louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06274086: Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
Official title: Safety and Clinical Outcomes of Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sclerotherapy
Endometrioma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:

• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?

Participants will:

* Receive the first session CDS for endometrioma
* Carry the catheter overnight and be monitored in the patient ward
* Receive the second session CDS the next day

Detailed description: Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain)
* Endometrioma ≥ 3 cm confirmed on ultrasound
* No evidence of solid lesions on ultrasound
* No suspected extraovarian endometriosis

Exclusion Criteria:

* History of gynecologic malignancy
* Active inflammation or infection
* Abnormal coagulation profile
* Loss to follow-up

Primary outcomes:
measure: Recurrence
timeFrame: Recurrence was assessed at 1, 3, and 6 months after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ji Hoon Shin, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06324786: Brain Mechanisms of Reducing Polysubstance Use
Official title: Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Drug Use
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mindfulness or/and active/sham neurofeedback
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.

Detailed description: The proposed study will test whether real-time NF could optimize IBMT practice and improve effects in reducing polysubstance use through targeting self-control networks in the brain.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Free of any psychiatric diagnoses or medication (besides a substance use disorder (SUD) to alcohol, tobacco, or cannabis)
* In the past month, at least 4 episodes of heavy episodic drinking; at least 3 occasions of cannabis use; and daily cigarette use for at least the past month
* Normal or corrected-to-normal vision
* Written informed consent
* No previous meditation or NF experiences

Exclusion Criteria:

* Any psychiatric diagnoses other than an SUD
* Medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
* Excluding cannabis, evidence of recent (past month) illicit drug use

Primary outcomes:
measure: Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)
timeFrame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
measure: Intervention effects on brain white matter using fMRI
timeFrame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
measure: Intervention effects on brain grey matter using fMRI
timeFrame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Secondary outcomes:
measure: Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit
timeFrame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: YiYuan Tang
state: Arizona
Study officials:
References:
Clinical trial NCT06155786: Cognitive Effects of tDCS and tRNS in Schizophrenia
Official title: Cognitive Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Random Noise Stimulation (tRNS) in Schizophrenia: A Random, Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Cognitive Impairment
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Leibniz Research Centre for Working Environment and Human Factors
name: Payame Noor University
First posted: 2023-12-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia based on Diagnostic and Statistical Manual (DSM)5
* Being 18-50 years old (male and female)
* If female, negative urine pregnancy test
* feasibility for tDCS/tRNS interventions according to safety guidelines
* stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment
* fluency in the native language
* right-handed
* Required written informed consent signed by patients' guardian

Exclusion Criteria:

* pregnancy
* alcohol or substance dependence
* comorbid bipolar disorder and mood disorder
* history of seizure
* history of neurological disorder
* history of head injury
* Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)

Primary outcomes:
measure: Spatial Working Memory behavioral performance
timeFrame: During procedure (4 minutes)
measure: executive function behavioral performance
timeFrame: During procedure (8-10 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: through study completion, an average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Payame Noor University, Tehran Branch
city: Zanjān
country: Iran, Islamic Republic of
facility: Zanjan University
Study officials:
References:
Clinical trial NCT01630863: The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Official title: The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: Central serous chorioretinopathy
photodynamic therapy
safe and effective dose
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.


Eligibility criteria: Inclusion Criteria:

1. Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
2. Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
3. Presence of abnormal dilated choroidal vasculature in ICGA
4. Patients with symptomatic CSC of at least 3 months duration

Exclusion Criteria:

1. Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
2. Patients receiving exogenous corticosteroid treatment
3. Patients with systemic diseases such as Cushing's disease or renal diseases
4. Pregnant patients

Primary outcomes:
measure: Changes of best corrected visual acuity
timeFrame: 6 month
Secondary outcomes:
measure: Change of central retinal thickness, success rate, recurrence rate, and complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University College of Medicine
Study officials:
References:
citation: Park DG, Jeong S, Noh D, Sagong M. Optimal fluence rate of photodynamic therapy for chronic central serous chorioretinopathy. Br J Ophthalmol. 2021 Jun;105(6):844-849. doi: 10.1136/bjophthalmol-2020-316837. Epub 2020 Jul 29.
Clinical trial NCT06106763: Mandala Colouring On Anxiety, Depression, Pain And Quality of Life
Official title: The Effect Of Mandala Colouring On Anxiety, Depression, Pain And Quality of Life in Patients Receiving Haemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patients
Keywords: Hemodialysis
Anxiety
Depression
Pain
Quality of Life
Mandala painting
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research was conducted as an experimental research to determine the effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.

Detailed description: The effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.

Eligibility criteria: Inclusion Criteria:

be over 18 Ability to communicate adequately Absence of psychiatric problems Volunteering to participate in the research Receiving hemodialysis treatment for at least 3 months

Exclusion Criteria:

None

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 1. week
measure: Visual Analogue Scale (VAS)
timeFrame: 3. week
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 1. week
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 3. week
measure: Kidney Disease Quality of Life Form (KDQOL-36)
timeFrame: 1. week
measure: Kidney Disease Quality of Life Form (KDQOL-36)
timeFrame: 3. week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: AYŞE NEFİSE BAHÇECİK, PhD
role: STUDY_DIRECTOR
References:
citation: Choi H, Hahm SC, Jeon YH, Han JW, Kim SY, Woo JM. The Effects of Mindfulness-Based Mandala Coloring, Made in Nature, on Chronic Widespread Musculoskeletal Pain: Randomized Trial. Healthcare (Basel). 2021 May 28;9(6):642. doi: 10.3390/healthcare9060642.
Clinical trial NCT05543863: Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy
Official title: Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasm
Cardiovascular Diseases
Cerebrovascular Disease
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are taking antiplatelet agents and scheduled for distal gastrectomy for gastric cancer

Brief summary: This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition.
* Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery)
* Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery.
* age 18 - 90 years
* A person who voluntarily agrees to participate in this study and signs the consent form.

Exclusion Criteria:

* Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT)
* Patients taking other anticoagulants in combination
* Patients with imparied liver or renal function that may affect drug metabolism.

Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher

* Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition)
* Patients participating in other clinical trials within 6 months
* Vulnerable patients (pregnant women, those with cognitive impairment, etc)

Primary outcomes:
measure: platelet function testing at 5 days
timeFrame: 5 days
Secondary outcomes:
measure: Platelet function testing at 3 months
timeFrame: 3 months
measure: postoperative complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dept. of Surgery, Kyungpook National University Chilgok Hospital
Study officials:
affiliation: Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal
name: Ji Yeon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03992963: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Participants will take part in both a passive and active emotion recognition task: (1) passively listening to semantically-neutral sentences with emotional prosody, and (2) actively listening and subsequently categorizing emotional sentences and sounds. Participants are seated and instructed to stare at a fixation cross while the stimulus is played. During this study, non-invasive physiological measurements of pupil dilation will be recorded from the participants. Using this paradigm we will be assessing the effect of frequency lowering on emotion recognition. The study takes the form of a partly three factorial design (passive task x frequency lowering x acclimatization). Participants also perform a two factor design (active task x frequency lowering). Each participant performs two passive tests (20 minutes long each) with frequency lowering on and off, and a four week acclimatization period in-between. Participants perform one active listening task after the acclimatization period with frequency lowering on and off.


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Changes in event-related-pupil-dilations (ERPDs) data
timeFrame: 6 weeks
Secondary outcomes:
measure: self-perceived speech intelligibility rating
timeFrame: 6 weeks
measure: behavioral emotion recognition categorical rating
timeFrame: 6 weeks
measure: behavioral emotion recognition continuous rating
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Juliane Raether
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252963: Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)
Official title: Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Upper Respiratory Infection
Acute Bronchitis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 346
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

Detailed description: Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis

Eligibility criteria: Inclusion Criteria:

* 19≤ age
* Patients with acute upper respiratory infection or acute bronchitis
* Patients with cough and phlegm within 48 hrs as of Visit 1
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Patients with high fever (≥39℃)
* Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
* Patients with a history of hypersensitivity to drug
* Patients with abnormal blood coagulation
* Patients with thrombocytopenia
* Patients with uncontrolled hypertension
* Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)
* Patients woth a clinically significant renal failure(MDRD eGFP \< 60 mL/min/1.73m2)

Primary outcomes:
measure: Change from baseline in BSS (Bronchitis Severity Score)
timeFrame: baseline, 7 days
Secondary outcomes:
measure: Change from baseline in each symptom score of BSS (Bronchitis Severity Score)
timeFrame: baseline, 7 days
measure: Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)
timeFrame: baseline, 7 days
measure: Complete resolution rate of each symptom
timeFrame: 7 days
measure: The number of use of relief drugs
timeFrame: 7 days
measure: Integrative Medicine Outcomes Scale
timeFrame: 7 days
measure: Integrative Medicine Patient Satisfaction Scales
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Kwang-Ha Yoo, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00251563: Epidemiologic, Laboratory, and Clinical Characterization of Individuals With Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cancer,Risk factors
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2005-11-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Environmental and genetic factors may play a role in the progression of cancer. The goal of this project is to establish a series of cross-sectional / case-control studies to evaluate risk factors of cancer in China.

Detailed description: This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with cancer (gastric, colorectal, esophageal, liver, prostate, lung, breast and endometrial cancer, etc.). We will accrue approximately 1600 patients as experimental group. The control group consists of subjects who will be confirmed without cancer. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress factors, angiogenic factors, and tumor markers, etc.) and genetic (including oxidative stress factors and angiogenic factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of various cancer.

Eligibility criteria: Inclusion Criteria:

* This is a study only of Chinese. Subjects will be allowed to participate if they self-identify as Chinese. The age range of the participants will be between 18 and 89 years. Individuals with cancer (gastric, colorectal, esophageal, liver, prostate, lung, breast and endometrial cancer, etc.) will be allowed to participate. To participate in the study as the control, subjects should be confirmed without cancer.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
name: Bin Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: