louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00891332: Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
Official title: Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically proved adenocarcinoma
* Unresectable and recurrent colorectal cancer
* Age20 ≤ at enrollment
* Performance status 0 or 1 (ECOG)
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
* Adequate hematologic, hepatic and renal functions
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* Serious drug hypersensitivity
* Pregnant or nursing
* Bleeding from gastrointestinal tract
* Diarrhea
* Simultaneously active double cancer
* Serious illness or medical condition
* Brain metastasis

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: During chemotherapy
Secondary outcomes:
measure: Safety
timeFrame: During chemotherapy
measure: Progression free survival (PFS)
timeFrame: Until progression
measure: Disease control rate(DCR)
timeFrame: During chemotherapy
measure: Time to treatment failure (TTF)
timeFrame: Until progression
measure: Overall survival (OS)
timeFrame: Over two years from registration
measure: Feasibility
timeFrame: During chemotherapy
measure: Pharmacokinetics
timeFrame: During chemotherapy
Other outcomes:
Locations:
city: Dong feng Dong road,Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center, Division of Oncology
state: Guangdong
city: Dong An Road, Shanghai
country: China
facility: Shanghai Fudan University Cancer Hospital, Division of Oncology
city: East Avenue, Fengtai District, Beijing
country: China
facility: PLA 307 Hospital, No.4 Division of Oncology
city: Fucheng Road, Haidian District, Beijing
country: China
facility: Beijing Cancer Hospital, Digestive System Medicine Department
city: Panjiayuan Nanli, Chaoyang District, Beijing
country: China
facility: Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
city: 1-1-1, Honjo Kumamoto-city, Kumamoto
country: Japan
facility: Graduate School of Medical Sciences Kumamoto University
Study officials:
affiliation: Graduate School of Medical Sciences Kumamoto University
name: Hideo Baba, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02924532: Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy
Official title: Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 300
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: Included patients underwent total thyroidectomy from 1 February 2012 to 1 December 2013 at the Nîmes University Hospital

Brief summary: The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.


Eligibility criteria: Inclusion Criteria:

* Patients consecutively operated on between February 1, 2012 and December 1, 2013
* Total thyroidectomy +/- lymphadenectomy
* Respect of clinicobiological protocol presented above
* The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
* The ( the ) patient ( e) is under ( e) at least 18 years

Exclusion Criteria:

* The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
* It is not possible to give to ( the ) patient ( e) informed information
* History of cervical radiotherapy
* Previous history of dysfunction of the parathyroid glands
* Previous history of surgery of the parathyroid glands
* A history of kidney failure or hepatocellular
* History of osteomalacia or Paget's disease
* unhealed cancer antecedent
* History of sarcoidosis

Primary outcomes:
measure: the presence/absence of hypoparathyroidism
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06912932: Physiological and Perceptual Responses During 4-Second Exercise
Official title: The Effects of The Exercise Intensity and Rest Duration on Physiological and Perceptual Responses During 4-Second Sprint Interval Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Fitness
Keywords: exercise
cardiovascular fitness
sprint
vo2max
interval training
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the acute effects of different intensities (i.e., 50, 75, and 100% of maximal anaerobic power) of 4-s sprint interval exercise on physiological responses. Secondly, it will determine the relationship between intensity and recovery duration (i.e., 15, 30, or 45-s) that will stimulate the cardiovascular and metabolic systems.

Detailed description: Background Short sprint interval training (sSIT) is typically performed at maximal intensity, generating power far above what is needed to reach peak oxygen consumption (VO₂peak). However, the physiological effects of submaximal sprint intensities and different recovery periods are not well understood.

Study Aim This study examined how power output and oxygen consumption (VO₂) respond to repeated 4-second sprints at 50%, 75%, and 100% of maximal power (Pmax) with rest periods of 15, 30, or 45 seconds.

Methods Eleven recreationally active participants completed nine trials, each consisting of thirty 4-second cycling sprints under different intensity and recovery conditions.

Eligibility criteria: Inclusion Criteria:

* Young (18-30),
* Healthy,
* Recreationally active, but untrained (not meeting ACSM's recommendations of 150 min/week of moderate-vigorous aerobic exercise)

Exclusion Criteria:

* Cardiovascular disease
* Smoking
* Subjects who were exercising regularly (\>75 min/week) were excluded.

Primary outcomes:
measure: Cardiovascular changes
timeFrame: From enrollment (Day 1) to the end of treatment (9 trials) (Day 11), through study completion, an average of 5 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Human Performance Laboratory, Department of Kinesiology and Health Education, the University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT05498532: Functional MRI Evaluation in Pyeloureteral Junction Syndrome in Children
Official title: Functional MRI Usage for Pyelo-ureteral Junction Syndrome : Results of Nancy Children Hospital Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stricture of Pelviureteric Juncture
Keywords: PUJS
MRI
Scintigraphy
Polar Vessel
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 0 and 17 years old followed for pyelo-ureteral junction syndrome in the Children hospital of Nancy.

Brief summary: Pyelo-ureteral junction syndrome is the most common urological abnormality in children.

Functional MRI has been evaluated several times, and had shown good correlation with scintigraphy, but tends to over estimate results. Moreover, those studies included a small number of cases. Its sensitivity to detect crossing polar vessel is limited.

We aimed to evaluate, in patients between 0 and 1 year old, the correlation between MRI and scintigraphy differential renal function.

Our secondary objectives are : evaluation of MRI performances to detect polar vessel ; comparison of surgery times depending of MRI only realisation or MRI and scintigraphy realisation.


Eligibility criteria: Inclusion Criteria:

* children between 0 and 17 years old
* followed for pyelo-ureteral junction syndrome

Exclusion Criteria:

* none

Primary outcomes:
measure: MRI and scintigraphy differential renal function correlation
timeFrame: from january 2007 to december 2021
Secondary outcomes:
measure: MRI and scintigraphy differential renal function correlation in operated patient
timeFrame: from january 2007 to december 2021
measure: Time difference in patient operated for PUJS depending on MRI realisation ou MRI and scintigraphy realisation
timeFrame: from january 2007 to december 2021
measure: performance of MRI in detecting polar vessel
timeFrame: from january 2007 to december 2021
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
affiliation: CHRU Nancy
name: Charles Mazeaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255432: Summative Evaluation to Validate the LEAFix Device With Users
Official title: Summative Evaluation to Validate That the Laryngeal, Endo-tracheal, Airway Fixator (LEAFix) Can be Used Safely and Effectively by Intended Users to Secure Airway Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-02-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practioners who perform airway placement

Brief summary: The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.


Eligibility criteria: Inclusion Criteria:

* Member of staff trained in placing airways

Exclusion Criteria:

* Previous knowledge of the device

Primary outcomes:
measure: Performance of user against the predetermined standard
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04090632: Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test
Official title: Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test (CKCUEST) - EPOLTEST Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: CKCUEST
Physical activity
rehabilitation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a monocentric interventional prospective study
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate impact of anthropometric criteria to CKCUEST score.


Eligibility criteria: Inclusion Criteria:

* Aged to 18 to 25 years
* Capacity to consent
* Who has signed the consent

Exclusion Criteria:

* fracture history or upper limb luxation
* is not possible to do the test because of pain
* pregnant or nursing
* refuse to participate
* guardianship or protection of vulnerable adult

Primary outcomes:
measure: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) score
timeFrame: Day 1
Secondary outcomes:
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: Day 1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
state: Finistère
Study officials:
References:
Clinical trial NCT04913532: Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Official title: A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Surgery
Adjuvant Radiotherapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Detailed description: Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
* Indication to adjuvant radiotherapy including boost radiotherapy
* Clearly identified primary tumor region preferably by radiopaque clips
* Primary wound healing after breast conserving therapy without signs of infection
* Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
* Written informed consent

Exclusion Criteria:

* Patients operated by mastectomy
* No indication for boost radiation
* Resection margins positive for disease or insufficient identification of the boost volume
* Indication for radiotherapy of the regional lymph nodes
* History of prior breast or thoracic radiotherapy
* Extended postoperative seroma at the beginning of radiotherapy
* Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
* Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Primary outcomes:
measure: Acute Toxicity
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of the radiation plan
timeFrame: 19 days
measure: other acute Toxicity
timeFrame: 0-6 months
Other outcomes:
measure: Skin toxicity (Cosmetic results)
timeFrame: 0 to 6 months
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
Study officials:
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Wenjie Ni, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818532: Corneal Astigmatism Measurement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Keywords: Corneal astigmatism
Low diopter
Corneal measurement
Corneal astigmatism < 1 Diopter
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: To assess which commercially available measurement device is most accurate in measuring low (\< 1.0 D) degrees of corneal astigmatism.


Eligibility criteria: Inclusion Criteria:

* 50 years of age and older
* Proof of eye exam within the last 3 months
* Corneal astigmatism of \<1.0 diopter

Exclusion Criteria:

* Prior history of refractive or corneal surgery
* Corneal trauma/disease
* Intraocular surgery

Primary outcomes:
measure: Measurement of corneal power
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03795532: Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value
Official title: Ultraslow Full-power SWL Versus Slow SWL in Renal Stones With High Attenuation Value
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Stones
Keywords: renal stones
SWL
High density stones
Ultraslow SWL
Slow SWL
Ramping
Pause
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2019-01-07
Enrollment: 124
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: Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value

Detailed description: To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones

Eligibility criteria: Inclusion Criteria:

* single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
* skin to stone distance (SSD) \> 11 cm
* BMI \> 30 Kgm/m2

Primary outcomes:
measure: stone free rate
timeFrame: 3 months following last session of SWL
Secondary outcomes:
measure: Complications rate
timeFrame: 3 months following last session of SWL
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef Hospitals
state: Outside U.S./Canada
Study officials:
affiliation: Beni-Suef University
name: Ahmad Aref Al-Dessoukey
role: STUDY_DIRECTOR
References:
Clinical trial NCT00921232: Assessment of the Burden Within the Dyad Patient/Caregiver
Official title: Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: Life-ending patient
caregiver
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Unité de REcherche en sciences Cognitives et Affectives URECA EA1059
name: University of Lille Nord de France
First posted: 2009-06-16
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is about the patients life ending and their caregiver, when a return to home is planned.

This is a behavioral sciences study (= interventional study for french law)


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Cancer for which no curative treatment is envisaged
* Palliative treatment only
* For the caregiver: designated by the patient like the referring individual

Primary outcomes:
measure: Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception)
timeFrame: At baseline, to the announcement of the exclusive palliative care
Secondary outcomes:
measure: Perception of the burden by the patient and its caregiver: search for potential predictive factors of the burden by statistic analysis HADS (The Hospital Anxiety and Depression Scale FRI (The Family Relationship Index)
timeFrame: At baseline, to the announcement of the exclusive palliative care
measure: Search for factors influencing the return at home of the life-ending patients by statistic analysis
timeFrame: Death
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Nicolas PENEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210132: Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Official title: Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Cancer
Keywords: Thoracic surgery
postoperative pain
ropivacaine
inter pleural analgesia
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 90
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: The purposes of this study are:

1. To determine the efficacy of inter pleural analgesia
2. To determine the plasmatic concentration of ropivacaine by inter pleural road


Eligibility criteria: Inclusion Criteria:

* Thoracotomy for oncology thoracic surgery
* Secondary or primary cancer
* American Society of Anesthesiology (ASA) class 1 or 2

Exclusion Criteria:

* Ropivacaine hypersensibility
* Psychiatric disorders
* Incapacity of using visual analog scale

Primary outcomes:
measure: To compare the incidence and the score of pain between the patients with ropivacaine and the patients without ropivacaine delivered by inter pleural road
Secondary outcomes:
measure: To compare the morphine consumption during 48 hours
measure: To determine ropivacaine plasmatic concentration by inter pleural road during first 48 hours
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Study officials:
affiliation: Institut Bergonié
name: Jean-Pierre GEKIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: