louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02520934: Miglustat on Gaucher Disease Type IIIB
Official title: Evaluation of Combination Therapy With Miglustat and Enzyme Replacement Therapy on Gaucher Disease Type IIIB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gaucher Disease
Keywords: Enzyme Replacement Therapy
Miglustat
Gaucher Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2015-08-13
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on Gaucher disease

Detailed description: understand if Miglustat (glucosylceramide synthase inhibitor) could improve neuropathy in patients with Gaucher disease

Eligibility criteria: Case_Miglustat

Inclusion Criteria:

1. Confirmed diagnosis of Gaucher Disease: blood test shown lack of beta- glucocerebrosidase, and found L444P homozygous on GBA gene.
2. Aged 6 years old or above.
3. Already have regular ERT (30-120 IU/kg/ every 2 weeks) at least a year; dosage and frequency of ERT had not been changed in recent 3 months.

Exclusion Criteria:

1. History of tremor and abnormal extremities perception ( pain, numbness, tingle etc.)
2. Abnormal kidney function.
3. Pregnant or plan to have a baby ( potentially pregnant patient need to be transferred to gynecologist for the test and promise to have proper contraception measures).
4. Allergic to Miglustat.

Control_normal Inclusion Criteria

1. Age 6-18 years
2. No significant physical, mental, or psychiatric problems

Exclusion criteria

1. Children with eye disease (not include myopia, hyperopia, Astigmatism)

Primary outcomes:
measure: Improve in Purdue Pegboard test speed
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02671734: Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Official title: Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Keywords: endoscopy
Lead sponsor: Huang, Jeannie, M.D.
Sponsor class: INDIV
First posted: 2016-02-02
Enrollment: 77
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.

Detailed description: IC = informed consent

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.

Eligibility criteria: Inclusion Criteria:

* For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
* Had to be undergoing pediatric endoscopy.
* English speaking

Exclusion Criteria:

* None.

Primary outcomes:
measure: Evaluation of Comprehension of Informed Consent Process via a scored scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Jeannie Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423134: Investigating the Performance of a New Adhesive Strip
Official title: A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the performance of a new adhesive


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)

Primary outcomes:
measure: trans epidermal water loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of the pre-clinical department
name: Lene F Nielsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409134: Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat
Official title: Cognitive Function and Patient-Reported Psychological and Functional/Quality of Life Outcomes Investigation in Patients Taking Vorinostat for Graft-versus-Host Disease Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Graft-vs-Host Disease
Keywords: Bone Marrow Transplantation
Hematologic Malignancies
Adults
Cognition
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on the primary study NCT01790568. Eligible patients who choose not to participate in this add-on study will not be excluded from participating in NCT01790568.

Brief summary: Psychological well-being and cognitive function will be measured in patients enrolled on the primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation. Validated questionnaires will be administered to assess patients' level of depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality. Cognitive testing will include reliable and valid measures of processing speed, attention, executive function, episodic memory, and visual learning and memory. The purpose of this study is to determine whether these measures are feasible to administer in patients before and at early time points after bone marrow transplantation .


Eligibility criteria: Inclusion Criteria:

* Patients must be enrolled on the parent study (NCT01790568; A phase 2 clinical trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation)
* Must speak, read and understand English

Exclusion Criteria:

* Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).

Primary outcomes:
measure: Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
References:
citation: Hoodin F, LaLonde L, Errickson J, Votruba K, Kentor R, Gatza E, Reddy P, Choi SW. Cognitive Function and Quality of Life in Vorinostat-Treated Patients after Matched Unrelated Donor Myeloablative Conditioning Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Feb;25(2):343-353. doi: 10.1016/j.bbmt.2018.09.015. Epub 2018 Sep 20.
Clinical trial NCT01279434: Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
Official title: Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve NASH when used alone, a combination of these two should be expected to give better results because of targeting two different pathogenetic mechanisms (cytokines amplification and oxidative stress) in NASH patients. This will be open labelled, prospective, randomized study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings suggestive of fatty liver and presence of insulin resistance or features of metabolic syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all cases.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NAFLD by ultrasonographic
* Presence of Insulin resistance
* Histological confirmation of NASH
* Increased transaminases (\>1.5 upper limit normal \[ULN\])

Exclusion Criteria:

* Patients with alcohol \> 20g/ day
* Other known liver disease
* Medications known to induce fatty liver

Primary outcomes:
measure: Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Normalization of serum transaminases levels
timeFrame: Baseline and 1 year
measure: Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).
timeFrame: Baseline and 1 year
measure: Improvement in HOMA-IR
timeFrame: Baseline and 1 year
measure: No worsening of fibrosis
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Ramesh Kumar, MD,DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691634: Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
Official title: Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tattoo Disorder
MRI
Keywords: Tattoo disorder
MRI
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: Cimror
First posted: 2023-01-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: MRI examinations are potential sources of complications related to the displacement of ferromagnetic objects, but also to heating effects that can go as far as burns. This overheating can be caused by contact with external equipment (sensors, cables, etc.). Patients with skin tattoos may experience specific complications as tingling or "burning" felt at the site of the tattoo. They can be followed by a transient erythema with edema around the reversible tattoo in 12 and 72 hours. One observation of severe 2nd degree burns has been reported. They would be linked to the presence of metallic salts in the dermis, resulting from interactions between the pigments and the magnetic field but their mechanisms are poorly identified and divergent.

The aim of this study is to assess the rate of MRI causing complications in patients with tattoos.


Eligibility criteria: Inclusion Criteria:

* Major patient
* tattoo patient
* Ability to answer the questionnaire
* Affiliated patient or beneficiary of a social security scheme
* Patient having been informed and not objecting to the research

Exclusion Criteria:

* Minor
* Patient unable to understand and respond to questionnaires due to language difficulties or cognitive impairment
* Patient objecting to research
* Pregnant or breastfeeding woman
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Proportion of MRIs resulting in at least one complication in patients with tattoos.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
Study officials:
References:
Clinical trial NCT04385134: Enterovirus Surveillance During the Perinatal Period
Official title: Establishment and Application of the National Surveillance Network for Enterovirus During the Perinatal Period
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enterovirus Infection During Perinatal Period
Lead sponsor: Seventh Medical Center of PLA General Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 6500
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three population would be studied. 1. General parturient; 2. Puerpera with fever; 3, Febrile newborns.

Brief summary: Neonates could be infected by non-polio enterovirus easily. Some of the neonates may develop fatal complications within one week. The objective of this study were as following: 1.To understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of China; 2.To understand the transmission from mother to their neonates; 3.To understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.To understand the genetic variation and changes of enteroviruses; 5.To establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.


Eligibility criteria: Inclusion Criteria:

* 1. General parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day; 2. Puerpera with fever: all puerperas with fever (body temperature \>=37.5 degree C) and their newborns were included in summer and autumn (from May); 3. Febrile newborns: those included in summer and autumn (from May) with the following clinical characteristics: fever \>=37.5 degree C, lasting for more than one day. And sign the informed consent form with the consent of the guardian.

Exclusion Criteria:

* 1. Pregnant women with urinary tract infection, chorioamnionitis and bacterial infection; 2. Puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection; 3. Newborns infected with other pathogens.

Primary outcomes:
measure: Detection of enterovirus
timeFrame: 42 days
Secondary outcomes:
measure: Detection of antibodies of enterovirus
timeFrame: 42 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bayi Children's Hospital, Seventh Medical Center, PLA general hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01214434: Promiseb Topical Cream for Cradle Cap
Official title: A Double Blind, Placebo-Controlled, Pilot Study to Estimate the Efficacy and Tolerability of Twice Daily Promiseb Topical Cream in Pediatric Subjects With Cradle Cap (Seborrheic Dermatitis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cradle Cap
Infantile Seborrheic Dermatitis
Keywords: Cradle Cap
Infantile seborrheic Dermatitis
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cradle cap
* Must be at least 30 days old
* Must be in good health as determined by investigator
* Naive to prior cradle cap therapy (may have used mineral, olive oils)

Exclusion Criteria:

* Known food, topical product or medicinal allergies.
* Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap
* Weighing less than 7 lbs

Primary outcomes:
measure: Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).
timeFrame: end of treatment (Day 7 or 14)
measure: Number of Participants With Excellent Overall Safety Score at End of Treatment.
timeFrame: End of treatment
Secondary outcomes:
measure: Precent Reduction From Baseline for Scaling at End of Treatment.
timeFrame: From Baseline to end of treatment (Day 7 or 14)
measure: Percent Reduction From Baseline for Crusting at End of Treatment.
timeFrame: From Baseline to end of treatment (Day 7 or 14)
measure: Percent Reduction From Baseline for Erythema at End of Treatment.
timeFrame: From Baseline to end of treatment (Day 7 or 14)
measure: Percent Reduction From Baseline for Oiliness at End of Treatment.
timeFrame: From Baseline to end of treatment (Day 7 or 14)
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Norwich Pediatric Group
state: Connecticut
city: Louisville
country: United States
facility: Derm Research
state: Kentucky
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Promius Pharma
name: Joanne M Fraser, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01340534: Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
Official title: Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Wound Infection
Keywords: Surgical wound infection
Oxygen
Cesarean
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 370
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.

Detailed description: Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.

Eligibility criteria: Inclusion Criteria:

* Gestational age \> 37 weeks
* Emergency cesarean section
* Regional Anesthesia

Exclusion Criteria:

* Elective cesarean section
* Fever of unknown origin at admission
* Twin pregnancy
* Chorioamnionitis
* Acute fetal distress that requires general anesthesia
* Immunocompromise
* Maternal Lung/Respiratory Disease

Primary outcomes:
measure: Number of participants with surgical site infection (SSI).
timeFrame: 2 months
Secondary outcomes:
measure: Number of participants with respiratory complications trans or post surgery.
timeFrame: 2 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Bleixen Admadé, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo A Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bleixen Admadé and Osvaldo Reyes, "Supplemental Perioperative Oxygen (80% FIO2) for the Prevention of Surgical Site Infection after Emergency Cesarean Section," ISRN Infectious Diseases, vol. 2013, Article ID 526163, 4 pages, 2013. doi:10.5402/2013/526163
Clinical trial NCT05261334: Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
Official title: Socket Shielding in Immediate Versus Early Implant Placement With Contour Augmentation of Fresh Extraction Sockets in the Esthetic Zone. A Randomized Pilot Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour

Detailed description: comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery

Eligibility criteria: Inclusion Criteria:

1. Non-restorable maxillary teeth in the esthetic zone
2. Intact adjacent teeth
3. Adequate palatal and apical bone that allows achieving implant primary stability.
4. Type I socket
5. ≥18 years
6. ≤ 60 years
7. Systemically healthy patients

Exclusion Criteria:

1. Extraction sockets with acute or chronic infection or with adjacent infected teeth
2. Heavy Smokers \> than 10 cigarettes daily
3. Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
4. Unmotivated patients to maintain adequate oral hygiene to follow up.
5. Patients with physical disabilities that could affect follow up.

Primary outcomes:
measure: facial bone thickness
timeFrame: 12 months
Secondary outcomes:
measure: facial bone height changes
timeFrame: 12 months
measure: Soft tissue height changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: