louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03514745: Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation
Official title: Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation in Patients With a Predicted Difficult Airway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation

Exclusion Criteria:

* presence of sore throat and hoarseness
* requirements for postoperative mechanical ventilation
* at risk of aspiration.

Primary outcomes:
measure: Intubation time taken for endobronchial intubation
timeFrame: During endobronchial intubation
Secondary outcomes:
measure: Number of intubation attempts
timeFrame: During endobronchial intubation
measure: Difficulty of DLT advancement towards the glottis
timeFrame: During endobronchial intubation
measure: Resistance to DLT insertion through the glottis
timeFrame: During endobronchial intubation
measure: The incidence and severity of postoperative sore throat
timeFrame: At 1 and 24 hours after surgery
measure: The incidence and severity of postoperative hoarseness
timeFrame: At 1 and 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul Metropolitan Government Seoup National University Boramae Medical Center
name: Jin-Young Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00171145: A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Official title: A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.


Eligibility criteria: Inclusion Criteria:

* Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
* Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria:

* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in warning time at week 12.
Secondary outcomes:
measure: Change in warning time at weeks 2 & 6.
measure: Change in frequency of urge incontinence episodes.
measure: Change in frequency of micturitions.
measure: Change in mean volume per void.
measure: Change in frequency of urgency.
measure: Safety and tolerability.
measure: Quality of life.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05450445: myHealthHub for Older Adult Inpatients
Official title: myHealthHub for Older Adult Inpatients to Lower Loneliness and Improve Patient Engagement, Quality of Life and Mental Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Engagement
Stress
Loneliness
Quality of Life
Keywords: Older adults
Hospital Inpatients
Technology
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess "myHealthhub" in hospitalized older adults throughout 5 days of their hospital stay. The investigators propose a mixed method randomized controlled trial (RCT) comparing myHealthHub platform vs. a simplified HealthHub system that provides only TV access, in order to evaluate patients' loneliness, stress, quality of life, patient engagement, and other mental health outcomes in n=60 older adult inpatients. The investigators will also use qualitative methods to assess user and stakeholder experience, and engagement.


Eligibility criteria: Quantitative Component:

Inclusion Criteria:

* ≥60 years old
* Admitted to non-surgical hospital unit
* Speak English or French
* Capable of giving consent

Exclusion Criteria:

* Delirium
* Active suicidal ideation
* Moderate/severe dementia diagnosis

Qualitative Component:

Inclusion Criteria:

* Participants from quantitative component
* Hospital staff, nurses, clinicians facilitative use of the service
* ≥18 years old
* Speak English or French

Exclusion Criteria:

• Hospital staff, nurses, clinicians who do not have experience with the service

Primary outcomes:
measure: Changes in Loneliness
timeFrame: Baseline, day 2, day 3, day 4, day 5
Secondary outcomes:
measure: Changes in Stress
timeFrame: Baseline, day 3, day 5
measure: Changes in Patient Engagement
timeFrame: Baseline, day 3, day 5
measure: Changes in Quality of Life in Older Adults
timeFrame: Baseline, day 3, day 5
Other outcomes:
measure: Feasibility Outcome: Enrollment
timeFrame: Day 5
measure: Feasibility Outcome: Recruitment
timeFrame: Day 5
measure: Feasibility Outcome: Retention
timeFrame: Day 5
measure: Exploratory Outcome: Changes in Depression
timeFrame: Baseline, day 5
measure: Exploratory Outcome: Changes in Anxiety
timeFrame: Baseline, day 5
measure: Qualitative Component: Semi-structured interviews
timeFrame: Day 5
Locations:
Study officials:
References:
Clinical trial NCT02114645: The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes
Official title: To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Luteal phase support,GnRH agonist,ART cycles
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.

Detailed description: This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Couples undergoing ART with their own gametes.
* Couples having at least one good embryo available for transfer.
* Normoresponder
* Infertility etiology is unexplained
* ovulation triggered by intramuscular injection of 10000 IU of HCG

Exclusion Criteria:

Patients older than 38 years old

* High and poor responder patients

Primary outcomes:
measure: Live Birth Rate
timeFrame: 42 weeks
Secondary outcomes:
measure: Ongoing pregnancy
timeFrame: more than 20 weeks
measure: miscarriage
timeFrame: up to 20 weeks
measure: OHSS
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Hospital
state: Cankaya
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Nagihan Cengaver, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242345: Capnography During Upper GI Endoscopy
Official title: Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy
Keywords: Hypoxemia
Capnography
Integrated pulmonary index
Sedation
Propofol
Safety
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized controlled trial the utility of capnography and IPI gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.


Eligibility criteria: Inclusion Criteria:

* Age\>=18
* Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation

Exclusion Criteria:

* No informed consent
* ASA IV or V
* Emergency endoscopy
* Preexisting hypotension, bradycardia or hypoxemia

Primary outcomes:
measure: Hypoxemia
timeFrame: From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
Secondary outcomes:
measure: Further complications
timeFrame: From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr Universität Bochum
city: München
country: Germany
facility: Technische Universität München
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
Study officials:
References:
citation: Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
Clinical trial NCT02687945: PT vs no PT Following THA
Official title: Study to Evaluate Outpatient Physiotherapy in Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-02-22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty


Eligibility criteria: Inclusion Criteria:

* Any patient undergoing unilateral primary total hip arthroplasty with age \> 60

Exclusion Criteria:

* Post-traumatic osteoarthritis
* Rheumatoid arthritis or other peripheral inflammatory disease
* Avascular necrosis
* Revision or conversion THA
* Post-septic osteoarthritis
* Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home

Primary outcomes:
measure: Harris Hip Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00423345: Colon Investigation - Factors Determining Choice of Procedure
Official title: Colon Investigation With Barium Enema, CT Colonography and Colonoscopy: A Prospective Registration of Indications, Delay and Procedure Results.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Irritable Colon
Colorectal Cancer
Inflammatory Bowel Disease
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2007-01-18
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for colonoscopy, barium enema or CT Colonoscopy and willing to participate

Brief summary: Registration of patients referred for colon investigation by barium enema, CT colonography and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period of minimum six months. Indications, delay and results of procedure will be recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on clinical indication, but factors like delay, patient preference, lack of knowledge about the the procedures by the referring physician may have a decisive influence. The study will also analyse the correlation between patients symptoms, clinical findings and laboratory results and major pathology findings by colon investigation. Further, delay from patient´s first symptoms to finally diagnosis by colon investigation will also be registered and analysed.

Detailed description: see extensive protocol in Norwegian

Eligibility criteria: Inclusion Criteria:

* Patients referred to colon investigation
* Patients must be 18 years or older

Exclusion Criteria:

* Patients not able to give a written consent

Primary outcomes:
measure: findings compared across investigation modes
timeFrame: events by dec 2014
Secondary outcomes:
measure: Delayed diagnosis of CRC
timeFrame: events by dec 2014
Other outcomes:
Locations:
city: Porsgrunn
country: Norway
facility: Telemark Radiology center
state: Telemark
city: Skien
country: Norway
facility: Department of gastroentology, Telemark Hospital
state: Telemark
city: Notodden
country: Norway
facility: Department of gastroentology, Blefjell Hospital Notodden
Study officials:
affiliation: Blefjell Hospital Notodden, Norway
name: Stein Dahler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Telemark Hospital, Norway
name: Gert Huppertz-Hauss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Telemark Radiology center, Porsgrunn, Norway
name: Arne R Hovland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688245: A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
Official title: A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Alcohol Intoxication
Keywords: young adults
alcohol consumption
mobile health
text message
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults.

Detailed description: Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common among young adults. Despite high rates of illness and injury associated with heavy episodic drinking, many young adults are not aware of the risks, few seek help for their drinking and many at-risk are not exposed to prevention-based intervention. Opportunistic screening in hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to prevent future alcohol-related harm among young adults, but efficacy across outcomes has been mixed and large-scale implementation of prevention programs is low. Given the rapidly growing use of cell phone text-messaging (SMS) as a primary form of communication among young adults, SMS could be used to deliver health prevention interventions. We will recruit young adults identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial to test the hypothesis that exposure to a 12-week SMS program will result in immediate (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.

Eligibility criteria: Inclusion Criteria:

* AUDIT-C score 3 or more for women and 4 or more for men

Exclusion Criteria:

* Current treatment for psychiatric disease
* Any prior treatment for drug or alcohol use disorder

Primary outcomes:
measure: Timeline Follow-back Procedure
timeFrame: 30 Days
Secondary outcomes:
measure: Injury Behavior Checklist
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Mercy Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian P Suffoletto, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suffoletto B, Kristan J, Chung T, Jeong K, Fabio A, Monti P, Clark DB. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes. PLoS One. 2015 Nov 18;10(11):e0142877. doi: 10.1371/journal.pone.0142877. eCollection 2015.
citation: Suffoletto B, Callaway CW, Kristan J, Monti P, Clark DB. Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial. Trials. 2013 Apr 3;14:93. doi: 10.1186/1745-6215-14-93.
Clinical trial NCT02879045: Comparison of 2 Body Oil in Prevention of Striae Gravidarum
Official title: The Effect of Elasticity Belly® Oil and Clarins® Tonic Body Treatment Oil in Prevention of Striae Gravidarum: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prevention Harmful Effects
Lead sponsor: Shanghai Changning Maternity & Infant Health Hospital
Sponsor class: OTHER
Collaborators: name: Tongji University
First posted: 2016-08-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.

Detailed description: Objective: To compare the clinical efficacy of Elasticity Belly® oil and Clarins® Tonic Body Treatment Oil on the occurrence and severity of striae gravidarum.

Design: Parallel randomized controlled clinical trial. Setting: Gynaecology and Obstetrics department, Shanghai Changning Maternity and Infant Health Hospital, China Interventions: We will enroll about 50 Nulliparous women randomly, who are in their second trimester of pregnancy. Volunteer's abdomen skin are divided into two parts through medioventral line, half of the abdomen skin will receive the elasticity Belly® oil to prevent striae gravidarum, and the other side will use the Clarins® Tonic Body Treatment Oil. Volunteers apply these two kinds of oil daily until gestational age of 38-40 weeks. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary outcome of the study.

Eligibility criteria: Inclusion Criteria:

* nulliparous females
* gestational age of 14-20 weeks
* 20 to 35 years old
* body mass index (BMI) from 18.5 to 25
* Clear consciousness, intelligence is normal,stable vital signs
* Voluntary participation, and sign the informed consent

Exclusion Criteria:

* allergy to skin care products
* twin pregnancies or polypregnancies
* polyhydramnios
* miscarriages
* development of a skin disease
* corticosteroid usage
* application of any other cream on the abdominal skin
* did not received allocated intervention
* drop out or lost to follow-up

Primary outcomes:
measure: occurrence and severity of striae gravidarum
timeFrame: second trimester to term birth
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changning Maternity & Infant Health Hospital
state: Shanghai
Study officials:
affiliation: Tongji University
name: Shating Lei, PhD
role: PRINCIPAL_INVESTIGATOR
References: