louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05273918: Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Official title: Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Hyperactivity Disorder
Attention Deficit
Keywords: FASD
ADHD
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.

It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.


Eligibility criteria: Inclusion Criteria:

* child with fetal alcohol spectrum disorder
* child with attention deficit disorder with / without hyperactivity
* child with a score upper than or equal to 180 points on the "Aggressive behavior", "Anxiety / Depression" and "Concentration problems" subscales of the CBCL
* child followed in La Reunion, Montpellier or Bordeaux University Hospital
* child whose parents are affiliated with social security
* child who accepts to participate and whose parents have given their consent

Exclusion Criteria:

* non-french speaking child or parents / non-creole speaking child or parents
* child who already participate to CBT or body mediation groups

Primary outcomes:
measure: effectiveness of cognitive behavioral therapy program
timeFrame: 7 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint Eloi
city: Saint Pierre
country: Réunion
facility: CHU de La Réunion
Study officials:
affiliation: CHU de La Réunion
name: Michel SPODENKIEWICZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04158518: De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
De-escalation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of nasopharyngeal carcinoma
* Stage III or IVA according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Can not take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)

Primary outcomes:
measure: DFS
timeFrame: 3 year
Secondary outcomes:
measure: OS
timeFrame: 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Centre
Study officials:
affiliation: Fudan University Shanghai Cancer Centre
name: Chaosu Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200718: A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Official title: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic
Lead sponsor: Immune Response BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy

Detailed description: A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy 12 subjects with pediatric MS

Eligibility criteria: Inclusion Criteria:

* Ages Eligible for Study: 5 Years to 17 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No Criteria
* Subject is between 5 and 17 years of age, inclusive
* Clinically diagnosed Pediatric MS
* Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
* Expanded Disability Status Scale (EDSS) \<= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
* Laboratory values within the following limits:

  * Creatinine 1 . 5 x high normal
  * Hemoglobin

Exclusion Criteria:

* Subjects currently prescribed Campath or Lemtrada

Primary outcomes:
measure: The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
timeFrame: 26 Weeks
Secondary outcomes:
measure: A Secondary clinical endpoint is the measurement of FOXP3+ expression
timeFrame: 26 Weeks
measure: A Secondary clinical endpoint is the measurment of EDSS scores
timeFrame: 26 Weeks
measure: A Secondary clinical endpoint is the measurement of clinical relapses
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: CRO
state: California
Study officials:
affiliation: Immune Response BioPharma, Inc.
name: Richard M Bartholomew, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05849818: Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
Official title: Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome DS
Virtual Reality VR
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with Down syndrome

Detailed description: Intellectual disability is recognized as one of the most prominent features of DS which is the most common genetic cause of intellectual disability. Cognitive functioning often changes across the lifespan and is moderated by several comorbid factors such as sensory impairments, seizures, autism, sleep disruption, and other medical and psychiatric conditions (Grieco et al., 2015).

There is encouraging evidence supporting the use of non-immersive virtual environments to provide useful learning, rehabilitation, and leisure experiences for people with intellectual disabilities. Therefore, immersive VR applications may also be an effective way to improve motivation and engagement for children with DS in learning settings (Michalski et al., 2022). Therefore, this study aims to investigate the effect of full-immersive VRapeutic software gaming technology on cognitive functions of children with Down syndrome

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Down Syndrome Age from 6-10 years Both Genders will be included IQ Ranges from 50-69(mild intellectual disability) they will be able to understand the instructions able to walk independently

Exclusion Criteria:

* Significant Visual or Hearing problems Significant mental or psychological problems that interfere with understanding instructions musculoskeletal problems or fixed deformities in upper or lower limbs Current hospitalization for urgent Medical reasons

Primary outcomes:
measure: Rate of change of cognitive function by using the rehacom device
timeFrame: up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Amira Eltohamy, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04852718: Rehabilitation Program for the Sequelae of COVID 19 Infection
Official title: Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.

Brief summary: SUBPROJECT 1:

Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital.

Retrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed.

SUBPROJECT 2:

Evaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life.

Prospective observational study of a single cohort of patients. The data will be collected from successive clinical visits.


Eligibility criteria: Inclusion Criteria:

* • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.

  * PCR or serological negative test or more than 28 days after diagnosis.
  * Dyspnoea in activities of daily living (mMRC ≥ 2), (Annex 5 of the clinical protocol).
  * Patients who had muscle weakness (Clinical Frailty Scale ≥ 3), (Annex 1 of the clinical protocol).

Exclusion Criteria:

* Patients with disease activity.
* Live outside the reference area of the Hospital de la Santa Creu i Sant Pau.
* Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.

Primary outcomes:
measure: Muscular function
timeFrame: 1 year
Secondary outcomes:
measure: Health-related Quality of life
timeFrame: 1 year
measure: Respiratory muscle function
timeFrame: 1 year
measure: Exercise capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Maria-Rosa Güel-Rous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrot JC, Segura M, Beranuy M, Gich I, Nadal MJ, Pintor A, Terra J, Ramirez E, Paz LD, Bascunana H, Plaza V, Guell-Rous MR. Comparison of post-COVID symptoms in patients with different severity profiles of the acute disease visited at a rehabilitation unit. PLoS One. 2022 Sep 16;17(9):e0274520. doi: 10.1371/journal.pone.0274520. eCollection 2022.
Clinical trial NCT06039618: Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina
Official title: Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Care
Lead sponsor: Evangelisches Krankenhaus Bethesda zu Duisburg
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 22897
Sex: ALL
Minimum age (years): 22
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina

Brief summary: The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the PHI of the first and second level, 159 newborns were referred to the third level. Out of a total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4 hours. In second level PHI, most LBWI died in the first 12 hours after birth.


Eligibility criteria: Inclusion Criteria:

* Newborns of both genders that were born in the maternity wards in 10 cantons of the FBiH
* A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.

Exclusion Criteria:

* Infants younger than 22 weeks or older than 42 weeks.
* Infants whose mothers refused to give consent for participation in the study.

Primary outcomes:
measure: Referral to a centre of higher organizational level.
timeFrame: Before birth and up to 4 hours or more after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Tešanj
country: Bosnia and Herzegovina
facility: General Hospital Tešanj
Study officials:
affiliation: General Hospital Tešanj
name: Anis Cerovac, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503018: Psychological Effects of Implant Loss
Official title: Psychological Effects of Implant Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Keywords: Breast reconstruction
Plastic surgery
Psychology
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-08-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Purposive criterion sampling technique is used. The population will identified through an operation planning software

Brief summary: Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* Biological women
* Age \>18 years
* Have lost an implant after a mastectomy and immediate breast reconstruction

Exclusion Criteria:

* Inability to give informed consent
* inability to speak and understand Swedish
* relapse of breast cancer after the reconstruction
* metastatic disease
* psychiatric co-morbidity.

Primary outcomes:
measure: Experiences and psychological effects of implant loss after immediate breast reconstruction
timeFrame: 10 years
measure: Effect on quality of life of implant loss: scale
timeFrame: 10 years
measure: Effect on body image of implant loss
timeFrame: 10 years
measure: Effect on depression and anxiety of implant loss
timeFrame: 10 years
measure: Coping strategies
timeFrame: 10 years
measure: Coping strategies
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Västra Götaland
Study officials:
affiliation: Göteborg University
name: Emma Hansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.
citation: Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.
Clinical trial NCT06662318: Perioperative Pain Management for Lumbar Spine Surgery
Official title: Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 75
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.

Opioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.

Non-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.


Eligibility criteria: Inclusion Criteria:

* Patients who had LDD and required lumbar discectomy,
* Patients are free of exclusion criteria and accepted to participate in the study.

Exclusion Criteria:

* The presence of other indications for spinal surgery;
* Obesity of grade ≥II;
* Patients of ASA grade \>II;
* opioid dependence for preoperative pain;
* The presence of other causes of preoperative pain;
* The presence of preoperative psychiatric manifestations especially delirium and/or cognitive dysfunction;
* The presence of contraindications for the use of the study drugs;
* The presence of uncontrolled cardiac, renal, or hepatic disorders and essential hypertension.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT05675618: Return to Golf After Orthopaedic Surgery
Official title: Golfing After Orthopaedic Surgery: a Longitudinal Follow-up (GOLF) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Shoulder Osteoarthritis
Keywords: return to golf, arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Royal Infirmary of Edinburgh
First posted: 2023-01-09
Enrollment: 432
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: Adult patients undergoing joint replacement surgery who are self-reported golfers and have a desire to return to golf postoperatively

Brief summary: The GOLF study is a multicenter, prospective study with the goal to investigate golfers' return to the sport following hip, knee or shoulder arthroplasty. The prevalence of return to golf, by level of returning to golf will be assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Patients who are active golfers undergoing joint replacement will be identified from outpatient clinics and pre-assessment clinics and given information about the study at least two weeks prior to surgery. Participants in this study must have a desire to return to golf after surgery. Previous studies have only been able to report the return to golf after arthroplasty retrospectively; the prospective nature of this study will allow for a greater understanding of this process.


Eligibility criteria: Inclusion Criteria:

* Age 18+ years
* A self-reported golfer
* Able to consent to treatment
* Indicated for one of the following surgical procedures: total hip arthroplasty, hip resurfacing, revision hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, revision knee arthroplasty, total shoulder arthroplasty, reverse shoulder arthroplasty, shoulder resurfacing arthroplasty, revision shoulder arthroplasty

Exclusion Criteria:

* Inability to complete follow-up questionnaires
* Declining operative management
* No desire to return to golf postoperatively
* Medical problem that affects the patient's ability to play golf (e.g., angina, shortness of breath, etc.)

Primary outcomes:
measure: Prevalence of return to golf following joint arthroplasty
timeFrame: Up to 1 year postoperatively
Secondary outcomes:
measure: Golf awareness after arthroplasty score
timeFrame: Up to 1 year postoperatively
measure: Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
timeFrame: Up to 1 year postoperatively
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
timeFrame: Up to 1 year postoperatively
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: Up to 1 year postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
References: