louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04127539: Evaluation of Strong & Steady - Fall Preventive Group Exercise Program
Official title: Evaluation of Strong & Steady: A Group Exercise Program for Preventing Functional Decline and Falls Among Community Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Exercise
Fall prevention
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Glasgow Caledonian University
name: Fysiofondet
First posted: 2019-10-15
Enrollment: 95
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate the effect of Strong and Steady (S\&S) group exercise on fall risk and physical function among community-dwelling older adults over 12 months. A pre-post test study deign will be used.

Detailed description: The S\&S group exercise program builds on the Otago and FaME exercise programs which have shown to be effective in preventing falls. Strong and steady has been adapted to more functionally fit older people.

The study period will be one year. Due to the corona pandemic all S\&S groups in Norway have been closed. Due to this all participants have had a break from their exercise program for more than 6 months and can be seen av new participants to the exercise groups. Participants that are about to start in a S\&S group in municipalities in Trøndelag will be asked to participate in this study. They will go through tests of muscle strength and balance in addition to questionnaires at baseline and after 6 and 12 months of exercise. Where possible the participants will go through the same tests 1 month before they start to exercise in addition to the three other test timepoints.

Eligibility criteria: Inclusion Criteria:

* Able to get to the training facilities on their own
* Able to walk without a walking aid indoors

Exclusion Criteria:

* Diagnosed with dementia

Primary outcomes:
measure: 30 sec chair rise
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Short Physical Performance Battery total score
timeFrame: Baseline, 3, 6 and 12 months
measure: Number of falls
timeFrame: 12 months
measure: The Short Falls Efficacy Scale-International
timeFrame: Baseline, 3, 6 and 12 months
measure: Everyday physical activity
timeFrame: One week monitoring at baseline, 3, 6 and 12 months
measure: 30 sec chair rise
timeFrame: Baseline, 6 and 12 months
measure: Four square step test
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian municipalities
Study officials:
affiliation: The Norwegian University of Science and Technology
name: Jorunn L Helbostad, PhD/Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03281239: Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study
Official title: Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Effects of Welding Fumes Components
Keywords: welder, airport agent, Welding fumes
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 51
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: Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.

Detailed description: In an exposed-non-exposed study, investigators will include 30 welders and 30 airport runway agents for control. As part of cardiovascular independent risk factors, microvascular endothelial function will be evaluated directly by laser Doppler flowmetry. Blood samples will be also collected and circulating markers of endothelial function (VW factor, E-selectin, VCAM, ICAM, circulating DNA), inflammation (CRP, IL-1β, IL-8, TNFα, IL-10), platelet activation (procoagulant microparticles, thrombin generation, fibin monomer) will be measured. A complete clinical and functional cardiovascular status will be documented in every participant.

Eligibility criteria: Inclusion Criteria:

* Male or Female ≥ 18 years
* Employee performing welding or airport operations
* free, informed and written consent
* Being affiliated to a social security system

Exclusion Criteria:

* Taking cardiovascular medications which modify endothelial function and / or coagulation (antiplatelet, antihypertensive, cardiotropic).
* People with a history of ischemic cardiovascular disease, thrombotic disease, chronic inflammatory disease
* Pregnant women
* People with health status would be likely, in the baseline state, to have parameters studied in the study disrupted.

Primary outcomes:
measure: Vascular reactivity
timeFrame: 1 day
Secondary outcomes:
measure: Coagulation activation
timeFrame: 1 day
measure: vascular inflammation
timeFrame: 1 day
measure: Impregnation of metals activation
timeFrame: 1 day
measure: Oxidative stress activation
timeFrame: 1 day
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
Clinical trial NCT03636139: Cognitive Control of Negative Stimuli in BPD
Official title: Effects of Transcranial Direct Current Stimulation on the Cognitive Control of Negative Stimuli in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 100
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: BASIC_SCIENCE

Brief summary: Borderline personality disorder (BPD) is characterized by impairments in the cognitive control of negative information. These impairments in cognitive control are presumably due to blunted activity of the dorsolateral prefrontal cortex (dlPFC) along with enhanced activations of the limbic system. However, the impact of an excitatory stimulation of the dlPFC still needs to be elucidated. In the present study, we therefore assigned 50 patients with BPD and 50 healthy controls to receive either anodal or sham stimulation of the right dlPFC in a double-blind, randomized, between-subjects design.


Eligibility criteria: Inclusion Criteria Borderline Personality Disorder:

* Diagnosis of borderline personality disorder

Exclusion Criteria Borderline Personality Disorder:

* Diagnosis of current or previous bipolar disorder
* Diagnosis of current substance dependency
* Diagnosis of current major depression
* Diagnosis of current or previous neurological disorders (e.g., epilepsy)
* Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

Inclusion Criteria Control Participants:

* No current or previous diagnosis of a mental disorder

Exclusion Criteria Control Participants:

* More than 2 criteria of borderline personality disorder are met
* Diagnosis of current or previous neurological disorders (e.g., epilepsy)
* Intake of psychotropic medication
* Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

Primary outcomes:
measure: Response latencies
timeFrame: Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03073239: Amyotrophic Lateral Sclerosis: a New Paradigm
Official title: Amyotrophic Lateral Sclerosis: a New Paradigm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Bulbar disfunction
Rik factors ALS
Lead sponsor: Conde, Bebiana, M.D.
Sponsor class: INDIV
First posted: 2017-03-08
Enrollment: 30
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 Amyotrophic Lateral Sclerosis sent to a medical consultation

Brief summary: Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment with most impact on the prognosis of ALS.

According to current knowledge, the clinical presentation of the disease is characterized by spinal or bulbar involvement, the latter being associated with a worse prognosis.

There are multiple factors described in the aetiology of ALS, as the successive damage the motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic mutations are also described, being associated to a higher prevalence of ALS.

Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per 100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this region are unknown.

Detailed description: The objective of this research is to pursue potentially involved genetic mutations in this disease (new or previously described), in addition to carry out a epidemiological questionnaire including data on personal history, environmental and occupational exposure that might be underlying this high prevalence.

Eligibility criteria: Inclusion Criteria:

* All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

Exclusion Criteria:

* Amyotrophic Lateral Sclerosis not confirmed
* Ages less than 18 years old

Primary outcomes:
measure: Finding environmental risk factor
timeFrame: 2 years
Secondary outcomes:
measure: Regional prevalence
timeFrame: 1 year
measure: Finding a genetic marker
timeFrame: 2 years
Other outcomes:
Locations:
city: Vila Real
country: Portugal
facility: Centro Hospitalar Tras-os-Montes e Alto Douro
Study officials:
affiliation: Centro Hospitalar Tras-os-Montes e Alto Douro
name: Bebiana Conde, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374439: Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents
Official title: Promoting Well-being in Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
adolescents
prevention
schools
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an interpersonal therapy program for preventing depressive symptoms in adolescents.

Detailed description: Hypothesis -- The cognitive-behavioral and interpersonal therapy prevention programs will be significantly better than the no-intervention control group in preventing depressive symptoms measured at post-intervention and at the 6-month follow-up. Gender differences also will be explored.

Eligibility criteria: Inclusion Criteria:

* All students in 9th grade Wellness classes who have parental consent

Exclusion Criteria:

* Students without parental consent

Primary outcomes:
measure: Children's Depression Inventory
timeFrame: 9 weeks
measure: Center for Epidemiological Studies - Depression scale
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Judy Garber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05170139: The Effects of Caffeine on Physical Performance of Ice Hockey Players
Official title: The Effects of Caffeine on Physical Performance of Ice Hockey Players: A Cross-over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Athletic Performance
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates. All participants will complete ice-hockey specific athletic tests in both conditions.
Primary purpose: TREATMENT

Brief summary: To date, only one study has evaluated the effect of caffeine supplementation on athletic performance in ice hockey players finding a lack of ergogenic effect. This lack of effect is surprising as caffeine has been suggested to be an effective and safe nutritional supplement to improve physical performance in both trained and untrained individuals. Therefore, the aim of the present study is to evaluate the effect of acute caffeine ingestion (3mg/kg body mass). Thirteen elite adult ice-hockey male players will perform specific ice hockey performance tests in two separate days. On both occasions players will ingest 330 ml of water with lemon powertabs isostar® (86 kcal / 19g of carbohydrates) tablets, which will include in one of these days 3 mg/kg body mass of anhydrous caffeine. Players will perform a 35-m sprint, an agility test (Weave agility - slalom with puck), and a reaction test.


Eligibility criteria: Inclusion Criteria:

* Over 18 years,
* Male
* Play in the Spanish ice hockey first division.

Exclusion Criteria:

* Participants taking drugs containing ephedrine or antibiotics.
* Having suffered a musculoskeletal injury in the 3 months prior to the tests.

Primary outcomes:
measure: 35m sprint time (Seconds)
timeFrame: One day (one hour post caffeine consumption)
measure: Agility test time (Seconds)
timeFrame: One day (one hour post caffeine consumption)
measure: Reaction test time (seconds)
timeFrame: One day (one hour post caffeine consumption)
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
References:
Clinical trial NCT01227239: Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
Official title: A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rectal Carcinoma
Lead sponsor: Japan Clinical Cancer Research Organization
Sponsor class: OTHER
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2010-10-25
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.

The purpose of this study is as follows,

* In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
* In phase II, to evaluate the antitumor effect (pCR rate) and the safety .


Eligibility criteria: Inclusion Criteria:

1. Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
2. Possible to R0 resection
3. Received no prior therapy
4. Performance status (ECOG) 0-1
5. Normal organ and marrow function.
6. Sufficient oral intake

Exclusion Criteria:

1. History of serious allergic reaction
2. Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
3. Female with pregnancy or lactation
4. Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment

Primary outcomes:
measure: Phase I: Determine the Recommended dose (RD)
timeFrame: 10 weeks
measure: Phase II: pathological complete response rate
timeFrame: 12-16 week
Secondary outcomes:
measure: R0 resection rate
timeFrame: 12-16 weeks
measure: down staging rate
timeFrame: 12-16 weeks
measure: local reccurence rate
timeFrame: 3 years
measure: desease free survuval
timeFrame: 3 years
measure: safety
timeFrame: 16-20 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Graduate School of Medicine
city: Osaka
country: Japan
facility: Osaka Medical College
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo University
city: Tokyo
country: Japan
facility: Cancer Institute Hospital
city: Tokyo
country: Japan
facility: Teikyo University
Study officials:
affiliation: Tokyo University
name: Toshiaki Watanabe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishihara S, Matsusaka S, Kondo K, Horie H, Uehara K, Oguchi M, Murofushi K, Ueno M, Mizunuma N, Shinbo T, Kato D, Okuda J, Hashiguchi Y, Nakazawa M, Sunami E, Kawai K, Yamashita H, Okada T, Ishikawa Y, Nakajima T, Watanabe T. A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial). Radiat Oncol. 2015 Jan 23;10:24. doi: 10.1186/s13014-015-0333-8.
Clinical trial NCT05297539: Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis: (LOARAL 2)
Official title: Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Surgery
Rehabilitation
Point Light Display
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The LOARAL 2 project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into three groups: a control group where patients will do standard rehabilitation associated with the judgments of videos represented non-human action and two experimental groups where patients will do standard rehabilitation associated with the judgement of human point-light display. The aim of this study is to measure the benefits of attentional focus and sex correspondence in the use of point-light display for the rehabilitation of patients with a total arthroplasty of the knee.


Eligibility criteria: Inclusion Criteria:

* Volunteers over 18 years of age who have undergone knee surgery

Exclusion Criteria:

* Any locomotor condition not due to knee surgery
* Uncorrected visual disturbances
* Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)

Non randomization criteria:

* Cognitive disorders (Mini Mental State Examination \<21)
* Depressive disorders (Beck Inventory index\> 9)

Primary outcomes:
measure: The score obtained on the Western Ontario and McMaster (WOMAC) test at inclusion and at the end of the program.
timeFrame: Rehabilitation during 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire Poitiers
Study officials:
References:
Clinical trial NCT01829139: Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
Official title: A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Common Bile Duct Stones
Gallbladder in Situ
Choleretics
Biliary Complications
Keywords: Common bile duct stone
Gallbladder in situ
Choleretics
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We randomized patients (\>18 years of age) who underwent therapeutic endoscopic biliary sphincterotomy and/or balloon dilation for the complete clearance of their bile duct stones.

Brief summary: In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.


Eligibility criteria: Inclusion Criteria:

* Complete clearance of CBD stones
* No definite GB stones
* Agree with the study protocol

Exclusion Criteria:

* \< 18 years of age
* Concomitant IHD stones
* Combined malignancy with a limted life span
* Prior cholecystectomy state
* refusal to agree to the study protocol

Primary outcomes:
measure: Complications
timeFrame: two year
Secondary outcomes:
measure: Natural outcomes
timeFrame: two year
measure: Other adverse events
timeFrame: two year
Other outcomes:
measure: Drug-related adverse event
timeFrame: three months
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungcheongnam-do
Study officials:
References:
Clinical trial NCT02753439: Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
Official title: Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Geistlich Pharma AG
First posted: 2016-04-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.

Detailed description: 40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "Bio-Oss" xenograft.

Post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.

Eligibility criteria: Inclusion Criteria:

* Bilateral impacted 3rd molars.
* Healthy individuals

Exclusion Criteria:

* Smokers
* Alcohol abusers
* Pregnancy

Primary outcomes:
measure: Mobility (Scale 0,1,2,3), change is being assessed.
timeFrame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
measure: Pocket Depth (mm), change is being assessed.
timeFrame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: