louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05160870: Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia
Official title: Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Ataxia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Spinocerebellar ataxia

Brief summary: The investigators aimed to find appropriate biomarkers such as serum neurofilament light chain in reflecting disease severity in hereditary ataxia from a large cohort during long-term follow-up. The disease severity is indicated by clinical scales and brain MRI tests.


Eligibility criteria: Inclusion Criteria:

* genetically diagnosed as Spinocerebellar ataxia

Exclusion Criteria:

* deny follow-yp

Primary outcomes:
measure: Serum neurofilament light chain
timeFrame: from 2021 to 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT04547270: High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove
Official title: High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove: A Prospective Observational Volunteer Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: interscalene groove
intermuscular bridges
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers among staff, residents and their friends

Brief summary: This study aims to define the intermuscular bridges between the scalene muscles at the interscalene groove (around neck area) using high definition US imaging in a cohort of volunteers.

Detailed description: The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve sparing interscalene approach, has better safety profile than before and because of this, it is often the technique of choice for anaesthesia and/or analgesia during shoulder and proximal arm surgery. Anatomical variations at the interscalene groove are not uncommon and few have been described in the literature. Understanding the anatomy of the brachial plexus and its sheath at the interscalene groove is vital for the success of the block and to reduce the risk of complications during ultrasound (US) guided ISBPB. Recently, with the use of high definition ultrasound, using high frequency linear transducer, the principal investigator have identified intermuscular bridges appearing between the ventral rami of the brachial plexus at the interscalene groove. These intermuscular bridges may affect the spread of local anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics of ISBPB. Therefore, this prospective observational study aim to define the intermuscular bridges at the interscalene groove using high definition ultrasound imaging in a group of healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* volunteers consented for the scanning

Exclusion Criteria:

* prior surgery on either side of the neck
* presence of obvious deformity

Primary outcomes:
measure: Identification of the interscalene muscular ridges
timeFrame: through study completion, an average of 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: Kowloon
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185170: DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections
Official title: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Medical Device
Fluorescence
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire TIMC-IMAG
name: FEMTO-ST Institute
name: LLTech laboratory
name: Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
First posted: 2014-07-09
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is divided in 4 different steps:

* the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
* the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,
* the third step is to validate the use of:

  1. the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
  2. the Light-CT scanner use for tissue structural observation.
* the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.


Eligibility criteria: Inclusion Criteria:

* Male patient over 18 years old.
* Patient scheduled for trans-urethral resection of prostate with:

  1. prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age \> 80 years old
  2. a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level \> 50 ng/ml or an existing prostate cancer
* Patient affiliated to social security or beneficiary of such a regime.

Exclusion Criteria:

* Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health

Primary outcomes:
measure: Complete fluorescence measurement over each field of vision.
timeFrame: 1 day
Secondary outcomes:
measure: Complete fluorescence measurement over each field of vision.
timeFrame: 1 day
measure: Quality criteria of the structure of tissue (ordinal qualitative variables).
timeFrame: 1 day
measure: Fluorescence measurements mean.
timeFrame: 1 day
measure: Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides
timeFrame: 1 day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital, Urology and Anatomopathology Department
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Luc Descotes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03525470: Autonomic Adaptations to Hydration and Brain Functioning
Official title: Autonomic Adaptation to Hydration and Brain Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Keywords: Hydration
Brain functioning
Heart-rate variability
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over design where on one occasion subjects lost 0.5% body weight,and drank 300ml water and on another occasion nothing was consumed
Primary purpose: BASIC_SCIENCE

Brief summary: The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain functioning when performing a mental arithmetic task. Heart rate variability will be monitored and related to differences in brain functioning when water has and has not been drunk

Detailed description: On two mornings twelve male participants will be exposed to a temperature of 30oC for four hours and either drink or not drink two 150ml glasses of water during that time. The subjects the participate in an fMRI protocol during which they complete a modified version of the Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit autonomic arousal.

Throughout the morning subjects will their heart rate variability (HRV) monitored. At periodic intervals subjects will rate their thirst and mood by visual analogue scales and at the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid loss (perspiration and urine) and urine osmolality will be monitored.

Eligibility criteria: Inclusion Criteria:

* Self declared as healthy and not taking any medication

Exclusion Criteria:

Primary outcomes:
measure: BOLD signal
timeFrame: One hour in scanner (1300-1400 hours)
measure: Heart-rate variability
timeFrame: Differences on two testing occasions (0900 and 1300 hours) will be related to BOLD
Secondary outcomes:
measure: Ratings of ,mood and perceived effort
timeFrame: Rated baseline (0830 hours), 30 mins later, 280 minutes later
measure: Change in body weight
timeFrame: Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)
measure: Osmolality
timeFrame: Baseline (0830 hours) and after 300 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04500470: Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
Official title: Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind placebo randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.

Detailed description: hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility criteria: Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to HSG

Primary outcomes:
measure: Intensity of pain
timeFrame: 15 minutes
Secondary outcomes:
measure: Intensity of pain
timeFrame: 30 minutes after the procedure
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT05652270: Maximizing Patient Goal Attainment
Official title: Maximizing Patient Goal Attainment, Motivations and Expectations (mGAME) in Elective Musculoskeletal Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Injuries
Knee Pain Chronic
Knee Injuries and Disorders
Keywords: Orthopaedic
Knee
Patient Goals
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Medacta USA
First posted: 2022-12-15
Enrollment: 258
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.


Eligibility criteria: Inclusion Criteria:

* Individuals 21 years of age or older
* New patients or existing patients with a new problem that are scheduled to see an orthopaedic surgeon in the Hip and Knee Arthroplasty service for a knee consult.

Exclusion Criteria:

* Individuals who are unable to consent or complete surveys without assistance
* Non-English speaking
* Patients who are less than 12 months from surgery on the knee they are being evaluated for, less than 6 months from surgery on the spine, or less than 3 months from another knee/hip surgery

Primary outcomes:
measure: To evaluate the effectiveness of the goal development intervention using the Goal Attainment Outcome Measure
timeFrame: 8 Months
Secondary outcomes:
measure: To assess the intervention's ability to improve shared decision making using the collaboRATE measure
timeFrame: 8 Months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kevin J McGuire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831270: Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Official title: Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Mitral Stenosis
Tricuspid Regurgitation
Keywords: cardiac surgery
acute normovolemic hemodilution
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery due to valvular heart disease

Brief summary: Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential procedure for cardiac surgery, dilutes patient's blood components, possible impact of applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well investigated.

In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years, n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery. In both groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1 hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical, USA).


Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

Exclusion Criteria:

* preoperative renal failure requiring reran replacement therapy
* preoperative liver disease
* preoperative low cardiac output (EF \< 50%)
* Preoperative IABP application, Atrial fibrillation, Pacemaker,
* contraindication for applying TEE
* intraoperative withdrawal

Primary outcomes:
measure: serum creatinine (s-Cr) concentration
timeFrame: before ANH
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT06757270: Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia
Official title: Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity


Eligibility criteria: Inclusion criteria

1. Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
2. Patients scheduled for chemotherapy treatment.
3. Patients who range from 3 to 13 years old.
4. Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria

1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.

Primary outcomes:
measure: Prevention of oral mucositis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
Study officials:
References:
Clinical trial NCT03976570: The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Official title: The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit and Disruptive Behavior Disorders
Lead sponsor: Erzurum Regional Training & Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.

Detailed description: Subthreshold attention deficit hyperactivity disorder may occur in a subset of children who are possibly more sensitive to their environment. Therefore, it is very important to target the elimination of symptoms with appropriate preventive therapies before this disorder occurs. One of the promising preventive therapy option may be occupational therapy.

Attention deficit hyperactivity disorder can have a negative impact on occupational performance such as: activities of daily living, education, resting, sleeping, playing and social participation. Occupational therapists are able to provide interventions to improve engagement in daily activities on social skills, play, executive functioning, impulsivity, inattention, and motor coordination.

Although the guidelines about the treatment of ADHD are primarily medically and psychologically based, certain treatment components are useful for occupational therapy practice; for example, behavioural management of the child and psychoeducational programmes for families.

However, treatment recommendations for subthreshold ADHD cases or the population at risk are limited. This study investigates the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.

Eligibility criteria: Inclusion Criteria:

* Subthreshold Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Attention Deficit Hyperactivity Disorder

Primary outcomes:
measure: Dunn Sensory Profile
timeFrame: 12 weeks
measure: K-SADS-PL
timeFrame: 12 weeks
Secondary outcomes:
measure: The Conner's parent rating scale
timeFrame: 12 weeks
measure: Conners' Teacher Rating Scale
timeFrame: 12 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 12 weeks
measure: Clinical Global Impressions (CGI) Scale:
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Regional Training and Research Hospital
Study officials:
affiliation: Erzurum Regional and Training Hospital
name: Hicran Doğru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918670: A French Multi-centric Atrial Fibrillation Catheter Ablation Survey
Official title: A French Multi-centric Atrial Fibrillation Catheter Ablation Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Observation of Outcome After Catheter Ablation of Atrial Fibrillation
Keywords: atrial fibrillation; catheter ablation; relapse; stroke; death
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
name: Nouvelle Clinique Nantaise, Nantes, France
name: Hôpital Privé de Parly II - Le Chesnay
name: Rennes University Hospital
name: University Hospital, Rouen
First posted: 2013-08-08
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: All patients undergoing catheter ablation in one of the registry centers

Brief summary: Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients.

We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter

Exclusion Criteria:

* patients undergoing catheter ablation of other types of arrhythmia

Primary outcomes:
measure: Atrial fibrillation relapse
timeFrame: starting 3 months after the procedure till an average of 18months follow-up
Secondary outcomes:
measure: Early atrial fibrillation relapse
timeFrame: first 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
References: