louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890862: Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily Activities
Official title: Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand Injuries
Keywords: Kinematics
Activity of Daily living
3D motion analysis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Institute for Biomechanics, ETH Zürich
First posted: 2016-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of healty persons, patients with tendon pathologies, arthrosis and dupuytren disease. In the future the new findings should assist the decision of surgical procedures.

Brief summary: Development of reliable and objective evaluation methods is required for natural upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool for quantitative assessment of multijoint movements.


Eligibility criteria: Inclusion Criteria:

* Volunteers of 20 healthy, right dominant hands
* 10 patients with tendon pathologies
* 10 patients with Dupuytren disease
* 10 patients with osteoarthritis of the wrist
* Patients older than 18 years
* Patient willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Primary outcomes:
measure: Joint angle of finger and wrist (Vicon)
timeFrame: 36 months
measure: Joint angle of finger and wrist (Goniometer)
timeFrame: 36 months
Secondary outcomes:
measure: Objective functional parameters: - daily activities: open a bottle, open a glass, type 3 words, write 3 words, turn a key, pick up small object, move heavy object (1/3kg), dart-throwing motion
timeFrame: 36 months
measure: Subjective functional parameters: - Mayo Wrist Score - Krimmer Wrist Score - Short Version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
timeFrame: 36 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Center for Reconstructive Surgery
state: ZH
Study officials:
affiliation: Plastic surgery and Handsurgery USZ
name: Maurizio Calcagni, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325662: A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)
Official title: A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from general population

Brief summary: This is a study to evaluate the feasibility and tolerability of low-rate continuous Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Must be in good health
* Must have a body mass index greater than or equal to 18 kg/m\^2 and less than or equal to 30 kg/m\^2

Exclusion Criteria:

* Is pregnant, nursing, or plans to become pregnant
* Has clinically significant cardiovascular, renal, hepatic, gastrointestinal (GI), neurological, endocrine, hematological, dermatological or metabolic disease, or clinically significant abnormalities, as determined by medical history, physical examination, electrocardiogram, vital signs, or laboratory tests
* Has a history of migraine headaches
* Has a history of recent lumbar CSF sampling within 3 weeks prior to screening, history of lumbar spine surgery, or chronic low back pain or injury
* Has an infection or inflammation of the skin in or in close proximity to the area of the lumbar puncture site
* Has a history of a seizure disorder
* Is noted to have papilledema or clinically significant focal neurological deficits at the screening physical examination, as well as abnormalities of CSF pressure on initial testing once access to the lumbar space is achieved
* Has absolute or relative anatomic abnormalities that would be a contraindication to lumbar puncture
* Is a heavy consumer of alcohol
* Has used nicotine in the past 6 months
* Has a history of a significant psychiatric disorder

Primary outcomes:
measure: Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01822262: Contrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy
Official title: All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gallstones
Keywords: Cholecystolithotomy with gallbladder reservation
cholecystolithiasis
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method： patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with gallbladder reservation and patients with cholecystolithiasis who received laparoscopic cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder reservation as trial group, patients who received LC as control group.the overall follow-up period is 1 year. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in trial group.

Detailed description: The investigators Prospect： Minimally invasive cholecystolithotomy with gallbladder reservation is meaningful for recovering the function of gallbladder.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of calculous cholecystitis.

Exclusion Criteria:

* Gallbladder's wall \>3mm, atrophied gallbladder,gallstone obstruct the Hartmann's pouch.
* Abdominal ultrasound display the contractibility of gallbladder is poor.
* The aged patients with bad heart and lung function.
* Patients who has acute cholecystitis,pancreatitis,pancreaticobiliary diseases, especially choledocholithiasis.
* Pregnant or lactational women.

Primary outcomes:
measure: The contraction function of the gallbladder
timeFrame: Participants will be followed for overall 1 year after surgery
Secondary outcomes:
measure: The thickness of gallbladder wall
timeFrame: Participants will be followed for overall 1 year after surgery
Other outcomes:
measure: The improvement of cholelith symptoms
timeFrame: Participants will be followed for overall 1 year after surgery
measure: The recurrence rate of gallstone
timeFrame: Participants will be followed for overall 1 year after surgery
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guiyang Medical College
state: Guizhou
Study officials:
affiliation: The Affiliated Hospital of Guiyang Medical College
name: Chengyi Sun, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT02047162: Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
Official title: Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Keywords: diarrhea
gastroenteritis
antimicrobial drug resistance
antimicrobial agents
Pakistan
ambulatory care
bismuth
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Procter and Gamble
name: Health Oriented Preventive Education
First posted: 2014-01-28
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.


Eligibility criteria: Inclusion Criteria:

* Persons aged 15 - 65 years old
* Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for \<3 days) to participating health care settings
* For whom the study physicians recommend antimicrobial treatment

Exclusion Criteria:

* Is pregnant
* Requires hospitalization
* Has signs or symptoms of septicemia
* Has a primary complaint of another acute illness
* Has a serious chronic illness
* Has an allergy to aspirin
* Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment
* Previously enrolled in study

Primary outcomes:
measure: use of antimicrobial medications
timeFrame: within 5 days of enrollment
Secondary outcomes:
measure: Patient's perceived need for antibiotics
timeFrame: Within 48 h of enrollment
measure: additional care obtained for diarrhea
timeFrame: within 48 h of enrollment
measure: Additional care obtained for diarrheal illness
timeFrame: within 5 days of enrollment
measure: Disease severity and duration
timeFrame: within 5 days of enrollment
measure: Patient experience with the study drug
timeFrame: within 5 days of enrollment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: HOPE
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Anna Bowen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowen A, Agboatwalla M, Pitz A, Salahuddin S, Brum J, Plikaytis B. Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199441. doi: 10.1001/jamanetworkopen.2019.9441.
Clinical trial NCT02624362: The Effect of Odors on Asthma Symptoms
Official title: The Effect of Suggestion of Harmful/Beneficial Effects of Odors on Asthma Symptoms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asthma
Keywords: Odor
trigger
inflammation
nocebo
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Research Foundation Flanders
First posted: 2015-12-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: An extended replication of Jaen \& Dalton (2014), the investigators aim to investigate the role of odors and associated trigger beliefs on symptom perception and airway inflammation in individuals with asthma

Detailed description: Participants with asthma are randomly assigned to a 15-min (phenylethyl alcohol) odor inhalation, accompanied by either an asthmogenic suggestion (nocebo), or a therapeutic suggestion (placebo). Airway inflammation, lung function, and asthma symptoms are measured in response to the odor/suggestion, up to 24 hours after odor inhalation. The investigators are also measuring worry and heart rate variability as potential mediators of the response.

Eligibility criteria: Inclusion Criteria:

* A physician diagnosis of asthma

Exclusion Criteria:

* FEV1 lower than 60% predicted
* clinical condition other than asthma

Primary outcomes:
measure: Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction
timeFrame: baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Secondary outcomes:
measure: asthma symptoms
timeFrame: baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
measure: Forced Expiratory Volume at one second (FEV1)
timeFrame: baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
measure: Worry
timeFrame: baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
measure: Cortisol
timeFrame: baseline, immediately after odor induction, 2 hours after odor induction, at awakening, 30 min after awakening, 24 hours after odor induction
measure: Change in Heart rate and Heart Rate Variability (HRV)
timeFrame: change from baseline to 24 hours after odor induction
measure: Change in Respiratory rate
timeFrame: change from baseline to 15 min odor presentation
measure: change in Fraction of end-tidal carbon dioxide (FetCO2)
timeFrame: change from baseline to 15 min odor presentation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Thomas Janssens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310062: The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
Official title: Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B,Chronic
Carcinoma,Hepatocellular
Keywords: hepatocellular carcinoma
microarray
gene expression profiling
biomarkers
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: GeneNews Sdn Bhd
First posted: 2011-03-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected hospitals for study

Brief summary: More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.


Eligibility criteria: Inclusion Criteria:

* Patients of at least 21 years old on day of giving consent for study
* Patients must be able and wiling to give an informed consent
* Patient with chronic HBV infection
* Patient with active hepatocellular carcinoma and chronic hepatitis B
* Healthy subjects

Exclusion Criteria:

* Patients who have co-infection with HIV or chronic hepatitis C
* Subjects with other types of cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alor Star
country: Malaysia
facility: Sultanah Bahiyah Hospital
state: Kedah
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital
state: Sabah
city: Kuching
country: Malaysia
facility: Hospital Umum Kuching Sarawak
state: Sarawak
city: Selayang
country: Malaysia
facility: Selayang Hospital
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Kuala Lumpur Hospital
state: Wilayah Persekutuan
city: Pulau Pinang
country: Malaysia
facility: Island Hospital
city: Pulau Pinang
country: Malaysia
facility: Lam Wah Ee Hospital
city: Pulau Pinang
country: Malaysia
facility: Penang Hospital
Study officials:
References:
Clinical trial NCT04548362: Biomarkers of Meats and Potatoes Intake
Official title: Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders
Keywords: Biomarkers of food intake
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Subjects were randomised to four meals with meats and starchy foods in such a way that all volunteers had each meat and each starchy food once and so that all combinations of meats and starchy foods were equally common. Each volunteer was also randomised to the sequence of the meals.
Primary purpose: BASIC_SCIENCE

Brief summary: This cross-over meal study is a four-way intervention with 12 volunteers randomized at the same time to four meals with fried meats (beef, pork, chicken and amino-acid matched non-meat control) and to four meals with potato products (boiled, chips, fries, and a control with boiled white rice) to search for biomarkers of intake.

Detailed description: In a two-dimensional, cross-over meal study, 12 healthy volunteers consumed in a randomized sequence four test meals: chicken, pork, beef, and a control made of egg white and pea. At the same time they were independently randomized to four starchy foods to be consumed together with the meats: boiled potatoes, fried potatoes, potato crisps or boiled white rice. Fasting and postprandial urine samples were collected to cover 48 h after each meal and samples were profiled by untargeted LC-ESI-qTOF-MS metabolomics. The profiles following the meal challenges were explored by univariate and multivariate analyses and single and combined markers of intake identified chemically by MS/MS fragmentation experiments and statistically by ROC curves and error rates as well as FDR statistics.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills

Primary outcomes:
measure: meat intake biomarkers
timeFrame: 0-48 hours
measure: Potato intake biomarkers
timeFrame: 0-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Lars Dragsted
Study officials:
affiliation: University of Copenhagen
name: Catalina Cuparencu, PhD
role: STUDY_DIRECTOR
References:
citation: Zhou X, Ulaszewska MM, Cuparencu C, De Gobba C, Vazquez-Manjarrez N, Gurdeniz G, Chen J, Mattivi F, Dragsted LO. Urine Metabolome Profiling Reveals Imprints of Food Heating Processes after Dietary Intervention with Differently Cooked Potatoes. J Agric Food Chem. 2020 Jun 3;68(22):6122-6131. doi: 10.1021/acs.jafc.0c01136. Epub 2020 May 8.
citation: Cuparencu C, Rinnan A, Dragsted LO. Combined Markers to Assess Meat Intake-Human Metabolomic Studies of Discovery and Validation. Mol Nutr Food Res. 2019 Sep;63(17):e1900106. doi: 10.1002/mnfr.201900106. Epub 2019 Jun 13.
Clinical trial NCT05511662: Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System
Official title: Influence of Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System on the Follow-up Compliance and Satisfaction of Patients With Atrial Fibrillation After Cryoablation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation; follow up；patient-reported outcomes；
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paroxysmal, symptomatic atrial fibrillation patients undergoing cryoablation；

Brief summary: Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.

Detailed description: Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.Among patients with left atrial fibrillation after cryoablation at several sites, 240 consecutive eligible patients were randomly assigned to routine follow-up (control) and PRO (test) for 12 months. Follow-up, comparison of postoperative follow-up compliance, satisfaction, etc.

Eligibility criteria: Inclusion Criteria:

* 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation；Ability to understand and sign informed consent；

Exclusion Criteria:

* none

Primary outcomes:
measure: follow-up rate
timeFrame: 1-year
Secondary outcomes:
measure: Anxiety Scale Score
timeFrame: 1 year
measure: Depression Scale Score
timeFrame: 1 year
measure: Quality of Life Scale Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jun Zhang
state: Shanghai
Study officials:
affiliation: Tongji University
name: Yawei Xu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03453762: The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
Official title: The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 88
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo surgery for more than 1 hour under general anesthesia
* Children under 6 years old
* American Society of Anesthesiologist Physical Status I or II

Exclusion Criteria:

* History of lung surgery
* Abnormal findings in chest x-ray
* Laparoscopic surgery
* Abdominal surgery

Primary outcomes:
measure: Incidence of postoperative atelectasis
timeFrame: within 1 hour after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.