louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04558099: Effectiveness of MBSR Among Student Teachers
Official title: Effectiveness of Mindfulness-based Stress Reduction Among Student Teachers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reduction
Mental Well-being
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 67
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate the effectiveness of Mindfulness-based Stress Reduction among Danish student teachers on their mental well-being. The study is a randomised, controlled trial including 100 teachers.


Eligibility criteria: Inclusion Criteria:

* Danish student teacher

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 2 months from baseline
Secondary outcomes:
measure: Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale
timeFrame: post MBSR (8 weeks from baseline)
measure: Symptom Check List - 5
timeFrame: post MBSR (8 weeks from baseline)
measure: WHO-5
timeFrame: post MBSR (8 weeks from baseline)
measure: Five Facet Mindfulness Questionnaire-15
timeFrame: post MBSR (8 weeks from baseline)
measure: Amsterdam Resting State Questionnaire
timeFrame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Study officials:
affiliation: Aarhus University, Danish Center for Mindfulness
name: Lone Fjorback, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Juul L, Brorsen E, Gotzsche K, Nielsen BL, Fjorback LO. The Effects of a Mindfulness Program on Mental Health in Students at an Undergraduate Program for Teacher Education: A Randomized Controlled Trial in Real-Life. Front Psychol. 2021 Dec 6;12:722771. doi: 10.3389/fpsyg.2021.722771. eCollection 2021.
Clinical trial NCT04828499: To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Official title: To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hard Nuclear Cataract
Corneal Endothelial Cell
Progressive Cracking Technique
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 60 participants at Eye Hospital of Wenzhou Medical University during January,2017 to June 2021 will be enroll in our study. And dived them randomly into 2 groups:Progressive Cracking Technique (30 eyes) and Conventional Chop Technique (30 eyes) .


Eligibility criteria: Inclusion Criteria:

* Cataract with Grade IV\~V nucleus sclerosis
* Cataract surgery is planned
* The operation was successful without any complications

Exclusion Criteria:

* Patients with other diseases that affect the corneal endothelium
* Has a history of anterior segment surgery
* Failure to cooperate with follow-up

Primary outcomes:
measure: corneal endothelial cell density
timeFrame: up to 1 months
measure: Coefficient of variation of endothelial cells
timeFrame: up to 1 months
measure: percentage of hexagonal cells of the cells marked
timeFrame: up to 1 months
measure: central corneal thickness
timeFrame: up to 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT04486599: Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations
Official title: Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Malformation
Keywords: Foam Sclerotherapy
Ultrasound
Electromagnetic Navigation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.

Detailed description: Primary interventional treatment of low flow vascular anomalies includes ultrasound guided foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However, procedures remain complicated to obtain the right trajectory in order to inject the foam at the center of the abnormality. Electromagnetic navigation system tracks the operator's needle, meaning the position and progression of the needle is visualized in 3D real time on the ultrasound probe interface.

The present trial evaluate the feasibility of the electromagnetic navigation system during the needle insertion and the improvement of needle placement accuracy.

Eligibility criteria: Inclusion Criteria:

* Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
* Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting

Exclusion Criteria:

* patients with pacemakers or internal defibrillator
* patients with ferromagnetic implanted material
* patients who are wards of court or under guardianship
* patients deprived of freedom by judicial or administrative decision
* patients under legal protection
* pregnant women

Primary outcomes:
measure: Percentage of patients for whom the procedure is successful
timeFrame: day 1
Secondary outcomes:
measure: Estimate the number of punctures required to achieve catheterization of the malformation.
timeFrame: day 1
measure: Estimate the time to complete catheterization of the malformation
timeFrame: day 1
measure: Estimate the undesirable effects associated with assisted electromagnetic navigation.
timeFrame: day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
state: Occitanie
Study officials:
affiliation: University Hospital, Toulouse
name: Wassim Mokaddem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00647699: Corneal Collagen Cross-linking for Progressive Keratoconus
Official title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Progressive Keratoconus
Keywords: keratoconus
cross-linking
riboflavin
UVA light
cornea
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 147
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Detailed description: This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus
* Documented progression over previous 24 months
* Decreased BSCVA
* Must complete all study visits

Exclusion Criteria:

* Prior corneal surgery or Intacs
* History of delayed wound healing

Primary outcomes:
measure: Mean Change From Baseline in Maximum Keratometry (Kmax)
timeFrame: baseline,12 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Eye Center
state: California
city: San Diego
country: United States
facility: Gordon -Weiss Vision Institute
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Kansas City
country: United States
facility: Durrie Vision
state: Kansas
city: Baltimore
country: United States
facility: Wilmer Eye Institute at Johns Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Teaneck
country: United States
facility: Cornea & Laser Eye Institute; Hersh Vision Group
state: New Jersey
city: New York
country: United States
facility: Edward Harkness Eye Institute at Columbia University Medical Center
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Cornea and Laser Institute
name: Peter Hersh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.
Clinical trial NCT02233699: A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
Official title: A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Idiopathic Cough.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Cough
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ario Pharma Ltd
First posted: 2014-09-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough.

The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[VAS\]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Male/female subjects aged 18 or over with chronic idiopathic cough

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results, ECGs or vital signs

Primary outcomes:
measure: Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: Ireland
facility: Belfast City Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
References:
Clinical trial NCT06099899: Qualitative Study on Factors Impeding Physical Activity During the Post-discharge Period After Hematopoietic Stem Cell Transplantation in Children
Official title: Qualitative Study on Factors Impeding Physical Activity During the Post-discharge Period After Hematopoietic Stem Cell Transplantation in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Physical Activities
Keywords: hematopoietic stem cell transplantation
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children during the post-hematopoietic stem cell transplantation period at home

Brief summary: The purpose is to gain a deep understanding of the hindering factors in physical activities during the home period after pediatric hematopoietic stem cell transplantation, in order to provide references for developing targeted intervention measures.

Detailed description: From October 2023 to September 2024, a purposive sampling method will be used to select 10 post-pediatric hematopoietic stem cell transplant patients and 10 family members receiving treatment at Sun Yat-sen Memorial Hospital, Zhongshan University, as the subjects for the study. The phenomenological approach in qualitative research will be employed to conduct in-depth interviews with them, and data analysis will be performed using the Colaizzi analysis method.

Eligibility criteria: Inclusion Criteria:

* The child's age ranges from 8 to 18 years old.
* They have undergone hematopoietic stem cell transplantation for at least one month.
* They do not have any mental disorders or consciousness impairments.
* The child is capable of independent walking.
* The interviewees are able to express their thoughts clearly.
* Both the child and their family members are informed about and have given consent to participate in this study.

Exclusion Criteria:

* Relapse or the presence of other tumors
* Physical activity prohibitions, such as movement disorders, platelet count \<20×10⁹, -acute bleeding, hemoglobin level \<80g/L
* Fever with a temperature of 38.8℃ or higher due to infection
* Pain score of 4 or higher
* Other severe complications, such as heart failure or severe malnutrition.

Primary outcomes:
measure: the hindering factors in physical activities interview
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: QIAN HAO, nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06158399: AZA Combined With RCHOP in P53-mutated DLBCL.
Official title: A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
TP53
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
Collaborators: name: Jiangsu Provincial People's Hospital
name: Sun Yat-sen University
name: Chinese Academy of Medical Sciences
name: Shanxi Province Cancer Hospital
First posted: 2023-12-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma

Detailed description: This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma

Eligibility criteria: Inclusion Criteria:

(1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.

Exclusion Criteria:

1. Primary and secondary central DLBCL;
2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;

4) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family

Primary outcomes:
measure: Complete remission rate (CR)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Partial remission rate (PR)
timeFrame: Up to 36 months
measure: Overall response rate (ORR)
timeFrame: Up to 36 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Bing Xu
state: Fujian
Study officials:
affiliation: The First Aiffiliated hosptical of xiamen University
name: Bing Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02467699: Navigation System for in Vivo Measurement of the Kinematics of the Knee
Official title: Validation of a Noninvasive Navigation System for in Vivo Measurement of the Kinematics of the Knee
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: Knee
Knee osteoarthritis
Knee replacement
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Brief summary: The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up 30%) say disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be poor adaptation of the implants to the patient's anatomy, resulting in a non-physiological kinematics for the patient. Multiple studies try to obtain an individual adaptation of the intervention according to multiple criteria. The measurement of the kinematics of the knee before surgery could participate in this process.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total hip knee prosthesis.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: in vivo measurement of the kinematics of the knee
timeFrame: patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre de Chirurgie Orthopédique et de la Main (CCOM)
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03225599: Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
Official title: Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion Injury of Cerebrum
Cranial Osteopathic Medicine
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2017-07-21
Enrollment: 9
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.


Eligibility criteria: Inclusion Criteria:

* Concussion occurred within 8 weeks
* Age greater or equal to 14 years
* Complains of post-concussive symptoms with a symptom score of \>10 on PCSS

Exclusion Criteria:

* Concussion occurred \> 8 weeks
* Age less than 14 years
* Surgery of the cervical and/or thoracic spine within the last 3 months
* Currently receiving or has received workers compensation within the last 3 months
* Currently or potentially become involved in litigation related to the injury
* Received osteopathic craniosacral treatments within the last 3 months
* History of hydrocephalus, current infection or active tumor
* Active or marked depression, anxiety or psychosis

Primary outcomes:
measure: Change in Concussive Symptoms on the Post Concussion Symptom Scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01969006: Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair
Official title: Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Post Operative Pain as Estimated by the Sue of the VAS Score
Keywords: inguinal hernia, postoperative pain, localanesthesia, nerve blockage
Lead sponsor: Randers Regional Hospital
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Horsens
name: Denmark
First posted: 2013-10-24
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.

Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.

Pain will be estimated using the VAS score in:

1. the wound 2 the abdomen 3 the shoulder

Scoring will be performed:

1. pre-operatively
2. 1 hour postoperatively
3. at discharge from the hospital d day 1,2 and 3 post OP

e. 1 year post OP

Detailed description: as above

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 year
2. Informed consent
3. a diagnosis of an inguinal hernia
4. ASA group ≤ 3
5. BMI ≤ 35

Exclusion Criteria:

1. Communication problems
2. No consent
3. Open procedure (not laparoscopic)
4. ASA-group 4
5. Use of Steroid or immunosuppressive tretament
6. Regular morphine use.

Primary outcomes:
measure: Post operative pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Regions Hospital
city: Randers
country: Denmark
facility: Randers regions Hospital
Study officials:
References: