louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04467814: Better Together: Reablement and Caregivers
Official title: Out and About: Reablement for Older Adults in the Hospital Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Older Adults
Sedentary Behavior
Physical Activity
Caregiver
Keywords: caregiver, patient, e-Course
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hospitalization creates opportunities for older adults to accumulate prolonged periods of sitting and lying (defined as sedentary behavior) which can result in mobility loss. We propose a Type 1 Hybrid Effectiveness-Implementation Trial with 1:1 randomization to test the effect of a caregiver intervention on older patients' physical activity at 3 months (home). We will recruit 61 patients and family caregivers from hospital units and follow them for 3 months; the primary outcome is patients' daily step count at 3 months.


Eligibility criteria: Inclusion Criteria: Older adults (60 years and older) with a recent hospitalization and their caregiver.

Exclusion Criteria: Caregivers and older adults with a dementia diagnosis, head injury, significant neurological impairment, or receive treatment for medical conditions that preclude exercising.

Primary outcomes:
measure: Veterans Rand-12 Quality of Life
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Daily minutes sedentary behavior
timeFrame: baseline to 3 months
measure: Daily minutes of physical activity
timeFrame: baseline to 3 months
measure: Patient Assessment with Chronic Illness Care Survey
timeFrame: 3 months
measure: Brief Action Planning (BAP)
timeFrame: baseline and 3 months
measure: Action Plans behaviors
timeFrame: baseline and 3 months
measure: Coping Plans
timeFrame: baseline and 3 months
measure: Physical Activity Intentions
timeFrame: baseline and 3 months
measure: Physical Activity Self-efficacy
timeFrame: baseline and 3 months
measure: Physical Activity Risk Perceptions
timeFrame: baseline and 3 months
measure: Physical Activity Outcome Expectancies
timeFrame: baseline and 3 months
measure: Self-reported Habit Index
timeFrame: baseline and 3 months
measure: Program implementation
timeFrame: baseline and 3 months
Other outcomes:
measure: Steps per day
timeFrame: baseline to 3 months
measure: Falls
timeFrame: baseline to 3 months
measure: Falls Efficacy Scale International (FES-I)
timeFrame: baseline and 3 months
measure: Brief Test of Adult Cognition by Telephone
timeFrame: baseline and 3 months
measure: Unified Theory of Acceptance and Use of Technology 2 Survey
timeFrame: baseline and 3 months
Locations:
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
Study officials:
References:
Clinical trial NCT06377514: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
Official title: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.


Eligibility criteria: INCLUSION CRITERIA

To be considered for enrollment in this study, patient must:

* be at least 22 years old
* have cataracts in both eyes
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires
* be available for study follow-up visits EXCLUSION CRITERIA

Patient will not be eligible to take part in the study if:

* currently participating in any other clinical study or have participated in a clinical study during the last 30 days
* have a certain disease/illness, such as poorly controlled diabetes
* have certain ocular conditions, such as uncontrolled pressure in the eye
* taking medication that may affect vision
* pregnant, plan to become pregnant during the study, or are breastfeeding

Primary outcomes:
measure: Monocular photopic DCIVA (first eyes) at 66 cm
timeFrame: 6 months
measure: Monocular Depth of Focus
timeFrame: 6 months
measure: Monocular Photopic BCDVA at 4m
timeFrame: 6 months
measure: Monocular Photopic DCVA at 100 cm
timeFrame: 6 months
Secondary outcomes:
measure: Monocular photopic DCNVA at 40 cm (first eyes)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Center
state: Iowa
city: Garden City
country: United States
facility: OCLI Vision
state: New York
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04335214: Advance Care Planning Among Older People From Moroccon Origin in Belgium
Official title: Advance Care Planning Among Older People From Moroccon Origin in Belgium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Ethnic Minorities
Moroccans
Advance Medical Directives
Muslims
Living Will
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one to one interviews
Primary purpose: OTHER

Brief summary: Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and care, to discuss these goals and preferences with family and health-care providers, and to record and review these preferences if appropriate. Research has shown that most Western patients express the need about what ACP entails. Ethnicity creates an important cultural impact on how people look at life and death, so that there is an influence on making decisions about end-of-life care.

The moroccan ethnic group is one of the largest visible non-Western minority groups in Western countries. Studies on how ACP is perceived among patients from moroccon origin are lacking. The objective of this study is exploring the knowledge, experiences, point of views, preferences, attitudes, facilitators and barriers concerning advance care planning of older people from moroccan origin in Belgium. Semi-structured interviews (in the native moroccan/arabic language) will be used.


Eligibility criteria: Inclusion Criteria:

* People with Moroccan origin who live in Belgium and are older than 65 years and who have also given informed consent to participate in this qualitative interview study

Exclusion Criteria:

* Patients who are terminal ill which means having a life-limiting disease with irreversible decline and who are actively dying (actively dying is related to patients with days of survival). (41)
* people who have cognitive impairment

Primary outcomes:
measure: Knowledge, experiences, views, preferences, barriers and facilitators about advance care planning from older people from moroccon origin in Belgium
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Faculteit Geneeskunde en Farmacie
Study officials:
affiliation: Vrije Universiteit Brussel
name: Hakki Demirkapu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765114: A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
Official title: A Phase II Open-label, Intra-individual Controlled, Single-center Study to Investigate the Efficacy, Safety and Tolerability of a Polyethylene Glycol-formulation and the Viral Shedding in Patients Suffering From Genital Herpes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Genital Herpes
Lead sponsor: Devirex AG
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* 18 - 65 years
* Positive for HSV-1 and/or -2 (as determined by serology testing in course of study)
* Initial infection \> 1 year ago
* ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy)
* ≥ 2 recurrences during the six-month baseline period

Exclusion Criteria:

* Known or suspected allergy or intolerability to PEG
* Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial
* Pregnancy and/or breast-feeding
* History of malignant diseases (described in chapter 7.2)
* Known or suspected non-compliance to study protocol
* Participation in another investigational drug study in the last 30 days prior to baseline period

Primary outcomes:
measure: Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.
timeFrame: Baseline and Treatment period (6 months each).
Secondary outcomes:
measure: The safety of the PEG-formulation via reporting of AEs.
timeFrame: Baseline and Treatment period (6 months each).
Other outcomes:
measure: The frequency of days with viral shedding which will be analysed by quantitative PCR.
timeFrame: Baseline and Treatment period (6 months each).
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Thomas Kuendig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704014: Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists
Official title: Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Floppy Iris Syndrome
Keywords: occurrence of
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All korean patients who underwent cataract surgeries in Samsung Medical Center

Brief summary: Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS. However the prevalence of IFIS in Korean population is not reported. The purpose of this study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris anatomical change in Korean patients taking α1-ARA.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cataract
* korean patients

Exclusion Criteria:

* history of iridocyclitis, iris neovascularization, or prior iris surgery
* traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease (e.g., uveitis)

Primary outcomes:
measure: occurrence of intraoperative floppy iris syndrome
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00393614: Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)
Official title: Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Subclinical Sleep-Activated Epileptiform Activity
CSWS
Keywords: CSWS, interiktal epileptiform activity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).


Eligibility criteria: Inclusion Criteria:

* Children 5-10 years
* IQ \> 50

Primary outcomes:
measure: 24 hour EEG
timeFrame: End of the study
Secondary outcomes:
measure: Neuro-psychological testing,
timeFrame: End of the study
measure: Health related quality of life
timeFrame: End of the study
measure: Behavioral problems
timeFrame: End of the study
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Ann-Sofie Eriksson, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856514: Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
Official title: Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofibromatosis 1
Social Skills
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: NF Midwest
First posted: 2021-04-23
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of neurofibromatosis type 1
* Age 12-17
* Main language spoken in the home is English
* Reliable internet access
* Current functional impairment in peer relationships
* Teen is interested and motivated to participate

Exclusion Criteria:

* Main language spoken in the home is not English
* Cognitive or developmental delays that affect reading comprehension or understanding of treatment material
* Significant behavioral concerns
* Other comorbid medical conditions
* Major surgery in past 6 months
* Prior social skills group treatment within past 6 months
* Prior participation in PEERS

Primary outcomes:
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017)
timeFrame: within four weeks of PEERS completion
measure: Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
timeFrame: within four weeks of PEERS completion
Secondary outcomes:
measure: Social Responsiveness Scale (SRS; Constantino, 2005)
timeFrame: within four weeks of PEERS completion
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Danielle Glad, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04297514: Effects of Respiratory Rehabilitation by Gender in COPD Patients
Official title: Effects of Pulmonary Rehabilitation According to Gender, in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Pulmonary Rehabilitation
Keywords: COPD
pulmonary rehabilitation
Dyspnea
quality of life
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients undergoing a pulmonary rehabilitation program

Brief summary: Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .

Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* No opposition filed
* Patient with COPD
* Completed participation in respiratory rehabilitation program

Exclusion Criteria:

* Refusal of participation
* Patient under tutorship or curatorship
* No final assessment
* Patients with sex changes in marital status

Primary outcomes:
measure: DYSPNEA-12
timeFrame: Change from baseline Dyspnea-12 score at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Morlaix
country: France
facility: CH des pays de Morlaix
Study officials:
affiliation: CH des pays de Morlaix
name: Marc Beaumont, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826495: Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients
Official title: Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Polyp
Oxidative Stress
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of fifty-four participants, aged 20 to 48, took part in the study, including twenty-four women diagnosed with endometrial polyps and thirty women as the control group.

Brief summary: Changes in Thiol Disulfide Balance and Oxidative Stress Mechanisms in Patients with Endometrial Polyps


Eligibility criteria: Inclusion Criteria:

For participants in the control group:

• To be without endometrial polyp

For the polyp group, they were as follows:

* Individuals experiencing menometrorrhagia
* A body mass index (BMI) of 25 or more
* Hypertension
* Endometrial polyps detected via saline infusion ultrasonography

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus
* Pelvic mass
* Malignancy
* The use of Tamoxifen, hormonal contraceptives, or hormone replacement therapy.

Primary outcomes:
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
measure: Oxidative stress markers
timeFrame: From January 2021 to January 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Training and Research Hospital Gynecology and Obstetrics Department
Study officials:
References:
Clinical trial NCT00161395: Study of Time to Pregnancy in Normal Fertility
Official title: Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fertility
Pregnancy
Keywords: fertility
pregnancy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-09-12
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

Detailed description: Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.

All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.

All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.

The primary outcome is time to pregnancy.

Eligibility criteria: Inclusion Criteria:

* couple with prior pregnancy within the past 8 years

Exclusion Criteria:

* any history that suggests subfertility
* any history that suggests a medical contraindication for pregnancy

Primary outcomes:
measure: Time to Pregnancy
timeFrame: Up to one year.
Secondary outcomes:
measure: Distribution of coitus within "fertile" days of menstrual cycle
timeFrame: Seven menstrual cycles.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, Dept. Family and Preventive Medicine
state: Utah
Study officials:
affiliation: University of Utah
name: Joseph B Stanford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.