louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06988995: Compassion Strikes Back
Official title: Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: LVAD Caregivers
LVAD (Left Ventricular Assist Device)
Quality of Life (QOL)
Self-Compassion
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation.

Over the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys.

Participants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.


Eligibility criteria: Inclusion Criteria:

* LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member

Exclusion Criteria:

* Currently or in the past 3 months received psychotherapy or psychosocial or peer support; hospitalized for psychiatric reasons in the past 6 months; current, active suicidal thoughts or a reported suicide attempt within the past year; a current alcohol/substance use disorder that required immediate treatment; or a current or past thought disorder, psychosis, or unmanaged bipolar disorder; enrolled in another investigational research/clinical trial; toxic/negative dynamic between pt and caregiver; extended post-LVAD implantation course (i.e., more than 2 months in the hospital).

Primary outcomes:
measure: Self-compassion
timeFrame: 2 months
measure: QOL
timeFrame: 2 months
Secondary outcomes:
measure: NYHA
timeFrame: 2 months
measure: Cardiac Self-Efficacy
timeFrame: 2 months
measure: General Self-Efficacy
timeFrame: 2 months
measure: Illness Denial
timeFrame: 2 months
measure: Perceived Stress Scale
timeFrame: 2 months
measure: Caregiver Burden
timeFrame: 2 months
measure: Acceptability & Feasibility of Intervention
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00826995: Comparison of Video-Based Versus Written Patient Education on Melanoma
Official title: Comparison of Video-based Versus Written Patient Education on Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Malignant Melanoma
Keywords: patient Education
dermatology Patient Education
melanoma
melanoma education
malignant melanoma
melanoma detection
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

Detailed description: We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.

At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Able to adhere to the study visit schedule and other protocol requirements.
* Capable of giving informed consent.

Exclusion Criteria:

* Non-English speaking individuals.

Primary outcomes:
measure: Knowledge of melanoma detection.
timeFrame: 1 month
Secondary outcomes:
measure: Subjects' comprehension and attitude towards video-based and written education materials.
timeFrame: 1 month
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: April W Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00368095: Rajavithi Health Promotion Project (Population Base Cohort)
Official title: The Rajavithi Prospective Cohort Study on Community's Member Health (HPH-cohort Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus
Hypertension
Dyslipidemia
Obesity
Cardiovascular Disease
Coronary Artery Disease
Keywords: DM
HT
Dyslipidemia
Obesity
Cardiovascular disease
Cerebrovascular disease
Myocardial infarction
stroke
Metabolic syndrome
CVD-CAD
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: U.S. Department of Education
First posted: 2006-08-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population in Dindang destrict Bangkok

Brief summary: Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular disease) In Community Survey was performed in central Bangkok.

Prospective Cohort and intensive educated intervention (health promotion program in specific high risk groups) were performed. The aim of the study is to identify high risk patients who can develop serious complications from metabolic syndrome. An analysis of health outcomes in multiple dimensions will be performed.


Eligibility criteria: Inclusion Criteria:

* Age 16 years or more
* Informed consent
* Living in selected community (Health Promotion area of Rajavithi Hospital)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Subsai Kongsaengdao
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Piyathida Harnsomboonrana, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Wilai Pauvilai, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01541995: Evaluation of Contrast Medium Enhanced Post-mortem CT in Virtual Autopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Vascular Conditions
Keywords: contrast medium enhanced post mortem CT
virtual autopsy
To evaluate the value of contrast medium enhanced post-mortem CT in virtual autopsy focussing on thromboembolic and vascular conditions
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients dying in the ICU during the study period

Brief summary: The study aims to compare the value of contrast medium enhanced post mortem CT to classic autopsy.


Eligibility criteria: Inclusion Criteria:

* Patients dying in the ICU
* age \>18y

Exclusion Criteria:

* relatives refusing to participation in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: Wichmann D, Heinemann A, Weinberg C, Vogel H, Hoepker WW, Grabherr S, Pueschel K, Kluge S. Virtual autopsy with multiphase postmortem computed tomographic angiography versus traditional medical autopsy to investigate unexpected deaths of hospitalized patients: a cohort study. Ann Intern Med. 2014 Apr 15;160(8):534-41. doi: 10.7326/M13-2211.
Clinical trial NCT01154595: Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition
Official title: Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Child
Malnutrition
Keywords: moderate acute malnutrition, prevention, Lipid-based supplement
Lead sponsor: Action Contre la Faim
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2010-07-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.


Eligibility criteria: Inclusion Criteria:

* WH≥80% of median of NCHS reference without bilateral pitting oedema;
* Age ≥ 6 months and ≤36 months;
* Member of a household with a dependency ratio \>4;
* Not planning to leave the study zone for the coming 5 months;

Exclusion Criteria:

* Not showing appetite;
* Age \< 6 months or age \> 36 months
* Weight-for-Height Z-score \<-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
* Member of a household with a dependency ration ≤ 4;
* Clinical complications
* Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
* Being allergic to one of the ingredients of the RUF.

Primary outcomes:
measure: Cumulative wasting incidence, hemoglobin concentration
timeFrame: monthly
Secondary outcomes:
measure: weight gain
timeFrame: monthly
measure: time to become wasted
timeFrame: monthly
measure: default rate
timeFrame: monthly
measure: RUF acceptability
timeFrame: monthly
measure: dietary intake
timeFrame: monthly
Other outcomes:
Locations:
city: Abéché
country: Chad
facility: Action Contre La Faim Tchad
Study officials:
affiliation: University Ghent
name: Patrick Kolsteren, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Lieven Huybregts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.
Clinical trial NCT01200095: Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique
Official title: Non-hardware Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique With Periosteum-Evenloping Hamstrings Tendon Autograft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCL TEAR
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PCL tear who received surgery

Brief summary: This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated the results of patients with PCL ruptures, who undergoing PCL reconstruction using this unique technique.


Eligibility criteria: Inclusion Criteria:

* PCL TEAR

Exclusion Criteria:

* PL INSTBILITY

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Tai-Yuan Chuang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02971995: Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies
Official title: Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Positron-Emission Tomography
Fluorocholine
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).

The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .


Eligibility criteria: Inclusion Criteria:

* Patients with suspicion of prostate cancer
* Patients who performed prostate mpMRI and F-Choline 18 PET scan
* Patient capable of receiving clear informations
* Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
* Patient covered by a healthcare insurance

Exclusion Criteria:

* Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan

Primary outcomes:
measure: Number of image guided prostate biopsy in the zones detected by the TEP scan
timeFrame: at inclusion
Secondary outcomes:
measure: Number of image guided prostate biopsy in the zones detected by the mpMRI
timeFrame: at inclusion
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Jean Louis Bonnal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072055: MOTO Post-marketing Surveillance Study
Official title: MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteonecrosis
Osteo Arthritis Knee
Keywords: Unicompartmental Knee Arthroplasty
UKA
antomic femoral component
anatomic tibial component
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 150
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: 150 patients

Brief summary: The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.


Eligibility criteria: Inclusion Criteria:

* Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use);
* Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment;
* Frontal deformity \< 10° (evaluated on weight-bearing long-axis x-rays);
* Flexion contracture \< 10°;
* Intact ligaments;
* Patients willing and able to provide written informed consent for participation in the study;
* Patient's age over 18 years old;
* Patient with BMI \< 40 kg/m2;
* Patients willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

* Patients with one or more medical conditions identified as a contraindication in the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery;
* Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction;
* Patients with BMI ≥ 40 kg/m2;
* Patients unable to understand and take action;
* Any case not described in the inclusion criteria.

Primary outcomes:
measure: Prosthesis survival
timeFrame: 5 years
Secondary outcomes:
measure: New Knee Society Score (KSS)
timeFrame: preoperative, 3 months, 1, 3 and 5 years
measure: Radiological analysis
timeFrame: preoperative, postoperative, 3 months, 1, 3 and 5 years
measure: Complication
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Knokke-Heist
country: Belgium
facility: AZ Zeno Campus Knokke-Heist
city: Liège
country: Belgium
facility: Clinique Saint-Joseph
Study officials:
References:
Clinical trial NCT02961855: Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery
Official title: Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fissure;Anal
Fistula;Rectal
Hemorrhoids
Lead sponsor: Hospital de Viladecans
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 120
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: Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.

Detailed description: 120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre.

Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery

Eligibility criteria: Inclusion Criteria:

* Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
* Use of subarachnoid anesthesia with lidocaine

Exclusion Criteria:

* Allergy or Hypersensitivity to lidocaine or other local anesthesics.
* Patients not accepting subarachnoid anesthesia
* Patients with general anesthesia
* Hypersensitivity or contraindication to acetylsalicylic acid.
* History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use
* Active or relapsing peptic ulcer/gastrointestinal hemorrhage
* Serious heart failure.
* Active Crohn disease
* Active ulcerative colitis
* Moderate or sever renal failure
* Severe liver disfunction
* Coagulation disorders requiring treatment with anticoagulant drugs
* Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases
* Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids
* Pregnancy

Primary outcomes:
measure: mean level of pain, as assessed by visual analog scale (VAS)
timeFrame: 3 days post-surgery
Secondary outcomes:
measure: Mean level of pain (VAS) at day 3 post-surgery
timeFrame: 6 days post-surgery
measure: Level of pain (VAS), assessed by Andersen scale
timeFrame: 6 days post-surgery
measure: Pain relief
timeFrame: 6 days post-surgery
measure: analgesics use
timeFrame: 6 days post-surgery
measure: patient satisfaction
timeFrame: 6 days post-surgery
measure: demographic and clinical characteristics-1
timeFrame: baseline
measure: demographic and clinical characteristics-2
timeFrame: baseline
measure: safety evaluation as assessed by recording fo adverse events
timeFrame: 6 days post-surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00515255: Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
Official title: Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Neuropharm
NPL-2003
Lead sponsor: Neuropharm
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
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 effect of NPL-2003 on the symptoms of Obsessive Compulsive Disorder (OCD) in an adolescent population.


Eligibility criteria: Inclusion Criteria:

* Meets DSM-IV criteria for Obsessive Compulsive Disorder.
* CY-BOCS score of greater or equal to 16 at screening.
* NIMH Global OC Scale score of 7 or higher at screening.

Exclusion Criteria:

* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
* Autistic Disorder or Pervasive Developmental Disorder.
* Moderate or severe mental retardation.
* Severe renal insufficiency.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: The change in OCD symptoms using CY-BOCS
timeFrame: Throughout the study
Secondary outcomes:
measure: The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: Throughout the study
measure: NIMH Global OC Scale
timeFrame: Throughout the study
measure: Clinical Global Impressions of Improvement (CGI-I)
timeFrame: Throughout the study
measure: The Children's Depression Rating Scale (CDRS-R)
timeFrame: Throughout the study
measure: Columbia Suicide-Severity Rating Scale (SSRS)
timeFrame: Throughout the study
measure: Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Throughout the study
measure: Global Assessment Scale for Children (CGAS)
timeFrame: Throughout the study
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute, Columbia University
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References: