louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03363230: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Official title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Skills
Interpersonal Effectiveness Skills
Keywords: mindfulness
emotion regulation
impulsivity
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Eligibility criteria: Inclusion criteria:

* BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV Axis II disorders and the Revised Diagnostic Interview for Borderlines
* Age between 18 and 50 years old
* No comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
* Not being participating in any other psychotherapy at the moment of the study.

Exclusion criteria:

• Having participated of skills training in the past.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 1-past week
measure: Barrat Impulsiveness Scale (BIS-11)
timeFrame: 1-past week
Secondary outcomes:
measure: Borderline Symptoms List (BSL-23)
timeFrame: 1-past-week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Clinical trial NCT00162630: Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase
Official title: Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fracture
Keywords: Hip fracture, pain, regional anaesthesia, analgesia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: IMK Fonden
First posted: 2005-09-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

Detailed description: Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Eligibility criteria: Inclusion Criteria:

* Primary hip fracture suspected
* able to give informed consent
* no substance abuse
* no regular opioid therapy
* no opioid treatment within the last 6 hours
* morphine intolerance
* allergies to local anaesthetics

Exclusion Criteria:

* Fracture ruled out on x-ray

Primary outcomes:
measure: Pain relief within 3 hours
Secondary outcomes:
measure: Nausea
measure: Pain on transfer
measure: Discomfort with block placement
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Nicolai B Foss, MD
role: STUDY_DIRECTOR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Clinical trial NCT01995630: Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
Official title: Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Spherical Aberrations
Intraocular Lenses
Depth of Focus
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.


Eligibility criteria: Inclusion Criteria:

* Cataract
* Dioptric power of IOL \>22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

Exclusion Criteria:

* Uveitis, pathology of the retina or the optic nerve
* Corneal scarring or irregularities
* Astigmatism \>1.5 D
* Amblyopia
* Perioperative complications
* Postoperative refractive error \>2.0 D of spherical equivalent
* Postoperative DCVA \<0.8 (ETDRS)

Primary outcomes:
measure: Distance-corrected intermediate visual acuity
timeFrame: 3 month postop
Secondary outcomes:
measure: Distance-corrected near visual acuity
timeFrame: 3 month postop
measure: Uncorrected distance visual acuity
timeFrame: 3 month postop
measure: Corrected distance visual acuity
timeFrame: 3 month postop
measure: Uncorrected near visual acuity
timeFrame: 3 month postop
measure: Corrected near visual acuity
timeFrame: 3 month postop
measure: Pseudoaccomodation
timeFrame: 3 month postop
measure: Photopic contrast sensitivity
timeFrame: 3 month postop
measure: Mesopic contrast sensitivity
timeFrame: 3 month postop
measure: Spherical aberrations
timeFrame: 3 month postop
measure: High order aberrations
timeFrame: 3 month postop
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Dept. of Ophthalmology, Medical University of Graz
Study officials:
affiliation: Dept. of Ophthalmology, Medical University of Graz
name: Navid Ardjomand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06415630: Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
Official title: Multiple Automated Machine-learning Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nomogram
Prediction Model
Type A Aortic Dissection
Postoperative Reintubation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 861
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 892 patients with AAD who underwent open surgery at Wuhan Union Hospital between January 2018 and October 2023 were enrolled using a convenient sampling method.

Brief summary: Reintubation is an adverse postoperative complication in patients with Type A aortic dissection (AAD) that correlates to poor outcomes. This study aims to analyze the risk factors associated with reintubation and to create a fully automated score model to predict the incidence of reintubation. A total of 861 patients diagnosed with AAD and undergoing surgical procedures in a single institution between January 2018 and October 2023 were selected in wuhan Union Hospital. Preoperative and postoperative informmation was used for seeking risk factors and build prediction model for postoperative reintubation. Finally, 5 risk factors wasidentified and a nomogram was established for predicting postoperative reintubation in patients with AAD.


Eligibility criteria: Inclusion Criteria:

(1) patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older.

Exclusion Criteria:

(1) patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.

Primary outcomes:
measure: postoperative reintubation
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01080430: Effects of a Vestibular Rehabilitation Maneuver
Official title: Short-term and Long-term Effects of the Rotational Maneuver in Patients With Chronic Vestibular Imbalance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertigo
Keywords: vestibular
vertigo
rehabilitation
rotation
balance
Lead sponsor: Day General Hospital.
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2010-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. Using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose that the rehabilitative effect is the result of a decrease in the vestibular imbalance, mainly due to a decrease in the response of the dominant vestibular side. Previously, we have shown the short-term effects of this maneuver on patients with recent onset vestibular imbalance. In the present study, we investigated the long-term effects of the rotational maneuver in patients with a history of peripheral vestibular vertigo for at least one year, originally confirmed by clinical tests. Our results show a significant improvement which lasted for \>4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover, there seems to be a relationship between the decrease in DP values and a decrease in subjective symptoms. We propose that this maneuver can be used as an effective method for both short- and long-term rehabilitation.


Eligibility criteria: Inclusion Criteria:

* History of vertigo for at least one year
* Not under drug therapy for vertigo
* directional preponderance \>10% measured by electronystagmography during rotation test

Exclusion Criteria:

* severe vertigo
* intolerance to rotation
* previously diagnosed for a central pathology (e.g., neuroma)
* previously diagnosed with a fluctuating vestibular disorder (e.g., Menier's)

Primary outcomes:
measure: Directional preponderance (DP)
timeFrame: Every 3-7 days for one month
Secondary outcomes:
measure: Subjective sense of a decrease in imbalance and dizziness.
timeFrame: every 3-7 days for one month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Vestibular and auditory center of Day General Hospital
Study officials:
affiliation: Shaheed Beheshti University
name: Nayer Rassaian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sadeghi NG, Sabetazad B, Rassaian N, Sadeghi SG. Rebalancing the Vestibular System by Unidirectional Rotations in Patients With Chronic Vestibular Dysfunction. Front Neurol. 2019 Jan 22;9:1196. doi: 10.3389/fneur.2018.01196. eCollection 2018.
Clinical trial NCT02137330: Obalon in Children With Severe Obesity
Official title: Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-)
Altered Liver Function Tests
Glycemic Intolerance
Keywords: Obalon swallowable intragastric balloons
Severe obesity
Children
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity.

Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients.

Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.


Eligibility criteria: Inclusion Criteria:

* Weight \> 97° pc -CDC BMI charts-

Exclusion Criteria:

* Prevous abdominal surgery
* Functional gastrointestinal motility disorders

Primary outcomes:
measure: Weight loss (Kg)
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children Hospital
Study officials:
References:
Clinical trial NCT03754530: Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
Official title: A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Brain Metastases
Keywords: NSCLC brain metastases
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Detailed description: Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
* Histological or cytological confirmation of EGRF positive sensitive mutation
* Diagnosis of brain metastases on a Gadolinium-enhanced MRI

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
* Previous usage of radiation with brain
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Primary outcomes:
measure: Progression-free survival of intracranial lesions
timeFrame: 10 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 8 months
measure: Objective response rate of intracranial lesions
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fujian oncology hospital
name: Li jiancheng
role: STUDY_DIRECTOR
References:
Clinical trial NCT04591730: First-time Fathers' Experiences of Childbirth in Lorraine
Official title: First-time Fathers' Experiences of Childbirth in Lorraine.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fathers
First Birth
Keywords: Fathers
Childbirth
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Father for the first time.

Brief summary: The primary aim of this study is to evaluate first time father's experience during childbirth in three different maternity hospitals in Lorraine.

Secondary aims of this study is to identify domains that need improvement in order to enhance fathers's experience during childbirth.


Eligibility criteria: Inclusion Criteria:

* First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks.

Exclusion Criteria:

-

Primary outcomes:
measure: First-time father questionnaire score
timeFrame: 1 month after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternité du CHRU de Nancy
state: Meurthe-et-Moselle
Study officials:
affiliation: CHRU de Nancy
name: Leonore Avercenc, PhD
role: STUDY_DIRECTOR
References:
citation: Premberg A, Carlsson G, Hellstrom AL, Berg M. First-time fathers' experiences of childbirth--a phenomenological study. Midwifery. 2011 Dec;27(6):848-53. doi: 10.1016/j.midw.2010.09.002. Epub 2010 Oct 16.
citation: Premberg A, Taft C, Hellstrom AL, Berg M. Father for the first time--development and validation of a questionnaire to assess fathers' experiences of first childbirth (FTFQ). BMC Pregnancy Childbirth. 2012 May 17;12:35. doi: 10.1186/1471-2393-12-35.
citation: Capponi I, Carquillat P, Premberg A, Vendittelli F, Guittier MJ. [Translation and validation in French of the First-Time Father Questionnaire]. Gynecol Obstet Fertil. 2016 Sep;44(9):480-6. doi: 10.1016/j.gyobfe.2016.07.011. Epub 2016 Aug 24. French.
Clinical trial NCT04375930: Peristomal Skin Complications and Quality of Life
Official title: The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Quality of Life
Stoma Ileostomy
Stoma Colostomy
Complication
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.
Primary purpose: PREVENTION

Brief summary: This study is a single blind semi-experimental study.

Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.

H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy.

H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.

Detailed description: In order to ensure blindness in the study design, patients were not informed about which group they belonged to.

Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care.

Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure.

All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.

Eligibility criteria: Inclusion Criteria:

* undergoing colorectal surgery,
* permanent or temporary ileostomy or colostomy
* end or loop ileostomy or colostomy

Exclusion Criteria:

* individuals who have previously had stoma surgery,
* having two or more stoma,
* individuals with crohn's disease
* individuals who do not want to participate in the study

Primary outcomes:
measure: Rate of Peristomal skin complication change
timeFrame: 0, 2nd, 6th and 12th weeks
measure: means of quality of life change
timeFrame: 2nd, 6th and 12th weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Dokuz Eylul University
name: Cahide Ayik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292030: Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure
Official title: Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure With or Without HTEA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: congestive heart failure.

Brief summary: The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Detailed description: The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Eligibility criteria: Inclusion Criteria:

* congestive heart failure accompanied by atrial fibrillation.

Exclusion Criteria:

* Valvular heart diseases.

Primary outcomes:
measure: recurrence of atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Ren Xiaohui
state: Heilongjiang
city: Harbin
country: China
facility: the first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References: