louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180180: Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO
Official title: Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Keywords: head-and-neck cancer
radiation therapy
F-18-FMISO
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes consecutive patients from the Department of Radiooncology with head and neck cancer (HNC) intended for a curative chemoradiotherapy.

Brief summary: The purpose of this study is to describe the regional and global tumor hypoxia in head-and-neck cancer during percutaneous radiation therapy


Eligibility criteria: Inclusion Criteria:

* histologically confirmed head-and-neck cancer not curable by surgery
* Karnofsky \> 70%
* tumor volume and localisation allow curative radiotherapy
* written consent

Exclusion Criteria:

* metastases
* earlier radiation therapy of head and neck
* pregnancy
* secondary malignancy excluding dermal carcinoma and Tis-carcinoma of cervix uteri
* psychiatric impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Nuclear Medicine
Study officials:
affiliation: Department of Nuclear Medicine
name: Joerg Kotzerke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396680: Ragweed-SPIRE Follow-On Study
Official title: An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis
Ragweed Allergy
Keywords: Ragweed Allergy
Rhinoconjunctivitis
Immunotherapy
Ragweed-SPIRE
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2015-03-24
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who completed at least 6 of 8 treatment visits in Study TR006

Brief summary: The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.


Eligibility criteria: Inclusion Criteria:

° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006

Exclusion Criteria:

* Subject or Investigator have been informed of treatment received in Study TR006
* Subjects with significant allergy to animal dander
* Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
* History of recurrent acute sinusitis or chronic sinusitis
* Received treatment with an investigational drug within 4 weeks of Screening
* Unable to understand study requirements or unable to communicate clearly with Investigator

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: Approximately 12 months after first dose in TR006
Secondary outcomes:
measure: Rescue Medication Score
timeFrame: Approximately 12 months after first dose in TR006
measure: Patient Global Assessment
timeFrame: Approximately 12 months after first dose in TR006
measure: Skin Prick Test
timeFrame: Approximately 12 months after first dose in TR006
measure: Immunoglobulin E Test
timeFrame: Approximately 12 months after first dose in TR006
Other outcomes:
Locations:
city: Kanata
country: Canada
facility: Kanata Allergy Services
state: Ontario
city: Mississauga
country: Canada
facility: Inflamax Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Allergy Asthma Associates
state: Ontario
Study officials:
References:
Clinical trial NCT02326480: Genetic Analysis of Childhood Obesity
Official title: Genetic Analysis of Childhood Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Childhood Obesity
Genetics
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
First posted: 2014-12-29
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three categories of obese children with their biological parents will be included (syndromic, familial, isolated obesity).

Brief summary: Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes


Eligibility criteria: Inclusion criteria:

* BMI \> curve of IOTF 30 (International Obesity Task Force)
* Age: between 6 months old and 18 years old
* Child presenting syndromic, isolated or familial obesity.

Exclusion Criteria:

* Common obesity
* Impossibility for blood sampling
* Impossibility to receive information
* Participation refusal of one of the parents
* Refusal to sign the informed consent
* Neither Healthcare coverage nor insurance

Primary outcomes:
measure: To identify the number of mutations or genes involved in genetic causes of Child obesity
timeFrame: first day of enrollement
Secondary outcomes:
measure: To identify the number of mutations in the population
timeFrame: first day of enrollement
measure: To identify the number of new mutations present in the children's DNA and absent from their parents' genomes
timeFrame: first day of enrollement
measure: To determine number of phenotypes associated to the child obesity genotype
timeFrame: first day of enrollement
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Louise Montagne
role: PRINCIPAL_INVESTIGATOR
affiliation: UMR CNRS 8199, Institut Pasteur de Lille
name: Philippe Froguel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749980: MyVHL: Patient Natural History Study
Official title: MyVHL: Patient Natural History Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Von Hippel-Lindau Disease
Hereditary Leiomyomatosis and Renal Cell Cancer
Birt-Hogg-Dube Syndrome
SDHB Gene Mutation
Keywords: VHL
BHD
HLRCC
SDHB
MyVHL
Lead sponsor: VHL Alliance
Sponsor class: OTHER
Collaborators: name: National Organization for Rare Disorders
First posted: 2018-11-21
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with von Hippel-Lindau Disease (VHL)

Brief summary: MyVHL is a multi-patient database which helps researchers identify patterns across VHL patients. MyVHL provides you -and researchers -with more complete information about VHL, like how your lifestyle, medications, and other factors impact the disease and quality of life. These insights help you better understand the condition and help researchers know where to focus their efforts.

Due to its rarity, there is less understanding of VHL and the factors that may have an impact. The data individuals provide in MyVHL helps researchers identify and uncover factors that may increase risk, inhibit or slow tumor growth, or lead to an effective cure.


Eligibility criteria: Inclusion Criteria:

* All patients with von Hippel-Lindau Disease (VHL)

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation.
timeFrame: Through study completion, an average of 1 year.
measure: Size of tumors in patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VHL Alliance
state: Massachusetts
Study officials:
affiliation: VHL Alliance
name: Joshua Mann, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larcher A, Rowe I, Belladelli F, Fallara G, Raggi D, Necchi A, Montorsi F, Capitanio U, Salonia A; OSR VHL Program. Von Hippel-Lindau disease-associated renal cell carcinoma: a call to action. Curr Opin Urol. 2022 Jan 1;32(1):31-39. doi: 10.1097/MOU.0000000000000950.
Clinical trial NCT04078880: Iron Supplementation in Hip/Knee Surgery
Official title: Sideral Forte in Prosthetic Hip and Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Hip Arthropathy
Knee Arthropathy
Anemia
Iron Poor Blood
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.


Eligibility criteria: Inclusion Criteria:

* Males and females
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery

Exclusion Criteria:

* ASA 4
* Present or past neuropsychiatric conditions
* Hip or knee revision surgery
* Use of iron as dietary supplement
* Known erythrocytosis
* Incompatible hypersensitivities
* Iron metabolism disorders
* Lymphoproliferative disorders

Primary outcomes:
measure: Change of blood hemoglobin levels
timeFrame: Baseline and 30 days +/- 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Paolo Perazzo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06693180: Registry HBOT in DFU
Official title: Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot Ulcers
Keywords: HBOT
Diabetic foot ulcer
Hyperbaric Oxygen Therapy
DFU
Peripheral arterial disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 600
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: Adult patients suffering from diabetes and peripheral ischaemia who have a diabetic foot ulcer for longer than 4 weeks.

Brief summary: Overview of available data to assess the benefits of HBOT to DFU patients

Detailed description: 10 year retrospective registry to measure outcomes regarding major amputations, mortality, hospital admissions in patients with a diabetic foot ulcer with peripheral ischaemia. Two groups will be compared: complementary HBOT and a control group.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Meggitt-Wagner classification grade 2-4, existing \> 4 weeks
* Complete 1 year follow-up

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
* Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within the last 3 months
* Metastasized malignancy
* Left ventricular ejection fraction (EF) \<20% or external pacemaker
* Recent thoracic or middle ear surgery
* Severe epilepsy
* Uncontrollable high fever
* Pregnancy

Primary outcomes:
measure: Major amputation rate
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Amputation-free survival rate
timeFrame: 1 year
measure: Complete wound healing
timeFrame: 1 year
measure: Pain score
timeFrame: 1 year
measure: Additional vascular interventions
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Center
name: Joost R Meijering, MD
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Center
name: Dirk T Ubbink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543580: TEAS-induced Analgesia: Dual vs Single Acupoints
Official title: Transcutaneous Electrical Acupoint Stimulation Decreases Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy: Dual Acupoints Versus Single Acupoint in a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative
Acute Pain
Chronic Pain
Keywords: mastectomy
transcutaneous electrical acupoint stimulation
acute pain
chronic pain
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 153
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: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of transcutaneous electric acupoint stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and postoperative pain in patients undergoing radical mastectomy


Eligibility criteria: Inclusion Criteria:

* patients aged from 18 to 65 yrs
* body mass index (BMI) of 18 to 30 kg/m2
* elective radical mastectomy under general anesthesia

Exclusion Criteria:

* contradictions to electric stimulation
* difficulties in communication
* histories of general anesthesia, drug or alcohol abuse or addiction
* cardiac dysfunction or severe hypertension, confirmed hepatic dysfunction and renal impairment
* participants recruited into other clinical trials during last three months

Primary outcomes:
measure: dose of remifentanil during anesthesia
timeFrame: from start of anesthesia to extubation, on average 2 hours
Secondary outcomes:
measure: time to recall
timeFrame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
measure: time to extubation
timeFrame: from end of remifentanil infusion to extubation,approximately 10 minutes on average
measure: incidence of respiratory depression during recovery
timeFrame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
measure: incidence of nausea and vomiting during recovery
timeFrame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
measure: visual analogue scale during recovery
timeFrame: from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average
measure: visual analogue scale at 24 hour after surgery
timeFrame: from end of surgery to 24 hours after surgery, totally 24 hours
measure: pain score at 3 months after surgery
timeFrame: from discharge from hospital to 3 months after surgery, approximately 3 months
measure: pain score at 6 months after surgery
timeFrame: from discharge from hospital to 6 months after surgery, approximately 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Lize Xiong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03275480: Institut Paoli Calmettes Myelodysplastic Syndromes Database
Official title: Institut Paoli Calmettes Myelodysplastic Syndromes Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic Syndromes
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with new diagnosis of Myelodysplastic Syndromes

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of Myelodysplastic Syndromes

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival of patients with myelodysplastic syndrome(MDS)
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Paca
Study officials:
affiliation: Institut Paoli-Calmettes
name: Norbert Vey, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278680: Incentives for Moving
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedentary Lifestyle; Obesity; General Well-being
Keywords: Behavioral economics
Incentives
Health
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Carnegie Mellon University
First posted: 2011-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Employees of Blue Shield of California (BSC) will be recruited to participate to regularly use Walkstations. Some participants will be randomly assigned to a "hold out" control condition and the remainder will be assigned to one of two experimental treatments: Personal Incentive vs. Charitable Incentive. In the Personal Incentive condition people will be paid $3 for every completed Walkstation session, whereas for participants in the Charitable Incentive condition $3 will be donated to a specific charity. The incentives will operate for approximately 45 days and then for an additional 45 days participants in the two experimental conditions will have access to the Walkstations. Participants in the hold out control condition will begin using the Walkstations after the initial 90 day period.


Eligibility criteria: Inclusion Criteria:

* Must pass the ParQ

Exclusion Criteria:

* Ineligible if person did not pass ParQ AND did not provide doctor's note authorizing their participation.

Primary outcomes:
measure: Walkstation usage
timeFrame: 45 days
Secondary outcomes:
measure: Questionnaire
timeFrame: baseline; 45 days; 90 days
measure: Walkstation usage
timeFrame: 90 days
measure: Biometrics
timeFrame: baseline & 45 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Blue Shield of California
state: California
Study officials:
References:
Clinical trial NCT00522080: Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates
Official title: Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip and Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2007-08-29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: Objective: To study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (OA) in the general population.

Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. A physical examination and knee or hip radiographs were offered when the screen was positive. A sample of individuals with negative screens was also examined. The diagnosis of hip/knee OA was based on either American College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic stage 2 or greater. Prevalence rates were estimated with correction for the performance of the screening procedure.


Eligibility criteria: Inclusion Criteria:

* Individual aged 40 to 75 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Rheumatology department, Nice University hospital
Study officials:
affiliation: CHU NICE
name: christian h roux, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097080: Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
Official title: Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Nobilis Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 60
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: This study evaluates the hypothesis that the gas mixture with xenon will have a positive effect on the symptoms in patients with Parkinson's Disease. The study will test the hypothesis that the gas mixture with xenon has a symptomatic treatment potential for patients with Parkinson's Disease, as measured by change from baseline in the Unified Parkinson Disease Rating Scale (UPDRS).


Eligibility criteria: Inclusion Criteria:

* The patient must be male or female over the age of 18.
* The subject must have idiopathic Parkinson's disease.
* The subject has Stage III by Hoehn and Yahr in the "on" state on a screening visit
* Subjects suffering from anxiety, depression, cognitive dysfunction
* Dopaminergic drugs should be taken in a stable dosage for 28 days prior to registration, and throughout the study
* Patients who have signed an approved consent form and are consistent with both the clinical trial plan and follow-up.

Exclusion Criteria:

* Patients have atypical parkinsonism (eg, neuroleptics, metoclopramide, flunarizin), metabolic neurodegenerative disorders (eg, Wilson's disease), encephalitis, cerebrovascular disease or degenerative disease (e.g. progressive supranuclear palsy)
* Patients who received deep brain stimulation
* Patients with cancer, HIV, kidney or liver disease.
* Patients taking new antipsychotic, antidepressant, anxiolytic or narcotic drugs for less than 3 months

Primary outcomes:
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: Baseline to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Addictology
city: Moscow
country: Russian Federation
facility: MONIKI
Study officials:
References: