louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02533778: ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
Official title: ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: with control group
Primary purpose: TREATMENT

Brief summary: A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Detailed description: Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not \> 1/3rd the territory.

Eligibility criteria: Inclusion Criteria:

* Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
* mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
* ACA NIHSS ≥ 7 MRI DWI/PWI or
* CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
* Signed informed consent

Exclusion Criteria:

* creat \>= 2
* NIHSS \< 7
* Baseline mRS \>= 2
* infarct \> 1/3rd MCA territory
* competing trials
* prior IV or IA treatment

Primary outcomes:
measure: Thrombolysis in Cerebral Infarction (TICI) score
timeFrame: 6 months
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: 6 months
measure: Montreal Cognitive Assessment (MoCA) tool
timeFrame: 6 months
measure: Modified Rankin Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Abington Memorial Hospital
name: Qaisar Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02974478: Orange Juice Consumption and Glucose Metabolism and Antioxidative Status
Official title: Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: orange juice consumption
glucose homeostasis
antioxidative status
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.

Detailed description: Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.

During wash-out weeks consumption of orange juice or citrus fruits is restricted.

During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* regular use of medication,
* smoking,
* chronic disease,
* vegan/vegetarian diet,
* fructose intolerance,
* irregular eating behaviour (less then 3 meals/day)

Primary outcomes:
measure: changes in daylong glycaemia between pre and post intervention periods
timeFrame: two weeks
Secondary outcomes:
measure: changes in uric acid between pre and post intervention periods
timeFrame: two weeks
measure: changes in insulin sensitivity between pre and post intervention periods
timeFrame: two weeks
measure: changes in antioxidative status between pre and post intervention periods
timeFrame: two weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Anja Bosy-Westphal, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913478: Evaluation Of Effect of Axial Length on Cup-To-Disc Ratio Among Non- Glaucomatous Hypertensive Patients
Official title: Evaluation Of Effect of Axial Length on Cup-To-Disc Ratio Among Non- Glaucomatous Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertensive Complication
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: his observational cross-sectional study aims to compare the effect of axial length on the cup-to-disc ratio in non-glaucomatous hypertensive patients. Data will be collected from Khursheed Begum Eye Hospital and LRBT Hospital

Brief summary: This observational cross-sectional study aims to compare the effect of axial length on the cup-to-disc ratio in non-glaucomatous hypertensive patients. Data will be collected from Khursheed Begum Eye Hospital and LRBT Hospital, with a sample size of 104 participants. A purposive sampling technique will be used.

Detailed description: Patients aged 18-70 years with systemic hypertension for at least one year and normal intraocular pressure will be included. Exclusion criteria include glaucoma, high myopia, hyperopia, ocular surgery, trauma, and optic nerve diseases. Axial length will be measured using optical biometry or A-scan ultrasonography, while the cup-to-disc ratio will be assessed through fundus examination using a slit lamp biomicroscope with a +90D lens or optical coherence tomography (OCT). Data will be meticulously documented, including patient demographics and medical history. The study will be completed within six months after approval, ensuring accurate and standardized measurements for reliable results.

Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed with systemic hypertension for at least 1 year.
* Age between 18-70 years.
* Normal intraocular pressure (IOP\<-21mmhg)
* Axial length between 21mm and 26mm (to exclude extreme refractive errors)

Exclusion Criteria:

* History of glaucoma or ocular hypertension.
* High myopia (\<-6.00 D) or hyperopia (\>+6.00D).
* History of ocular surgery, trauma, or retinal diseases.
* Any optic nerve diseases.

Primary outcomes:
measure: Axial length measured by biometry and CD ratio by slitlamp
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Alshifa eye clinic Ali Pur chattha
state: Punjab
Study officials:
References:
Clinical trial NCT02632578: Influenza Vaccine in HIV Study
Official title: A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from two sites in Melbourne, Australia:

* Melbourne Sexual Health Centre (HIV-positive and HIV-negative subjects)
* The University of Melbourne at the Peter Doherty Institute for Infection and Immunity (HIV-negative subjects only)

Brief summary: The aims of this study are:

1. to investigate if HIV infection alters the antibody responses to influenza and
2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.


Eligibility criteria: Inclusion Criteria:

* HIV-1 positive by licensed diagnostic test (for HIV-positive group only)
* Planning to receive the seasonal influenza vaccine outside the study
* Provision of written informed consent

Exclusion Criteria:

* Previous allergy to influenza vaccination
* Pregnancy or planning to become pregnant
* Unwilling or unable to provide blood samples

Primary outcomes:
measure: Anti-influenza antibody responses in plasma with Fc-mediated functions
timeFrame: Four weeks after influenza vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Melbourne
name: Stephen Kent, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547178: Changes in Everyday Life After a Tai Chi or Eurythmy Intervention in Elderly People at Risk of Falling: a Qualitative Exploration as a Sub-Study of the ENTAiER Study
Official title: Self-perceived Changes in Everyday Life Among Participants of a Fall Prevention Study With Tai Chi or Eurythmy Intervention Versus Standard Care: a Qualitative Exploration as a Sub-Study of the ENTAiER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Increased Risk of Falls
Keywords: Old age
Chronic disease
Risk of falls
Fear of falling
Fall prevention
Eurythmy
Tai Chi
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have consented to participate and are enrolled in the ENTAiER main study will be approached for participation in this sub-study. Sub-study will be conducted at the ARCIM Institute, Filderstadt.

Brief summary: The ENTAiER fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. In the course of the ENTAiER study, the participants observed changes in themselves and in their everyday life and described them in conversation, which could not be recorded with the research methods used. A qualitative exploration of these subjectively experienced changes among participants of the ENTAiER study will be conducted as part of a sub-study. For this purpose, group interviews will be conducted.


Eligibility criteria: Inclusion Criteria:

* Enrolled and randomized participant of ENTAiER main study
* Written informed consent for participation in EYT_13 sub-study
* Participation in eurythmy or tai chi intervention for 24 weeks (-28d/+21d) (the standard care group will be time-equated to eurythmy and tai chi)

Exclusion Criteria:

* Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)

Primary outcomes:
measure: Self-reported changes in daily life through movement exercises
timeFrame: 90-minute interviews
Secondary outcomes:
measure: Self-reported changes in the experience of movement in general
timeFrame: 90-minute interviews
measure: Self-reported changes in movement security through movement exercises
timeFrame: 90-minute interviews
measure: Self-reported changes in health through movement exercises
timeFrame: 90-minute interviews
measure: Integration of movement exercises into everyday life
timeFrame: 90-minute interviews
measure: Experiencing movement exercises
timeFrame: 90-minute interviews
measure: Need for offers on movement exercises
timeFrame: 90-minute interviews
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute
name: Jan Vagedes, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888571: Pre-pectoral Breast Reconstruction With or Without Mesh
Official title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prepectoral Breast Reconstruction
TiLOOP Mesh
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 164
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 explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Detailed description: The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Eligibility criteria: Inclusion Criteria:

1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
3. Tissue expander size =\<800cc, implant size =\<600cc;
4. The blood perfusion of breast skin flap was well;
5. Do not smoking in the last 4 weeks or more
6. Patients with normal expectations and mental health for breast reconstruction;
7. Signed consent to participate

Exclusion Criteria:

1. Poor perfusion of breast mastectomy flap;
2. II stage breast reconstruction patients;
3. History of chest radiotherapy;
4. BMI greater than 35;
5. Patients who have not quit smoking within the last 4 weeks;

Primary outcomes:
measure: Major Complication Rates
timeFrame: up to 12 months after surgery
measure: Patient Breast-Q questionnaire
timeFrame: up to 12 months after surgery
Secondary outcomes:
measure: Minor Complication Rates
timeFrame: up to 12 months after surgery
measure: Rates of capsule contracture
timeFrame: up to 24 months after surgery
measure: The rate of surgical revision of reconstructed breasts
timeFrame: up to 12 months after surgery
measure: The rate of implant or tissue expander removal
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01718678: Effect of Melatonin on Multiple Sclerosis Related Fatigue
Official title: Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Keywords: Multiple sclerosis
Melatonin
Fatigue
Quality of life
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

Detailed description: Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Eligibility criteria: Inclusion Criteria:

1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria
2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0
3. aged between 18 and 55 years of either sex
4. treated with one type of interferon beta-1a (IFNB-1a);
5. signed an informed consent

Exclusion Criteria:

1. clinical relapsing of MS during past 30 days;
2. use of melatonin and warfarin within 30 days prior to participation;
3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ;
4. working more than one nighttime shift per month;
5. Pregnancy or lactation;
6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;
7. failure to adhere to the study protocol

Primary outcomes:
measure: Fatigue
timeFrame: at one month after treatment
Secondary outcomes:
measure: Quality Of Life
timeFrame: at one month after treatment
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
References:
Clinical trial NCT06912971: Fibromyalgia: Impact of Self-Knowledge on Well-Being
Official title: Fibromyalgia: The Impact of Self-Knowledge on the Well-Being of People With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
self-knowledge
quality of life
Enneagram
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 16
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: The goal of this observational study is to evaluate the impact of self-knowledge training on the well-being of individuals with fibromyalgia. The main questions it aims to answer are:

Does self-knowledge training improve participants' perceived quality of life?

Does self-knowledge training influence the way participants manage their fibromyalgia symptoms?

Participants will:

Take part in a structured self-knowledge intervention based on the Enneagram framework.

Complete validated questionnaires before and after the intervention to assess their well-being.

Provide qualitative feedback on their experience with the training.

This study will help understand whether self-awareness strategies can be integrated into non-pharmacological approaches for fibromyalgia management.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia
* Age ≥ 18 years
* Ability to understand and provide informed consent

Exclusion Criteria:

* Cognitive impairment that prevents comprehension of the intervention

Primary outcomes:
measure: Quality of Life (EQ-5D-3L)
timeFrame: Baseline and after completion of the 10-week intervention
measure: Perceived Quality of Life (EQ-VAS)
timeFrame: Baseline and after completion of the 10-week intervention
measure: Mental Health - Depression, Anxiety, and Stress (DASS-21)
timeFrame: Baseline and after completion of the 10-week intervention
Secondary outcomes:
measure: Psychological Flexibility (Psy-Flex Scale)
timeFrame: Baseline and after completion of the 10-week intervention
measure: Self-Reflection and Insight (SRIS Scale)
timeFrame: Baseline and after completion of the 10-week intervention
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculdade de Medicina da Universidade de Coimbra
Study officials:
References:
Clinical trial NCT03623971: Validation of a Universal Cataract Intelligence Platform
Official title: Validation of the Utility of a Universal Cataract Intelligence Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Artificial Intelligence
Keywords: Cataract
Artificial Intelligence
Medical Referral Pattern
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Xidian University
First posted: 2018-08-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study established and validated a universal artificial intelligence (AI) platform for collaborative management of cataracts involving multi-level clinical scenarios and explored an AI-based medical referral pattern to improve collaborative efficiency and resource coverage.The datasets were labeled using a three-step strategy: (1) categorize slit lamp photographs into four separate capture modes; (2) diagnose each photograph as a normal lens, cataract or a postoperative eye; and (3) based on etiology and severity, further classify each diagnosed photograph for a management strategy of referral or follow-up. A deep residual convolutional neural network (CS-ResCNN) was used for the image classification task. Moreover, we integrated the cataract AI agent with a real-world multi-level referral pattern involving self-monitoring at home, primary healthcare, and specialized hospital services.


Eligibility criteria: Inclusion Criteria:

Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center.

Exclusion Criteria:

The patients who cannot cooperate with the examinations.

Primary outcomes:
measure: Diagnostic accuracy of the cataract AI agent
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02742571: Validation of PINI Score in ICU
Official title: Validation of PINI Score in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICU Patients
Keywords: Biological evaluation of denutrition
Denutrition
PINI score
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU

Detailed description: Main objective: to evaluate the relationship between PINI score and biomarker related to PINI, and 28 days mortality in ICU

Secondary objectives:

* to evaluate the relationship between PINI score (and biomarkers related to PINI) and morbidity in ICU : SOFA score, duration of ventilation, duration of antibiotherapy, duration of extra renal epuration, length of stay
* to evaluate the relationship between PINI score (and biomarkers related to PINI) and nutrition in ICU (type of nutrition, calorie content)

Eligibility criteria: Inclusion Criteria:

* Both patient in ICU

Exclusion Criteria:

* minor patient
* No possibility to calculate PINI score
* Pregnant woman

Primary outcomes:
measure: PINI Score
timeFrame: at day 1
measure: Biomarkers related to PINI
timeFrame: at day 1
measure: Mortality at 28 days
timeFrame: after admission
Secondary outcomes:
measure: Length of stay
timeFrame: at day 1
measure: Duration of ventilation
timeFrame: at day 1
measure: Duration of antibiotherapy
timeFrame: at day 1
measure: Duration of renal replacement therapy
timeFrame: at day 1
measure: Type of nutrition (enteral/parenteral)
timeFrame: at day 1
measure: Calorie content per day
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: