louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04968782: Appendicitis Choice of Treatment Study
Official title: Appendicitis Choice of Treatment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: Decision Making
Decisional Conflict
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department with acute appendicitis who are considered to be candidates for operative or nonoperative management by the treating clinical team. Patients can ultimately have undergone either treatment.

Brief summary: A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.


Eligibility criteria: Inclusion Criteria:

* English Speaking
* Diagnosed with acute appendicitis
* Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics)
* Access to an internet connected device capable of taking the survey

Exclusion Criteria:

* Patients who do not make their own medical decisions
* Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team
* Under 18 years of age

Primary outcomes:
measure: Decisional conflict
timeFrame: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
Secondary outcomes:
measure: Preparation for decision making
timeFrame: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: David R Flum, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01882582: Evaluation of Immune Signaling Networks in Healthy Human Volunteers
Official title: Evaluation of Immune Signaling Networks in Healthy Human Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Immune Cell Function
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consists of a community sample.

Brief summary: The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Results of this study will provide the foundation for helping us evaluate changes in immune cell activities in response to surgery and drugs used in anesthesia. The overall purpose of our research is to understand immune health in the context of anesthesia and surgery.


Eligibility criteria: Inclusion Criteria:

1. Age 18-50
2. Good general health

Exclusion Criteria:

1. Recent cold or flu
2. Chronic use of medications affecting the immune system
3. Chronic illness
4. Smoking habit
5. History of drug abuse
6. Current recreational drug use

Primary outcomes:
measure: Numerical and functional changes of circulating immune cells over time in healthy individuals
timeFrame: Day 1, Day 2, Day 7, Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University SOM
name: Martin S Angst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00478582: Validation of a New Standardized Clinical Anemia Evaluation Score Using a Hb Visual Scale in Nephrological Patients
Official title: Validation of a New Standardized Clinical Anemia Evaluation Score Using a Hb Visual Scale in Nephrological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Visual scale
nephrological patients
Anemia in nephrological patients
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2007-05-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The clinical evaluation of anemia is usually done by examination of the palpebral conjontivae coloration. This appreciation remains crude and largely observer dependent, as no reference scale was successfully proposed,. A Hb visual scale allowing the assessment of the degree of clinical anemia has been developed. Its use has been validated so far in small patient groups in the following settings: blood donation, cardiac surgery, oncology and consultation of general practitioners.

The objective of the present investigation is to validate the use of a Hb visual scale for the clinical evaluation of anemia in patients with kidney disease patients


Eligibility criteria: Inclusion Criteria:

* Patients with chronich kidney disease

Primary outcomes:
measure: Comparison of visual estimated Hb concentrations with measured Hb concentrations
Secondary outcomes:
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of nephrology and hypertension, University hospital of berne
Study officials:
name: Dominik Uehlinger, Prof
role: STUDY_DIRECTOR
name: Dominik Uelinger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026882: Supreme LMA Use in Urgent Caesarean Section
Official title: Supreme Laryngeal Mask Use in Urgent Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: Airway, Caesarean
Lead sponsor: QuanZhou Women and Children's Hospital
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
First posted: 2014-01-03
Enrollment: 584
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low risk patients undergoing elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents.

The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.

Detailed description: Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 50 years old
* American Society of Anesthesiology status 1 or 2
* Weight 40 to 75kg
* Normal airway assessment
* Term pregnancy (36 weeks or more)
* Urgent Caesarean Section

Exclusion Criteria:

* Body mass index (35 or more)
* Difficult airway (Mallampati 4 or abnormal airway assessment)
* Gastrooesophageal reflux

Primary outcomes:
measure: First attempt insertion success rate
timeFrame: 1 hour
Secondary outcomes:
measure: Time to effective airway placement
timeFrame: 1 hour
measure: Aspiration
timeFrame: 1 hour
measure: blood on SLMA on removal
timeFrame: 1 hour
measure: Sore throat
timeFrame: 1 hour
measure: Regurgitation
timeFrame: 1 hour
measure: Seal pressure
timeFrame: 1 hour
measure: Gastric aspirate
timeFrame: 1 hour
measure: Neonatal outcomes
timeFrame: 1 hour
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: Quanzhou Women's and Children's Hospital
state: Fujian
Study officials:
References:
citation: Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.
citation: Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.
citation: Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.
Clinical trial NCT03870282: Increasing Childhood Sleep Duration in the Primary Care Setting
Official title: Increasing Childhood Sleep Duration in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Childhood sleep promotion
Sleep promotion
Sleep
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 97
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.

Detailed description: Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).

Eligibility criteria: Inclusion Criteria:

1. Males or females age 9 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
5. Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm \& get out of bed at 6am).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Diagnosed with a psychiatric disorder \[e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety\].
3. Diagnosed with an eating disorder.
4. Musculoskeletal or neurological disorder that limits physical movement and activity.
5. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.

Primary outcomes:
measure: Actigraphy Estimated Weeknight Sleep Duration
timeFrame: 10 weeks
Secondary outcomes:
measure: Sleep Disturbance Score
timeFrame: 15 minutes
measure: Sleep Related Impairment Score
timeFrame: 15 minutes
Other outcomes:
measure: Actigraphy Estimated Nighttime Sleep Duration
timeFrame: 10 weeks
measure: Actigraphy Estimated Weekend Night Sleep Duration
timeFrame: 10 weeks
measure: Actigraphy Estimated Sleep Efficiency (Nighttime, Weeknight and Weekend Night)
timeFrame: 10 weeks
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Childern's Hospital of Philadelphia
name: Jonathan A Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05204082: A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children
Official title: Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intravenous Access
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 169
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.


Eligibility criteria: Inclusion Criteria:

* Patient age \< 18 years old.
* Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
* Written informed consent/ assent from the patient or legal guardian.

Exclusion Criteria:

- Patient age \> 18 years old.

Primary outcomes:
measure: Percentage of Participants With IV Access at First Attempt
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Nemergut, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05469282: CEFID-I (CEra Flow Improves DVT-1)
Official title: A Single Center Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Medical Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT) and the Ordinary Person
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Circulation Disorder
Deep Vein Thrombosis
Lead sponsor: Ceragem Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.

Detailed description: The efficacy and safety evaluation are conducted before and after (or during) the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day.

Eligibility criteria: Inclusion Criteria for all subjects; 1. Adult men and women over 19 years of age 2. Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.

1. Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea
2. D-dimer negative test result (Even if the D-dimer test is positive, the subject can be selected through the additional test at the discretion of investigator.)

3. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

Additional Inclusion Critetia for the DVT risk subjects;

1. Subjects have two or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells scroe) at the time of screening

Exclusion Criteria:

1. Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain
2. Subjects who have inflammation or trauma on the skin that directly touches the device

Primary outcomes:
measure: Peak Systolic Velocity (PSV) change
timeFrame: While 2 consecutive application (36 minutes) per one subject
Secondary outcomes:
measure: Antero-posterior (AP) diameter
timeFrame: While 2 consecutive application (36 minutes) per one subject
measure: Cross Sectional Area
timeFrame: While 2 consecutive application (36 minutes) per one subject
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
Study officials:
affiliation: Presbyterian medical center
name: Yong Soon Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670082: Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
Official title: Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

Detailed description: Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.

For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.

All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged ≥18 and ≤55 years
* Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion Criteria:

* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
* The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Absolute bioavailability Fabs
timeFrame: 0 to 120 hours
Secondary outcomes:
measure: AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours
timeFrame: 0 to 120 hours
measure: Cmax: maximum observed plasma concentration
timeFrame: 0 to 120 hours
measure: tmax: time at maximum observed plasma concentration
timeFrame: 0 to 120 hours
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01623882: Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
Official title: Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes Mellitus
Wounds
Ulcers
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Organogenesis
name: 3M
First posted: 2012-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower extremity venous and diabetic ulcers.

Brief summary: The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.


Eligibility criteria: Inclusion Criteria:

* Wound \< 10 cm in greatest diameter
* Wound age \> 4 weeks and patient shows \< 50% wound area healing after 4 weeks of treatment
* Patient \> 18 years of age
* Patient is willing and able to sign consent
* Patient is willing and able to complete study visits and comply with study dressing protocols

Exclusion Criteria:

* Wound size reduction of \> 50% in last 4 weeks of treatment
* Patients with active wound infections, including cellulitis and osteomyelitis
* Patients with wounds not able to have eschar debrided
* ABI \< 0.65 or SPP \< 30mmHg
* Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
* Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
* Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
* Pregnant patients
* Patients unable to tolerate NPWT
* Patients with dialysis dependent ESRD
* Index ulcer is on the plantar surface of the foot

Primary outcomes:
measure: Percentage of wounds closed
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: O'Connor Hospital
name: Peter Schubart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154582: Nutritional Quality of Egg Proteins and Effect on Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiology
Nutrition
Keywords: ingestive behavior
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2010-07-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 25

Exclusion Criteria:

* Allergy to egg or milk protein
* Digestive or metabolic pathology
* Positiveness to HIV, Hepatitis B and C
* Smokers

Primary outcomes:
measure: energy intake at lunch following the snack
measure: Dietary amino acid utilization
Secondary outcomes:
measure: plasma incretin concentrations
measure: postprandial nutrient waves
measure: neoglucogenesis
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre de recherche sur volontaires
city: Nantes
country: France
facility: Centre de recherche sur Volontaires
Study officials:
References:
citation: Fromentin C, Tome D, Nau F, Flet L, Luengo C, Azzout-Marniche D, Sanders P, Fromentin G, Gaudichon C. Dietary proteins contribute little to glucose production, even under optimal gluconeogenic conditions in healthy humans. Diabetes. 2013 May;62(5):1435-42. doi: 10.2337/db12-1208. Epub 2012 Dec 28.