louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01632176: A Brief Intervention
Official title: A Brief Intervention to Prevent Adolescent Dating Aggression Perpetration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dating Violence
Dating Abuse
Keywords: dating abuse
dating violence
domestic violence
sexual violence
sexual assault
youth violence
underage alcohol use
alcohol use
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-07-02
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial (RCT) study is a small scale test of the feasibility and preliminary efficacy of a brief motivational interview-style intervention. The intervention took place in the pediatric emergency departments by a trained interventionist and will followed an intervention algorithm developed by a team of dating abuse and brief intervention experts. The research design is as follows: the investigators will randomize youth ages 12-19 years old to one of two groups: one group who receives the intervention (N=\~18), and the other which does not (N=\~18). The investigators compared changes in outcomes from baseline to 1-month follow-up for those in both groups. The investigators looked at outcomes including dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization).

Statement of study hypothesis: Youth who receive the intervention will show improvements in dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while those in the comparison group will show no similar change.


Eligibility criteria: Inclusion Criteria:

* 15-19 years old
* English-speaking
* Have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months

Exclusion Criteria:

* Patient's reason for ED visit is an acute mental health problem (e.g., suicidal ideation or attempt, severe anxiety attack)
* Patient is a prisoner
* Patient is determined to be potentially lethal
* Patient attends batterer intervention classes

Primary outcomes:
measure: Dating abuse perpetration
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Emily F Rothman, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rothman EF, Wang N. A feasibility test of a brief motivational interview intervention to reduce dating abuse perpetration in a hospital setting. Psychol Violence. 2016 Jul;6(3):433-441. doi: 10.1037/vio0000050. Epub 2016 Mar 24.
Clinical trial NCT03439176: Investigating the Adhesion of New Adhesive to the Skin
Official title: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The adhesion of the new adhesive strips is investigated on healthy volunteers

Detailed description: Inclusion visit:

* Introduction to the study
* Inclusion in study
* Baseline information is obtained
* Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

* Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
* Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Adhesive strips are weighted and applied
* Potential shower/bicycle exercise (max 60 minutes)
* Adhesive strips are removed at pre-defined timeslots (peel force measured)
* Discomfort when strip was peeled of is evaluated by subject (VAS)
* Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Acclimatization ½
* Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Adhesive strips are weighed
* Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)

Primary outcomes:
measure: Swelling of the adhesive
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of the pre-clinical department
name: Lene F Nielsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755676: Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
Official title: A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent;
* Adults Male and Female ≥ 18 years old;
* Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);

Exclusion Criteria:

* Pregnancy and Lactation or women without effective contraception;
* Relevant clinical diseases;
* Obesity associated to genetic syndrome;
* Decompensated Diabetes;
* Psychiatric disorders;
* Alimentary disorders;
* Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
* Patients using cyclosporine or amiodarone;
* Patients with bowel disease;
* Prior bariatric surgery;
* Anemia;
* Hemoglobinopathies and coagulopathy;
* History of cancer in the past five years;
* Use of corticosteroids, oral or injectable, in the last 30 days.

Primary outcomes:
measure: Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
timeFrame: 112 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 112 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
state: RS
city: Campinas
country: Brazil
facility: Loema
state: SP
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
city: Jau
country: Brazil
facility: CIPMED
state: São Paulo
city: São José dos Campos
country: Brazil
facility: Marcio Antonio Pereira Clinica de Endocrinologia
state: São Paulo
Study officials:
References:
Clinical trial NCT03631576: CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)
Official title: CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Relapsed/Refractory AML
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 20
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged \< 70 years
* Patients with relapsed/refractory AML
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Primary outcomes:
measure: Leukemia free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events that are related to treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT01663376: Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
Official title: Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: Pusan National University Hospital
First posted: 2012-08-13
Enrollment: 20
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 investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia


Eligibility criteria: Inclusion Criteria:

* At least 6 months since the onset CLI(Chronic ASO or Buerger disease)
* Patients with luminal stenosis \> 50% by leg angiography
* Age is between 20 and 80
* Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis)
* Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization
* Patients who can give informed consent themselves in writing

Exclusion Criteria:

* Previous or current history of neoplasm or comorbidity that could impact the patient's survival
* Detection of proximal source of emboli including atrial fibrillation
* Primary hematologic disease, including hypercoagulable states
* Detection of proliferative retinopathy
* Entrapment syndrome
* Alcohol abuse, cocaine amphetamine etc.
* Detection of osteomyelitis
* Uncontrolled DM

Primary outcomes:
measure: Major Adverse Events Analysis (MAEs)
timeFrame: 48 weeks
Secondary outcomes:
measure: Ankle-Brachial Index (ABI)
timeFrame: 48 weeks
measure: Digital subtraction angiography (DSA)
timeFrame: 48 weeks
measure: Thermography
timeFrame: 48 weeks
measure: Wong-Baker FACES Pain Rating Score
timeFrame: 48 weeks
measure: Treadmill test
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Han Cheol Lee, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.
Clinical trial NCT05875376: Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
Official title: Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism spectrum disorder, couple therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. In the Adult ASD Clinic of National Taiwan University Hospital, we observe that the wives of the ASD husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. To date, there are limited intervention models focusing on couple therapy for ASD adults (or neurodiverse couple). Given the strong needs of clinical service, this study aims to identify the common problems of the ASD couples and develop a program to improve their partner relationships.


Eligibility criteria: Inclusion Criteria:

* one person of each couple has either Autism Spectrum Disorder diagnosis or the autism spectrum quotient scoring above or equal to 26
* able to communicate in Chinese
* Wechsler Intelligence scoring above 70

Exclusion Criteria:

* Psychiatric disorder (i.e. schizophrenia, substance abuse)
* unable to communication (i.e. visual or auditory impairment)

Primary outcomes:
measure: The Autism Diagnostic Observation Schedule, ADOS
timeFrame: 6 weeks
measure: Autism Spectrum Quotient
timeFrame: 6 weeks
measure: Empathy Quotient
timeFrame: 6 weeks
measure: Social Responsiveness Scale, SRS
timeFrame: 6 weeks
measure: Quality of socialization questionnaire, QSQ
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02223676: Clinical Pharmacists in the Emergency Department
Official title: Is Length of Stay in the Emergency Department Reduced When Clinical Pharmacists Conduct Medication History? - a Cluster Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Reconciliation
Keywords: Pharmacy
Length-of-stay
Emergency Department
Lead sponsor: Randers Regional Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-08-22
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the effect of implementing clinical pharmacists in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists conduct medication history, make medical interaction screenings, -reconciliations and -reviews on unscheduled patients admitted to the Emergency Department during daytime.


Eligibility criteria: Inclusion Criteria:

* unscheduled patients admitted to the Emergency Department at Randers Regional Hospital at weekdays during daytime (9 am to 16.15 pm)
* 4 or more drugs prescribed

Exclusion Criteria:

* patients triage red
* patients who cannot give informed consent
* terminal patients
* patients admitted to detoxification
* patients refered to the acute outpatient department
* patients remaining in the Emergency Department overnight

Primary outcomes:
measure: Emergency Department Length of stay
timeFrame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
Secondary outcomes:
measure: Time from patient arrival to the treatment schedule is ready
timeFrame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
measure: Patient safety
timeFrame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
Other outcomes:
measure: The impact of the intervention in the Emergency Department on the existing medication review by clinical pharmacist at the acute ward
timeFrame: 1-3 days after admission to Emergency Department when the secondary medication review takes place
measure: The impact of the intervention in the Emergency Department on the dispensing of medicine (done by nurses)
timeFrame: During actual admission to the Emergency Department and the period after inclusion of patients
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Region Midt
Study officials:
References:
Clinical trial NCT04954976: Orthodontic Retention In France - ORIF
Official title: Epidemiologic Study of Orthodontic Retention Practices in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Retention Procedures
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 262
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: French orthodontists

Brief summary: The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.

Detailed description: Questionnaire aggregating 27 questions on orthodontic retention strategies, was sent to a professional list of French orthodontists from health authorities. The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.

Eligibility criteria: Inclusion Criteria:

* All French Specialist orthodontists trained in France who answer the survey

Exclusion Criteria:

* Non-specialist orthodontists, not trained in France

Primary outcomes:
measure: Description of technics
timeFrame: Day0 = Response to the Suvey
measure: Description of materials
timeFrame: Day0 = Response to the Suvey
measure: Description of retention strategies used by clinicians.
timeFrame: Day0 = Response to the Suvey
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT04372576: Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
Official title: Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Corona Virus Infection
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2020-05-04
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: Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for \> 48 hours.

Brief summary: The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.

Detailed description: Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed.

The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.

Eligibility criteria: Inclusion Criteria:

* Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease
* Started mechanical ventilation for \> 48 hours
* Informed consent signed by the patient or authorised representative

Exclusion Criteria:

* Participation in an interventional trial aiming nosocomial infections
* refused informed consent

Primary outcomes:
measure: 28-day all-cause mortality
timeFrame: at study completion, anticipated 5 months
Secondary outcomes:
measure: Days of mechanical ventilation
timeFrame: average time frame expected 2-3 weeks
measure: ICU length-of-stay
timeFrame: average time frame expected 3-4 weeks
measure: Antibiotic utilization
timeFrame: average time frame expected 3-4 weeks (at discharge from ICU)
measure: Ventilator-associated pneumonia rate
timeFrame: at study completion, anticipated 5 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References: