louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04851951: Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis
Official title: Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraspinatus Tendinitis
Keywords: Supraspinatus tendinosis; PRP; Shoulder;
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and July 2020 with Supraspinatus tendinosis were prospectively recruited.

Brief summary: It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old;
* Supraspinatus tendinosis detected by MRI.

Exclusion Criteria:

* Supraspinatus rupture;
* Previous shoulder surgery;
* Rotator cuff tears secondary to fracture;
* Hemoglobin \<7 g/dL or Platelets \< 30,000 microL;
* Active infection;
* Pregnant patients;
* Patients with hematologic and oncologic diseases.

Primary outcomes:
measure: Change in Visual Analogic Scale
timeFrame: Day 0; Month 1; Month 3; Month 6 (after the injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Study officials:
References:
Clinical trial NCT06554951: Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Official title: Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CAR-T Cell Therapy
Extracellular Vesicles
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include all patients who will undergo to CAR-T cell infusion per any hematological malignancies with AIFA approved CAR-T cell product.

Brief summary: Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested.

Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.


Eligibility criteria: Inclusion Criteria:

* patients affeccted by any hematological malignancies (r/r B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product;
* age: 18 years or greater;
* obtained written consent to the study participation.

Exclusion Criteria:

* none

Primary outcomes:
measure: Response rate to treatment with CAR-T cells
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
References:
Clinical trial NCT03336177: Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.
Official title: Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Symptoms and Signs
Aged
Keywords: gynecology
cancer
aged
delay
help-seeking behavior
qualitative research
semiopragmatic analysis
psychodynamic analysis
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of 65 years or more treated or followed at Lorraine Institute of Oncology Diagnosed after 65 years or later of a low gynecological cancer

Brief summary: Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.

The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

Detailed description: Our study assess the reasons for which the patient took time to go to the doctor despite of their symptoms. We use a qualitative methodology. Our study categorizes lived experiences, recorded in semistructured interview transcripts. We use psychodynamic and semiopragmatic analyses of the discourse to obtain hypotheses about possible reasons of the delay in the help-seeking process."

Eligibility criteria: Inclusion Criteria:

* Women of 65 years or more treated or followed at Lorraine Institute of Oncology
* Diagnosed after 65 years or later of a low gynecological cancer
* Without diagnosis of dementia
* Retained ability to express by herself without assistance
* Affiliated to public health system
* Informed and having expressed her non-opposition

Exclusion Criteria:

* Women under 65 or diagnosed before being 65 of a low gynecological cancer
* Diagnosed of dementia
* No longer to express herself
* Patient deprived of freedom

Primary outcomes:
measure: Experience of help-seeking period for low gynecological cancers.
timeFrame: 1 day
Secondary outcomes:
measure: Motivators and barriers to help-seeking for low gynecological cancers.
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL)
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: MARCHAL FREDERIC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02895477: Quest Sound Recover (SR2) vs. Venture SR2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.

To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Ability to fill in a question conscientious
* Healthy outer ear (w/o previous surgical procedures)
* Sensorineural symmetric hearing loss (HL)
* N4 to N7 (degree of HL)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
* Massively limited dexterity
* Known Psychological problems
* Central hearing problems

Primary outcomes:
measure: Functional gain
timeFrame: after 2 weeks
measure: Phoneme Perception Test
timeFrame: after 2
measure: Functional gain
timeFrame: after 8 weeks
measure: Phoneme Perception Test
timeFrame: after 8 weeks
Secondary outcomes:
measure: sound quality ratings
timeFrame: after 6 and 12 weeks
measure: questionnaires
timeFrame: after 2, 6, 8 and 12 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT00290277: Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
Official title: Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.

Detailed description: Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.

Eligibility criteria: Inclusion criteria:

* A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
* Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
* Subjects must have a negative urine pregnancy test.
* Healthy subject before entering the study as established by medical history and clinical examination.
* Subject must be of non-childbearing potential.

Exclusion criteria:

* Pregnant or breastfeeding.
* Previous vaccination against HPV.
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."

Primary outcomes:
measure: To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Secondary outcomes:
measure: To evaluate safety and reactogenicity throughout the study period.
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Kwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02501577: Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation
Official title: Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 30
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: BASIC_SCIENCE

Brief summary: Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position

Detailed description: Feasibility for fiberoptical verification of pharyngeal position of supraglottic airway device

Eligibility criteria: Inclusion Criteria:

* will to participate

Exclusion Criteria:

* none

Primary outcomes:
measure: Visibility of vocal cords
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Regensburg
Study officials:
affiliation: Uni Regensburg
name: Thomas Metterlein, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04931277: Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye
Official title: Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcome of Stepped Cataract Surgery in Uveitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.


Eligibility criteria: Inclusion Criteria:

* the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement

Exclusion Criteria:

* the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis

Primary outcomes:
measure: Visulal acuity
timeFrame: 6 months
Secondary outcomes:
measure: Intraocular inflammation
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlyia
Study officials:
affiliation: Mansoura University
name: Amgad El Nokrashy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Dina Abd El Fattah, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Rania Bassiouny, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Shreen Gaafar, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Waleed Gaafar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05140577: Reliability and Validity of the Evaluation of Hip Abductors Strength (RAVEHABDS)
Official title: Reliability and Validity of the Measurement Procedure for the Evaluation of Hip Abductors Strength in Unipodal Standing Position
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Healthy People
Keywords: hip abductors strengthening
one-leg standing
maximal voluntary isometric strengthening
rate of force generated
dynamometer
aged category
so surgery
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be healthy adults belonging to the three age groups mentioned above

Brief summary: The aim is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles.

Detailed description: Within this Master thesis project, we will investigate intra- and inter-tester reliability, as well as construct validity of a measurement procedure to assess hip abductor strength in a closed-chain position. Additionally, we aim to investigate some aspects of feasibility using a questionnaire about the measurement procedure and by evaluating if the test can be completing in a suitable timeframe for practical use.

To investigate intra- and inter-tester reliability, as well as construct validity, we will analyze and compare the maximal voluntary isometric strength (MVIS) and the rate of force generated (RFG) of the three groups of healthy participant (group 1: 18-30 years old; group 2: 31-65 years old; group 3: 65+ years old).

Eligibility criteria: Inclusion Criteria:

* Persons over 18 years old, good understanding of French, German, English or Italian, with the capacity of discernment regarding their own participation in the study

Exclusion Criteria:

* Persons with cognitive impairment or who are unable to take their own decisions about participation in the study, or who have undergone surgery on the lower limb or lumbopelvic area during the last 6 months that could contradict or influence the strength tests, will be excluded from the study

Primary outcomes:
measure: Intra-tester Correlation
timeFrame: 1 March, 2022
measure: Inter-tester correlation
timeFrame: 1 March, 2022
measure: Construct validity
timeFrame: 1 March, 2022
Secondary outcomes:
measure: Feasibility of the measurement procedure
timeFrame: 1 March, 2022
Other outcomes:
Locations:
city: Ittigen
country: Switzerland
facility: Sport Medical Center Ittigen
state: Bern
Study officials:
References:
Clinical trial NCT05963477: Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study
Official title: Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Dehiscence
Incision
Keywords: abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
Lead sponsor: French Medical Institute for Mothers and Children
Sponsor class: OTHER_GOV
First posted: 2023-07-27
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients from neonatal age until 18 years old who were planned to undergo abdominal surgery.

Brief summary: This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence


Eligibility criteria: Inclusion Criteria:

-all abdominal surgeries patient under 18-year-old.

Exclusion Criteria:

* Umbilical hernia, redo laparatomy, laparoscopic surgery.

Primary outcomes:
measure: Wound dehiscence or burst abdomen
timeFrame: one month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: French Medical Institute for Mothers and Children
Study officials:
References:
Clinical trial NCT00974077: Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression
Official title: Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: recurrent depression,
mindfulness training
attention
Evoked EEG potentials
Relapse prevention in recurrent depression
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study investigates cognitive attention, rumination and psychophysiological (EEG) processes in healthy subjects and remitted patients with at least three previous depressive episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future depressive episodes and has influence on cognitive and psychophysiological measures.


Eligibility criteria: Inclusion Criteria:

* recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)

Exclusion Criteria:

* current depression
* lifetime schizophrenia
* bipolar or schizoaffective disorder
* any neurological disorders
* other psychopathology during last 3 years

Primary outcomes:
measure: Relapse (MDE)
timeFrame: 12 month
Secondary outcomes:
measure: Electroencephalography (EEG)
timeFrame: 6 month
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Psychology University of Tuebingen
Study officials:
affiliation: Eberhard Karls University
name: Martin Hautzinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bostanov V, Keune PM, Kotchoubey B, Hautzinger M. Event-related brain potentials reflect increased concentration ability after mindfulness-based cognitive therapy for depression: a randomized clinical trial. Psychiatry Res. 2012 Oct 30;199(3):174-80. doi: 10.1016/j.psychres.2012.05.031. Epub 2012 Jul 6.
citation: Keune PM, Bostanov V, Hautzinger M, Kotchoubey B. Approaching dysphoric mood: state-effects of mindfulness meditation on frontal brain asymmetry. Biol Psychol. 2013 Apr;93(1):105-13. doi: 10.1016/j.biopsycho.2013.01.016. Epub 2013 Feb 11.