louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01159613: Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
Official title: Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C Viral Infection
Keywords: SVR
Cholesterol level
fibrosis score
HDL
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Hillel Yafe MC Hadera
First posted: 2010-07-09
Enrollment: 80
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: chronic HCV genotype 1 naïve patients

Brief summary: The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.

Detailed description: Lipoproteins are closely connected to the process of hepatitis C virus (HCV) infection. Metabolic syndrome predicts negative treatment outcome in HCV infection.

Aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (SVR).

Eligibility criteria: Inclusion Criteria:

* Chronic HCV genotype 1 naive patients

Exclusion Criteria:

* Co infection with HBV, HIV, HDV
* Decompensated liver disease

Primary outcomes:
measure: sustained viral response
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References:
Clinical trial NCT07007013: Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental Study
Official title: Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medically Unexplained Symptoms
Keywords: Medically unexplained symptoms
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to study the effectiveness of the intervention for medically unexplained symptoms(MUS) in terms of changes in emotional well-being before and after the intervention (humor therapy)


Eligibility criteria: Inclusion Criteria:

Participants may be included in the trial if they meet all of the following inclusion criteria:

Men and women over 18 years of age.

Diagnosed with the condition under study (see Section 2: Definitions).

Expected to undergo follow-up for their condition at the study center.

Ability to participate in the required assessments.

Legal capacity to provide informed consent.

Signed informed consent for inclusion in the study, either by the participant or their legal representative.

Exclusion Criteria:

Participants will be excluded if they meet any of the following exclusion criteria:

Participants diagnosed with any of the following conditions:

Severe mental health disorder, as determined by the investigator

Cognitive impairment of any etiology, as recorded in the medical history

Treatment for the condition under study using community-based resources prescribed in Primary Care within the past 6 months.

Cognitive or affective disorders that limit the ability to comply with study procedures.

Participation in another study involving an experimental intervention during the period of the present trial and/or requiring visit schedules that are incompatible with this trial.

Primary outcomes:
measure: emotional well-being
timeFrame: From baseline to 6 months after ending the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Vilanova i la Geltrú
country: Spain
facility: CAPI Baix A Mar (CSAPG)
state: Barcelona
Study officials:
affiliation: CSAPG
name: Sarai Cuevas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367713: Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management
Official title: Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteitis
Cranial Flap
Keywords: Osteitis
cranial flap
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cranial flap osteitis after craniectomy, treated at CRIOAc Lyon.

Brief summary: Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.


Eligibility criteria: Inclusion Criteria:

* Patients with cranial flap osteitis after craniectomy
* Patients who did not object to participating in the study
* Adult patients

Exclusion Criteria:

* NA

Primary outcomes:
measure: rate of cranial flap osteitis after craniectomy
timeFrame: between 2010 and 2021
Secondary outcomes:
measure: rate of failure in management of cranial flap osteitis after craniectomy
timeFrame: between 2010 and 2021
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT06631313: PureWick™ Adolescent Study
Official title: A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers, Adolescent
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.


Eligibility criteria: Inclusion Criteria:

1. Healthy Adolescent Male or Female aged 12 through 21 years old
2. Able to independently and voluntarily void urine
3. Ability to speak and understand English.
4. Willing to comply with all study procedures in the protocol.
5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Has urinary retention
2. Incontinent to feces
3. Has any irritation, wound, open lesion at the device application site.
4. For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
5. For females: currently pregnant at time of consenting (self-reported)
6. Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
7. Has ever been employed as a home health aide or homecare provider.
8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Primary outcomes:
measure: Performance of the PureWick System in adolescents after HCP placement and self-placement
timeFrame: Approximately 2 hours after device placement
Secondary outcomes:
measure: Participant Comfort
timeFrame: Approximately 2 hours after device placement
measure: Participant Ease of Use
timeFrame: Approximately 2 hours after device placement
measure: IFU Comprehension
timeFrame: Approximately 2 hours after device placement
measure: HCP Ease of Use
timeFrame: From date of first enrollment until the date of last patient completion, approximately 4 weeks
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
References:
Clinical trial NCT04581213: Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
Official title: Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Reaction
Children, Only
Keywords: General anesthesia
Children
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.

Brief summary: General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial doppler), and the depth of anesthesia in children between 6 months and 5 years old during the induction of general anesthesia (induced with sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be maintained despite systemic variations.


Eligibility criteria: Inclusion Criteria:

* General anesthesia for elective surgery
* American Society of Anesthesiologists score 1 and 2
* Written informed consent obtained from the parents or legal tutors.

Exclusion Criteria:

* 3 unsuccessful attempts of IV access
* ultrasound device non available
* neurologic comorbidity

Primary outcomes:
measure: Changes in NIRS values during induction
timeFrame: baseline and 1 minute after intubation
measure: Changes in cerebral velocity of the middle cerebral artery during induction
timeFrame: baseline and 1 minute after intubation
measure: Changes of Response Entropy (RE) value during induction
timeFrame: baseline and 1 minute after intubation
measure: Changes of State Entropy (SE) value during induction
timeFrame: baseline and 1 minute after intubation
Secondary outcomes:
measure: Changes in NIRS values after induction
timeFrame: At 1 minute, 3 minutes after intubation and at the start of surgery
measure: Change in cerebral velocity of the middle cerebral artery after induction
timeFrame: At 1 minute, 3 minutes after intubation and at the start of surgery
measure: Changes of arterial blood pressure during induction
timeFrame: At baseline and 1 minute after intubation
measure: Changes of Response Entropy (RE) values after induction
timeFrame: At 1 minute, 3 minutes after intubation and at the start of surgery
measure: Endtidal Co2 after induction
timeFrame: 1 minute after intubation
measure: Changes of State Entropy (SE) value after induction
timeFrame: At 1 minute, 3 minutes after intubation and at the start of surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sainte Justine Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT06437613: "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness.
Official title: "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hamstring Flexibility
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomised controlled trial and the purpose of this study is to determine the effects of Passive Static Stretching of 30 seconds versus 60 seconds on the Hamstring Flexibility in adults with Hamstring Tightness.

The study is conducted in Rehabilitation department of Fauji Foundation Hospital on the sample of 38 participants. Hamstring flexibility will be evaluated at the beginning by Active knee extension test.

The subjects will be randomized into two group by sealed envelope method. Baseline assessment would be done by using tools of SLR and modified knee extension test and then final assessment will be done after 4 weeks.

Detailed description: The purpose of this study is to determine the effects of passive static stretching on hamstring flexibility in adults with hamstring tightness" adults (age : 18-45 years ) by using

1. Goniometer
2. Straight leg raise (SLR)
3. Passive Hip Flexion Test(PHFT)
4. Active Knee Extension Test( AKET)
5. Modified Knee Extension Test(MKET) Data will be collected before and after the intervention protocol for each participant.

Data collection procedure:The subjects will be advised of the training session schedule following the baseline assessment. Pre and post intervention scores will be recorded.

Eligibility criteria: Inclusion criteria:

* Adults age ranging from 18-45 years
* Both males and females are included in the study
* Individuals with 90 degree hip flexion having a minimum reduction of 15 degrees in knee extension position.

Exclusion criteria :

* Old adults
* Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
* Post-surgical cases
* Hamstring strain or any other dysfunction in past two years.

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
measure: Range of motion
timeFrame: 4 weeks
measure: Physical Function
timeFrame: 4 weeks
measure: Lumbar range of motion
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT06181513: Probiotics in Mild Alzheimer's Disease
Official title: Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Neurodegenerative Diseases
Cognition Disorders in Old Age
Keywords: probiotics
Electroencephalogram (EEG)
cognitive function
Alzheimer's Disease
neuropsychological testing
Electrocardiogram (EKG)
Lead sponsor: University of Nicosia
Sponsor class: OTHER
Collaborators: name: Cyprus Institute of Neurology and Genetics
First posted: 2023-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).

Detailed description: We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.

Eligibility criteria: Inclusion Criteria:

* Adults ≥65 years, able to give consent
* Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
* approximately equal male:female ratio

Exclusion Criteria:

* Inability to give consent
* other neurological disease
* relevant psychiatric disorders (e.g. major depression)
* gastrointestinal/metabolic conditions
* history of alcohol/substance dependence
* use of systemic antibiotics in the previous 6 months
* corticosteroid use
* immune stimulating medications
* immunosuppressive agents
* probiotics consumption in the previous 6 months.
* immunosuppression
* structural heart disease
* neutropenia
* radiation
* active intestinal disease

Primary outcomes:
measure: Level of inflammatory markers
timeFrame: Baseline (week 0), end of study (week 16)
Secondary outcomes:
measure: Cognitive function and neuropsychological scores
timeFrame: Baseline (week 0), end of study (week 16)
measure: Cognitive function and neuropsychological scores
timeFrame: Baseline (week 0), end of study (week 16)
measure: Cognitive function and neuropsychological scores
timeFrame: Baseline (week 0), end of study (week 16)
measure: Cognitive function and neuropsychological scores
timeFrame: Baseline (week 0), end of study (week 16)
measure: Neurophysiological activity changes
timeFrame: Baseline (week 0), end of study (week 16)
measure: Microbiome profile
timeFrame: Baseline (week 0)
Other outcomes:
measure: Dietary habits
timeFrame: Baseline (week 0)
Locations:
city: Nicosia
country: Cyprus
facility: The Cyprus Institute of Neurology and Genetics
Study officials:
References:
Clinical trial NCT05798013: Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis
Official title: Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis: A Multicenter, Cluster Randomized Controlled Trial Based on Chinese Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Vascular Stenosis
Keywords: head and neck vascular stenosis
digital health management
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 102072
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of digital health management for intervention on Chinese population with head and neck vascular stenosis.


Eligibility criteria: Inclusion Criteria:

1. Inclusion criteria of the clusters

   Hospitals with the qualification of "head and neck ultrasound center" in China.
2. Inclusion criteria for individuals

   * (1)Age ≥ 35 years old, with no restriction on gender.
   * (2)Patients with clinically diagnosed head and neck stenosis or occlusion, including mild, moderate or severe stenosis or occlusion of the carotid artery and mild, moderate or severe stenosis or occlusion of the intracranial artery.
   * (3)Ability to use a smartphone and have a mobile application installed on the handset.
   * (4)Subjects or their legal representatives agreed to the study and signed the project informed consent form.

Exclusion Criteria:

1. Exclusion criteria for the clusters

   The included centers did not have the capacity to undertake the trial.
2. Exclusion criteria for individuals

   * (1)Combination of severe systemic diseases such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation dysfunction, malignancy, etc.
   * (2)Patients with a life expectancy of less than 2 years or who are unable to complete the study for other reasons.

Primary outcomes:
measure: New-onset stroke events at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: New-onset stroke events at 12 months
timeFrame: 12 months
measure: Composite and separate indicators of new clinical vascular events at 12 and 24 months
timeFrame: 12 months, 24 months
measure: All-cause deaths at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT02930213: The Core Body Temperature Rhythms: Distinguishing MCS From UWS
Official title: The Core Body Temperature Rhythms:A Promising Indicator of Distinguishing MCS From UWS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Consciousness
Keywords: unresponsive wakefulness syndrome
minimally conscious state
circadian rhythms
free-running period
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 7
Sex: ALL
Minimum age (years): 39
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators chossen patients with UWS or MCS.The subjects include 4 UWS and 3 MCS.

Brief summary: In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .

Detailed description: Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (\>24h ), which is also called free-running period.

Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.

Researchers expected to see the difference between MCS and UWS.

Eligibility criteria: Inclusion Criteria:

* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 1 months after the acute brain injury

Primary outcomes:
measure: Measuring the continuous external auditory canal temperature
timeFrame: Continuous temperature measurements for 168 hours (8days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: