louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01723410: Neural and Physiological Responses to Real-World Experiences
Official title: Neural and Physiological Responses to Real-World Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gene Expression
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with internet access, are not pregnant, planning to become pregnant, or currently breastfeeding (if female), to participate in a study investigating whether real-world experiences alter the brain and body. This study takes place over an eight week period and involves providing the names of 8 close friends or family members, completing a neuroimaging session, providing blood and saliva (for genetic analysis), and a 6-week period in which participants login twice a week to complete online questionnaires. Compensation is up to $210 for those who complete all aspects of the study. Please email realworld.ucla@gmail.com for more information.


Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 35-50

Exclusion Criteria:

Following a structured telephone interview, prospective participants with the following conditions will not be able to participate:

1. claustrophobia, left-handedness, or presence of metal in their body (for the neuroimaging procedures),
2. possible presence of a depressive disorder, which may interfere with the gratitude intervention (assessed by the Patient Health Questionnaire; Spitzer et al., 1999),
3. regular use of medications that may impact inflammatory processes (anti-inflammatory drugs, steroids, opioids),
4. current smokers or excessive caffeine users (\> 600 mg/day) because of known effects on inflammation, and
5. pregnancy (which would affect oxytocin gene expression).

Primary outcomes:
measure: inflammatory gene expression
timeFrame: baseline, six weeks post manipulation
Secondary outcomes:
measure: neural activity
timeFrame: baseline, six weeks post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CTRC & Brain Mapping Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Naomi I Eisenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357910: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
Official title: A Randomized, Open Label, Single Dose, Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2303 and Co-administration of RLD2302 and RLD2102 in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who cannot consume the high-fat meal provided during this clinical trial
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~48 hours
measure: Cmax
timeFrame: 0~48 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~48 hours
measure: Tmax
timeFrame: 0~48 hours
measure: t1/2
timeFrame: 0~48 hours
measure: CL/F
timeFrame: 0~48 hours
measure: Vd/F
timeFrame: 0~48 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02048410: Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
Official title: Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dyslipidemia
Familial Hypercholesterolemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).

Detailed description: FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.

Eligibility criteria: Inclusion Criteria:

* aged ≥ 6 and ≤ 12 years.
* Diagnosis of hypercholesterolemia (LDL cholesterol\> 140 mg / dl)
* Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.

Exclusion Criteria:

* Age \<6 or\> 12 years.
* Patients undergoing drug treatment for hypercholesterolemia.
* Any medical condition that may interfere with participation in this study
* Participation in clinical trials still in progress.
* Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment

Primary outcomes:
measure: change of LDL cholesterol after 6 months of treatment wiyh symbiotic
timeFrame: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: university of naples federicoII
name: Roberto berni canani, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385710: Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)
Official title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Progressive Supranuclear Palsy
Keywords: Progressive supranuclear palsy (PSP)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. The investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.


Eligibility criteria: Inclusion Criteria:

* Patients with possible or probable PSP
* from 45 to 75 year of age

Primary outcomes:
measure: PSPRS score (specific score for PSP)
timeFrame: This score will be measured every three months during the two-year follow up of the study
Secondary outcomes:
measure: Neuropsychological evaluation
timeFrame: inclusion, one year and two years follow up
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Service de Neurologie A, Hôpital Gabriel Montpied-BP
city: Lille
country: France
facility: Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille
city: Nantes
country: France
facility: Service de Neurologie, CHU Nantes
city: Poitiers
country: France
facility: Service de Neurologie, CHU Poitiers
Study officials:
affiliation: Nantes University Hospital
name: Pascal Derkinderen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848310: Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Official title: Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Atresia
Prognosis
Keywords: Biliary Atresia
FGF19
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolled patients meeting following conditions.

* Patients diagnosed as biliary atresia in Children's Hospital of Fudan University
* Patients with at least one-year follow-up records after surgery
* Patients with a record of serum total bilirubin levels three months after surgery
* Patients with preoperative serum left（volume \> 500ul)

Brief summary: To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.

Detailed description: Kasai portoenterostomy is currently one of the main treatment methods for biliary atresia, but about 30% of children still require liver transplantation even after receiving the surgery. Accurate prognosis will help select the most suitable treatment method for children, but there is currently a lack of effective preoperative predictive indicators. Serum FGF19 has recently been considered a possible preoperative predictive indicator for biliary atresia, but its predictive value has not been confirmed in a large sample and in Asian population, thus the investigators try to further explore the prognostic value of serum FGF19 in children with biliary atresia based on a large sample.

Eligibility criteria: Inclusion Criteria:

* Samples diagnosed as biliary atresia in Children's Hospital of Fudan University
* Samples with one-year follow-up records after surgery
* Samples with a record of serum total bilirubin levels three months after surgery
* Samples with preoperative serum left（volume \> 500ul)

Exclusion Criteria:

* None

Primary outcomes:
measure: Serum total bilirubin level (umol/l)
timeFrame: Three months after surgery
measure: Native liver survival (%)
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT01179412: Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Official title: Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Viral Conjunctivitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 172
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.

Detailed description: The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.

Eligibility criteria: Inclusion Criteria:

* patients who were diagnosed with EKC at the outpatient ophthalmic unit

Exclusion Criteria:

* children younger than six years
* women being pregnant or during lactation
* history of allergy to povidone-iodine
* prior ocular surgery
* contact lens usage and chronic eye diseases with current eye medications.

Primary outcomes:
measure: the recovery rate within one week of treatment
timeFrame: 1 week
Secondary outcomes:
measure: drug tolerability
timeFrame: 1 week
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Ophthalmology, Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Adisak Trinavarat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005112: Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Genentech, Inc.
First posted: 2000-04-17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies by our group and others have shown that human recombinant growth hormone (GH) improves height velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive results have prompted us to ask further questions regarding GH use in CF including: a) Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) Does GH use improve the patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained? We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life. We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit 40 prepubertal children from five CF centers across the United States (8 per center). Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either the first or the second year. All subjects will be seen every three months. We will evaluate the following parameters every three months: 1) height, height velocity and Z-score, 2) body weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL forms specific for CF ("The Cystic Fibrosis Questionnaire"). After one year of study, subjects will "cross-over" to the other treatment arm. This 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers, and will allow us to assess sustained effect in the 20 subjects who receive GH during the first year, by comparing their results to results obtained during the year post treatment.


Eligibility criteria: Inclusion Criteria:

* CF patients ages 5-12 who are less than the 25th percentile for age and sex normal values for height and/or weight

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Dept of Pediatric Endocrinology
state: Utah
Study officials:
name: Dana Hardin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196310: Single Blinded First CMC Osteoarthritis Treatment
Official title: Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Thumb
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 150
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: Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.


Eligibility criteria: Inclusion Criteria:

* Stage 1-3 osteoarthritis of the basal joint

Exclusion Criteria:

* Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
* Patients who have received a corticosteroid injection in the last year to the 1st CMC joint on the proposed study side
* Patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis
* Patients who have concurrent DeQuervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months
* Patients undergoing evaluation of cervical radiculopathy
* Patients with fibromyalgia or inflammatory rheumatic disease
* Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
* Patients with any history of primary or secondary bone tumor
* Patients that are pregnant or terminally ill

Primary outcomes:
measure: Disabilities arm shoulder and hand score
timeFrame: 1 year
Secondary outcomes:
measure: Pinch Strength
timeFrame: 1 year
Other outcomes:
measure: Visual Analog Score
timeFrame: 1 year
Locations:
city: Centerville
country: United States
facility: Orthopedic Associates of Southwest Ohio
state: Ohio
Study officials:
References:
Clinical trial NCT04816110: Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration
Official title: Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Horizontal Alveolar Bone Defect
Alveolar Bone Loss
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone.


Eligibility criteria: Inclusion Criteria:

* Patients with missing anterior maxillary teeth and having deficient alveolar thickness.
* Good oral hygiene
* Alveolar ridge width less than 4 mm.

Exclusion Criteria:

* Medically compromised patients.
* Heavy smokers.
* Current chemotherapy or radiotherapy

Primary outcomes:
measure: Postoperative Pain
timeFrame: up to 1 week
measure: Postoperative Edema
timeFrame: up to 1 week
measure: Peri-implant Probing depth
timeFrame: up to 9 months
measure: Implant stability
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Yomna M Abo Serie, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Moustafa El Dibany, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Gaafar N El Halawani, PhD
role: STUDY_DIRECTOR
References: