louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03035240: Finances First: A Health Intervention in Low Income Single Mother Households
Official title: Finances First: A Health Intervention in Low Income Single Mother Households. A Prospective, Randomized, Controlled Trial to Assess the Effect of Financial Education on Health Outcomes in Single Mother Households.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Financial Stress
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 345
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized, controlled three-year study is to compare the effect of a year-long financial education program versus usual care on health outcomes in single mother low income households.


Eligibility criteria: Inclusion Criteria:

* Unmarried
* Currently employed
* Annual salary must be less than 200% of the Federal Poverty Guideline
* Supporting at least one child at home
* Able to read and speak either English or Spanish

Exclusion Criteria:

* Currently abusing alcohol or recreational drugs
* Currently living in a domestic violence situation
* Pregnant or planning to become pregnant in the next year

Primary outcomes:
measure: Changes in Quality of Life as measured by the WHO QOL BREF survey
timeFrame: Baseline and one year later
measure: Weight loss
timeFrame: Baseline and one year later
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Professor
name: Kathleen Packard, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Nicole White, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04621344: Complications After Endosonography and Guided Bronchoscopy
Official title: 30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Bronchoscopy
Keywords: Endosonography
Guided bronchoscopy
Complications
Hospital admission
Lung cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication to guided bronchoscopy, endosonography, or both-

Brief summary: The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years,
* Indication to undergo bronchoscopy, endosonography, or both.
* Signed informed consent

Exclusion Criteria:

* Absolute contraindications to the bronchoscopic examination based on international guidelines \[31\].
* Platelet count \<50000

Primary outcomes:
measure: Incidence of severe complications
timeFrame: 30 days
Secondary outcomes:
measure: Overall incidence of complications
timeFrame: 30 days
measure: Risk factors associated with severe complications
timeFrame: 30 days
measure: Rate of unplanned hospital admissions
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli IRCS, Università Cattolica del Sacro Cuore
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01984944: Characterisation of Circadian Rhythm in Autistic Spectrum Disorder
Official title: Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: circadian rhythm
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Henri Mondor University Hospital
name: Albert Chenevier Hospital (Department of Psychiatry)
name: Hopital Universitaire Robert-Debre
name: Pasteur Institute (Cognitive Function and Human Genetic)
name: Fondation FondaMental
First posted: 2013-11-15
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.


Eligibility criteria: Inclusion Criteria:

* Patients with autistic spectrum disorders
* At least 6 years old
* Membership of a social security scheme
* Informed consent signed by the patient or both holders of parental authority if the subject is a minor, or by a guardian if the subject is under guardianship

Exclusion Criteria:

* Recent sleep symptoms
* Incapacity to keep rested for 24 hours

Primary outcomes:
measure: Urinary sulfatoxymelatonin secretion
timeFrame: The determination will be performed at 14 days ( child)
measure: Urinary sulfatoxymelatonin secretion
timeFrame: The determination will be performed at 21 days ( adults)
Secondary outcomes:
measure: Core body temperature rhythm
timeFrame: The determination will be performed at 5 days (adult)
measure: Circadian rhythms assessed with actometer
timeFrame: The determination will be performed at 14 ( child) and 21 days (adult)
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Xavier DROUOT, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03642444: Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
Official title: Replacing Canes With an Elasticated Orthotic-garment in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
hemiplegia
Lead sponsor: Technical University of Bern
Sponsor class: OTHER
Collaborators: name: Bildungszentrum Gesundheit Basel-Stadt
name: Rehab Basel
First posted: 2018-08-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: N-of-1 series
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of an elasticated orthotic garment "Thera Togs" on walking ability and balance in currently cane using chronic stroke subjects (minimum 6 months post stroke) using a series of N-of-1 Trials.

Detailed description: Aim: To investigate the effect of replacing canes with an elasticated orthotic-garment on gait and balance in chronic stroke subjects.

Design Experimental, multiple baseline N-of-1 series with an ABC design with randomised period duration.

Participants Four cane using chronic stroke subjects. Interventions Phase A (9-12 weeks) usual cane-walking to establish baseline values; Phase B (9-19 weeks) intervention: orthotic-garment worn throughout the day with maximal cane reduction; Phase C (9-10 weeks) individually determined follow-up: either no walking-aid, orthotic-garment or cane.

Weekly measurement of Outcome Measures for gait and balance function

Eligibility criteria: Inclusion Criteria:

* Chronic stroke (\> six months since last stroke)
* Independent cane walkers. Subjects usually use canes to walk inside (this could be intermittent changing from cane to holding furniture etc.) and always when outside
* A Mini Mental Score of 22 or above.

Exclusion Criteria:

* Patients at risk of falling identified as a Berg Balance Score ≤42/56

Primary outcomes:
measure: Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
timeFrame: Post intervention up to 28 weeks (on average 21.5 weeks)
Secondary outcomes:
measure: Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)
timeFrame: Post intervention up to 28 weeks (on average 21.5 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: Maguire CC, Sieben JM, Lutz N, van der Wijden G, Scheidhauer H, de Bie R. Replacing canes with an elasticated orthotic-garment in chronic stroke patients - The influence on gait and balance. A series of N-of-1 trials. J Bodyw Mov Ther. 2020 Oct;24(4):203-214. doi: 10.1016/j.jbmt.2020.06.006. Epub 2020 Jul 30.
Clinical trial NCT02712944: Testosterone Replacement in Renal Failure
Official title: Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypogonadism
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the effect of testosterone replacement in men with renal failure (on dialysis) who also have low testosterone. Specifically, the investigators will assess the change in requirement of Erythropoietin Stimulating agents.

Detailed description: Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.

Eligibility criteria: Inclusion Criteria:

1. Men between ages of 18-80 years of age.
2. Renal failure on hemodialysis
3. Free testosterone \<5 ng/dl.
4. Willing to be randomized to intramuscular (IM) testosterone or placebo
5. Currently getting intravenous Epoetin alfa

Exclusion Criteria:

1. Use of testosterone treatment currently or in the past 6 months, including use of over the counter androgen containing health supplements.
2. Congestive heart Failure, class III or IV.
3. Baseline hemoglobin of \> 12 g/dl.
4. Allergic reactions to testosterone Vehicle (i.e. Peanut oil)
5. prostate specific antigen\>4 ng/ml.
6. History of Prostate Cancer.
7. Liver enzymes \>twice the upper limit of normal.
8. HIV or hepatitis C.
9. Severe untreated obstructive sleep apnea (defined as apnea-hypopnea index\> 30).
10. Subjects on warfarin or other blood thinners.
11. Active infection (such as foot ulcer)
12. History of adverse events with testosterone use in past.

Primary outcomes:
measure: Change in dosage of Erythropoietin stimulating agents (ESA)
timeFrame: primary outcome will be measured at months 5 and 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Odessa
country: United States
facility: TTUHSC-Permian Basin
state: Texas
Study officials:
affiliation: TTUHSC
name: Sandeep Dhindsa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046044: Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction
Official title: Comparing the Effects of Digoxin and Ivabradine on Mortality and Morbidity in Chronic Heart Failure With Reduced Ejection Fraction and Sinus Rhythm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart failure
Digoxin
Ivabradine
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.

Detailed description: Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.

Eligibility criteria: 1. Inclusion Criteria:

   * Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
   * Sinus rhythm with heart rate of 70 beats per minute or higher
   * Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV
2. Exclusion Criteria:

   * Chronic renal failure with glomerular filtration rate \<30 ml/min
   * Atrial fibrillation
   * Pace maker rhythm
   * Advanced stage chronic obstructive lung disease
   * Comorbidity with expected survival below 1 year

Primary outcomes:
measure: Cardiac function and functional status and biochemical parameters
timeFrame: After 6 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: Up to 6 months
measure: All cause mortality
timeFrame: Up to 6 months
measure: Hospital admission for worsening heart failure
timeFrame: Up to 6 months
measure: Heart rate and blood pressure
timeFrame: After 6 months
Other outcomes:
measure: Hospitalization for a cardiovascular reason
timeFrame: Up to 6 months
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Kurtulus Karauzum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04448444: Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Official title: Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuronal Plasticity
Multiple Sclerosis
Rehabilitation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
Primary purpose: TREATMENT

Brief summary: Imaging methods bring new possibilities for describing the brain plasticity processes that underly the improvement of clinical function after physiotherapy in people with multiple sclerosis (pwMS). The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.

Detailed description: The study was designed as parallel group randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.

MS patients were examined by fMRI (primary outcomes) and clinical tests (secondary outcomes) at the beginning of study. Then, they were randomly divided into two groups (by drawing lots in a 1:1 ratio). The first group underwent Vojta reflex locomotion (VRL), and the second Motor Program Activating Physiotherapy (MPAT). The length and intensity of treatment was the same in both groups (two months, one hour twice a week). After the treatment, a clinical and fMRI examination was performed. Healthy volunteers underwent an fMRI examination that was considered to be a control.

Eligibility criteria: Inclusion Criteria:

* definite MS
* stable clinical status in the preceding 3 months
* imuno-modulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab)
* Expanded Disability Status Scale (EDSS)≤6
* predominant motor impartment
* six months or more without any physiotherapy
* ability to undergo ambulatory physiotherapy

Exlusion criteria:

-other neurological disease or conditions disabling movement

Primary outcomes:
measure: Brain activity
timeFrame: 0 month
measure: Brain activity
timeFrame: 0 and 2 months
Secondary outcomes:
measure: Nine Hole Peg Test - NHPT
timeFrame: 2 months
measure: Paced Auditory Serial Addition Test - PASAT
timeFrame: 2 months
measure: Berg Balance Scale - BBS
timeFrame: 2 months
measure: Timed 25 Foot Walk - T25FW
timeFrame: 2 months
measure: Timed Up and Go - TUG
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Third Faculty of Medicine Charles University
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04152044: Obesity and Liver Function in Oesophageal Cancer
Official title: Elucidating the Role of Obesity, Liver Function and Pathology With Overall Outcomes in Oesophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Liver Function
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 658
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oesophageal cancer patients

Brief summary: There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

Detailed description: Oesophageal cancer rates are increasing as a result of obesity in Western society. Thr investigators are evaluating the influence of viscerala dn subcutaneous obesity on overall outcomes of the participants. In addition the investigators are evaluating if there is a correlation with Liver Function Tests and liver histopathology such as steatosis on survival in participants and post operative sequele.

Eligibility criteria: Inclusion Criteria:

* Those undergoing oesophagectomy

Exclusion Criteria:

* patients who only had chemotherapy/chemoradiotherapy without surgery

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
measure: Disease free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital
state: IE
Study officials:
References:
Clinical trial NCT01583244: Korean Post-marketing Surveillance for Orencia®
Official title: Korean Post-marketing Surveillance for Orencia®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-04-23
Enrollment: 701
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

Brief summary: The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Detailed description: Time Perspective: Prospective / Retrospective(On-treatment)

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA

Or

* Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA

Exclusion Criteria:

* Children aged \<6 years
* Pregnant or lactating women
* Patients who are participating in another study
* Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
* Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
* Patients who have a positive hepatitis virus test
* Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug

Primary outcomes:
measure: Adverse events occurrence
timeFrame: 30 days after last dose of study drug
Secondary outcomes:
measure: Number of Adverse Events and Serious Adverse Events
timeFrame: 30 days after last dose of study drug
measure: Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity
timeFrame: 24 weeks of registration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.