help doctors better understand how to personalize care, increase length of life, and increase quality of life in patients with endometrial cancer and their relatives.

PRIMARY OBJECTIVES:

I. Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.

II. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.

III. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.

IV. Provide local access to genetic counseling for patients with harmful germline mutations.

V. Identify molecular signatures that may be associated with favorable response to specific treatments (including chemotherapeutic agents, non-surgical options, and novel clinical trials \[in particular, patients with mismatch repair (MMR)-deficient or POLE-mutant tumors\]).

VI. Determine if recurrence likelihood can be predicted from molecular signature.

VII. Identify EC patients with select molecular signatures for recruitment to long-term follow-up, cancer prevention, and treatment studies.

OUTLINE:

Patients with endometrial cancer undergo clinical testing for inherited cancer mutations using blood DNA and via next-generation sequencing of tumor samples. Patients testing positive for Lynch syndrome or other cancer susceptibilities will undergo genetic counseling and testing and counseling will be offered to their family members.

Eligibility Criteria:
Inclusion Criteria:

* Adult women who had a hysterectomy or diagnostic biopsy proving endometrial adenocarcinoma (any stage) between 10/1/2017 and 4/30/2020, and received care at one of the participating hospitals
* Adult relatives of the EC patients found to have LS

Exclusion Criteria:

* Individuals must be able to speak and read English; non-English speaking individuals will be excluded
* Individuals must be able to consent for themselves; those who are unable to consent for themselves for any reason will be excluded
* Prisoners will be specifically excluded from participation in the study
* Women who have uterine sarcomas are excluded
* Pregnant women are not eligible for the study
Drug to Drug Interaction Study With ASP1941 and Metformin

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Stable disease under metformin monotherapy (between 1500-3000

mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months

* Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
* Stable Fasting Blood Glucose (FBG) at the end of wash-out
* BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria:

* Subjects with type 1 diabetes
* Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
* Clinical significant renal disease (CLcr \<60 ml/min as assessed during a 24h creatinine clearance on Day-2
* Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose \<3 mmol/l (\<55 mg/dl) or requiring hospitalization
* Pulse \<40 or \>90; Systolic Blood Pressure \>160 mmHg; Diastolic Blood Pressure \> 100 mmHg