cyrilzakka/clinical-trials huggingface dataset:
Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis

Complementary and alternative medicine are increasingly used all around the world and more specifically in chronic diseases such as atopic dermatitis. Sociodemographic and disease determinants associated with their use remain unclear. Moreover, most of studies involved children and little data are available for adults.

The main objective of this study is to identify factors associated with complementary and alternative medicine use in children and adults suffering from atopic dermatitis. The secondary objectives are to determine the prevalence of complementary and alternative medicine use, the main forms used and their modalities of use, patients' motivations for using these therapies and sources of information.

Patients of all ages consulting for their atopic dermatitis at the dermatology or pediatric allergology department of Nancy University Hospital over a 6 months period will be asked to fill out a questionnaire about their pathology and their use of complementary and alternative medicine. This questionnaire will be collected before they leave the hospital.


Eligibility Criteria:
Inclusion Criteria:

* All patients, adults or children, without age limit;
* Patients visiting the dermatology or pediatric allergology department of Nancy University Hospital;
* Patients with atopic dermatitis confirmed on clinical examination by the physician;
* Patients with a history of atopic dermatitis or newly diagnosed patients;
* Patient affiliated to a social security plan or beneficiary of such a plan;
* Patients who understand French and are able to complete a self-administered questionnaire or have the option of assistance in completing it.

Exclusion Criteria:

* Patient with at least one other dermatological pathology or non-atopic eczema (contact eczema, ...);
* Patient without a confirmed diagnosis of atopic dermatitis by a physician;
* Patient who has already completed the questionnaire during a previous consultation;
* Pregnant and breastfeeding women;
* Refusal of the patient or at least one of the parents for children;
* Patient placed under court protection, guardianship or curatorship;
* Patient deprived of liberty by a judicial or administrative decision.
A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections

The objective of this study is to determine whether continuous infusion of ceftazidime-avibactam (CAZ-AVI) could improve clinical outcomes in critically ill patients compared with intermittent infusion.

This study employs a prospective, open-label, randomized controlled, multicenter clinical trial design comparing "CAZ-AVI continuous infusion" versus "CAZ-AVI intermittent infusion," .The secondary objectives is to observe the clinical cure, Bacterial clearance, the probability of target attainment (PTA) of TDM. etc

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old, male or female.
* Patients who are admitted to ICU wards.
* Patients clinically diagnosed with carbapenem-resistant organism (CRO) infections, and has been commenced on targeted therapy with ceftazidime-avibactam.
* One or more organ dysfunction criteria in the previous 24 hours i. MAP \< 60 mmHg for at least 1 hour; ii. Vasopressors required for \> 4 hours; iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour.

iv. Serum creatinine concentration \> 220 μmol/L or \>2.49 mg/dL

Exclusion Criteria:

* Patient has a known allergy to ceftazidime-avibactam.
* Patient has received ceftazidime-avibactam for more than 48 hours during current infectious episode.
* Patient is in severe condition or expected to survive for no more than 48 hours.
* Patient who receives lung or heart transplant or stem cell transplant.
* Patient is known or suspected to be pregnant.
* Patient has previously been enrolled in the current study.
* Other conditions which are regarded as inappropriate for enrollment.
Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status

A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.

Twenty participants were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=10) participants after team soccer training additional received 4 weeks eccentric exercises, in the control group (n=10) - did not perform additional exercises. The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. Pre- and post- training assessment included concentric/eccentric knee extension and flexion at 60°/s and 120°/s, changes in muscle contractile characteristics and dynamic balance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy players able to participate in training and competitions.
* Playing football for at least 2 years.
* Regularly participating in team training, 2-3 times a week.

Exclusion Criteria:

* Female soccer players with a lower extremity injury (in a period of 6 months)
* Pain is less than 2 points on the Visual Analog Pain Scale.
* Irregular exercise
* The number of years of training attended is too low
A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure

To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Men/Women, 40 or older, diagnosed with hip or knee Osteoarthritis.
* Hypertensive patient with treated and controlled essential hypertension.
* Must receive at least one antihypertensive treatment from the following drug classes: Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) or Beta-Blocker (BB).
* Must be current chronic user of NSAIDS or acetaminophen.
* Must discontinue all analgesic therapy at Screening.

Exclusion Criteria:

* More than two different classes of antihypertensive drugs.
* Uncontrolled diabetes.
* Hepatic or renal impairment.
* A history of alcohol/drug abuse.
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
* History of congestive heart failure.
* Clinically relevant abnormal ECG.
* Current or expected use of anticoagulants.
* Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
* Participation within 30 days prior to pre-screening in another investigational study.
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.

PRIMARY OBJECTIVES:

I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion.

SECONDARY OBJECTIVES:

I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo RARC with IUD.

ARM II: Patients undergo RARC with EUD.

After completion of study treatment, patients are followed up within 90 days and then for 2-5 years.

Eligibility Criteria:
Inclusion Criteria:

* Grade G1 - G3 bladder cancer
* T stage: cTis - T2
* N0
* M0
* American Society of Anesthesiologists (ASA) \< 4
* Informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
* Hemoglobin (Hgb) \> 8.0 g/dL
* White blood cell (WBC) \> 2.0 k/uL
* Platelets \> 50,000
* Creatinine \< 3.0 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 5.0 x ULN
* Alanine transaminase (ALT) \< 5.0 x ULN

Exclusion Criteria:

* Patient unsuitable for or refusing radical cystectomy
* T stage ≥ T3 (mass extending outside the bladder)
* Gross nodal or metastatic disease at presentation (≥ N1, M1)
* Prior pelvic radiation
* Prior open or laparoscopic/robotic bladder or prostate surgery
* Prior colorectal surgery or history of inflammatory bowel disease
* Body mass index (BMI) ≥ 40
* ECOG performance status 3 or worse
* History of coagulopathy or bleeding disorders
* Chronic steroid use
* Patients with end stage renal disease (ESRD) and/or on dialysis
Airway Management During Unusual Tracheal Stenosis

Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.

Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study.

Exclusion Criteria:

1. Patients who did not agree to participate in the study.
2. Congestive heart failure (ejection fraction ≤ 35 %)
3. Emergency laryngeal procedures.
4. Patients under 18 years old.
5. Patients with ASA \> 3.
A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707

Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.

Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be surgically sterilized and use condoms or must practice an effective contraceptive method to prevent pregnancies.
* Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
* Regular defecation pattern (minimum once per day).

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal.
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
* Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
* History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit.
* Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
* Positive serology test for Hepatitis B Surface Antigen (HBsAg), anti Hepatitis A Virus (HAV) Immunoglobulin M (IgM), anti Hepatitis C Virus (HCV) or anti Human Immunodeficiency Virus (HIV) 1+2.
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. A confirmed clinical diagnosis of SMS
2. Informed consent from the patient or the legal guardian
3. Male or female between the ages of 3- 65 years of age
4. Recent history of sleep disturbances
5. Have an appointed care-giver complete the required outpatient assessments
6. Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

1. Unable to dose daily with medication
2. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
3. Any other sound medical reason as determined by the clinical investigator
Navigation Study: Durham

The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and infant health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office and provides up to several visits (prenatally, 12 months, 24 months, and 36 months) to assess family needs, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals.

Of note, 400 families were enrolled under Navigation 1.0, however, their data will not be included in any analysis due to the design changes (Navigation 2.0). The anticipated total of 800 subjects is specific to the 2.0 enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Families will be eligible for the study if they go to the certain OB/GYN offices (to be updated later) for their first prenatal visit
* Families will be eligible for the study if they go to the Roxboro Road Pediatric Care Practice for their child's 12-, 24-, or 36-month well visit
* Primary language is English or Spanish

Exclusion Criteria:

* Families residing outside of Durham County
* Families that are planning to move out of either county within the next 2 months at the time of recruitment
* Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.
A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)

Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects between 18 - 55 years of age.
* Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Patients with the ability to comprehend and sign the informed consent.
* Written informed consent obtained prior to any screening procedures.
* Subjects in good health with no baseline disease of any kind.

Exclusion Criteria:

* Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
* Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
* Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
* Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
* Have a known history of drug substance abuse.
* Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
* Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
* Any condition or situation precluding or interfering with the compliance with the protocol.
* Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
Maternal Serum Vascular Endothelial Growth Factor in Pregnant Women With Foetal Growth Restriction

In this study we explore To explore the role of maternal serum vascular endothelial growth factor (VEGF) in pregnancies complicated by foetal growth restriction.

Small-for-gestational age (SGA) is defined as an estimated foetal weight (EFW) or abdominal circumference (AC) less than the 10th centileand severe SGA as an EFW or AC less than the 3rd centile. Foetal Growth Restriction refers to failure of the foetus to achieve its predetermined growth potential for various reasons.Foetus with foetal growth restriction (FGR) greatly contributes to perinatal mortality and short- and long-term morbidity. There is a 3-10 fold increase in perinatal mortality in pregnancies complicated by this FGR .The incidence of FGR in newborns ranges between 3 and 7% of the total population .FGR is thought to stem from placental hypoxia-induced vasoconstriction of the fetoplacental vessels, leading to placental hypoperfusion and thus fetal undernutrition. However, the effects of hypoxia on the fetoplacental vessels have been surprisingly little studied.Vascular endothelial growth factor (VEGF) is one of the factors that take part in placental angiogenesis. It is highly expressed during embryonic and foetal development..Angiogenesis involves the branching of new microvessles from pre-existing larger blood vessels.Angiogenesis plays a role in the development of the villous vasculature and the formation of terminal villi in human placenta. IUGR occurs as a result of the failure of elongation, branching and dilatation of the capillary loops and of terminal villous formation.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years
* Gestational age 28-36 weeks
* Fetal growth restriction
* Patient consents to the procedure.
* BMI 20-30

Exclusion Criteria:

* Preeclampsia
* Diabetes Mellitus
* Fetal congenital anomalies
Tezosentan in Pulmonary Arterial Hypertension

Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Male and female patients 18 years of age or older
3. Patients with PAH according to one of the following subgroups of the Venice Classification Group 1:

   * Idiopathic (iPAH), or
   * Familial/heritable (FPAH), or
   * Associated (APAH) with collagen vascular disease
4. Modified NYHA functional class II-III
5. Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:

   * Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
   * Resting mean PVR ≥ 240 dyn•s•cm-5 and
   * Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

Exclusion Criteria:

1. Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
2. Hypotensive patients (systemic systolic blood pressure \< 100 mmHg)
3. Patients with body weight \< 50 kg (110 lbs)
4. Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
5. Patients with clinically significant chronic renal insufficiency (serum creatinine \> 2.5mg/dL / 221µmol/L)
6. Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
7. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
8. Patients who have received any investigational drugs within 28 days of Baseline
9. Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
10. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
11. Life expectancy less than 12 months
12. Females who are lactating or pregnant or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after study drug intake
13. Known hypersensitivity to any of the excipients of the drug formulation
14. Patients with positive response to vasoreactivity test
The Effect of Chewing Gum on Small Bowel Transit Time

The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.

The subjects will include patients already referred to us for a capsule endoscopy (CE) in this unit. We have calculated how many patients we need from small bowel transit times from the last 100 patients who had a CE at our centre. We will include 122. These will be randomly divided into two groups. The patients (chew chewing gum) and the controls (do not chew chewing gum).

Eligibility Criteria:
Inclusion Criteria:

* All out-patients \> 19 years old presenting for capsule endoscopy

Exclusion Criteria:

* Patients on narcotics
* Patients on motility enhancing and/or slowing drugs should stop these at least 5 days prior to the procedure or be excluded from the study.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or gastric surgery.
* Patients with an ileostomy.
* Patients who have a known and/or have a history of swallowing disorder
* Patients with diabetes and/or hypo-/hyper- thyroidism
* Patients in whom the capsule become impacted at a stricture (these patients will be taken out of the study and given the necessary medical/surgical treatment).