louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05712330: Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
Official title: Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Invasive Ventilation
Spinal Muscular Atrophy
Respiratory Bacterial Infection
Keywords: non invasive ventilation
Spinal Muscular Atrophy
Respiratory Bacterial Infection
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 8
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: SMA (Spinal Muscular Atrophy) is a rare neuromuscular disease characterized by motoneuron damage. Symptoms consist of respiratory involvement with numerous respiratory infections and eventually respiratory failure, for which NIV (Non Invasive Ventilation) is often used. Ventilation machines are in close contact with the respiratory tract of patients. They contain heated water to humidify the circuit. These humid and warm environments are conducive to the development of bacteria such as Pseudomonas aeruginosa. In this context, it is interesting to look for the presence or absence of bacteria, in comparison with the respiratory ecology of the patients. The aim is to highlight the microbiological role of NIV on the occurrence of respiratory bacterial infections or secondary infections in patients with SMA. To do this, samples are taken from the machines, and ECBCs are performed on patients during respiratory physiotherapy sessions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AMS (previous diagnosis or new diagnosis during the inclusion period)
* Age from 0 to 12 years old
* Nusinersen treatment
* Benefiting from a NIV
* Current monitoring at the University Hospital of Amiens

Exclusion Criteria:

* Invasive ventilation on tracheotomy
* No ventilation
* Other treatment than Nusinersen or no treatment
* Parental refusal to participate in the study

Primary outcomes:
measure: number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT00344630: TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?
Official title: TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To compare the relative efficacy and safety of the TAXUS Express2 stents and the Cypher stents among a broad, unselected patient population treated in a nationwide, multi-center clinical registry representative of 'real-world,' contemporary clinical practice. A secondary objective is to examine performance of the two stents in pre-specified subgroup populations and examine regional and national patterns in outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients treated with a TAXUS Express2 stent or a Cypher stent between April 1, 2005 and June 30, 2005.

Exclusion Criteria:

* Simultaneous treatment with both TAXUS and Cypher stents during the index revascularization. Patients who have undergone previous target vessel(s), stenting procedure within 9 months of the index procedure will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: William O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942630: Value of Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage
Official title: Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage (PTBD) - a Prospective Study on Endoscopic Findings and Clinical Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Stricture Not Treatable by ERC
Keywords: percutaneous
transhepatic
biliary
drainage
cholangioscopy
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving a PTBD

Brief summary: In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. The impact on clinical decision will be evaluated.


Eligibility criteria: Inclusion Criteria:

PTBD with at least 14 French in diameter

Exclusion Criteria:

missing informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
References:
Clinical trial NCT04403230: Outcomes on Teeth Prepared With BOPT
Official title: Periodontal and Prosthetic Outcomes on Teeth Prepared With Biologically Oriented Preparation Technique: Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Soft Tissues
Prosthetic
Outcome
Keywords: BOPT
dental preparation
dental crown
zirconia
periodontal health
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line in a prospective clinical study.

Detailed description: The purpose is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line.

This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD). Restorations were fabricated with zirconium oxide cores and ceramic coverings. Patients attended regular annual check-ups when probe depth, presence of inflammation with bleeding on probing, presence of plaque, gingival thickness, marginal stability, biological or mechanical complications, and the patient's level of satisfaction were registered.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged over 18 years).
* non-smokers.
* periodontally healthy or periodontally managed.
* patients who had undergone restoration with fixed prostheses (one-piece crowns or fixed partial dentures FPDs) in the aesthetic zone (incisors, canines, premolars, first molars), which needed to be replaced due to biological, esthetic or some other type of problem.

Exclusion Criteria:

* patients who were smokers.
* patients who presented unmanaged parafunctional habits.
* patients with severe systemic diseases.

Primary outcomes:
measure: A possible periodontal complications
timeFrame: Through study completion, an average of 15 years.
measure: biological or mechanical prosthetic complications
timeFrame: Through study completion, an average of 15 years.
Secondary outcomes:
measure: Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS).
timeFrame: Through study completion, an average of 15 years.
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Blanca Serra Pastor, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784030: High Water Intake to Slow Progression of Polycystic Kidney Disease
Official title: The Effect of Water Loading on Urinary Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney, Polycystic, Autosomal Dominant
Keywords: Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney Disease
Water Loading
Biomarkers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
* Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
* Ages between 18 and 65
* Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) \> 60 ml/min/1.73 m2 with no history of kidney disease

Exclusion Criteria:

* Women who are pregnant or nursing
* Active dependency on drugs or alcohol
* Diagnosis of syndrome of inappropriate antidiuresis
* Currently taking a vasopressin agonist or antagonist
* Blood sodium level less than \< 135 mEq/L
* For healthy participants, estimated glomerular filtration rate (level of kidney function) less than \< 60 ml/min/1.73 m2

Primary outcomes:
measure: Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
timeFrame: pre- and post-water loading (2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Irina Barash, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00260130: Food Rheology and Feeding in Lean and Obese Humans
Official title: Study 1: Viscosity Study Study 2: Meal Timing Study Study 3:Chronic Fluid and Solid Food Intake in Lean and Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Diabetes
Keywords: obesity
food intake
human
energy balance
beverage
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-12-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods.

Detailed description: Three human studies are propsed to more fully characterized attributes of liquids and solids that may account for the differential appetitive responses they elicit, potential contributory mechanisms as well as the dietary implications of their consumption. Study 1 will contrast the acute effects of fluid and solid foods varying in macronutrient content on satiation, satiety and feeding. Study 2 will determine if the pattern of fluid and solid ingestion influences satiety and feeding by monitoring appetitive and dietary responses to energy and macronutrient matched fluid and solid loads ingested as meal components or between meal snacks. To better assess the clinical implications ofdiets incorpprating liquid or solid supplements. Study 3 will entail chronic ingestion of matched energy yeilding fluid or solid loads with concurrent measurement of appetite, dietary intake, energy expenditureand body weight/composition.

Eligibility criteria: Inclusion Criteria:

* BMI 18-23 or 27-35
* weight stable
* constant habitual activity pattern
* low fruit/vegetable consumer
* non-restrained eater

Exclusion Criteria:

* diabetic
* taking medication known to influence appetite

Primary outcomes:
measure: satiation and satiety on liquid verses solid foods with concurrent measurements of appetite, dietary intake, energy expenditure and body weight/composition.
timeFrame: 8 weeks
Secondary outcomes:
measure: cephalic phase testing at week 8
timeFrame: 30 minutes
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, MPH, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093430: Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?
Official title: Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Techniques
Laparoscopy
Keywords: Gynecological surgery
laparoscopic ports
neuropathy
Lead sponsor: Royal Free Hampstead NHS Trust
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery.

Detailed description: We plan to study patients undergoing gynaecological laparoscopy. Patients will be randomized to two techniques for determining where to position the right and left lateral laparoscopic ports, and port symmetry will be assessed at the end of surgery. We also plan to study patients undergoing any type of gynaecological surgery to determine the incidence of sensory neuropathy involving the lower abdomen according to the route of surgery.

Eligibility criteria: Inclusion Criteria:

* Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

* Previous laparoscopy
* Junior intern as primary surgeon

Primary outcomes:
measure: Symmetry of lateral laparoscopic ports
timeFrame: On the completion of laparoscopy and before the general anaesthetic is reversed
Secondary outcomes:
measure: Neuropathy
timeFrame: Before, immediately after and 2 weeks after gynaecological surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hamsptead NHS Trust
name: Adam Magos, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465030: Identification of Pattern and Factors Affecting Recurrence in Head and Neck Carcinoma
Official title: Identification of Pattern and Factors Affecting Recurrence of Head and Neck Carcinoma After Radical IMRT and VMAT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Head and Neck Squamous Cell Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent head and neck cancer after radical treatment by IMRT and VMAT, in Sohag city.

Brief summary: The study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.

Detailed description: The investigators will evaluate the local experience in treatment of head and neck SCC by retrospectively analyzing the incidence and location of recurrence, either; local recurrence (LR), regional recurrence (RR), or distant mets in eligible head and neck cancer patients treated with IMRT and VMAT in the period from 2018 till 2022 to allow a follow-up for at least 1 year.

Eligibility criteria: Inclusion Criteria:

* Adults aged more than 18 years. Patients with primary non nasopharyngeal head and neck squamous cell carcinoma. Patients who were intended to receive radical treatment delivered by IMRT and VMAT techniques.

Exclusion Criteria:

* Adults who had double malignancies. Metastatic HNSCC cases.

Primary outcomes:
measure: Pattern of relapse in recurrent head and neck squamous cell carcinoma, evident clinically and measured by images "US,CT, MRI and endoscopy".
timeFrame: At least obsevation of 1 year FU of the patient
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag university hospital, oncology and nuclear medicine department
name: Reem Gamal, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618330: The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.


Eligibility criteria: Inclusion Criteria:

* Patients after active orthodontic treatment;
* Must be healthy without systemic and oral diseases;
* The central incisors, canines and first molars of both upper and lower arches must be existed;
* Agreed to the trial and signed informed consent forms, either by themselves, or their parents.

Exclusion Criteria:

* Oral habits such as bruxism and clenching,
* Do not accept this type of retainers

Primary outcomes:
measure: Survival times via recording to the patients' re-visit
timeFrame: one year
Secondary outcomes:
measure: SF-36 scale for Quality of life
timeFrame: one month
measure: Comfort degrees assessed through Visual Analog Score
timeFrame: one month
measure: Retention effectiveness assessed according to 3D models
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: Zhu Y, Lin J, Long H, Ye N, Huang R, Yang X, Jian F, Lai W. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):433-439. doi: 10.1016/j.ajodo.2016.10.019.
Clinical trial NCT02962830: Sufentanil Pharmacokinetics After Intra Amniotic Injection
Official title: Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prenatal Diagnosis
Keywords: fetal pain
fetal analgesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.

To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.


Eligibility criteria: Inclusion Criteria:

* Termination of pregnancy for fetal malformation
* Gestational age \> 24 weeks of gestation

Exclusion Criteria:

* Multiple pregnancy
* Allergy or contraindication to sufentanil
* Morphinic addiction
* fetal gastroschisis, omphalocele or swallowing disorder
* maternal cardiac or respiratory distress

Primary outcomes:
measure: fetal plasma concentrations
timeFrame: at 30 minutes after intra-amniotic injection
Secondary outcomes:
measure: Maternal plasma concentrations
timeFrame: at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection
measure: amniotic fluid concentrations
timeFrame: Immediately within 5 min after intra-amniotic injection
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Véronique HOUFFLIN-DEBARGE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: