louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02209207: Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study
Official title: Continuous Versus Interval Walking Training in Patients With Severe Chronic Obstructive Pulmonary Disease - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Airway Disease
Keywords: chronic obstructive pulmonary disease
endurance training
interval training
continuous training
walking training
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of interval walking training versus continuous walking training in patients with chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized to one of the two intervention groups. All walking training sessions will be performed on the same treadmill. Walking intensity in the continuous walking group will be 60 percent of the average speed of the 6-minute walking test. Patients in the interval training group will perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds alternating with 60 seconds of rest. The total exercise duration will be progressively increased from 10 to 32 minutes.


Eligibility criteria: Inclusion Criteria:

* COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease \[GOLD\]
* stationary patient in the Schön Klinik Berchtesgadener Land

Exclusion Criteria:

* acute, severe exacerbation of COPD
* failure to comply with study process

Primary outcomes:
measure: perceived exertion for dyspnea during walking training
timeFrame: day 1 to 21
Secondary outcomes:
measure: heart rate during walking training
timeFrame: day 1 to 21
measure: perceived exertion for leg fatigue (Borg-scale)
timeFrame: during three weeks of rehabilitation
measure: Oxygen saturation during walking training
timeFrame: day 1 to 21
measure: fat free mass in kilogram
timeFrame: day 1 to 21
measure: forced expiratory volume in 1 second (FEV1) in liter
timeFrame: day 1 to 21
measure: Sit-to-stand-test
timeFrame: day 1 to 21
measure: 6-minute walking test
timeFrame: day 1 to 21
measure: 36 item short-form health Survey (SF-36)
timeFrame: day 1 to 21
measure: chronic respiratory questionnaire (CRQ)
timeFrame: day 1 to 21
measure: hospital anxiety and depression scale (HADS)
timeFrame: day 1 to 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
Clinical trial NCT05912907: Potassium Nitrate in Polycarboxylate as a Direct Pulp Capping
Official title: Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as a Direct Pulp Capping in Young Permanent Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulp Disease, Dental
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears


Eligibility criteria: Inclusion Criteria:

* 7-10 years of children
* Healthy children classified as ASA I or II
* Asymptomatic vital immature mandibular first molar with extensive and deep caries
* Signs and symptoms of reversible pulpitis

Exclusion Criteria:

* Necrotic teeth or teeth with irreversible pulpitis
* Medically compromised children

Primary outcomes:
measure: clinical success rate
timeFrame: 24 months
measure: Radiographic success rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT00715507: Evaluation of Drug Display in Critical Care Setting
Official title: Evaluation of Drug Display in Critical Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decision Making
Keywords: decision making
graphic display
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents

Brief summary: To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.

Detailed description: This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.

Eligibility criteria: Inclusion Criteria:

* Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display

Exclusion Criteria:

* Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display

Primary outcomes:
measure: assess differences between medication administration data and patient information with and without the use of the graphical medication monitor.
timeFrame: preoperative, intraoperative and postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Ken Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427607: An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Official title: An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Perampanel
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.


Eligibility criteria: Inclusion Criteria

1. Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel).
2. Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained.
3. Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\]).

Exclusion Criteria

1. Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study.
2. Female participants who are nursing, pregnant, or planning to become pregnant.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
timeFrame: From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Matsuyama
country: Japan
state: Ehime
city: Sapporo
country: Japan
state: Hokkaido
city: Inashiki-gun
country: Japan
state: Ibaraki
city: Uji
country: Japan
state: Kyoto
city: Sakai
country: Japan
state: Osaka
city: Matsue
country: Japan
state: Shimane
city: Nerima-Ku
country: Japan
state: Tokyo
city: Niigata
country: Japan
Study officials:
References:
Clinical trial NCT02365207: Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Official title: Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 6
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: Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

Detailed description: Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.

After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Eligibility criteria: Inclusion Criteria:

1. Have suspected or known invasive (≥T1) bladder cancer
2. Be able to give informed consent
3. Be age 18 or older
4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)

Exclusion Criteria:

1. Have non-invasive (\<T1) bladder cancer
2. Unable to give informed consent
3. \< 18 or older
4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)

Primary outcomes:
measure: Ability of BCG to Enhance Tumor Specific Immunity
timeFrame: At cystectomy at 3-6 weeks after BCG treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: MARC - The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Robert Svatek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538807: EMG Finding According to the Type of Lumbar Disc Herniation
Official title: A Study for Electrodiagnostic Finding According to the Type of Lumbar Disc Herniation on MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intervertebral Disc Displacement
Electromyography
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral hospital

Brief summary: Disc herniation is a common cause of low back pain and leg pain. Electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. This study aimed to compare the MRI findings of disc herniation and the aspects of electromyography.


Eligibility criteria: Inclusion Criteria:

* Radicular pain within 6 months
* Disc herniation confirmed by lumbar MRI
* undergoing electromyography

Exclusion Criteria:

* Patients who refused electromyography
* Patients taking warfarin
* Lower limb amputation patient
* Pregnant women
* Patients who have undergone surgical treatment for disc herniation
* Patients with peripheral neuropathy ( AIDP, CIDP, diabetic amyotrophy, peroneal pals et al.)

Primary outcomes:
measure: Denervation pattern of muscles in lower extremity
timeFrame: 1 day During the examination of Electromyogram
Secondary outcomes:
measure: Disc herniation findings of lumbar MRI
timeFrame: 1 day During the examination of lumbar MRI
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
References:
Clinical trial NCT04644107: Expanded Access for Marizomib
Official title: Expanded Access for Marizomib
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumor
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2020-11-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to Marizomib.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Bristol Myers Squibb
state: New Jersey
Study officials:
References:
Clinical trial NCT06020807: Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Official title: Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Urothelial Carcinoma
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 168
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and urology patients without prior history or evidence of bladder cancer will be recruited from urology group clinics.

Brief summary: This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Age 22 or older
* Able to sign the informed consent form
* Normal, healthy subjects or subjects with one of the following conditions:

  1. Benign non-genitourinary disease (e.g. heart disease)
  2. Non-genitourinary cancers (e.g. lung, CRC, breast)
  3. Genitourinary disease other than bladder cancer including:
  4. Benign prostatic hyperplasia (BPH)
  5. Microhematuria proven negative for bladder cancer through prior UCC evaluation
  6. Inflammation/infection
  7. Symptomatic sexually transmitted disease (STD)
  8. Urinary tract stones
  9. Genitourinary trauma
* Subjects with native bladder

Exclusion Criteria:

* Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
* Currently in work-up due to suspicion of cancer of any kind

Primary outcomes:
measure: Specificity
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT05802407: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer
Official title: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Resectable Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:

* prognostic value of baseline MRD;
* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.


Eligibility criteria: Inclusion Criteria:

* patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);
* both sexes, age ≥18 years old;
* ECOG performance status score ≤2;
* the expected survival time was ≥3 months.

Exclusion Criteria:

* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
* treated with any systemic antitumor treatment before first-line chemotherapy onset;
* died or lost to follow-up within one month after the initiation of adjuvant chemotherpay;
* combined with other primary malignances.

Primary outcomes:
measure: Disease-free survival
timeFrame: Baseline until death from any cause (up to approximately 36 months)
Secondary outcomes:
measure: Overall survival
timeFrame: Baseline until death from any cause (up to approximately 60 months)
Other outcomes:
measure: The prognostic value of MRD
timeFrame: Baseline until death from any cause (up to approximately 60 months)
measure: The prognostic role of targeted therapy selected based on MRD
timeFrame: Baseline until death from any cause (up to approximately 60 months)
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chunmei Bai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319407: EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery
Official title: EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning.

Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo robotic assisted laparoscopic genitourinary surgery
* Patients who are scheduled to have EPAD monitoring as part of their clinical care intraoperatively

Exclusion Criteria:

• Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies

Primary outcomes:
measure: Somatosensory Evoked Potential Monitoring
timeFrame: in the first 24 hours of postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Robert McClain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917707: Integrative Analysis of CRC Liver Metastasis
Official title: Integrative Analysis of CRC Liver Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastasis
Keywords: CRC
liver metastasis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Ganzhou City People's Hospital
First posted: 2016-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with CRC

Brief summary: The investigators will perform integrative analysis of CRC liver metastasis

Detailed description: The investigators will analyzed proteomes of paired normal colorectal tissues and colorectal cancer (CRC) with or without liver metastasis, sequenced transcriptomes, performed whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal colorectal tissue, primary colorectal carcinoma, and its synchronous matched liver metastasis, as well as analyzed genomics of CRC characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 75 years with histologically proven CRC
* No severe major organ dysfunction
* WHO performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* World Health Organization (WHO) performance status of \>1
* Prior cancer chemotherapy

Primary outcomes:
measure: 5 years overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 5 years disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: Ganzhou City People's Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: the Shanghai Tenth People's Hospital
name: Da Fu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
citation: Ma YS, Huang T, Zhong XM, Zhang HW, Cong XL, Xu H, Lu GX, Yu F, Xue SB, Lv ZW, Fu D. Proteogenomic characterization and comprehensive integrative genomic analysis of human colorectal cancer liver metastasis. Mol Cancer. 2018 Sep 21;17(1):139. doi: 10.1186/s12943-018-0890-1.