louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03447444: Music and Physical Activity in Persons With Dementia
Official title: Dignity for Persons With Dementia and Signs of Frontotemporal Affection in Institutions.See us and Dance With us
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Frontal
Keywords: dignity
music therapy
physical activity
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case studies
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (\>65). People with neuronal degeneration in frontal and temporal lobes demonstrate a decline in social conduct, apathy, loss of insight that is gradual and progressive. Family members often experience guilt and shame because of the patients' behavior before institutionalization, and different behavioral disorders will cause great challenges to family caregivers and to staff after institutionalization. Preservation of dignity, both in regards to the person being affected, and their relatives, therefore seem highly relevant both before and after institutionalization.

Detailed description: The purpose of this study was to evaluate whether a combined intervention of physical activity and music therapy could reduce restlessness, irritability, and aggression among institutionalized people with severe dementia. An exploratory design was used to evaluate a combined intervention of physical activity, music therapy, and in- or outdoors walking daily, systematically implemented for eight weeks for persons with severe dementia in institutional care.

Eligibility criteria: Inclusion Criteria:Persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home

-

Exclusion Criteria:

-

Primary outcomes:
measure: Brøset Violence Checklist
timeFrame: change from baseline to eight weeks into intervention
Secondary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Dagfinn Nåden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00397644: Assisting Low-Income Families at Pediatric Well-Child Care Visits
Official title: Enhancing a Medical Home for Vulnerable Children by Addressing Family Psychosocial Problems at Well-Child Care Visits: THE WE CARE Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low-income Children's Well-child Care Visit
Keywords: pediatrician
well-child care visit
low-income children
family psychosocial problem
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Commonwealth Fund
First posted: 2006-11-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.

Detailed description: Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity. Pediatric guidelines that pediatricians should be discussing and assisting these families. However, to date few routine do. The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.

Eligibility criteria: Inclusion Criteria:

* Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic

Exclusion Criteria:

* Non-English speaking
* Foster parents
* Previously enrolled parent
* No access to telephone

Primary outcomes:
measure: Discussion of family psychosocial problem
measure: Referral of family psychosocial problem
measure: Contacting community resources
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harriet Lane Clinic at Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Arvin Garg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Janet Serwint, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
citation: Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
Clinical trial NCT00515944: Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: No condition
healthy volunteers
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-08-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes local weakening. Botulinum toxin type A is used for certain neurological and aesthetic treatments. This study will investigate the migration potential of Xeomin®.

Detailed description: Conducted in Europe

Eligibility criteria: Inclusion Criteria:

* Healthy females, 18 to 65 years

Primary outcomes:
measure: Measurement of area
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Merz Pharmaceuticals GmbH
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT03297944: Sedative-Anxiolytic Effects on Simulated Driving Performance
Official title: Alprazolam and Simulated Driving Performance: Next Day Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psychomotor Impairment
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.


Eligibility criteria: Inclusion Criteria:

* valid driver's license
* english-speaking and literate

Exclusion Criteria:

* using daily medication for chronic condition
* acute narrow angle glaucoma
* previous adverse experience with study drugs
* experiences motion sickness in response to driving simulator
* BMI \> 30
* women who are pregnant, lactating, or planning on becoming pregnant
* regular use of tobacco products
* current substance use disorder
* clinically significant ECG
* current ongoing psychiatric disorder

Primary outcomes:
measure: Standard Deviation of Lane Position (SLDP)
timeFrame: 16 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Center on Drug and Alcohol Research
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Marion Coe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575444: Cervical Cancer Screening Project Part C
Official title: Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Cancer
Keywords: Pap test
HPV testing
cervical cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Somali female - Participants may speak Somali or English as their primary language.

Brief summary: This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

Detailed description: The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Eligibility criteria: Inclusion Criteria:

* Somali female age 25-70 years

  * have lived in the U.S. 10 years or less
  * have not had a Pap test (by self report) in the last 3 years

Exclusion Criteria:

* Women with a self reported past history of any of the following will not be eligible:

  * total hysterectomy
  * cervical cancer
  * active history of cervical dysplasia

Primary outcomes:
measure: Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test
timeFrame: Within 3 months after Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Rahel Ghebre, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02345044: A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Keywords: Essential hypertension
mineralocorticoid receptor antagonist
CS-3150
Japanese
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 426
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and \< 180 mmHg, Sitting DBP ≥ 90 mmHg and \< 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L
* Reversed day-night life cycle including overnight workers
* eGFR \< 60 mL/min/1.73 m\^2

Primary outcomes:
measure: Change from baseline in sitting systolic and diastolic blood pressure
timeFrame: baseline to end week 12
Secondary outcomes:
measure: Change from baseline in 24-hr blood pressure (ABPM)
timeFrame: Baseline to end week 12
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
References:
Clinical trial NCT00037544: Study Evaluating ReFacto AF in Severe Hemophilia A
Official title: An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Severe
Hemophilia
A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.


Eligibility criteria: Inclusion Criteria:

* Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
* Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
* Age greater than or equal to 12 years
* History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
* Adequate laboratory results

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressive drugs
* Current or historical Factor VIII inhibitor
* Treatment with any investigational drug or device within the past 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02194244: Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662
Official title: A Randomized, Open-Label, Four Period, Four-Treatment Crossover Study to Investigate the Comparative Bioavailability of Film-Coated Tablet and Granule Formulations of RG1662 Under Fed and Fasted Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized, four-period, four-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers, 18 to 60 years of age, inclusive

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Primary outcomes:
measure: Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
timeFrame: Up to 9 weeks
measure: Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
timeFrame: Up to 9 weeks
measure: Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
timeFrame: Up to 9 weeks
measure: Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
timeFrame: Up to 9 weeks
Secondary outcomes:
measure: Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
timeFrame: Up to 9 weeks
measure: Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
timeFrame: Up to 9 weeks
measure: Palatability of the granule formulation, as assessed by questionnaire
timeFrame: Day 1, Day 3 in granule administration periods
measure: Safety: Incidence of adverse events with either formulation
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02967744: NSAID Treatment of Patients With Osteoarthritis
Official title: BEVAR: Patientspecifik Behandling Ved Artrose - Et "Proof-of-concept"- Kvalitetssikringsstudie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis,Knee
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed Knee Ostoarthritis

Exclusion Criteria:

* Current ulcer diagnosed by endoscope
* Asthma or other allergic reaction to NSIADs
* Kidney disease
* Myocardial infarction within the last six months
* Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg)
* Severe thrombocytopenia (thrombocyst count \<50x10\^9/l)
* Insufficience lever or kidney function

Primary outcomes:
measure: Pain intensity measured on a 10cm visual analog scale
timeFrame: 8 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg East
country: Denmark
facility: Center for Sensory Motor Interaction, Aalborg University
Study officials:
References:
Clinical trial NCT05006144: Effects of Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy
Official title: Effects of Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Cerebral Palsy
Keywords: Bilateral Cerebral Palsy
Selective dorsal rhizotomy
segmental trunk control
Motor development
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.

Detailed description: increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.

selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy

Eligibility criteria: Inclusion Criteria:

* CP, spastic diplegia
* 4-7 years of age
* On Level IV-V on Gross Motor Function Classification System
* At least six months after the last Botulinum toxin A injection in the lower extremities
* Average intelligent quotient according to medical records for active participation
* Partial trunk control (sitting with support).

Exclusion Criteria:

* Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
* Ankle clonus
* Exaggerated deep tendon reflex in the legs
* Babinski sign;
* Moderate to severe signs of dystonia, athetosis or ataxia.

Primary outcomes:
measure: Segmental trunk control
timeFrame: period of the treatment was 4 successive months
measure: Gross motor function
timeFrame: period of the treatment was 4 successive months
Secondary outcomes:
measure: upper extremity function
timeFrame: period of the treatment was 4 successive months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amira Mahmoud Abd-elmonem
Study officials:
affiliation: PhD of physical therapy for pediatrics, faculty of physical therapyCairo university
name: Hazem A Aly, Phd
role: STUDY_CHAIR
affiliation: Department of neurosurgery, faculty of medicine , Alexandria university
name: Ahmed rabie, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01204944: Swiss Transplant Cohort Study
Official title: Swiss Transplant Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: All Transplanted Individuals in Switzerland
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Bern
name: University of Basel
name: University of Lausanne
name: Cantonal Hospital of St. Gallen
name: University of Geneva, Switzerland
First posted: 2010-09-17
Enrollment: 7500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All transplanted indivduals in Switzerland

Brief summary: The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all patients after solid organ and stem cell transplantation since 5/2008 in Switzerland. Predefined variables are collected at defined time points. Individual samples (PBMC, plasma, DNA) will be stored for future projects. Data relevant to transplantation outcome with emphasis on immunological and infectious complications as well as psychosocial variables will be gathered.


Eligibility criteria: Inclusion criteria:

* All patients after organ and stem cell (planned 2009) transplantation.

Exclusion criteria:

* No informed consent given

Primary outcomes:
measure: Outcome after transplantation
timeFrame: open
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Branca-Dragan S, Koller MT, Danuser B, Kunz R, Steiger J, Hug BL. Evolution of disability pension after renal transplantation: methods and results of a database linkage study of the Swiss Transplant Cohort Study and Swiss Disability Insurance. Swiss Med Wkly. 2021 Sep 23;151:w30027. doi: 10.4414/smw.2021.w30027. eCollection 2021 Sep 13.
citation: Krisl A, Stampf S, Hauri D, Binet I, Mueller T, Sidler D, Hadaya K, Golshayan D, Pascual M, Koller M, Dickenmann M, The Swiss Transplant Cohort Study Stcs. Immunosuppression management in renal transplant recipients with normal-immunological risk: 10-year results from the Swiss Transplant Cohort Study. Swiss Med Wkly. 2020 Dec 5;150:w20354. doi: 10.4414/smw.2020.20354. eCollection 2020 Nov 30.