louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02571621: Serial Usage of Combitube in Anesthesiology
Official title: Evaluation of Serial Usage of Combitube in Anesthesiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 745
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia physical status ASA class I and II

Brief summary: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Detailed description: Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the pre-hospital setting and has proven its value both there and in difficult airway management. The ETC is a double-lumen tube and as such it enables ventilation independent of its position in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical setting.

Objectives: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* patients ASA class I and II

Exclusion Criteria:

* patients not able to sign informed consent

Primary outcomes:
measure: Success rate
timeFrame: 3 minutes
Secondary outcomes:
measure: BMI
timeFrame: 1hour
measure: method of insertion and size of the tube,
timeFrame: 1hour
measure: Intubator's qualification and experience in the use of the ETC;
timeFrame: 1 hour
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Med. Univ. Vienna, Dept. Internal Med. I
Study officials:
affiliation: Medical University of Vienna
name: Michael Frass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sethi AK, Desai M, Tyagi A, Kumar S. Comparison of combitube, easy tube and tracheal tube for general anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):526-32. doi: 10.4103/0970-9185.142849.
Clinical trial NCT01154621: Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects
Official title: A Phase I, Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability, and Pharmacokinetics of a Single Dose of AZD9742 in Healthy Elderly Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tolerability
Healthy
Elderly
Keywords: Phase I
Double-blind
Randomized
Placebo-controlled study
Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
* Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
* Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Primary outcomes:
measure: To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
timeFrame: The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.
Secondary outcomes:
measure: To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers
timeFrame: Blood and urine samples will be collected for the 4 days while in residence.
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Research Site
state: Missouri
Study officials:
affiliation: Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802
name: Billings W Billings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Colleen Jensen
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Brendan Smyth
role: STUDY_CHAIR
References:
Clinical trial NCT04857021: Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Investigate the Sleep Quality Enhancing Effect and Safety of Lactobacillus-fermented GABA in Subjects With Mild, Transient Sleep Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.

Detailed description: The subjects will take GABA or placebo capsule once daily before sleep for 14 days.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects older than 19 years old
* Who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, Insomnia Severity Index ≥ 8)
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes.
* Who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation
* Who is suffering from obstructive sleep apnea.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.

Primary outcomes:
measure: Change of total sleep time of polysomnography
timeFrame: Baseline, Week 2
measure: Change of sleep latency of polysomnography
timeFrame: Baseline, Week 2
measure: Change of sleep efficiency of polysomnography
timeFrame: Baseline, Week 2
measure: Change of NonREM stage3 of polysomnography
timeFrame: Baseline, Week 2
measure: Change of total wake time of polysomnography
timeFrame: Baseline, Week 2
measure: Change of wake after sleep onset of polysomnography
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Change of Pittsburgh Sleep Quality Index
timeFrame: Baseline, Week 2
measure: Change of Insomnia Severity Index
timeFrame: Baseline, Week 2
measure: Change of Epworth sleepiness scale
timeFrame: Baseline, Week 2
measure: Change of Fatigue Severity Scale
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
Study officials:
References:
Clinical trial NCT01006421: Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo
Official title: Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Keywords: phototherapy
Gingko biloba
repigmentation
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: University Hospital
First posted: 2009-11-01
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: DERMATOLOGY CLINIC

Brief summary: Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.

Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.

Detailed description: Adding GB to phototherapy, especially the most commonly used one; Narrow-Band UVB (NBUVB) might give better results than using either one alone. This might improve repigmentation as well as patients' quality-of-life. (QOL).

This will be a prospective double-blind randomized controlled clinical trial. One-hundred-sixty Vitiligo patients will be randomly divided into 2 groups( 80 patients per group).

One group will receive oral GB (2 tablets of 60 mgs twice daily) with NBUVB twice weekly.

The other group will receive placebo tablets( identical in size, shape and color) to GB twice daily with NBUVB twice weekly.

Both groups will be treated for 6 months. Standard protocol of phototherapy will be used for both groups.

Our aim here is to see whether adding GB to NBUVB will lead to better repigmentation than placebo or not.

Eligibility criteria: Inclusion Criteria:

* Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
* Body surface area (BSA) involvement ≥ 3%.

Exclusion Criteria:

* Unable to consent
* Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
* Pregnancy, breast feeding.
* Liver or kidney disease.
* Epilepsy
* Bleeding disorder or anticoagulant treatment

Primary outcomes:
measure: Repigmentation (more than 50% from baseline) as the primary outcome
timeFrame: 3,6 and 9 months
Secondary outcomes:
measure: Quality-of-life - as secondary outcome .
timeFrame: 3,6 and 9 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
state: Central
Study officials:
affiliation: KSU
name: KHALID M ALGHAMDI, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01818921: An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
Official title: Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Over-weight
Prader-Willi Syndrome
Keywords: Beloranib
ZGN-440
ZGN-440 for injectable suspension
ZGN-433
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-27
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
* BMI ≥25 kg/m2
* Type 2 diabetes mellitus is allowed
* Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
* Stable body weight during the past 3 months, except for during home visits

Exclusion Criteria:

* Use of weight loss agents in the past 3 months
* Type 1 diabetes mellitus
* Current or anticipated chronic use of narcotics or opiates

Primary outcomes:
measure: Percent change in body weight from baseline to the end of the randomized dosing period.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in body weight (kg) from baseline to the end of the randomized dosing period
timeFrame: 4 weeks
measure: Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jennifer Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434521: Comparison of Different Refraction Measurements in Adults
Official title: Comparison of Different Refraction Measurements in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Loss Night
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.

The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.

The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.

The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.


Eligibility criteria: Inclusion Criteria:

* Age over 18 ;
* Non-presbyopic subject;
* Stereoscopic acuity ≤ 60 arc seconds.

Exclusion Criteria:

* Accommodative insufficiency;
* Accommodative inertia;
* Compensation by orthokeratology (i.e. night lenses);
* Present or past binocular pathology (strabismus or amblyopia);
* Pregnant or nursing woman;
* Incomprehension of French (written and spoken).

Primary outcomes:
measure: Maximum convex equivalent sphere values
timeFrame: At visit 1 (day 1)
Secondary outcomes:
measure: High contrast monocular acuity values
timeFrame: At visit 1 (day 1)
measure: Low contrast monocular acuity values
timeFrame: At visit 1 (day 1)
measure: High contrast binocular acuity values
timeFrame: At visit 1 (day 1)
measure: Low contrast binocular acuity values
timeFrame: At visit 1 (day 1)
measure: Difference between binocular perceptual assessment scores before and after subjective adjustment
timeFrame: Difference between visit 1 (day 1) and visit 2
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT06149221: Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
Official title: Using Direct Non-thermal Atmospheric Pressure Plasma With Penetration Enhancement for the Treatment of Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: The Skin Center Dermatology Group
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp


Eligibility criteria: Inclusion Criteria:

* diagnosis of mild-to moderate androgenetic alopecia
* ability to keep in-person follow-up appointments

Exclusion Criteria:

* any inflammatory scalp condition
* starting or discontinuing any hair loss treatments within 6 months of start date
* allergy to any components of the carrier solution

Primary outcomes:
measure: Presence of detectable hair growth
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Adverse effects related to the treatment
timeFrame: throughout study completeion, 6 months
Other outcomes:
Locations:
city: New City
country: United States
facility: The Skin Center Dermatology Group
state: New York
Study officials:
References:
Clinical trial NCT05397821: Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
Official title: The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant; Complications
Kidney Transplant Infection
Kidney Transplant Failure and Rejection
Keywords: Kidney transplantation
Pediatrics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2022-05-31
Enrollment: 398
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric kidney recipients that were transplanted between 1994-2018 in either Radboudumc or Winconsin University

Brief summary: In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.

Detailed description: Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin.

Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.

Eligibility criteria: Inclusion Criteria:

* received kidney graft in the participating centres at an age \<19
* received kidney graft between 1994-2018
* follow-up data of at least 1 year

Exclusion Criteria:

- Loss of follow up \< 1 year

Primary outcomes:
measure: Urinary tract infections
timeFrame: 25 year
measure: Ureteral obstruction
timeFrame: 25 year
Secondary outcomes:
measure: Graft survival
timeFrame: 25 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center
name: Liesbeth Lamers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364221: Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
Official title: The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Insulin Resistance
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2006-08-15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome

Exclusion Criteria:

* Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver and Health Sciences Center General Clinical Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christina L Aquilante, PharmD
role: PRINCIPAL_INVESTIGATOR
References: