louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02044302: A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Official title: A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-operative Pain
Keywords: pain
breast cancer
breast implant
breast reconstruction
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.


Eligibility criteria: Inclusion Criteria:

* Women undergoing immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy requiring postoperative expansions
* Women undergoing immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring postoperative tissue expansions.

Exclusion Criteria:

* Subjects who are unable to read or speak English;
* Breast reconstruction using the latissimus dorsi flap combined with a tissue expander;
* Documented diagnosis of chronic pain, chronic migraine, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;
* Hypersensitivity to any botulinum toxin (BT) preparation or to any of the components in the formulation;
* Infection at the proposed site of injection;
* Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis);
* Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of BT);
* Women who are pregnant or breast feeding.

Primary outcomes:
measure: Pain Score Questionnaire
timeFrame: Post Operation Day 1
Secondary outcomes:
measure: Pain Score Questionnaire
timeFrame: Post Operation Week 1
measure: Pain Score Questionnaire
timeFrame: Post Operation One Month
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie Kwei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387321: A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
Official title: A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Pi3K
Advanced solid tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, BYL719 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample
* At least one measurable or non-measurable lesion Age ≥ 18 years
* Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit

Exclusion Criteria:

* Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
* Prior treatment with PI3K inhibitor
* Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
* Patient with diarrhea NCI-CTC Grade ≥ 2
* Patient with acute or chronic pancreatitis
* Impaired cardiac function or clinically significant cardiac disease incl unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug
* Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
* Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 4 Weeks
Secondary outcomes:
measure: Safety assessed by type, frequency and severity of adverse events
timeFrame: 4 Months
measure: Efficacy assessed by RECIST
timeFrame: 4 months
measure: To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)
timeFrame: 4 months
measure: Levels of biomarkers in tumor and skin
timeFrame: 4 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02104921: Innovative Ultrasound Technology in Neuromuscular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Muscular Dystrophy
Radiculopathy
Myopathy
Polyneuropathy and Mononeuropathies
Trauma Injury
Orthopedic Disorder
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-04-07
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with any neuromuscular disorder (i.e. primary nerve or muscle disease), both localized and generalized, producing some degree of weakness or disability.

Brief summary: This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.


Eligibility criteria: Inclusion Criteria:

* History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.

Exclusion Criteria:

* Multiple generalized neuromuscular conditions.

Primary outcomes:
measure: Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02782221: Lipolytic Effects of GH in Human Subjects in Vivo
Official title: Lipolytic Effects of GH in Human Subjects in Vivo: Molecular Mechanisms and Temporal Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Growth Hormone Treatment
Keywords: lipolysis
ATGL
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism, and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent signaling pathways.

In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose tissue biopsies taken after GH exposure and GH blocking, respectively.

Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.


Eligibility criteria: Inclusion Criteria:

* healthy males
* no medication
* BMI 28-35

Exclusion Criteria:

* known diseases
* regular medication

Primary outcomes:
measure: Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).
timeFrame: 1 year
Secondary outcomes:
measure: Substrate metabolism as measured by indirect calorimetry
timeFrame: 3 months
measure: GH signaling proteins in adipose tissue measured by western blotting
timeFrame: 1,5 years
measure: Intracellular lipolytic activity measured by an ATGL assay
timeFrame: 1 year
measure: GH signaling gene targets in adipose tissue measured by qPCR
timeFrame: 1,5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University Hospital of Aarhus
Study officials:
affiliation: University Hospital of Aarhus
name: Jens Otto L Jørgensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen TS, Jessen N, Jorgensen JO, Moller N, Lund S. Dissecting adipose tissue lipolysis: molecular regulation and implications for metabolic disease. J Mol Endocrinol. 2014 Jun;52(3):R199-222. doi: 10.1530/JME-13-0277. Epub 2014 Feb 27.
citation: Moller N, Jorgensen JO. Effects of growth hormone on glucose, lipid, and protein metabolism in human subjects. Endocr Rev. 2009 Apr;30(2):152-77. doi: 10.1210/er.2008-0027. Epub 2009 Feb 24.
citation: Hjelholt AJ, Lee KY, Arlien-Soborg MC, Pedersen SB, Kopchick JJ, Puri V, Jessen N, Jorgensen JOL. Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial. Mol Metab. 2019 Nov;29:65-75. doi: 10.1016/j.molmet.2019.08.013. Epub 2019 Aug 20.
Clinical trial NCT01687621: Omphalitis Community Based Algorithm Validation Study
Official title: Omphalitis Community Based Algorithm Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Omphalitis
Keywords: Omphalitis
Neonate
Zambia
Neonatal mortality
Umbilical cord infection
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Thrasher Research Fund
First posted: 2012-09-19
Enrollment: 1009
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia

Brief summary: The objective of this study is to develop and test a simple community-based diagnostic algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated community-based algorithms developed and tested in the sub-Saharan context where the manifestations of omphalitis presentation may vary and diagnosis could be potentially more challenging in infants with darker skin color. Given the current attention to cord care at the global and national policy level, validated community-based algorithms will be needed to allow primary health workers to identify cord infections and reduce associated morbidity.

After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits will undergo two independent, parallel evaluations; first, by a community level worker and second, by a Zambian medical doctor (gold standard). A third independent assessment of a photo of the cord will be performed remotely by a board-certified pediatrician. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.


Eligibility criteria: Inclusion Criteria:

* Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia
* No prior diagnosis of omphalitis
* Guardian willing to allow their newborn to participate in the study
* Guardian aged 15 and above

Primary outcomes:
measure: Validity of the omphalitis algorithm
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Livingstone
country: Zambia
facility: Hospitals & Community Health Centers
state: Southern Province
Study officials:
affiliation: Boston University
name: Julie M Herlihy, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854321: Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital
Official title: One Centre Follow-up Study on Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
rituximab
therapy
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 49
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: patients with active RA in one centre

Brief summary: One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.

Detailed description: Data is collected on regular visits in the outpatient department. In collection national register forms have been used.

Eligibility criteria: Inclusion Criteria:

* active RA without response to earlier treatment

Exclusion Criteria:

* contraindications to rituximab

Primary outcomes:
measure: ACR20 ACR50 ACR70 response
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Duration of clinical response
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Oili Kaipiainen-Seppänen, MD
role: STUDY_DIRECTOR
References:
citation: Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.
Clinical trial NCT00615121: Genetics of Peripheral Artery Genomics
Official title: Genetics of Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Smoking
Hypertension
Diabetes
Cardiovascular disease
Renal Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral artery occlusive disease.

Brief summary: Peripheral artery disease is a disease that contributes to significant morbidity and mortality of millions of Americans yearly. Very little is known about the pathophysiology of atherosclerosis in peripheral artery disease. We plan to collect peripheral arteries and muscle tissue from patients undergoing amputation for end stage peripheral arterial occlusive disease. By extracting the RNA from these arteries and tissues and comparing them with RNA expression from normal arteries, we hope to have a better understanding of the pathophysiology of atherosclerosis in this setting. We aim to prove the hypothesis that a novel gene expression pattern can be discovered by the successful extraction of RNA from plaques from human peripheral arteries.

Detailed description: Patients scheduled to undergo lower extremity amputation will be consented for extraction of plaque from the carotid artery or arterial tissue from the amputated limbs. The surgeon will perform the amputation, then the harvest team will collect arterial tissue from amputated limbs. These samples will be immersed in RNALater solution to preserve the integrity of the RNA. Tissues will stored at -80oC in the RNALater until the RNA is later extracted using a standardized protocol. The RNA will be examined for quality using an Agilent bioanalyzer, and will then be processed on Affymetrix U133A chips for gene expression data. The data will be analyzed with the MATLAB software package.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing amputations for peripheral artery disease
* Patients undergoing free fibular transfer

Exclusion Criteria:

* those that are not able to consent to the study

Primary outcomes:
measure: Discover novel gene expression pattern in peripheral arterial disease
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeffrey H Lawson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00277121: Genetic Origin of Lipid Disorders
Official title: Genetic Origin of Lipid Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lipid Disorder
Keywords: Lipid disorder
Gene mutation
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Lipid Clinic, The National Hospital, Oslo, Norway
name: Research Institute of Internal Medicine, The National Hospital, Oslo, Norway
name: Ullevaal University Hospital
name: Norwegian Institute of Public Health
name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
name: CIGENE, Agricultural University of Norway, Aas, Norway
First posted: 2006-01-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Several lipid disorders are without known genetic origin. The scope of this project is to sequence genes superior involved in lipid and carbohydrate metabolism in patients with severe lipid disorders. The resulting mutations will be tested in suitable in vitro systems to detect their part in development of the specific disease.

Detailed description: See "brief summary" above.

Eligibility criteria: Inclusion Criteria:

* proven written informed consent prior to recruitment
* male or female
* 18-55 years old
* patients with severe lipid disorders
* fasting plasma cholesterol, triglyceride or glucose, blood pressure or waist circumference/BMI out of normal range

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Nutrition, University of Oslo
Study officials:
affiliation: Department of Nutrition, University of Oslo
name: Hilde I Nebb, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition, University of Oslo
name: Karianne Solaas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, University of Oslo
name: Monica H Carlsen
role: PRINCIPAL_INVESTIGATOR
affiliation: Lipid Clinic, The National Hospital
name: Leiv Ose, Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of Internal Medicine, The National Hospital
name: Marit S Nenseter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of Internal Medicine, The National Hospital
name: Kirsten Holven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of Internal Medicine, The National Hospital
name: Bente Halvorsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Preventive Medicine, Ullevål university hospital
name: Serena Tonstad, Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Institute of Public Health
name: Håkon Gjessing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hormone laboratory, Aker university hospital
name: Per Thorsby, Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: Agricultural university of Norway
name: Sigbjørn Lien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agricultural university of Norway
name: Paul Berg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lipid Clinic, The National Hospital
name: Kjetil Retterstøl, Dr med
role: PRINCIPAL_INVESTIGATOR
References: