louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004397: Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria.

II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.

Detailed description: PROTOCOL OUTLINE: This is an unblinded study. Patients start a preventive heme regimen and are followed for 6 months prior to tin mesoporphyrin. The frequency of attacks is recorded.

Patients receive tin mesoporphyrin once a week for 6 months. Patients must avoid sunlight during treatment and for 2 months thereafter. The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored.

Patients are followed for 6 months after last treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria causing 6 or more attacks per year Fewer than 2 attacks in the preceding 6 months if already on preventive heme therapy --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Urinary porphobilinogen at least 20 mg/24 hours during acute symptoms Other: Not pregnant Fertile female patients must use effective contraception during and for 6 months prior to study No recurrent symptoms due to another illness No continuous (for longer than 1 month) symptoms of porphyria unless it is in addition to acute exacerbations No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to tin mesoporphyrin No known hypersensitivity to any intravenous heme preparation No other condition which may increase risk to patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT01164397: Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients
Official title: Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Keywords: Hypercholesterolemia
Statins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Care clinic private practice

Brief summary: The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks
* Who have completed at least 80% of the treatment
* To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine

Exclusion Criteria:

* Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin

Primary outcomes:
measure: The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks.
timeFrame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
Secondary outcomes:
measure: The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks.
timeFrame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Veracruz
country: Mexico
facility: Research Site
state: Xalapa
city: Merida
country: Mexico
facility: Research Site
state: Yucatan
city: Durango
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Ana Polanco, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05255497: The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
Official title: Effects of Balance Exercises in Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Diabetes Mellitus
Exercise Training
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study examined the effects of balance exercises performed with the Biodex Balance System (BBS) on nerve conduction, sensory symptoms, and muscle strength in patients with diabetes-related neuropathy.

Detailed description: We enrolled twenty-seven patients in this study. Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management. All patients underwent pretest and posttest peripheral nerve conduction studies. Sensory examination performed by using 5.07 Semmes-Weinstein monofilaments and 128-Hz tuning fork. Muscle strength measurements obtained with manual dynamometer

Eligibility criteria: Inclusion Criteria:

* diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study

Exclusion Criteria:

* increased risk of non-diabetes related neuropathy: history of autoimmune, cerebrovascular, or chronic infectious disease, cancer, chemotherapy and/or radiotherapy, radicular neuropathy, chronic kidney and liver failure, alcoholism or other substance abuse, and mental or physical disabilities (including blindness). We also excluded patients who didn't speak Turkish

Primary outcomes:
measure: The effect of biodex balance training on muscle strength was evaluated.
timeFrame: Change from baseline to 8 weeks
measure: The effect of biodex balance training on protective senses
timeFrame: Change from baseline to 8 weeks
measure: The effect of biodex balance training on motor nerves
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
state: Balcova/Incialtı
Study officials:
affiliation: Dokuz Eylul University
name: Gaye Yıldırım, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT02027597: Improving Oral Health With Serious Games
Official title: Improving Oral Health With Serious Games
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Tooth Decay
Cavities
Gingivitis
Keywords: video games
oral health
social cognitive theory
behavior change
randomized trial
growth modeling
minority
gender
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-01-06
Enrollment: 161
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.

In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.


Eligibility criteria: Inclusion Criteria:

For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.

Exclusion Criteria:

None

Primary outcomes:
measure: Self-Efficacy
timeFrame: 8 months post treatment
Secondary outcomes:
measure: Self-care behavior
timeFrame: 8 months post treatment
Other outcomes:
measure: Oral health literacy
timeFrame: 8 months post treatment
Locations:
city: Seattle
country: United States
facility: Firsthand Technology Inc.
state: Washington
Study officials:
affiliation: Firsthand Technology
name: Howard A Rose, M.Ed.
role: PRINCIPAL_INVESTIGATOR
affiliation: Firsthand Technology
name: Ari J Hollander, MSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04900597: Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Official title: Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enteral Feeding Intolerance
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.

Detailed description: The investigators hypothesize that rates of gastroesophageal reflux will be lower in blenderized diets compared to formula. The investigators will determine if reflux burden as measured by multichannel intraluminal impedance/esophageal pH monitoring performed for clinical purposes differs between low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet in 45 children receiving conventional formula via gastrostomy. All participants will receive each of the three test diets in random order in a 3-way crossover design. Results of gastric emptying scans will be recorded if done for clinical purposes.

Eligibility criteria: Inclusion Criteria:

* Age 1-21 years
* G-tube
* Able to tolerate bolus gastric feeds over 30 minutes
* Use of conventional enteral formula
* Undergoing impedance study for clinical purposes

Exclusion Criteria:

* History of allergy or intolerance to any component of the test diets
* History of Nissen fundoplication (participants with suspected or documented unwrapped fundoplication will be eligible for participation)
* Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)

Primary outcomes:
measure: Reflux episodes
timeFrame: 4 hours (following feed)
Secondary outcomes:
measure: Full column reflux episodes
timeFrame: 4 hours (following feed)
measure: Percent of time esophageal pH < 4
timeFrame: 4 hours after feed
measure: Average height of refluxate
timeFrame: 4 hours after feed
measure: Number of symptoms
timeFrame: 4 hours after feed
Other outcomes:
measure: Gastric emptying (percent of ingested contents remaining in stomach at 1 hour)
timeFrame: 1 hour
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Bridget M Hron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03948997: The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
Official title: The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port Wine Stain
Keywords: port wine stain, PI3K, vascular malformation,PDL
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force General Hospital of the PLA
name: First Hospital of China Medical University
name: Chinese Academy of Medical Sciences
First posted: 2019-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.


Eligibility criteria: Inclusion Criteria:

* Age 1 month - 70 years old, male or female;
* The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
* Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.

Exclusion Criteria:

* Patients with severe infectious diseases;
* Heart disease patients;
* Epilepsy patient;
* Pregnant patient;
* Researchers believe that patients who are not suitable for this experiment

Primary outcomes:
measure: Exon mutation sequences and mutation frequencies
timeFrame: Baseline (before treatment)
Secondary outcomes:
measure: Changes in the levels of cytokines in serum and skin tissues
timeFrame: baseline (before treatment) and 1, 3, 7 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140697: Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf Extract supplementation on body weight regulation in humans are lacking.

Detailed description: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Hippophae rhamnoides L. Leaf Extract on body fat. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.

Eligibility criteria: Inclusion Criteria:

* age between 19 and 65 years,
* BMI 25\~29.9 kg/m2 or Waist circumference ≥ 90(men), ≥ 85(women),
* subjects giving written informed consent

Exclusion Criteria:

* BMI ≥ 30 kg/m2
* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.

Primary outcomes:
measure: Changes in body fat mass
timeFrame: Baseline and 12 week
Secondary outcomes:
measure: Change in percent body fat
timeFrame: Baseline and 12 week
measure: Change in fat free mass
timeFrame: Baseline and 12 week
measure: Change in weight
timeFrame: Baseline and 12 week
measure: Change in body mass index
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT04644497: Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.
Official title: Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population:

-ACL-reconstruction in one knee, operated in to periods (2001-2010 or 2013-2018) with two different techniques in each period.

Brief summary: This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique.

Data including: x-ray exam, patient reported questionnaires and clinical evaluation will be compared between the 2 groups.


Eligibility criteria: Inclusion Criteria:

* ACL reconstruction as skeletally immature

Exclusion Criteria:

* Other ligament injuries in index knee
* Other ligament injuries in opposite knee
* Revision ACL reconstruction
* Pregnant
* Not able to read or understand the danish languages

Primary outcomes:
measure: Leg-length differences
timeFrame: 2 Years Follow-up
measure: Knee Angle differences
timeFrame: 2 Years Follow-up
Secondary outcomes:
measure: Knee Laxity
timeFrame: 2 Years Follow-up
measure: IKDC-Questionnaire
timeFrame: 2 Years Follow-up
measure: Tegner-Questionnaire
timeFrame: 2 Years Follow-up
measure: KOOS- Questionnaire
timeFrame: 2 Years Follow-up
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT05215197: Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
Official title: Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: cochlear implant
platelet rich fibrin
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open uncontrolled
Primary purpose: PREVENTION

Brief summary: Fibrosis due to surgical trauma is a common problem with cochlear implants. Fibrosis limits the effectiveness of implant and increases the power consumption. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.

Detailed description: The most common problem with cochlear implants is that their effectiveness decreases over time and they are not functional enough mainly due to fibrosis.

Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.

Cochlear implant application will be performed under general anesthesia. After the postauricular incision and mastoidectomy, posterior tympanotomy will find the middle ear and from there the round window, and platelet fibrin prepared with the i-prf technique will be locally applied to the round window during the operation, and then implantation will be performed.

The points where the electrode enters the cochlea will be covered with fascia.

Intraoperative NRT and impedances will be measured on all electrodes in all patients, and NRT and impedance measurements will be repeated in the 1st week, 1st month, 3rd and 6th months postoperatively.

Custom Sound EP 5.0 (5.0.4.136) program provided by Cochlear company will be used for these measurements.

Eligibility criteria: Inclusion Criteria:

* Patients with sensorineural hearing loss
* Patients who will have cochlear implant surgery with CI422 electrode

Exclusion Criteria:

* Patients with cochlear abnormality
* Patients with auditory neuropathy

Primary outcomes:
measure: Electrode Impedance(Ohm)
timeFrame: 1-6 months
Secondary outcomes:
measure: Electrode thresholds(CL)
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: