louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06367036: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain
Official title: Effect of Hypericum Perforatum Oil on Prevention Ecchymosis and Pain Associated With Subcutaneous Low Molecular Weight Heparin Injection: a Self-controlled Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Ecchymosis
Keywords: Hypericum Perforatum oil
low molecular weight heparin
subcutaneous injection
ecchymosis
pain
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied.
Primary purpose: PREVENTION

Brief summary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Normal platelet value,
* Normal international normalised ratio (INR) and prothrombin time (PTZ) values,
* No infection, scar tissue or incision in the lateral upper arm

Exclusion Criteria:

* Pregnancy
* Administration of haemodialysis

Primary outcomes:
measure: Pain point
timeFrame: 48 hours after injection
measure: Ecchymosis
timeFrame: 48 hours after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Hatice Demirdağ
state: İstanbul
Study officials:
affiliation: Üsküdar University
name: Nurcan UYSAL, Associate Professor
role: STUDY_CHAIR
affiliation: Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital
name: Zehra KAMBER
role: STUDY_CHAIR
References:
Clinical trial NCT06539013: Efficacy of Remifentanil in Preventing Emergence Agitation
Official title: Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergence Agitation
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.


Eligibility criteria: Inclusion Criteria:

The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.

-

Exclusion Criteria:

* Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35\>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from the study.

Primary outcomes:
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: Postoperative care unit 1.second_5. second_15.second
Secondary outcomes:
measure: mean arterial pressure
timeFrame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
measure: Heart rate
timeFrame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Kayapınar
Study officials:
References:
Clinical trial NCT06639113: From Administration of Oral Medicines by Nurses to Controlled Self-administration: Impact on Safety of Administration During Hospitalisation
Official title: Evaluation of the Safety of a Change of Practice in the Administration of Oral Medication During Hospitalisation: From Administration by the Nurse to Supervision of Self-administration of Medication in the Locomotor and Polyvalent Rehabilitation Department of the Valenciennes Hospital Centre.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self Administration
Keywords: Rehabilitation
Self-management of medication
Administration
Autonomy
Lead sponsor: Centre Hospitalier de Valenciennes
Sponsor class: NETWORK
First posted: 2024-10-15
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medication administration practices during patient hospital stay tend to improve patient autonomy. Several studies have concluded that self-administration of medication programs in hospital centers have a beneficial effect on patients' knowledge of their medications, their compliance and the safety of administration. Nevertheless, few studies have been carried out in France on this subject. The aim of this study is to evaluate the impact of the change of nurses administration practices from the administration of each drugs to supervision of self-administration by the patient under a self-administration program.


Eligibility criteria: Inclusion Criteria:

* Care in the rehabilitation unit of Hospital in Valenciennes, France
* Patient with a planned stay of 7 days or more
* Patient on chronic treatment before admission to hospital ;
* Patients taking their treatment alone at home;

Exclusion Criteria:

* Age \< 18 years old
* Patients with poor compliance
* No chronic treatment
* Unstable disease
* Major cognitive, memory or depressive disorders
* Swallowing disorders
* Prehension problems
* Patient under legal protection
* Patient under guardianship or curatorship
* Patient included in another trial

Primary outcomes:
measure: Total number of oral medication administration errors in self-administered patients
timeFrame: After 7 days of self-administration
measure: Total number of oral medication administration errors in patients receiving administration by nurses
timeFrame: After 7 days of administration by nurses
Secondary outcomes:
measure: Medication compliance in self-managed patients
timeFrame: At the beginning of the study
measure: Medication compliance in self-managed patients
timeFrame: 15 days after hospital discharge for self-managed patients
measure: Patient satisfaction with self-administration of oral medication
timeFrame: Within 24 hours of discharge from hospital
measure: Care staff satisfaction with self-administration
timeFrame: 6 months after the beginning of the study
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: CH Valenciennes
Study officials:
affiliation: Centre Hospitalier de Valenciennes
name: Quentin HIVER, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06999213: Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors
Official title: Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Current devices often assist movement but fail to promote functional motor learning. Research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. The LegExoNET (Exoskeletal Network for Elastic Torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. It stores and releases elastic energy to aid movement while allowing natural joint motion. The system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. Initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. The LegExoNET has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old
* Ability to provide informed consent
* Capable of ambulating without the use of assistive devices for 2 hours

Exclusion Criteria:

* History of stroke, SCI, or other neurological medical diagnoses
* Pregnant
* Severe medical diagnoses (e.g. cardiovascular, orthopedic)
* Skin allergies or irritation; open wounds
* Prisoners
* Cognitively impaired adults

Primary outcomes:
measure: Electromyography (EMG) amplitude during walking under each intervention condition
timeFrame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
measure: 10 Meter Walk Test
timeFrame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
measure: Gait Symmetry
timeFrame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Other outcomes:
Locations:
Study officials:
affiliation: Shirley Ryan AbilityLab
name: James L Patton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03695913: Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Official title: Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Pre-diabetes, low carbohydrate diet
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will recruit pre-diabetic patients to see if continuous glucose monitoring (CGM) with a low carbohydrate diet can reduce the percentage of time the CGM readings are above the normal range. Through this study it will demonstrate the feasibility of using CGM with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes.

Patients that appear to be eligible will be recruited from Michigan Medicine in the Family Medicine Clinic at the Livonia Center.


Eligibility criteria: Inclusion Criteria:

* A1C Glucose Measurement between 5.7 to 6.4 (for most recent A1C test, not older than 1 year)
* No diabetes medication including Metformin
* BMI (body mass index) \>30
* Must speak, read, and write in English
* No current pregnancy or breastfeeding
* Must not classify as either Vegan or Vegetarian
* Must be a patient at the Livonia Health Center

Exclusion Criteria:

* previous bariatric surgery

Primary outcomes:
measure: Participant Satisfaction With Continuous Glucose Monitoring (CGM)
timeFrame: 33 days after day 1 (visit 3 completion)
measure: Participant Satisfaction With Continuous Glucose Monitoring
timeFrame: 60 days (30 days after visit 3 completion)
Secondary outcomes:
measure: Feasibility, Measured by Recruitment
timeFrame: 3 months
measure: Feasibility of Pre-diabetic Patients to Wear CGM Sensors
timeFrame: completed within 60 days of enrollment
measure: Weight Change
timeFrame: day 11 (visit 2), day 22 (visit 3)
measure: Change in Percentage of Time Glucose is Above 140
timeFrame: 33 days after day 1
measure: Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call
timeFrame: Approximately 5 days each new sensor is placed (days 5 and 16)
measure: Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log
timeFrame: days 11 through 22
measure: Change in Knowledge of Low Carbohydrate Eating
timeFrame: baseline, day 22
measure: Change in Cravings From Day 11 to Day 22
timeFrame: 11 days
measure: Intention to Continue Low Carbohydrate Eating
timeFrame: day 22
measure: Utility of CGM Feedback for Changing Diet
timeFrame: 60 days (30 days after visit 3 completion)
Other outcomes:
Locations:
city: Livonia
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Caroline Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846713: Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter
Official title: Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation Complication
Hoarseness
Sore Throat
Keywords: double-lumen tube
intubation
airway exchange catheter
thermosoftening
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes

Exclusion Criteria:

* Preoperative hoarseness or a sore throat
* History of upper airway diseases
* Anticipated difficult airway

Primary outcomes:
measure: Time to intubate
timeFrame: Intraoperative (During exchanging single- to double-lumen tube)
Secondary outcomes:
measure: Postoperative hoarseness (4-points scoring)
timeFrame: up to 48 hours after surgery
measure: postoperative sore throat (4-points scoring)
timeFrame: up to 48 hours after surgery
measure: Vocal cord injuries assessed by videolaryngoscope
timeFrame: up to 1 hour after double-lumen tube extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Hyon Bahk, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01476813: Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Official title: A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 281
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Detailed description: A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Eligibility criteria: Inclusion Criteria:

* COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
* Patients under Double
* Patients under triple therapy (for 1 Mo prior Screening)

Exclusion Criteria:

* Pregnant or lactating women
* Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
* concommitant diseases impacting feasibility or safety

Primary outcomes:
measure: Aera under curve FEV1 AUC 0-12h
timeFrame: day 1 and 7 of treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit Ltd.
Study officials:
affiliation: Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh D, Schroder-Babo W, Cohuet G, Muraro A, Bonnet-Gonod F, Petruzzelli S, Hoffmann M, Siergiejko Z; TRIDENT study investigators. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study). Respir Med. 2016 May;114:84-90. doi: 10.1016/j.rmed.2016.03.018. Epub 2016 Mar 26.
Clinical trial NCT04464213: Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Official title: Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Foot Ulcer
Keywords: Human placental mesenchymal stem cells
Gel
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designated to:

1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and Age ≤ 75
* Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
* Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
* Full understand the informed consent form, and signed it voluntarily

Exclusion Criteria:

* Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
* Be allergic to any component of the drug or showed allergic constitution
* Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
* Have malignancy in the ulcer pathology test, or have a history of malignant tumor
* Unable to clean the wounds due to the formation of tract between the ulcer and other condition
* Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
* Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr\>200 μmol/L
* Have a history of apoplexy, unstable angina pectoris, myocardial infarct
* Have a psychiatric history, drug abuse or alcohol abuse history
* Had participated in any other clinical trials in the past 3 months
* Any other circumstances judged by the researchers disqualify the patient to participate in the trial

Primary outcomes:
measure: Rate of adverse event
timeFrame: 0 hour - 24 hours
measure: Rate of adverse event
timeFrame: 0 Day - 7 Days
Secondary outcomes:
measure: Rate of serious adverse event
timeFrame: 0 hour - 1 hour
measure: Rate of cure rate
timeFrame: 0 day - 34 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
state: Beiijng
Study officials:
affiliation: Beijing Tongren Hospital, CMU
name: Xiuli Zhao, Doc
role: PRINCIPAL_INVESTIGATOR
References: