louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04249063: Fundal Block in Pre-menopausal Women to Reduce Pain During Outpatient-based Endometrial Ablation (FUNDAL-PAIN)
Official title: FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Abnormal Uterine Bleeding
Endometrial Ablation
NovaSure
Pain
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 288
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to assess the efficacy of a fundal block in reducing women's perception of pain during NovaSure endometrial ablation (EA) in an outpatient-based setting.

Detailed description: The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS).

The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.

Eligibility criteria: Inclusion Criteria:

* Abnormal uterine bleeding
* Pre-menopausal as determined by the presence of menstrual cycles
* Must have completed their family or have no desire to preserve fertility
* Uterus and cervix must meet eligibility criteria; based on hysteroscopy exam performed by the physician prior to the ablation procedure
* Must be a female participant 25-55 years of age

Exclusion Criteria:

* Any uterine characteristics that preclude performing EA
* Past allergic reactions to local anaesthetic
* Weight \<50kg
* Submucous fibroids requiring myomectomy
* Lack of patient consent

Primary outcomes:
measure: Intraoperative pain
timeFrame: 30 seconds into active ablation procedure
Secondary outcomes:
measure: Post-operative pain
timeFrame: 1 hour post-procedure
measure: Rescue analgesics/and or sedation
timeFrame: From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).
measure: Adverse reactions
timeFrame: From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).
measure: Acceptability of the procedure
timeFrame: Post-procedure prior to discharge (t = ~3hrs).
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Gynaecology & Pediatric Associates
state: Saskatchewan
Study officials:
affiliation: Saskatchewan Health Authority - Regina Area
name: Darrien Rattray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04905563: NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
Official title: Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Keywords: Elbow surgery
Pain
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Campbell Foundation
First posted: 2021-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.

Detailed description: For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.

Eligibility criteria: Inclusion Criteria:

* isolated supracondylar humerus fracture
* undergoing closed reduction with percutaneous pinning (CRPP)

Exclusion Criteria:

* Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
* Liver or renal disease
* history of bleeding disorder
* medical diagnosis of juvenile arthritis
* on chronic NSAIDs or Opioids PRIOR to the procedure
* medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
* vascular compromise and/or compartment syndrome upon admission

Primary outcomes:
measure: Pain Scores
timeFrame: 24 hours (duration of post-operative stay)
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Le Bonheur Children's Hospital
name: Lindsey Locke, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686863: Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children
Official title: Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Effect
Keywords: remiazolam
esketamine
bidirectional endoscopy
children
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized controlled study
Primary purpose: TREATMENT

Brief summary: To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Detailed description: It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Eligibility criteria: Inclusion Criteria:

* Age 0-17;
* ASA Class I-II;
* Sign the informed consent form.

Exclusion Criteria:

* Patients with high risk of stomach satiety and reflux aspiration;
* Patients allergic to the study drug;
* Obesity or severe malnutrition;
* Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
* Hypertension without treatment;
* Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
* Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
* Participate in other clinical studies within 4 weeks.

Primary outcomes:
measure: Sedation success rate
timeFrame: Procedure (From the beginning of anesthesia to the end of examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Hong Liu, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT07008963: Interview of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant
Official title: A Non-interventional, Observational Qualitative Interview Study of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients with HR+/HER2- metastatic breast cancer who received capivasertib + fulvestrant

Brief summary: A cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed


Eligibility criteria: Inclusion criteria (self-reported):

* Adult (over the age of 18 years)
* Diagnosed with HR+/HER2- metastatic breast cancer
* Received at least 1 week of capivasertib + fulvestrant (Patients will be invited to provide documents demonstrating the use of capivasertib. Patients will be able to participate even if unable to obtain such documentation)

Exclusion criteria (self-reported):

* Patients who had discontinued capivasertib for more than 6 months before the date of the interview
* Unable or unwilling to follow study procedures (including providing informed consent)
* Not proficient in spoken English, as assessed by the moderator
* Receiving capivasertib in a clinical trial setting
* Patients who are not able to recall instruction for administration of capivasertib in a manner consistent with the labeling (e.g. 4 days on followed by 3 days off)

Primary outcomes:
measure: Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen
timeFrame: Day 1
Secondary outcomes:
measure: Self-reported tolerability experiences related to patients' ability to follow the prescribed regimen and stay on treatment among those who received capivasertib + fulvestrant.
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05597163: Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
Official title: A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Peking University People's Hospital
name: Shandong University of Traditional Chinese Medicine
First posted: 2022-10-27
Enrollment: 588
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.


Eligibility criteria: Inclusion Criteria:

1. The age of the screening stage is 3-15 years, both sexes;
2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
4. Informed consent from the guardian and the child.

Exclusion Criteria:

1. strabismus, amblyopia or other ocular abnormalities;
2. The presence of systemic disease abnormalities;
3. have taken myopia control treatment in the past month;
4. Allergic to low concentration atropine or sulfuric acid drugs.

Primary outcomes:
measure: Proportion of SE changes over -0.75D
timeFrame: 2 years
Secondary outcomes:
measure: AL change
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Haidong Zou
role: STUDY_DIRECTOR
References:
Clinical trial NCT03700463: Executive Functions and Preterm Children in 3 to 4 Year Old
Official title: Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2018-10-09
Enrollment: 356
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients which former preterm of gestational age less than 34 weeks

Brief summary: Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof executive functions is not described for preterm infants.

Detailed description: It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 3 to 4 year old during the period study, are contacted by mail. Patientswith congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as, gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 63 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.

Eligibility criteria: Inclusion Criteria:

* patient in 3 to 4 year old, included in LIFT cohort

Exclusion Criteria:

* Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents

Primary outcomes:
measure: Incidence of disorders of executive functions in 3 to 4 year old which former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.
timeFrame: 3 to 4 years after preterm birth
Secondary outcomes:
measure: neonatal factors
timeFrame: 3 to 4 years after preterm birth
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References:
Clinical trial NCT04918563: Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva
Official title: Investigation of the Endothel Dependent and Independent Vasodilatation in Human Gingiva: Comparison of the Effect of NO and ACH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasodilatation
Oral Soft Tissue Conditions
Keywords: spreading vasodilatation
gingial microcirculation
LSCI
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.

Detailed description: Gender differences were observed in studies according to gingival microcirculation between physiological circumstances and during wound healing as well.

For blood flow measurement Laser Spackle Contrast Imaging is a reliable tool. It has good reproducibility, it doesn't get in touch with the measured surface, it's easy to use and it can measure on a bigger surface in same time.

Two wells were fabricated on the labial surface of the right lateral incisor (test tooth) and on the labial surface of the left central incisor (control tooth). These wells are opened towards the high-prermeability gingival sulcus, so the dropped solutions nitroglycerine vs physiological saline or nitroglycerine vs physiological saline can esasily penetrate to the gingival tissues. After applying the solutions, the blood flow was monitored fot 15 minutes.

Eligibility criteria: Inclusion Criteria:

* general health
* minimum 5 mm keratinized gingiva at the upper front teeth
* good oral hygiene

Exclusion Criteria:

* pregnancy and breast-feeding
* smoking
* medication
* insufficient marginal integrity
* periodontitis
* caries

Primary outcomes:
measure: Blood flow change after applying the test solutions
timeFrame: 20 minutes
Secondary outcomes:
measure: Comparison the change in blood flow between the two solutions
timeFrame: 30 minutes
measure: Comparison the change in blood flow in genders
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Conservative Dentistry
Study officials:
References:
citation: Vag J, Nagy TL, Mikecs B. Sex-related differences in endothelium-dependent vasodilation of human gingiva. BMC Oral Health. 2022 May 13;22(1):177. doi: 10.1186/s12903-022-02186-2.
Clinical trial NCT03524963: Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
Official title: A Randomized, Open Label, Multiple Does, Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between Pleetal SR Cap. and Cilostan CR Tab. in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Artery Disease
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers

Detailed description: Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1).

From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day).

Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing.

After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* BMI (body mass index) between 18.0 and 27.0
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
* Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin \> 1.5 x UNL)
* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab
* Taking OTC (Over the counter) medicine including oriental medicine within 7 days
* Clinically significant allergic disease
* Subject with known for hypersensitivity reaction to Cilostazol
* Previous whole blood donation within 60 days or component blood donation within 30 days
* Previous participation of other trial within 90 days
* Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)

Primary outcomes:
measure: Cmax
timeFrame: up to 24 hours after 1st dose
measure: AUC0-24
timeFrame: up to 24 hours after 1st dose
measure: Cmax,ss
timeFrame: up to 72 hours after 5th dose
measure: AUCtau
timeFrame: up to 24 hours after 5th dose
Secondary outcomes:
measure: AE
timeFrame: Up to 30 days after final dose
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
Study officials:
References: