louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02983084: Orthodontic Archwire Comparison Trial
Official title: SmartWire Multiforce Archwire Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontic wires
Root resorption
Lead sponsor: Ormco Corporation
Sponsor class: INDUSTRY
Collaborators: name: Indiana University
First posted: 2016-12-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.

Detailed description: This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.

Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.

Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.

Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.

Eligibility criteria: Inclusion Criteria:

* Adult \>14yrs of age
* Amenable to treatment with metal brackets
* Crowding of 3-8mm in one or both arches (non-extraction treatment)
* Overbite \>3mm
* Read and speak English without a translator
* Individuals in good general health at the discretion of the investigator(s)

Exclusion Criteria:

* Medical/Dental History (Hx):

  * Documented metabolic disorder(s)
  * Nickel allergy
  * Bisphosphonate treatment
  * Amelogenesis, dentinogenesis or osteogenesis imperfect
  * Active caries or periodontal disease
  * Root resorption (moderate to severe)
  * Patients who are pregnant or breast feeding or plan to be pregnant during the study

Primary outcomes:
measure: Alignment of dental arches
timeFrame: Initial six months of treatment
Secondary outcomes:
measure: Leveling of dental arches
timeFrame: Initial six months of treatment
measure: Expression of external apical root resorption (EARR)
timeFrame: Initial six months of treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IUSD Orthodontic Clinic
state: Indiana
Study officials:
affiliation: Indiana Unversity
name: Kelton T Stewart, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316484: Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms
Official title: Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Gastroparesis
Keywords: Cognitive Debriefing
Lead sponsor: Tranzyme, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital/Clinic Database

Brief summary: The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.


Eligibility criteria: Inclusion Criteria:

1. Subject has Type 1 or Type 2 diabetes mellitus
2. Subject is 18 to 70 years old
3. Subject has chronic, active symptoms of gastroparesis for at least the past three months
4. Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
5. Subject can speak and read English
6. Subject is able to give his/her informed consent

Exclusion Criteria:

1. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit

-

Primary outcomes:
measure: Qualitative, Content Analysis of Cognitive Debriefing Data
timeFrame: 90-minute interview
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Health Sciences Center
state: Pennsylvania
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Temple University Health Sciences Center
name: Henry Parkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Tuba Esfandyari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: Irene Sarosiek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Kenneth Koch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06008184: Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
Official title: Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Insufficiency
Cushing Syndrome
Hyperaldosteronism
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations, current methods of cortisol measurement have limitations.

Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in real-time.

The main aim of the study is to compare cortisol levels across biological fluids (sweat, saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and non-invasive cortisol measurement device (currently under development).


Eligibility criteria: Healthy controls:

Inclusion Criteria:

* age between 18 and 30 years old
* normal BMI 18 to 25 kg/m2
* weight stability

Exclusion Criteria:

* pregnancy, breastfeeding, irregular menses
* any medical treatment
* any medical issues
* pilocarpine allergy, or latex allergy
* glaucoma or acute irritis

Primary outcomes:
measure: Cortisol levels in 4 biologicals fluids
timeFrame: 24 hours
Secondary outcomes:
measure: Aldosterone levels in 4 biological fluids
timeFrame: 24 hours
measure: Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours
timeFrame: 24 hours
measure: Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Nelly Pitteloud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05589584: N-acetyl Cysteine and Patients with Non-alcoholic Fatty Liver Disease
Official title: Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients with Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Simple Steatosis Non Fatty Liver
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18-60 years diagnosed with NAFLD

Exclusion Criteria:

* History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
* Patients with schistosomiasis, active hepatitis B or C, autoimmune and diabetes mellitus.
* current Consumption of any antioxidant supplements and hepatotoxic drug.
* Pregnancy or lactation or expecting to get pregnant during the study.
* Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
* Active Cancer patients.
* Anyone having hypersensitivity to N-acetylcysteine.
* Anyone already taking N-acetylcysteine.

Primary outcomes:
measure: assessment of the effect of NAC on leptin
timeFrame: 3 months
Secondary outcomes:
measure: assessment of the effect of NAC on MDA
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References:
Clinical trial NCT02528084: The Effects of Yoga on Patients With Rotator Cuff Injuries
Official title: The Effects of Yoga on Patients With Rotator Cuff Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: rotator cuff, shoulder, rehabilitation, yoga
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control).

Detailed description: Patients awaiting rotator cuff surgery spend months waiting for a doctor's consultation and even longer for surgery. The proposed study is to see if there is a difference between three groups: patients who follow an online yoga video, patients who follow an online standard exercises video and patients who do not undergo either treatment (control).

Eligibility criteria: Inclusion Criteria:

* minimum 18 years old
* rotator cuff injury
* access to YouTube

Exclusion Criteria:

* under 18 years of age
* patient has past yoga experience
* patient will/has undergone any surgery other than rotator cuff

Primary outcomes:
measure: Shoulder Pain and Disability Index (Pain Level)
timeFrame: 6 weeks
measure: Range of motion (Shoulder Impairment)
timeFrame: 6 weeks
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph Health Care
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Joy MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Dolly Mehta, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213784: Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"
Official title: Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Diabetes Association
First posted: 2010-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.


Eligibility criteria: Inclusion Criteria:

* Ejection fraction =\<45%
* Diabetes
* Hba1c =\>7,5%
* In anticongestive treatment
* NYHA class 2-4

Exclusion Criteria:

* Severe angina (CCS 3-4)
* Hemodynamic significant heart valve disease
* Congenital heart disease
* Pregnancy

Primary outcomes:
measure: Left ventricular function
timeFrame: 4 month
Secondary outcomes:
measure: hormonal and metabolic profile
timeFrame: 4 month
measure: 6-minutes hall walk test
timeFrame: 4 month
measure: Exercise capacity and peak oxygen consumption
timeFrame: 4 month
measure: Muscle strength and mass
timeFrame: 4 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of cardiology, Aarhus university hospital Skejby
state: Region Midtjylland
Study officials:
affiliation: Dept. of cardiology, University hospital Aarhus Skejby
name: Roni R Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen R, Wiggers H, Thomsen HH, Bovin A, Refsgaard J, Abrahamsen J, Moller N, Botker HE, Norrelund H. Effect of tighter glycemic control on cardiac function, exercise capacity, and muscle strength in heart failure patients with type 2 diabetes: a randomized study. BMJ Open Diabetes Res Care. 2016 Apr 29;4(1):e000202. doi: 10.1136/bmjdrc-2016-000202. eCollection 2016.
Clinical trial NCT03280784: Clinical Audit on the Use of Upper Endoscopy in Assist University Children Hospital
Official title: Clinical Audit on the Use of Upper Gastrointestinal Endoscopy in Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Endoscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-09-13
Enrollment: 1
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children admitted at assiut university hospital for upper gastrointestinal endoscopy

Brief summary: this protocol aides to evaluate:( 1)whether upper gastrointestinal endoscopy (UGE) is used appropriately according to the Guideline on pediatric GI endoscopy \[1\] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition(ESPGHAN) and the European Society of Gastrointestinal Endoscopy(ESGE). In our hospital setting and(2) whether there is any relationship between appropriateness of gastrointestinal endoscopy and the presence of lesions detected by endoscopy.

Detailed description: gastrointestinal endoscopy is a safe and effective procedure. However,complications do exist and procedure-related costs are significant The rapid escalation of the cost of medical care, in the face of limited resources, is making the appropriateness of indications more and more essential to the rational utilization of such resources.Upper Gastrointestinal (UGI) endoscopy in the pediatric population has evolved during the last 30 years with an increasing number of diagnostic and therapeutic applications.

years with an increasing number of diagnostic and therapeutic Technological improvements and endoscopic devices have contributed to the evolution This prospective study is to determine whether upper gastrointestinal endoscopy is used appropriately in our hospital setting according to, the Guideline on pediatric GI endoscopy \[1\] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts the probability of detecting significant lesions by endoscopy

Eligibility criteria: Inclusion Criteria:

* Weight loss,

failure to thrive

Unexplained anemia

Abdominal pain with suspicion of an organic disease

Dysphagia or odynophagia

Caustic ingestion

Recurrent vomiting exclusion criteria

patients with perforated viscous

Primary outcomes:
measure: improve the use of upper gastrointestinal endoscopy in assiut university hospital of upper gastrointestinal endoscopy in assiut university children hospital
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university children hospital
Study officials:
affiliation: Assiut
name: mahmoud mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803684: Contribution of Diffusion MRI in Renal Graft Transplantation
Official title: Diagnostic Ability of Diffusion MRI and Diffusion Tensor in Renal Graft Biopsies: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplantation
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: While renal graft outcomes were really improved for the last decade, long time outcomes remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect precociously renal injuries at a reversible stage before clinical manifestation. However, renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a non-invasive diagnostic tool allowing the early detection of renal injuries, especially allograft rejection without hemorrhagic risk. This tool could be applied routinely to the renal allograft recipient in replacement of protocol biopsies.

Here, aim of this study is to correlate the results from diffusion MRI of renal graft with pathologic findings from protocol renal graft biopsies.

In this view, the investigators include prospectively all recipients of renal transplantation who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination. Thus, the investigators exclude patients who are not be able to beneficiate of a MRI examination and patient obstacle to renal graft biopsy.

Expected results are the Banff classification from the histopathologic analysis of biopsies. The expected results for MRI examination are signal intensity, diffusive coefficient, anisotropy fraction and change of the diffusion way. Next, the investigators search an association between these features by statistical analysis (Wilcoxon test, Chi², Fisher, Pearson or Spearman).

The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.


Eligibility criteria: Inclusion Criteria:

* Renal graft recipient from Reims hospital
* Over 18 years
* With consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Signal intensity by Diffusion MRI
timeFrame: since transplantation to 12 months after
measure: Banff score (histopathologic findings)
timeFrame: since transplantation to 12 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT01633684: Type 1 Diabetes Mellitus Effect on Bone Mineral Density
Official title: Type 1 DM Effect on BMD: a Longitudinal Study in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Osteoporosis
Keywords: diabetes mellitus
bone
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 123
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have Type 1 DM and their age and sex matched control and have been enrolled in a study of Type 1 DM and bone and had a baseline DXA and pQCT during the last 4 years. Persons that completed visit 1 for the previous study and had a DXA and pQCT done will be invited back for repeat DXA and pQCT measurement. If a diabetic patient does not have an age and sex matched control or their control does not want to be in the longitudinal study a new age and sex matched control will be recruited.

Brief summary: Because the diabetics are fracturing at a younger age than the general population (12), this leads us to believe there are significant factors that lead to fracture in Type 1 diabetes mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

Detailed description: Because the diabetics are fracturing at a younger age than the general population(12), this leads us to believe there are significant factors that lead to fracture in Type 1 DM other than BMD. Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

Eligibility criteria: Inclusion Criteria:

* diabetic patients must have completed Visit 1 of the previous study.

Primary outcomes:
measure: Bone mineral Density
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura Armas, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: