louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03166410: Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
Official title: Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Texas Plastic Surgery
Sponsor class: INDUSTRY
First posted: 2017-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.


Eligibility criteria: Inclusion Criteria:

1. Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
2. Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
3. Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
4. Subjects with ASA grade I, II, or III
5. Males and females 25-85 years old
6. Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months

Exclusion Criteria:

1. Subjects that are allergic to lidocaine, epinephrine or valium
2. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
3. Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
4. Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
5. Women that are pregnant or planning to become pregnant during the study
6. Subjects on long term use of oral steroids
7. History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site

Primary outcomes:
measure: Safety - Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy - Change in Pain Scores at All Follow-up Visits
timeFrame: 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Plastic Surgery
state: Texas
Study officials:
References:
Clinical trial NCT03364010: Dyslexia, Motor Control and Proprioception
Official title: Relationships Between Proprioception, Motor Control and Reading in Children With Dyslexia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyslexia
Keywords: Motor control
Proprioception
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-12-06
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesize that children with dyslexia present proprioceptive disorders and the purpose of the present study is to better understand relationships between motor control, proprioception and academic learnings. The investigators compare a group of French students with and without dyslexia aged 10-12.

Detailed description: 2 groups of children (dyslexics and control) will be evaluated on 2 tasks:

* Evaluation of the proprioception: Perception of the speed and Perception of the position
* Evaluation of the motor learning: Estimation of state in the framework of a motor perturbation

Eligibility criteria: Inclusion criteria for all children

* Child with a French social security
* School child
* Native French speaker
* right-handed
* Normal or corrected vision
* Without neurological or psychiatric histories
* Agree to participate in the study in agreement with parental rights representatives

For the dyslexic group :

* pluridisciplinary diagnostic
* never consulted for proprioception before
* without any other leaning disorders like dysphasia
* attention deficit hyperactivity disorder (ADHD) or developmental coordination disorder (DCD)

For the control group :

* regular school attendance
* never consulted for learning disabilities
* No learning disorders known for their parents or siblings.

Exclusion criteria for all children

* genetic disorder
* neurological or psychiatric history
* Delayed psychomotor development
* Reeducation or current treatment interfering with the evaluation

Primary outcomes:
measure: Evaluation of proprioception through velocity perception
timeFrame: 1day
Secondary outcomes:
measure: Evaluation of proprioception through position perception
timeFrame: 1 day
measure: Motor learning
timeFrame: 1 day
measure: Text reading
timeFrame: 1day
measure: Phonological awareness: phonemic blending and phonemic elision
timeFrame: 1day
measure: Identifying words
timeFrame: 1day
Other outcomes:
Locations:
city: Dijon
country: France
facility: Inserm U1093
state: Bourgogne
Study officials:
affiliation: Unité Inserm d'affiliation : Laboratoire U1093 Cognition, Action et Plasticité Sensorimotrice
name: Patrick QUERCIA, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laprevotte J, Papaxanthis C, Saltarelli S, Quercia P, Gaveau J. Movement detection thresholds reveal proprioceptive impairments in developmental dyslexia. Sci Rep. 2021 Jan 11;11(1):299. doi: 10.1038/s41598-020-79612-4.
Clinical trial NCT06157710: Randomised Controlled Trial of a Digital Programme for Procrastination in UK University Students
Official title: Randomised Controlled Trial of a Digital Programme for Procrastination in UK University Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Procrastination
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Linkoeping University
First posted: 2023-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of an 8-week self-directed internet based CBT intervention on various psychological outcomes for young students struggling with procrastination in the UK. The psychological outcomes consist of motivation, depressive symptoms, impulsivity and anxiety. More specifically, the study aims to compare the effect of the intervention vs waitlist control at 8 weeks on primary and secondary outcomes. Additionally, the study aims to explore whether changes in primary and secondary outcomes as the result of the intervention are mediated or moderated by key intervention processes.


Eligibility criteria: Inclusion Criteria:

* Resident in the UK
* Fluent in English
* Aged between 16 and 24 years of age
* Have access to computer or smartphone
* Score at least 40 points on the Pure Procrastination Scale (indicating difficulties with procrastination)

Exclusion Criteria:

* Ongoing psychological treatment
* New course of change in dose of psychotropic medication in the last two months (self-reported)

Primary outcomes:
measure: Procrastination: Pure Procrastination Scale (PPS; Rozental, Forsell, et al., 2014)
timeFrame: Baseline, WK4, WK8
Secondary outcomes:
measure: Demographics
timeFrame: Baseline
measure: Clinical Perfectionism Questionnaire (CPQ) (Fairburn et al., 2003)
timeFrame: Baseline, WK4, WK8
measure: Depressive symptoms: Patient health questionnaire-8 (PHQ-8) (Kroenke et al., 2008)
timeFrame: Baseline, WK4, WK8
measure: Anxiety symptoms: General Anxiety Disorder Scale (GAD-7) (Spitzer et al., 2006)
timeFrame: Baseline, WK4, WK8
measure: Impulsivity: Short form Barratt Impulsiveness Scale (Spinella 2009)
timeFrame: Baseline, WK4, WK8
measure: International physical activity questionnaire short form (Lee et al., 2011
timeFrame: Baseline, WK4, WK8
measure: Behavioural activation for depression scale (BATDS-SF) (Manos et al., 2011)
timeFrame: Baseline, WK4, WK8
measure: Intervention acceptability and appropriateness using the Intervention Appropriateness Measure (IAM), acceptability of Interventions Measure (AIM) and feasibility of intervention measure
timeFrame: WK4, WK8
measure: Usage data from intervention platform (e.g., time spend on modules, completion of worksheets)
timeFrame: Baseline to WK8
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
References:
Clinical trial NCT06162910: Validation of Aspiration Risk Assessment in Stroke Units
Official title: Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".

Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.

Detailed description: For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.

Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.

Eligibility criteria: Inclusion Criteria:

* Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT
* Neurological deficits
* Written informed consent

Exclusion Criteria:

* Cerebral hemorrhage
* Pre-existing swallowing disorders of other etiologies
* Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)

Primary outcomes:
measure: Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Functional Oral Intake Scale-German (FOIS-G)
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Giesen
country: Germany
facility: University Hospital Giessen and Marburg, Campus Giessen
state: Hessen
Study officials:
affiliation: University Hospital Giessen and Marburg, Campus Giessen
name: Samra Hamzic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Giessen and Marburg, Campus Giessen
name: Tobias Braun, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04622410: Registry for Hirschsprung Disease of the BELAPS
Official title: Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hirschsprung Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 432
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All Hirschsprung disease patients consecutively
* Male and female
* \< 18 years
* Operated by a participating surgeon
* Elective and emergency surgery
* Informed consent form signed by the parents of the child

Brief summary: Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym

/ Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation


Eligibility criteria: Inclusion Criteria:

Hirschsprung Disease, surgery

Exclusion Criteria:

-

Primary outcomes:
measure: To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium.
timeFrame: at least 10 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT05112510: Prognostic Prediction of NPC Based on MR Diffusion-weighted Imaging
Official title: Prognostic Prediction of Nasopharyngeal Carcinoma Based on Radiomics Features of MR Diffusion-weighted Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Nasopharyngeal Carcinoma
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with nasopharyngeal carcinoma

Brief summary: The purpose of this study is to explore whether the imaging model based on RESOLVE-DWI sequence can exploiting the heterogeneity of nasopharyngeal carcinoma and indicate the prognosis, so as to provide intervention information for clinical decision-making. All patients were randomly divided into the training group and the validation group. Radiomics features extracted from T2-weighted, DWI, apparent diffusion coefficient (ADC), and contrast- enhanced T1-weighted were used to build a radiomics model. Patients'clinical variables were also obtained to build a clinical model. Model of training cohort was established using cross-validation for nasopharyngeal carcinoma prognosis by machine learning, including Logistics Regression, SVM, KNN, Decision Tree, Random Forest, XGBoost, and then, the model will be verified in the validation cohort. Area under the curve (AUC) of the Machine learning model was used as the main evaluation metric.


Eligibility criteria: Inclusion Criteria:

1. patients with nasopharyngeal carcinoma diagnosed by pathology;
2. complete clinical data and MR imaging data;
3. without radiotherapy, chemotherapy or operation before MR examination.

Exclusion Criteria:

1. incomplete follow-up data;
2. poor image quality and can not be used for analysis;
3. patients with other tumors in the past or at the same time.

Primary outcomes:
measure: Calculating AUC of machine learning model based on MR diffusion-weighted imaging to evaluate efficacy for prognosis
timeFrame: Before January 2022
Secondary outcomes:
measure: Comparing AUC of machine learning model based on MR diffusion-weighted imaging and conventional MR sequences for prognosis
timeFrame: Before January 2022
measure: Calculating AUC of machine learning model based on MR diffusion-weighted imaging combinated with conventional MR sequence to evaluate efficacy for prognosis
timeFrame: Before January 2022
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03417310: Clinical Applications of a Joystick in Femoral Shaft Fractures
Official title: Studying the Clinical Applications of "H" Joystick for Reduction in Femoral Shaft Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Shaft Fracture
Keywords: closed reduction
locked intramedullary nailing
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
First posted: 2018-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will use a new "H" joystick for reduction on patients with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Detailed description: This study will design a new "H" joystick for reduction (which has received the national utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Eligibility criteria: Inclusion Criteria:

* Femur shaft fractures

Exclusion Criteria:

* Not suitable to receive intramedullary nail treatment

Primary outcomes:
measure: Operating time
timeFrame: One day
measure: Fluoroscopy times
timeFrame: One day
measure: Blood loss
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Xinjia Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05989581: Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
Official title: Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypertension in Pregnancy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 74
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with stage 1 HTN in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.
Primary purpose: TREATMENT

Brief summary: The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.


Eligibility criteria: Inclusion Criteria:

* Viable singleton gestation
* No fetal anomalies
* Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation
* Planning to deliver at UAB Hospital
* No indication for pregnancy termination
* Receiving care at the UAB prenatal clinics

Exclusion Criteria:

* Declines Randomization
* Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use
* Fetal demise diagnosed prior to enrollment
* Known major structural of chromosomal abnormalities prior to enrollment
* Contraindication to first line antihypertensive (Nifedipine/ Labetalol)
* Comorbidities requiring BP goals \< 130/80mmHg

Primary outcomes:
measure: Neonatal Birthweight percentile
timeFrame: at delivery of infant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
Clinical trial NCT04725981: Vaginal Stump Infection After Laparoscopic Hysterectomy
Official title: Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Vaginal Infection
Keywords: vaginal closure technique
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2021-01-27
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
Primary purpose: TREATMENT

Brief summary: Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.

Detailed description: Comparing two surgical techniques for vaginal stump infection after total laparoscopic or robot-assisted hysterectomy. Analysis of patient-based and therapy-based risk factors with the aim of optimizing the surgical technique and objectifying the risk factors. Control group: old colpotomy technique (3 Z-sutures PDS 0); Intervention group: new colpotomy technique (3 Z sutures with PDS 0 and 1 continuous suture with V-Loc 2-0)

Eligibility criteria: Inclusion Criteria:

1. Patient \> = 18 years old
2. Indication for total laparoscopic or robot-assisted hysterectomy
3. Benign uterine disease
4. Signed informed consent for study participation

Exclusion Criteria:

1. Patient with malignant gynecological diseases
2. Combination with other abdominal / vaginal interventions, except:

   * Adhesiolysis
   * Endometriosis removal (without rectovaginal endometriosis)
   * Conization
   * Hysteroscopy / curettage
3. Immunosuppressive therapy with cytostatics, glucocorticoids, HIV
4. Bleeding tendency / haemophilia
5. Acute infection

Primary outcomes:
measure: Number of participants with vaginal stump infection in intervention group and control group
timeFrame: 6 weeks
Secondary outcomes:
measure: Identify of patient-based and treatment-based risk factors for vaginal stump infection.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: Kanton Zurich
Study officials:
affiliation: Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren
name: Tatiana Naydina Ragaz
role: PRINCIPAL_INVESTIGATOR
References: