louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06246487: Sensory Intervention for Children With Autism
Official title: Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 40
Sex: MALE
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Greater than 80% of children with autism spectrum disorder (ASD) experience sensory differences that make it difficult for them to fully participate in meaningful everyday activities. In this research study, we will use MRI and behavioral methods to assess how sensory interventions might change sensory brain structures, allowing us to better predict which sensory interventions might work best for whom.


Eligibility criteria: Inclusion Criteria: Male children 6 years, 0 months to 8 years, 6 months of age with a diagnosis of autism spectrum disorder (ASD) will qualify for inclusion. Our inclusion age ensures all study participants will complete intervention/control conditions and be retested before they turn 9 years of age. Additional inclusion criteria include:

1. The families of children will have access to transportation to attend intervention sessions 2 times per week for 16-weeks.
2. Children who qualify will be verbal, and will speak and understand English. The native language of caregivers can include Spanish.
3. Children who qualify will have sensorimotor delays as assessed by the study team using the standardized, norm-referenced assessments described in this research proposal (z-scores on 3 of 5 tests -1.0 or lower).

Exclusion Criteria: Children younger than 6 years of age or older than 8 years, 6 months of age will be excluded. Additional exclusion criteria include:

1. Female children
2. Auditory hyperresponsivity as assessed during screening procedures.
3. Medical co-morbidities such as extreme prematurity (less than 28 weeks), blindness, deafness, cerebral palsy, Down Syndrome, tuberous sclerosis, or head-injury with loss of consciousness.
4. History of individual occupational therapy services in a clinical setting that includes sensory equipment.
5. Non-removable metal in the head or body (e.g. dental fillings \& braces, metal pins, screws or plates).
6. Children unable to complete neurocognitive or sensorimotor testing.
7. Children unsuccessful in 3 mock scanning sessions during baseline testing.

Primary outcomes:
measure: Neuroimaging
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT04489186: Continuous Cardiorespiratory Monitoring in Cystic Fibrosis
Official title: Piloting the Clinical Value of Wearable Cardiorespiratory Monitoring for People With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: wearable
cardiorespiratory monitoring
digital medicine
Lead sponsor: Byteflies
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2020-07-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is intended to evaluate the feasibility of a prototype wearable device for continuous cardiorespiratory monitoring in an inpatient and outpatient population with CF in preparation of a larger ambulatory clinical trial.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for long-term monitoring of disease progression and early signs of PEx to intervene as early as possible, thereby improving long-term outcomes.

This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to collect relevant cardiorespiratory data in people with CF and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence of two known disease-causing mutations

Exclusion Criteria:

* Inability to provide written informed consent
* A known allergy to any of the used medical adhesives
* Presence of any type of electronic implanted medical device

Primary outcomes:
measure: Sensor Dot usability
timeFrame: Up to 24 hours
measure: Sensor Dot data quality
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Quality of calculated vital signs: heart rate
timeFrame: Up to 24 hours
measure: Quality of calculated vital signs: respiratory rate
timeFrame: Up to 24 hours
measure: Cough detection
timeFrame: Up to 24 hours
measure: Screen for candidate digital biomarkers in CF
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Erica A Roesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840786: Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Official title: Occlusive Disease of Lower Extremity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Ischemia
Keywords: stents
atherectomy
femoral artery
popliteal artery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: Beijing Chao Yang Hospital
First posted: 2016-07-21
Enrollment: 221
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: This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Detailed description: This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Eligibility criteria: Patients were included if they were de novo stenosis\>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Primary outcomes:
measure: 12-month Primary Patency Rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: freedom from clinically-driven TLR
timeFrame: 12 months
measure: Major Adverse Events at 12-month Post Procedure
timeFrame: 12 months
measure: 12-month Limb Salvage Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gu Yong Quan
state: Beijing
Study officials:
References:
Clinical trial NCT01115686: Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)
Official title: Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Sleep Apnea
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 0
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 initial hypothesis is that branched-chain aminoacids (BCAA) administration could be beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work is to verify this hypothesis.

The literature data demonstrate that a BCAA complementation improves the physical performances, protects lean mass and increases VO2 max during training.

We demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.


Eligibility criteria: Inclusion Criteria:

* Adult with healthy mind, who has attained his majority, and affiliated to Social Security.
* Patient suffering from SAS confirmed by polysomnography (PSG).
* Written informed consent form signed.

Exclusion Criteria:

* Patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study.
* Patients suffering for severe SAS : those who have a number of IAH higher than 30 in a validated sleep hour, will be excluded for security reasons.
* Pregnant women, nursing mothers or women susceptible to procreate without efficient contraception.
* Patient presenting hypersensitivity to understudying products and their excipients.

Primary outcomes:
measure: The principal criterion of BCAA efficacy is based on the depth of arterial desaturation during sleep, assessed by the level of SaO2 during the validated sleep time measured during the polysomnography performed at the end of the study.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02444286: The RESHAPE-HF1-FU Study
Official title: Observational Study of Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation - Follow Up of the Former Participants in the RESHAPE-HF Trial (Abbott Vascular).
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mitral Valve Insufficiency
Lead sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
First posted: 2015-05-14
Enrollment: 0
Sex: ALL
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: The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).

Brief summary: To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.

Detailed description: The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).

Eligibility criteria: Inclusion Criteria:

* Former participant in the RESHAPE-HF Trial (Abbott Vascular)
* Subject agrees to return for all required follow-up visits
* The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion Criteria:

* Withdrawal of Informed Consent
* Subject belongs to a vulnerable population

Primary outcomes:
measure: cardiovascular (CV) death
timeFrame: 24 months
Secondary outcomes:
measure: Mitral Regurgitation (MR) severity reduction
timeFrame: at 12 and 24 months
measure: 6 Minute Walk Test (6MWT)
timeFrame: at 6, 12 and 24 months
measure: CV hospitalizations and CV death
timeFrame: 24 months
measure: Quality of Life (QoL)
timeFrame: 12 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 6, 12 and 24 months
measure: Patient-reported Global Assessment (PGA)
timeFrame: 6, 12 and 24 months.
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Goettingen
city: Mainz
country: Germany
facility: University Hospital Mainz
Study officials:
References:
Clinical trial NCT06307886: Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
Official title: Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-13
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator

Brief summary: Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator


Eligibility criteria: Inclusion Criteria:

* patients suitable for laparoscopic surgery patients ages 18-75 patients diagnosed figo stage 1 and 2 endometrial cancer

Exclusion Criteria:

* patients not suitable for laparoscopic surgery patients diagnosed figo stage 3 and 4 endometrial cancer pregnant patients

Primary outcomes:
measure: five year survival in patients diagnosed with endometrial cancer
timeFrame: 5 year
measure: disease-free survival in patients diagnosed with endometrial cancer
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and research hospital
Study officials:
References:
Clinical trial NCT00638586: Comparison of Patients Undergoing Radial or Femoral Arterial Access for Percutaneous Catheterization-Nursing Aspects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Artery Access
Radial Artery Access
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalized patients that are candidates for undergoing PTCA.

Brief summary: Transradial access is a recently developed alternative for diagnostic andf interventional cardiac catheterization. We sought to compare the differences between patients that have undergone PTCA transradial and transfemoral access from the nursing point of view:

1. Anxiety levels
2. Pain at access point, pain in general and level of pain during mobility
3. Differences in feelings of embarrassement
4. Differences in satisfaction


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for PTCA without any exclusion criteria

Exclusion Criteria:

* Dementia
* Psychiatric patients
* Unconscious
* Minors
* Patients who had PTCA in past
* Patients who were initially scheduled for different access

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT04194086: Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Official title: Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Acute
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2019-12-11
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Detailed description: Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.

Eligibility criteria: Inclusion Criteria:

* 1、Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.

  2、Karnofsky/Lansky score of 60% or greater. 3、defined as alanine transaminase (ALT) \<3 x upper limit of normal (ULN),aspartate aminotransferase (AST) \<3 x ULN; serum bilirubin and alkaline phosphatase \<2 x ULN.

  4、No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.

  5、Able to take oral medication or take medication via enteral feeding tube. 6、Ability to give informed consent. 7、No history of anaphylaxis attributed to the azole class of antifungal agents.

Exclusion Criteria:

* 1、Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.

  2、Subject is not considered eligible for this clinical research program with posaconazole.

  3、Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.

Primary outcomes:
measure: Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0
timeFrame: 1 year
measure: Plasma posaconazole concentration monitoring and its pharmacokinetic
timeFrame: 1 year
Secondary outcomes:
measure: Serious Adverse events and drug-related adverse events monitoring
timeFrame: 2 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00160186: Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
Official title: Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrectomy
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 40
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 purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Males or females
* Age \>= 18 years
* Total or subtotal gastrectomy
* Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control.

Exclusion Criteria:

* Diseases or conditions limiting the participation in, or completion of, the study
* Progressive tumors/metastasis
* Complications leading to insufficient peroral nutrition
* Known allergy to pancreatin
* Known exocrine insufficiency
* Experimental drug intake

Primary outcomes:
measure: Baseline-adjusted body mass index (BMI) after 6 months therapy
timeFrame: 6 months
Secondary outcomes:
measure: Effect on body composition, on stool fat, on the coefficient of fat absorption, stool weight, quality of life (Qol), clinical symptoms (gastrointestinal), data from the diary, Elastase
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Site 9
city: Tampere
country: Finland
facility: Site 10
city: Bergen
country: Norway
facility: Site 1
city: Frederikstad
country: Norway
facility: Site 2
city: Tromso
country: Norway
facility: Site 3
city: Linköping
country: Sweden
facility: Site 5
city: Malmo
country: Sweden
facility: Site 7
city: Stockholm
country: Sweden
facility: Site 6
city: Stockholm
country: Sweden
facility: Site 8
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: