louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00246922: Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
Official title: A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: Asthma
Roflumilast
phosphodiesterase 4 inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.


Eligibility criteria: Main inclusion criteria:

* Patients with asthma disease
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-05

Main exclusion criteria:

* % FEV1.0 \< 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
* Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
* Serious diseases

Primary outcomes:
measure: Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .
Secondary outcomes:
measure: Efficacy.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT06978725: A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Sarcoidosis
Keywords: sarcoidosis
cutaneous sarcoidosis
brepocitinib
Lead sponsor: Priovant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 28
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: TREATMENT

Brief summary: This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.


Eligibility criteria: Inclusion Criteria:

1. Adults subjects (18-74)
2. Cutaneous sarcoidosis with characteristic skin biopsy histology
3. A CSAMI activity score ≥ 10
4. Weight \> 40 kg to \< 130 kg with BMI \< 40 kg/m2 .

Exclusion Criteria

1. History of

   * Lymphoproliferative disorder
   * Active malignancy;
   * History of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix).
2. High risk of thrombosis or cardiovascular disease
3. High risk of herpes zoster
4. Active or recent infection

Primary outcomes:
measure: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
timeFrame: Screening up to 28 days after the last dose of study drug at 16 weeks
Secondary outcomes:
measure: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: Durham
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Philadelphia
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Madison
country: United States
facility: Clinical Trial Site
state: Wisconsin
Study officials:
References:
Clinical trial NCT03302325: Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC
Official title: Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor, Adult
Keywords: stage IV solid tumor
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with stage IV cancer that start a new line of treatment and agree to have blood drawn

Brief summary: 1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when available, with those of primary tumor and metastasis.

Detailed description: The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors (including lymphoma)
* Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3
* Life expectancy ≥ 3 months
* Patients must be able to provide consent
* Patients can be enrolled in other interventional clinical trials

Exclusion Criteria:

- Age \< 18-year-old

Primary outcomes:
measure: Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
timeFrame: 24 months
measure: Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Antonio Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366625: Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Official title: Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: hypertension, resistant
obstructive sleep apnea
renal denervation
continuous positive airway pressure therapy
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* \>= 18 and =\< 70 years of age.
* systolic blood pressure \>=140mmHg (office);
* on 3 or more antihypertensive medications (including diuretic)
* mean daytime systolic ABPM \>= 135 mmHg
* obstructive sleep apnea (AHI \>=15 event/hour, indications for CPAP treatment)

Exclusion Criteria:

* renal artery abnormalities
* eGFR \< 60mL/min
* previous TIA, stroke, heart failure
* Type 1 diabetes
* ICD or pacemaker
* others

Primary outcomes:
measure: Blood Pressure Reduction
timeFrame: 3 months
Secondary outcomes:
measure: Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)
timeFrame: Through 1 year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: Institute of Cardiology
name: Aleksander Prejbisz, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warchol-Celinska E, Prejbisz A, Kadziela J, Florczak E, Januszewicz M, Michalowska I, Dobrowolski P, Kabat M, Sliwinski P, Klisiewicz A, Topor-Madry R, Narkiewicz K, Somers VK, Sobotka PA, Witkowski A, Januszewicz A. Renal Denervation in Resistant Hypertension and Obstructive Sleep Apnea: Randomized Proof-of-Concept Phase II Trial. Hypertension. 2018 Aug;72(2):381-390. doi: 10.1161/HYPERTENSIONAHA.118.11180. Epub 2018 Jun 25.
Clinical trial NCT03347825: Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer
Official title: A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes With Lobectomy for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent robotic-assisted, VATS or open lobectomy for primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy.

Brief summary: The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.

Detailed description: This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:

Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older
* Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy

Exclusion Criteria:

* Subject with stage IIIB lung cancer
* Subject who received lobectomy as an emergent procedure
* Subjects who received lobectomy for metastatic cancer

Primary outcomes:
measure: Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases
timeFrame: 2013-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: BaylorScott&White
state: Texas
Study officials:
References:
Clinical trial NCT01530425: Outcome Measures for Pediatric Wheelchairs in Low-resource Settings
Official title: Development of a Suite of Outcomes Measures Suitable for Use in Low-resource Settings to Compare Pediatric Wheelchairs Within the Framework of the International Classification of Function, Disability and Health
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Impingement
Pressure Ulcer
Keywords: pediatric wheelchairs
low-income
comparisons
Lead sponsor: Bethany Relief and Rehabilitation International Inc.
Sponsor class: OTHER
Collaborators: name: LeTourneau University
name: Queen's University
First posted: 2012-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with disabilities in a primary school in Kenya who would benefit from available study wheelchairs, and who can provide feedback. Assent provided with parental consent.

Brief summary: Two wheelchair types available for children in Kenya are assessed for energy costs, utility, and complications. This study will arrive at a protocol for assessing wheelchairs in low-income settings, and in the process, provide wheelchair makers and providers with specific feedback. It also serves as a means to increase the skills of local health professionals working with the children in this study, while providing them with appropriate wheelchairs to use.

Detailed description: In each of 2011, 2012, and 2013, two different low cost wheelchairs were assessed. User feedback, health professional feedback, and objective measures were employed for these assessments in the real world setting. Participants for each phase were recruited from a Kenyan Primary or Secondary Schools for children with disability.

Eligibility criteria: Inclusion Criteria:

* Children who would benefit from available study wheelchairs who are able to provide feedback

Exclusion Criteria:

* Children who are not able to provide feedback on the study wheelchairs

Primary outcomes:
measure: physiologic costs (FEW)
timeFrame: within 1 year of wheelchair acquisition for each phase
Secondary outcomes:
measure: medical complications
timeFrame: within 24 months after wheelchair distribution for each phase
measure: participation
timeFrame: within 24 months after wheelchair distribution for each phase
Other outcomes:
Locations:
city: Thika
country: Kenya
facility: Kenyan Primary School
Study officials:
affiliation: LeTourneau University
name: Karen Rispin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274725: Men's Experience of Prostate Biopsy
Official title: Managing the Experience of Prostate Biopsy: What Are Men's Perceptions of Their Lived Experience and Support Needs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Biopsy
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men aged over 18

Brief summary: Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience

Detailed description: Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital will be approached by their Urology team or study Researcher with an information sheet about the study pre or post biopsy. The participant information sheet outlines that the study will involve being interviewed by the researcher, Kathryn Myhill as part of her doctoral research and being asked about their perceptions of their biopsy experience and what it was like to go through it. Men who return an expression of interest reply slip by post will be contacted by the researcher or they can contact her directly via the email or phone details given in the PIS. The researcher will answer any queries about the study and explore whether they would like to take part in an interview. A one to one interview will then be offered in a non-clinical, private room at the hospital where their biopsy took place (Royal Marsden Hospital, Epsom General Hospital) or at their workplace or home.

Eligibility criteria: * Inclusion Criteria:
* Men aged over 18 having a first or second diagnostic prostate biopsy at either the Royal Marsden NHS Foundation Trust or Epsom General Hospital
* Within 6 months of their prostate biopsy being done
* Exclusion Criteria:
* Men unable to give informed consent/ men needing a translator

Primary outcomes:
measure: To review the experience of prostate biopsy
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Epsom General Hospital
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03973125: Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma
Official title: Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma: Short-term Follow-up of Anatomical and Functional Responses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Circumscribed Choroidal Haemangioma
Keywords: circumscribed choroidal haemangioma
conbercept
effectiveness
safety
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the safety and effectiveness of application of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma.

Detailed description: This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Eligibility criteria: Inclusion Criteria:

* 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

Exclusion Criteria:

* patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: half a year
Secondary outcomes:
measure: Central foveal thickness
timeFrame: half a year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Kunbei Lai
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06167525: Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device
Official title: Assessment of the Effects of Maladaptive Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain Musculoskeletal
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Consultant and senior registrars performing microsurgery will be invited to participate in this Study. The study will take place at single site (Beaumont Hospital). A questionnaire to collect demographic information (age, height, sex, year of training, prior neck trauma or know neck issues) will be given to the consented surgeons. Additionally, surgery characteristics will be recorded (procedure, surgeon role (i.e lead or assisting), table height, frequency of adjustment of table height, and use of sitting or step stool, headlight, and/or loupes for \>50% of the procedure).

A postural training device, Upright Go 2 will be positioned at the spinous process of the cervical vertebrae of each surgeon and used to measure neck positions during microsurgical procedures. The device will be calibrated to an ideal neutral cervical spine position, so that excessive flexion and extension of the neck can be recorded.

The device contains built-in sensors that provide bio-feedback in the form of gentle vibrations if posture has deviated from neutral position.

During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures.

The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for \>1 minute. Response of surgeons to bio-feedback signals will also be recorded.

The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.


Eligibility criteria: Inclusion Criteria:

* Plastic and reconstructive surgeons performing microsurgery
* Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration

Exclusion Criteria:

* Surgeons not performing microsurgery on a regular basis (at least once a month)
* Plastic and reconstructive surgery trainees with \<1 years experience in microsurgery.

Primary outcomes:
measure: Measuring neck positioning using upright go 2 device during microsurgery procedures and adjustments in neck positioning after receiving bio-feedback signals.
timeFrame: 3 months
measure: Time and rate spent in maladaptive neck positions in surgeons during as measured by the upright go 2 device.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: