louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04526314: Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older
Official title: Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Adenocarcinoma
Keywords: stage 3 colon cancer
elderly
survival
surgery
chemotherapy
Lead sponsor: Registre des Tumeurs Digestives du Finistère
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 308
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinical data

Brief summary: The objective of this study was to assess survival trends in elderly patients with stage III colon cancer

Detailed description: This retrospective population-based study included patients aged 80 years and older with stage III colon adenocarcinoma who underwent surgery between 2007 and 2014.

Eligibility criteria: Inclusion Criteria:

• Stage 3 colon adenocarcinoma

Exclusion Criteria:

* Rectal tumors
* Patients receiving neo-adjuvant chemotherapy or radiotherapy
* Tumours of the appendix
* Tumours with histology other than adenocarcinoma

Primary outcomes:
measure: Overall survival
timeFrame: 2007-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Registre de tumeurs digestives du Finistère
Study officials:
affiliation: REGISTRE DES TUMEURS DIGESTIVES DU FINISTERE
name: Michel Robaskiewicz, MD PhD
role: STUDY_CHAIR
References:
citation: Badic B, Oguer M, Cariou M, Kermarrec T, Bouzeloc S, Nousbaum JB, Robaszkiewicz M, Queneherve L. Prognostic factors for stage III colon cancer in patients 80 years of age and older. Int J Colorectal Dis. 2021 Apr;36(4):811-819. doi: 10.1007/s00384-021-03861-6. Epub 2021 Feb 2.
Clinical trial NCT02183714: The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
Official title: The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.


Eligibility criteria: Inclusion Criteria:

* Psychophysiologic insomnia
* Severity: mild to moderate
* Duration: subacute to chronic
* Subjects age \> 18 and \< 65, men or women
* Subject had to give written informed consent

Exclusion Criteria:

* Regular use of psycho-active drugs
* Work in shifts
* Use of psychoactive drugs during the past 30 days
* Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
* known hypersensitivity to any of the ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential not using an established contraceptive
* Drug and alcohol abuse
* Participation in another trial within the past 30 days

Primary outcomes:
measure: Change in sleep quality on a 100 mm visual analogue scale (VAS)
timeFrame: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment
Secondary outcomes:
measure: Feeling refreshed score (six point rating scale)
timeFrame: up to week 5
measure: Ability to concentrate and perform well score (six point rating scale)
timeFrame: up to week 5
measure: Night-time total sleeping time
timeFrame: up to week 5
measure: Difficulty in falling asleep (five point rating scale)
timeFrame: up to week 5
measure: Number of awakenings during the night
timeFrame: up to week 5
measure: Physical and mental health state by short form (SF-36) questionnaire
timeFrame: up to week 5
measure: Anxiety by State-Trait Anxiety Inventory
timeFrame: up to week 5
measure: Frequency of adverse events
timeFrame: up to week 5
measure: Global clinical impression on insomnia by short questionnaire
timeFrame: up to week 5
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05821114: End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia
Official title: The Effects of High-Flow Nasal Cannula and Body Position On Atelectasis Using Electric Impedance Tomography in Children Awakening From Propofol Anesthesia: A Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atelectasis, Postoperative Pulmonary
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.

The main question\[s\] it aims to answer are:

* High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
* Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?

Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.

And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing airway surgery with high flow nasal oxygen

Exclusion Criteria:

* Loss of spontaneous ventilation during surgery
* less than 1 months
* cyanotic patients

Primary outcomes:
measure: Changes in Electric Impedance Tomography parameter
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
Study officials:
References:
Clinical trial NCT01763814: Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Official title: A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Lead sponsor: Chicago Anesthesia Pain Specialists
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.

Detailed description: This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:

Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter

Eligibility criteria: Inclusion Criteria:

* 18- 90 years old
* Scheduled for total knee arthroplasty

Exclusion Criteria:

* Redo surgery on the same knee
* BMI ≥45
* Radicular pain in the same leg
* Allergy to local anesthetics
* Opioid habituation
* Pregnancy
* Contraindication to regional block
* Inability to communicate with hospital staff or investigators.
* Neuropathy of any etiology in the surgical extremity.

Primary outcomes:
measure: Change in the Numeric Rating Pain Score
timeFrame: Postoperative
Secondary outcomes:
measure: Change in the ability to move the knee
timeFrame: Postoperative
measure: Change in Supplemental pain medications
timeFrame: Postoperative
Other outcomes:
measure: Change in the overall satisfaction
timeFrame: Postoperative
Locations:
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
Study officials:
affiliation: Chicago Anesthesia Pain Specialists
name: Antony Tharian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00298714: Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C
Official title: Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Liver Fibrosis
Keywords: Hepatitis C, Chronic
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis.

The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).


Eligibility criteria: Inclusion Criteria:

* age between 35 and 65 years
* chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score).
* non-responder or contraindication to antiviral therapy.

Exclusion Criteria:

* any other cause of liver disease
* HIV positive
* alcohol consumption
* arterial hypertension
* creatinine \> 1.5mg/dL
* treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months.
* antiviral therapy in the past 12 months
* contraindications to oral losartan

Primary outcomes:
measure: Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
name: Pere Ginès, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
name: Vicente Arroyo, M.D.
role: STUDY_CHAIR
References:
citation: Colmenero J, Bataller R, Sancho-Bru P, Dominguez M, Moreno M, Forns X, Bruguera M, Arroyo V, Brenner DA, Gines P. Effects of losartan on hepatic expression of nonphagocytic NADPH oxidase and fibrogenic genes in patients with chronic hepatitis C. Am J Physiol Gastrointest Liver Physiol. 2009 Oct;297(4):G726-34. doi: 10.1152/ajpgi.00162.2009. Epub 2009 Jul 23.
Clinical trial NCT02023814: Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest
Official title: Peripheral Blood CD34+ Cells Count as Predictor of Stem Cell Harvest After Chemotherapy and G-CSF. A Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Stem Cell Harvest Failure
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent mobilization

Brief summary: Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest


Eligibility criteria: Inclusion Criteria:

* Mobilization with chemotherapy and G-CSF
* Years 2002-2013

Exclusion Criteria:

* mobilization with G-CSF alone
* mobilization with plerixafor

Primary outcomes:
measure: Blood Stem cell harvest failure rate
timeFrame: 7 days from hematological recovery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale S Croce e Carle
name: Roberto Sorasio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02152514: RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo
Official title: Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thoracic Surgery, Video-assisted
Postoperative Pain
Rachianesthesia
Sufentanil
Morphine
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.

Detailed description: This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.

Eligibility criteria: Inclusion Criteria:

* VATS
* ASA 1,2 or 3
* Minimum weight of 50 kg
* Patient able to consent

Exclusion Criteria:

* Patient refusal
* Patient unable to understand PCA
* Contraindication to rachianalgesia
* Zona
* Pregnancy
* Over 30 mg of morphine during the last 24 hours
* Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain
* Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic
* Intubation over 1 hour after surgery (unability to use PCA)
* High risk of conversion to thoracotomy
* Unable to perform rachianalgesia due to technical difficulties

Primary outcomes:
measure: Hydromorphone consommation
timeFrame: 24hr
Secondary outcomes:
measure: Pain
timeFrame: Every 4h x 24hr
measure: Adverse effects of narcotics
timeFrame: Every 4h x 24hr
measure: Adverse reactions associate with rachianesthesia
timeFrame: 24hr
measure: Adverse reactions of narcotics
timeFrame: 24hr
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Yanick Sansoucy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02441114: Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Official title: A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).

Detailed description: Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.

Eligibility criteria: Inclusion Criteria:

* Age between 19 to 45, healthy male subjects (at screening)
* Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent

Exclusion Criteria:

* Volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUClast)
timeFrame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Secondary outcomes:
measure: Time to Maximum Concentration (Tmax)
timeFrame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
measure: Maximum Observed Concentration (Cmax)
timeFrame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06267014: Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity
Official title: Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer-related Cognitive Difficulties
Keywords: virtual reality
cognitive rehabilitation
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.

Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age
* Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
* Maximum 2 years after completion of adjuvant treatment,
* Patients who have cognitive complaints at inclusion (answer yes to the question: 'Since your cancer treatment, have you had any difficulties with memory, concentration, etc.?)
* Patients planning to return to work or who have returned to work in the past year,
* Signature of informed consent prior to any specific procedure relating to the study,
* Patient affiliated to a social security system.

Exclusion Criteria:

* Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
* Patients with personality disorders and/or psychiatric pathology,
* Patients deprived of their liberty or placed under the authority of a guardian,
* Pregnant women

Primary outcomes:
measure: Proportion of patients adhering to the Virtual Reality program
timeFrame: At 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References: