louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05216185: The Assessment of Bone Health in a Clinical Setting
Official title: The Assessment of Bone Health in a Clinical Setting
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Case Series/Case Note Review
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2022-01-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients on database

Brief summary: The study will use data already obtained through the metabolic clinical service to improve diagnosis and management of our patients.

Detailed description: Patients are referred for assessment of their bone health routinely have a bone density (BD) scan (DXA) and many also have a bone marker (BM) measurement, either NTx ( breakdown product of bone) or PINP ( formation product of bone). Patients diagnosed with osteoporosis are usually treated with a bisphosphonate drug which can halt or at least decrease the rate of bone loss.

BMs are measured pre- and post -treatment to assess adherence and effectiveness of treatment. BD measured by DXA is also used for this but in clinical practice is not recommended at intervals of less than 2 years. BMs show a much earlier clinical meaningful change - typically 2-6 months, vs BD -typically 2 years, thereby aiding swift knowledge of response or lack of response to treatment.

Although DXA remains the gold standard for initial assessment of bone health by measuring BD, BMs have an increasing role to play in patient follow up.

We propose to interrogate available data to explore whether utilizing BMs can provide monitoring information up to 5 years post-treatment thereby increasing the follow up time of the next DXA scan. This would ensure patients are not being subjected to scans using x-rays unduly and that a DXA scan is only performed when clinically needed. Additionally we want to investigate if BM levels pre-treatment reflect the response to treatment of the marker and BD, prediction of BM levels from age, fracture history, treatment, and does site of fracture affect BM and BD.

Previous work by other investigators has covered some of this ground but has not come up with definitive answers.

The study is expected to take 5 years and will not involve additional investigations compared to standard care.

Eligibility criteria: Inclusion Criteria: All patients on database -

Exclusion Criteria: Not recruiting

-

Primary outcomes:
measure: Use of Bone markers as a surrogate for Bone mineral density
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03117985: Tracking and Exploring the Source of Viral REbound
Official title: Tracking and Exploring the Source of Viral REbound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hiv
Keywords: HIV reservoirs
HIV persistence
Viral rebound
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
Collaborators: name: Laboratoire de Virologie Moléculaire de Montpellier
First posted: 2017-04-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption


Eligibility criteria: Inclusion Criteria:

* - Age\>18year old
* Nadir CD4\>200/mm3
* CD4/CD8 ratio\> 0.5
* Continuous antiretroviral therapy for more than 2 years
* Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic acid (RNA) \<50 copies/ml in the last 2 years
* Viral Load (VL)\<20copies at inclusion
* Patients who are willing to participate and who understand the trial (particularly, the obligation to have protected intercourse during the study).
* Informed consent
* Short half-life treatment
* Health insurance
* A subset of CD4 (T4cells) express CD32a.

Exclusion Criteria:

* - Acquired Immune Deficiency Syndom (AIDS)
* Pregnancy
* Human immunodeficiency virus (HIV)-2 co infection
* Thrombopenia
* Neurological events during primary infection
* Hepatitis B + (HBV+)
* Hepatitis C + (HCV+)
* Cancer during the last 5 years.
* Life expectancy \< 12 months
* Autoimmunity
* Acute infectious disease in the last 60 days.
* Hemoglobin\<7g/dl
* Glomerular filtration \< 60ml/min
* Refusing protected intercourse
* Risk of HIV transmission
* Psychiatric disorders.
* Alcool and drug abuse
* Involvement in another clinical trial evaluating a therapeutic.
* Being under tutorship
* Being deprived of liberty

Primary outcomes:
measure: Genetic Cartography
timeFrame: Week 1
measure: Genetic Cartography
timeFrame: Week 2
measure: Genetic Cartography
timeFrame: Week 3
measure: Genetic Cartography
timeFrame: Week 4
measure: Genetic Cartography
timeFrame: Week 5
measure: Genetic Cartography
timeFrame: Week 6
measure: Genetic Cartography
timeFrame: Week 8
measure: Genetic Cartography
timeFrame: Week 10
measure: Genetic Cartography
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Orleans
country: France
facility: Chr Orleans
Study officials:
affiliation: CHR ORLEANS
name: LAURENT HOCQUELOUX
role: STUDY_DIRECTOR
References:
citation: Descours B, Petitjean G, Lopez-Zaragoza JL, Bruel T, Raffel R, Psomas C, Reynes J, Lacabaratz C, Levy Y, Schwartz O, Lelievre JD, Benkirane M. CD32a is a marker of a CD4 T-cell HIV reservoir harbouring replication-competent proviruses. Nature. 2017 Mar 23;543(7646):564-567. doi: 10.1038/nature21710. Epub 2017 Mar 15.
Clinical trial NCT03424785: Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
Official title: Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Intramural Hematoma
Keywords: Aortic intramural hematoma
Chinese patients
Clinical outcomes
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 270
Sex: ALL
Minimum age (years): 30
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123 patients were retrospectively examined. Thirty-nine patients presented with type A aortic IMH, and 84 presented with type B aortic IMH

Brief summary: The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.

Detailed description: 270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study. The primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.

Eligibility criteria: Inclusion Criteria:

* Type A aortic hematoma
* Type B aortic hematoma

Exclusion Criteria:

* Aortic without initial intimal flap formation.

Primary outcomes:
measure: hematoma thickness and a baseline MAD
timeFrame: 14years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Harris KM, Braverman AC, Eagle KA, Woznicki EM, Pyeritz RE, Myrmel T, Peterson MD, Voehringer M, Fattori R, Januzzi JL, Gilon D, Montgomery DG, Nienaber CA, Trimarchi S, Isselbacher EM, Evangelista A. Acute aortic intramural hematoma: an analysis from the International Registry of Acute Aortic Dissection. Circulation. 2012 Sep 11;126(11 Suppl 1):S91-6. doi: 10.1161/CIRCULATIONAHA.111.084541.
Clinical trial NCT00777985: Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
Official title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Hypertension
Keywords: Cardiovascular system
Sleep
Endothelial function
Endothelin system
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Actelion
First posted: 2008-10-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.


Eligibility criteria: Inclusion Criteria:

* Documented obstructive sleep apnea
* with untreated mild systemic hypertension

Exclusion Criteria:

* pregnancy or lactation
* daytime alveolar hypoventilation
* severe arterial hypertension (systolic pressure \> 180 mmHg; diastolic pressure \> 110 mmHg)
* treatment with anti-hypertensive drugs
* cardiovascular disorder other than mild hypertension
* severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
* contra-indication to nCPAP treatment
* known allergy to bosentan
* active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
* active treatment with a drug acting on systemic arterial blood pressure or endothelial function
* liver or kidney dysfunction

Primary outcomes:
measure: 24 hour mean diastolic blood pressure
timeFrame: before and after each treatment completion (4 weeks)
Secondary outcomes:
measure: Peripheral Arterial Tonometry measure
timeFrame: before and after each treatment completion (4 weeks)
measure: mean 24 hour systemic systolic blood pressure
timeFrame: before and after each treatment completion (4 weeks)
measure: mean 24 hour nocturnal blood pressure
timeFrame: before and after each treatment completion (4 weeks)
measure: carotid Intima Media Thickness
timeFrame: before and after each treatment completion (4 weeks)
measure: Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma
timeFrame: before and after each treatment completion (4 weeks)
measure: Circulating Big ET1 and ET1 levels
timeFrame: before and after each treatment completion (4 weeks)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Sandrine H Launois, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000285: Effects of Phenytoin on Cocaine Use in Humans - 2
Official title: Effects of Phenytoin on Cocaine Use in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.

Detailed description: The purpose of this study was to determine the effects of phenytoin on smoked cocaine-base self-administration using our laboratory self-administration model. A total of 12 patients randomized, 6 to phenytoin and 6 to placebo treatment group. There were 2 phases in this 10-day inpatient study. Phase 1 subjects underwent one cocaine self-admin session. Randomization took place at the start of Phase 2, Day 4 where subjects received either placebo or phenytoin. The subjects assigned to phenytoin treatment received an oral loading dose (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/L). During Phase 2, subjects had the opportunity to self-administer cocaine on Days 5, 7, and 9. The plasma phenytoin levels were expected to decrease gradually during Phase 2 which provided an opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine self-administration.

Eligibility criteria: Inclusion Criteria:

Males/Females between the ages of 20-40. History of smoked cocaine use on the avg. of at least 2 times/week over a 6 month period. Have currently used at least 1 g of cocaine within a 4-6 hr period. Current history of good health, normal serum albumin levels and normal QTc intervals. Nonreactive for HIV. No participation in any of our studies for the past 6 months. For females: not pregnant as determined by pregnancy screening nor breat feeding, and using acceptable birth control methods (e.g. birth control pills, diaphragm, condoms plus foam).

Exclusion Criteria:

History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other durgs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treated for chemical dependency within the past 6 months. Use of any psychotropic drugs including MAOIs in the past 6 months.

Primary outcomes:
measure: Subjective effects
measure: Physiological effects
measure: Behavioral
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drug Alcohol Depend. 53:273-75, 1999. Manuscript in preparation.
Clinical trial NCT06020885: Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Official title: Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Split-course hypofractionated concurrent chemoradiotherapy
Fraction dose escalation
Induction chemo-immunotherapy
Unresectable locally advanced esophageal squamous carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.

Detailed description: This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed ESCC
* II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002)
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Charlson Comorbidity Index score≤4
* oral medication can be administered despite esophageal obstruction
* adequate hematological, renal and hepatic functions

Exclusion Criteria:

* contraindication for radiotherapy or chemotherapy
* prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ
* distant metastasis, except for celiac or supraclavicular lymph nodes metastases

Primary outcomes:
measure: Tolerated fraction dose
timeFrame: 6 months
Secondary outcomes:
measure: 2-year overall survival rate
timeFrame: 2-year
measure: 2-year progression-free survival rate
timeFrame: 2-year
measure: Clinical response rate
timeFrame: 2 months after radiotherapy
measure: The rate of grade 3 or 4 toxicities according to CTCAE5.0
timeFrame: 1 year after therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663585: Intensive Meditation and Migraines: Effects on Health and Well Being
Official title: Intensive Meditation and Migraines: Effects on Health and Well Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Daily Headache
Keywords: Migraine
Headache
Vipassana
Meditation
Intensive
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.


Eligibility criteria: Inclusion Criteria:

* Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.

Exclusion Criteria:1.

* Severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course
* Active alcoholism on screening or use of illicit drugs within the last 3 months
* Already completed a 10 day course
* Actively involved in another form of meditation over the past 6 months
* Women who are pregnant, planning pregnancy during trial period, or lactating.

Primary outcomes:
measure: number of migraine days, number of headache days
timeFrame: 3,6,12 months
Secondary outcomes:
measure: severity of headaches
timeFrame: 3,6,12 months
measure: quality of life
timeFrame: 3,6,12 months
measure: Heart Rate Variability
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Madhav Goyal, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01576185: Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia
Official title: Development of Pediatric Acute Myeloid Leukemia Xenograft Models for the Testing of Targeted Therapeutic Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-12
Enrollment: 10
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: Cryopreserved human AML samples FLT3-ITD samples with high allelic ratios

Brief summary: These laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the rate of engraftment of pediatric FMS-Like Tyrosine Kinase-3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) samples in NOD scid gamma (NSG) mice.

II. To determine the efficacy of treatment of FLT3-ITD xenografts with tyrosine kinase inhibitors.

OUTLINE:

Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.

Eligibility criteria: Inclusion Criteria:

* Cryopreserved human AML samples

  * FLT3-ITD samples with high allelic ratios

Primary outcomes:
measure: Engraftment ratio of human AML cells to murine cells
timeFrame: Up to 9 months
measure: Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Sarah Tasian, MD
role: PRINCIPAL_INVESTIGATOR
References: