louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02482012: Minor Increase Over Minimal Risk Research in NICU
Official title: Minor Increase Over Minimal Risk Without Direct Patient Benefit Research in the NICU: Parental and Staff Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Infant, Late
Infant, Preterm
Infant
Keywords: research
vulnerable population
45 CFR 46.406
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NICU staff and parents of infants

Brief summary: Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations.

This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.


Eligibility criteria: Inclusion Criteria:

* Parents of infants in the NICU
* Parents of infants on well-baby nursery
* NICU Staff (nurses and physicians)

Exclusion Criteria:

* Non-English Speaking
* Less than 18 years old

Primary outcomes:
measure: determination of willingness to participate in research
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services, Inc.
name: Robert G. Locke, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191112: Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Official title: Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Diseases
Feeding Intolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.


Eligibility criteria: Inclusion Criteria:

* Male or nonpregnant female between 1 and 13 years of age.
* Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
* Subject requires enteral tube feeding as sole source of nutrition.

Exclusion Criteria:

* History of diabetes.
* Requires artificial ventilation.
* Requires parenteral nutrition.
* Subject has intestinal obstruction.
* Subject is receiving dialysis treatment.
* Subject has an allergy or intolerance to any ingredient in the study product.

Primary outcomes:
measure: Stool frequency
timeFrame: 14 Days
measure: Frequency and intensity of irritability, vomiting, distension
timeFrame: 14 Days
Secondary outcomes:
measure: Average Energy Intake
timeFrame: 14 Days
measure: Anthropometrics
timeFrame: 14 Days
measure: Medication Use
timeFrame: 14 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT01028612: Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size
Official title: A Pilot Study of Interventional Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days) for patients with early stage lung cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible.
* To be considered node negative for N2 disease, patients will have mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on FDG PET in those areas.
* All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions.
* The CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where RFA is technically achievable based on the proximity of adjacent organs and structures.
* Age ≥ 18 years old
* Performance Status 0-2 (ECOG)

Exclusion Criteria:

* History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA of \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
* Previous chest radiation to the region of interest.
* Pregnant or lactating women.
* A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.

Primary outcomes:
measure: Assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
References:
Clinical trial NCT01608412: A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
Official title: An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant Recipients
Keywords: renal transplantation
everolimus
tacrolimus
molecular evaluation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypotheses to be tested in this study are:

* Conversion to everolimus at 3 months post-transplantation is safe and effective;
* Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
* Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
* Older than 18 years;
* Panel-reactive antibodies lower than 20%;
* Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

Exclusion Criteria:

* eGFR \< 35 mL/min at randomization;
* Urine protein-to-creatinine ratio \> 0.8 at randomization;
* Episode of acute rejection with Banff histological classification \> 1A in the first 3 months post-transplant;
* Cholesterol \> 350 mg/dL or triglycerides \> 400 mg/dL with therapy at randomization;
* Active infection at randomization;
* Chronic liver disease;
* Refusal to participate in the study;
* Contraindications to kidney biopsy;
* Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.

Primary outcomes:
measure: Evaluate cumulative patient and graft survival at 12 months post conversion
timeFrame: one year
Secondary outcomes:
measure: Evaluation of estimated glomerular filtration rate 12 months post-conversion
timeFrame: one year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: HCPA
name: Luiz Felipe S. Gonçalves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065112: Individualised Mapping in Persistent AF Ablation
Official title: Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
catheter ablation
individualized mapping
focal activity
rotational activity
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 212
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: A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Signed informed consent.
3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
4. In atrial fibrillation at the time of the index procedure.

Exclusion Criteria:

1. Paroxysmal atrial fibrillation.
2. Previous ablation procedure for atrial fibrillation.
3. Left ventricular ejection fraction \< 45%
4. Obesity with BMI \> 35 kg/m2
5. Congenital heart disease.
6. Previous cardiac surgery with atriotomy.
7. Previous left atrial appendage closure/ligation.
8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
9. Pregnancy
10. Current enrolment in a study evaluating another device or drug.

Primary outcomes:
measure: Freedom from atrial arrhythmia
timeFrame: 12 monts
Secondary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: 12 months
measure: Atrial fibrillation burden reduction
timeFrame: 12 months
measure: Absolute atrial fibrillation burden
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Royal Brompton Hospital, London, UK
name: Vias Markides, MD, FESC
role: STUDY_DIRECTOR
References:
Clinical trial NCT01399112: A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis
Official title: A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Psychosis
Keywords: Smoking Cessation
First episode psychosis
Electronic Decision Support System
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to recruit patients who have experienced a recent first episode of psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify themselves as a current cigarette smoker. Aiding this population with smoking cessation is crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which is leading to early mortality. While these individuals can benefit from standard evidence-based treatment, these treatments are underutilized. Web based programs, such as the EDSS and thetruth.com, can provide education and motivational tools to help people with a recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to test these two web-based programs among young people with a recent episode of psychosis for usability and likeability and to explore whether use of these two programs will motivate users to seek smoking cessation treatment or to engage in other quitting behaviors in the month following use of the programs. Information gathered from this proposal will be used to help the researchers decide whether either of these two programs will be reasonable to include in a larger study of a comprehensive treatment for individuals with first episode psychosis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnoses of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features
* Diagnosed with one of above diagnoses within the past five years
* Ages 15-30 years old.
* Self-identified current cigarette smokers
* 5th grade reading level
* Willing to be audio recorded.
* Willing and legally able to provide informed consent to participate in the study or have a guardian provide informed consent with assent of a minor

Exclusion Criteria:

* Physically unable to use a computer with assistance.

Primary outcomes:
measure: number of cigarettes smoked
timeFrame: One month
Secondary outcomes:
measure: Satisfaction
timeFrame: Immediately (up to 10 minutes) following the use of one of the web-based programs.
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Tara Mandel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613612: Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)
Official title: Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Avascular Necrosis of Femur Head
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.


Eligibility criteria: Inclusion Criteria:

* femoral head necrosis patients
* stage I/II/III (Ficat)
* age from 18 to 55 years
* stop steroid treatment for minimal 6 months

Exclusion Criteria:

* age younger than 18 or older than 55
* any hemopathy
* tumor
* femoral head/neck fracture

Primary outcomes:
measure: change of Visual Analogue Scale
timeFrame: before invention and 24 months after invention
measure: change of lequensne algofunctional index
timeFrame: before invention and 24 months after invention
measure: change of WOMAC index
timeFrame: before invention and 24 months after invention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Li M, Ma Y, Fu G, Zhang R, Li Q, Deng Z, Zheng M, Zheng Q. 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head. Stem Cell Res Ther. 2020 Jul 16;11(1):287. doi: 10.1186/s13287-020-01810-8.
citation: Ma Y, Wang T, Liao J, Gu H, Lin X, Jiang Q, Bulsara MK, Zheng M, Zheng Q. Efficacy of autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of femoral head: a prospective, double-blinded, randomized, controlled study. Stem Cell Res Ther. 2014 Oct 14;5(5):115. doi: 10.1186/scrt505.
Clinical trial NCT06226012: Effect of Pulsed Magnetic Field Versus Low Level Laser Therapy on Functional Performance in Children With Juvenile Idiopathic Arthritis
Official title: Effect of Pulsed Magnetic Field Versus Low Level Laser Therapy on Functional Performance in Children With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assignment
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to compare between the effect of pulsed magnetic field versus low level laser therapy on functional performance in children with juvenile idiopathic arthritis

Detailed description: This study directed to investigate effect of pulsed magnetic field versus low level laser therapy on functional performance in children with juvenile idiopathic arthritis children with juvenile idiopathic arthritis suffer from some problems such as pain, swelling and limited motion in knee joints here in this study i used these devices to help in solving these problems pain was measured by visual analogue scale swelling was measured by tape measurement and Range of motion was measured by digital geniometre

Eligibility criteria: Inclusion Criteria:

* 1 Confirmed diagnosis of Juvenile Idiopathic Arthritis (JIA).
* 2 Polyarticular onset of JIA with bilateral involvement of the knee joint.
* 3 Age between 8 and 16 years
* 4 Stable conditions (i.e., receive stable doses of medications in the past three months).
* 5 Not participating in a regular exercise program in the past six months.

Exclusion Criteria:

* 1 Fixed deformities
* 2 History of joint surgery
* 3 Ankylosing or fractures
* 4 Bone destruction ( erosive changes of the knee joints ).

Primary outcomes:
measure: Swelling
timeFrame: 3 months
measure: Sensation of Pain
timeFrame: 3 months
measure: Range of motion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Physical Therapy
state: Kafr Elsheikh
Study officials:
References:
Clinical trial NCT05634512: Evaluation of Intravenous Laronidase Pharmacokinetics Before and After Hematopoietic Cell Transplantation in Patients With Mucopolysaccharidosis Type IH.
Official title: Evaluation of Intravenous Laronidase Pharmacokinetics Before and After Hematopoietic Cell Transplantation in Patients With Mucopolysaccharidosis Type IH.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic Cell Transplantation
Mucopolysaccharidosis Type I
Keywords: MPS I
HCT
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study entry is open to pediatric patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is dependent upon the MPS-IH populations at the University of Minnesota.

Brief summary: This is a prospective, observational multicenter study to collect blood from patients with mucopolysaccharidosis type IH undergoing laronidase therapy and a stem cell transplant.

Sixteen patients will be enrolled over a 24 month period.


Eligibility criteria: Inclusion Criteria:

* Between 0 to 3 years of age

  * Meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
  * Planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course.

Exclusion Criteria:

* Patient's parent/ legal guardians are unable to provide informed consent.

Primary outcomes:
measure: Identify covariates that impact drug exposure
timeFrame: 2 years
measure: Identify key differences pre- and post-HCT leading to variability in PK parameters
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Cancer Center
name: Paul Orchard
role: PRINCIPAL_INVESTIGATOR
References: