louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06860620: Efficacy of Zinc Supplementation in Maintaining Sustained Remission in Children With Steroid-sensitive Nephrotic Syndrome
Official title: Efficacy of Zinc Supplementation in Maintaining Sustained Remission in Children With Steroid-sensitive Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Steroid-Sensitive Nephrotic Syndrome
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 192
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to fill the gaps by determining the efficacy of zinc supplementation in maintaining sustained remission in children with steroid sensitive nephrotic syndrome (SSNS).

Detailed description: There is a need to ascertain the efficacy of zinc supplementation in maintaining sustained remission in children with SSNS, thereby lowering the number of relapses and disease morbidity. The findings of this study could pave the way for reasonable evidence about the role of zinc supplementation is sustained remission in children with SSNS.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Aged 2-12 years
* With steroid-sensitive nephrotic syndrome, with frequent relapses

Exclusion Criteria:

* Children with steroid-resistant nephrotic syndrome
* With a history of chronic systemic illness (cardiac, metabolic, malignancy, pulmonary, neurologic, or rheumatologic)
* With a history of kidney disease like polycystic kidney disease

Primary outcomes:
measure: Sustained remission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital
state: Punjab
Study officials:
affiliation: Nishter Hospital Multan, Pakistan
name: Rabia Saleem, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nishter Hospital Multan, Pakistan
name: Afsheen Asghar, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nishter Hospital Multan, Pakistan
name: Sheeba Yousuf, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508220: Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
Official title: Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Otosul -Otorrinolaringologia Sul-Fluminense
First posted: 2015-07-24
Enrollment: 15
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: The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.


Eligibility criteria: Inclusion Criteria:

* chronic tinnitus with a duration \> 6 months
* medical examination by an ENT specialist
* sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires
* VAS score \>4 points

Exclusion Criteria:

* vascular tinnitus
* muscular tinnitus
* conductive hearing loss
* previous experience with oxytocin nasal spray
* additional medications during the intervention

Primary outcomes:
measure: Change of tinnitus on VAS
timeFrame: 30 minutes after intervention
measure: Change of Clinical global impression scale
timeFrame: 30 minutes after intervention
Secondary outcomes:
measure: Audiometry measured in dB HL
timeFrame: within one hour before intervention
measure: Minimum Masking Level measured in dB HL
timeFrame: within one hour before intervention
measure: Tinnitus Matching
timeFrame: within one hour before intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05896020: A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Official title: Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gynaecological Malignancies
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of SHR-A1811
Primary purpose: TREATMENT

Brief summary: This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the ICF.
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.

Exclusion Criteria:

1. Symptomatic, untreated or active central nervous system metastases.
2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
3. Have uncontrolled or severe cardiovascular disease.
4. With any active autoimmune disease or history of autoimmune disease.
5. Patients with active hepatitis B or hepatitis C.
6. Severe infections within 28 days prior to initiation of study treatment.
7. Active tuberculosis within one year prior to initiation of study treatment.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 12 months
measure: Objective response rate (ORR)
timeFrame: 12 months
measure: Disease control rate (DCR)
timeFrame: 12 months
measure: Duration of response (DOR)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Incidence and severity of adverse events (AEs)
timeFrame: From Day 1 to 90 days after last dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT01260220: Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
Official title: Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 120
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: An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.

Detailed description: This is a randomized controlled non-inferiority designed trial.

Follow up:

Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
* Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
* Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
* Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for \>4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
* Patient must provide written informed consent to participate in the clinical trial

Exclusion Criteria:

* Contraindications to oral anticoagulants
* History of any previous ablation for AF
* Intracardiac thrombus
* AF due to reversible causes
* Pregnancy
* atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)

Primary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: six months
Secondary outcomes:
measure: Procedure time
timeFrame: (4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab)
measure: Ablation Time
timeFrame: (4-6 hours) Measured during the procedure.
measure: Fluoroscopy Time
timeFrame: (4-6 Hours) Measured during the procedure.
measure: complications
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Lorne J Gula, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595620: Cannabinoid Modulation of Pain
Official title: Cannabinoid Modulation of Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Cannabis
THC
Pain
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.


Eligibility criteria: Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Acceptable Birth Control methods for females

Exclusion Criteria:

* Cannabis naive
* Medical or psychiatric contraindications
* Analgesic medication
* Previous sensitivity to THC or cannabis

Primary outcomes:
measure: Capsaicin-induced hyperalgesia
timeFrame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Secondary outcomes:
measure: Pain Measures
timeFrame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
measure: Non-pain subjective responses
timeFrame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
measure: Cognitive subjective responses
timeFrame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02800720: Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
Official title: Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndromey
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 148
Sex: ALL
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: A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome.

Detailed description: Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to poor quality of life. The need for more effective FMS treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. However, studies have predominantly focused on first-generation mindfulness-based interventions (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice.

Aims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for treating FMS.

Method: Adults with FMS will receive MAT or an active control intervention known as Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention, post-intervention, and follow-up phases.

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of fibromyalgia syndrome
* Aged between 18 and 65 years
* Able to read and write using the English language
* Available to complete an eight-week intervention and six-month follow-up assessment

Exclusion Criteria:

* Currently undergoing formal psychotherapy
* Changes in psychopharmacology type or dosage one-month prior to intervention
* Currently practicing mindfulness or meditation

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: 8 weeks
measure: Short Form McGill Pain Questionnaire
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
measure: Depression Anxiety and Stress Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nottingham Trent University
name: William Van Gordon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01552720: Clinical Characteristics, Management and Outcomes of Chinese Patients With Acute Aortic Dissection
Official title: Clinical Investigation of Chinese Patients With Aortic Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: aorta
dissection
feature
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients suffering acute aortic dissection

Brief summary: Data reported by the international registry of acute aortic dissection (IRAD) in not sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of this study is analyze changing trend of clinical characteristics of Chinese patients with acute aortic dissection.

Detailed description: Acute aortic dissection is the most common aortic emergency, with an annual incidence of 3-5 cases per 100 000 population. About 50% of these patients are dead within 48 hours, if untreated. To assess the clinical manifestation, diagnosis, management, and outcomes of patients with AAD, the International Registry of Acute Aortic Dissection (IRAD) was established in 1996, and has grown to include about 2000 patients from 26 large referral centers to date. All patients from IRAD are caucasians from developed countries wiht advanced medical care, however, the proportion of Asian is very low. Data reported by the IRAD in not sufficient to reflect clinical characteristics of Acute aortic dissection in China. Clinical characteristics of Chinese patients with acute aortic dissection have not evaluated to data. The aim of this study is to analyze clinical characteristics of Chinese patients with acute aortic dissection and clinical trend of acute aortic dissection.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute aortic dissection
* Type A dissection
* Type B dissection
* Retrograde type B dissection

Exclusion Criteria:

* Aortic aneurysm
* Myocardial infarction
* Cerebral accident
* Active infection
* Unwillingness to cooperation with study procedures or follow-up visits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Dihua Yi, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06609720: Randomized Clinical and Radiographic Study
Official title: Evaluation of Autogenous Dentin Graft Versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autogenous Dentin Graft
Keywords: dentin graft, tooth graft
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA
Primary purpose: TREATMENT

Brief summary: Randomized clinical and radiographic trial

Detailed description: Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects

Eligibility criteria: Inclusion Criteria:

-

Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.

* Horizontal probing depth ≥3 mm using Naber's probe.
* Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
* Evidence of radiolucency in the furcation area on panoramic radiograph.
* Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding periodontal surgery.

  * Mandibular first or second molars with root caries or endodontic treatment.
  * Smokers, diabetics, pregnant or lactating women.
  * History of chemotherapy, radiotherapy in head and/or neck region.
  * Bisphosphonate therapy.

Primary outcomes:
measure: Probing pocket depth
timeFrame: Measured at baseline, 6 months and 12 months
measure: Clinical attachment level
timeFrame: Measured at baseline, 6 months and 12 months
measure: Bleeding on probing
timeFrame: Measured at baseline, 6 months and 12 months
Secondary outcomes:
measure: Radiographic outcome
timeFrame: measured at baseline and 1 year follow up
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Tanta University
name: Banan L Amer, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Samia A Darwish, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06279520: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.
Official title: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Automobile Driving
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result

Detailed description: VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.

It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.

Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 19 who are currently driving.
* Individuals capable of understanding and following the researcher's instructions.
* Individuals who can understand the purpose of the research and have consented to participate

Exclusion Criteria:

* Those who have not signed the consent form.
* Individuals with a history of severe dizziness or epilepsy.
* Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
* Patients with severe shoulder pain.
* Patients whose range of motion in major joints is restricted by more than 50%.
* Pregnant women.
* Patients with pressure sores.
* Patients with limitations on simulator use due to heterotopic ossification.
* Patients with acute fractures.
* Other patients for whom participation in the study is expected difficult.

Primary outcomes:
measure: Feasibility of VR driving simulator
timeFrame: 2 hours
measure: Driving performance in simulator, measured by driving errors
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: