louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06490497: Expectations and Needs of a Glioblastoma Caregiver
Official title: Analysis of the Expectations and Needs of a Caregiver of a Glioblastoma Patient Undergoing in Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: family caregiver
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of a person with glioblastoma glioblastoma undergoing oncology treatment

Brief summary: Cancers of the central nervous system have a poor prognosis. Glioblastoma is most common glial tumor of the central nervous system. The presence of a tumour in the brain determines the particular and specific nature of care for these patients and their families. Symptoms affect daily life and the balance of the family sphere.It's easy to imagine a difficult and disturbed family's daily routine.

Caregivers find themselves in great distress but can still benefit from support to lighten the domestic burden, and financial burden, thanks to the various recommendations of successive Cancer Plans. In fact, support for patients and their families during the illness and after is one of the key points of the programs in place. The aim of this research will be to provide food for thought in order to improve the support provided to family and friends.


Eligibility criteria: Inclusion Criteria:

* Caregivers of a person with glioblastoma glioblastoma undergoing oncology treatment
* Caregivers aged 18 and over

Exclusion Criteria:

- Patient's opposition to participating in the study

Primary outcomes:
measure: Difficulties and specific needs of a caregiver
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT02287597: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer eligible for second-line chemotherapy and Avastin in Croatia.

Brief summary: This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \>/=18 years
* Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC)
* First line progression-free survival (PFS) \>6 months
* Eligible for second-line chemotherapy regimen
* Period between first progression and start of second line treatment with Avastin and chemotherapy \</=6 weeks

Exclusion Criteria:

* Contraindications, warnings and precautions for use specified in the Avastin SmPC

Primary outcomes:
measure: Effectiveness: Second-line time to progression, in months
timeFrame: Time between treatment initiation and tumor progression or death from cancer related cause, with censoring of patients who are lost to follow-up; up to 2 years
Secondary outcomes:
measure: Safety (composite outcome measure): Incidence of all adverse events, adverse events of special interest (AESI) for bevacizumab and pregnancies reported in second line mCRC treatment with Avastin plus chemotherapy
timeFrame: Up to 2 years
measure: Safety (composite outcome measure): Incidence, nature and severity of all serious adverse events reported in second line mCRC treatment with Avastin plus chemotherapy and information on outcome and action taken with the drug
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
city: Split
country: Croatia
facility: Uni Hospital Split; Oncology & Radiotherapy
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Uni Hospital For Tumours; Dept of Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00991497: A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
Official title: A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: varicose veins
foam sclerotherapy
compression bandaging
duration
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-10-08
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: The purpose of this study is to compare the results of foam treatment of varicose veins (foam sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after treatment.


Eligibility criteria: Inclusion Criteria:

* Proven truncal venous incompetence (of \>1 second duration) on venous duplex scanning. (Great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory thigh vein (AATV) or other major tributary).
* Agreed preference for foam sclerotherapy treatment.
* Signed consent form agreeing to be part of the trial.

Exclusion Criteria:

* Total deep venous reflux.
* Known allergy to liquid sclerosant.
* Pregnancy or breast feeding.
* Arterial disease.

Primary outcomes:
measure: Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
timeFrame: 2 and 6 weeks
Secondary outcomes:
measure: Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment
timeFrame: 2 and 6 weeks
measure: Change in SF-36 score from time of treatment to 6 weeks after treatment.
timeFrame: 6 weeks
measure: Target vein occlusion rate on duplex imaging at 6 weeks
timeFrame: 6 weeks
measure: Number and type of complications seen
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital NHS Trust
state: Gloucestershire
Study officials:
affiliation: Gloucestershire Royal Hospital NHS Trust
name: Jonothan J Earnshaw, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg. 2010 May;97(5):650-6. doi: 10.1002/bjs.6951.
Clinical trial NCT03384797: Blood Biomarker in Early Parkinson's Disease
Official title: Blood Biomarker in Early Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: blood
biomarker
Parkinson's disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients will be recruited from the Duke Movement Disorders Clinic. Healthy adult volunteers will be recruited from the healthy volunteer registry at DEPRU or caregivers of patients seen at the Duke Movement Disorders Clinic.

Brief summary: Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.


Eligibility criteria: Inclusion

Age matched to PD patient Parkinson's Disease Patients:

* 50 years and older
* PD patient who is seen at the Duke Movement Disorders Center
* Early PD diagnosis (Hoehn and Yahr scale ≤ 3)
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Healthy Control Participants:

* 50 years and older
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Exclusion Criteria:

Parkinson's Disease Patients:

* Known additional neurological disease
* Clinical trial intervention within the last 6 months

Healthy Control Participants:

* Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)
* Clinical trial intervention within the last 6 months

Primary outcomes:
measure: Biological marker of Parkinson's disease
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Facility
state: North Carolina
Study officials:
affiliation: Duke University
name: Laurie Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04502797: A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)
Official title: A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The intervention consists of participants completing the ePVA every other week during radiation therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data, including pain reports and patient-reports of pain medications, will be sent to providers to inform their clinical decisions.


Eligibility criteria: Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Histologically diagnosed HNC
2. Undergoing RT with or without chemotherapy,
3. English speaking,
4. aged 18 years or older.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to attend scheduled appointment due to geographical, social or mental reseaons,
2. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitve or physical impairment).

Primary outcomes:
measure: Patient completion of 6 out of 7 assessments
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline, week 4, week 12, week 24
measure: Change in pain severity
timeFrame: Baseline, Day 7, Day 21, Day 35
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Rory Meyers College of Nursing
state: New York
Study officials:
affiliation: NYU Langone Health
name: Janet VanCleave, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00969397: Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
Official title: Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Port Wine Stain
Keywords: Birthmark
PWS
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2009-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Detailed description: Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.

The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Eligibility criteria: Inclusion Criteria:

* 16 years of age and older
* Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

* Less than 16 years old
* Are pregnant
* Have skin cancer
* Currently taking immunosuppressive or steroids or photosensitizing drugs
* Current participation in any other investigational drug evaluation
* Concurrent use of known photosensitizing drugs

Primary outcomes:
measure: Improve PWS lesion blanching.
timeFrame: 8 weeks
Secondary outcomes:
measure: To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S Nelson, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01350297: Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency
Official title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetraplegia
Keywords: tetraplegia
reinnervation
phrenic nerve
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.


Eligibility criteria: Inclusion Criteria:

* tetraplegia c3-c4
* respiratory insufficiency

Exclusion Criteria:

* PM

Primary outcomes:
measure: recovery of spontaneous ventilation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: VERIN
Study officials:
affiliation: University Hospital, Rouen
name: VERIN Eric, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00000297: Effects of Labetalol on Nicotine Administration in Humans - 14
Official title: Effects of Labetalol on Nicotine Administration in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine

Detailed description: The purpose of this study is to determine whether labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine in humans. A total of 12 subjects will participate in the double blind placebo controlled, outpatient study. Subjects will have 3 separate experimental sessions 3-9 days apart. On each of the experimental sessions, a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered. Two hours after labetalol or placebo treatment, subjects will receive 15 variance grams nicotine base/kg intravenously. Several physiological endocrine and subjective measures will be obtained during the sessions. We propose that blockage of adrenergic receptors by labetalol will significantly block the physological and subjective effects of nicotine.

Eligibility criteria: Inclusion Criteria:

Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.

Primary outcomes:
measure: Subjective
measure: Physiologic measures
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02924597: Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
Official title: Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.


Eligibility criteria: Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
* patients scheduled for robot-assisted laparoscopic nephron sparing surgery
* patients with normal contralateral renal function (diﬀerential renal function of \>40% as determined by radionuclide scintigraphy)
* patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

* patients' aged \>80 years
* patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
* patients not able to tolerate the robot-assisted laparoscopic procedure
* patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney
* patients with the renal tumor involving urinary collecting system

Primary outcomes:
measure: The absolute change in glomerular ﬁltration rate (GFR) of the aﬀected kidney
timeFrame: baseline and 12 months
measure: The changes of estimated GFR (eGFR)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: estimated blood loss
timeFrame: during surgery
measure: changes in GFR of total kidneys by renal scintigraphyby
timeFrame: baseline and 12 months
measure: surgical margin
timeFrame: postoperative，up to 2 weeks after surgery
measure: postoperative complications
timeFrame: postoperative，up to 30 days
measure: progression-free survival
timeFrame: 12 months
measure: local recurrence
timeFrame: 12 months
measure: operative time
timeFrame: During surgery
measure: Hospital stay time
timeFrame: The time from the surgery day to patient discharge, up to 2 weeks
measure: changes in GFR of total kidneys by renal scintigraphyby of 6 month
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Shanghai Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06259097: Different Medications to Induce Labor
Official title: Misoprostol Versus Pitocin for Induction of Labor in Patients With BMI > 30: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pregnancy
Labor
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bronx Care Health System
First posted: 2024-02-14
Enrollment: 300
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: This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.

Detailed description: This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.

Eligibility criteria: Inclusion Criteria:

- Pregnant patient presenting to labor \& delivery for induction of labor with a BMI \> = 30

Exclusion Criteria:

- Pregnant patient presenting to labor \& delivery for induction of labor with BMI \< 30

Primary outcomes:
measure: Time from induction to delivery
timeFrame: start of induction until delivery
Secondary outcomes:
measure: Delivery outcome
timeFrame: at delivery
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Care Health System
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nicola F Tavella, MPH
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Angela Bianco, MD
role: PRINCIPAL_INVESTIGATOR
References: