louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06182969: A Study of APG-2575 in Patients with Mild-to-moderate Systemic Lupus Erythematosus.
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients with Mild-to-moderate Systemic Lupus Erythematosus.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: SLE
Keywords: SLE
APG-2575
Lead sponsor: Ascentage Pharma Group Inc.
Sponsor class: INDUSTRY
Collaborators: name: Suzhou Yasheng Pharmaceutical Co., Ltd.
First posted: 2023-12-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

Detailed description: This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosis of systemic lupus erythematosus for at least 6 months.
* 2. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
* 3. SLEDIA-2000 score: 4-12
* 4.Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

* 1. Severe systemic lupus erythematosus.
* 2. Significant autoimmune disease other than lupus.
* 3. Significant, uncontrolled or unstable disease in any organ.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.
timeFrame: At Day1 and Day 28 since the first dose of study drug.
measure: Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.
timeFrame: At Day1 and Day 28 since the first dose of study drug.
measure: Time to Peak (Tmax) of APG-2575 in SLE patients.
timeFrame: At Day1 and Day 28 since the first dose of study drug.
measure: Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.
timeFrame: Up to 1 year
Other outcomes:
measure: Change in the number and percentages of immune cells clusters.
timeFrame: Up to 1 year
measure: Change in the number and percentages of cytokines.
timeFrame: Up to 1 year
Locations:
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medical
state: Shanghai
Study officials:
affiliation: Renji Hospital Shanghai Jiaotong University School of Medical
name: Sheng Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06652269: The Impact of Equine-Assisted Psychotherapy on Depression, Anxiety, and Stress in Patients with Substance Use Disorder in a Psychiatric Hospital
Official title: The Impact of Equine-Assisted Psychotherapy on Depression, Anxiety, and Stress in Patients with Substance Use Disorder in a Psychiatric Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse Disorder
Anxiety
Depression Secondary to Other Disease
Keywords: Equine asssited psychotherapy
substance use disorder
psychotherapy
Lead sponsor: Czech University of Life Sciences Prague
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of psychiatric hospital with substance use disorder

Brief summary: This study aims to assess whether an EAP program affects anxiety, depression, and stress, which are often associated with substance use disorder. The management of these conditions has a major impact on the control of the addiction.

Detailed description: This study aimed to evaluate the effect of an EAP program on 32 respondents in the experimental group and 36 in the control group. These respondents were patients in a psychiatric hospital who were taking part in an addiction treatment program. The EAP program was conducted weekly over four weeks, with each session lasting three hours. The treatment effects were assessed using the STAI-Y modules 1 and 2, BAI, PSS, and DASS-21 questionnaires. The groups were compared before and after the four-week observation period.

Eligibility criteria: Inclusion Criteria:

Patients of psychiatric hospital of Kosmonosy with substance use disorder

Exclusion Criteria:

Exclusion criteria were possible cognitive deficit or reluctance to work with animals. Participants who did not complete all required materials or left the treatment program before completion were excluded from the study (N = 9).

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: through study completion, an average of 18 months
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: through study completion, an average of 18 months
measure: Perceived Stress Scale (PSS)
timeFrame: through study completion, an average of 18 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kosmonosy
country: Czech Republic
facility: Psychiatrická nemocnice Kosmonosy
Study officials:
affiliation: Czech university of life sciences
name: Kristýna Machová, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01661569: A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace
Official title: A Randomised Controlled Trial to Investigate the Effects of the Headspace Mindfulness Smartphone App on Psychological Well-being and Biological Indicators of Stress in the Workplace
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Well-being, Work Stress
Keywords: Mindfulness
meditation
stress
well-being
work stress
blood pressure
cortisol
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Headspace Meditation Limited
name: Technical University Dresden
First posted: 2012-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being.

We hypothesise that after 8 weeks participants who complete the meditation programme will show increases in psychological well-being and reduced activation of stress-related biological pathways.

Detailed description: Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects. Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group sessions led by an experienced practitioner, plus home practice and one full day of meditation. In this study we aim to investigate whether a mindfulness programme delivered as a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction in stress.

Eligibility criteria: Inclusion Criteria:

* Employees of a UK high-tech company
* Raised levels of work stress (overcommitment\>2) or depression (CESD\>1)

Exclusion Criteria:

* treated for anxiety, depression or hypertension
* taking medication containing steroids

Primary outcomes:
measure: Well-being
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
Other outcomes:
measure: Psychological stress
timeFrame: 8 weeks
measure: Cortisol
timeFrame: 8 weeks
Locations:
city: London
country: United Kingdom
facility: UK high-tech company office
Study officials:
affiliation: University College, London
name: Andrew Steptoe, DPhil, DSc, FMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00225069: Thoracoscopic Sympathectomy for Blushing
Official title: Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Blushing
Keywords: Facial blushing
Sympathectomy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2005-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.

Detailed description: To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery

Eligibility criteria: Inclusion Criteria:

* Isolated disabling facial blushing
* Over 18 years of age
* Willing to be randomized

Exclusion Criteria:

* Primary hyperhidrosis in palms or axillae
* Previous lung surgery
* Bradycardia
* Arrythmias
* Pregnancy

Primary outcomes:
measure: Effect of operation. Side effects: compensatory and gustatory sweating.
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital
city: Odense
country: Denmark
facility: Dept Cardiothorcic Surgery, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Peter B Licht, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skejby Sygehus, Aarhus University Hospital
name: Hans K Pilegaard, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05978869: Gamified Fitness Training to Promote Children's Physical Activity
Official title: The Effectiveness of Gamified Fitness Training Integrated Into Health Education to Promote Children's Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity Levels
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 91
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children.

Detailed description: A cluster experimental design was conducted in a small-scale context of school children. Participants were recruited by inviting two elementary schools located in the same district area for testing the physical fitness training effects. Two schools were randomly assigned to either the training group (TG; n = 47) receiving physical fitness training or the control group (CG; n = 44) without the training. Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team from the TG school. PA outcome indicators were assessed using AI-wireless sensors attached to participants' wrists over 12 weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified physical fitness training in health education classes. Data collection occurred during school days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week (T3). Generalized estimating equation statistics were used to assess the program effects.

Eligibility criteria: Inclusion Criteria:

* school children in 5th grade

Exclusion Criteria:

* physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.

Primary outcomes:
measure: physical activity levels
timeFrame: week 0
measure: Learning Self-Efficacy
timeFrame: week 0
measure: physical activity levels
timeFrame: week 6
measure: physical activity levels
timeFrame: week 12
measure: Learning Self-Efficacy
timeFrame: week 12
Secondary outcomes:
measure: Satisfaction levels
timeFrame: Week 12
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chi-Jane Wang
Study officials:
affiliation: Department of Nursing, College of Medicine, National Cheng Kung University
name: Chi-Jane Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03567369: 92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus
Official title: Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar, Third
Surgery
Keywords: Third molar
Surgery
Swelling
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular


Eligibility criteria: Inclusion Criteria:

* Patients with indication of asymptomatic bilateral extractions of lower third molars;
* Aged 18 years or older;
* Have a good health and no disease.

Exclusion Criteria:

• Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

Primary outcomes:
measure: Postoperative sequelae following thir molar extraction
timeFrame: up to seven days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Universidade Federal dos Vales do Jequitinhonha e Mucuri
state: Minas Gerais
Study officials:
References:
Clinical trial NCT04145869: Fluorescent Cholangiography During Acute Cholecystitis
Official title: Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Cholecystitis
Keywords: Fluorescence
Cholangriography
Cholecystectomy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
name: Zealand University Hospital
First posted: 2019-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis


Eligibility criteria: Inclusion criteria

* Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)

Exclusion criteria

* Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography
* Allergy towards iodine, Iohexol or indocyanine green
* Legally incompetent (any reason)
* Cholangitis (as defined above)15
* Withdrawal of inclusion consent at any time

Primary outcomes:
measure: Visualizationrate
timeFrame: 1 hour
Secondary outcomes:
measure: Visualizationrate
timeFrame: 1 hour
measure: Bile duct stones
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Northzealand Hospiral Hillerød
state: Danmark
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Danmark
city: Køge
country: Denmark
facility: Zealand University Hospital Køge
Study officials:
References:
Clinical trial NCT04716569: Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19
Official title: Faculty of Medicine ,South Valley University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Ivermectin intranasal spray in covid19
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 150
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: Ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well

Detailed description: 150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs

Eligibility criteria: Inclusion Criteria:

* early covid19 pateints

Exclusion Criteria:

* children and pregnant women

Primary outcomes:
measure: progression of covid 19 clinical picture
timeFrame: [ Time Frame: within 14 days after enrollement ]
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Zaky Aref
state: Qina
Study officials:
References:
citation: Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Rashad A, Hassan RG, Abdelmaksoud AA. Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19. Int J Nanomedicine. 2021 Jun 15;16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.
Clinical trial NCT06377969: Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
Official title: Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot prospective single arm interventional study
Primary purpose: TREATMENT

Brief summary: Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.


Eligibility criteria: Inclusion Criteria:

The investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management

Exclusion Criteria:

* Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.)
* Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions
* Major untreated psychological comorbidities
* Anatomical challeneges to place spinal cord stimulator
* Ongoing legal or disability claims

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline, 3-month, 6-month and 12-month
Secondary outcomes:
measure: Change in Disability
timeFrame: Baseline, 3-month, 6-month and 12-month
measure: Patient Global Impression Change
timeFrame: Baseline, 3-month, 6-month and 12-month
measure: Change in Quality of Life
timeFrame: Baseline, 3-month, 6-month and 12-month
measure: Change in Pain Catastrophizing Scale
timeFrame: Baseline, 3-month, 6-month and 12-month
measure: Change in sleep quality
timeFrame: Baseline, 3-month, 6-month and 12-month
measure: Change in Social Functioning
timeFrame: Baseline, 3-month, 6-month and 12-month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04099069: The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy
Official title: The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transbronchial Cryobiopsy
Anesthesia
Tracheal Intubation
Rigid Bronchoscopy
Safety
Keywords: Transbronchial Cryobiopsy
anesthesia
tracheal intubation
rigid bronchoscopy
safety
interstitial lung disease
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.

Detailed description: To evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. This is a prospective, randomized, controlled trial.

Eligibility criteria: Inclusion Criteria:

1. The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.
2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed

Exclusion Criteria:

1. The radiological data indicates non-ILD
2. The clinical examinations mentioned above are not completed.
3. The patient cannot endure or does not agree the procedure.

Primary outcomes:
measure: the fluctuation of heart rate
timeFrame: 24 hours
measure: the fluctuation of blood pressure
timeFrame: 24 hours
measure: the fluctuation of arterial partial pressure of carbon dioxide
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affilliated hospital of Guanghzhou Medical university
state: 广东
Study officials:
References: