louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00053651: Prevention of Postpartum Depression in Low-Income Women
Official title: Depression Intervention for Poor Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression, Postpartum
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-02-05
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine whether a prevention program reduces the incidence of postpartum depression in pregnant women who receive public assistance and are at risk for postpartum depression.

Detailed description: The impact of major depression in the postpartum period is profound, with considerable emotional pain for the new mother as well as disturbances in infant development. Unfortunately, few preventive interventions have been developed or systematically tested to reduce the risk of postpartum depression. An area of even greater neglect is the development of such an intervention for financially disadvantaged women who are at high risk for postpartum depression and for the disturbances associated with postpartum depression. This study will develop a psychosocial intervention for financially disadvantaged pregnant women at risk for postpartum depression.

Participants are randomly assigned to receive either the "Life at Home with a New Baby" intervention or care as usual. Women who receive the intervention join a counseling group in which information about mother-baby relationships is shared. This information is reinforced with a follow-up "booster" session after the infant is born. Participants are assessed at baseline, after the booster session (for the intervention condition) or after 2 weeks postdelivery (for the care as usual condition), and at 3 months postpartum. Depression levels and social adjustment are measured at baseline and 2 weeks after delivery. Functional status is also measured. A self-report questionnaire is completed by the mothers to measure parental distress, parent/child dysfunctional behavior, and difficult child interactions. At 3 months postpartum, a brief standardized interview is used to assess the presence of a depressive disorder.

Eligibility criteria: Inclusion criteria:

* Receive public assistance
* At risk for postpartum depression
* Pregnant women between 23-32 weeks gestation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT06851351: Respiratory Restriction in Prader-Willi Syndrome
Official title: Study of Respiratory Restriction in Patients With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader-Willi Syndrome
Keywords: thoraco-abdominal volumes
lung volumes
optoelectronic plethysmography
respiratory manoeuvres
posture
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Prader Willi Syndrome and obesity

Brief summary: The main aim of this study is therefore to evaluate the impact of Prader Willi Syndrome (PWS) on lung and thoracoabdominal volumes, respiratory muscle strength and awake ventilatory pattern, and to quantify and localize the PWS-induced respiratory restriction.

Detailed description: The aim is to study lung function in obese PWS patients using both volitional (spirometry, nitrogen wash-out, and maximal pressure measurements (MIP and MEP)) and non-volitional (awake ventilatory pattern by opto-electron plethysmography) tests, both in sitting and supine positions.

Spirometry, nitrogen wash-out, and MIP and MEP measurements are comprehensive assessments, while optoelectronic plethysmography allows restriction location through accurate measurement of thoracoabdominal volumes.

The results of the study could provide useful information about the calculation of the volumes enclosed by the grid of markers (in particular, the volume of the rib cage, which reflects the action of the intercostal muscles, the volume of the abdomen, which reflects the action of the diaphragm in the inspiratory phase and of the abdominal muscles during exhalation and their sum, which represents the total variation of the thoraco-abdominal wall. All these finds could be useful for respiratory rehabilitation protocols for obese PWS patients.

Eligibility criteria: Patients with Prader Willi Syndrome

Inclusion Criteria:

* Age 20-50 years
* Prader Willi Syndrome
* Body Mass Index \> 30 kg/m2

Exclusion Criteria:

* Lack of signed consent form

Control subjects

Inclusion Criteria:

* Age 20-50 years
* Body Mass Index \< 25 kg/m2

Exclusion Criteria:

* Lack of signed consent form

Primary outcomes:
measure: Rib cage contribution to ventilation
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT02536651: Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Official title: Reliability and Validity of the Finnish Versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Diseases
Ankle Disease
Keywords: validation studies, patient-reported outcome measures
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
First posted: 2015-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone surgery due to foot and ankle pathology

Brief summary: There are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric properties of these two questionnaires

Detailed description: This study assesses the reliability and validity of the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale. The English versions were translated and trans-culturally adapted into Finnish language according to well accepted international translation guidelines. The psychometric properties are assessed by internal validity, intraclass correlation coefficient and test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* Pathology of the foot and ankle and
* Surgery due to foot and ankle problems

Exclusion Criteria:

* Other than foot and ankle surgery
* age under 18 years

Primary outcomes:
measure: The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
timeFrame: 2 months to 10 years
measure: The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
timeFrame: 2 months to 10 years
Secondary outcomes:
measure: Visual Analogue Scale Foot and Ankle questionnaire
timeFrame: 2 months to 10 years
measure: Lower Extremity Functional Scale questionnaire
timeFrame: 2 months to 10 years
measure: Kasari FIT (Function Intensity Time) index
timeFrame: 2 months to 10 years
measure: The 15-Dimensions health-related quality of life instrument
timeFrame: 2 months to 10 years
measure: Visual Analogue Scales
timeFrame: 2 months to 10 years
measure: Visual Analogue Scales
timeFrame: 2 months to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Hospital and University of Helsinki
name: Erkki J Tukiainen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00286351: Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome


Eligibility criteria: Inclusion Criteria:

* Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles
* Couples with indication and wish for IVF/ICSI
* Age of women: 20-40 years
* Regular menstrual cycle within normal range (21-35 days)
* Body Mass Index (BMI): 18-30 kg/m2

Exclusion Criteria:

* History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
* Treatment of endometriosis with GnRH agonist during the last 3 month

Primary outcomes:
measure: size of endometriomas after 2½ month of combined downregulation
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
state: Copenhagen East
Study officials:
affiliation: The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
name: Kristine Lossl, medical doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06466551: The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children
Official title: The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children: A Randomized Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Procedural
Anxiety
Pain Management
Keywords: distraction
fear
pain
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.

Detailed description: Provide a brief summary of the study, including the purpose, objectives, and brief methodology.

Eligibility criteria: Inclusion Criteria:

* Children aged 6-12 years,
* Between April 20, 2024 and October 20, 2024, children admitted to Mersin Toros State Hospital Pediatrics Departments,
* Children scheduled for intravenous catheterization,
* Those who signed the informed consent form (child and parent),
* Children without mental and developmental retardation,
* They are children who can speak and communicate in Turkish.

Exclusion Criteria:

* Children under 6 years old and over 12 years old,
* Children hospitalized between April 20, 2024 - October 20, 2024 in clinics other than Mersin Toros State Hospital Pediatrics Service,
* Children for whom intravenous catheterization is not planned,
* Those who did not sign the informed consent form (child and parent),
* Children with mental and developmental retardation,
* They are children who cannot speak Turkish and cannot communicate.

Primary outcomes:
measure: Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
timeFrame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
measure: Change in Fear Scores Assessed by the Children's Fear Scale
timeFrame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Toros Üniversty
Study officials:
References:
Clinical trial NCT06220851: Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease
Official title: Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
handgrip strength
air trapping
lung volume
correlation
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (postbronchodilator FEV1/FVC \<0.7) and smoking history 10 pack-years or more.

Brief summary: The goal of this observational study is to investigate the relationship between handgrip strength and air trapping in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Is handgrip strength correlated with air trapping in COPD patients? Participants will perform handgrip strength test and lung volume measurement.

Detailed description: This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and lung volume measurement will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Lung volume will be assessed using a body plethysmograph.

Eligibility criteria: Inclusion Criteria:

* Age 40 years or older
* Postbronchodilator FEV1/FVC \<0.7
* \>10 pack-year smoking history

Exclusion Criteria:

* COPD exacerbation within 3 months
* Inability to perform handgrip strength test or lung volume measurement

Primary outcomes:
measure: Correlation between handgrip strength and air trapping in COPD patients
timeFrame: At day 1 of the study
Secondary outcomes:
measure: The best cutoff value of handgrip strength for predicting air trapping in COPD patients
timeFrame: At day 1 of the study
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University Faculty of Medicine
Study officials:
References:
Clinical trial NCT06426251: Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty
Official title: A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammation
Osteoarthritis
Post Operative Pain
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 15
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: Photobiomdoulation is the use of near-infrared light to relieve pain, stimulate healing and reduce inflammation. Swelling and inflammation is a common condition after orthopedics surgeries over extremity and spine. This study aim to evaluate the effect of photobiomodulation over patients after Total Knee Arthroplasty.

Detailed description: Patients aged over 20 after Total Knee Arthroplasty in our institution would be candidate for recruitment. The patients will be randomized to receive routine post operative care or photobiomodulation therapy. The swelling extent and subjective outcome will be recorded.

Eligibility criteria: Inclusion Criteria:

* total knee arthroplasty

Exclusion Criteria:

* open injury
* pregnancy
* wound without primary closure
* infection
* previous surgery over surgical site
* skin defect

Primary outcomes:
measure: the change of bioimpedance
timeFrame: the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks
Secondary outcomes:
measure: pain score (visual analogue score)
timeFrame: once daily since post operative day1 to day6
measure: active range of motion of knee
timeFrame: once daily since post operative day1 to day6
measure: 2 minute walk test
timeFrame: once daily since post operative day1 to day6
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Hsin-Chu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Hsiang-Chieh Hsieh
role: STUDY_CHAIR
References:
citation: de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17.
citation: Vassao PG, Renno AC, Smith BN, Bennett GB, Murphy M, Liebert A, Chow R, Laakso EL. Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 Study. Photobiomodul Photomed Laser Surg. 2020 Apr;38(4):206-214. doi: 10.1089/photob.2019.4751. Epub 2020 Mar 18.
Clinical trial NCT05642351: Autobiographical Specificity
Official title: Autobiographical Specificity in Alzheimer's Disease and Behavioral Variant Frontotemporal Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Memory
Alzheimer Disease
Frontotemporal Dementia
Keywords: Autobiographical memory
Alzheimer's disease
with behavioral variant of frontotemporal dementia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited through the active file of memory consultations of the "memory resource and research center" (CMRR) of the Nantes University Hospital.

Brief summary: Autobiographical memory is diminished in patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia, and research has focused on the hampered ability of patients in retrieving specific memories. However, this study proposes a detailed methodology to provide a qualitative analysis of autobiographical specificity.

Detailed description: Patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia will be invited to retrieve autobiographical memories. Memories will be analyzed and categorized into specific, categoric, extended, or semantic autobiographical retrieval.

Eligibility criteria: Inclusion Criteria:

* Alzheimer' disease or avioral variant of frontotemporal dementia
* No opposition from the patient to be included in the study
* For Alzheimer's patients: a score of more than 24 out of 30 on the Mini Mental State Examination (McKhann et al., 1984)

Exclusion Criteria:

* Other psychiatric/neurological disorders
* Minor patients
* Adults under guardianship or protection.

Primary outcomes:
measure: Autobiographical specificity
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: EL HAJ Mohamad
Study officials:
References:
Clinical trial NCT05144451: Transcranial Doppler During Liver Transplantation
Official title: Transcranial Doppler and Neurological Complications After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Ultrasonography, Doppler, Transcranial
Complication, Postoperative
Neurologic Deficits
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm trial involving 100 patients undergoing living donor liver transplantation; all will be examined using transcranial doppler to find out its predictive value on post-transplant neurological deficits.
Primary purpose: SCREENING

Brief summary: This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.

Detailed description: Objectives:

Participants \& Setting:

Intervention \& Measurements:

Sample size:

Eligibility criteria: Inclusion Criteria:

* all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)

Exclusion Criteria:

* Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery

Primary outcomes:
measure: Post-transplant Neurological Complication
timeFrame: 28 days after transplantation
Secondary outcomes:
measure: flow patterns throughout the transplant surgery and in the ICU
timeFrame: intraoperative and 7 days after transplantion
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit
state: Dakahlia
Study officials:
affiliation: Mansoura University Faculty of Medicine
name: Amr M Yassen, MD
role: STUDY_DIRECTOR
References: