louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02716389: Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinematics
Reliability
Cervical
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The measurement of cervical spine range of motion (ROM) figures among the most common aspects of clinical diagnosis. Good reliability has been demonstrated for assessments using ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the sagittal plane), separating the respective components provides less reliable results. Current research suggest that this is due to the participants' determination of the zero position. This position is influenced by possible disposed treatments and, in particular, by the subject in case of subjective determination. The present study therefore aims to examine the test-retest reliability of separate ROM assessments using a bulls eye spirit meter.

Twenty healthy participants will be included in the trial that adopts a two-armed randomized, crossover design. With a washout-period of one week in between, each subject participates in two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension, rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all measurements, the zero position will be determined by means of a bulls eye spirit level. The difference of the two sessions consists in the design of the waiting period. In one session, the subjects will keep the mask carrying the ultrasound markers on their head. In the other session, the mask will be removed during the break.


Eligibility criteria: Inclusion Criteria:

* Subscribing informed consent
* Healthy

Exclusion Criteria:

* Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases
* Not completely healed traumata
* Drug intake in the past 48 hours
* Pregnancy
* Muscle soreness

Primary outcomes:
measure: Maximal cervical range of motion in flexion/extension
timeFrame: 2 min.
Secondary outcomes:
measure: Maximal cervical range of motion in lateral flexion
timeFrame: 2 min.
measure: Maximal cervical range of motion in rotation
timeFrame: 2 min.
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Sports Medicine, Goethe University Frankfurt/Main
state: Hessen
Study officials:
References:
citation: Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Reliability and normative database of the Zebris cervical range-of-motion system in healthy controls with preliminary validation in a group of patients with neck pain. J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):450-5. doi: 10.1016/j.jmpt.2007.05.003.
Clinical trial NCT00319189: Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients
Official title: Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant Recipients
Posttransplant Diabetes Mellitus
Posttransplant Impaired Glucose Tolerance
Keywords: Nateglinide
Renal
Kidney
Transplantation
Diabets
Glucose
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.


Eligibility criteria: Inclusion Criteria:

* Reduced glucose tolerance (fasting glucose \< 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose \> 6.1 mmol/L OR 2 hour glucose between \>= 10.0 mmol/L)
* Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine \< 200 micromol/L

Exclusion Criteria:

* Patients with indulin dependent diabetes mellitus before or after transplantation
* Planned change in daily prednisolone dose during the study period
* Haemoglobin \< 8g/dL

Primary outcomes:
measure: Glucose tolerance
measure: Insuline release
Secondary outcomes:
measure: Glucose oxidation
measure: Postprandial hyperlipidemia
measure: Glomerular filtration rate
measure: HbA1C
measure: Fasting glucose
measure: Plasma nitric oxide
measure: Plasma endothelin-1
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Section of Nephrology
Study officials:
affiliation: Rikshospitalet, Section of Nephrology
name: Trond Jenssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04141189: Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation
Official title: Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Surveillance
Intrauterine Growth Restriction
Keywords: Intrauterine Growth Restriction
fetal surveillance
fetal doppler
fetal growth
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will be undertaken to determine whether the frequency of fetal surveillance can be safely reduced from bi-weekly to weekly in the case of fetusus with intrauterine growth restriction.

Detailed description: In this prospective randomized study, the cases whose fetal weight predicted by ultrasonography (USG) between the 28th and 37th weeks of gestation are below 10percentile according to the World Health Organization (WHO) normograms. The cases will be divided into two groups as group 1:weekly and group 2:bi-weekly (twice-weekly) The cases will be evaluated by fetal Doppler, amniotic fluid volume, nonstress test (NST) and maternal preeclampsia tests.Maternal severe hypertension/preeclampsia, category 3 NST, oligohydramnios (after 37 weeks amniotic fluid index \<5; after 34 weeks single deepest pocket \<2 cm) ,pathological doppler (before 34 weeks reverse flow in an umbilical artery , after 34 weeks absent end-diastolic flow in an umbilical artery) in cases of birth decision will be taken. Cases without the above mentioned complications will be delivered between 38 weeks 3 days and 39 weeks.

Eligibility criteria: Inclusion Criteria:

* 28-37 weeks pregnant women with estimated fetal weight below 10 percentile
* singlton pregnancy

Exclusion Criteria:

* maternal preeclampsia
* maternal systemic disease (pregestational diabetes, gestational diabetes mellitus a2, antiphospholipid antibody syndrome, chronic kidney disease)
* oligohydramnios (after 34 weeks amniotic fluid index \<5; before 34 weeks single deepest pocket \<2 cm)
* pathological doppler (high umbilical artery resistance index, absence of end-diastolic flow velocity in the umbilical artery, reverse flow in the umbilical artery, brain sparing effect in middle cerebral artery, abnormal ductus venosus flow)

Primary outcomes:
measure: neonatal hospital stay
timeFrame: 3 months
Secondary outcomes:
measure: antenatal hospital stay
timeFrame: 3 months
Other outcomes:
measure: gestational age at delivery
timeFrame: 24 hours
measure: neonatal hospital stay
timeFrame: 3 months
measure: acidosis
timeFrame: 24 hours
measure: perinatal death
timeFrame: 3 months
measure: cesarean delivery
timeFrame: 24 hours
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital
Study officials:
References:
Clinical trial NCT06136689: Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
Official title: Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Aortic Valve Disease
Aortic Valve Calcification
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Polish Cardiac Society
First posted: 2023-11-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve patients undergoing surgical aortic valve replacement (SAVR) for different phenotypes of severe AS (high-flow high-gradient, classical low-flow low-gradient, and paradoxical low-flow low-gradient) or moderate AS with coexisting aortic aneurysm as part of Bentall procedure. Patients undergoing heart transplant will be considered control group without aortic valve stenosis.

Brief summary: The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.


Eligibility criteria: Inclusion Criteria:

* aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
* pre-surgical computed tomography angiography
* informed consent

Primary outcomes:
measure: Aortic valve tissue composition measured from pre-procedural computed tomography angiography
timeFrame: up to 30-days before surgery
measure: Aortic valve tissue composition measured from quantitative histology
timeFrame: immediately post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Medical University of Warsaw
name: Zenon Huczek, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304.
Clinical trial NCT02751489: Human Phototoxicity Test
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria: Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive;
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* Have a visible sunburn;
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04800289: Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist
Official title: Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients received in a joint rheumatologist/dermatologist consultation at the Le Mans Hospital

Brief summary: Current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. More specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in Rheumatology and Dermatology.


Eligibility criteria: Inclusion Criteria:

* All patients received in a joint rheumatologist/dermatologist consultation at the Le Mans Hospital

Exclusion Criteria:

* Diagnosis of psoriatic arthritis not retained

Primary outcomes:
measure: impact on patient satisfaction and the evolution of their pathology of these mixed consultations, Dermatologist and Rheumatologist, in the context of psoriatic arthritis.
timeFrame: 5 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT00664989: Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty
Official title: Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Hemiarthroplasty Stemmed Resurfacing Conventional Shoulder
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2008-04-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: recent humeral resurfacing

Brief summary: Hypothesis: What is the difference in disease specific quality of life between patients who receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed hemiarthroplasty

Detailed description: The purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (Western Ontario Osteoarthritis of Shoulder Score- WOOS) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. The first phase of this study will be a one year pilot recruitment period. This is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. If a full randomized trial is not considered feasible following Phase 1, then a prospective cohort study will be completed.

Eligibility criteria: Inclusion Criteria:

* Recent humeral resurfacing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: OHRI
state: Ontario
Study officials:
affiliation: OHRI
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06416189: Teeth Decrowding With and Without Fixed Appliances
Official title: The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Crowding
Lead sponsor: Samer Mheissen
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups; one with fixed braces and one without fixed braces.
Primary purpose: TREATMENT

Brief summary: In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.

Detailed description: In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.

Eligibility criteria: Inclusion Criteria:

- Patients with permanent dentition between age group of 13 - 30 years.

* Maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
* Fully erupted teeth from 1st molar to the 1st molar.
* Patients with periodontally sound dentition.
* Patients with good general health. No previous history of extraction or orthodontic tooth movement.

Exclusion Criteria:

* Cases requiring orthognathic surgery.

  * History of systemic and medical illness.
  * Contraindication of extraction.
  * Previous history of orthodontic treatment.
  * Poor oral hygiene.
  * Nickel allergy.

Primary outcomes:
measure: Anterior teeth alignment every 4 weeks at each time point.
timeFrame: 6 months
Secondary outcomes:
measure: Molar anchorage loss at each time point.
timeFrame: 6 months
measure: Gingival invagination
timeFrame: 9 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Medical Services
Study officials:
affiliation: Private Practice
name: Samer Mheissen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681689: PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Official title: PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Post-Treatment
Efficacy
Lead sponsor: ARJ Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples.

Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System.

Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.


Eligibility criteria: Inclusion Criteria:

* Male or Female at least 18 years of age
* Patients who have been diagnosed with H. pylori and have been treated within the past 6 months
* Naive to H. pylori treatment in the past 4 weeks (including PPIs)

Exclusion Criteria:

* Pregnant and/or lactating women.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Participation in other interventional trials.
* Allergy to test substrates.
* Antibiotics taken within 4 weeks of the testing.
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food

Primary outcomes:
measure: Overall Percent Agreement
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Union City
country: United States
facility: Hudson County Clinical Trials Research Center
state: New Jersey
Study officials:
References: