louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01874028: A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients
Official title: A Phase 1 Pharmacokinetic Profiling Study in Patients Receiving Trientine Dihydrochloride for the Treatment of Wilson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wilson's Disease
Keywords: Trientine
Pharmacokinetics
Lead sponsor: Univar BV
Sponsor class: INDUSTRY
Collaborators: name: Aptiv Solutions
First posted: 2013-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.

Detailed description: An open, single-dose study to determine the pharmacokinetics, and safety of oral administration of trientine dihydrochloride in both children and adult patients with Wilson's Disease. Blood samples will be taken pre-dose and at 10 time-points post-dose to investigate the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study medication in 20 patients.

Eligibility criteria: Inclusion Criteria:

1. Children ≥ 6 years and adult patients
2. Confirmed diagnosis of Wilson's disease by Leipzig-Score \>3 (Ferenci et al 2003)
3. Current treatment with trientine dihydrochloride
4. Signed informed consent including parental consent in patients ≤ 18 years
5. Agree to remain in the study site1 for the PK measurements period.

Exclusion Criteria:

1. Known clinically significant allergy or hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient's safety
2. Have any clinically significant conditions that would interfere with the collection or interpretation of the study results or would compromise the patient's health
3. Women of child bearing potential who do not use contraceptives, breastfeeding, or pregnant women
4. Severe anaemia (haemoglobin \<9 mg/dL)
5. In the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development
6. Participation in any interventional clinical study at the same time or within the 4 weeks prior his study.

Primary outcomes:
measure: Pharmacokinetic measurements
timeFrame: Evaluation of PK parameters will occur at 11 time points:Pre-dose), and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg
Study officials:
References:
Clinical trial NCT03170128: Functional Outcomes After Radial Head Fractures Treated Non-operatively
Official title: Functional Outcomes After Radial Head Fractures Treated Non-operatively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Head Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of physical therapy as part of the non-operative treatment of radial head fractures.There is currently no data to support the use of physical therapy in the non-operative treatment of radial head fractures. Likewise, there is no data that shows that physical therapy is harmful to patients being treated non-operatively for radial head fractures. Investigators believe that prescribing physical therapy for patients with non-displaced radial head fractures treated non-operatively is unnecessary, and that that it would be equally efficacious to teach patients simple stretching exercises that they could perform by themselves. Subjects will be randomized into 2 groups: Group 1 - Patients will be prescribed physical therapy within the first month following fracture; Group 2 - Patients will be given simple stretching exercises to perform at home and will not be given a prescription for physical therapy. Patients who agree to participate in this study and sign the informed consent will be randomly assigned to one of the two groups.


Eligibility criteria: Inclusion Criteria:

* Individuals to be approached for participation in this study will include all adult (age \> 18 years old) patients who are receiving or seeking medical care in the outpatient setting.

Exclusion Criteria:

* Patients who are initially determined to need surgical fixation of a radial head fracture will not be included in this study. There are no additional exclusion criteria.

Primary outcomes:
measure: Successful fracture union
timeFrame: 3 Months
Secondary outcomes:
measure: Functional outcome score
timeFrame: 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Hospital for Joint Diseases
name: Kenneth Egol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02169128: Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
Official title: Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Fasciitis
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Karolinska Institutet
name: Rigshospitalet, Denmark
First posted: 2014-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for necrotizing fasciitis at the three study sites

Brief summary: Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with necrotizing fasciitis and their significant others
* Age above 18 yrs

Exclusion Criteria:

* Persons with dementia or severe psychiatric illness
* Persons that do not master the Scandinavian language

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Quality of life
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life of significant others
timeFrame: 6 months
measure: Quality of life of significant others
timeFrame: 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Gothenburg
country: Sweden
facility: Sahlgrenska University hospital
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
Study officials:
affiliation: Sahlgrenska University Hospital
name: Sven-Egron Thörn, MD, ass prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03502928: Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Official title: Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Injuries
Keywords: Dry Needling
Manual Therapy
Motor Control
Whiplash
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 30
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: INTRODUCTION: Whiplash is an injury produced by an acceleration-deceleration mechanism that transmits energy to the cervical spine. According to the bibliography, the conservative treatment (motor control exercises and manual therapy) has shown benefits in approaching this lesion, but its efficacy is limited. Dry needling has already shown its usefulness in different musculoskeletal pathologies, however, its efficacy is unknown when it is included in conservative treatment.

OBJECTIVES: The objective of this study is to assess the effects of the incorporation of dry needling in the conventional treatment with manual therapy and motor control exercises, compared to the conventional non-invasive treatment in patients with acute or subacute whiplash.

HYPOTHESIS: The inclusion of dry needling in conventional non-invasive treatment is more effective than conventional non-invasive treatment in patients with acute or subacute whiplash.

METHODS: A randomized clinical trial will be conducted in which the subjects of study will be assigned to two groups, a control group (conventional treatment) and an experimental group (conventional treatment and dry needling).


Eligibility criteria: Inclusion Criteria:

* Medical Diagnosis of Whiplash Grade I-II in the QTF
* Neck Pain
* Whiplash in Acute or Subacute Phase

Exclusion Criteria:

* Pregnancy
* Belonephobia
* Cervical Fractures-Dislocations or Neurological Deficit Secondaries to Accident
* Previous Surgery of the Cervical Spine
* Circulatory Disease, Respiratory Disease, Neurological Disease, Rheumatologic Disease and Mental Illness
* Athletes

Primary outcomes:
measure: Neck Disability Index. Changes from Baseline
timeFrame: 3 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Pressure pain thresholds. Changes from Baseline
timeFrame: 3 weeks, 6 weeks, 3 months
measure: Cervical Range of Movement. Changes from Baseline
timeFrame: 3 weeks, 6 weeks, 3 months
measure: Kinesophobia. Changes from Baseline
timeFrame: 3 weeks, 6 weeks, 3 months
measure: Cervical Motor Control. Changes from Baseline
timeFrame: 3 weeks, 6 weeks, 3 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Universidad de Alcalá
Study officials:
affiliation: University of Jaén
name: Alexander Achalandabaso, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05411328: Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail
Official title: Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxic Cerebral Palsy
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is


Eligibility criteria: Inclusion Criteria:

* ataxic cerebral palsy aged 9-14 years

Exclusion Criteria:

* any musculoskeletal conditions that affect balance previous surgeries that affecting balance

Primary outcomes:
measure: Change in overall stability index
timeFrame: [Time Frame: baseline and after 3 months of intervention.]
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta University for Science and Technology
state: Dakahelia
Study officials:
References:
Clinical trial NCT00726128: Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
Official title: A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Tumor
Pseudarthrosis
Scoliosis
Degenerative Disc Disease
Keywords: Degenerative Disc disease (DDD)
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 371
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from multiple centers with disease of the cervical spine

Brief summary: To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Detailed description: The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.

Eligibility criteria: Inclusion Criteria:

1. The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
2. The patient must be available for follow-up during the study.
3. The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria:

1. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
2. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
3. Pregnant or nursing females.
4. Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.

Primary outcomes:
measure: Proportion of Patients with radiographic fusion
timeFrame: 24 Months
Secondary outcomes:
measure: Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline
timeFrame: 24 Month
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: San Diego
country: United States
facility: Alvarado Orthopedic Clinic
state: California
city: Avon
country: United States
facility: American health Network
state: Indiana
city: Raleigh
country: United States
facility: Raliegh Orthopedic Research Foundation
state: North Carolina
Study officials:
affiliation: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
name: John Evangelsita, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01581528: Studying Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
Official title: Metabolic Pathways in T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: T-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-20
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with T-ALL

Brief summary: RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors identify learn more about biomarkers related to cancer. It may also help doctors to find better ways to treat cancer.

PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia (T-ALL).

Detailed description: OBJECTIVES:

* Determine the metabolic status and regulation of primary T-cell acute lymphoblastic leukemia (T-ALL) relative to control resting peripheral T cells.
* Establish the effects of metabolic inhibition on metabolic stress pathways and apoptosis.
* Determine how metabolic inhibition interacts with chemotherapy or targeted therapy drugs to kill T-ALL cells.

OUTLINE: T-ALL samples cultured alone or with gamma secretase inhibitors (GSI) or PI3K inhibitors are analyzed for metabolic characteristics including glucose transporter 1 (Glut1) expression, mitochondrial mass, phospho-flow for 5' adenosine monophosphate-activated protein kinase (AMPK), acetyl-CoA carboxylase (ACC), and mammalian target of rapamycin (mTOR) by flow cytometry. T-ALL samples and normal CD4+ T cells (control) are also exposed to ± 2-deoxyglucose or ± the glutaminolysis inhibitor media and analyzed for metabolic stress responses over time in particular, AMPK activation, autophagy (immunofluorescence for LC3-II processing), and BCL2-associated X protein (Bak) and Bax activation to indicate apoptosis. These cells (T-ALL and control) are then cultured with cyclophosphamide, dexamethasone, or the B-cell CLL/lymphoma 2 (Bcl-2) inhibitor, ABT-737, to determine cell death over time.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Sample from patients diagnosed with T-ALL
* Samples from independent healthy donors obtained through the Gulf Coast Regional Blood Center (controls)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Metabolic status of primary T-ALL
measure: Effects of metabolic inhibition on metabolic stress pathways and apoptosis
measure: Metabolic inhibition interaction with chemotherapy or targeted drugs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke Cancer Institute
name: Jeffrey C. Rathmell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04592328: Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.
Official title: The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Sternal Wound Infection
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing cardiac surgery at the Cardiothoracic and Vascular surgery Department at the University Hospital in Örebro.

Brief summary: The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth.

Cultures will be taken from the skin, subcutaneous, and from the implanted valve prostheses with a rayon swab.Graft and Felt material will, after being pressed subcutaneous for 15 sec, placed into prepared sterile bottles containing broth for aerobe and anaerobe cultures. Surgical gloves will be cultured.


Eligibility criteria: Inclusion Criteria:

* Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these.

Exclusion Criteria:

* Skin conditions such as eczema, psoriasis.
* Revision surgery
* Aortic surgery

Primary outcomes:
measure: Bacterial growth, C acnes
timeFrame: Five months
measure: Bacterial growth, other
timeFrame: Five months
Secondary outcomes:
measure: Difference between subgroups
timeFrame: Five months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University hospital
Study officials:
References:
Clinical trial NCT00048828: Treating Drug-Resistant Childhood Schizophrenia
Official title: Treating Refractory Childhood Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-11-13
Enrollment: 41
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.

Detailed description: Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.

Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.

Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.

Eligibility criteria: Inclusion criteria:

* DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
* Willingness to use an acceptable form of birth control, if applicable

Exclusion Criteria:

* Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
* IQ less than 70
* DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
* Failure of an adequate trial of olanzapine or clozapine

Primary outcomes:
measure: Psychotic, manic, aggressive, and depressive symptoms
timeFrame: Measured over 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Children's Psychiatric Center
state: New York
city: Dix Hills
country: United States
facility: Sagamore Children's Psychiatric Center
state: New York
city: Glen Oaks
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital
name: Christoph U. Correll, MD
role: PRINCIPAL_INVESTIGATOR
References: