louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668979: Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults
Official title: Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Fallers
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy older adults with a history of falls

Brief summary: The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.


Eligibility criteria: Inclusion Criteria:

1. Healthy older adults with a history of falls or complaints of gait instability
2. Able to walk independently for at least 10 minutes

Exclusion Criteria:

1. Systemic chronic or acute pathologies:

   1. Ischemic heart disease
   2. Orthopedic or Rheumatic diseases
   3. Severe vision problems
   4. Neurological disease: PD, AD, CVA
2. Patients who underwent brain surgery in the last 6 months prior to the study

Primary outcomes:
measure: usability of the system to detect Near Falls
timeFrame: one year
Secondary outcomes:
measure: Near Fall severity
timeFrame: one year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nir Giladi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391479: A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
Official title: A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed on or After Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Penile Cancer
Advanced Cancer
Metastatic Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy.

The usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate.

Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (PD-L1) and blocks its communication with another protein called programmed death protein 1 (PD-1). The communication of these proteins are thought to be important in the growth of tumors. Blocking these proteins from communicating may stop or shrink tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the penis
* Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
* Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
* ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

* Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
* Known symptomatic central nervous system (CNS) metastases requiring steroids
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy

Primary outcomes:
measure: Objective Response Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Progression-free Survival Rate
timeFrame: 3 years
measure: Overall Survival Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Srikala Sridhar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05275179: Pharmacokinetic of Posaconazole in Critically Ill Patients
Official title: Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutic Drug Monitoring
Critical Illness
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 10
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: Critically ill patients treated with posaconazole intravenously.

Brief summary: The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.

Detailed description: The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.

Eligibility criteria: Inclusion Criteria:

* treatment with intravenous posaconazole
* critically ill patient
* written declaration of consent

Exclusion Criteria:

- no declaration of consent

Primary outcomes:
measure: Posaconazole Drug Exposure
timeFrame: seven days from therapystart
Secondary outcomes:
measure: population-pharmacokinetic analysis 1
timeFrame: 12 months after close out
measure: population-pharmacokinetic analysis 2
timeFrame: 12 months after close out
measure: Evaluation of probability of target attainment of posaconazole
timeFrame: 12 months after close out
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Dominic Wichmann, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06376279: Genetic Diagnosis in Inborn Errors of Metabolism
Official title: Genetisk Diagnostik Vid medfödda Metabola Sjukdomar
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolic Disease
Mitochondrial Diseases
Epilepsy in Children
Epilepsy
LHON
Motor Neuron Disease
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2024-04-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inborn errors of metabolism, a group of around one thousand different monogenic diseases with a wide spectrum of presentation.

Brief summary: Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.

The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism.

Detailed description: Approximately one in two thousand infants is born with a metabolic disorder that often leads to brain damage. By means of high-tech genetic mapping using whole genome sequencing (WGS), we have discovered the molecular foundations for several of these diseases.

For investigation of mitochondrial diseases, mitochondria are isolated from muscle biopsies for analysis of ATP production using a range of substrate combinations, determination of activities of respiratory chain complexes, and analysis of nuclear and mitochondrial DNA.

The center also performs the national neonatal screening program, currently comprising 26 treatable diseases. Dried blood spot samples (DBS) are stored in the phenylketonuria (PKU) biobank, currently (2024 january) holding around 4.9 million of Sweden's 10.6 million inhabitants.

Many metabolic disorders, however, lack effective counter-measures.

Eligibility criteria: Inclusion Criteria:

* Medical inferral, suspicion metabolic disease incl epilepsy and their relatives

Exclusion Criteria:

* Disease other than metabolic

Primary outcomes:
measure: Genetic variant identification using NGS for diagnosis
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital, Karolinska Institutet
name: Anna Wedell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832479: Costs of Care and Adherence to Treatment for Cystic Fibrosis
Official title: Costs of Care and Adherence to Treatment for Cystic Fibrosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 500
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cystic fibrosis living in Rhône-Alpes region

Brief summary: Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of new born since 2002, prescription of expensive new molecules or new presentation. This evolution justifies to realize an update of statistics of costs of care and to assess adherence to treatment


Eligibility criteria: Inclusion Criteria:

* Patients with cystic fibrosis,
* Followed by one of the cystic fibrosis center of the Rhône-Alpes region (pediatric and adult of Lyon and Grenoble)
* Affiliated to the general scheme of health insurance,
* And domiciled in the Rhône-Alpes region.

Exclusion Criteria:

* Transplanted patients

Primary outcomes:
measure: treatment cost
timeFrame: 12 months
Secondary outcomes:
measure: adherence rate for chronic treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Hospices civils de Lyon, centre hospitalier lyon Sud
Study officials:
References:
Clinical trial NCT02790879: Transition From Pediatric to Adult Cystic Fibrosis Care Center
Official title: Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: Transitional care
teenagers
cystic fibrosis
pulmonary function
nutritional function
Patients who experiment a transition pediatric - adult care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status

Brief summary: The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients.

This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis.

Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).


Eligibility criteria: Inclusion Criteria:

- patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status.

Exclusion Criteria:

- Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.

Primary outcomes:
measure: Changes in FEV (FEV is the slope expressed in percentage of the predicted value).
timeFrame: Two years
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Two years
measure: Pseudomonas aeruginosa colonization
timeFrame: Two years
measure: External pancreatic insufficiency
timeFrame: Two years
measure: Diabetes
timeFrame: Two years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A
state: Auvergne-Rhône-Alpes
Study officials:
affiliation: Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
name: Sandrine TOUZET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06649279: Oxygen Reserve Index in Different Fresh Gas Flow
Official title: Variations in Oxygen Reserve Index in Different Fresh Gas Flow Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Reserve Index
Keywords: Oxygen reserve index
Minimal flow anesthesia
High flow anesthesia
Hypoxia
Hyperoxia
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective ear, nose, throat surgery.

Brief summary: Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage.


Eligibility criteria: Inclusion Criteria:

* ASA I-III patients
* 18-75 years old
* underwent general anesthesia
* elective ear, nose and throat surgery, lasting longer than 60 minutes

Exclusion Criteria:

* who did not consent to participate,
* those with finger deformities
* unregulated diabetes mellitus, severe heart, kidney, or liver failure, sensitivities to local anesthetics or opioids, those who were morbidly obese (BMI \&amp;gt;40 kg/m²), and breastfeeding women.

Primary outcomes:
measure: Oxygen Reserve Index Value
timeFrame: For each patient, from preoxygenation stage to the end of the general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
Study officials:
References:
Clinical trial NCT01557179: Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness
Official title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
Collaborators: name: Fidia Farmaceutici s.p.a.
First posted: 2012-03-19
Enrollment: 144
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.


Eligibility criteria: Inclusion Criteria:

* under 70 years old,
* had been naturally or surgically postmenopausal for more than 6 months,
* had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen

Exclusion Criteria:

* unmarried, pregnant and breast-feeding women,
* patients with vaginal infections such as trichomonas,
* candida and bacterial vaginosis,
* patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
* genital bleeding of unknown origin,
* patients with acute hepatopathy, embolic disorders,
* severe primary disease of the kidney and hematopoietic system
* recent malignant tumors

Primary outcomes:
measure: percentage of improvement of vaginal dryness symptoms
timeFrame: 30 days
Secondary outcomes:
measure: percentage of improvement of itching, dyspareunia and burning sensation
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06393179: Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients
Official title: Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation Pressure High
Critical Illness
Keywords: mechanical ventilation
airway closure
alveolar collapse
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 60
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: Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing controlled mechanical ventilation
* The duration of endotracheal intubation \< 48 hrs

Exclusion Criteria:

* Severe hemodynamic instability
* Severe chronic lung disease requiring long-term home oxygen therapy
* Patients without analgesic sedation
* Decline to participate in the study
* Refusal to sign informed consent

Primary outcomes:
measure: the rate of airway closure and alveolar collapse
timeFrame: up to 24 hours
measure: Phenotype of respiratory open pressure
timeFrame: up to 24 hours
Secondary outcomes:
measure: respiratory system compliance
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: ling liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00323479: Arthralgia During Anastrozole Therapy for Breast Cancer
Official title: A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Breast Cancer
Keywords: breast cancer treatment
joint disorders
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.


Eligibility criteria: Inclusion Criteria:

* Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
* WHO performance status 0, 1 or 2
* Provision of written informed consent

Exclusion Criteria:

* Recurrence of breast cancer, inflammatory rheumatism
* treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
* Diabetes treated by insulin
* Severe renal or hepatic disease
* Known hypersensitivity to anastrozole

Primary outcomes:
measure: Number of Participants With New Events of Arthralgia
timeFrame: 12 months
Secondary outcomes:
measure: Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
timeFrame: 12 months
measure: Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
timeFrame: 12 months
measure: Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
timeFrame: 12 months
measure: Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
timeFrame: 12 months
measure: Percentage of Participant With Therapeutic Maintenance Under Anastrozole
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References: