louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06855862: An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab
Official title: An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis (UC)
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 105
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: Chinese ulcerative colitis treated with Vedolizumab

Brief summary: It is uncertain the relationship between serum cytokine levels and the clinical efficacy of vedolizumab in the treatment of ulcerative colitis. The effects of cytokines on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with UC were recorded. These patients were detected the levels of cytokines.


Eligibility criteria: Inclusion Criteria:

* UC patients Treated with Vedolizumab

Exclusion Criteria:

* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status

Primary outcomes:
measure: The partial Mayo score was applied to evaluate the clinical activity UC patients
timeFrame: 16 week and 34 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04688762: The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.
Official title: The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Keywords: empathy
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 206
Sex: FEMALE
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: Patient with breast cancer with surgery indication

Brief summary: Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Patient referred for first consultation for surgery
* Patient referred for a breast tumorectomy and axillary sentinel node
* No patient opposition to participating in this study

Exclusion Criteria:

* Non-surgical management
* Management by any surgery other than breast tumorectomy and axillary sentinel node
* Any associated medical, social or psychopathological condition that could compromise the patient's ability to participate in the study
* Patient deprived of liberty or under guardianship
* Person subject to legal protection or unable to express their consent

Primary outcomes:
measure: Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.
timeFrame: before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT06512662: Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
Official title: Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Otorhinolaryngologic Neoplasms
Keywords: surgery
quality of life
anxiety
supportive care
Lead sponsor: Clinique Pasteur Lanroze
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. The surgical procedure and its after-effects can be anxiety-provoking and have a major psychological, physical and social impact on patients over the long term.

Our institution's standard protocol is based on a pre-operative supportive care day hospital. The aim of this study is to compare our current care pathway with a more extensive interdisciplinary care pathway focused on patients' needs, in order to reduce anxiety and improve the quality of life of patients undergoing surgery for cancers of the upper respiratory / digestive tract.

Our aim is to use a prospective single-centre interventional study to assess the impact of adding three post-operative day hospitals to the existing care pathway in terms of reducing anxiety and improving the quality of life of patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* patient undergoing surgery for VADS cancer requiring at least one night's post-operative hospitalisation
* Understanding of spoken and written French
* Patient covered by a social security scheme

Exclusion Criteria:

* Protected patient under a protective measure or legal safeguard
* Pregnant or breast-feeding patients
* Patients suffering from major cognitive disorders
* Patients with major anxiety disorders prior to the onset of cancer

Primary outcomes:
measure: Anxiety
timeFrame: 1 month ; 3 months ; 6 months
Secondary outcomes:
measure: Quality of life evaluation
timeFrame: 1 month ; 3 months ; 6 months
measure: pain evaluation
timeFrame: 1 month ; 3 months ; 6 months
measure: Toxic behaviour (tobacco and alcohol) evaluation
timeFrame: 1 month ; 3 months ; 6 months
measure: Weight status evaluation
timeFrame: 1 month ; 3 months ; 6 months
measure: nutritional status evaluation
timeFrame: 1 month ; 3 months ; 6 months
measure: swallowing assessment
timeFrame: 1 month ; 3 months ; 6 months
measure: vocal status assessment
timeFrame: 1 month ; 3 months ; 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique Pasteur Lanroze
Study officials:
References:
Clinical trial NCT00223262: Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Memory Impairment Due to Corticosteroid Use
Hypomania Due to Corticosteroid Use
Hippocampal Atrophy Due to Corticosteroid
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.


Eligibility criteria: Inclusion Criteria:

* Current Corticosteroid Use of 7 mg or more for 6+ months
* 18-65 years of age

Exclusion Criteria:

* Primarily non-English speaking
* Pregnant/nursing woman
* Currently taking Depakote
* Currently taking Rifampin
* Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar II (not related to corticosteroid use)
* Diseases with CNS involvement
* Is to start a brief steroid taper
* History of Alcohol/drug abuse/dependence

Primary outcomes:
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: The UT Southwestern Medical Center
name: E. Sherwood Brown, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139462: Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
Official title: Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Online Training for Therapists
Keywords: FBT, fidelity, training
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-05-15
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will use a data base of archived therapy sessions of family therapy for adolescent anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it will develop a novel, more efficient way to train therapists in family therapy for adolescent anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel training to standard, more intensive training.


Eligibility criteria: Inclusion Criteria:

* masters or doctoral training in their field (psychology, psychiatry, family therapy).
* must be licensed
* have no reports of malpractice or loss of privileges at clinical institution
* minimum caseload 5 adolescents with AN each year over past 3 years
* no previous training in FBT
* computer/web access

Exclusion Criteria:

* Previous FBT training for AN

Primary outcomes:
measure: Feasibility
timeFrame: end of treatment (approximately 1.5 years after beginning training)
Secondary outcomes:
measure: Fidelity
timeFrame: Session 4, end of training (approximately 1.5 years after beginning training)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James Lock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Daniel Le Grange, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: W. Stewart Agras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963762: The Effect of Mirror Therapy Applied to Stroke Patients on Motor-Sensory Status and Quality of Life
Official title: The Effect of Mirror Therapy Applied to Stroke Patients on Motor-Sensory Status and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Mirror Movement Therapy
Rehabilitation
Keywords: stroke
mirror movement therapy
rehabilitation
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: The research will be conducted to evaluate the effect of Mirror Therapy applied to Stroke Patients on motor-sensory status and quality of life.

Method: The research will be carried out as a randomized controlled experimental study at Bilecik Training and Research Hospital and Bozüyük State Hospital between 01.08.2024-01.05.2025. The population of the research consists of 350 people. Individuals will be distributed to the experimental (30) and control (30) groups by simple randomization method. In collecting research data; The patient introduction form, Brunnstrom Staging and SF-36 Quality of Life Scale will be administered to the patients in both groups by the researcher using face-to-face interview technique (pre-test). Patients in the experimental group will be informed about mirror therapy.

In addition to conventional rehabilitation, patients in the experimental group will receive mirror therapy for 30 minutes, 4 times a week for 4 weeks.

Patients in the control group will only receive conventional rehabilitation for 30 minutes, 4 times a week for 4 weeks. At the end of the 4th week, patients in both groups will be administered Brunnstrom Staging and SF-36 Quality of Life Scale (posttest).

If both groups are discharged before 4 weeks, the planned practices will continue at home.


Eligibility criteria: Inclusion Criteria:

1. Being literate,
2. Being over the age of 18,
3. Having sufficient communication skills to answer oral and written questions and follow instructions,
4. Having been diagnosed with a stroke and at least 6 days have passed since it occurred,
5. Not having severe vision problems,
6. Not having a vertigo problem,
7. Not having been diagnosed with epilepsy,
8. Upper extremity Stage 2 and above in Brunnstrom staging
9. Lower extremity Stage 2 and above in Brunnstrom staging

Exclusion Criteria:

1. Being under 18 years of age
2. Upper extremity Stage 2 and below in Brunnstrom staging
3. In Brunnstrom staging, Lower extremity Stage 2 and below

Primary outcomes:
measure: Brunnstrom Motor-Sensory Staging
timeFrame: 1 month
Secondary outcomes:
measure: SF-36 Quality of Life Scale
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06354062: Talent Management Intervention Program for First-Line Nurse Managers
Official title: Talent Management Intervention Program for First Line Nurse Managers and Its Effect on Their Job Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Behavior
Knowledge, Attitudes, Practice
Keywords: Talent
Management,
Practice
Job Performance
Nurse Manager
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A quasi-experimental design
Primary purpose: OTHER

Brief summary: Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems.

Detailed description: Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems. This study aimed to examine the effect of the talent management intervention program for first-line nurse managers on their job performance

Eligibility criteria: Inclusion Criteria:

* First-line nurse managers

  * willing to participate in the study
  * work in all inpatient care units of Alexandria University hospitals
  * Sign a consent

Exclusion Criteria:

* First-line nurse managers

  * work in outpatient units
  * Did not sign a consent
  * Absent from training

Primary outcomes:
measure: Questionnaire to measure nurse managers' knowledge
timeFrame: one month
measure: Questionnaire to measure talent management practice among first line nurse managers.
timeFrame: one month
measure: Questionnaire to measure first-line nurse manager job performance
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mersa Matruh
country: Egypt
facility: Faculty of Nursing, Matrouh University
Study officials:
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Nagah Abd El-Fattah Mohamed Aly, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Wael M. Lotfy, Ph.D
role: STUDY_DIRECTOR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Safaa M. El-Shanawany, Ph.D
role: STUDY_CHAIR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Maha Ghanem, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01529762: Observational Study of Osseotite Certain Tapered Implants in Immediate Loading Cases
Official title: A Prospective, Observational Study of Immediate Loading Cases Using Osseotite Certain Tapered Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
Osseotite Certain Tapered
randomized
clinical study
partial edentulism
immediate loading
crestal bone level
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 47
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 with partial edentulism needing a minimum of one dental implant restored immediately (same visit)

Brief summary: Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.

Detailed description: Osseotite Certain Tapered implants are placed and restored immediately (during the same visit)

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: cumulative success rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad San Sebastian
Study officials:
affiliation: Universidad San Sebastian
name: Fernando Fuentes, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235362: A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706
Official title: A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Type 2 Diabetes Mellitus
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers

Detailed description: This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

Eligibility criteria: Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Primary outcomes:
measure: YHR1705, YHR1706 AUCtau
timeFrame: 0 - 24hours
measure: YHR1705, YHR1706 Css, max
timeFrame: 0 - 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03123562: Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus
Official title: Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Stem cells
Neonatal icterus
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Detailed description: The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy of any types caused by neonatal icterus

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections

Primary outcomes:
measure: GMFM-88 and GMFM-66 Percentile
timeFrame: Time Frame: Baseline and 6 months after transplantation
Secondary outcomes:
measure: Change in Muscle tone
timeFrame: Time Frame: Baseline and 6 months after transplantation
measure: Number of adverse events
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem T Nguyen, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.
citation: Jasovic M, Kamenica S, Draganic M, Vasovic P, Nikolajevic A. [Differential diagnosis between mediastinal tumors and aneurysms of the thoracic aorta]. Srp Arh Celok Lek. 1977 Jan;105(1):39-45. No abstract available. Serbian.
citation: Thanh LN, Trung KN, Duy CV, Van DN, Hoang PN, Phuong ANT, Ngo MD, Thi TN, Viet AB. Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial. BMC Pediatr. 2019 Aug 22;19(1):290. doi: 10.1186/s12887-019-1669-2.