louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00870831: Islet Function and Clinical Analyses of Transplant Recipients
Official title: Islet Function and Clinical Analyses if Transplant Recipients (Project 2 of JDFI Washington University Center For Islet Transplantation) (Please Note That the JDRFI Funded Has Ended
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type One Diabetes Mellitus
Keywords: diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetics that have successfully received and maintained an islet transplant here at Washington University. Loss of transplant function is an exclusion criteria.

Brief summary: To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University
* "control" subjects were matched to the transplant recipients base upon age, height, weight, \& race (and could not have diabetes)

Exclusion Criteria:

* well controlled Type 1 diabetes
* transplant failure
* unable to match potential subject to a recipient

Primary outcomes:
measure: OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant
timeFrame: 5 years
Secondary outcomes:
measure: The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function
timeFrame: 5yrs
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Kenneth S Polonsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Daniel C Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803231: Follow-up Data of Patients Treated With XIGRIS® in France
Official title: Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients treated with Xigris® between January 1st, 2006 and August 31st 2008 in intensive care units in France will be enrolled retrospectively, whereas all adult patients treated with Xigris® between September 1st, 2008 and September 1st, 2009 will be enrolled prospectively.

Brief summary: The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

Detailed description: The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:

* To describe the characteristics of the patients treated with Xigris®

  * socio-demographic characteristics,
  * clinical profile
* To determine the conditions of use of Xigris®

  * To describe previous treatments,
  * To observe delay before Xigris® initiation,
  * To describe dose, duration of treatment,
  * To study the concomitant treatments and the associated treatments
* To describe the clinical evolution of the patients

  * To observe mortality after 1 month
  * To describe reasons of death

Eligibility criteria: Patients are eligible to be included in the study if they meet the following criteria

* Patients treated with Xigris® during the study period in intensive care units in France
* Patients with a minimum age of 18 years
* Patients who are presenting in the normal course of care

Primary outcomes:
measure: Mortality
timeFrame: 28 and 31 days
Secondary outcomes:
measure: Severe bleeding events
timeFrame: 28 and 31 days
measure: Length of hospital stay
timeFrame: 28 and 31 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- fri 9AM-5PM eastern time (UTC/GMT- 5 hours,EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02049931: Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
Official title: The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compression Fracture
Keywords: osteoporosis, compression fracture, brace
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.

Detailed description: Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.

Eligibility criteria: Inclusion Criteria:

* the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
* compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.

Exclusion Criteria:

* the presence of more than two recent vertebral fractures,
* pathologic malignant compression fractures,
* neurologic complications,
* a history of previous injury or surgery to the fractured level,
* inability to complete the questionnaires about pain and disability.

Primary outcomes:
measure: Oswestry Disability Index (ODI) at 12 Weeks
timeFrame: 12 weeks after injury
Secondary outcomes:
measure: Visual Analog Pain Scale (VAS) for Back Pain
timeFrame: 2 weeks, 6 weeks, 12 weeks after injury
measure: Oswestry Disability Index (ODI)
timeFrame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
measure: General Health Status
timeFrame: at the initial enrollment and 12 weeks after compression fracture
measure: the Progression of Body Compression Ratio Over All Follow-up Assessments
timeFrame: 2 weeks, 6 weeks, and 12 weeks after compression fracture
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ho-Joong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.
Clinical trial NCT01990131: Computerized Anxiety Treatment for Suicide
Official title: Suicide Risk Prevention Among Patients With Anxiety Psychopathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Suicide
Keywords: computerized intervention
cognitive bias modification
anxiety
suicide
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 74
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 study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

Detailed description: CATS is a newly developed computerized treatment targeting specific risk factors associated with anxiety symptoms and suicidal thoughts. Individuals will be asked to complete four appointments, where they will complete various self-report questionnaires as well as a newly developed computerized treatment targeting risk factors associated with anxiety.

Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.
* Show evidence of current suicidal ideation (BSS above 6.
* Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.

Exclusion Criteria:

* No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).
* Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder
* No current substance dependence
* Must be an English speaker.
* Must be 18 years or older.
* Must have normal or corrected vision
* Cannot begin treatment/therapy within 1 month of baseline.
* Cannot begin a new medication within 3 months of baseline.

Primary outcomes:
measure: Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: Month 4 follow-up
Secondary outcomes:
measure: Beck Suicide Scale (BSS)
timeFrame: Month 4 follow-up
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
References:
citation: Schmidt NB, Norr AM, Allan NP, Raines AM, Capron DW. A randomized clinical trial targeting anxiety sensitivity for patients with suicidal ideation. J Consult Clin Psychol. 2017 Jun;85(6):596-610. doi: 10.1037/ccp0000195. Epub 2017 Mar 13.
Clinical trial NCT03330431: Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?
Official title: Effects of Videos Aiming to Optimize Expectations on Effectiveness of Progressive Muscle Relaxation (PMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Group 1 (Video Personal Expert)
Experimental Group 2 (Video Factual Expert)
Control Group
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's aim is to determine whether a short video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the actual effectiveness of PMR in comparison with a neutral (no video) control group.


Eligibility criteria: Inclusion Criteria:

* Healthy participants
* fluency in the German language to provide informed consent

Exclusion Criteria:

* Chronic illness
* Mental disorder

Primary outcomes:
measure: Change in perceived/subjective relaxation
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Secondary outcomes:
measure: Change in perceived stress
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
measure: Change in physiological relaxation
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Psychology, Philipps University Marburg
state: Hessen
Study officials:
affiliation: Philipps Universität Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salzmann S, Wilhelm M, Schindler S, Rief W, Euteneuer F. Optimising the efficacy of a stress-reducing psychological intervention using placebo mechanisms: A randomized controlled trial. Stress Health. 2022 Oct;38(4):722-735. doi: 10.1002/smi.3128. Epub 2022 Jan 24.
Clinical trial NCT04633031: The Effect of Bracing on Sagittal Balance in Scoliosis
Official title: The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Idiopathic Scoliosis
Keywords: bracing
sagittal balance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female and male subjects who underwent bracing therapy for an idiopathic scoliosis

Brief summary: The goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. In special we want to observe if there is a difference between two types of TLSO-brace, namely boston and cheneau.

Retrospective analyses of Full Spine X-rays of patients who underwent bracing-therapy in the context of scoliosis.

Different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis.

Four different X-rays will be reviewed for these parameters:

1. Profile before bracing therapy
2. Profile after initiation of bracing therapy
3. Profile immediately after termination of bracing therapy
4. Profile more than 3 months after termination of brace

It concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis).

Goal of the study is to check if treatment with TLSO-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis).

The zero-hypothesis: TLSO causes no decrease in lumbar lordosis.

Secondary goal is to compare the effect of the BOSTON TSLO-brace and otherwise the CHENEAU TLSO-brace on spinopelvic parameters and lumbar lordosis in special.


Eligibility criteria: Inclusion Criteria:

* late onset idiopathic scoliosis
* non-operative indication

Exclusion Criteria:

* early onset idiopathic scoliosis
* neuromuscular scoliosis
* congenital scoliosis
* associated spondylolisthesis
* operative indication

Primary outcomes:
measure: Delordosing effect of TLSO brace
timeFrame: 3 years
Secondary outcomes:
measure: Difference between Boston and Cheneau brace concerning delordosing effect
timeFrame: 3 years
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: UZ Pellenberg
Study officials:
affiliation: UZ Leuven
name: Pierre Moens, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190031: Respiratory Muscle Training in CF Patients
Official title: Respiratory Muscle Training in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Respiratory Muscles
Keywords: training
exercise
quality of life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomized in 2 different groups, one being involved in an endurance respiratory muscle training program, the other being involved in resistance inspiratory muscle training.
Primary purpose: TREATMENT

Brief summary: The present study aims at evaluating the effect of respiratory muscle training in adult patients with cystic fibrosis on lung function, exercise performance and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of cystic fibrosis
* Patients in steady state

Exclusion Criteria:

* Patients during exacerbation
* Patients treated by oral corticotherapy (\>0.5 mg/kg/j during \>7 days) during the past 2 months
* Pregnant patients

Primary outcomes:
measure: Respiratory muscle endurance
timeFrame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
measure: Maximal cycling performance
timeFrame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
measure: Quality of life of patients after the intervention
timeFrame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
References:
citation: Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.
Clinical trial NCT00248131: Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
Official title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy, octreotide acetate in microspheres
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.


Eligibility criteria: Inclusion Criteria:

* written informed consent provided prior to participation in the extension study
* successful completion of study CSMS995 0802
* willingness to comply with all study requirements

Exclusion Criteria:

* more than 8 weeks interval since the completion of study CSMS995 0802
* premature discontinuation from study CSMS995 0802

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: long-term safety and tolerability
Secondary outcomes:
measure: monitor long-term efficacy
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01390831: Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Official title: Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypertension
Lead sponsor: The Second People's Hospital of Chengdu
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.

Detailed description: Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age
* a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
* receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
* estimated glomerular filtration rate (eGFR) of ≥45mL/min
* agrees to have the study procedure(s) performed and additional procedures and evaluations
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* secondary hypertension
* renal arterial abnormalities
* has experienced MI, unstable angina pectoris, or CVA within 6 months
* has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
* requires respiratory support
* patients with sick sinus syndrome
* pregnant woman
* others

Primary outcomes:
measure: Blood Pressure Reduction
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Second People's Hospital of Chengdu
name: Jian Xiong Liu
role: PRINCIPAL_INVESTIGATOR
References: