cyrilzakka/clinical-trials huggingface dataset:
Validation of the MBI-C Scale in French

This study aims to validate the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale, hypothetically effective for measuring behavioral symptoms in patients presenting with a subjective cognitive complaint or mild cognitive impairment (MCI).

Neuropsychiatric symptoms are common in the prodromal stage of dementia and may precede cognitive impairment. Their presence in patients without cognitive impairment, but with a subjective cognitive complaint or mild cognitive impairment (MCI), is associated with an increased risk of progression to dementia. The concept of Mild Behavioral Impairment (MBI) was developed to identify populations at risk from the early stages of the disease. MBI is characterized by long-lasting psychiatric symptoms appearing late, in patients without cognitive deficits or with MCI, and can precede dementia.

The general hypothesis is that the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale has good psychometric capabilities to correctly measure behavioral symptoms in patients with subjective cognitive complaint or MCI. The main objective is to verify the reliability and internal and external validity of the MBI-C score. Secondary objectives include studying the prevalence of MBI and determining the best cutoff for the diagnosis of MBI in patients with MBI or subjective cognitive complaint.

This is an observational, national, multicenter and cross-sectional study. It will include 170 patients (5 per scale item, or 34 items), with an inclusion period of 24 months and a total research duration of 25 months. Patients must be over 50 years old, have had subjective cognitive complaint or mild cognitive impairment for at least 6 months, and have a person who visits them at least once a week.

Validation of the MBI-C scale in French could play a crucial role in the identification and early management of neurodegenerative disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting a subjective cognitive complaint (SCP) or mild cognitive impairment (MCI) for at least 6 months.
* Patient with a relative visiting them at least once a week.
* No opposition from the patient and his loved one

Exclusion Criteria:

* Patient presenting criteria for major neurocognitive disorder according to DSM-V criteria.
* Neuropsychiatric symptoms secondary to concomitant treatments, or to a medical or psychiatric pathology.
* Concomitant major depressive episode (DSM-V).
* Presence of concomitant pathologies preventing participation in the study (taking tests).
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

SOVS2019-070 is a single-center, single-masked (the individual(s) performing efficacy measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized, parallel group study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

Eligibility Criteria:
Inclusion Criteria:

* MGD Patients:

  * Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
  * Reported dry eye signs and symptoms within the past 3 months
  * TBUT \< 10 seconds in both eyes
* CLD Patients:

  * Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
  * A history of wearing soft contact lenses for at least 6 months
  * Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.
  * Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"
  * Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.
  * Baseline CLDEQ-8 score \>12
  * Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing.

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease
* Patient has glaucoma or ocular hypertension
* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
* BCVA worse than 20/40 in either eye at the baseline visit
Thyroid Function and Diabetes Complications

The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM).

Aims: We investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).

Subjects: Elderly inhospital patients with T2DM who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.

Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted.

The relationships levels of thyroid function and diabetic complications are analysed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999.
2. Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).

Exclusion Criteria:

1. Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer.
2. Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives.
3. Patients are pregnant or lactating women.
4. Patients with acute intercurrent illness of diabetes.
5. Patients with an acute infection.
6. Patients with a history of drug abuse alcohol dependence in the past 5 years.
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.

Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk. The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis. These events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)

Eligibility Criteria:
Inclusion Criteria:

* Inclusion:≥ 18 years of age
* Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)
* serum calcium ≥ 8.4mg/dL (2.1 mmol/L)
* Ca x P ≥ 45 mg2\*/dL2 (3.63 mmol2/L2)

Exclusion Criteria: - Exclusion:

* Parathyroidectomy in the 12 weeks before the date of informed consent
* Received therapy with cinacalcet within 3 months of randomization
* Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned presentation to a health care facility that would require mechanical intervention \[i.e., unplanned dialysis treatment\]) d. Peripheral vascular disease (other than dialysis vascular access revision) e. Stroke
* History of seizure within 12 weeks prior to randomization
* Scheduled date for kidney transplant from a known living donor
* Anticipated parathyroidectomy within 6 months after randomization

  * in all instances, the 2 refers to squared.
A Clinical Study of B007 in the Treatment of Pemphigus.

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
3. Subjects with first diagnosis or relapse;
4. Subjects who have the ability to follow the study protocol as determined by the investigator.

Exclusion Criteria:

1. Subjects diagnosed with prescribed diseases;
2. Since the diagnosis of pemphigus, Disease duration\>4 years;
3. Subjects using prescribed drugs;
4. Presence of a specified disease or history of disease;
5. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
6. A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
7. Subjects who participate in another interventional clinical trial at a specified time before randomization;
8. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
9. Pregnant and lactating women;
10. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.

    Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;
11. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.
12. Other conditions deemed unsuitable for participation in this study by the researchers.
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.


Eligibility Criteria:
Inclusion Criteria:

* Male and females of at least 18 years of age
* A 12-month history of constipation (defined as \< three spontaneous bowel movements per week and ≥1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining)

Exclusion Criteria:

* Patients with cancer, inflammatory bowel disease or other structural bowel disease
* Patients who participated in a prior tegaserod study
* Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function

The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.

This study is seeking participants that are:

* stable loss of liver function with mild or moderate severity
* none of underlying conditions possibly affecting the study medicine being absorbed by the body

All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.

Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
* Stable hepatic impairment that meets the criteria for Class A or B of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
* Stable concomitant medications for the management of individual participants' medical history

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery);
* Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
* A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI;
* Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically active Stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.
Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study

The objective of this non-interventional long-term follow-up observation is to evaluate the long-term sustainability of two surgical treatments of peri-implantitis with and without Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study

The study is a non-interventional long-term follow-up observation without any study specific procedure outside normal clinical routine. Patients from a previous study are selected to participate in this study within a standard maintenance Programm. Primary and secondary oucomes refer to the previous study

Eligibility Criteria:
Inclusion Criteria:

* Implant survival at the treated site from the previous study
* Written informed consent

Exclusion Criteria:

* Implant failure at the treated site
* Severe trauma to implant site causing removal of the implant since the last visit of previous study
Epidemiology of Pediatric Traumatology

Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.

Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.


Eligibility Criteria:
Inclusion criteria:

* Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma.
* Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

* Patient or legal representative who expressed their opposition to participating in the study
* Impossibility of giving informed information to the subject
Premature Infant Exposure to Noise Generated by Respiratory Support

Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula: \>1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in infants on NCPAP, there have been no comparative trials done comparing noise exposure in infants undergoing both NCPAP and HFNC.

Objective: Using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by NCPAP and HFNC.

Infants born \< 32 weeks, in an incubator, and \> 7 days postnatal that were maintained on either on NCPAP or HFNC to maintain SaO2 in a range of 88 - 92 %. Study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (NoisePro DLX-1). The microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. The exhalation port for NCPAP was placed outside of the incubator. Repeated measurement periods on the same mode of support were made within a 72 hour period. Each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar SaO2 goals and repeat measurements were obtained. Comparisons of mean decibel levels during recording were compared using paired t-tests.

Eligibility Criteria:
Inclusion Criteria:

* Premature infant born \< 32 weeks and 0 days post-conceptional age;
* Seven or more days of age and not in acute respiratory distress;
* Need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery;
* In a neutral-thermal environment (i.e. isolette)

Exclusion Criteria:

* Oro-facial congenital anomalies;
* Congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale);
* Unstable respiratory status as deemed by the attending physician
* Patients under isolation for infectious disease
Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.

Use of materials such as an endotracheal tube, orogastric catheter, nasal cannula, and peripheral vein catheter, which are frequently used in neonatal intensive care.

Medical adhesives are needed for fixing. While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. Many materials are being tested and developed in clinics to reduce this risk.Skin barrier products minimize trauma in the removal of medical adhesives by creating a protective layer between the epidermis and the adhesive.

Silicone-based spray removers, one of the skin barrier products, are used in the entire patient population, including newborns.Silicone-based spray removers leave residue on the skin as they evaporate easily. doesn't let go. Since it does not contain alcohol, it does not cause pain. Sunflower oil is a traditional method for premature When used in baby massage applied to babies, it increases the weight gain and height growth of babies and reduces the morbidity rate.The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.

Eligibility Criteria:
Inclusion Criteria:

* Babies born between 32-36 gestational ages
* Babies admitted to Neonatal Intensive Care
* Babies who have not had medical adhesive tape applied to their lips before
* Babies who do not have any skin diseases
* Noninvasive Mechanical Ventilation or Free Ventilation in the Intensive Care Unit
* Babies who need oxygen
* Babies who do not have any obstacle to inserting an oragastric catheter

Exclusion Criteria:

* Babies followed intubated in care
* Babies with any skin disease
* Babies with a disease that is not suitable for oragastric catheter insertion
* Babies for whom medical adhesive should not be applied on the lips
Yoga for Patients With Epilepsy

To establish the safety and feasibility of having patients with epilepsy perform yoga.

Subjects will keep logs of seizure frequency prior to, during, and following training in a yoga regimen. Instruction in the yoga regimen will occur at BIDMC, and home practice following classroom instruction will occur as part of the study. Side effects, changes in seizure frequency, and quality of life assessments will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Must be able to give full informed consent.
2. Must have one or more of the following seizure types: simple partial, complex partial, or secondarily generalized.
3. Age 18-64.
4. Must have 4-20 during the baseline phase.
5. Must have medical clearance from their primary care giver sufficient to allow for participation in yoga exercises.
6. Must be stable enough to allow for all anticonvulsant levels to remain constant for the duration of the study.

Exclusion Criteria:

1. Having primary generalized epilepsy or atonic seizures.
2. Having a history of status epilepticus in the past two years.
3. Any medical problem that would preclude participation in a yoga class.
4. Nonepileptic or psychogenic seizures.
5. Pregnancy.
Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study
* One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
* Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
* Female or male aged 70 years or above

Exclusion Criteria:

* Patients must not have received prior anti-cancer therapy except in the adjuvant setting
* Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial
* Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
* History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG