louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04232514: Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
Official title: A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

Detailed description: This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1\~7 and Day 13\~19.

Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
* Be able to complete the study according to the trail protocol.
* Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
* Male subjects and must be 18 to 45 years of age inclusive.
* Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
* Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

* Use of \>5 cigarettes per day during the past 3 months.
* Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
* History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
* Donation or loss of blood over 450 mL within 3 months prior to screening.
* 12-lead ECG with clinically significant.
* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Subjects deemed unsuitable by the investigator for any other reason.

Primary outcomes:
measure: Adverse Events
timeFrame: From Days 1-26
measure: Cmax
timeFrame: Day 7-12 and Day 19-26
measure: AUC
timeFrame: Day 7-12 and Day 19-26
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06511414: Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Official title: Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia
Ileostomy - Stoma
Keywords: duramesh,
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.


Eligibility criteria: Inclusion Criteria:

* • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)

  * Age 18 or greater
  * Surgical oncology patient where routine radiologic surveillance for malignancy is planned
  * Patient accepts participation and gives informed consent

Exclusion Criteria:

* • Pregnancy

  * Prior mesh hernia repair at laparotomy site
  * Life expectancy less than 1 years
  * Patient is unable / unwilling to provide informed consent
  * Patient is unable to comply with the protocol or proposed follow-up visits
  * Patient is enrolled in another hernia study
  * Non-English-speaking participants
  * Data from children will not analyzed in this study.
  * Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
  * Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.

Primary outcomes:
measure: hernia rates
timeFrame: 1 year
Secondary outcomes:
measure: infection rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT05619614: The Influence of Artificial Intelligence (AI )Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy
Official title: The Influence of Artificial Intelligence (AI) Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Neoplasms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Utrecht University
name: Lund University
First posted: 2022-11-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who are referred for regular care colonoscopy

Brief summary: In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.


Eligibility criteria: Inclusion Criteria of patients:

* Referred for diagnostic, screening or surveillance colonoscopy

Exclusion Criteria of patients:

* Therapeutic procedure
* Boston Bowel Prep Score (BBPS) score of \<6

Primary outcomes:
measure: Mean gaze time per area of influence
timeFrame: End of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center Nijmegen
state: Gelderland
Study officials:
References:
Clinical trial NCT04287114: Cardiac Stroke Volume at Rest and During Different Exercise Intensities
Official title: Cardiac Stroke Volume at Rest and During Different Exercise Intensities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Function
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.


Eligibility criteria: Inclusion Criteria:

* Age 18-45
* BMI 18-30
* Resting Blood pressure \< 140/90 mmHg
* Participation in regular exercise

Exclusion Criteria:

* Acute illness
* Pregnancy
* Pace maker
* Artificial joint
* History of a cardiac event
* Insulin or medically treated diabetes
* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
* Abundant use of alcohol
* Use of narcotics
* Smoking of tobacco or consuming snuff tobacco
* Diagnosed depressive or bipolar disorder
* Abnormalities in resting ECG (revised by the study physician)

Primary outcomes:
measure: Cardiac stroke volume
timeFrame: 1 min
Secondary outcomes:
measure: End-diastolic and end-systolic volumes
timeFrame: 1 min
measure: Ejection fraction
timeFrame: 1 min
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
city: Turku
country: Finland
facility: University of Turku
Study officials:
References:
Clinical trial NCT05221814: Pathological Classification of Pulmonary Nodules in Images Using Deep Learning
Official title: Pathological Classification of Pulmonary Nodules From Gross Images of Tumor Using Deep Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Artificial Intelligence
Keywords: lung cancer
pathologic prediction
deep learning
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2022-02-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Guangdong Provincial People's hospital from June 30, 2020 to September 15, 2021.

Brief summary: This study aimed to develop a deep-learning model to automatically classify pulmonary nodules based on white-light images and to evaluate the model performance. Besides, suitable operation could be chosen with the help of this model, which could shorten the time of surgery.

Detailed description: All white-light photographs of pulmonary nodules from phones of pathologically confirmed adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC) were retrospectively collected from consecutive patients who underwent surgery between June 30, 2020 and September 15, 2021 at Guangdong Provincial People's Hospital.Finally, a total of 1037 white-light images from 973 individuals were included in the study. The entire dataset was divided into training and test datasets, which were mutually exclusive, using random sampling. Of these, 830 images were used as the training dataset and 104 images from were used as the test dataset. The CNN model was used in classifying images, namely, Resnet-50. For the CNN model, pretrained model with the ImageNet Dataset were adopted using transfer learning. After constructing the CNN models using the training dataset, the performance of the models was evaluated using the test dataset and the prospective validation dataset.

Eligibility criteria: Inclusion Criteria:

1. Male or female，18 years and older.
2. Patients haven't undergone any therapy.
3. The pulmonary nodules were confirmed AIS, MIA or IAC.
4. The sizes of pulmonary nodules were less than 3cm.
5. The images were jpg format.

Exclusion Criteria:

1. Suffering from other tumor disease before or at the same time.
2. Images with poor quality or low resolution that precluded proper classification.

Primary outcomes:
measure: 1. Pathological subtype
timeFrame: through study completion, an average of 2 year
measure: Area Under the Curve (AUC)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guagndong Provincial People's Hospital
state: Guangdong
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Haiyu Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06603714: Effects of Soft Tissue Mobilization at Different Muscle Lengths
Official title: Immediate Effects of Instrument Assisted Soft Tissue Mobilization at Different Muscle Lengths
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Muscle, Ligament and Fascia Disorders
Instrument Assisted Soft Tissue Mobilization
Range of Motion
Pain
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will complete two visits. During one visit the treatment will be performed at short, whilst during the other at long muscle lengths.
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to compare the effects of instrument assisted soft tissue mobilization at different muscle lengths on pain pressure thresholds and measures of flexibility.

Detailed description: Instrument assisted soft tissue mobilization is a widely used manual therapy technique, which aims at reducing pain and improving range of motion. Evidence regarding acute responses to instrument assisted soft tissue mobilization at different muscle lengths is lacking. Therefore, the purpose of our study was to conduct a cross-over trial and compare the acute effects of instrument assisted soft tissue mobilization at short and long muscle lengths of the calf muscles on pain pressure thresholds and measures of flexibility.

Eligibility criteria: Inclusion Criteria:

* without previous lower limb injuries in the last year
* healthy individuals
* students

Exclusion Criteria:

* Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
* General hypermobility: Beighton score \>4.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 30 minutes
measure: Passive dorsiflexion range of motion
timeFrame: 30 minutes
Secondary outcomes:
measure: Stand and reach test
timeFrame: 30 minutes
measure: Lumbar spine flexibility
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
state: Primorska
Study officials:
References:
Clinical trial NCT01362114: The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung
Official title: Phase 4 Study of The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung : A Randomized, Double Blind, Placebo-control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hwa-byung
Keywords: Hwa-byung
Sihogayonggolmoryeo-tang
Anxiety
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2011-05-27
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, double blinded, Placebo-control Trial, the investigators planned to give Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.


Eligibility criteria: Inclusion Criteria:

* male or female aged 20-65
* subjects who meet structured interview criteria for Hwa-Byung Diagnosis
* subjects who have axiety (more than 17 score in HAMA)

Exclusion Criteria:

* duration of illness less than 6 months
* current or past history of delusions, hallucination
* past history of at least one manic episode, hypomanic episode, or mixed episode
* current or past history of alcohol abuse or alcohol dependence history
* taking substances(e.g. steroids) which might affect symptoms
* medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms
* current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* pregnancy, lactation, women not using medically accepted means of birth control
* considered not apt to carry out clinical trial

Primary outcomes:
measure: Hamilton Anxiety Scale(HAM-A)
timeFrame: 8 weeks
Secondary outcomes:
measure: State-Trait Anxiety Inventory(STAI)
timeFrame: 8 weeks
measure: Beck Depression Inventory(BDI)
timeFrame: 8 weeks
measure: WHO Quality of Life Abbreviated(WHOQOL-BREF)
timeFrame: 8 weeks
measure: Heart Rate Variability(HRV)
timeFrame: 8 weeks
measure: likert scale
timeFrame: 8 weeks
measure: Hwa-byung scale
timeFrame: 8 weeks
measure: State-Trait Anger Expression Inventory (STAXI)
timeFrame: 8 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 8 weeks
measure: Instrument of Oriental Medical Evaluation for Hwa-Byung
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Daejon
country: Korea, Republic of
facility: Oriental Hospital of Daejon University
state: Choong-Chung-Do
Study officials:
affiliation: Oriental Hospital of Daejon University
name: In-Chul Jung, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591214: Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
Official title: A Phase I, Open-Label, Single-Dose Study of MP-424 in Patients With Genotype 1b Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Protease Inhibitor
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C
* Patients naive to the concomitant medications with interferon

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test

Primary outcomes:
measure: Cmax (Maximum Observed Concentration in Plasma) of MP-424
timeFrame: Date were collected at Day1 to Day85
measure: Tmax (Time of Maximum Plasma Concentration) of MP-424
timeFrame: Date were collected at Day1 to Day85
measure: AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
timeFrame: Date were collected at Day1 to Day85
measure: Ctrough (Plasma Trough Concentration) of MP-424
timeFrame: Date were collected at Day1 to Day85
measure: t1/2 (Half Life Period) of MP-424
timeFrame: Date were collected at Day1 to Day85
Secondary outcomes:
measure: Change in HCV RNA Levels of MP-424
timeFrame: Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamada I, Suzuki F, Kamiya N, Aoki K, Sakurai Y, Kano M, Matsui H, Kumada H. Safety, pharmacokinetics and resistant variants of telaprevir alone for 12 weeks in hepatitis C virus genotype 1b infection. J Viral Hepat. 2012 Feb;19(2):e112-9. doi: 10.1111/j.1365-2893.2011.01514.x. Epub 2011 Oct 7.
Clinical trial NCT01545414: Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
Official title: Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Depression
Anxiety
Insomnia
Keywords: Self-help treatment
Internet treatment
Cognitive Behavioral Therapy
Internet-based Cognitive Behavioral Therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-03-06
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease
* At least mild to moderate depression or anxiety defined as HADS-A or HADS-D \> 7

Exclusion Criteria:

* Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
* Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
* Difficulties that hamper the use of a computer
* The patient states difficulties in finding enough time for treatment
* Too low cognitive functioning defined as MoCA \< 24
* Too severe depression, defined as MADRS-S over 30
* Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview

Primary outcomes:
measure: Change (from baseline) in HADS
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
Secondary outcomes:
measure: Change (from baseline) in MADRS-S
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
measure: Change (from baseline) in ISI
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
measure: Change (from baseline) in PDQ-8
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
measure: Change (from baseline) in EQ-5D
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
measure: Change (from baseline) in SDS
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
measure: Change (from baseline) in NMSQuest
timeFrame: 12 weeks (Post), 3 and 6 months (FU)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Study officials:
affiliation: Karolinska Institutet
name: Viktor Kaldo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: