louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02933853: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
Official title: This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
* Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
* HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion Criteria:

* Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 30 minutes
Secondary outcomes:
measure: Maximum observed serum insulin aspart concentration
timeFrame: Within 0 to 12 hours after dosing
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)
measure: Maximum glucose infusion rate
timeFrame: Within 0 to 12 hours after dosing
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10.
Clinical trial NCT02546453: Use of Specific Genetic Alteration s of Tumoral Cells Identified by the Next Generation Sequencing Techniques (NGS) to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor - NGSKids
Official title: Use of Specific Genetic Alteration s of Tumoral Cells Identified by NGS to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic and/or High Risk Solid Tumor of Children
Keywords: high risk solid tumor pediatric, genetic alteration, Metastatic solid tumor pediatric
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The search for genetic alterations in primary tumor by NGS techniques followed by the detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.


Eligibility criteria: Inclusion Criteria:

* Children with metastatic and/or high risk solid tumor, of the following pathologies :

Neuroblastoma, sarcoma, malignant brain tumor (medulloblastoma, high-grade glioma), bone tumors, rhabdoid tumors, others rare tumors

* Availability of a frozen tumoral sample (primary tumor or metastasis whatever the localization) at diagnosis allowing analysis of genetic alterations by a NGS technique
* Age \< 18 years
* Signed informed consent by parents or legal representatives
* Patient having health care insurance

Exclusion Criteria :

* Age ≥ 18 years
* No signed informed consent by parents or legal representatives

Primary outcomes:
measure: Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations
timeFrame: at the inclusion
measure: Detection of specific genetic alterations of tumoral cells in peripheral samples
timeFrame: Up to 6 years
Secondary outcomes:
measure: Detection of genetic alterations in solid tumor pediatric samples
timeFrame: At the inclusion
measure: Change of CTC/DTC/circulating tumoral DNA levels detected by PCR targeting specific genetic alterations of tumoral cells in peripheral samples will be confronted to clinical features including patient outcome
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References:
Clinical trial NCT05381753: Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World
Official title: A National Multicenter, Noninterventional Clinical Study Evaluating the Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Avapritinib
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GIST patients with specific genetic mutations who were treated or will be treated with avapritinib (other TKIs in corhort 4) in about 20 hospitals from 1 May 2021 to 31 Aug. 2023.

Brief summary: This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.


Eligibility criteria: Inclusion Criteria:

* Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18.
* Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
* Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14.

Exclusion Criteria:

* Participants who have participated and may participate in any other interventional clinical trail in the future.
* Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.

Primary outcomes:
measure: Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3
timeFrame: AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 3 years.
measure: Dose adjustment of avapritinib in cohort 1, 2, and 3
timeFrame: From the start of study drug until 30 days after the last dose, up to 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00450853: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients
Official title: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vomiting
Keywords: emesis
granisetron
pharmacokinetics
subcutaneous.
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

Detailed description: 5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.

Eligibility criteria: Inclusion Criteria:

* Cancer patients receiving platinum-based chemotherapy
* adequate bone marrow, hepatic and renal function, respectively defined by: platelets \>100000/mm3 and absolute neutrophil count \>1500/mm3; bilirubin, AST and ALT \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl.
* ECOG performance status \<2 and body mass index from 20-28 kg/m2.

Exclusion Criteria:

* Pregnancy
* Serious concomitant diseases, in the invesgator´s criteria

Primary outcomes:
measure: Bioavailability
timeFrame: Approximately 6 weeks
Secondary outcomes:
measure: Safety
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
Study officials:
affiliation: Oncology Department. Clinica Universitaria de Navarra
name: Alfonso Gurpide
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06831253: Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome
Official title: Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma (PRP) Into the Lacrimal Gland in Severe Dry Eye Syndromes (ReLIPSSO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Dry Eye Syndromes
Dry Eye Syndromes
Keywords: Dry Eye Syndromes
lacrimal gland
platelet-rich plasma
aqueuous deficiency
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.

Detailed description: injections in lacrimal gland four times during the study for each patient

Eligibility criteria: Inclusion Criteria:

* Platelet counts, and clotting factors in the standarts
* Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist

Exclusion Criteria:

* Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
* Patients with complete stenosis of both lacrimal meatus in the treated eye

Primary outcomes:
measure: To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
timeFrame: week 16
Secondary outcomes:
measure: To compare the different clinical follow-up parameters of qualitative dry ocular syndrome and quantitative after 4 monthly injections of PRP into the lacrimal gland
timeFrame: week 16
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Site Principal Investigator
Study officials:
References:
Clinical trial NCT04567953: COVID-19 Tests With Saliva Specimens
Official title: COVID-19 Tests With Saliva Specimens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Paradigm Laboratories LLC
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.


Eligibility criteria: Inclusion Criteria:

* Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and

  * Is able to give informed consent
  * Is able to understand oral or written instructions, and
  * Is able to mentally and physically perform self-collection of saliva using the provided collection device.

Exclusion Criteria:

* - Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Employees of Paradigm lab and the assisted living facilities involved in the study
* Members of other vulnerable populations

Primary outcomes:
measure: The clinical evaluation of saliva as specimen for COVID-19 molecular test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Paradigm Laboratories
state: Arizona
Study officials:
affiliation: Paradigm Laboratories
name: Wenli Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03919253: Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Official title: Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2\*ULN, but ≤5\*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

* 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.

Primary outcomes:
measure: Progress-free survival(PFS)
timeFrame: three years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: three years
measure: Clinical Benefit Rate (CBR)
timeFrame: three years
measure: Disease control rate(DCR)
timeFrame: three years
measure: Overall survival (OS)
timeFrame: up to death
measure: Safety (number of Participants with adverse events)
timeFrame: three years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04168853: Impact of Pumps on Internal Thoracic Arteries (IPITA)
Official title: Cardiopulmonary Bypass and Internal Thoracic Arteries: Can Roller or Centrifugal Pumps Change Vascular Reactivity of the Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: cardiopulmonary bypass
pulsatility
systemic inflammatory response
arterial graft
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-11-19
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The IPITA (Impact of Pumps on Internal Thoracic Arteries) study consisted of two parallel prospective, monocenter, randomized, active-treatment-controlled clinical trials
Primary purpose: BASIC_SCIENCE

Brief summary: Cardiopulmonary bypass (CPB) induces a systemic inflammatory response and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity and the inflammatory response of the internal thoracic arteries (ITAs) between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.

Detailed description: Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.

Eligibility criteria: Inclusion Criteria:

* male patients and elective coronary artery bypass grafting using at least one of the two ITAs.

Exclusion Criteria:

* female patients because their complement activation has been shown to be greater than that in men during surgery under cardiopulmonary bypass ; age \< 18 years; CABG requiring additional valve repair or replacement; emergency surgery and insufficient length of the internal thoracic artery

Primary outcomes:
measure: Myography
timeFrame: 1 day
Secondary outcomes:
measure: Superoxide detection and confocal microscopy
timeFrame: 1 day
measure: Immunochemistry
timeFrame: 1 day
measure: Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis
timeFrame: 1 day
measure: Blood sampling and biochemical analysis
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Fouquet O, Dang Van S, Baudry A, Meisnerowski P, Robert P, Pinaud F, Binuani P, Chretien JM, Henrion D, Baufreton C, Loufrani L. Cardiopulmonary bypass and internal thoracic artery: Can roller or centrifugal pumps change vascular reactivity of the graft? The IPITA study: A randomized controlled clinical trial. PLoS One. 2020 Jul 9;15(7):e0235604. doi: 10.1371/journal.pone.0235604. eCollection 2020.
Clinical trial NCT05715853: Prospective Assessment of Rejection in Kidney Transplant (PARK)
Official title: Prospective Assessment of Rejection in Kidney Transplant (PARK)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplant Failure and Rejection
Keywords: kidney transplant
kidney biopsy
allograft rejection
Lead sponsor: NephroSant
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 1000
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: Adult kidney transplant recipients

Brief summary: The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy.

QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection.

Detailed description: Non-randomized, unblinded observational study to collect urine samples, coincident allograft biopsy results, and relevant clinical data to evaluate the QSant test.

Participants will be recruited prior to or on the day of an already scheduled kidney biopsy.

Urine samples will be collected before biopsy (protocol and for-cause).

Eligibility criteria: Inclusion Criteria:

1. Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
2. Kidney biopsy scheduled on a date \> 14 days post-transplant
3. Able to understand risks and requirements of participation and provide informed consent
4. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Inability to provide a voided urine sample per collection protocol
2. Urological abnormalities such as catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
3. History of or current multi-organ transplant

Primary outcomes:
measure: Collect coincident urine specimens and biopsy results from participants
timeFrame: Prior to biopsy
measure: QScore specificity and sensitivity in relation to kidney biopsy
timeFrame: Prior to biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References: