louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06646640: Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy
Official title: Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemoglobin Disorder
Keywords: Transplant
Gene Therapy
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with hemoglobin disorders that have received, or are planning to receive, either a genetically modified cell product or allogenic HCT will be invited to enroll on this long term follow up study.

Brief summary: This is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per FDA guidelines after receipt of an allogeneic HCT or autologous genetically modified cellular products for hemoglobin disorders.

Primary objective:

- To provide long term follow up, for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation (HCT) or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy. For individuals receiving a genetically modified cellular product, this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration (FDA).

Detailed description: This protocol will provide a mechanism to appropriately monitor individuals with hemoglobin disorders that have received an allogenic HCT or an autologous genetically modified cellular product for hemoglobinopathies. Monitoring will include potential long-term adverse effects after receipt of these treatments, as well as long-term monitoring after the receipt of the genetically modified cellular product.

Eligibility criteria: Inclusion Criteria:

* Receipt, or planned receipt, of an allogeneic HSCT or infusion of genetically modified autologous cells for hemoglobin disorders within 15 years prior to enrollment

Exclusion Criteria:

* Inability or unwillingness of research participant and/or legal guardian/ representative to provide written informed consent.

Primary outcomes:
measure: To provide ongoing review of long-term clinical and psychosocial outcomes and late effects of hematopoietic stem cell transplant and gene therapy recipients at St. Jude Children's Research Hospital.
timeFrame: long term follow up. Can also be stated as "up to 15 years after transplant"
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Akshay Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03010540: Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair
Official title: Emergence Delirium and Recovery Profile in Patients Undergoing Cleft Lip and Palate Repair: Comparison of Combination of Morphine and Fentanyl With Fentanyl Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Emergence Delirium
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone


Eligibility criteria: Inclusion Criteria:

* ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion Criteria:

* CNS Disorders
* Respiratory Infection
* GERD

Primary outcomes:
measure: Emergence Delirium ( PAED Scale)
timeFrame: 30 Minutes Postoperatively
Secondary outcomes:
measure: Post Operative Pain (FLACC Scale )
timeFrame: 30 Minutes Postoperatively
measure: Saturation Of Oxygen (SpO2 in %)
timeFrame: 30 Minutes Postoperatively
measure: Temperature (degree Celsius)
timeFrame: 30 Minutes Postoperatively
measure: Heart Rate (Beats Per Minute)
timeFrame: 30 Minutes Postoperatively
measure: Respiratory Rate (Per Minute)
timeFrame: 30 Minutes Postoperatively
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: Punjab
Study officials:
References:
Clinical trial NCT04651140: Research on the Effect and Mechanism of Aerobic Exercise on PD
Official title: Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Physical Exercise
Keywords: Parkinson's Disease
Physical exercise
Mechanism
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is expected to recruit patients with primary Parkinson's disease and give them four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism

Detailed description: This trial is expected to recruit patients with primary Parkinson's disease who are distributed into tremor group and stiff group and give them the same kind of four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism

Eligibility criteria: Inclusion Criteria:

* Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria
* Participants are between 55 and 65 years old

Exclusion Criteria:

* Severe heart
* liver dysfunction
* kidney dysfunction
* severe cognitive dysfunction
* severe anxiety and depression
* history of mental illness
* history of cerebral infarction or ischemic attack in the past three months
* acute myocardial infarction or acute coronary in the past three months
* Parkinson's Pulse syndrome
* medication history (drugs that improve blood circulation in the brain and increase the excitability of the nervous system)

Primary outcomes:
measure: Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: changes of MDS-UPDRS score from baseline at four weeks
measure: Montreal Cognitive Assessing(MoCA) score
timeFrame: changes of MoCA score from baseline at four weeks
measure: The Epworth Sleeping Scale(ESS)
timeFrame: changes of ESS score from baseline at four weeks
measure: Non-Motor Symptom Scale (NMSS)
timeFrame: changes of NMSS score from baseline at four weeks
Secondary outcomes:
measure: cerebral blood variation by Head MRI
timeFrame: changes of the cerebral blood from baseline at four weeks
measure: cerebral blood flow velocity
timeFrame: changes of the cerebral blood flow velocity from baseline at four weeks
measure: the level of arterial blood pressure
timeFrame: changes of the arterial blood pressure from baseline at four weeks
measure: the concentration of microRNA in peripheral blood by gene chip
timeFrame: changes of microRNA from baseline at four weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: FirstJilinU
Study officials:
affiliation: The First Hospital of Jilin University
name: Ying Zhang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05639140: A Registered Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.
Official title: A Registered Observational Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodegenerative Disorders
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients include who suffer from Neurodegenerative Disorders whether Color discrimination deficit or not.

Brief summary: Color discrimination deficit is a common manifestation of Alzheimer's disease (AD). However, the pathophysiology of this dysfunction remains poorly understood. The aim of the present study was to evaluate color discrimination using the Farnsworth-Munsell 100 hue test in patients with AD and mild cognitive impairment (MCI), compared with age-matched control subjects. As a secondary aim, we evaluated whether the outcomes of these visual tests were associated with cognitive.


Eligibility criteria: Inclusion Criteria:

* All patients underwent extensive clinical examination including thorough neurological and somatic examination by a specialized neurologist or geriatrician and extensive neuropsychological examination by a trained psychologist. AD was diagnosed according to the NINCDS-ADRDA criteria.

Exclusion Criteria:

* We excluded individuals with noncompensated somatic illnesses, a history of a psychiatric disorder, color blindness, ophthalmological pathology, severe cranial trauma, focal neurological signs or magnetic resonance imaging examinations suggestive of cerebrovascular disturbances.

Primary outcomes:
measure: MoCA scores
timeFrame: Baseline
Secondary outcomes:
measure: ACE-III scores
timeFrame: Baseline
Other outcomes:
measure: TES
timeFrame: Baseline
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT06159140: Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
Official title: Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Vessel Disease
Keywords: MRI
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 82
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Small vessel disease (SVD) accounts for 25% of strokes and is the second most common cause of dementia after Alzheimer's disease. Unlike other causes of stroke, SVD manifests itself years before the stroke by the accumulation of tissue damage. Although heterogeneous, these lesions appear on Magnetic Resonance Imaging (MRI) as white matter hypersignals (WMH). In this context, the ANR SUMMIT project will characterize these lesions in vivo to develop new markers in the early stages of stroke. It is subdivided into 4 work packages, the third one being promoted by CHRU de Tours.


Eligibility criteria: Inclusion Criteria:

Prior Enrollement in Tours body donation program Age ≥ 82 years Able to remain supine in the MR scanner for acquisition (duration 60-minutes) Affiliation to social security Informed and written consent

Exclusion Criteria:

Contraindications to body donation, especially infectious disease (VIH, HBV...) Contraindications to MRI

Primary outcomes:
measure: In vivo and ex vivo MRI measures data
timeFrame: baseline
Secondary outcomes:
measure: FLAIR and SUMMIT maps (MRI evaluation)
timeFrame: baseline
measure: Scores at neuropsychological evaluation
timeFrame: baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: UHT of Tours
Study officials:
References:
Clinical trial NCT01918540: Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty
Official title: Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Radiostereometry
Total Hip Arthroplasty
Stem design
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the hip necessitating primary hip replacement
* Charnley classification group A and B
* Age 60 - 85 years old at the inclusion time of the study.

Exclusion Criteria:

* Secondary osteoarthritis
* Rheumatoid arthritis
* Malignant disease
* Severe osteoporosis
* Earlier fracture or operation in the hip to be operated on
* Peroperative fracture
* Ongoing corticosteroid (oral) or immunosuppressive medication
* Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.

Primary outcomes:
measure: Radiostereometric Analysis (RSA)
timeFrame: The first postoperative day, 6 months, 1, 2, 5 and 10 years
Secondary outcomes:
measure: x-ray
timeFrame: The first postoperative day, 6 months, 1, 2, 5 and 10 years
measure: Hip specific questionnaire
timeFrame: Preoperatively, 1, 2, 5 and 10 years
measure: General health questionnaire
timeFrame: Preoperatively, 1, 2, 5 and 10 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Orthopedics, Skane University Hospital, Lund University
state: Skåne
Study officials:
References:
Clinical trial NCT05089240: Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
Official title: Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
Collaborators: name: Elite School of Optometry and Sankara Nethralaya
First posted: 2021-10-22
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.


Eligibility criteria: Inclusion Criteria:

* Subjective report of visual fatigue
* Non-presbyopes
* Permanent wearers who wear glasses for at least 5 hours a day
* Distance refractive error within the range of \[+6.00 to -6.00\]\* (with cylinder in the negative form),
* Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes,
* Anisometropia ≤ 1.00 D in sperical equivalent,
* Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance),
* Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance)
* Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance),
* Study frame characteristics: Frame B size at least 22 mm

Exclusion Criteria:

* Vulnerability of the subject,
* Participation in another study which might have an influence on vision or interfere with study assessments,
* Binocular vision problems,
* Known ocular pathology (e.g., age-related macular degeneration, glaucoma...),
* Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery...),
* Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure...),
* Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects...),
* Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists...)

Primary outcomes:
measure: The difference in number of participants with treatment-related adverse events between the two lenses
timeFrame: Immediately after the first and second wearing period (21 days each)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03546140: Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex
Official title: Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men MSM that come from HIV, urgency service and other from the hospital and from a local ONG

Brief summary: The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex

Detailed description: The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group (MSM users of Chemsex) with the purpose of conduct diagnosis, early treatment and monitoring of this infections and reduce the incidence rate of the same ones

Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years)
* Men MSM/transgender referred from PEP office
* Men MSM/transgender referred from urgency service attended for acute intoxication or an STD
* Men MSM/transgender referred from STD office
* Men MSM/transgender referred from a local ONG attended for chemsex use
* Specifically drug use for having sexual relations, at least once in a month in the lasts 6 months or more than 10 times the last year
* Reading and understanding ability
* Patients should be given written informed consent
* Negative HIV and HCV men
* HIV positive men but HIC negative referred from HIV daily hospital
* Disposal of sanitary card from CatSalut

Exclusion Criteria:

* Men that not accomplish inclusion criteria
* Drug use for another purposes not sexual
* Drug use for having occasional sexual relations, least than once in the past 6 months

Primary outcomes:
measure: Number of HIV,
timeFrame: 2 years
measure: number of HCV seroconversion
timeFrame: 2 years
measure: number STD seroconversion
timeFrame: 2 years
Secondary outcomes:
measure: type of consumer drug
timeFrame: 2 years
measure: clinical outcomes
timeFrame: 2 years
measure: analytical outcomes
timeFrame: 2 years
measure: analytical outcomes
timeFrame: 2 years
measure: weight
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06329440: Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients
Official title: Comparison of Diaphragma Thickness and Perfusion Index Change in Supraclavicular and Costoclavicular Brachial Plexus Block in Adult Patients Undergoing Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm Injury
Keywords: regional anaesthesia
acute pain
peripheral block
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated.


Eligibility criteria: Inclusion Criteria:

* adult patients who will undergone upper extremity peripheral block

Exclusion Criteria:

* coagulation disorders
* paediatric patients
* Patients who do not accept regional anaesthesia
* known local anaesthetic allergy
* Patients who are under anticoagulant therapy
* Pregnancy

Primary outcomes:
measure: Diaphragm thickness fraction (centimeters)
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Diaphragm thickness at the end of expirium (centimeters).
timeFrame: Up to 4 hours
measure: Diaphragm thickness at the end of inspirium (centimeters).
timeFrame: Up to 4 hours.
measure: Perfusion index change
timeFrame: Up to 4 hours
measure: Motor and sensory block onset time
timeFrame: Up to 45 minute
measure: Postoperative pain scores (0-10)
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, MD, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: