louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03117868: Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
Official title: Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Morality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 310
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: All the patients operated with an EFSF and meeting the inclusion criteria

Brief summary: Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.

In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.

The reduction of the incidence of post-operative complications includes the identification of risk factors.

No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.


Eligibility criteria: Inclusion Criteria:

* All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens
* Patients transferred to the CHU after being cared for in another structure will be included.
* If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized

Exclusion Criteria:

* Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)
* Fractures of the upper end of the femur associated with polytrauma will not be included.

Primary outcomes:
measure: Mortality at 6 months of EFSF patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT06804668: Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
Official title: Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Brain stimulation
Parkinson
Movement disorder
Non-invasive brain stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own.

Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.


Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of Parkinson's disease, aged between 40 and 70, who provide verbal and written informed consent will be included. Patients should have access to a computer system for video calls and completing the questionnaires, and they must be able to use it.

Exclusion Criteria:

* Psychiatric symptoms such as moderate or severe depression
* Cranial metal implants
* Cardiac pacemaker
* Epilepsy, stroke
* Substance abuse
* Inability to adjust the neoprene cap with the electrodes independently due to movement disturbances

Primary outcomes:
measure: Feasibility of repeated network-targeted multifocal tDCS at home
timeFrame: 8 days.
Secondary outcomes:
measure: Safety of repeated network-targeted multifocal tDCS at home
timeFrame: 8 days.
measure: Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects
timeFrame: 8 days.
measure: Motor outcome
timeFrame: 8 days.
Other outcomes:
measure: Support
timeFrame: 8 days.
Locations:
city: Boston
country: United States
facility: Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA
name: Michael D Fox, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544668: A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases
Official title: A Clinical Study to Establish a Dynamic Prediction Model for Bone Metastases Based on Breast Cancer Real-world Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Bone Metastases
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 3500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3500 breast cancer patients diagnosed between 2010 and 2020.

Brief summary: The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

Detailed description: Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(\~70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with breast cancer by histopathology;
2. Age between 20 and 70 years old;
3. The first diagnosis time is between 2010 and 2020;
4. Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.;
5. Sufficient available follow-up information.

Exclusion Criteria:

1. Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment);
2. With distant metastasis at the initial diagnosis;
3. Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis);
4. Other malignant tumors;
5. Unclear information about distant metastasis.

Primary outcomes:
measure: To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT02045472: A Study of VIS410 to Assess Safety and Pharmacokinetics
Official title: Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
Monoclonal antibody
Lead sponsor: Visterra, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Body mass index between 18 and 33 kg/m2, inclusive
* Normal labs
* Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria:

* Prior receipt of antibody or biologic therapy
* History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
* Any chronic condition requiring daily prescription or over the counter medication
* History of a previous severe allergic reaction
* Drug or alcohol abuse within previous 12 months
* Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
* Positive pregnancy test
* Breast feeding
* Positive drug or alcohol test at screening or check-in
* Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration

Primary outcomes:
measure: Safety assessment
timeFrame: 120 days post-infusion
Secondary outcomes:
measure: Pharmacokinetic analysis
timeFrame: 56 days post-infusion
measure: Immunogenicity
timeFrame: 120 days post-infusion
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Davita Clinical Research
name: J K Berg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.
Clinical trial NCT01931072: Exercise-induced Changes in DNA-methylation
Official title: The Effect of Exercise on Maximal Aerobic Capacity, DNA-methylation and Gene Expression in Healthy Elderly Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Exercise
High-intensity interval training
Moderate training
Healthy elderly
Skeletal muscle
DNA-methylation
Gene expression
subjects
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-08-29
Enrollment: 37
Sex: MALE
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. In addition, the investigators will determine whether the intensity of the training could be an affecting factor of the possible DNA-methylation change as well. The null hypothesis was that no such exercise-induced changes occur.


Eligibility criteria: Inclusion Criteria:

* Male
* 70-75 years old
* Signed written informed consent

Exclusion Criteria:

* Incompatible with exercise
* Known cardiac disease
* Active cancer
* Significant pulmonary disease
* Uncontrolled hypertension
* Use of blood thinning medicine (except Albyl-E)
* Drug abuse
* Alcohol abuse
* Finishing less than 80% of the exercise sessions (this complies to the training groups)

Primary outcomes:
measure: DNA-methylation
timeFrame: 8 weeks
measure: Gene Expression
timeFrame: 8 weeks
Secondary outcomes:
measure: Maximal Aerobic Capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institute for Circulation and Medical Imaging, NTNU
Study officials:
affiliation: National Taiwan Normal University
name: Ulrik Wisløff, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02005172: Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Official title: Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia, Palpitations, Lightheadedness
Keywords: arrhythmia, palpitations, lightheadedness
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.

Hypothesis:

1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
2. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.


Eligibility criteria: Inclusion Criteria:

Patients \>18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.

Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.

Exclusion Criteria:

1. Patients \<18 years of age.
2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
3. Patients with NYHA class IV heart failure.
4. Patients with unstable angina.
5. Patients with syncope as the presenting symptom.
6. Patients unable to or unwilling to use the device.

Primary outcomes:
measure: Validation of an iPhone-based Event Recorder for Arrhythmia Detection
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Dent Towers
state: New York
Study officials:
affiliation: University at Buffalo
name: Anne Curtis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403572: A Study of Cerebral-circulatory Response to Intravenous Antihypertensive Treatment in Women With Serious Preeclampsia
Official title: A Study of Cerebral-circulatory Response to Intravenous Antihypertensive Treatment in Women With Serious Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Trans cranial Doppler
Cardiac output
systemic vascular resistance
blood pressure
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with moderate-to-severe pre-eclapmsia

Brief summary: The purpose of this study is a systematical registration of hemodynamic measurements (cardiac output, blood pressure and systemic vascular resistance) in women with serious preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Women with serious preeclampsia

Primary outcomes:
measure: Hemodynamic and cerebral-circulatory variations in preeclamptic women
timeFrame: days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Eldrid Langesæter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465972: The Treatment of Insomnia in Patients With HIV Disease
Official title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Insomnia
Keywords: HIV
Insomnia
Cytokines
Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

Detailed description: Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.

Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.

Eligibility criteria: Inclusion Criteria:

* Insomnia
* HIV Seropositive
* Stable HIV Disease

Exclusion Criteria:

* Other psychiatric illnesses
* Unstable HIV disease

Primary outcomes:
measure: Response: Change in Insomnia Severity Rating Scale at 3 Months.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Piper Fatigue Scale at 3 Months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew D Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. doi: 10.1097/01.psy.0000151771.46127.df.
citation: Low Y, Preud'homme X, Goforth HW, Omonuwa T, Krystal AD. The association of fatigue with depression and insomnia in HIV-seropositive patients: a pilot study. Sleep. 2011 Dec 1;34(12):1723-6. doi: 10.5665/sleep.1446.
Clinical trial NCT02192372: Metabolic Syndrome and Contrast Induced Nephropathy
Official title: Impact of Metabolic Syndrome on Development of Contrast Induced Nephropathy After Elective Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Induced Nephropathy
Metabolic Syndrome
Keywords: creatinine
glomerular filtration rate
metabolic syndrome
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective percutaneous coronary intervention Patients with metabolic syndrome

Brief summary: Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. An observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

Patients must be scheduled for elective percutaneous coronary intervention Clinical diagnosis of metabolic syndrome Patients must give informed consent

Exclusion Criteria:

Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention Exposure to contrast agent within 1 week before the procedure.

Primary outcomes:
measure: Contrast induced nephropathy
timeFrame: 24-48 hours after the percutaneous coronary intervention
Secondary outcomes:
measure: glomerular filtration rate
timeFrame: 48 hours after the percutaneous coronary intervention
Other outcomes:
measure: Cut-off point for baseline glomerular filtration rate to predict development of contrast induced nephropathy
timeFrame: baseline glomerular filtration rate
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine, Department of Cardiology
Study officials:
affiliation: Ankara University
name: Ozgur Ulas Ozcan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozcan OU, Adanir Er H, Gulec S, Ustun EE, Gerede DM, Goksuluk H, Tulunay Kaya C, Erol C. Impact of metabolic syndrome on development of contrast-induced nephropathy after elective percutaneous coronary intervention among nondiabetic patients. Clin Cardiol. 2015 Mar;38(3):150-6. doi: 10.1002/clc.22364.