louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00659815: Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration
Official title: Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comfort
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration


Eligibility criteria: Inclusion Criteria:

* Subject is a habitual wearer of planned replacement soft contact lenses
* VA correctable to 0.3 LogMar or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings

Primary outcomes:
measure: Comfort
timeFrame: Over-all follow-up visits from baseline to 1 month
measure: Slit Lamp Findings
timeFrame: Over-all follow-up visits from baseline to1 month
measure: Lens Deposits
timeFrame: Over-all study visits, baseline to 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James Ferrari, OD
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, PhD, MCOptom
role: STUDY_DIRECTOR
affiliation: James Ferrari, OD
name: James Ferrari, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03072615: Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS
Official title: Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Liver Cirrhoses
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 83
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: This prospective multicentre study included patients, which underwent TIPS insertion and had reliable SWE or TE measurement of the liver before TIPS.

Brief summary: The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).

Detailed description: We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.

Eligibility criteria: Inclusion Criteria:

* TIPS insertion and had reliable SWE or TE measurement

Exclusion Criteria:

* contraindication for TIPS
* no reliable SWE or TE measurement

Primary outcomes:
measure: Survival
timeFrame: 3 months
Secondary outcomes:
measure: Acute-on-chronic Lvier failure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Jansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20.
Clinical trial NCT01593215: Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant
Official title: Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: genetics
type 2 diabetes
insulin secretion
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Lund University
First posted: 2012-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.

Detailed description: We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* informed consent
* age 18-70, for females only postmenopausal

Exclusion Criteria:

* heart disease
* anxiety disorder
* antidiabetic treatment other than metformin
* adrenergic blockers
* ulcus
* allergy to any component in the capsules

Primary outcomes:
measure: Insulin Secretion
timeFrame: 30 minutes after oral glucose
Secondary outcomes:
measure: Glucose
timeFrame: 30 minutes after oral glucose
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus
state: Skane
Study officials:
affiliation: Region Skane
name: Anders Rosengren, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00969215: Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
Official title: Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Keywords: burn scar
fractional carbon dioxide laser
scar revision
Lead sponsor: Moy-Fincher Medical Group
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if fractional carbon dioxide laser treatment of a burn scar is a more effective method for improving the appearance of scars than the current available treatments.


Eligibility criteria: Inclusion Criteria:

* Have a mature burn scar and desire revision
* Fluent in English
* Must reside in the Los Angeles vicinity for the duration of the study

Exclusion Criteria:

* Previous history of scar revision
* Non-English speakers
* Pregnant or cognitively impaired subjects

Primary outcomes:
measure: Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.
timeFrame: 2 weeks after each procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Moy-Fincher Medical Group
state: California
Study officials:
affiliation: Moy-Fincher Medical Group
name: David Ozog, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01250015: Does Numerical And Pictorial Information On Risk And Benefit Affects The Uptake Of Colorectal Cancer Screening?
Official title: THE RESULTS OF A RANDOMISED CONTROLLED QUESTIONNAIRE-BASED TRIAL ON WHETHER PROVISION OF NUMERICAL AND PICTORIAL INFORMATION ON RISK AND BENEFIT AFFECTS THE UPTAKE OF COLORECTAL CANCER SCREENING?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Screening
Keywords: colorectal cancer
consent
screening
Lead sponsor: County Durham and Darlington NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Internal funding Local Gastroenterology Research fund (Questionnaire only study)
First posted: 2010-11-30
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects attending GP and hospital outpatients

Brief summary: To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening.

Design and Intervention. Randomised questionnaire and telephone study comparing the responses of a control group given the standard National Health Service (NHS) CRC screening information with the responses of an intervention group given the same information but enhanced with additional numerical and pictorial information.

Setting


Eligibility criteria: Inclusion Criteria:

Age 60 - 70

-

Exclusion Criteria:

* No previous cancer or previous colonoscopy Not able to give informed consent

Primary outcomes:
measure: Comparison of the two groups' overall wish to be screened
timeFrame: 1 year
Secondary outcomes:
measure: Impact of different summary points on subject's desire to be screened
timeFrame: 1 year
Other outcomes:
Locations:
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
state: Co durham
Study officials:
References:
Clinical trial NCT03038815: The Influence of Stability Boots on Gait Pattern in Healthy Adults
Official title: The Influence of Stability Boots on Gait Pattern in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation After Ankle Injuries
Lead sponsor: Institute for Biomechanics, ETH Zürich
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle support limit the range of motion in the joint, help pain relief, control loading of the injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable accurate analysis of human movement.

The study is set to describe and compare the gait analysis of two modifiable stability boots (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.

Detailed description: The participants are joining one session in the gait lab. Here the are measured during walking with normal shoes and two modifiable stability boots. The duration of a session is typically 3 hours.

Eligibility criteria: Inclusion Criteria:

* healthy
* 18-45 years old
* shoe size 5,6,9 or 10

Exclusion Criteria:

* injuries of the lower limbs
* previous surgeries on the lower limbs
* neuromuscular disorders
* restriction in gait capabilities
* current medical treatment

Primary outcomes:
measure: ROM Ankle Joint
timeFrame: duration of a session is typically 3 hours
Secondary outcomes:
measure: Symmetrie Index
timeFrame: duration of a session is typically 3 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute for Biomechanics ETH Zürich
state: ZH
Study officials:
affiliation: Institute for Biomechanics
name: Silvio Lorenzetti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06960915: Efficacy of Virtual Reality Reminiscence Therapy in Nursing Home Residents With Alzheimer's Disease or Related Diseases
Official title: Efficacy of Virtual Reality Reminiscence Therapy in Nursing Home Residents With Alzheimer's Disease or Related Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Reminiscence Therapy
Nursing Home
Alzheimer&#39;s Disease or Related Diseases
Crossover Study
Keywords: Virtual reality
Reminiscence therapy
Nursing home
Alzheimer&#39;s disease or related diseases
crossover study
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This project provides the easiest possible access to heritage elements that older persons with Alzheimer's disease or related diseases knew well but to which they no longer have access due to the motor and functional dependencies they present. It will strengthen the possibilities of reminiscence by using, rather than the usual supports, virtual reality technology to reinforce the immersion effect. It will involve carrying out virtual reality reminiscence workshops intended for residents in nursing home with Alzheimer's disease or related diseases and allowing them to explore the heritage of towns and villages in the Somme region thanks to these innovative solutions. The aim of this project is to reduce behavioral disorders and improve their quality of life.


Eligibility criteria: Inclusion Criteria:

* Residents of the long-term care facilities of the Amiens-Picardie University Hospital,
* Residents with mild to moderate Alzheimer's disease or related diseases, i.e. with an MMSE ≥ 10,
* Residents or their legal representative agreeing to participate in the study.

Exclusion Criteria:

* Non-residents of the long-term care facilities of the Amiens-Picardie University Hospital,
* Residents with an MMS \< 10,
* Residents or their legal representative refusing to participate in the study,
* Residents in terminal palliative care,
* Residents with disruptive behavioral disorders.

Primary outcomes:
measure: Reduced behavioral problem frequency in immersive virtual reality group
timeFrame: 1 year
Secondary outcomes:
measure: Improved quality of life in the immersive virtual reality group
timeFrame: 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT01567215: Treatment of Granuloma Umbilical in Newborn Babies
Official title: Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fetus or Newborn Affected by Condition of Umbilical Cord
Keywords: granuloma umbilical
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2012-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators want to show that steroid creme and even better alcohol swaps are just as effective or equal to the current treatment with silver nitrate of granuloma umbilical in newborns.

Detailed description: The change of treatment will make it possible for parents to treat the children themselves at home, whereas treatment with silver nitrate only is an in hospital regimen.

Eligibility criteria: Inclusion Criteria:

* Gestational age more than 37 weeks
* More than 3 weeks old baby
* Granuloma umbilical diagnosed by a pediatrician
* No infections due to the umbilicus
* Parents do understand and speak danish

Exclusion Criteria:

* Gestational age less than 37 weeks
* Less than 3 weeks old baby
* Granuloma umbilical not diagnosed by a pediatrician
* Infections due to the umbilicus
* Parents do not understand or speak Danish

Primary outcomes:
measure: Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?
timeFrame: 2 years
Secondary outcomes:
measure: Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents
timeFrame: 2 years
Other outcomes:
measure: Avoid side effects by changing treatment of granuloma umbilical
timeFrame: 2 years
Locations:
city: Kettegård Alle 31
country: Denmark
facility: Hvidovre Hospital
state: Hvidovre
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Kettegård alle 30
Study officials:
affiliation: Hvidovre University Hospital, Childrens apartement
name: Pernille Pedersen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584.
Clinical trial NCT06417515: The Potential Benefit of Xiao-Yao-San Treatment in Patients With Insomnia
Official title: Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment
Lead sponsor: Tainan Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators recruited patients ages 20-65 from 2 groups in Tainan Hospital. One was from a weight loss class, also called WLC, one was from our regular clinic. These patients have no history of schizophrenia, narcolepsy, neurological disease, alcohol and drug addiction but had Pittsburgh Sleep Quality Index (PSQI) scores for psychometric properties ≥ 5 between January 1 to November 30 of 2019. The study group were the patients who received XYS for 28 days and the control group were those who didn't receive any Chinese medicine but attended the WLC. Age, gender, personal biodata, polysomnography findings, and these subjective sleep questionnaires were collected. The Wilcoxon test was used to compare the difference in pre and post evaluation in two groups. After comparing the objective and subjective assessment between the better and poorer performance in the XYS group, we would find more suitable criteria for XYS in traditional Chinese medicine.


Eligibility criteria: Inclusion Criteria:

* 20- to 65-year-old patients.
* Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5.

Exclusion Criteria:

* Schizophrenia.
* Narcolepsy.
* Neurological diseases (history of stroke, neurodegenerative diseases, etc.).
* Alcohol addiction.
* Drug addiction.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) scores
timeFrame: Up to 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Tainan Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Tainan Hospital, Ministry of Health and Welfare
name: YU-CHING HSU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450315: Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors
Official title: Effects of Targeted Versus Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Behaviour Change
Keywords: Physical Activity
Young Adult Cancer
Behavior Change
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).


Eligibility criteria: Inclusion Criteria:

* diagnosed with cancer in Alberta, Canada
* Still living in Alberta, Canada
* Read English

Exclusion Criteria:

-

Primary outcomes:
measure: Effects of Targeted Versus Generic Print Materials
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Behaviour Medicine Laboratory
state: Alberta
Study officials:
References: