cyrilzakka/clinical-trials huggingface dataset:
Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.

After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.

An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age.

In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen.

Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative.

We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers.

Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study.

Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours.

In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon treatment, IV glucose will immediately be instituted.

Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is achieved and the number of hospitalization days in both groups.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic hypoglycemia
* infant of insulin treated diabetic mother
* AGA or LGA
* no other known medical problems

Exclusion Criteria:

* concurrent medical problems
* symptomatic hypoglycemia
* glucose under 20 mg%
Development and Validation of Intraoperative Image-quality Criteria

An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons.

The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of proximal femur fracture
* Operated between May 2010 and December 2010
* Open Reduction Internal Fixation (ORIF)
* Lateral and anteroposterior intraoperative images available

Exclusion Criteria:

None
1% Metformin Gel in the Treatment of Class II Furcation Defects

Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Background: Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Methods: Sixty four patients with single mandibular buccal class II furcation defects were categorized into two treatment groups: SRP plus 1% MF (group 1) and SRP plus placebo (group 2). Clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and radiographic parameters were recorded at baseline, 6 months, and 9 months. Defect fill at baseline, 6 months, and 9 months was calculated on standardized radiographs using image analysis software.

Eligibility Criteria:
Inclusion Criteria:

1. the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD≥ 5 mm and horizontal PD≥3 mm following phase I therapy (SRP)

Exclusion Criteria:

* patients with known systemic disease; patients with known or suspected allergy to the MF; patients receiving systemic MF therapy; patients with aggressive periodontitis; patients using tobacco in any form; patients with alcoholism; patients who were immunocompromised; pregnant or lactating females.
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.


Eligibility Criteria:
Inclusion Criteria:

* Children with overweight/obesity
* Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF \>10%
* Known NAFLD or elevated ALT for sex (\>22 for females and \>26 for males)

Exclusion Criteria:

* MRI-PDFF \<10%
* Baseline habitual (\>3 days per week) consumption of soy foods
* Allergy to soy or cow's milk protein
* Inability to undergo MRI
* Recent (past 8 weeks) antibiotic exposure
* Treatment for existing endocrine disorders
Nurse-led Sheath Insertion in Cardiac Patients

The aim of project NUSHI is to elucidate, that radial sheath insertion can be performed by nurses and physicians with the same level of comfort and safety.

Background: Insertion of sheath in the radial artery in connection with examination and treatment of patients with coronary artery disease is usually performed by specialized invasive cardiologists or trainees. Whether sheath insertion can be performed by nurses with the same level of comfort and pain is uncertain.

Eligibility: Patients referred for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) due to suspicion of coronary artery disease are included

Randomization: Patients are randomized 1:1 to sheath insertion by nurse or physician

Methods: Insertion of 5 or 6 radial sheaths is performed in local anesthesia

Outcome measures: Comfort and pain level is registered from immediately after sheath insertion until start of CAG/PCI.

Additional outcome measures: Oximetry test is performed immediately after sheath removal - and repeated after 1 month in case of occlusion. Any complication is recorded from the patient enters the wake-up room until discharge.

All patients are contacted after 1 year in order to register adverse events.

Eligibility Criteria:
Inclusion Criteria:

* patients suspected of having coronary artery disease
* with normal puls oxymetry on the right hand
* understands patient information and accepts to participate

Exclusion Criteria:

* under consideration for cardiac valve replacement
* systolic blood pressure persistently \>180 mmHg
School-based Multicomponent Intervention on Physical Fitness Related to Health and Body Image

The main purpose of this study is to analyse the effect of a multicomponent intervention, applied during one scholar semester, on body composition, strength, flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image of students from sixth to ninth grade. This is a non-randomized controlled design. Approximately 568 schoolchildren of grades sixth through ninth were recruited from 2 public secondary schools in Florianópolis, Brazil. The main component of the intervention entitled "MEXA-SE" (move yourself) consisted of the implementation of three physical education classes per week with aerobic exercises, strength and flexibility activities. In addition, play activities in school recess, and educational activities on physical activity, sedentary behaviour, eating habits and body image were performed. Data collection was performed before and immediately after 14 weeks of intervention. The primary outcomes included the body composition, strength, flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image. Other variables included were: physical activity level, sedentary behaviour, and blood pressure level. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health) also were evaluated in the participants. Descriptive analysis, two-way ANOVA for mixed models and ANCOVA will be applied for within and between comparison groups, if the premises of this test are met. The level of significance for the study was 5% for two-tailed tests.


Eligibility Criteria:
Inclusion Criteria:

* Students volunteering as participation;
* Students regularly enrolled from the 6th to the 9th grades in the Florianópolis municipal school system.

Exclusion Criteria:

* Students of other grades;
* Students who dropout of school;
* Students with incomplete data at baseline and end 14 weeks;
* Students who are absence in the school days of data collection;
* Students who refused to participate in data collection or intervention;
Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

The investigators wish to study the obstetrical data of pregnant women who had an ultrasound estimation of fetal weight and who delivered at the University Hospital of Strasbourg over the last 20 years. These retrospectively collected data are a valuable source of scientific information since they are "real life data", currently of growing interest in the scientific community, and have a large volume and quality due to the number of years included and the variety of information collected in the computerized media records.

From this study, the investigators hope not only to better understand the consequences of ultrasound screening for fetal growth, but also to improve its accuracy and to develop useful models in obstetrical decision making in order to decrease maternal and neonatal morbidity.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years of age).
* Female and with a single pregnancy
* Subject having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021
* Subject who gave birth at HUS between 01/01/2000 and 12/31/2021
* Subject who does not object to the reuse of her data for scientific research purposes

Exclusion Criteria:

* Subject who has expressed opposition to the reuse of their data for scientific research purposes
* Multiple pregnancies
* Delivery before 24 weeks of amenorrhea
* Diagnosis of a malformative fetal pathology
* Diagnosis of fetal death in utero
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint

Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.

Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.

There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
* clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment
* having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ
* having had treatment with local or systemic corticosteroids.

Exclusion criteria:

* Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
* Absence of corticosteroid treatment
Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women

Obesity and overweight are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.

Aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment

Weight management problems (being obese or overweight) are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.

Aim: to evaluate the effectiveness of a 3-month internet-based program focusing on the promotion of healthy lifestyles (especially weight loss and healthy eating and physical exercise habits) in women who also have a diagnosis of infertility and are on the waiting list for IVF treatment.

Design: randomised controlled trial Setting: Hospital La Plana (Villarreal)

Eligibility Criteria:
Inclusion Criteria:

* women of childbearing age
* overweight (BMI \> 25 kg/m2) or obese (BMI \> 30 kg/m2)
* diagnosed with primary infertility -access to the internet-

Exclusion Criteria:

* over 40 years
* morbid or extreme obesity (BMI \> 40 kg/m2)
* bilateral obstruction of the fallopian tubes
* endometriosis
* women whose partner has a severe male factor (oligoasthenoteratozoospermia).
Epidemiologic Analysis for the Prevalence of Chronic Airway Diseases in Old Population

Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old population (\> 60 yrs) in Korea.

List to do

1. History taking
2. physical examination
3. Routine blood test
4. All spirometric data
5. In subgroup: further evaluation of allergic airway disease


Eligibility Criteria:
Inclusion Criteria:

* \> 60 yrs olds
* no known specific respiratory diseases

Exclusion Criteria:

* taking any medication for respiratory diseases
* History of diagnosis as a respiratory disease
Use of Repris Needle in Bladder Injection

Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.

This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age or older)
* Able to undergo routine cystoscopy
* Willing to provide verbal assessment of her condition within 5 days after the procedure

Exclusion Criteria:

* History of urethral strictures
* Presence of a suprapubic catheter or tube due to urethral trauma
* history of interstitial cystitis
* currently being treated for a urinary tract infection (UTI)
* gross hematuria present
* Known allergy or sensitivity to any component of the medication or solution to be injected during the study
* is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study
* cannot empty her bladder on her own and is routinely catheterizing the urethra
* unable to read, understand, and/or provide a ranking of pain level during the procedure,
* unable or unwilling to provide consent
Impact of Catch-up HPV Vaccination

Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.


Eligibility Criteria:
Inclusion Criteria:

* Age limit
* Patient must have done a HPV or smear test during the study period
* Consent necessary

Exclusion Criteria:

* Age limit
* No HPV or smear test done in the study period
* Patient not able to give her consent
A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.
* Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice.
* Discontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment.
* Adequate organ function.

  * allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x upper limit of normal (ULN) if liver metastases.
  * allow bilirubin up to 2.5 times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval.

Exclusion Criteria:

* Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for \>30 days prior to study treatment initiation are eligible.
* Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c (HbA1c) \<7%.
* Have symptomatic central nervous system metastasis. Screening of asymptomatic participants is not required for enrollment.
* Have had major surgery within 7 days prior to initiation of study drug to allow for postoperative healing of the surgical wound and site(s).
* Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6 inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor or have a known hypersensitivity to any component of the investigational products in this study.
* Have a known hypersensitivity to investigator's choice of standard of care (gemcitabine or capecitabine).
Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study

Effective antimicrobial use in the burn population is important since this population is at an increased risk for infections during their stay in hospital as a result of their burn injury. Tobramycin is an antibiotic that has activity against common burn wound associated pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due to the increased incidence of bacterial resistance to currently utilized antibiotics. Once daily dosing of tobramycin has been safely and effectively used in the majority of infected patients for many years with the proposed benefits of optimized antibacterial activity and reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has yet to be validated in the burn population. The purpose of this study is to validate the plausibility of once daily tobramycin dosing in the burn population with intent to determine a safe, effective, and efficient dosing regimen for this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult burn patient (≥ 18 years old)
* Total burn surface area less than 20%
* At least 48 hours after the time of the initial burn injury event
* Has a suspected or confirmed infection
* Has been receiving antibiotic therapy for at least 24 hours

Exclusion Criteria:

* Pediatric patients (\< 18 years old);
* Pregnant
* Documented history of cochlear or vestibular injury
* Creatinine clearance \< 50 ml/min
* Requiring any modality of dialysis
* Has been receiving antibiotic therapy for longer than 72 hours
* Known allergy or adverse reaction to aminoglycoside antibiotics
* Known allergy or adverse reaction to sulfites
* Diagnosis of Parkinson's disease or myasthenia gravis