louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00723801: Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
Official title: Effects of Losartan vs Atenolol on Aortic Stiffness and Diastolic Function in Adults With Marfan Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Marfan Syndrome
Keywords: Marfan syndrome
Losartan
Atenolol
Diastolic Function
Aortic Stiffness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2008-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often present, and can be a predictor of aortic dilation and cardiovascular complications. In addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and logical therapeutic targets in adults with Marfan syndrome.

TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic stiffness and improves diastolic function in hypertension, renal disease and hypertrophic cardiomyopathy.

This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and echocardiography for diastolic function will be performed at the beginning and end of treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation will also be performed at 0 and 6 months. We plan to determine whether losartan decreases aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.

Detailed description: Please See Summary.

Eligibility criteria: Inclusion Criteria:

* Age greater than 25 years
* Clinical Marfan Syndrome

Exclusion Criteria:

* Previous aortic or cardiac surgery
* Pregnancy
* Renal Insufficiency
* Medication intolerance

Primary outcomes:
measure: Aortic Biophysical Properties - Pulse Wave Velocity
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Diastolic Function - Ejection Fraction
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women;s Hospital
name: Mark A Creager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596401: The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer
Official title: The Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer and the Medical Care Cost in Iijima Town
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori
Eradication
Gastric Cancer
Medical Care Cost
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who live in Iijima town

Brief summary: Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the incidence of gastric cancer has been reported. By Hp eradication treatment being performed for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric cancer and/or the medical care cost can be reduced as compared with those in the previous years.


Eligibility criteria: Inclusion Criteria:

* People who live in Iijima town at their age of 19 to 69 years

Primary outcomes:
measure: the annual incidence of gastric cancer in Iijima town
timeFrame: 10 years
Secondary outcomes:
measure: The annual medical care cost in Iijima town
timeFrame: 10 years
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04250701: Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
Official title: Investigation of Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Disability
Developmental Dyslexia
Intellectual Disability
Keywords: Postural Control,
Body Posture
Hand Grip
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consisted children diagnosed with Dyslexia and Intellecutal Disability who continue their regular special education. The investigators also enrolled age matched typical developed children to establish control group

Brief summary: This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated.

Detailed description: Children with Intellectual Disability and Dyslexia have academic and behavioral problems but also they might have physical changes related to poor motor development.

Three evaluation method was used in study. Postural Deformities were evaluated by PostureScreen Mobile App which is a mobile app allows to assess photographic body posture in four aspects (anterior, posterior, lateral) Postural Control was tested by Wii Balance Board. Wii balance board is a force plate that can measure person's center of gravity displacements Hand grip strength tested by Jamar Hand Dynamometer. It was completed according to American Hand Therapist's Association guidelines.

All data collected from participants have analysed within the control group (typical developed children)

Eligibility criteria: Inclusion Criteria:

1. no comorbid diagnosis alongside ID and Dyslexia (dysgraphia, dyscalculia, attention deficit hyperactivity disorder, etc.)
2. no orthopedic/physical disability

Exclusion Criteria

1. Presence of previous training for physical or motor development
2. Previous surgery.

Primary outcomes:
measure: Body Posture Assessment
timeFrame: through study completion, an average of 1 year
measure: Postural Control Evaluation
timeFrame: through study completion, an average of 1 year
measure: Hand Grip Strength
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Ahmet Emir, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05537701: Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
Official title: Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 316
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: Patients with resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue for analysis will be included.

Brief summary: The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC.

Secondary objectives are:

* to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population;
* to investigate the correlation between T-Eos and overall \& disease-free survival;
* to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).


Eligibility criteria: Inclusion Criteria:

* Resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue

Exclusion Criteria:

* Inclusion in a clinical study contraindicating enrollment in the present study

Primary outcomes:
measure: Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification
timeFrame: October 2022
Secondary outcomes:
measure: to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population
timeFrame: December 2022
measure: to investigate the correlation between T-Eos and overall & disease-free survival
timeFrame: December 2022
measure: to investigate the localization of T-Eos (periphery vs. center of the tumor lesions)
timeFrame: December 2022
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liege
Study officials:
References:
Clinical trial NCT02880267: Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Official title: Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 304
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Detailed description: The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

Eligibility criteria: Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy
* Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

* Use of acetaminophen
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification of the study-assigned blood glucose meter

Primary outcomes:
measure: Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
timeFrame: 10 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Santa Barbara
country: United States
facility: Sansum
state: California
city: Walnut Creek
country: United States
facility: Diablo
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Seattle
country: United States
facility: Rainier
state: Washington
Study officials:
affiliation: DexCom, Inc.
name: David PRice, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01052467: Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
Official title: Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scalp Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 724
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: Patients visiting their attending dermatologist in the primary care clinic

Brief summary: This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis


Eligibility criteria: Inclusion Criteria:

* Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway

Exclusion Criteria:

* Contraindications of Xamiol® Gel listed in the German package insert
* Pretreatment with Xamiol® within the last 4 weeks
* Systemic treatment of psoriasis
* UV light therapy

Primary outcomes:
measure: Physician's Global Assessment of scalp psoriasis
timeFrame: After approximately 4 weeks
Secondary outcomes:
measure: Patient's Quality of Life
timeFrame: After approximately 4 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Clinical Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: University Clinic Schleswig-Holstein
name: Ulrich Mrowietz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030167: Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Official title: Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Attachment
Psychosocial functioning
Adults
Lead sponsor: Parnassia Groep
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 83
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: The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults.

Detailed description: The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

Eligibility criteria: Inclusion Criteria:

* a primary clinical diagnosis of DSM-5 ASD (APA, 2013)
* age ≥ 18 years
* at least eight years of education.

Exclusion Criteria:

* intellectual disability (IQ ≤ 80)
* presence of current suicidal ideation.

Primary outcomes:
measure: Experiences in Close Relationships - Revised questionnaire (ECR-r)
timeFrame: 15 minutes
measure: World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 15 minutes
Secondary outcomes:
measure: Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)
timeFrame: 10 minutes
measure: Green Paranoid Thought Scales (GPTS)
timeFrame: 15 minutes
measure: FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Parnassia Antes
state: South-Holland
Study officials:
affiliation: Parnassia Antes
name: Richard Vuijk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026167: Spinal Cord Injury Collaborative Care Study
Official title: SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Chronic Pain
Mood
Physical Activity
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2014-01-01
Enrollment: 174
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 objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.

Detailed description: Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* diagnosis of traumatic spinal cord injury by medical record review
* receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
* positive screening for pain related to SCI diagnosis and/or
* positive screening for low mood and/or
* negative screening for physical activity levels
* able to speak and understand English

Exclusion Criteria:

* psychiatric condition that would interfere with participation
* major surgery in the next 8 months

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in Pain
timeFrame: Baseline, 4 months, 8 months
measure: Change in Mood
timeFrame: Baseline, 4 months, 8 months.
measure: Change in Physical Activity
timeFrame: Baseline, 4 months, 8 months
measure: Change in Quality of Life
timeFrame: Baseline, 8 months
measure: Adverse events
timeFrame: baseline to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Charles H Bombardier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05138367: Effects of UCA-PSCs in Women With POF
Official title: Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Premature Ovarian Failure
Keywords: POF
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center randomized controlled trial at the Affiliated Drum Tower Hospital of Nanjing University Medical School. There were patients who underwent clinical follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or WJ-MSC.

Detailed description: At entry, all patients had already received a standard non-physiologic hormone replacement regimen. According to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. One group received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group), while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Premature Ovarian Failure
2. Patients show no response to drug treatment
3. Willing to receive follow up
4. Willing to conceive a baby
5. Age between 18 to 39

Exclusion Criteria:

1. Patients with chromosome abnormalities
2. Patients with congenital ovarian malformations
3. Patients with severe endometriosis
4. Patients with thyroid dysfunction
5. Patients with pregnancy contraindications
6. Patients with hormone replacement therapy contraindications
7. Past history of ovarian tumors or after radiotherapy
8. Can not take the follow-up, or want to take other treatment during the follow-up period
9. Patients with immune system diseases

Primary outcomes:
measure: blood perfusion in the ovary
timeFrame: within the first 30 weeks (plus or minus 10 weeks) after surgery
measure: Antral Follicle Diameter
timeFrame: within the first 30 weeks (plus or minus 10 weeks) after surgery
Secondary outcomes:
measure: blood flow index in the ovaries
timeFrame: within the first 30 weeks (plus or minus 10 weeks) after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: