louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01133704: Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hormone-Refractory Prostate Cancer
Keywords: asymptomatic metastatic hormone-refractory prostate cancer
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 98
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically documented adenocarcinoma of the prostate
* Metastatic disease as evidenced by soft tissue and/or bony metastases
* Prostate-specific antigen value of at least 5 ng/mL
* Tumor progression while on hormonal therapy
* Castration levels of testosterone (defined as less than 50 ng/dL)
* Life expectancy of at least 16 weeks
* Adequate hematologic, renal, and liver function

Exclusion Criteria:

* Visceral organ metastases
* Metastatic disease expected to be in need of radiation therapy within 4 months.
* Concurrent therapy with experimental agents

Primary outcomes:
measure: Overall Time to Disease Progression
timeFrame: from randomization to 36 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Time from randomization until 36 months
Other outcomes:
Locations:
Study officials:
References:
citation: Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
citation: Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
Clinical trial NCT05956704: The Different Design of Orthokeratology
Official title: The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.


Eligibility criteria: Inclusion Criteria:

* The age is greater than 8 years and less than 18 years
* The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
* Be able to complete 12 months of follow-up
* They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians

Exclusion Criteria:

* One eye met the inclusion criteria
* Patients with systemic diseases causing immunocompromised or affecting orthokeratology
* There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
* Abnormal cornea
* Previous corneal surgery or corneal trauma history
* Active keratitis (e.g., corneal infection)
* Patients with best corrected distance visual acuity of less than 5.0
* Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
* Patients with refractive instability
* Patients with overt strabismus
* The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
* Patients with dry eye are not suitable for orthokeratology
* Patients with corneal endothelial cell density less than 2000 cells /mm2
* Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days

Primary outcomes:
measure: Changes in axial length
timeFrame: The change of baseline and 1years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT03826004: Clemastine in Cardiovascular Surgery
Official title: Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy and Safety
Keywords: Cardiovascular Surgery
Histamine H1 Receptor Antagonist
Anaphylaxis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

Detailed description: In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
* Written informed consent obtained.

Exclusion Criteria:

* Previous history of cardiac surgery
* Allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol)
* Myasthenia gravis
* Porphyria patients
* Bronchial asthma
* Usage of monoamine oxidase (MAO) inhibitors
* Pregnant or lactating women
* Mentally or legally disabled patients

Primary outcomes:
measure: Histamine concentration in plasma
timeFrame: Perioperative period
Secondary outcomes:
measure: Blood pressure
timeFrame: Perioperative period
measure: Airway pressure
timeFrame: Perioperative period
measure: Skin manifestation
timeFrame: Perioperative period
measure: Arrhythmia
timeFrame: Perioperative period
measure: Specific symptoms
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Jia Shi, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00941304: Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Official title: A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.


Eligibility criteria: Inclusion Criteria:

* extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
* males or non-pregnant females, aged 18 to 45 years
* good general health and capable of providing informed consent

Exclusion Criteria:

* history of substance abuse or dependence
* positive urine toxicology screen or alcohol breath test
* history of hypersensitivity to or allergy to any study drug
* donation of blood within prior 30 days
* use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours

Primary outcomes:
measure: Sum of Pain Intensity Difference From Baseline to 8 Hours
timeFrame: Baseline, 8 hours
Secondary outcomes:
measure: Total Pain Relief Over 8 Hours
timeFrame: 8 hours
measure: Sum of Pain Relief and Intensity Differences Over 8 Hours
timeFrame: 8 hours
measure: Sum of Pain Relief and Intensity Differences Over 2 Hours
timeFrame: 2 hours
measure: Peak Pain Intensity Difference
timeFrame: 24 hours
measure: Peak Pain Relief
timeFrame: 24 hours
measure: Onset of Analgesia
timeFrame: 8 hours
measure: Duration of Analgesia
timeFrame: 24 hours
measure: Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"
timeFrame: 8 hours and 24 hours
measure: Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug
timeFrame: 24 hours
measure: Change From Baseline in Cognitive Assessment Using CNS-VS
timeFrame: Baseline (screening), 2 hours 15 minutes postdose
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
city: San Marcos
country: United States
facility: Donald P. Bandy, DDS
state: Texas
city: Salt Lake City
country: United States
facility: Premier Research Group Limited
state: Utah
Study officials:
affiliation: BioDelivery Sciences International
name: David Blum, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06905704: Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
Official title: Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stem Cell Donors
Keywords: stem cell donors, safety, transplantation
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stem cell donors

Brief summary: Haematopoietic stem cell donation represents a unique chance for curing patients affected with onchohaematologic and inherited diseases.If a related donor is unavailable a unrelated donor must be used. For both categories an accurate physical and laboratory examination is mandatory to establish the eligibility to bone marrow or peripheral blood stem cell collection since side effects related to donation may occur. To ensure high standards of safety and satisfaction of unrelated stem cells donors dedicated guidelines are available. On the other hand, there is no unambiguous guidance on the management of the related donor and published data on donation and long term follow-up are scarce.

Detailed description: The study, for the retrospective part, aims to report the experience in family and registry donor management at Transfusion Service from 2016 to 2022 (enrollment, stem cell donation, 30-day follow-up) and, for the prospective part, to continue monitoring on donors who will be enrolled in the next five years (2023 to 2028).

Eligibility criteria: Inclusion Criteria:

* Family donors ≥18 years referred by the Hematology and Oncohematology Transplant Center Pediatric of the Foundation of Centro Donatori -SIMT, following the national and international guidelines after medical evaluation
* Volunteer donors from IBMDR registry ≥18 years, following the national and international guidelines after medical evaluation

Exclusion Criteria:

* Donors 18 \< years

Primary outcomes:
measure: safety of stem cell donation
timeFrame: From enrollment to 30 days after stem cell donation
Secondary outcomes:
measure: peripheral stem cells analysis
timeFrame: From enrollment to 30 days after stem cell donation
measure: lymphocyte analysis
timeFrame: From enrollment to 30 days after stem cell donation
measure: CBC analysis
timeFrame: From enrollment to 30 days after stem cell donation
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References:
Clinical trial NCT01070901: Immune Status in Solid Organ Transplantation
Official title: Evaluation of Predictors of Immune Status in Solid Organ Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Transplants
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2010-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tranplant clinic population

Brief summary: Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by transplant center and no practical strategies are available to guide an individuals' response to immune suppression. In this study we will conduct research to assess immunologic status in solid organ transplant recipients, predicting immune reconstitution and outcomes after transplant to better guide the use of immunosuppressive medications.


Eligibility criteria: Inclusion Criteria:

* Impending kidney transplant
* Age \>18
* Able to provide informed consent and comply with the study procedures

Exclusion Criteria:

* Age\<18
* Concomitant illness, which by decision of investigator, may compromise the ability to perform this trial

Primary outcomes:
measure: Immune Markers
timeFrame: 0, 3, 6, 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT01368601: Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
Official title: Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
CPAP
PPC
lobectomy
One-lung ventilation
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 60
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 is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer undergoing lobectomy.

Detailed description: Pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. This inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (PPC). Thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and PPC.

Eligibility criteria: Inclusion Criteria:

* Adults (18-80 aged) with American Society of Anesthesiologists physical status I-III, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring OLV (one lung ventilation)during surgery.

Exclusion Criteria:

* Ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated C-reactive protein \[CRP\]), history of recurrent pneumothoraces, previous thoracic surgery.

Primary outcomes:
measure: Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
timeFrame: From preoperative to postoperative (24h) period.
Secondary outcomes:
measure: Alveolar MICA
timeFrame: From preoperative to postoperative period (24h)
measure: CT-Scan
timeFrame: 22-24h after surgery
measure: Postoperative pulmonary complications (PPC).
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT05979701: Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages
Official title: Use of Simulation Training Versus Theoretical Learning for the Retention of Knowledge and Skills in the Management of Postpartum Hemorrhage: A Multicenter, Comparative Study in Eastern DRCongo.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage
Simulation Training
Healthcare Providers
Keywords: OSCE
Lead sponsor: Université Evangélique enAfrique
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2023-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo.


Eligibility criteria: Inclusion Criteria:

* Work in one of the selected maternity units
* Have two years' experience
* Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician.

Exclusion Criteria:

-

Primary outcomes:
measure: Score obtained before training and immediatly after training
timeFrame: Before and immediatly after training
measure: Score obtained before training and 3 months after training
timeFrame: 3 months after training
measure: Score obtained before training and 6 months after training
timeFrame: 6 months after training
Secondary outcomes:
measure: OSCE (Objective Structural Clinical Exam) Score
timeFrame: Immediatly and 6 months after training
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06761001: Investigation of the Effect of I-PRF Application on Pain in Alveolitis
Official title: Investigation of the Effect of I-PRF Application on Pain in Alveolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Osteitis
Pain
Dry Socket
Keywords: injectable platelet rich fibrine
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Literature review showed that there are no studies on the use of i-PRF in alveolitis cases. The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis. The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain.

Detailed description: The present study will include 60 healthy patients over 18 years of age with alveolitis. 60 patients will be randomly divided into two groups: Control and I-PRF. After irrigation of the sockets, no substance will be applied to the control group, and I-PRF will be applied to the study group. Postoperative pain will be measured on the 3rd and 7th days.

Eligibility criteria: Inclusion Criteria:

Healthy individuals without systemic disease Patients with complete data and attending their appointments

Exclusion Criteria:

Patients who smoke Pregnant or breastfeeding female patients with bleeding disorders and diabetics Patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw Patients unable to consent to participate in the study

Primary outcomes:
measure: Change in post-operative pain assessed: visual analog (VAS) scale
timeFrame: postoperative 3rd, and 7th days
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
affiliation: Eskişehir Osmangazi University Faculty of Dentistry
name: Görkem TEKİN, Assist.Prof.
role: STUDY_CHAIR
References:
citation: Uranbey O, Ayranci F. How effective are concentrated growth factor and injectable platelets in reducing complications following impacted third molar surgery? Quintessence Int. 2024 May 30;55(5):380-390. doi: 10.3290/j.qi.b5213477.
citation: Laforgia A, Inchingolo AD, Riccaldo L, Avantario P, Buongiorno S, Malcangi G, Bordea IR, Palermo A, Inchingolo F, Inchingolo AM, Dipalma G. The Use of Platelet-Rich Fibrin (PRF) in the Management of Dry Socket: A Systematic Review. Int J Mol Sci. 2024 Sep 19;25(18):10069. doi: 10.3390/ijms251810069.
citation: Sharma A, Aggarwal N, Rastogi S, Choudhury R, Tripathi S. Effectiveness of platelet-rich fibrin in the management of pain and delayed wound healing associated with established alveolar osteitis (dry socket). Eur J Dent. 2017 Oct-Dec;11(4):508-513. doi: 10.4103/ejd.ejd_346_16.
Clinical trial NCT02950701: Suspected Cases of Carbon Monoxide Poisoning
Official title: Data During Emergency Medical Transport in Suspected Carbon Monoxide Poisoning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Intoxication
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 82
Sex: ALL
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: The participants will be selected based on symptoms during medical transport.

Brief summary: The purpose of this study is to collect non-invasive opportunity sample data in suspected or known cases of carbon monoxide poisoning.


Eligibility criteria: Inclusion Criteria:

* Known or suspected carbon monoxide poisoning.

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Values from the test device will be compared to the values from the reference device.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthEast Medical Transportation
state: Minnesota
Study officials:
affiliation: HealthEast Medical Transport
name: Keith Wesley, MD
role: PRINCIPAL_INVESTIGATOR
References: