louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04159337: NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
Official title: A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in shanghai chest hospital

Brief summary: Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Detailed description: Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Eligibility criteria: Inclusion Criteria:

* Participant aged 18 or above, and gender unrestricted
* Individual with pathologically diagnosed lung cancer

Exclusion Criteria:

* Patients with concomitant other tumors
* Individual with severe cardiopulmonary insufficiency and hypoproteinemia
* Women who were pregnant and were during their lactation

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: through the whole study period, an average of 3 year
measure: Tumor Mutational Burden (TMB)
timeFrame: halfway of the study, an average of 1.5 year
Secondary outcomes:
measure: Other biomarkers
timeFrame: halfway of the study, an average of 1.5 year
measure: Clonality
timeFrame: halfway of the study, an average of 1.5 year
measure: Overall survival (OS)
timeFrame: through the whole study period, an average of 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06053437: Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.
Official title: Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Surgery-Complications
Keywords: transsphenoidal surgery
pituitary adenoma
post-operative complications
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 211
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: All patients having undergone transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma are to be included.

Brief summary: Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. Furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies.

In a retrospective study on the "HYP'OP" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.


Eligibility criteria: Inclusion Criteria:

* Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.

Exclusion Criteria:

* No 4 month evaluation.

Primary outcomes:
measure: Risk factors associated with complications
timeFrame: Within 6 months after surgery
Secondary outcomes:
measure: Factors predictive of the 'success' of surgery
timeFrame: Within 6 months after surgery
measure: Is immediate postoperative hypoprolactinemia predictive of the onset of a new, clinically significant hormonal insufficiency?
timeFrame: Within 6 months after surgery
Other outcomes:
measure: Is hypoprolactinemia at the 4-month follow-up is correlated with the number of affected pituitary axes?
timeFrame: Within 6 months after surgery
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
References:
Clinical trial NCT06113237: Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Official title: Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Complications
Pregnancy Complication
Birth Outcomes, Adverse
Pregnancy
Keywords: Epidiolex
Epidyolex
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who were exposed to at least one dose of Epidiolex/Epidyolex during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy.

Brief summary: The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.


Eligibility criteria: Inclusion Criteria:

1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy.
2. Verbal or written informed consent to participate

Exclusion criteria:

1) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.

Primary outcomes:
measure: Rate of MCM
timeFrame: Up to 12 months post birth
Secondary outcomes:
measure: Rate of pregnancy outcomes
timeFrame: Up to 10 months gestation
measure: Rate of other events of interest in the developing neonate and infant
timeFrame: Up to 12 months post birth
measure: Rate of maternal complications during pregnancy
timeFrame: Up to 10 months gestation
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: United Biosource LLC
state: West Virginia
Study officials:
References:
Clinical trial NCT01652937: BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
DMARD-IR
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 0
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: Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).


Eligibility criteria: Inclusion Criteria:

* Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
* Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
* No prior treatment with biologics
* Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening

Exclusion Criteria:

* History of inflammatory joint disease other than RA
* Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
* History of malignancy, carcinoma in situ, or high-grade dysplasia
* History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
* Clinically significant cardiac disease
* Treatment with prednisone \>10 mg orally daily
* Intra-articular steroid injection within 28 days before screening
* Clinically significant abnormality in hematology or blood chemistry values at screening

Primary outcomes:
measure: Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
timeFrame: Week 12
Secondary outcomes:
measure: Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
timeFrame: Up to 16 weeks
measure: Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32
timeFrame: Week 12
measure: Proportion of subjects achieving ACR50 and ACR70 response
timeFrame: Week 12
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Quispamsis
country: Canada
facility: Research Site
state: New Brunswick
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
References:
Clinical trial NCT04070937: Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy
Official title: Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Sensorineural
Bilateral Vestibular Deficiency
DFNA9
Radiology
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients presenting at our Department of ENT with vestibular or balance disorders, in whom videonystagmography, video head impulse test and VEMP tests meet the Barany criteria for bilateral vestibulopathy.

Brief summary: In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.

The purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.


Eligibility criteria: Inclusion Criteria:

* must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain \<0.6, measured by the video-HIT5 or scleral-coil technique and/or
* reduced caloric response6 (sum of bither- mal max. peak SPV on each side \<6◦/sec7) and/or
* reduced horizontal angular VOR gain \<0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ /sec) and a phase lead \>68 degrees (time constant \<5 sec).
* must be 18 or older

Exclusion Criteria:

* \< 18 y
* does not meet Barany criteria for BV
* contraindication for CT and MR imaging

Primary outcomes:
measure: CT and MR findings
timeFrame: at time of recruitment
measure: genetic test
timeFrame: at time of recruitment
Secondary outcomes:
measure: vestibular test 1
timeFrame: at time of recruitment
measure: vestibular test 2
timeFrame: at time of recruitment
measure: vestibular test 3
timeFrame: at time of recruitment
measure: audiometry
timeFrame: at time of recruitment
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References:
Clinical trial NCT00596037: Treatment of Adults With Growth Hormone Deficiency
Official title: A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pituitary Disorders
Adult Growth Hormone Deficiency
Keywords: Growth hormone Deficiency
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: BioPartners GmbH
First posted: 2008-01-16
Enrollment: 136
Sex: ALL
Minimum age (years): 23
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.


Eligibility criteria: Inclusion Criteria:

* Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
* If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
* Written informed consent of the patient

Exclusion Criteria:

* Evidence of active malignancy or growth of a previously stable tumor
* Benign intracranial hypertension
* Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
* Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
* Patients who are not able to comply with the study protocol for any reason

Primary outcomes:
measure: Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LG Life Sciences
name: HJ Ji, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00603837: Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Official title: Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: Hypothermia
Prevention
ELGANs(Extremely low gestational age neonates)
Polyethylene Wrap
Sodium Acetate Transport Mattress
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 36
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.


Eligibility criteria: Inclusion Criteria:

* Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and \<1250g.

Exclusion Criteria:

* Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
* Blistering skin conditions
* Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):

  * Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.

    * Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
    * Anencephaly
    * Confirmed Trisomy 13 or Trisomy 18 syndrome
    * Meconium staining of amniotic fluid
    * Birth assessment of gestational age \> 28 weeks or \>1250 grams
    * Maternal temp \>38 degrees C around the time of delivery.

Primary outcomes:
measure: Neonatal Intensive Care Unit (NICU) Admission Temperature
timeFrame: At time of admission to the NICU - usually within 10-15 min of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Douglas Dannaway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Parker L Simon, DO, MPH
role: STUDY_DIRECTOR
affiliation: University of Oklahoma
name: Marilyn Escobedo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02924337: Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
Official title: A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Qt Interval, Variation in
Keywords: QT/QTC interval
Hypoglycemic Agents
Imeglimin
Healthy Volunteers
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* BMI between 18.5 and 29.9 kg/m2
* weighing between 55 and 95 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using highly effective contraception
* clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
* clinically significant QT/QTc interval prolongation at Baseline
* history of drug-induced or risk factors for Torsade de Pointes
* any contraindication to moxifloxacin
* severe adverse reaction to any drug or sensitivity to the trial medication or its components
* significant food allergy; use of vitamins, herbal medicines, prescription or over-the-counter medication (with the exception of paracetamol \[acetaminophen\] and oral contraceptives for women) within 20 days or 6 half-lives before first dose of trial medication
* participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* drug or alcohol abuse; smoking of more than 5 cigarettes, 1 cigars or 1 pipes daily
* regular consumption of more than 5 cups of caffeinated drinks per day
* positive test for hepatitis A, B \& C, HIV
* objection by a General Practitioner.

Primary outcomes:
measure: Change from baseline in QTcF (deltaQTcF)
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
affiliation: Poxel SA
name: Julie Dubourg, MD
role: STUDY_DIRECTOR
affiliation: Poxel SA
name: Pascale Fouqueray, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, Voiriot P, Fouqueray P. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus. Eur J Clin Pharmacol. 2020 Oct;76(10):1393-1400. doi: 10.1007/s00228-020-02929-6. Epub 2020 Jun 18.
Clinical trial NCT02708537: Effect of Plasma Rich in Growth Factors on Semen Quality
Official title: Effect of Plasma Rich in Growth Factors (PRGF) on Semen Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Endothelial Growth Factor Overexpression
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
Collaborators: name: bTI Vitoria
First posted: 2016-03-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.

Brief summary: The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy rates.

Detailed description: Platelet growth factors are a group of proteins involved in cellular communication modifying biological responses. Obtaining plasma rich in growth factors is already widespread and simple protocol technique that is being used in various areas of medicine with superb results. Described many of the growth factors present in the PRGF are related to sperm parameters, especially motility The described effects have been studied in mammalian and each growth factor individually. PRGF contains a pool of growth factors and therefore be interesting to analyze their effect on various sperm parameters.

One of those parameters is very important for fertilization sperm motility, since the lack of it will prevent displacement by the cervix to meet the egg in the fallopian tube.

Eligibility criteria: Inclusion Criteria:

* 18-35 years
* more than 5 million sperm per milliliter

Exclusion Criteria:

* Not having genetic and infectious diseases
* Do not suffer mental illness
* Have a family study determined that there is no risk of hereditary diseases
* There have fathered more than 6 children in the country

Primary outcomes:
measure: Evaluate the percentage of motile sperm adding PRGF versus those samples that growth factors were not added
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
city: Vitoria
country: Spain
facility: BTI
Study officials:
affiliation: IVI Bilbao
name: Marcos Ferrando
role: STUDY_DIRECTOR
References: