louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05254899: Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
Official title: Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Early-stage
High-Risk Cancer
Keywords: NK/T-Cell Lymphoma, Nasal and Nasal-Type
anti-PD-1 antibody
radiotherapy
chemotherapy
Pegaspargase
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Peking University Cancer Hospital & Institute
name: The Affiliated Hospital Of Guizhou Medical University
name: The First Hospital of Jilin University
First posted: 2022-02-24
Enrollment: 54
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: The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type


Eligibility criteria: Inclusion Criteria:

* Biopsy proved extranodal NK/T cell lymphoma
* No previous anti-cancer treatment
* Measurable lesion on baseline PET/CT and MRI
* Stage I-II
* Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
* ECOG PS 0-1
* Sufficient organ functions

Exclusion Criteria:

* Other mature T- or NK- lymphoma
* Hemophagocytic lymphohistiocytosis
* Primary CNS lymphoma or CNS-involved lymphoma
* History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment

Primary outcomes:
measure: Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
timeFrame: At the end of Cycle 3 (each cycle is 14 days)
Secondary outcomes:
measure: Progression-free survival rate at year 2 after enrollment, 2y-PFS
timeFrame: 2 year
measure: Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
timeFrame: 2-year, 5-year
measure: acute toxicity
timeFrame: From enrollment to 3 months after treatment
measure: Quality of Life，QoL
timeFrame: baseline, 1/3/6/12/24 months after treatment
measure: Quality of Life，QoL
timeFrame: baseline, 1/3/6/12/24 months after treatment
Other outcomes:
measure: biomarkers (single cell transcriptomics)
timeFrame: baseline, 2 years
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Shunan M Qi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731299: Muscle Synergies After Stroke
Official title: Are Spatial and Temporal Muscle Synergy Modules Related to Functional Ability After Stroke?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: muscle synergies
gait
functional ability
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care clinic

Brief summary: The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait.

Detailed description: The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait. Although literature has suggested that merging of synergies occurs after stroke and that a larger number of is associated with increased motor function if compared with healthy adults. IIt is still unknown if this hypothesis is also relevant when comparing different functional levels within a stroke population and what functional impact of altered synergies on walking behavior is.

Eligibility criteria: Inclusion Criteria Stroke:

1. haemorrhagic or ischaemic stroke diagnosis, confirmed on the basis of CT or MRI imaging;
2. no known history of previous stroke;
3. stroke onset within five months; 4 patients are between 18 and 85 years of age;

Exclusion Criteria Stroke:

1. A score of 20 or higher on the Trunk Impairment Scale which indicates normal truncal function;
2. A score lower than two on the Functional Ambulation Categories (FAC) as patients needed to be able to ambulate without physical support to ensure that gait analysis can be executed safely;
3. Not able to sit independently for 30 seconds on a stable surface;
4. They suffer from other neurological and orthopaedic disorders that could influence motor performance and balance;
5. not able to understand instructions.

Primary outcomes:
measure: Amount of muscle synergies derived by non-negative matrix factorization
timeFrame: Once, in the week of inclusion
Secondary outcomes:
measure: Distribution of muscle synerigies derived by non-negative matrix factorization
timeFrame: Once, in the week of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Universiteit Antwerpen
name: Steven Truijen, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00793299: Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
Official title: Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.

Detailed description: In addition to the above outcome measures:

The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cancer
* Age 10-18
* In active treatment for cancer
* Followed at the Strong Memorial Hospital/Golisano Children's Hospital

Exclusion Criteria:

* Non-English Speaker
* Cognitively impaired so as to make data collection difficult

Primary outcomes:
measure: Memorial Symptom Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Rosenberg Self Esteem Scale
timeFrame: 3 mopnths
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester School of Medicine and Dentistry, Golisano Children's Hospital at Strong
state: New York
Study officials:
affiliation: Medical Student
name: Emily Hahn, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Barbara Asselin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06518499: Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
Official title: Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pilonidal Sinus
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged 18 and older with pilonidal sinus disease and three or fewer pits, with no previous surgical treatment.

Brief summary: Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.

Detailed description: This study is a single-center, prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascom's pit-pick methods in treating pilonidal sinus disease in women. Female patients aged 18 and over, with three or fewer pits, will be included, and each patient will be followed for 12 months. The Bascom pit-pick method will be performed under local anesthesia, while the Karydakis method will be performed under spinal or general anesthesia. Postoperative recovery time, complications, recurrence rates, and patient satisfaction will be evaluated. Ethics committee approval has been obtained (Approval No: TE 172, Date: June 12, 2024).

Eligibility criteria: Inclusion Criteria:

* Female patients 18 years old and older
* Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
* No previous surgical treatment for pilonidal sinus.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy
* Presented with acute abscesses
* Patients with recurrent disease, Stage-R.
* \>3 pit
* Collagen tissue disease
* Exceed to navicular area
* Lateral extension in both directions
* Accidentally discovered (asymptomatic) sinus or with follow-up \<12 months

Primary outcomes:
measure: Recurrence Rate
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Complication Rate
timeFrame: 30 days post-surgery
measure: Aesthetic Outcome (Visual Analog Score for pain)
timeFrame: Up to 1 year post-surgery
measure: Healing Time
timeFrame: Up to 12 weeks post-surgery
measure: Functional Recovery
timeFrame: Up to 24 weeks post-surgery
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
state: Other
Study officials:
References:
Clinical trial NCT03276299: Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
Official title: Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* acute or chronic lung, cardiac or neuromuscular disease
* at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex)
* a motor disability

Primary outcomes:
measure: distance
timeFrame: six minutes
Secondary outcomes:
measure: heart rate
timeFrame: six minutes
measure: pulsed oxygen saturation
timeFrame: six minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique universitaire Saint-Luc
Study officials:
References:
citation: Morales Mestre N, Audag N, Caty G, Reychler G. Learning and Encouragement Effects on Six-Minute Walking Test in Children. J Pediatr. 2018 Jul;198:98-103. doi: 10.1016/j.jpeds.2018.02.073. Epub 2018 Apr 24.
Clinical trial NCT05517499: Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
Official title: Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy, Self
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2022-08-26
Enrollment: 120
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To determine efficacy of dexamethasone in treatment of meconium aspiration syndrome.

Study design: Randomized control trial. Place and duration: Services hospital, Neonatal unit, Lahore. During time span of 1st January to 30th June 2021.

Material and methods Total 100 neonates were randomly divided in two groups. Group A (n=50) was treated with dexamethasone (Cases) and Group B (n=50) served as control. Dexamethasone was given in dose of 0.2mg/kg, 12 hourly for 7 days after confirmation of diagnosis. Infants present in clinical trial were evaluated by ventilation duration (invasive and non-invasive), oxygen therapy and hospital stay.

Detailed description: Data was analyzed in statistical analysis SPSS version 23. Means and Standard deviation were calculated for duration of non-invasive and invasive ventilation, hospital stay and oxygen therapy. Independent sample T test was applied and value \< 0.05 was taken as significant. Whereas frequency and percentages were taken for gender, gestation, mode of delivery and outcome of MAS and Chi-square test was applied, and p value \< 0.05 was taken as significant.

Eligibility criteria: Inclusion Criteria:

1. Term and Post-Term babies who met the operational definition of MAS (inborn)
2. Presenting within 24 hours of life

Exclusion Criteria:

1. Preterm babies or babies with congenital malformations
2. Preterm babies or babies with dysmorphism
3. Preterm babies or babies with hypoxic-ischemic encephalopathy

Primary outcomes:
measure: The number of days required for ventilation in participants
timeFrame: 7 days
measure: The number of days required for oxygen therapy in participants
timeFrame: 7 days
measure: The number of days required for hospitalization in participants
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences, Lahore
name: Uzair Qureshi, FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT06175299: Social Functions to Promote Home-based Cognitive Training
Official title: Evaluating the Social Functions to Promote the Adherence and Reduce Social Isolation in Home-based Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Treatment
Social Isolation
Keywords: Cognition
Adherence
Social isolation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation.

Detailed description: The goal of this project is to conduct a pilot study to test the feasibility of two new features, a chat function and a leaderboard function, to encourage social interactions and support adherence to cognitive training protocols (mental exercises delivered via a tablet) over a period of time (2 months), and uncover individual difference factors that can predict poor adherence in the future and social interactions in the game. Even effective cognitive interventions may fail if individuals do not adhere to them for an extended period. This project will compare cognitive training games with chat function and leaderboard in reducing social isolation and improving adherence to the training, compared to an external control group using a generic reminder system delivered via smartphone text messages to promote adherence. The ultimate goal, as effective technology-based interventions to improve cognition become available, is to help support their benefit for older adults by maximizing long-term adherence.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older
* Normal or corrected to normal visual acuity
* Must pass a dementia screening.

Exclusion Criteria:

* Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
* Terminal illness
* Severe motor impairment
* Not living in the Tallahassee area for the entire 6 month study period

Primary outcomes:
measure: Three-Item Loneliness Scale
timeFrame: Assessed at baseline and at the end of the 2-months of training
Secondary outcomes:
measure: Adherence (session number)
timeFrame: 2 months
measure: Adherence (session length)
timeFrame: 2 months
measure: General Self-Efficacy (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 2 months
measure: Perceived Training Efficacy (predictor of adherence)
timeFrame: Assessed at baseline
measure: Self-Efficacy of Cognitive Training (predictor of adherence and training outcome)
timeFrame: Assessed at baseline and at the end of the 2-months of training
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Zhe He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318199: Emergence Agitation in Adult Patients After Intracranial Surgery
Official title: Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care, Surgical
Postoperative Care
Neurosurgery
Keywords: emergence agitation
intracranial surgery
general anesthesia
incidence
risk factor
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospital, China
First posted: 2014-12-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients after craniotomy

Brief summary: Emergence agitation is a frequent complication that can have serious consequences during recovery from general anesthesia. However, agitation has been poorly investigated in patients after craniotomy. In this prospective multicenter cohort study, adult patients will be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk factors and outcome will be investigated.


Eligibility criteria: Inclusion Criteria:

* Both supratentorial and infratentorial intradural cranial operations

Exclusion Criteria:

* Unarousable state (SAS=1) during the first 24 hours after the operation
* Interval longer than 24 hours between the end of the surgery and neurosurgical ICU admission

Primary outcomes:
measure: Emergence agitation
timeFrame: 12 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Daxing Teaching Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Clinical College, Fujian Medical University
state: Fujian
city: Shijiazhuang
country: China
facility: Bethune International Peace Hospital, Hebei Medical University
state: Hebei
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang HW, Yan LM, Yang YL, He X, Sun XM, Wang YM, Zhang GB, Zhou JX. Bi-frontal pneumocephalus is an independent risk factor for early postoperative agitation in adult patients admitted to intensive care unit after elective craniotomy for brain tumor: A prospective cohort study. PLoS One. 2018 Jul 19;13(7):e0201064. doi: 10.1371/journal.pone.0201064. eCollection 2018.
citation: Yan LM, Chen H, Yu RG, Wang ZH, Zhou GH, Wang YJ, Zhang X, Xu M, Chen L, Zhou JX; Acute Brain Injury and Critical Care Research Collaboration (ABC Research Collaboration). Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study. BMJ Open. 2015 Apr 21;5(4):e007542. doi: 10.1136/bmjopen-2014-007542.