louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03795181: Prediction Model for Multiple Pulmonary Nodules
Official title: Prediction Model for Multiple Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Pulmonary Nodules
Keywords: multiple pulmonary nodules; predictive model
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population include patients with multiple pulmonary nodules who will be diagnosed and treated between January 1，2019 and March 30, 2019. Patients with at least 2 nodules resected will be enrolled in this study.

Brief summary: This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.

Detailed description: It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.

Eligibility criteria: Inclusion Criteria:

* Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans
* Patients with at least two nodules resected for pathological evaluation

Exclusion Criteria:

* History of malignancy within 5 years
* Presence of pneumonia or pleural effusion on thoracic CT scans
* Patients with none or only one nodule resected
* Patients with initial chemo-radiation therapy

Primary outcomes:
measure: Performance of PKUM model
timeFrame: 3 months
Secondary outcomes:
measure: Comparison between PKUM model and clinicians
timeFrame: 3 months
measure: Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Haidian Section of Peking University Third Hospital
name: Yuqing Huang
role: STUDY_DIRECTOR
affiliation: People's Hospital Affiliated to Hebei Medical University
name: Jiabao Liu
role: STUDY_DIRECTOR
affiliation: Beijing Aerospace 711 Hospital
name: Yingtai Chen
role: STUDY_DIRECTOR
affiliation: Beijing Aerospace 731 Hospital
name: Mingru Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT01323881: Intermittent Theta Burst Stimulation After Acute Stroke
Official title: Theta Burst Stimulation on the Motor Cortex in Acute Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke,
Keywords: theta burst stimulation, stroke, motor, plasticity
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2011-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.

Detailed description: The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized medical and intensive rehabilitation treatments. The outcome measures included Action Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of ECR.

Eligibility criteria: Inclusion Criteria:

* Patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (MCA) territory, and mild to moderate hand paresis (NIHSS motor arm score 1-2) are enrolled.

Exclusion Criteria:

* age over 75, severe hand paresis without detectable active motor threshold (aMT) of the extensor carpi radialis (ECR), seizure history (clinical or EEG abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.

Primary outcomes:
measure: The changes of Action Research Arm test
timeFrame: 60th day post-stroke
Secondary outcomes:
measure: The changes of upper limb function and corticospinal excitability
timeFrame: 60th day post-stroke
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan
name: I-Hui Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu YF, Huang YZ, Lin YY, Tang CW, Liao KK, Lee PL, Tsai YA, Cheng HL, Cheng H, Chern CM, Lee IH. Intermittent theta burst stimulation over ipsilesional primary motor cortex of subacute ischemic stroke patients: a pilot study. Brain Stimul. 2013 Mar;6(2):166-74. doi: 10.1016/j.brs.2012.04.007. Epub 2012 May 12.
Clinical trial NCT01828281: Effects of CPAP on Visceral Fat Thickness
Official title: A Randomized Controlled Study on the Effects of Continuous Positive Airway Pressure (CPAP) on Visceral Fat Thickness, Carotid Intima-media Thickness and Adipokines in Patients With Obstructive Sleep Apnoea Syndrome (OSAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.

Detailed description: This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.

Eligibility criteria: Inclusion Criteria:

* symptomatic patients with OSA of apnea hypopnea index (AHI) \>= 5/hr

Exclusion Criteria:

* Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy,
* patients with clinical features of any active infection
* those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery)
* moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy.

Primary outcomes:
measure: Mesenteric Fat Thickness
timeFrame: 3 months
Secondary outcomes:
measure: Mean Changes in Adiponectin Over 3 Months
timeFrame: Baseline, 3 months
Other outcomes:
measure: Mean Hours of CPAP Usage Per Day
timeFrame: 3 months
Locations:
city: Hong Kong
country: China
facility: Respiratory Division
Study officials:
affiliation: Chinese University of Hong Kong
name: Hui David, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng SS, Liu EK, Ma RC, Chan TO, To KW, Chan KK, Ngai J, Yip WH, Ko FW, Wong CK, Hui DS. Effects of CPAP therapy on visceral fat thickness, carotid intima-media thickness and adipokines in patients with obstructive sleep apnoea. Respirology. 2017 May;22(4):786-792. doi: 10.1111/resp.12963. Epub 2016 Dec 9.
Clinical trial NCT06590181: Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes
Official title: Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
meditation
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
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: Yoga Nidra is a scripted mind-body intervention (MBI) that uses guided relaxation technique in a reproducible sequence of mechanisms that naturally produce a parasympathetic response. This is a randomized controlled trial in which participants will be randomly assigned to one of three interventions: 1) yoga nidra (Yoga Nidra Script Basic), 2) yoga nidra with pain acceptance (Yoga Nidra Acceptance Intention), 3) yoga nidra with pain acceptance and Explicit Motor Imagery (Yoga Nidra Acceptance Intention and Visualization).


Eligibility criteria: Inclusion Criteria:

* Chronic pain in the neck, low back, shoulder, hip, elbow, knee, wrist, or ankle that has lasted for over three months
* Pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable)

Exclusion Criteria:

* non-English speaking
* systemic medical conditions that affect sensation (such as uncontrolled diabetes)
* History of surgery or fracture within the past six months
* any blood clotting disorders (such as hemophilia)
* any contraindication to the application of ice (blood pressure \&gt; 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* Exceed pressure and heat sensory thresholds
* Unable to access internet or email
* Pregnant

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Pre/Post intervention, Day 1
measure: Temporal Summation
timeFrame: Pre/Post intervention, Day 1
measure: Conditioned Pain Modulation
timeFrame: Pre/Post intervention, Day 1
measure: Heat Pain Threshold
timeFrame: Pre/Post intervention, Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Anderson, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01175681: Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Official title: Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: rheumatic heart disease
degenerated heart valve disease
heart valve prolapse
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
First posted: 2010-08-05
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.


Eligibility criteria: Inclusion Criteria:

* All heart valve diseases needing heart valve surgery.

Exclusion Criteria:

* All four limbs existed ischemic condition

Primary outcomes:
measure: plasma troponin I level
timeFrame: with 7 days after surgery
Secondary outcomes:
measure: serum creatinine
timeFrame: within 7 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
affiliation: The Frist Affiliated Hospital, Sun Yat-sen University
name: Jing-song Ou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
citation: Xie JJ, Liao XL, Chen WG, Huang DD, Chang FJ, Chen W, Luo ZL, Wang ZP, Ou JS. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing heart valve surgery: randomised controlled trial. Heart. 2012 Mar;98(5):384-8. doi: 10.1136/heartjnl-2011-300860. Epub 2011 Nov 22.
Clinical trial NCT05811481: Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy
Official title: Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Transcatheter Arterial ChEmoembolization
Regorafenib
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 192
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: PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma

Brief summary: . 1 Clarify the difference in efficacy of regofinib combined with TACE compared with second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of TACE in the second-line treatment of advanced HCC.


Eligibility criteria: Inclusion Criteria:

( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver.

Exclusion Criteria:

( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;

Primary outcomes:
measure: Overall survival
timeFrame: 2022.12.27-2025.09.30
Secondary outcomes:
measure: Progression-free survival for the first subsequent treatment PFS 2
timeFrame: 2022.12.27-2025.09.30
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: FirstSunYetSen
state: Guangdong
Study officials:
References:
Clinical trial NCT01066481: A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
Official title: A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Dementia
Dimebon
Investigational Drug
Keywords: Alzheimer's disease
clinical trial
memory loss
investigational drug
neurodegenerative disease
dementia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 50
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 demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).


Eligibility criteria: Inclusion Criteria:

* Mild-to-Moderate Alzheimer's disease
* MMSE score 10-24 inclusive

Exclusion Criteria:

* Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
* Complication of other causes of dementia

Primary outcomes:
measure: Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
timeFrame: 26 weeks
measure: Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
timeFrame: 26 weeks
Secondary outcomes:
measure: Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
timeFrame: 12, 26 weeks
measure: Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
timeFrame: 12, 26 weeks
measure: Mean change in Mini-Mental State Examination (MMSE) score from baseline.
timeFrame: 6, 12, 18, 26 weeks
measure: Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
timeFrame: 12, 26 weeks
measure: Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).
timeFrame: 12, 26 weeks
measure: Population PK parameters (CL/F, V/F, etc.)
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00329810: Effect on Cognitive Function of a Treatment With Aripiprazole
Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia
* score of 2-6 in the CGI-S scale at basline
* ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment

Exclusion Criteria:

* women of child bearing potential
* women pregnant or breast feeding
* patients with a score of 0,-1 or 7
* substance use

Primary outcomes:
measure: Clinical Global Impression scale at endpoint
Secondary outcomes:
measure: Change in Clinical Global Impression scale and cognition scales at endpoint
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bervoets C, Morrens M, Vansteelandt K, Kok F, de Patoul A, Halkin V, Pitsi D, Constant E, Peuskens J, Sabbe B. Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study. CNS Drugs. 2012 Nov;26(11):975-82. doi: 10.1007/s40263-012-0003-4.