louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03771079: MS Detection of Somatic Mutations in Hematological Malignancies
Official title: Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematological Malignancy
Keywords: Hematological Malignancy
mutations
NGS sequencing
mass spectrometry
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anonymized samples from patients already studied with NGS in Strasbourg university hematology center for somatic mutations

Brief summary: Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies


Eligibility criteria: Inclusion Criteria:

* adults \>18 years old
* anonymized samples already studied with NGS in Strasbourg university hematology center for somatic mutations
* non-opposition of the patient for testing the archive sample with the new method

Exclusion Criteria:

* opposition for testing the archive sample with the new method
* insufficient archival material
* patient under protection

Primary outcomes:
measure: Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire d'Hématologie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Laurent MAUVIEUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05007379: Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids
Official title: Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids (CARMA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a cohort study conducted in breast cancer patients requiring a surgery or a tumor biopsy as part of their care.

Brief summary: Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or more
* Histologically confirmed breast cancer at any stage
* Requiring surgery or tumor biopsy as standard of care
* Any or no systemic treatment
* Signed informaed consent
* Health insurance coverage

Exclusion Criteria:

* Opposed to biospecimen collection

Primary outcomes:
measure: Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers
timeFrame: 24 months
measure: Antitumor activity of the CAR-macrophages compared to non-modified macrophages
timeFrame: 24 months
Secondary outcomes:
measure: Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02478879: A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
Official title: An Open-label Crossover Study to Determine the Patient Preference Between ZP-PTH Patches and Forteo Pens After Daily Treatment for 14 Days in Women 55-85 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Zosano Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.

Detailed description: The purpose of this study is to determine which of two delivery methods of PTH is preferred by patients after 14 days of use for each. Patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete. Adverse events will also be collected.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

* Significant health issue
* previous use of teriparatide
* History of Paget's disease

Primary outcomes:
measure: Overall Preference
timeFrame: 28 days
Secondary outcomes:
measure: Safety (adverse events)
timeFrame: 28 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Daytona Beach Clinical Research Unit
state: Florida
Study officials:
affiliation: Convance
name: Hugh Coleman, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780779: Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults
Official title: Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ewing Sarcoma
Osteosarcoma
Keywords: Diffusion weighted MRI
Patient outcome assessment
Treatment response
Histopathology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Ewing sarcoma or Osteosarcoma, proven by biopsy and histolopathology.

Brief summary: The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery.

Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.

Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.


Eligibility criteria: Inclusion Criteria:

* Ewing or Osteosarcoma, proven by biopsy and histopathology
* all patients are treated by chemotherapy defined by EURAMOS and EURO-EWING protocol

Exclusion Criteria:

* Patients under the age of 6 years old
* patients with contra-indication for MR exam (pace-maker...)
* Patients with renal insufficiency
* Claustrophobia

Primary outcomes:
measure: tumor necrosis - therapy response
timeFrame: 6 months
Secondary outcomes:
measure: Prognosis and outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT00419484: Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Hypertension
Dyslipidemia
Diabetic Nephropathy
Lead sponsor: Dokkyo Medical University
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Detailed description: Primary composite endpoints:

Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)

Secondary endpoints:

urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes HbA1c: more than 7% and less than 9%

Exclusion Criteria:

* insulin treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Koshigaya
country: Japan
facility: Dokkyo Medical University, Koshigaya Hospital
state: Saitama
Study officials:
affiliation: Dokkyo Medical University, Koshigaya Hospital
name: Yoshimasa Aso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741584: Effects of Physical Activity on the Brain in Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate whether exercise improves cognitive and motor functions in Parkinson's disease. To test this hypothesis, the researchers study general brain functions in subjects with PD during a 6-months exercise program.


Eligibility criteria: Inclusion Criteria:

* UPDRS \<15
* L-DOPA responsive
* \<5 yrs since diagnosis

Exclusion Criteria:

* severe other diseases
* MMSE \< 26
* treatment with psychiatric medication

Primary outcomes:
measure: UPDRS motor score
timeFrame: Prior to intervention and after 6 months of intervention
Secondary outcomes:
measure: Functional/Structural brain changes
timeFrame: Prior to intervention and after 6 months of intervention
measure: Plasma biomarkers
timeFrame: Prior to intervention and after 6 months of intervention
measure: Cognitive Function based on neuropsychological test-performance
timeFrame: Prior to intervention and after 6 months of intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neurology, Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404284: Assessment of Family Planning and Immunization Service Integration in Malawi
Official title: Assessment of Family Planning and Immunization Service Integration in Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Contraceptive Usage
Contraception Behavior
Infant, Newborn, Diseases
Keywords: Immunization
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
First posted: 2018-01-19
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 43 health facilities and associated outreach sites in Ntchisi and Dowa districts of Malawi

Brief summary: This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities and through outreach services in Dowa and Ntchisi districts of Malawi. The study involved qualitative methods (in depth interviews and focus group discussions with service providers, mothers and fathers of infants \<1 year, and supervisors and program managers) as well as secondary analysis of service statistics for family planning and immunization services and of supervision reports.


Eligibility criteria: Inclusion Criteria:

* All health facilities and associated outreach sites in Ntchisi and Dowa districts implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Exclusion Criteria:

* All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Primary outcomes:
measure: Number of modern family planning users
timeFrame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
measure: Number of Penta 1 doses administered
timeFrame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
measure: Number of Penta 3 doses administered
timeFrame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02924584: Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan
Official title: The Treatment For Recurrent Female Breast Cancer After Initial Endocrine Therapy Among Taiwanese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ER/PR(+), Her2(-) Breast Cancer
Keywords: hormonal receptor positive, human epidermal growth factor receptor 2 negative, breast cancer, aromatse inhibitor, overall survival, prevalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer

Brief summary: Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer Registration 2012, while more than11,305 were registered as early breast cancer. With broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can survive longer and longer. However, there is no prevalence of metastatic breast cancer can be available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be an appropriate surrogate of prevalence. In this retrospective database analysis, we will explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.


Eligibility criteria: Inclusion Criteria:

* hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer

Exclusion Criteria:

-

Primary outcomes:
measure: clinical use of aromatase inhibitors in breast cancer
timeFrame: base line, up to 60 months
Secondary outcomes:
measure: prevalence
timeFrame: base line up to 60 months
measure: dose exposure
timeFrame: base line, up to 60 months
measure: overall survival
timeFrame: base line, up to 60 months
measure: treatment cost
timeFrame: base line, up to 60 months
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03935984: Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Official title: Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Hyperparathyroidism
Hypercalcemia
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
Collaborators: name: University of Toledo Health Science Campus
First posted: 2019-05-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary hyperparathyroidism
* Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study
* Patient desires surgical intervention for treatment of PHPT
* No contraindications to 99mTC-Sestamibi
* No contraindications to treatment with calcitonin
* Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL
* Patient consents to participate and undergo second SPECT-CT for purposes of research

Exclusion Criteria:

* Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary
* Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT
* Allergy to calcitonin
* Hypocalcemia (contraindication to calcitonin)
* Vitamin D deficiency (contraindication to calcitonin)
* Previous treatment with radioactive iodine
* New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan)
* Lithium exposure within one year of SPECT-CT (index and research scans)
* Secondary hyperparathyroidism
* Benign familial hypocalciuric hypercalcemia
* Known malignancy, particularly multiple endocrine neoplasia
* New prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan)
* Currently taking calcium channel blockers
* Pregnancy

Primary outcomes:
measure: Sensitivity of SPECT-CT
timeFrame: one year
Secondary outcomes:
measure: Surgical Approach
timeFrame: 6 months
measure: Success Rate
timeFrame: 6 months from surgery
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
affiliation: University of Toledo College of Medicine
name: Joseph Sferra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680584: Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
Official title: Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Effect of Drug
Anxiety
Keywords: Melatonin
Hydroxyzine
Preoperative Anxiety
Pediatric
Adenotonsillectomy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three study groups
Primary purpose: PREVENTION

Brief summary: Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

Detailed description: The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.

The primary outcomes:

1. Ease of parenteral separation.
2. The compliance to anesthesia induction in pediatric patients.

The secondary outcomes:

1. Assessment of postoperative pain.
2. Time to first analgesic request.

Eligibility criteria: Inclusion Criteria:

1. ASA: class l
2. Sex: male and female
3. Age: from 3 to 10 years old
4. Children scheduled for adenotonsillectomy

Exclusion Criteria:

1. All children with a history of chronic illness, or developmental delay were excluded from the study
2. History of an autoimmune disease
3. Concurrent use of immunosuppressive treatment
4. Sleep disturbances, speech or communication problems
5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
6. hydroxyzine is contraindicated in patients with acute porphyria

   -

Primary outcomes:
measure: Ease of parenteral separation.
timeFrame: 20-30 minutes after administration
measure: The compliance to anesthesia induction in pediatric patients.
timeFrame: one hour after administration
Secondary outcomes:
measure: Assessment of postoperative pain
timeFrame: immediately before and at induction procedure
measure: First analgesic request
timeFrame: Three hours postoperative
Other outcomes:
Locations:
city: Al Minyā
country: Egypt
facility: Sarah Omar
Study officials:
affiliation: Minia University
name: Sarah Omar
role: STUDY_DIRECTOR
References:
Clinical trial NCT03523884: Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
Official title: Development of A Technology-Enabled Intervention for Musculoskeletal Health: The Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if a technology-enabled Exercise program plus Education (TEEP + E) is more effective than Education program (EP) alone, in providing better outcomes (quality of life, at-work disability and productivity loss, firefighters' perception, adherence, overall improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow ups.


Eligibility criteria: Inclusion Criteria:

* Active duty firefighters aged 18 to 100 years, with shoulder pain.
* Do not permanently use strong pain medications.
* Able to understand spoken and written English.
* Access to computer, internet and telecommunications application software (Skype).

Exclusion Criteria:

* Firefighters who have had shoulder related surgeries in the last 6 months.

Primary outcomes:
measure: Firefighter Work Limitation Questionnaire
timeFrame: 3-months
measure: Firefighter Work Limitation Questionnaire
timeFrame: 6-months
measure: Firefighter Work Limitation Questionnaire
timeFrame: 12-months
measure: Short- Western Ontario Rotator Cuff Index
timeFrame: 3-months
measure: Short- Western Ontario Rotator Cuff Index
timeFrame: 6-months
measure: Short- Western Ontario Rotator Cuff Index
timeFrame: 12-months
Secondary outcomes:
measure: Single Assessment Numeric Evaluation
timeFrame: 3-, 6- and 12-months
measure: Number of days lost
timeFrame: 3-, 6- and 12-months
measure: Therapy Adherence Assessment Tool
timeFrame: 3-, 6- and 12-months
measure: Global Rating of Change Scale
timeFrame: 6- and 12-months
measure: Adverse Effects
timeFrame: 3-, 6- and 12-months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Fire Station
state: Ontario
Study officials:
affiliation: Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)
name: Joy C MacDermid, PhD
role: STUDY_CHAIR
References: