louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04777604: Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Organoid
Official title: Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Ex Vivo Analysis of Organoid Culture
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreas Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A patient who is in need of neoadjuvant chemotherapy before surgery, having been diagnosed with pancreatic cancer via EUS-FNA and EUS-FNB at Samsung Medical Center. And a patient who is eligible for surgery after neoadjuvantchemotherapy.

Brief summary: The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.


Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. Newly discovered pancreatic cancer and not a relapse
3. Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
4. who is in need of neoadjuvant chemotherapy before surgery
5. Patients who can undergo surgery for pancreatic cancer after neoadjuvant chemotherapy
6. Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery
7. Able to make decisions for oneself for participation
8. Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)

Exclusion Criteria:

• None

Primary outcomes:
measure: Overall survival rate
timeFrame: From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00230204: Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis
Official title: Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Antibodies
Serum
Infectious agents
Immunoglobulin G
Immunoglobulin M
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \[CMV\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (rheumatoid arthritis \[RA\], undifferentiated connective tissue disorder \[UCTD\], Sjogren, antiphospholipid syndrome - APS, vasculitides, systemic lupus erythematosus \[SLE\], polymyositis, Hashimoto, multiple sclerosis, primary biliary cirrhosis \[PBC\], etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).

Detailed description: The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \[CMV\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (RA, UCTD, Sjogren, antiphospholipid syndrome - APS, vasculitides, SLE, polymyositis, Hashimoto, multiple sclerosis, PBC, etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).

We will assess in our Center 100 patients with multiple sclerosis for the antibody profile of different infectious agents. Comparative assessments will be performed with normal matched subjects.

Eligibility criteria: Inclusion Criteria:

* Definite multiple sclerosis

Exclusion Criteria:

* Intravenous immune globulin (IVIg) treatment

Primary outcomes:
measure: Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis
Secondary outcomes:
measure: Assess correlation between antibody levels to various infectious agents with clinical disease variables
Other outcomes:
Locations:
city: Ramat-gan
country: Israel
facility: Multiple Sclerosis Center, Sheba Medical Center
Study officials:
affiliation: Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
name: Anat Achiron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
name: Yehuda Shoenfeld
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083004: Brilliant Blue Versus Indocyanine Green
Official title: A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Macular Pucker
Macular Hole
Vitreoretinal Surgery
Keywords: dye
internal limiting membrane
macular hole
macular pucker
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.


Eligibility criteria: Inclusion Criteria:

* age over 50
* macular pucker or macular hole with subjective disturbances
* All phakic or pseudophakic patients
* far visual acuity better than 20/400
* able to read, understand, and willing to sign the informed consent form

Exclusion Criteria:

* any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
* prior vitreoretinal surgery in the study eye

Primary outcomes:
measure: Best corrected far visual acuity (ETDRS)
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Reading ability (Radner)
timeFrame: 1 Year
measure: Optical coherence tomography
timeFrame: 1 year
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Center of Ophthalmology, University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany
name: Bernd Kirchhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580304: Evaluation of Physical and Cognitive Industrial Workload
Official title: Evaluation of Mental and Physical Load During Lab-simulated Industrial Work
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Work-Related Condition
Physical Stress
Mental Fatigue
Keywords: Fatigue Mental
Fatigue Signs and Symptoms
Behavioral Symptoms
Industrial work
physical effort
mental effort
questionnaires
ergonomic evaluation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In this stage of the project, a study analysing the physical and mental load during occupational work will be carried out. High risk tasks will be identified in the field and simulated in lab-setting to analyse physical and mental load using physiological and biomechanical data.These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front of, to the side of, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.


Eligibility criteria: Inclusion Criteria:

* male
* 18 - 65 yrs old

Exclusion Criteria:

* injury

Primary outcomes:
measure: EEG: change in power spectral density (change in mental fatigue: physiological component)
timeFrame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Secondary outcomes:
measure: EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)
timeFrame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
measure: Change in mental fatigue (behavioral component: part 1)
timeFrame: Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
measure: Change in mental fatigue (behavioral component: part 2)
timeFrame: Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
measure: Change in mental fatigue (subjective component)
timeFrame: Before and after each 90 minute task subjective questionnaire will be filled out
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Lichamelijk Opvoeding en Kinesitherapie
Study officials:
affiliation: Vrije Universiteit Brussel
name: Romain Meeusen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062604: The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
Official title: The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Treatment
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for the surgical interventions

Brief summary: The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

Detailed description: All four questionnaires (LLTQ, LEFS LLFI-10 and LLFI) will be translated and adopted to the Polish conditions. The detailed medical/ epidemiological history will be collected in each patient. The fracture will be assessed based on the x-ray examination and will be qualified according to AO classification. NRS (Numerical Rating Scale) will be used to assess the pain intensity. SF36, QoL, CSQ, COPE and HADS questionnaire will be used to evaluate patient's the quality of life (subjective assessment). First assessment will be done before operation and then after 3, 6, 12, 24 month postoperation treatment.

With this main study, there is a plan to assess not only femur fractures patients, but the investigators would like to have addtional groups of the patients with hip and knee allopasty and knee arthroscopy with slightly different follow-up period: before the oparation, 1 and 12 month after the treatment.

Eligibility criteria: Inclusion Criteria:

* Signed Patient Informed Consent
* Patients planned for the surgical treatment

Exclusion Criteria: n.a.

Primary outcomes:
measure: Subjective assessment of the lower limb function
timeFrame: 12 month
measure: Objective assessment of the lower limb function
timeFrame: 12 month
Secondary outcomes:
measure: Subjective assessment of the lower limb function
timeFrame: 3, 6, 24 months
measure: Objective assessment of the lower limb function
timeFrame: 3, 6, 24 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Jagiellonian University
name: Marcin Bednarek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04411004: Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis
Official title: Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis, Rectum
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 100
Sex: FEMALE
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: Patients underwent shaving of rectal endometriosis

Brief summary: When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.


Eligibility criteria: Inclusion Criteria:

* patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum

Exclusion Criteria:

* patients underwent previous bowel surgery (except appendectomy);
* patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)

Primary outcomes:
measure: Number of patients with rectal recurrence of endometriosis
timeFrame: 3 months after the surgical approach
measure: Number of patients with rectal recurrence of endometriosis
timeFrame: 6 months after the surgical approach
Secondary outcomes:
measure: Satisfaction of patients to the previous surgical treatment
timeFrame: 3 months after the surgical approach
measure: Volume of nodules in patients with rectal recurrence of endometriosis
timeFrame: 3 months after the surgical approach
measure: Satisfaction of patients to the previous surgical treatment
timeFrame: 6 months after the surgical approach
measure: Volume of nodules in patients with rectal recurrence of endometriosis
timeFrame: 6 months after the surgical approach
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
References:
citation: Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.
Clinical trial NCT04430504: Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
Official title: Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Telerehabilitation
Case series
Traumatic brain injury
Lead sponsor: Vetrea Terveys Oy
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series of eligible patients
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..

Detailed description: Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to participate in a multidisciplinary telerehabilitation containing total of 20 video meetings over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation ward for the pre-treatment clinical assessments and education on the telerehabilitation protocol. A self-exercise program is supervised and monitored using a health platform application on a tablet computer through weekly video meetings. A digital diary recordings enable the therapists to track on the progress of therapies. The primary goal is to achieve the individual goals set in the Goal Attainment Scaling. The secondary goals are related to the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).

Eligibility criteria: Inclusion Criteria:

* sequelae of traumatic brain injury
* capable of doing self exercises at home and participating in video meetings

Exclusion Criteria:

* moderate or severe aphasia
* poor recovery potential for return to school or working life based on clinical assessment

Primary outcomes:
measure: Goal Attainment Scaling
timeFrame: 20 weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 20 weeks
measure: WHOQOL-Bref
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: VetreaNeuron
state: North Savo
Study officials:
affiliation: VetreaNeuron
name: Kauko Pitkänen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02331004: Effectiveness of an Intervention Program for Fine Motor Skills
Official title: Effectiveness of an Intervention Program for Fine Motor Skills in Institutionalized Elderly Residents: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Keywords: Frail Elderly
Motor Skills
Upper Extremity
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators have created a protocol of intervention to treating the general disability of upper limbs.

Detailed description: A protocol of intervention for fine motor skills will be performed on institutionalized elderly people.

This protocol consist on implementation of a manual activity that it is well known in the clinical setting.

This activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life.

The intervention or rehabilitation will be implemented for two month.

Eligibility criteria: Inclusion Criteria:

* Institutionalized elderly people, on a full or part-time.
* Voluntary participation.

Exclusion Criteria:

* Cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
* Postural control problems.
* Balance disorders, while the subject is seated.

Primary outcomes:
measure: Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
timeFrame: Sixteen weeks
Secondary outcomes:
measure: Change from Baseline in General self-efficacy at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in General self-efficacy at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in Purdue Pegboard Tests at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Purdue Pegboard Tests at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in finger goniometer at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in finger goniometer at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in Pinch Gauge at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Pinch Gauge at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
timeFrame: Sixteen weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Maria Encarnación Aguilar Ferrandiz
Study officials:
affiliation: Universidad de Granada
name: Mª Encarnacion ME Aguilar, PdH
role: PRINCIPAL_INVESTIGATOR
References: