louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03845387: A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Official title: A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.


Eligibility criteria: Inclusion Criteria:

* Japanese patients
* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
* Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion Criteria:

* Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
* Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
* Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points

Primary outcomes:
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
timeFrame: 12 weeks
measure: Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Naomi Koshihara
role: STUDY_DIRECTOR
References:
Clinical trial NCT01830387: Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy
Official title: Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Polymetric Clips (Hem-o-Lok)
Laparoscopic Appendectomy
Endoscopic Staplers
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, aged 18 years of age or older, scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Brief summary: The purpose of this study is to compare the clinical outcomes and the operative costs of appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers. Prospective data will be collected before, during, and after surgery on patients undergoing a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at Duke Regional Hospital. Retrospective data will be collected from patients who had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open appendectomy to compare outcomes.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Exclusion Criteria:

1. Less than 18 years of age
2. Signs of appendiceal rupture or abcess on preoperative imaging studies (CT or ultrasound)
3. Inability to provide informed consent

Primary outcomes:
measure: Length of stay
timeFrame: Subjects will be followed for the duration of their hopsital stay, an expected average of 2-3 days.
measure: Total Hospital Charges
timeFrame: Financial data will be gathered for the duration of the subjects hospital stay, an expected average of 2-3 days.
measure: Operative time
timeFrame: Length of operation is approximately one and a half hours
Secondary outcomes:
measure: Rates of Surgical Outcomes
timeFrame: Immediatly Postoperative to 30 days postoperative
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Metabolic and Weight Loss Surgery
state: North Carolina
Study officials:
affiliation: Duke University
name: Chan Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04114487: Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
Official title: Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Rehabilitation
Keywords: Cognitive rehabilitation
Dual task
Balance
Motor skills
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The 45-person study group will be randomized to 3 groups of 15 persons each. The first group will not be subjected to any application except education. The second group will be the control group and will be taken to the balance training in addition to normal education. In the third group, dual task balance training will be applied within the scope of cognitive rehabilitation.
Primary purpose: OTHER

Brief summary: With this study, it will be tried to determine whether the addition of physiotherapy program to the education of mentally disabled individuals is effective and necessary in terms of mental performance.

Detailed description: Mental disability levels IQ = 50-79 individuals with mild / border mental disabilities will be included in the study. The disability status of the individuals will be determined by the health report, and the cognitive status of the individuals will be determined by the report given as a result of the evaluation made by the Guidance Research Centers of the National Education Directorates. The 45-person study group will be randomized to 3 groups of 15 persons each. The first group will not be subjected to any application except education. The second group will be the control group and will be taken to the balance training in addition to normal education. In the third group, dual task balance training will be applied within the scope of cognitive rehabilitation

Eligibility criteria: Inclusion Criteria:

* IQ 50-79
* 6-14 years old
* take command of Turkish
* do not have physical disability
* not have metabolic and systemic disease
* To have a report on the mental disability and education required by the Ministry of National Education

Exclusion Criteria:

* To have any situation that prevents the taking of commands related to the exercise program to be implemented
* To have a chronic systemic disease
* To have an educational diagnosis other than the mental disability

Primary outcomes:
measure: cognitive functions
timeFrame: 3 months
Secondary outcomes:
measure: motor functions
timeFrame: 3 months
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Ebrar Atak
Study officials:
affiliation: Gerçek Dünya special education and rehabilitation center
name: Ebrar Atak, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896687: Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
Official title: A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: nonspecific low back pain
chronic low back pain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.

Detailed description: This pilot study will evaluate the feasibility of the experimental protocol and provide sufficient pilot data to estimate statistical power and sample size requirements. The study will include 30 individuals (15 per group) diagnosed with persistent low back pain who will receive a standard protocol of Scrambler therapy or sham treatment. Participant data will include subjective measures of low back pain, pain sensitivity using quantitative sensory testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to treatment) and 1 and 3 weeks post-treatment.

Eligibility criteria: Inclusion Criteria:

* be 18-50 years of age
* diagnosed with persistent nonspecific LBP
* comprehend English

Exclusion Criteria:

* \<18 or \>50 years of age
* chronic pain at another site or associated with a painful condition
* pregnant or within 3 months post-partum
* implanted drug delivery system
* heart stents or metal implants such as pacemakers, automatic defibrillator, aneurysm clips, vena cave slips, or skull plates
* history of myocardial infarction or ischemic heart disease within the past six months
* history of epilepsy
* skin conditions such as open sores that would prevent proper application of electrodes

Primary outcomes:
measure: Worst Low Back Pain Score
timeFrame: baseline to 3 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Nursing
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University School of Nursing
name: Angela Starkweather, PhD, ACNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare(R): results from a double-blinded randomized sham-controlled study. Res Nurs Health. 2015 Feb;38(1):29-38. doi: 10.1002/nur.21632. Epub 2015 Jan 8.
Clinical trial NCT01972087: Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest
Official title: Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-10-30
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is to test the use of simulation training to improve 9-1-1 telecommunicators' call processing and response. Training sessions will expose 9-1-1 telecommunicators to several realistic emergency situations through mock 9-1-1 calls with a trained actor playing the part of a reporting party, followed immediately by feedback on call handling provided by a trained call observer. Investigators hypothesize that simulation followed by trained observer-directed feedback will increase correct triage of medical emergency and delivery of pre-arrival instructions during simulated calls and in actual 9-1-1 calls.


Eligibility criteria: Inclusion Criteria: 9-1-1 call-center call receivers. -

Exclusion Criteria:

-

Primary outcomes:
measure: Change in elapsed seconds from call answer to start of telephone-cardiopulmonary resuscitation (T-CPR) instructions in cardiac arrest calls in simulations and in actual calls.
timeFrame: Once monthly over 4 months (during simulations); at event (actual cardiac arrest 9-1-1 call) over 12 months.
Secondary outcomes:
measure: Change in proportion of calls with querying behaviors compliant with the "all-callers" interviewing protocol.
timeFrame: Once monthly over 4 months (during simulations); at event (actual cardiac arrest 9-1-1 call) over 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Hendrika Meischke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stangenes SR, Painter IS, Rea TD, Meischke H. Delays in recognition of the need for telephone-assisted CPR due to caller descriptions of chief complaint. Resuscitation. 2020 Apr;149:82-86. doi: 10.1016/j.resuscitation.2020.02.013. Epub 2020 Feb 20.
citation: Meischke H, Painter IS, Stangenes SR, Weaver MR, Fahrenbruch CE, Rea T, Turner AM. Simulation training to improve 9-1-1 dispatcher identification of cardiac arrest: A randomized controlled trial. Resuscitation. 2017 Oct;119:21-26. doi: 10.1016/j.resuscitation.2017.07.025. Epub 2017 Jul 29.
citation: Meischke H, Painter I, Turner AM, Weaver MR, Fahrenbruch CE, Ike BR, Stangenes S. Protocol: simulation training to improve 9-1-1 dispatcher identification of cardiac arrest. BMC Emerg Med. 2016 Feb 1;16:9. doi: 10.1186/s12873-016-0073-6.
Clinical trial NCT01727687: Investigation of Road-crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians
Official title: An Investigation of Road Crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: To asses the training effects on traffic safety between normal and patients with Parkinson's disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: As society ages, a large amount of human factors related research has been carried out into the subject of the safety of the elderly in their daily lives. However, most research focuses on the general elderly population and there is a serious lack of research into elderly sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in medical circles. In the investigators previous study, the investigators have found that patient with PD had decreased ability to cross the road as compared to age/gender matched control subjects. Hence, this research proposed several training programs to enhance the safety of crossing road, including safe place finding，roadside search，time gap and perception of other's intentions. The investigators will compare the parameters of crossing road ability before and after training programs in patients with PD and control subjects.

The results of this research will clarify the correlation between medical scale test indicators and movement safety for patients with PD. The effects of training programs will be provided for further safety management and design concepts to improve the lives of this disease group.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease
* Age between 18-80 years
* Patients signed the consent form

Exclusion Criteria:

* Patients with atypical parkinsonism

Primary outcomes:
measure: The parameters of cross road
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Hsien Lin, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03615287: Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases
Official title: Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients

Brief summary: The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

Detailed description: The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

In particular, three subject groups will be enrolled, as follows:

40 patients \[Crohn's disease (CD) \& ulcerative colitis (UC)\] who will undergo medical treatment (Group A), 40 patients (CD \& UC) who will undergo surgery (Group B) and a healthy control group (Group C) comprising 40 subjects.

Assessment of the inflammation load (CRP, WBC, IL-6, TNFa), the endothelial function (FMD, PWV, cIMT, endothelial glycocalyx) and the cardiac function - via echocardiographic parameters (systolic and diastolic echo values, tissue doppler imaging-GLS-strain rate) - will be carried out for every subject group in two phases: prior to treatment and four months after the treatment, as applicable.

The objective is to investigate whether there is a statistically significant reduction of endothelial and cardiac dysfunction following medical and surgery treatment in IBD patients as well as to examine associations across the three groups.

Eligibility criteria: Inclusion Criteria:

* Patients with IBD diagnosed \> 6 months via biopsy confirming the diagnosis
* Patients with IBD at an advanced \& non-controllable phase (IBD scores,clinical status, endoscopic and biochemical values) requiring the initiation of a new medical treatment or surgical intervention.

Exclusion Criteria:

* Coronary Artery Disease
* Peripheral Arterial Disease
* Thromboembolic Disease (acute or chronic)
* Heart failure of any cause
* Valvular Disease
* Congenital Heart Defect
* Heart Rhythm Disorder
* Stroke, Renal or liver failure, malignancy, endocrine disorder
* Other autoimmune disorder or angiitis
* IBD diagnosed \< 6 months
* BMI \> 40 Kg/m2

Primary outcomes:
measure: Change of CFR
timeFrame: Just before treatment and four (4) months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: ''Attikon'' University General Hospital
state: Attiki
Study officials:
affiliation: 2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece
name: Ioannis Papaconstantinou, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00978887: Retorna Facial Cream in the Treatment of Facial Wrinkles
Official title: Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Wrinkles
Keywords: Facial cream
natural product
facial wrinkles
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 148
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of Retorna facial cream usage in the reduction or total correction of facial wrinkles. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be recruited and randomized for the study is 148. Occurrence of adverse effects will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Facial wrinkles
* Signed informed consent
* Given verbal agreement on solar exposure prevention within hours of intense solar radiation (10 am - 4 pm) by the usage of physical protection methods such as umbrellas, caps and hats.

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Use of steroids within 6 months.
* Patients under other experimental treatment
* Decompensated concomitant diseases
* Malignant neoplastic conditions.
* Alcoholism
* Handicap and/or psychiatric condition preventing treatment accomplishment.

Primary outcomes:
measure: Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
measure: Presence of adverse effects within the 4 week treatment period
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Commander Manuel Fajardo Rivero" Hospital
state: Havana
Study officials:
affiliation: "Commander Manuel Fajardo Rivero" Hospital
name: Jose Dominguez Gómez, MD
role: PRINCIPAL_INVESTIGATOR
References: