louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02805166: PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
Official title: The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Solid Tumors
Keywords: PEG-rhG-CSF
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with age ≥ 18 years
* diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
* Karnofsky Performance Status ≥ 70
* life expectancy of at least 3 months
* Written informed consent are acquired

Exclusion Criteria:

* uncontrolled infection,Temperature is 38.0 ℃ or higher
* pregnancy
* Other situations that investigators consider as contra-indication for this study

Primary outcomes:
measure: The occurrence rate of adverse event during at least three consecutive cycles chemotherapy
timeFrame: up to 30 days after the patient study completion
measure: The severity of adverse event during at least three consecutive cycles chemotherapy
timeFrame: up to 30 days after the patient study completion
Secondary outcomes:
measure: the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy
timeFrame: through the study completion,an average of 5 months
measure: the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy
timeFrame: through the study completion,an average of 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03946566: The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
Official title: The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 1500
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: The study population will be stroke convalescent patients from The Third Affiliated Hospital of Zhejiang Chinese Medical University from January 2012 to December 2019.

Brief summary: Electronic health records of stroke convalescent patients will be selected from the third affiliated hospital of Zhejiang Chinese Medical University from January 2012 to December 2019. Relevant clinical data will be extracted according to case data, and model-based decision tree analysis will be conducted to establish and evaluate the clinical prediction Model.

Detailed description: Cases will be screened according to inclusion and exclusion criteria.Patients' basic information, risk factors, types of stroke, TCM diagnosis, all treatment during hospitalization, neurological impairment evaluation, imaging examination results and other contents will be recorded.Finally, statistical processing will be carried out to establish the prediction model, draw ROC curve and evaluate the model.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stroke
* The incidence is between 30 days and 180 days
* Age ≥ 18 years old
* The first onset

Exclusion Criteria:

* Subarachnoid hemorrhage
* transient ischemic attack
* other intracranial lesions
* Non-atherosclerotic thrombotic cerebral infarction
* Surgery, trauma, congenital disability leading to limb dysfunction

Primary outcomes:
measure: Clinical Neurological Functional Impairment Assessment for Stroke Patients
timeFrame: Change from neurological functional impairment score at 6 months(or the last discharge time ，which less than 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Ruijie Ma, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06915766: Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Official title: Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Systemic Mastocytoses, Indolent
Systemic Mastocytoses, Aggressive
Keywords: Systemic Mastocytosis
NonAdvanced Systemic Mastocytosis
Advanced Systemic Mastocytosis
Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN)
Aggressive Systemic Mastocytosis (ASM)
Mast Cell Leukemia (MCL)
Bone Marrow Mastocytosis (BMM)
Lead sponsor: Cogent Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.


Eligibility criteria: Key Inclusion Criteria:

* Able to provide written informed consent and commit to EAP assessments.
* ≥18 years of age.
* Able to swallow tablets.
* Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
* Not receiving adequate disease control on current therapy(ies).
* Have clinically acceptable laboratory screening results.

Exclusion Criteria:

* Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
* Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
* Pregnant or currently breastfeeding.
* Prior or ongoing clinically significant illness or medical or physical condition

Other protocol-defined criteria apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cogent Biosciences, Inc.
name: Rachael Easton, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05995366: A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
Official title: Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-903
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the mass balance and safety of \[14C\] ABBV-903 in healthy male volunteers following a single oral dose administration.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.
* Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.
* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.

Primary outcomes:
measure: Maximum observed concentration (Cmax) of ABBV-903
timeFrame: Up to Day 16
measure: Time to Cmax (peak time, Tmax) of ABBV-903
timeFrame: Up to Day 16
measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-903
timeFrame: Up to Day 16
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903
timeFrame: Up to Day 16
measure: AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903
timeFrame: Up to Day 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 46
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc. /ID# 253962
state: Wisconsin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04471766: Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
Official title: Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Respiratory Illness
Keywords: Face mask
COVID-19
Respiratory illness
Mortality
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Engineers without Borders, Denmark (https://iug.dk/en)
First posted: 2020-07-15
Enrollment: 40000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level.

In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone.

Follow-up will be implemented through telephone calls and post-epidemic home visits.


Eligibility criteria: Inclusion Criteria:

* Household resident
* Age: 10 years and older

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Reported COVID-like illness
timeFrame: Four months follow-up
measure: Consultation
timeFrame: Four months follow-up
measure: Severe illness
timeFrame: Four months follow-up
measure: Mortality
timeFrame: Four months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
state: Bissau Codex
Study officials:
References:
Clinical trial NCT02307266: Patient Education in Adherence on Acne (PEAce)
Official title: Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects age of 12 years or older,
2. With facial acne vulgaris that can be managed in primary care

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study,
2. Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

Primary outcomes:
measure: Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Bolton
country: United Kingdom
facility: Swan Lane Medical Centre
city: Burbage
country: United Kingdom
facility: Burbage Surgery
city: Epworth
country: United Kingdom
facility: South Axholme Practice
city: Harrogate
country: United Kingdom
facility: Dr Moss and Partners
city: Manchester
country: United Kingdom
facility: Barlow Medical Centre
city: Northampton
country: United Kingdom
facility: Leicester Terrace Health Care Centre
city: Nottingham
country: United Kingdom
facility: University of Nottingham Health Service
city: Rothwell
country: United Kingdom
facility: Rothwell and Desborough Healthcare Group
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
city: Whitby
country: United Kingdom
facility: Whitby Group Practice
Study officials:
References:
citation: Myhill T, Coulson W, Nixon P, Royal S, McCormack T, Kerrouche N. Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study. Dermatol Ther (Heidelb). 2017 Dec;7(4):515-524. doi: 10.1007/s13555-017-0203-4. Epub 2017 Oct 12.
Clinical trial NCT04374266: Tegmen Defect Management During Mastoidectomy
Official title: Clinical and Postoperative Radiologic Assessment and Long Term Results of Tegmen Defects During Mastoidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Otitis Media
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.

Brief summary: In this study, we aimed to discuss our clinical experience on the management of the tegmen defects which were revealed during the mastoidectomy surgeries.


Eligibility criteria: Inclusion Criteria:

* underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.

Exclusion Criteria:

* patients who did not come to follow up

Primary outcomes:
measure: defect size
timeFrame: a year
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References:
Clinical trial NCT00773266: Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes
Official title: Intraocular Architecture of Secondary Implanted Anterior Chamber Iris-Fixated Lenses in Aphakic Eyes Evaluated With Anterior Segment Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aphakia
Keywords: Aphakia
Secondary IOL-Implantation
Iris-Fixated IOL
Artisan
Anterior Segment OCT
Aphakia - secondary iris-fixated IOL position
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with long standing Aphakia and eligibility for secondary IOL implantantion were retrospectively examined

Brief summary: The purpose of this study is to evaluate the intraocular stability and safety of secondary iris-fixated IOLs in aphakic patients.

Detailed description: 18 eyes of 16 patients received secondary anteriorly iris-fixated intraocular lenses (IOLs) to correct for aphakia without capsular support, partly combined with anterior or complete pars plana vitrectomy. Primary outcome measurements included visual acuity (6m Snellen charts), central endothelium cell count (cECC) and postoperative intraocular position of the IOL assessed with anterior segment optical coherence tomography (OCT).

Eligibility criteria: Inclusion Criteria:

* Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome

Exclusion Criteria:

* Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count

Primary outcomes:
measure: Intraocular IOL position
timeFrame: 12-35 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Zentrum für Augenheilkunde
state: Hessen
Study officials:
References:
Clinical trial NCT00123266: Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Official title: An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Keywords: stroke
vertebrobasilar
basilar
Acute vertebrobasilar artery occlusion
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2005-07-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

Detailed description: Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Eligibility criteria: Inclusion Criteria:

1. Patients with angiographically documented vertebrobasilar artery occlusion
2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
3. Age 18-75 (inclusive).

Exclusion Criteria:

1. Patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
2. Rapidly improving neurologic signs at any time before initiation of study drug administration.
3. Known contrast agent-sensitivity
4. Uncontrolled hypertension defined as a systolic blood pressure \> 180 mm Hg or a diastolic blood pressure \> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
5. History of stroke within the previous 6 weeks.

Primary outcomes:
measure: Recanalization rate
timeFrame: Day-7, Day-30 and Day-90
Secondary outcomes:
measure: Clinical assessment
timeFrame: Day-7, Day-30 and Day-90
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: UniversitÃ¤tsklinikum Erlangen
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Homburg/Saar
country: Germany
facility: UniversitÃ¤tsklinikum des Saarlandes
city: Kiel
country: Germany
facility: UKSH Campus Kiel
city: Munich
country: Germany
facility: Ludwig-Maximilians-University Hospital
city: Wiesbaden
country: Germany
facility: HSK Dr. Horst Schmidt Hospital
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis
Study officials:
affiliation: HSK Dr. Horst Schmidt Hospital
name: Gerhard Hamann, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: