louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06278545: Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Official title: Randomized Phase II Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
* Metastatic or locally advanced unresectable tumour with curative intent
* Patient who never received first-line chemotherapy
* Measurable lesion according to RECIST 1.1 criteria
* ECOG status \< or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years
* Life expectancy estimated at over 3 months
* Patient over 18 years of age
* Patient able to understand and sign the information and informed consent note
* Women of childbearing age and men who have sex with women of childbearing age must agree to use contraception during the trial treatment and for at least 9 months after stopping the experimental treatments.

Exclusion Criteria:

* MSI/dMMR tumor
* Adenocarcinoma of the ampulla of Vater
* Neutrophils \< 1500/mm3, platelets \< 100 000/mm3
* Hemoglobin \< 9 g/dL, total bilirubin \> 1.5x normal, alkaline phosphatase \> 2.5x normal (or \>5x normal if liver metastases), creatinine clearance \> or = 40 ml/min. according to MDRD
* Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment.
* Adjuvant chemotherapy completed less than 6 months ago
* History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
* Severe renal failure
* Peripheral sensory neuropathy with functional discomfort
* Active and/or potentially severe infection or other uncontrolled conditions
* Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of the protocol)
* Patients currently undergoing treatment using St John's Wort
* Treatment with brivudine within 4 weeks prior to the administration of protocol

Primary outcomes:
measure: Assess the percentage of patients alive without progression
timeFrame: At 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01025245: Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperalgesia
Keywords: Remifentanil induced postoperative hyperalgesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thyroidectomy,
* Age 20-65,
* American Society of Anesthesiologists physical status classification I or II.

Exclusion Criteria:

* History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs,
* History of drug \& alcohol abuse,
* Psychiatric disorder,
* Use of opioids within 24hrs,
* Renal disease with decreased GFR,
* Neuromuscular disease, Severe cardiac disease.

Primary outcomes:
measure: Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs
timeFrame: postoperative 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01637545: Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
Official title: Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Facial Bones Fracture
Keywords: facial bones
Post operative nasea vomiting
fractures
reduction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.

Detailed description: 1. Participants

   * 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
2. Randomization

   * G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
   * G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
   * G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
3. The primary endpoint

   * the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
4. The secondary endpoints

   * the severity of nausea, need for rescue medication
   * patient satisfaction with efficacy

Eligibility criteria: Inclusion Criteria:

* Patient who sign informed consent form for the study
* patient who are considered as surgical candidates with facial bones fracture

Exclusion Criteria:

* Patient who have had nausea/vomiting episodes

Primary outcomes:
measure: incidence and severity of nausea and vomiting
timeFrame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
Secondary outcomes:
measure: patient satisfaction with the effect
timeFrame: at 24 h after surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chanyeong Heo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02145845: Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
Official title: Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Peripheral Arterial Disease
Peripheral Vascular Disease
Keywords: critical limb ischemia
wound healing
amputation
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of critical limb ischemia
* Rutherford 4-5 or Leriche-Fontaine IIIB
* Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

* Patient's age is \<21
* Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
* Patient has had a previous surgery, within 30 days of the study procedure
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure
* Patient has a life expectancy less than 1 year
* Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue
* Additional restrictions as specified in the Clinical Investigation Plan

Primary outcomes:
measure: Frequency and types of adverse events after treatment with the Cook Injectable SIS
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Vaclav Prochazka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573545: Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
Official title: Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Biopsy
Keywords: liver
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:

* a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
* a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old
* Affiliated to a social security scheme
* Informed consent
* Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI

Exclusion Criteria:

* Patient with a contraindication for MRI exam
* Patient with a contraindication for performing a biopsy
* Pregnancy
* Exclusion period
* Patient unable to receive and understand information about the study
* Patients under guardianship
* Patients under judicial protection

Primary outcomes:
measure: Total duration of the intervention (planning and implementation)
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hôpital civil
Study officials:
References:
Clinical trial NCT00912145: To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg
Official title: Bioavailability of Alprazolam Tablets, 2 mg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 26
Sex: MALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 13 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Calvin F. Fuhrmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229745: Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
Official title: Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-oxygenation in Term Pregnant Women
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: term pregnant women undergoing elective Caesarean section

Brief summary: Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo elective caesarean delivery
* singleton pregnancy
* American Society of Anaesthesiologists (ASA) Physical Status Grade II
* gestational age between 37 - 42 weeks

Exclusion Criteria:

* multiple pregnancy
* pre-eclampsia
* known fetal abnormality
* maternal cardio-respiratory comorbidity
* Body Mass Index (BMI) \> 35 kg/m2.

Primary outcomes:
measure: Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9
timeFrame: 8 months study period
Secondary outcomes:
measure: EN90 using THRIVE with mouth open versus mouth closed
timeFrame: 8 months study period
measure: comfort score of THRIVE
timeFrame: 8 months study period
measure: changes in fetal wellbeing during pre-oxygenation time
timeFrame: 8 months study period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCLH
Study officials:
References:
Clinical trial NCT06645145: Language Learning and Language Experience
Official title: Language Experience and Language Learning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Typically Developing Children Ages 3 to 6
Keywords: verb learning
orthographic facilitation
typical development
Lead sponsor: Montclair State University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 36
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if text can support children in learning new verbs in healthy children ages three through six. The main questions it aims to answer are:

Does text support help children learn new verbs? Does a child's relative benefit from text support vary according to their literacy skills?

Participants will

* Watch videos of actions and hear novel words
* Name alphabet sounds to determine their literacy skills


Eligibility criteria: Inclusion Criteria:

* Primarily exposed to English
* Typical development
* Hearing and vision within normal limits or corrected to be so

Primary outcomes:
measure: Accuracy
timeFrame: 15 minutes
Secondary outcomes:
measure: Literacy as a Mediator
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: Online Asynchronous
state: New Jersey
Study officials:
affiliation: Montclair State University
name: Grace Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018745: Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan
Official title: Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-2

Exclusion Criteria:

* Subject has uncontrolled intercurrent illness

Primary outcomes:
measure: To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
timeFrame: Within the first 28 days
Secondary outcomes:
measure: To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
timeFrame: Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter
measure: To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors
timeFrame: Day 1, 5, 15, 19 and 29
measure: To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)
timeFrame: Every 8 weeks
measure: To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity
timeFrame: Day 1, 5, 15, 19, 29 and every 4 weeks thereafter
Other outcomes:
Locations:
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02528045: Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
Official title: Efficacy of Surgical Treatment of Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole Retinal Detachment
Myopic Traction Maculopathy
Keywords: Myopic traction maculopathy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who underwent vitrectomy with scleral shortening for macular hole retinal detachment or myopic traction maculopathy

Brief summary: The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal reattachment and macular hole closure, the shape of staphyloma determined by optical coherence tomography and 3-dimensional magnetic resonance imaging were assessed.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients who had highly myopic eyes with macular hole retinal detachment to myopic traction maculopathy

Exclusion Criteria:

* The patients with follow-up less than 6 months

Primary outcomes:
measure: Visual acuity before and after surgery
timeFrame: 6 months
Secondary outcomes:
measure: Retinal reattachment
timeFrame: 6 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Akito Hirakata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968045: Fibrinogen and Bleeding After Cardiac Surgery
Official title: Fibrinogen and Bleeding After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complications
Bleeding
Coronary Artery Disease
Keywords: Fibrinogen
Postoperative bleeding
Transfusions
CABG
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2009-08-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* Age 18 years and above
* Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L
* Signed informed consent to participate in the study

Exclusion Criteria:

* Patients undergoing redo surgery
* Clinical or laboratory signs of bleeding disorder
* Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
* Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
* Administration of other investigational drugs within eight weeks preceding the preentry examination
* Pregnant or lactating women

Primary outcomes:
measure: To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
timeFrame: 2 years
measure: Blood loss first 12 postoperative hours
timeFrame: 12h
Secondary outcomes:
measure: Transfusions
timeFrame: 7 days
measure: Biomarkers of coagulation, fibrinolysis and platelet function
timeFrame: 7 days
measure: Pharmcoeconomic analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Cardiothoracic Surgery unit, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Anders Jeppsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeppsson A, Walden K, Roman-Emanuel C, Thimour-Bergstrom L, Karlsson M. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: A randomized controlled study. Br J Anaesth. 2016 Feb;116(2):208-14. doi: 10.1093/bja/aev367. Epub 2015 Nov 17.