louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06555276: Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
Official title: Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Disease
Keywords: stapler
anastomosis
Lead sponsor: Suzhou Kerui Medical Technology Co., Ltd
Sponsor class: OTHER
Collaborators: name: Jiangsu Channel Medical Device Co., Ltd.
First posted: 2024-08-15
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need open or endoscopic surgery using the study device for resection, transection and anastomosis for liver, bronchial tissue, stomach and intestines. Those who meet the inclusion criteria and don't meet the exclusion criteria will be enrolled.

Brief summary: This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.

Detailed description: The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.

Eligibility criteria: Inclusion Criteria:

* gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.

  * use the study device during surgery

Exclusion Criteria:

* patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;

  * combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.

Primary outcomes:
measure: anastomosis success rate
timeFrame: within six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: zhengliang Tu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03112876: Sebum Collection and Skin Barrier Function Analysis
Official title: Sebum Collection for Analysis and Correlation to Sebum Production, Barrier Function, and With Cutaneous and Internal Inflammatory Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Acne
Atopic Dermatitis
Aging
Keywords: younger age
older age
atopic dermatitis
acne
smoker
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study patients will be recruited from the UC Davis Department of Dermatology, UC Davis undergraduate campus, Sacramento State University, and from the greater Sacramento area.

Brief summary: The goal is this study is to evaluate how the skin surface lipid composition is correlated with overall sebum production, barrier function, and inflammatory disease status. We hypothesize that there will be differences in the skin surface composition among subjects of various groups:

1. Young vs older healthy population
2. Atopic dermatitis vs Acne vs Healthy controls
3. Active smokers vs non-smoker controls

Detailed description: This study will be conducted through the use of painless tapes to collect lipid. These will be applied to the skin and removed. Secondly, the barrier function will be evaluated through the use of non-invasive painless devices that measure sebum, skin water loss, and skin hydration.

Eligibility criteria: Inclusion Criteria:

* Subjects that are 12 years of age or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Lipid Profile-aging
timeFrame: 1 day
measure: Lipid Profile-acne
timeFrame: 1 day
measure: Lipid Profile-atopic dermatitis
timeFrame: 1 day
measure: Lipid Profile-smoking
timeFrame: 1 day
Secondary outcomes:
measure: Skin Barrier Function- aging
timeFrame: 1 day
measure: Skin Barrier Function- acne
timeFrame: 1 day
measure: Skin Barrier Function- atopic dermatitis
timeFrame: 1 day
measure: Skin Barrier Function- smoking
timeFrame: 1 day
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: UC Davis
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ni Raghallaigh S, Bender K, Lacey N, Brennan L, Powell FC. The fatty acid profile of the skin surface lipid layer in papulopustular rosacea. Br J Dermatol. 2012 Feb;166(2):279-87. doi: 10.1111/j.1365-2133.2011.10662.x.
citation: Sakai S, Kikuchi K, Satoh J, Tagami H, Inoue S. Functional properties of the stratum corneum in patients with diabetes mellitus: similarities to senile xerosis. Br J Dermatol. 2005 Aug;153(2):319-23. doi: 10.1111/j.1365-2133.2005.06756.x.
Clinical trial NCT01616576: Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe to Profound Hearing Loss
in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Keywords: cochlear implant
adults
HiResolution™
Fidelity 120™
listening benefits
noise
cochlear implant benefit
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
* 18 years of age or older at time of implant
* Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
* At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
* English language proficiency
* Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
* Willingness and ability to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing

Primary outcomes:
measure: Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
timeFrame: 2 weeks
measure: Device-related Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Clinic
state: California
city: Tampa
country: United States
facility: Tampa Bay Hearing and Balance
state: Florida
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Kansas City
country: United States
facility: Midwest Ear Institute (MEI)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT00350376: Impact of Asthma Treatments on Daily Activities
Official title: Study on Asthma Treatments on Daily Activities as Reported by Patients (STAR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Allergies
Keywords: asthma
allergies
Xolair
Advair
Lead sponsor: Ovation Research Group
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2006-07-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The primary objective of this web-based, cross-sectional study is to assess and compare the ability to sleep, work or go to school, and to participate in leisure activities among subjects who are receiving Xolair treatment and subjects who were eligible to receive Xolair, but instead have been using Advair for at least 1 year.


Eligibility criteria: Inclusion Criteria:

* Have asthma and allergies
* Currently taking Xolair® or Advair®
* Started Xolair® treatment within the last 4 to 12 months OR have been taking Advair® for at least 12 months
* Between 18 and 55 years of age
* A non-smoker for at least 6 months
* Have internet access

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ovation Research Group
state: California
Study officials:
affiliation: Ovation Research Group
name: Susan D Mathias, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872676: Immediate Effects of Upper Thoracic Manipulation on Skin Surface Temperature of T3 Vertebral Region and Biceps Brachii Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Dysfunction
Keywords: Thermography
Skin Temperature
Manipulation, Spinal
Physical Therapy Modalities
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to assess the immediate effects of upper thoracic manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women of the university community were randomly allocated to an experimental group (n = 13) and a placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment T3)was performed. Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni test and the independent samples t-test were used for the intragroup and intergroup comparisons, respectively, with the level of significance set to 5%.


Eligibility criteria: Inclusion Criteria:

* Healthy women
* 18 and 30 years of age

Exclusion Criteria:

* use of vasoactive medication
* body mass index greater than 25 kg/m2
* having undergone spinal manipulation in previous month
* and any red flag sign, such as malignant tumor, inflammatory or infectious disease that contraindicated manual therapy

Primary outcomes:
measure: Skin temperature
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Methodist University of Piracicaba
state: São Paulo
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Amanda Packer, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827176: Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
Official title: Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Recurrent Sinusitis
Keywords: Characteristic
Recurrent Acute Rhinosinusitis
Children
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 94
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients from pediatric allergy clinic will be selected.

Brief summary: The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.


Eligibility criteria: Inclusion Criteria:

* Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.

Exclusion Criteria:

* Children who had lost medical record.

Primary outcomes:
measure: Presenting symptoms of recurrent acute rhinosinusitis
timeFrame: 12 months
Secondary outcomes:
measure: Age of onset
timeFrame: 12 months
Other outcomes:
measure: Number of sinusitis after received treatment
timeFrame: 12 months
measure: Immunological profile
timeFrame: 12 months
measure: Number of participants with allergic rhinitis
timeFrame: 12 months
measure: Number of participants with immunodeficiency
timeFrame: 12 months
measure: Number of participants with adenotonsillar hypertrophy
timeFrame: 12 months
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Jittima Veskitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veskitkul J, Vichyanond P, Pacharn P, Visitsunthorn N, Jirapongsananuruk O. Clinical characteristics of recurrent acute rhinosinusitis in children. Asian Pac J Allergy Immunol. 2015 Dec;33(4):276-80. doi: 10.12932/AP0591.33.4.2015.
Clinical trial NCT00901576: A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Official title: A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.


Eligibility criteria: Inclusion Criteria:

* Subjects must be normal healthy adult volunteers with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at the screening visit

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Time of Plasma Half-Life(T 1/2) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Cmax of d-Methylphenidate
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: AUC of d-Methylphenidate
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Tmax of d-Methylphenidate
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: T 1/2 of d-Methylphenidate
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research, Inc.
state: New Jersey
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Roesch B, Corcoran M, Haffey M, Stevenson A, Wang P, Purkayastha J, Martin P, Ermer J. Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release. Drugs R D. 2013 Mar;13(1):53-61. doi: 10.1007/s40268-013-0009-5.
Clinical trial NCT02551276: Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
Official title: Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Hypertrophy in Healthy Young Men
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University of Southern Denmark
First posted: 2015-09-16
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.


Eligibility criteria: Inclusion Criteria:

* Physical active
* Non-smokers
* Non-asthmatics
* No chronic diseases
* Informed consent

Exclusion Criteria:

* Smoker
* Allergy towards study drug

Primary outcomes:
measure: Skeletal Muscle Hypertrophy (lean body mass in Kilograms)
timeFrame: 2 days
Secondary outcomes:
measure: Left Ventricular Hypertrophy (mass in grams)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02146976: Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
Official title: Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Sleep Quality
Keywords: postoperative
sleep quality
propofol
sevoflurane
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 124
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: TREATMENT

Brief summary: The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.

Detailed description: The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.

Eligibility criteria: Inclusion Criteria:

* Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy

Exclusion Criteria:

* Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.

Primary outcomes:
measure: The Change of postoperative sleep quality
timeFrame: preoperation, first postoperative night
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: the Anesthesiology Department
name: Hong Ma, M.D.,Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02509676: Dynamic Stretching Training and Muscle Tendon Unit
Official title: Effects of Dynamic Stretching Exercise Training on Muscle Tendon Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dynamic stretching training
muscle tendon unit
ultrasound
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of a 5-week dynamic stretching exercise training on muscle-tendon unit of gastrocnemius muscle.

Detailed description: Muscle stretching is a common practice applied in warm-up process to enhance performance in sports and to prevent or decrease the risk of sports injury. Muscle stretching is also used for therapeutic purposes in many clinical conditions.

It is generally performed in either static or dynamic manner. The effects of stretching depend on the type, duration and timing of stretching. However, the acute and chronic effects of a stretching can be different in the same muscle.

Recent studies suggest that static stretching has adverse effects on performance, reduces maximal muscle force and is not successful in preventing non-contact injuries, as believed so. Dynamic type is reported to improve flexibility and range of motion better. But there is still debate over which prescription provides the best results in terms of flexibility, power, performance or injury protection. And the answer to the question what happens to the viscoelastic properties of a muscle when it is stretched dynamically for some period of time has not been clearly established.

This study is planned to investigate the effect of a 5-week dynamic stretching exercise training on muscle tendon unit of gastrocnemius muscle. The effects of the training program will be assessed by ultrasound.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Healthy males,
* aged between 18-30 years

Exclusion Criteria:

* Cases with history of recent musculoskeletal injuries or neurological diseases.

Primary outcomes:
measure: muscle-tendon unit length
timeFrame: at the end of 5 weeks of training
measure: pennation angle
timeFrame: at the end of 5 weeks of training
measure: muscle thickness
timeFrame: at the end of 5 weeks of training
Secondary outcomes:
measure: range of ankle dorsiflexion
timeFrame: at the end of 5 weeks of training
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Funda DEMIRTURK, PhD
role: PRINCIPAL_INVESTIGATOR
References: