louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03810521: Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis
Official title: A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Keywords: mesenchymal stromal cells
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Patient between 30 and 75 years old
* Knee-OA Kellgren Lawrence grade I to III
* Pain density according to visual analogue scale superior or equal to 50 mm
* Patelar condromalacia grade I to III
* Stable joint with normal physical exploration

Exclusion Criteria:

* Bilateral symptomatic disease
* Local or systemic infection
* Neoplasia
* Immunosuppression state
* Pregnancy
* Anticoagulant therapy
* Other types of arthritis
* Symptomatic disease of hip and/or spine
* Intra-articular infiltration with steroids in the last 3 months
* Intra-articular infiltration with hyaluronic acid in the last 12 months

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Change in WOMAC score
timeFrame: 6 months
measure: Change in VAS score
timeFrame: 6 months
measure: Changes in structural joint assessment by MRI
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Universidad de los Andes
state: Xiii
Study officials:
affiliation: CMO
name: Francisco Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933321: Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS, stem cells
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.

Detailed description: There is no more extensive information

Eligibility criteria: Inclusion Criteria:

* patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
* Over 18 years old. Forced vital capacity ≥ 40%.
* One year of evolution.
* Adequate nutritional state

Exclusion Criteria:

* Severe bulbar ALS involucre.
* Inadequate nutritional status.
* Spondylotic myelopathy, or abnormalities in imaging study.
* Having concomitant neurological or psychiatric disease.
* Systemic disease with poor-control.
* History of treatment with steroids or immunoglobulins in the last year.
* Participate in the past three months in a Clinical Trial.
* History of malignancy or cancer today.
* Intracranial hypertension.
* Clinical suggestive data of infection in the site of lumbar puncture.
* Tracheostomy.
* Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.

Primary outcomes:
measure: Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
timeFrame: up to 12 months
Secondary outcomes:
measure: To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.
timeFrame: During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Servicio Hematología Hospital Universitario
state: Nuevo León
Study officials:
affiliation: Hospital Universitario "Dr. José Eleuterio González"
name: David Gomez-Almaguer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario "Dr. José Eleuterio González"
name: Jose C Jaime-Pérez, MD PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario "Dr. José Eleuterio González"
name: Héctor R Martínez-Rodríguez, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01389921: Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract
Official title: Investigation of Lower Urinary Tract Afferent and Cortical Brain Activity During Lower Urinary Tract Stimulation Using Electroencephalogram Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Nonneurogenic Neurogenic Bladder Dysfunction
Neurogenic Bladder Dysfunction Nos
Keywords: lower urinary tract
sensory evoked potential
contact heat evoked potential stimulation
electroencephalogram
cortical processing
bladder sensations
lower urinary tract dysfunction
overactive bladder
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: NCCR (National Center of Competence in Resaerch, Switzerland)
First posted: 2011-07-08
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate afferent and cortical activities during bladder filling under different stimulations of the lower urinary tract. The participants of the study are healthy test persons and patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Right-handed
* Written informed consent

Exclusion Criteria:

* Any psychological diseases
* Any renal, cardiac, and pulmonary diseases
* Pregnancy or breastfeeding
* Problems keeping calm for 60 minutes in the sitting position
* Medication influencing EEG or bladder function

Primary outcomes:
measure: Establishment of somatosensory evoked potentials of lower urinary tract stimulations
timeFrame: 3 times on an average period of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital
Study officials:
affiliation: Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
name: Ulrich Mehnert, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gregorini F, Knupfer SC, Liechti MD, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the bladder and urethra in middle-aged women: the effect of age. BJU Int. 2015 Apr;115 Suppl 6:18-25. doi: 10.1111/bju.13066.
citation: Knupfer SC, Liechti MD, Gregorini F, De Wachter S, Kessler TM, Mehnert U. Sensory function assessment of the human male lower urinary tract using current perception thresholds. Neurourol Urodyn. 2017 Feb;36(2):469-473. doi: 10.1002/nau.22956. Epub 2016 Jan 15.
citation: Gregorini F, Wollner J, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the human lower urinary tract. J Urol. 2013 Jun;189(6):2179-85. doi: 10.1016/j.juro.2012.11.151. Epub 2012 Nov 30.
Clinical trial NCT06851221: Β3-adrenoreceptor As Prognostic Marker in Neuroblastoma and Ewing Sarcoma
Official title: Β3-adrenoreceptor As Prognostic Marker in Neuroblastoma and Ewing Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroblastoma
Ewing Sarcoma
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 95
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study on biological samples of patients affected by neuroblastoma and Ewing sarcoma aims at validating the beta3-adrenoreceptor as prognostic biomarker.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Ewing sarcoma or neuroblastoma

Exclusion Criteria:

* sieropositivity

Primary outcomes:
measure: expression of beta3-adrenoreceptor
timeFrame: from enrollment to the performance of the analysis that can take up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Laboratorio traslazionale in oncoematologia
Study officials:
References:
Clinical trial NCT03787121: Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers
Official title: Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: health economics
care management pathways
overtreatment
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Evathyr database collected by the Oncomip network: Cohort describing the initial management of 423 patients with TC diagnosed in 2014 and passed in the process of Multidisciplinary Team Meeting (MTM).

Brief summary: The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.

The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.

This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.


Eligibility criteria: Inclusion Criteria:

* all patients with a good prognosis of the TC
* diagnosed in 2014
* whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees

Exclusion Criteria:

* patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)

Primary outcomes:
measure: cost related to the different management pathways of TC patient
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University HospitalToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Nadège Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076721: Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis
Official title: The Role of Simulation-Based Training to Improve Team Performance in Implementing One Sepsis Hour Bundle in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
Simulation Training
Sepsis
Keywords: medical education
simulation training
sepsis
high-fidelity manikin
one-hour bundle sepsis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to compare simulation training with conventional training (case-based discussion only) to improve team performance in implementing one-hour sepsis bundle in the intensive care unit

Detailed description: This was an experimental randomized single-blind study to examine the role of simulation-based training in improving team performance in conducting sepsis management. Subjects were sixteen doctors and twenty-four nurses working in the intensive care unit. The subjects were randomly divided into two treatment groups: the discussion group and the simulation group. Each treatment group was further divided into four small groups consisting of two doctors and three nurses. Prior to the training, every subject received a pretest for cognitive evaluation and a posttest at the end of the training. The performance of both groups in implementing one-hour sepsis bundle was assessed by solving a sepsis case in high fidelity manikin.

Eligibility criteria: Inclusion Criteria:

* Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU
* Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU

Exclusion Criteria:

* Doctors and nurses who are not fit or healthy to undergo this training

Primary outcomes:
measure: Differences in score of skills in implementing one-hour bundle sepsis in the intensive care unit assessed with checklist which were designed by four anesthesiologist-intensivists
timeFrame: upon study completion, in 1 day
Secondary outcomes:
measure: Differences in intrateam communication's score in implementing one hour sepsis bundle assessed with checklist which were designed by four anesthsiologist-intensivists
timeFrame: upon study completion, in 1 day
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: adhrie sugiarto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873621: Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
Official title: Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lymph Node Cancer Metastatic
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are:

* Does the use of ICG increase the total number of harvested lymph nodes?
* Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes?

Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.


Eligibility criteria: Inclusion Criteria:

* Low or middle rectal adenocarcinoma
* Indication for sphincter-saving surgery
* Neoadjuvant chemoradiation
* Indication for laparoscopic surgery
* Signed informed consent

Exclusion Criteria:

* Distant metastases at diagnosis, included peritoneal carcinomatosis
* Squamous cell cancer
* Allergy to indocyanine green

Primary outcomes:
measure: Total number of harvested lymph nodes
timeFrame: 15 days
measure: Number of harvested extra-mesorectal lymph nodes
timeFrame: 15 days
Secondary outcomes:
measure: Intraoperative and postoperative complications rates
timeFrame: 15 days
measure: Time of surgery
timeFrame: 15 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
name: Maurizio Cosimelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colletti G, Battaglia L, Sorrentino L, Guaglio M, Cosimelli M. Indocyanine green-guided lymphadenectomy of the inferior mesenteric artery in laparoscopic total mesorectal excision for low rectal cancer after neoadjuvant chemoradiotherapy - A Video Vignette. Colorectal Dis. 2022 Apr;24(4):547. doi: 10.1111/codi.16031. Epub 2022 Jan 6. No abstract available.
Clinical trial NCT04957121: Comparison of On-hours Versus Off-hours Anesthesia of Hip Surgery
Official title: Comparison of Anesthesia Beginning at On-hours Versus Off-hours on Outcomes in Patients Undergoing Hip Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Off-hours Anesthesia
Keywords: off-hours
hip surgery
perioperative care
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 1843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had hip surgery during on-hours or off-hours.

Brief summary: To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery.

Detailed description: The patients undergoing hip surgery between were divided into the on-hours group or the off-hours group depending on the begin time of anesthesia in this retrospective cohort study. In-hospital mortality and early prognosis were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.

Exclusion Criteria:

* under 18 years old
* had incomplete perioperative data

Primary outcomes:
measure: in-hospital mortality
timeFrame: up to 7 months
Secondary outcomes:
measure: postoperative LOS
timeFrame: up to 4 months postoperatively
measure: total LOS
timeFrame: up to 7 months
measure: ICU admission
timeFrame: within 3 days postoperatively
measure: postoperative complications
timeFrame: within 3 days postoperatively
measure: intraoperative fluid management
timeFrame: intraoperative
measure: intraoperative sufentanil
timeFrame: intraoperative
measure: using vasoactive drugs
timeFrame: intraoperative
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Mei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840121: Personalizing Window of Implantation During Frozen Embryo Transfer
Official title: ADHESIORT - Personalizing Window of Implantation During Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
Collaborators: name: Ferring Pharmaceuticals
First posted: 2021-04-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in either the study group - AdhesioRT or in the control group - standard of care. All participants recruited, including the control group, will have the AdhesioRT biopsies performed.
Primary purpose: DIAGNOSTIC

Brief summary: Embryo implantation is a crucial event in the establishment of a pregnancy. Although the clinical and culture conditions to obtain a "good quality" embryo are well advanced today, endometrial receptivity remains a major barrier in assisted reproductive techniques. Once a high-quality embryo is transferred, impaired uterine receptivity is believed to be one of the major reasons behind failure of the establishment of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 to 40 inclusive at the time of oocyte retrieval
* Prescription of a single frozen embryo transfer - substituted cycle protocol
* Participant has at least 2 vitrified good quality blastocysts

Exclusion Criteria:

* Women undergoing fertility preservation
* Stage IV severe endometriosis
* Severe malformation, adenomyosis or uterine anomaly including fibroids deforming the uterine cavity ≥ 5 cm
* Positive results of screening for either participant or partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C

Primary outcomes:
measure: Determination of appropriate window of implantation
timeFrame: 14 days after embryo transfer
Secondary outcomes:
measure: Rate of clinical pregnancy
timeFrame: 14 days after embryo transfer
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Isaac-Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References: