louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00615043: Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure
Official title: A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Disease
Keywords: Transurethral resection of bladder tumor
TURBT
Lead sponsor: Tengion
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients otherwise undergoing TURBT

Brief summary: The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.


Eligibility criteria: Inclusion Criteria:

* Subjects 18-90 years and undergoing TURBT
* Willing and able to give signed informed consent

Exclusion Criteria:

* Known active infection
* Known colonization with MRSA or VRE
* Receipt of blood or blood products for transfusion during the previous 3 months

Primary outcomes:
measure: Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure
timeFrame: ongoing throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
affiliation: Tengion, Inc
name: Sunita Sheth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01405443: Simulator Training for Gastrointestinal Endoscopy
Official title: Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Performance of Inappropriate Operation
Keywords: Simulator training
Flexible endoscopy
Gastrointestinal endoscopy
Colonoscopy
Training
Performance
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy

Brief summary: This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.

Detailed description: Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.

Eligibility criteria: Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy

Primary outcomes:
measure: Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one
timeFrame: Score is evaluated after one week training
measure: Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group three
timeFrame: Score is evaluated after three weeks of training
measure: Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group two
timeFrame: Score is evaluated after two weeks of training
Secondary outcomes:
measure: Simulator score
timeFrame: Score is evaluated after the training period (at one week for group 1, at 2 weeks for group 2, and at three weeks for group 3)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thomas Rösch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155843: Neural Mechanisms in Asthma
Official title: Neural Mechanisms by Which Chronic Stress Regulates Inflammation in Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing substantial impairment that is reflected in the tens of millions of missed days of work, and doctors' and emergency room visits it leads to annually. Those who have asthma are twice as likely to develop depression and anxiety, which are associated with more frequent and severe asthma symptoms, especially in those under chronic stress. The project proposed here seeks to understand the role of the brain in these associations and to evaluate the neural mechanisms through which a safe, low-cost intervention, that influences the function of body via the mind, may diminish the expression of asthma symptoms.


Eligibility criteria: Inclusion Criteria:

* Asthmatics:

  * Physician diagnosed asthma with previous use of asthma medication
* Controls:

  * negative skin-prick test to cat dander or house dust mite and have no history of asthma
* Chronic Stress:

  * score 3 or above on any subscale of the UCLA (University of California Los Angeles) chronic stress interview

No chronic stress:

score 1.5 or below on all subscales of the UCLA chronic stress interview

Exclusion Criteria:

* Individuals with severe asthma, or those whom currently require the use of corticosteroids
* Individuals with significant medical problems
* Individuals who smoke cigarettes
* Individuals a previous adverse reaction to corticosteroids, a recent (\< 1 month) viral illness, a history of severe asthma or anaphylaxis.
* Breastfeeding women or women who are, suspect they might be or are trying to become pregnant

Primary outcomes:
measure: Neural activity in response to stress
timeFrame: duration of stress (30 minutes)
measure: inflammation
timeFrame: 24 hours
measure: lung function
timeFrame: 24 hours
measure: peripheral acute stress reactivity
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT06155643: EKO SENSORA: Detecting Clinically Significant Murmurs
Official title: EKO SENSORA: Detecting Clinically Significant Murmurs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Heart Murmurs
Keywords: eko
heart murmur
ai
machine learning
heart murmur detection
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of the Eko device
Primary purpose: SCREENING

Brief summary: The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).

The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.

The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.


Eligibility criteria: Inclusion Criteria:

* Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
* Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI\>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography

Exclusion Criteria:

* Contact isolation patients
* Pediatric patients under the age of 18

Primary outcomes:
measure: Number of new clinically significant heart murmurs detected
timeFrame: through study completion, an average of 90 days
Secondary outcomes:
measure: Number of echocardiograms ordered
timeFrame: through study completion, an average of 90 days
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Corewell Health Lakeland
state: Michigan
Study officials:
References:
Clinical trial NCT05087043: Effects of Oral Stimulation and Supplemental Nursing System
Official title: Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Preterm
oral stimulation
supplemental nursing system
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.

Detailed description: This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.

Eligibility criteria: Inclusion Criteria:

* a birth weight of 1,000 gr and above,
* a gestational age between 30 and 34 weeks,
* no congenital anomaly,
* no severe asphyxia or chronic lung disease,
* spontaneous breathing,
* grades III and IV intracranial hemorrhage and no periventricular leukomalacia

exclusion criteria.

* congenital anomaly
* grades III and IV intracranial hemorrhage and periventricular leukomalacia

Primary outcomes:
measure: transition times to oral feeding
timeFrame: up to three weeks
measure: transition times to full breast
timeFrame: up to 15 days
measure: the weight of the babies when they started oral nutrition
timeFrame: up to three weeks
measure: the weight of the babies when they started full breastfeeding
timeFrame: up to 15 days
measure: the duration of the baby's discharge
timeFrame: up to 2 months
measure: The oral nutrition body weight
timeFrame: up to three weeks
measure: The full breastfeeding body weight
timeFrame: up to 15 days
measure: The discharge body weight
timeFrame: up to 2 months
measure: The sucking success
timeFrame: In the first month after discharge
Secondary outcomes:
measure: Heart rate of the babies
timeFrame: 15 minutes
measure: respiratory rate of the babies
timeFrame: 15 minutes
measure: oxygen saturation of the babies
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Fethiye
country: Turkey
facility: Gonca Muslu
state: Muğla
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: gonca muslu
role: STUDY_CHAIR
References:
Clinical trial NCT03619343: Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)
Official title: A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control Intervention : ETOIMS apply group
Primary purpose: TREATMENT

Brief summary: Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea
* Patients who are able to perform daily activities before surgery and were able to walk independently.
* Adults over 20

Exclusion Criteria:

* Patients with history of previous open surgery

  * Patients who are not able to exercise due to severe musculoskeletal pain except surgery-related diseases
  * Patients who can not walk because of difficulty breathing related to myalgia
  * Patients who can not exercise due to severe musculoskeletal pain
  * Patients who had a limb defect before surgery and were unable to walk without assistive devices and others
  * Pregnant / lactating mothers
  * Patients who have cognitive impairment and can not answer the questionnaire
  * Patients with Pacemaker
  * Patients who can not read the consent form

Primary outcomes:
measure: Pain: VAS (visual analogue scale)
timeFrame: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
citation: Park J, Kim HS, Park JH, Park YG, Shin S, Park JE, Hwang S, Jun SY, Park JS. Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Sep;231(3):339-350. doi: 10.1016/j.jamcollsurg.2020.06.008. Epub 2020 Jul 2.
Clinical trial NCT00781443: A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Asthma
Keywords: Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.


Eligibility criteria: Inclusion Criteria:

* Meet criteria for the diagnosis of allergic asthma
* Diagnosis of asthma ≥ 6 months
* Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
* Body weight between 40-120 kg
* Normal chest X-ray within 2 years of screening

Exclusion Criteria:

* Require daily controller medication for asthma
* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
* Documented medical history of anaphylaxis
* Immunotherapy currently or within the past 3 months prior to screening
* Lung disease other than mild allergic asthma
* Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
* Pregnant or lactating
* Significant concurrent medical illness other than asthma
* Clinically significant abnormality on ECG at the screening visit
* Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
* History of helminthic infection

Primary outcomes:
measure: Late asthmatic response (LAR)
timeFrame: Day 92
Secondary outcomes:
measure: Early asthmatic response (EAR)
timeFrame: Day 92
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Edward Conner, M.D.
role: STUDY_DIRECTOR
References:
citation: Scheerens H, Arron JR, Zheng Y, Putnam WS, Erickson RW, Choy DF, Harris JM, Lee J, Jarjour NN, Matthews JG. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.
Clinical trial NCT00881738: To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04075838: The Development and Efficacy of a Recovery Group for People With Mental Illness
Official title: The Development and Efficacy of a Recovery Group for People With Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. This approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. However, few recovery-oriented programs are available in Taiwan. This study aimed to develop of a recovery-oriented program for people with mental illness and investigate its feasibility.

Detailed description: The study participants with mental illness were from a community mental health center in the south of Taiwan. The recovery-oriented program was conducted by a group leader, a senior occupational therapist, with one supervisor and one observer. The program was designed based on Pathways to Recovery, a self-help book published by University of Kansas. Participants attended a 1-hour class per week. The teaching methods included didactic presentation, peer exchange, group discussion, and practice. The group leader, supervisor, and observer reviewed the content and participants' performance after each class and made content adjustments if needed.

Eligibility criteria: Inclusion Criteria:

* diagnosis of mental illness

Exclusion Criteria:

-

Primary outcomes:
measure: Stages of Recovery Scale：Change from Baseline at 10 weeks and 18 weeks
timeFrame: baseline, 10 weeks, 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Chang Yen-Ching
role: STUDY_CHAIR
References:
Clinical trial NCT06081738: Neostigmine Versus Sugammadex on Renal Functions
Official title: Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sugammadex
Neostigmine
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy


Eligibility criteria: Inclusion Criteria:

* normal renal function (serum Cr 0.4- 1.4 g/dL)
* American Society of Anesthesiologists (ASA) Class I-II

Exclusion Criteria:

* Incapacity to consent.
* Pre-existing impaired kidney functions.
* Severe neuromuscular disease, as: myasthenia gravis \& muscular dystrophy.
* Intra-operative bleeding
* Lengthy operations that exceed 2 hours.
* Hemodynamic changes more than 20% of the base line

Primary outcomes:
measure: neutrophil gelatinase associated lipocalin (NGAL) values
timeFrame: baseline ( 2 days preoperative) and 12 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University Hospitals
state: Menoufia
Study officials:
References: