louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06354569: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children
Official title: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Respiratory Adverse Events
Keywords: respiratory adverse events, risk prediction, children
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1 month to 12 years, Asa Class I or II, scheduled for surgery under general anesthesia

Brief summary: to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children

Detailed description: 600 children undergoing elective surgery under general anesthesia were selected. Age, sex, weight, height, allergy history, past history, snoring, passive smoking, abnormal laboratory examination and chest X-ray before operation, upper respiratory tract infection 14 days before operation, Operation Site, working years of anesthesiologist, anesthesia method, Operation Duration, anesthesia duration, perioperative vital signs and respiratory adverse events were collected. The risk prediction model of perioperative respiratory adverse events in children was established by using LASSO (least absolute shrinkage and selection operator) algorithm and gradient boosting machine (GBM) algorithm to screen the relevant data collected during routine diagnosis and treatment, such as demographic characteristics, physical conditions, airway sensitivity, environmental sensitivity and anesthesia management

Eligibility criteria: Inclusion Criteria:

* （1）Children aged 1 month to 12 years, （2） ASA Class I or II, （3）scheduled for surgery under general anesthesia

Exclusion Criteria:

-（1）Children and guardians declined to participate in the study (2) children with severe chronic respiratory, cardiovascular, central nervous system, liver and kidney diseases; (3) on the day of operation, the patients had active URTI and pulmonary infection, such as severe nasal obstruction, large amount of airway secretion, severe cough, fever (body temperature \> 37.5 ° C) , in addition to the above symptoms, signs of pulmonary consolidation and/or wet Rales, or peripheral white blood cells \> 10 × 109/L or \< 4 × 109/L with or without left shift of the nucleus, and chest X-ray showed new patchy, patchy infiltrative shadows or interstitial changes.

(4) the child had severe anaphylaxis to narcotic drugs

Primary outcomes:
measure: The occurrence of perioperative respiratory adverse events
timeFrame: perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan provincial Peopel'Hospital
state: Sichuan
Study officials:
affiliation: Sichuan provincial Peopel'Hospital
name: Ting Xu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02667769: Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes
Official title: Comparison of Two Protocols on the Implementation of a Fasting Day to Check the Basal Insulin Replacement in Type 1 Diabetes: Complete Fasting Compared to the Permission for Carbohydrate- and Calorie-free Food
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Lead sponsor: Diabeteszentrum Bad Lauterberg im Harz
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump
* Diabetes duration \> 2 years
* Body-mass-index between 19 and 35 kg/m², including
* written consent

Exclusion Criteria:

* No pregnancy in woman

Primary outcomes:
measure: Plasma glucose day- and night profiles
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Lauterberg
country: Germany
facility: Diabeteszentrum Bad Lauterberg
state: Niedersachsen
Study officials:
affiliation: Diabeteszentrum Bad Lauterberg
name: Michael A. Nauck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haase M, Kahle M, Janert M, Meier JJ, Nauck MA. Basal rate tests (24-hour fasts) performed in type-1 diabetic subjects with either absolute fasting or snacks containing negligible carbohydrate amounts result in similar glucose profiles: A randomized controlled prospective trial. Diabetes Obes Metab. 2017 Jun;19(6):783-790. doi: 10.1111/dom.12868. Epub 2017 Mar 20.
Clinical trial NCT00531869: Safe Water Techniques in Kenya
Official title: A Study of End-User Preferences for and Use of POU Safe Water Technologies in Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Consumer Willingness to Pay for POU Products
Consumer Preferences and Use of POU Products
Keywords: safewater
randomized
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2007-09-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Consumer preferences for POU technologies vary across consumers and products, and largely determine their adoption and subsequent usage. This is a marketing study that asks which products consumers prefer and why, and what is their willingness to pay, as understanding this is crucial to attain their widespread adoption and usage.

Detailed description: Visit 400 households and distribute 1 of 3 different POU technologies on randomized basis for a two-month trial. Cycle each household through trials with all 3 technologies in random order such that at the end of 6 months all households have experienced 2-month trials with each technology.

Eligibility criteria: Inclusion Criteria:

* At least partial reliance on turbid water supply

Exclusion Criteria:

* At least partial reliance on turbid water supply

Primary outcomes:
measure: Consumer preferences and use of POU products
Secondary outcomes:
measure: Consumer willingness to pay for POU products
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Care Kenya
Study officials:
affiliation: UC Berkeley
name: David Levine, PhD Econ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645369: Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection
Official title: The Effectiveness of Mechano-Analgesia and Cold Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Reaction
Injection Site Bruising
Keywords: subcutaneous heparin
injection pain
ecchymosis
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.

Detailed description: The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).

All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).

Eligibility criteria: Inclusion Criteria:

* Must be older than 18 years
* Open to communication
* No complications during the operation
* Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and
* Platelet count (150.000-300.000)
* Give consent to participate in the study

Exclusion Criteria:

* Oral and parenteral anticoagulant treatment for at least 5 days
* Infection, scar tissue or incision, and parenteral treatment in their abdominal area
* Hematological and allergic disease

Primary outcomes:
measure: Pain Intensity Measure via VAS
timeFrame: Immediately after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.
Clinical trial NCT04894669: Convenience Sample Data Collection for INVSENSOR00045
Official title: Convenience Sample Data Collection for INVSENSOR00045
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Oxygen Saturation
Keywords: Oxygen Saturation
SpO2
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 7
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 1 month of age
* Gestational age greater than 23 weeks
* Weight less than or equal to 5 kg
* Subjects with standard of care arterial blood sampling line already in place

Exclusion Criteria:

* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Subjects with axillary arterial lines
* Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator

Primary outcomes:
measure: Form, Fit and Function of INVSENSOR00045.
timeFrame: Up to 8 hours per subject.
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Site 2
state: California
Study officials:
References:
Clinical trial NCT04490369: Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
Official title: Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Comfort
Keywords: Procedural sedation
Cardiac Catheterization
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients coming to Duke University for Cardiac Catheterization

Brief summary: The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.

Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Coming to Duke University for Cardiac Catheterization

Exclusion Criteria:

-

Primary outcomes:
measure: Total medication administration dosage as measured by the procedural database
timeFrame: During procedure, up to 2.5 hours
measure: Frequency of medication administration as measured by the procedural database
timeFrame: During procedure, up to 2.5 hours
Secondary outcomes:
measure: Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)
timeFrame: Within 2 hours of procedure
measure: Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)
timeFrame: During procedure, to 2.5 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Bradi Granger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.
Clinical trial NCT05236569: Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
Official title: Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: melasma
tranexamic acid
modified melasma area and severity index
melanin index
erythema index
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
Primary purpose: TREATMENT

Brief summary: A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.

Detailed description: All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.

The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).

Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.

Eligibility criteria: Inclusion Criteria:

* aged 18 to 60 years old
* Fitzpatrick skin type IV - V
* diagnosed with melasma

Exclusion Criteria:

* pregnancy and breastfeeding
* use of oral contraceptives within six months
* use of topical or systemic melasma therapy within two weeks
* history of superficial peeling within four weeks
* history of dermabrasion within six months
* use of photosensitizer drugs
* history of thrombosis or currently using antithrombotic or anticoagulant drugs
* history of TA allergy
* experiencing any COVID-19 symptoms

Primary outcomes:
measure: Modified Melasma Area and Severity Index (mMASI) score
timeFrame: 12 weeks
measure: Erythema Index
timeFrame: 12 weeks
measure: Melanin Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 12 weeks
measure: Subject's satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT05438069: German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
Official title: German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: Charite University, Berlin, Germany
name: Technische Universität Dresden
name: Deutsches Herzzentrum Muenchen
name: University of Rostock
name: Ruhr University of Bochum
name: Universitätsmedizin Mannheim
name: LMU Klinikum
First posted: 2022-06-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran

Brief summary: The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Detailed description: The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

Eligibility criteria: Inclusion Criteria:

* patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
* patients 18 years and older

Exclusion Criteria:

- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.

Primary outcomes:
measure: LDL-C change
timeFrame: 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
Study officials:
affiliation: Jena University Hospital
name: Oliver Weingaertner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383369: Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty
Official title: Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Abilities
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.

Brief summary: The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty (3 days before and 10 days after) combined with cognitive testing preoperatively, on postoperative day 1,2,10.


Eligibility criteria: Inclusion Criteria:

* above 60
* ASA classification I-IV

Exclusion Criteria:

* general anaesthesia within 90 days
* daily use of sedatives, hypnotics og anxiolytics
* alcohol abuse
* insufficient written and verbal Danish
* severe hearing loss and poor sight
* Parkinsons Disease or other functional neurological deficits
* Mini mental status \< 24
* Shift work

Primary outcomes:
measure: Stroop colour word test result on the first postoperative morning compared to preoperatively.
timeFrame: 4 days on average between preoperative and postoeperative testing
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Krenk, MD
role: PRINCIPAL_INVESTIGATOR
References: