louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05930847: Digital Respiratory Game in Asthma
Official title: Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Digital game
Pediatric asthma
Quality of life
Respiratory training
Psychological status
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effects of a digital game designed for respiratory training in childhood asthma. Fifteen children aged 8-14 years with asthma were included in the study. There were two groups a digital game group (n=9) and a control group (n=6). Respiratory training was given to the digital game group with a digital game. The control group was followed with medication. Both groups were evaluated at baseline and after 3 weeks.

Detailed description: Asthma is a chronic obstructive disease that is common in children worldwide. This study aims to examine the effects of a digital game designed for respiratory training in childhood asthma.

Fifteen children aged 8-14 years with asthma were included in the study. There were two groups a digital game group (n=9) and a control group (n=6). Demographic information of the children was recorded. Pulmonary function test (PFT) was evaluated with a portable spirometer (Spirobank MIR), the quality of life of the children was evaluated with the Paediatric Asthma Quality of Life Questionnaire and psychological status was evaluated with the child depression scale. Respiratory training was given to the digital game group with a digital game. The control group was followed with medication. Both groups were evaluated at baseline and after 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with asthma according to GINA criteria
* Cooperative

Exclusion Criteria:

* Presence of neurological problems
* Presence of systemic disorders

Primary outcomes:
measure: Pulmonary Function Test (PFT)
timeFrame: 6 months
Secondary outcomes:
measure: The Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: 6 months
measure: Childhood Depression Inventory (CDI)
timeFrame: 4 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege university faculty of health sciences
state: Karsıyaka
Study officials:
References:
Clinical trial NCT02907047: Tourniquet vs. no Tourniquet During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
2. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Revision surgery
2. Bilateral knee surgery
3. Age \<18 or \>80
4. BMI \>40
5. Baseline lower extremity strength less than 5/5
6. Vascular calcifications
7. History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
8. Functionally limiting spine disease
9. Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
10. Patients who cannot perform the baseline functional tests
11. Allergy/contraindication to protocol medications
12. Post-traumatic arthritis
13. Inflammatory arthritis
14. Pregnancy
15. Prisoners
16. Patients receiving care as part of a worker's compensable injury

Primary outcomes:
measure: timed up and go (TUG) score
timeFrame: 4 weeks following surgery
measure: Stair Climb test
timeFrame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
measure: Visual Analog Scale: Pain
timeFrame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Secondary outcomes:
measure: blood loss
timeFrame: intra-operative
measure: surgical field visualization
timeFrame: intra-operative
measure: range of motion
timeFrame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00915447: Diesel Exhaust Particles and Leukotriene Production
Official title: Diesel Exhaust Particles and Leukotriene Production
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Allergic Rhinitis
Keywords: Cat Allergic Rhinitis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study is to measure the effects of allergens and/or diesel exhaust particles in the nose to learn more about allergic responses in individuals with cat allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 65 years old.
2. Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare.
3. Ability to give informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.)
2. Systemic corticosteroid use within the previous three months or anytime during the challenge protocol.
3. Topical nasal corticosteroid use within the past month or anytime during the challenge protocol.
4. Systemic antihistamines or decongestant use within past two weeks or anytime during the trial.
5. Chronic sinusitis or chronic non-allergic rhinitis.
6. Use of reserpine.
7. Cigarette smoking within the past year or during the challenge protocol
8. Use of topical nasal antihistamines, chromoglycolates (chromolyn, Cromlon®), decongestants or non-steroidal anti-inflammatory agents (NSIADS) within the preceding week or anytime during the challenge protocol.
9. Present or treatment within the past 10 years with allergy immunotherapy (injections).
10. Present or past treatment with anti-IgE therapy.
11. Any unusual exposure to air pollutants (e.g., working as a diesel mechanic) that, in the opinion of the investigators, might compromise the individual's ability to participate in the study.
12. Living arrangement where the subject has a cat dwelling within the subject's habitation.
13. Any serious heart, lung, neurological or kidney disease that in the opinion of the investigators would impair the individual's ability to participate in the study.
14. Use of asthma-required medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Marc Riedl, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01672047: Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
Official title: Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Vitamin D Deficiency
Keywords: The 25(OH) vitamin D level
The 1.25(OH) vitamin D level
The intact PTH level
The calcification score of coronary artery
The microalbuminuria level
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.

Detailed description: We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* chronic kidney disease patients (3-5D)
* serum 25（OH）D \< 40nmol/L(16ng/ml)，serum calcium \< 2.55mmol/L（10.2mg/dL）；
* willing to sign
* could obey the follow up design

Exclusion Criteria:

* allergy to vitamin D
* heart failure (NYHA more than 2 grade)
* pregnant
* malignant tumor
* critical hepatic disease
* taking Vitamin D or analogue in 3 recent months
* taking other clinical trial

Primary outcomes:
measure: the improvement of coronary artery calcification
timeFrame: 2 years
Secondary outcomes:
measure: the improvement of proteinuria
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Mei Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04990947: Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
Official title: Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery Candidate
Lifestyle
Obesity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RYGB or obesity with lifestyle intervention

Brief summary: To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.


Eligibility criteria: Inclusion Criteria:

* Woman
* Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
* Patients must be able to adhere to the study visit schedule
* Independently mobile
* Patients must be able to give informed consent (IC) prior to any study procedures
* Surgical (1) and non-surgical (2) groups:

  1. Eligible for bariatric surgery (BMI \> 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
  2. Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program

Exclusion Criteria:

* Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
* Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
* Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
* Pregnancy or lactation, or planning to get pregnant during the study period
* Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
* Active and significant psychiatric illness including substance misuse
* Significant cognitive or communication issues
* Medications with documented effect on food intake or food preference
* Participating in another scientific study at the same time, if

Primary outcomes:
measure: Changes in caloric intake
timeFrame: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle
Secondary outcomes:
measure: Weight / BMI
timeFrame: baseline, 4weeks, 3 months, 6 months, 12 months
measure: Drinking microstructure over time
timeFrame: baseline, 4weeks, 3 months, 6 months, 12 months
measure: Change in self-reported hunger, thirst, fullness, preference
timeFrame: baseline, 4weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Yonta van der Burgh
Study officials:
References:
Clinical trial NCT02886247: Pancreatic Cancer Registry: For Any Person With a Personal or Family History
Official title: National Familial Pancreas Tumor Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer, ATM, BRCA, Hereditary Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-09-01
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with a personal or family history of pancreas tumors

Brief summary: The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the investigators are interested in both the genetic and non-genetic causes of pancreatic cancer. The investigators are particularly interested in finding the genes that cause pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another close relative who has also developed pancreatic cancer. This clustering of pancreatic cancers in families has yet to be explained; however, the investigators continue to identify new familial pancreatic cancer genes that explain this clustering in subsets of families. For example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in families.


Eligibility criteria: Inclusion Criteria:

* personal or family history of pancreas tumors

Exclusion Criteria:

* none

Primary outcomes:
measure: pancreatic cancer
timeFrame: 35 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alison Klein, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05481047: Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery
Official title: Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension During Surgery
Hemodynamic Instability
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for abominal surgery

Exclusion Criteria:

* Emergency surgery
* end-stage renal disease
* pregnancy
* obesity
* atrial fibrillation
* previous cerebral ischaemia
* central nervous system disorders
* severe cardiac valvular disease

Primary outcomes:
measure: Cerebral tissue oximetry
timeFrame: immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitairo Agostino Gemelli
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494947: Coronary Disease and the Effect of High-intensity Interval Training
Official title: Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary Angiography
Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-07-10
Enrollment: 60
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 primary purpose of this study is to investigate if systematic, high intensity, interval-based aerobic exercise training results in regression of lipid content of atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with stable coronary heart disease. Composition and morphologic characteristics of plaques will be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* stable coronary artery disease
* will undergo cardiac catheterization
* will be treated with percutaneous coronary intervention (PCI)
* signed written informed consent
* able to execute the intervention

Exclusion Criteria:

* earlier bypass surgery
* known inflammatory disease other than atherosclerosis
* planned surgery within 4 months
* included in another randomized controlled study

Primary outcomes:
measure: lipid content of atherosclerotic coronary artery plaques
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Rune Wiseth, phd prof
role: STUDY_DIRECTOR
References:
citation: Vesterbekkmo EK, Madssen E, Aamot Aksetoy IL, Follestad T, Nilsen HO, Hegbom K, Wisloff U, Wiseth R. CENIT (Impact of Cardiac Exercise Training on Lipid Content in Coronary Atheromatous Plaques Evaluated by Near-Infrared Spectroscopy): A Randomized Trial. J Am Heart Assoc. 2022 May 17;11(10):e024705. doi: 10.1161/JAHA.121.024705. Epub 2022 May 16.
Clinical trial NCT05006547: Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training
Official title: Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training: a Cross Sectional-controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Participants
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.

Brief summary: Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). However, there is almost no information regarding the function of the ankle muscles at the middle-age as most experiments have compared young (\<35 years) and older subjects (\>65 years). Moreover, neuromuscular training can improve the function of ankle muscle in response to perturbation; yet, no previous study has compared the level of effectiveness between middle-aged and young adults.


Eligibility criteria: Inclusion Criteria:

- Healthy participants

Exclusion Criteria:

* Neurological disease accompanied by motor, sensory or cognitive impairment.
* Illness or condition that does not allow strenuous activity.
* Significant orthopedic injury to the back or lower limbs in the last six months, which limits strenuous activity or weight-bearing.
* History of orthopedic injury that includes injury to the knee or ankle ligaments.
* Taking medications that may affect stability or balance. Significant visual impairment that is not corrected using glasses/contact lenses
* Pregnancy

Primary outcomes:
measure: Time to stabilization
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "The height of the amplitude"- expected fall
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "Time to Peak"- expected fall
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "Time to Onset"- expected fall
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "The height of the amplitude"-unexpected fall
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "Time to Peak"-unexpected fall
timeFrame: Within 24 hours
measure: Electromyography of peroneus longus- "Time to Onset"-unexpected fall
timeFrame: Within 24 hours
measure: Maximal voluntary isometric peroneal contraction force
timeFrame: Within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University -The Neuromuscular & Human performance laboratory
Study officials:
References:
Clinical trial NCT05954247: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers
Official title: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Eligibility criteria: Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteers

Exclusion Criteria:

* Eye disorders including cataracts
* Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Primary outcomes:
measure: Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543
timeFrame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
measure: Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
timeFrame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: