louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02502305: Liveonline Training Course to Improve Food Habits and Enhance Physical Activity in Older Adults
Official title: Liveonline Training Course to Improve Food Habits and Enhance Physical Activity in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Health
Motivation
Keywords: health literacy
attitude
motivation
Lead sponsor: Jacobs University Bremen gGmbH
Sponsor class: OTHER
Collaborators: name: Liveonline Coaching
First posted: 2015-07-20
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to find out if the live online course is effective with regard to health promotion. Older adults receive support to initiate a health behavior (i.e., to enhance physical activity or to improve food habits).

Motivation, confidence and self-management strategies are optimized to make sure participants are able to integrate the physical activity or healthy diet into their daily life.

Detailed description: Aim of the study is to support older adults to define a personal health behavior (to enhance physical activity, to improve food habits), to check and optimize this intention regarding self-efficacy and volitional competencies, such as action and coping planning, disability management to adopt and maintain their behavior successfully.

Research questions:

* What is the pathway from health information/intention to behavioural change (motivational and volitional processes)?
* Which are the crucial social-cognitive variables in educating/coaching adults with low health literacy in daily self-management?
* Which other resources (e.g. social support) should be targeted in interventions to empower people in health behaviour change and maintenance?

Eligibility criteria: Inclusion Criteria:

* internet access at home
* proficient language skills (German)

Exclusion Criteria:

* no internet access at home
* no proficient language skills (German)
* contra-indication for physical activity or a diet rich in fruit and vegetables

Primary outcomes:
measure: health literacy
timeFrame: up to 4 months
Secondary outcomes:
measure: physical activity
timeFrame: up to 4 months
measure: healthy diet
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Jacobs University Bremen gGmbH
Study officials:
affiliation: Jacobs University Bremen gGmbH
name: Sonia Lippke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03607305: Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass
Official title: Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 506
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: Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.

Excess BMI loss 5 years after surgery was investigated

Detailed description: Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).

Excess BMI loss 5 years after surgery was investigated

Eligibility criteria: Inclusion Criteria:

* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* Age older than 18 years

Exclusion Criteria:

* Patients undergoing other bariatric techniques than RYGB
* Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
* Any other surgical procedure added to the bariatric surgery
* Impossibility to comply with pre-established clinical follow-up.

Primary outcomes:
measure: Weight loss
timeFrame: 5 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HOSPITAL REY JUAN CARLOS
name: Jaime Ruiz-Tovar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.
Clinical trial NCT03509805: Sleep Apnea Syndrome in Obese Women During Pregnancy
Official title: Sleep Apnea Syndrome in Obese Women During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea, Obstructive Sleep
Pregnancy Complications
Pre-Eclampsia
Obesity
Keywords: sleep apnea syndrome
obesity
pregnancy
preeclampsia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.

The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.

the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* BMI \> 35
* \> 24th weeks of pregnancy
* informed consent,
* health assurance

Exclusion Criteria:

* no informed consent
* twin pregnancy or more
* no health assurance

Primary outcomes:
measure: Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
timeFrame: during the sleep time, an average 8 hours
Secondary outcomes:
measure: occurrence of vascular disease
timeFrame: from inclusion at the beginning of the management of pregnancy to delivery
measure: Evaluation of fetal impact by correlation of birth weight to gestational age
timeFrame: from inclusion at the beginning of the management of pregnancy to delivery
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU,Hôpital Jeanne de Flandre
state: North
Study officials:
affiliation: University Hospital, Lille
name: Anne-Frédérique Dalmas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06664905: Resistance Exercise in Severe Knee Osteoarthritis
Official title: Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Resistance Training
Knee Osteoarthritis
Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* men and women at least 55 years old
* diagnosed with severe knee OA
* scheduled for unilateral Total Knee Arthroplasty (TKA) surgery

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities)
* another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated
* participated in exercise programs (\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study
* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of study tasks

Primary outcomes:
measure: Change in self-reported pain intensity
timeFrame: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
measure: Change in pressure pain thresholds
timeFrame: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Secondary outcomes:
measure: WOMAC questionaire
timeFrame: pre-exercise
measure: Tampa Scale of Kinesiophobia (TSK 11)
timeFrame: pre-exercise
measure: Chronic Pain Self-Efficacy Scale
timeFrame: pre-exercise
measure: Pain Catastrophizing Scale
timeFrame: pre-exercise
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clinic Universitary Hospital of Valencia
Study officials:
References:
Clinical trial NCT06583005: Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
Official title: Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Keywords: vibrotactile
vibrotactile coordinated reset
parkinsons disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.


Eligibility criteria: Inclusion Criteria:

* Age at the time of enrollment: Adults 18 and older
* Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
* Fluent in English
* Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
* Lives in the United States

Exclusion Criteria:

* Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
* Any current drug or alcohol abuse.
* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
* Pregnancy, breast-feeding or wanting to become pregnant.
* Patient is unable to communicate properly with staff (i.e., severe speech problems).
* Excessive drooling

Primary outcomes:
measure: MDS-UPDRS Part 3
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06308705: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis
Official title: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strongyloides Stercoralis Infection
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-center interventional study with an IVD medical device.

The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.

All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.

The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.

The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.


Eligibility criteria: Inclusion Criteria:

* All sera available in our biobank and originating from the Strong Treat trial
* availability of the baseline and the 12-month follow up serum of each included case

Exclusion Criteria:

* unavailability of the baseline or of the 12-month follow up serum of each included case

Primary outcomes:
measure: Result of the SsIR/NIE ELISA
timeFrame: Baseline and at the 12-month follow-up
Secondary outcomes:
measure: Seroconversion
timeFrame: Baseline and at the 12-month follow-up
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References:
Clinical trial NCT03105505: The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis
Official title: The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inflammation of the Eyelids
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 75
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 study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .

Detailed description: 3 arms study. 75 patient total, 25 patients in each group.

Group A (study group) patients will apply facially Permethrin 5% every night for 3 months.

Group B patients will apply on the eyelids Fusidic acid 1% every night for 3 months.

Group C patients will apply on the eyelids Synthomycine 5% every night for 3 months

Follow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.

Eligibility criteria: Inclusion Criteria:

- Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.

Exclusion Criteria:

- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.

Primary outcomes:
measure: Decrease in demodex infestation in group A (permethrin 5%).
timeFrame: 2 months
measure: Improvement in symptoms and complaints in group A.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ashqelon
country: Israel
facility: Barzilai Medical Center
Study officials:
References:
Clinical trial NCT03001505: Registry for Pancreatic Cancer
Official title: Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pancreatic cancer who are treated at DUHS

Brief summary: This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.


Eligibility criteria: Inclusion Criteria:

* Pancreatic cancer

Exclusion Criteria:

* Younger than 18 years of age

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 10 years
measure: Metastasis
timeFrame: 10 years
measure: Local recurrence
timeFrame: 10 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: DUHS
name: Sabino Zani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04997005: The Medacta International AMIStem-P Post-Marketing Surveillance Study
Official title: Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthrosis
Traumatic Arthritis
Rheumatoid Polyarthritis
Congenital Hip Dysplasia
Avascular Necrosis of the Femoral Head
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Brief summary: This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis


Eligibility criteria: Inclusion Criteria:

* Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
* Patient eligible to receive an uncemented AMIStem-P femoral stem
* Patient agreeing to comply with the study requirements
* Patient willing to provide written informed consent
* Patient affiliated to a social security system
* Patients between 18 and 85 years old

Exclusion Criteria:

* Participation in biomedical research
* Patients younger than 18 years old
* Vulnerable adult patients according to article L1121-6 of the French Public Health Code
* Pregnant or breastfeeding women
* Patients unable to provide written informed consent

Primary outcomes:
measure: Survival rate
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 3/6 months, 1, 3, 5 and 10 years
measure: Oxford Hip Score
timeFrame: 3/6 months, 1, 3, 5 and 10 years
measure: Radiographic performance of the implants
timeFrame: 3/6 months, 1, 3, 5 and 10 years
measure: Quality of life - Euroqol questionnaire
timeFrame: 3/6 months, 1, 3, 5 and 10 years
measure: Adverse events
timeFrame: intraop, 3/6 months, 1, 3, 5 and 10 years
Other outcomes:
Locations:
city: Blendecques
country: France
facility: Clinique de Saint Omer
city: Castres
country: France
facility: Hôpital Castres
city: Floirac
country: France
facility: Nouvelle Clinique Bordeaux Tondu
city: Orange
country: France
facility: Clinique d'Orange
city: Rodez
country: France
facility: Hôpital Jacques-Puel
Study officials:
affiliation: Hôpital Jacques-Puel
name: Alexandru Nebunescu-Schirliu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876405: Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses
Official title: Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation, Traumatic
Prosthesis User
Keywords: hand prosthesis
sensory feedback
amputation
upper limb
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

Detailed description: A non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. Pretests and follow up will contain objective outcome assessments and semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

* acquired forearm amputation

Exclusion Criteria:

* psychiatric disorders

Primary outcomes:
measure: Assessment of Myoelectric Control - ACMC
timeFrame: 2 days
measure: Task performance questionnaire
timeFrame: 2 days
measure: Pointing task
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wijk U, Carlsson IK, Antfolk C, Bjorkman A, Rosen B. Sensory Feedback in Hand Prostheses: A Prospective Study of Everyday Use. Front Neurosci. 2020 Jul 7;14:663. doi: 10.3389/fnins.2020.00663. eCollection 2020.