louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05665439: Local Treatment for Bone Metastases
Official title: Study on Local Treatment for Patients With Bone Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 348
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 will carry out a prospective randomized controlled study to study the effect of different local treatment on disease control, quality of life, economic cost and even survival period of patients by randomly giving local radiotherapy or observation to patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients who are definitely diagnosed as malignant tumor by pathology or cytology;
2. At least one bone metastasis site;
3. Aged over 18;
4. ECOG：0-1；
5. The pain score is less than 5 or after vertebroplasty within 1 month.

Exclusion Criteria:

1. The expected life span is less than 3 months;
2. Spinal metastatic tumor stability score (SINS) is greater than 7;
3. Spinal cord compression;
4. The patient refused the treatment decision of the integrated team.

Primary outcomes:
measure: Disease control rate at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00331539: Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Official title: Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hearing Loss
Keywords: Cochlear implant
threshold (T) measurement
comfort (C) level
profound hearing loss
auditory stimuli
profound hearing loss patients eligible for the study should be capable of providing reliable
subjective counted thresholds and has good NRT recordings, implanted with
the Nucleus Freedom system
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochlear implant. Success of implantation largely depends on the adequacy of this map. Cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically deafened children. It requires competence of experienced audiologists with expertise in behavioral techniques for hearing function assessment.Our goal is to establish the offset correlation between objective measurements (NRT and ESRT) and the behavioral measurements of T \& Cs in different stimulation rates in the Freedom SP System.

Detailed description: An open trail. The implantees will go through their routine programming sessions after implantation, the specified data will be collected and analyzed in order to establish the offset correlation which we seek for.

Eligibility criteria: Inclusion Criteria:Patients eligible for the study should be capable of providing reliable subjective counted thresholds (e.g. children older than 12 years of age at CI or adults) and has good NRT recordings, implanted with the Nucleus Freedom system

-

Exclusion Criteria:Implantees With any other serious illness, Who can not give a reliable subjective counted thresholds

-

Primary outcomes:
measure: To find possible correlation between behavioral counted T & C levels at different stimulation rates and NRT thresholds using the Auto NRT and ESRT over time, from switch on up to 12 months period.
measure: To find possible changes over time in NRT thresholds (12 months period).
measure: To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion MC
Study officials:
affiliation: Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL
name: Michal Luntz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433939: Position Changes During Colonoscope Insertion Increases Patient Comfort
Official title: Position Changes During Colonoscope Insertion Increases Patient Comfort: a Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy Technique
Keywords: colonoscopy
position changes
patient comfort
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to gastroenterologists for colonoscopy.

Brief summary: The investigators wish to study the effects of position changes during colonoscope insertion on patient comfort. The investigators hypothesize that early position changes would reduce colonoscope loop formation and patient discomfort.


Eligibility criteria: Inclusion Criteria:

* age 19 years or older
* outpatient colonoscopy

Exclusion Criteria:

* inpatient
* unable to provide informed consent
* previous bowel resection, inflammatory bowel disease
* musculoskeletal disorder or other mobility issues limiting effective patient position changes.
* inadequate bowel preparation

Primary outcomes:
measure: Intensity and frequency of abdominal pain
timeFrame: 30min
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Jennifer Telford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04950439: Pyrophosphate and Arterial Calcification in Chronic Kidney Disease
Official title: Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.


Eligibility criteria: Inclusion Criteria:

* eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval

Exclusion Criteria:

1. kidney transplantation
2. acute inflammatory disease or active cancer

Primary outcomes:
measure: Plasma levels of PPI
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
affiliation: CHU de Nice, Service de Néphrologie
name: Favre Guillaume, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05853939: Measuring rTMS-induced Neuroplasticity With EEG Steady-state Visual-evoked Potentials
Official title: Inducing and Measuring Visual-evoked Potential Plasticity in Humans With Repetitive Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Visual Cortical Plasticity
Repetitive Transcranial Magnetic Stimulation
Visual Attention
Keywords: visual-evoked potentials
TMS
neuroplasticity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over: 1 Hz vs 10 Hz vs sham rTMS; stimulation to attended or unattended hemisphere
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of this study are to 1) use EEG steady-state visual evoked potentials as a noninvasive measure of the neuroplasticity induced by repetitive transcranial magnetic stimulation (rTMS), 2) use visual contrast detection paradigms as a behavioral measure of rTMS effects, and 3) to investigate how visual spatial attention augments or suppresses the neuroplastic impact of rTMS. Participants will observe visual stimuli on a screen while allocating their attention to different parts of the visual field and making responses when they observe changes in the visual stimuli. rTMS is performed to visual cortex using MRI-retinotopy neuronavigation. Then the visual task paradigm is performed again.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 to 65
* Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
* Left- or Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures

Exclusion Criteria:

* Those with a contraindication for MRIs (e.g. implanted metal)

  * Any unstable medical condition
  * History of head trauma with loss of consciousness
  * History of seizures
  * Neurological or uncontrolled medical disease
  * Active substance abuse
  * Diagnosis of psychotic or bipolar disorder
  * Currently taking medications that substantially reduce seizure threshold (e.g., bupropion, olanzapine, chlorpromazine, lithium)
  * Currently pregnant or breastfeeding

Primary outcomes:
measure: post-rTMS change in ssVEP Response Amplitude
timeFrame: 60 minutes
measure: post-rTMS change in visual contrast perceptual sensitivity
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00317239: VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Official title: Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
Chronic Kidney Disease
Iron
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 255
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Detailed description: This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Eligibility criteria: Inclusion Criteria:

* Males or females \> or = 12 years of age
* NDD-CKD subjects
* Baseline hemoglobin \< or = 11g/dl
* Stable erythropoietin (EPO) status

Exclusion Criteria:

* Known hypersensitivity to ferrous sulfate or IV iron
* Unstable EPO status
* Anemia not related to CKD
* Chronic, serious infection
* Recent IV iron
* Recent blood transfusion
* Recent blood loss
* Need for surgery
* Received investigational drug within 30 days
* Female subjects who are pregnant or lactating

Primary outcomes:
measure: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
timeFrame: anytime during the study
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
citation: Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.
citation: Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.
Clinical trial NCT03916939: Osteopathic Treatment to Alcohol Withdrawal Syndrome
Official title: Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Withdrawal
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Ecole Supérieur d'Ostéopathie
First posted: 2019-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The alcohol withdrawal syndrome has a hierarchical symptomatology depending on the severity (minor, moderate or severe). These signs express a state of psychic, behavioral and physical deprivation.

The management of withdrawal syndrome involves the establishment of pharmacological and psychosocial interventions.

Osteopathy is an exclusively manual practice whose purpose is to overcome the dysfunction of mobility of tissues of the human body. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in reducing alcohol withdrawal symptoms in adult patients.

Detailed description: The use of osteopathic techniques for facial equilibration decreases the severity of withdrawal symptoms experienced by patients hospitalized in a weekday hospital.

Eligibility criteria: Inclusion Criteria :

* Age\> 18 years
* Patient hospitalized for a programmed alcohol withdrawal
* Patient not abstinent with alcohol before hospitalization
* Signed informed consent

Exclusion Criteria :

* Minor patient
* Patient with an addiction other than alcohol (except tobacco and benzodiazepines)
* Previous participation in the OSTEOOL study

Primary outcomes:
measure: Cushman score (0 to 27)
timeFrame: Day one
Secondary outcomes:
measure: CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
timeFrame: day 0
measure: CIWA Ar test (0 to 67)
timeFrame: day 1
measure: CIWA Ar test (0 to 67)
timeFrame: day 2
measure: CIWA Ar test (0 to 67)
timeFrame: day 3
measure: CIWA Ar test (0 to 67)
timeFrame: day 4
measure: cardiac frequency (beat per minute)
timeFrame: day 1
measure: cardiac frequency (beat per minute)
timeFrame: day 3
measure: cardiac frequency (beat per minute)
timeFrame: day 4
measure: quality sleep scale (0 to 5)
timeFrame: day 0
measure: quality sleep scale (0 to 5)
timeFrame: day 1
measure: quality sleep scale (0 to 5)
timeFrame: day 2
measure: quality sleep scale (0 to 5)
timeFrame: day 3
measure: quality sleep scale (0 to 5)
timeFrame: day 4
measure: quantity of benzodiazepine mg per 24 hours
timeFrame: day 2
measure: quantity of benzodiazepine (mg per 24 hours)
timeFrame: day 3
measure: quantity of benzodiazepine (mg per 24 hours)
timeFrame: day 4
measure: Cushmamn score (0 to 27)
timeFrame: day 3
Other outcomes:
Locations:
city: Creteil
country: France
facility: Chi Creteil
Study officials:
References:
Clinical trial NCT00856739: Obesity and the Initiation of Knee Osteoarthritis
Official title: Obesity and Initiation of Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
arthritis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-03-06
Enrollment: 177
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged 20-60, of varying weights.

Brief summary: Healthy adults aged 20-60 of varying weights will participate in this minimally invasive study. There is one 4-hour appointment for which subjects are paid $120. The tests involve: 1 tube blood draw, 1 gait test (motion capture) and 1 MR of both knees.

Detailed description: The tests will be done at the VA and Stanford and are not dangerous or painful. They are designed to help us learn more about the relationship of excess weight on cartilage degradation by testing a biomarker in blood. Gait testing involves walking in a lab that is about 20 meters long about 20 times. MR involves lying in a tube for less than 1 hour.

Eligibility criteria: Inclusion Criteria:

* Healthy Adults aged 20-60 who have no history of LE surgery
* Healthy adults able to walk 30 minutes
* Healthy adults able to have MR

Exclusion Criteria:

* Adults who have had LE surgery
* Adults cannot walk 30 minutes
* Adults who cannot tolerate MR
* Adults with osteoarthritis

Primary outcomes:
measure: Gait Knee Adduction Moment
timeFrame: baseline or first and only visit.
measure: Cartilage Thickness
timeFrame: baseline or first and only visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Thomas P. Andriacchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blazek K, Favre J, Asay J, Erhart-Hledik J, Andriacchi T. Age and obesity alter the relationship between femoral articular cartilage thickness and ambulatory loads in individuals without osteoarthritis. J Orthop Res. 2014 Mar;32(3):394-402. doi: 10.1002/jor.22530. Epub 2013 Nov 26.
citation: Blazek K, Asay JL, Erhart-Hledik J, Andriacchi T. Adduction moment increases with age in healthy obese individuals. J Orthop Res. 2013 Sep;31(9):1414-22. doi: 10.1002/jor.22390. Epub 2013 Jun 4.
Clinical trial NCT05671939: Different Algorithm Models to Predict Postoperative Pulmonary Complications in Elderly Patients
Official title: Different Algorithm Models to Predict Postoperative Pulmonary Complications in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Complications
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: older patients received general anesthesia in Wuhan Union Hospital from January 1, 2014 to December 31, 2019.

Brief summary: Although a number of clinical predictive models were developed to predict postoperative pulmonary complications, few predictive models have been used in elderly patients. In this study, the researchers aim to compare different algorithms to predict postoperative pulmonary complications in elderly patients and to assess the risk of postoperative pulmonary complications in elderly patients.

Detailed description: Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has been an important predictor of postoperative pulmonary complications. As the world's population ages, more and more older people are undergoing surgery as indications for surgery expand. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we plan to use database information and different algorithms such as logistic regression, random forest, and other algorithms to build models respectively and evaluate the effects of the models.

Eligibility criteria: Inclusion Criteria:

1. Age 65 years or older
2. receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

1. preoperative mechanical ventilation
2. procedures related to a previous surgical complication
3. a second operation after surgery
4. organ transplantation
5. discharged within 24 hours after surgery
6. cardiac surgery

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: within one week after surgery
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00917839: The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Official title: Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: neuroprotection
multiple sclerosis
brain atrophy
mr-spectroscopy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* definitive multiple sclerosis according to Mc Donald criteria
* clinical isolated syndrome according to Mc Donald criteria
* Expanded Disability Status Scale Score 0-5
* Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion

Exclusion Criteria:

* relapse within 30 days prior to randomisation
* steroid pulse therapy within 30 days prior to randomisation
* pregnancy or poor contraception
* contraindication for lamotrigine
* depressive symptoms
* drugs with possible interaction with lamotrigine according to instruction leaflet
* other medical relevant conditions but multiple sclerosis
* clinically relevant laboratory results
* contraindication for MRI
* missing informed consent

Primary outcomes:
measure: N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
timeFrame: 12 months
measure: Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: relapse rate
timeFrame: 12 months
measure: Expanded disability status score
timeFrame: 12 months
measure: Fatigue Severity Score
timeFrame: 12 months
measure: N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
timeFrame: 6 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
Study officials:
References: