louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704951: Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)
Official title: P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mycoses
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

Brief summary: The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy.

A further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Immunocompromised patients with refractory IFI
* Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

Exclusion Criteria:

* None

Primary outcomes:
measure: Safety: adverse events
timeFrame: Depending on treatment modality every 2 to 4 weeks
Secondary outcomes:
measure: Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status
timeFrame: Depending on treatment modality every 2 to 4 weeks
measure: Treatment and follow up period: Performance status; Medication; Duration of treatment; Frequency of infectious episodes; Management of infections
timeFrame: Depending on treatment modality every 2 to 4 weeks
measure: Adverse events; Survival status
timeFrame: Depending on treatment modality every 2 to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03375151: An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
Official title: An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Brainmarc Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral recommendations for physical exercise. Some recommendations could also be found for cognitive practice. However, currently, there is no consensus regarding effective cognitive treatment or practice for MCI. Among the populations suffering from MCI, there is a significant segment of patients with amnestic disorder. For these patients, it seems that cognitive training of memory, including verbal memory, is very important. In recent years, we have developed an effective tool for managing rehabilitation practice by monitoring the patient's engagement with an easy-to-use EEG (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when the patient is recruited, the clinical improvement is significantly better. The aim of this study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve functional improvement in verbal memory training in patients with Amnestic MCI.


Eligibility criteria: Inclusion Criteria:

* Male or female above the age of 65 years
* Ability to read, write and understand the Hebrew language so to comply with study demands.
* Diagnosed with Amnestic MCI. Mini Mental State Examination (MMSE), A score of MSSE ≥27 for college educated subjects and MSSE ≥ 26 for all others; and (CDR) Clinical Dementia Rating, 0.5 ≥ CDR
* Diagnosed with memory impairment, Visual Paired Association = VPA (WMS-R), for subjects of ages 65-70, 16.5 ≥ WMS-R and for subjects of age above 71, 15.5 ≥ WMS-R

Exclusion Criteria:

* Diagnosed with major psychiatric or neurological disorder.
* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.

Primary outcomes:
measure: Cognitive test grade
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Rey Auditory-Verbal Learning Test
timeFrame: up to 5 weeks
measure: Free And Cued Selective Reminding Test
timeFrame: up to 5 weeks
measure: Rivermead Behavioral Memory Test
timeFrame: up to 5 weeks
measure: Clinical Global Impression of Change
timeFrame: up to 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Reuth rehabilitation medical center
name: David Dvir, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543751: Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 610
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
* Non-pregnant females

Exclusion Criteria:

* Patients with Type 1 Diabetes or history of ketoacidosis
* Patients who have been treated with insulin or other antihyperglycemic agents
* Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01356251: Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma
Official title: Mesothelioma From a Patient Perspective: A Survey of Psychosocial Needs and Exploration of Online Support for Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mesothelioma
Keywords: Quality of life
support group
questionnaires
Internet-based support group
11-066
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to learn about how mesothelioma affects patients' emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pleural mesothelioma and receiving care at MSKCC
* At least 18 years of age or older
* Able to read and speak English
* Patients who choose to participate in the Internet-based discussion groups, need a telephone, a computer, Internet access, and an e-mail account.

Exclusion Criteria:

* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).

Primary outcomes:
measure: To describe the psychological needs of patients with mesothelioma.
timeFrame: 1 year
Secondary outcomes:
measure: the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02444351: Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis With Nocturnal Calf Cramps
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).


Eligibility criteria: Inclusion Criteria:

1. diagnosed lumbar spinal stenosis with MRI finding
2. nocturnal calf cramps symptoms at least once per week

Exclusion Criteria:

1. electrolyte disorder
2. congenital muscle disease
3. muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
4. cognitive impairments

Primary outcomes:
measure: Pain score
timeFrame: follow up 2 weeks (14 days) after injection
Secondary outcomes:
measure: patient satisfaction questionnaire using 0 to 4 scale
timeFrame: follow up 3 months after injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Park SJ, Yoon KB, Yoon DM, Kim SH. Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):957-963. doi: 10.1016/j.apmr.2017.01.017. Epub 2017 Feb 14.
Clinical trial NCT06695351: Pain in Subjects with High Capacity Cognitive Abilities
Official title: Pain in Subjects with High Capacity Cognitive Abilities: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High Cognitive Abilities
Pain
Prevalence
Keywords: high cognitive abilities
Pain
Prevalence
Kinesiophobia
Catastrophising
giftedness
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with a diagnosis of high cognitive abilities and spanish language

Brief summary: In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. With this study the investigators will try to know better pain experience in this population and chronic pain prevalence

Detailed description: It's said that people with high cognitive abilities suffered pain. However, there are no scientific literature. With this study the investigators would like to know better pain experience in this population. There are two target groups include inside this population that we consider to study: Children population and adults population.

The aim of this study is to know the prevalence of chronic pain in this population and to analize the pain experience of this population and the related psychosocial variables that can modify it, like catastrophicing, kinesiophobia, anxiety, quality of life and level of physical activity,

The investigators will use a questionnaire that includes different questionnaires like TSK-11SV, PCS, STAI, SF-36 and IPAQ and many question to evaluate the demographic factor of the sample and the prevalence

The investigators will do an statistical analysis to observe the relationship and the predictors factors

Eligibility criteria: Inclusion Criteria:

* People with a diagnosis of high cognitive abilities

Exclusion Criteria:

* People with incapacity to answer the questionnaire
* People that's not have a good level of Spanish language

Primary outcomes:
measure: Perceived quality of life
timeFrame: 1 day
Secondary outcomes:
measure: Kinesiophobia
timeFrame: 1 day
measure: Catastrophising
timeFrame: 1 day
measure: Anxiety
timeFrame: 1 day
measure: Physical activity
timeFrame: 1 day
Other outcomes:
measure: Pain
timeFrame: 1 day
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
References:
Clinical trial NCT02277951: Intubation During Resuscitation
Official title: Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Cardiopulmonary Resuscitation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Personnel of emergency medical services and hospital emergency units

Brief summary: The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model.

The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.

Detailed description: Devices using in study:

The Bonfils Intubation Fibrescope (BONFILS)(KARL STORZ Endovision, Inc., Charlton, MA, USA), The Video Rigid Flexing Laryngoscope (RIFL)( AI Medical Devices, Inc., Williamston, MI, USA), The C-MAC® S Video Laryngoscope Blade Mac#3(C-MAC®S) (KARL STORZ Endovision, Inc., Charlton, MA, USA) The Macintosh Laryngoscope Blade no. 3 (MAC) (LifeLine Medical, Inc., Brooksville, FL, USA).

Eligibility criteria: Inclusion Criteria:

* experienced emergency personnel: nurses, paramedics

Exclusion Criteria:

* no experience in out-of-hospital emergency medicine

Primary outcomes:
measure: Time to successful intubation
timeFrame: Subjects complete study in 1 day
measure: Success rate of ETI
timeFrame: Subjects complete study in 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03044951: Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
Official title: Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
cryoablation
irrigated radiofrequency ablation
pulmonary vein isolation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

Detailed description: The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* ECG recording of atrial fibrillation
* first time of ablation
* refractory to at least one anti-arrhythmia drug
* sign informed consent for participation in the study

Exclusion Criteria:

* had ablation before
* serious heart failure
* left atrial diameter\>55mm
* Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
* Stroke in 6 months before the ablation
* Endocardial thrombosis

Primary outcomes:
measure: Efficacy endpoint (time to first documented clinical recurrence after blanking period)
timeFrame: one year
measure: Safety endpoint (Any procedure-related complications)
timeFrame: one year
Secondary outcomes:
measure: Procedure time (min)
timeFrame: one year
measure: Left atrial time (min)
timeFrame: one year
measure: X-ray time (min)
timeFrame: one year
measure: time to first time cardiovascular hospitalization (month)
timeFrame: one year
measure: QoL changes at 12 months (Units on a Scale)
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Li-Qun Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
citation: Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.
Clinical trial NCT00789451: The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man
Official title: The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Diseases
Keywords: Ischaemia reperfusion
t-PA
Fibrinolysis
Endothelial function
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: University of Oxford
First posted: 2008-11-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility criteria: Inclusion Criteria:

* Healthy males between 18-65 years of ages, non-smokers.

Exclusion Criteria:

* Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.

Primary outcomes:
measure: Net t-PA release from the endothelium after ischaemia reperfusion
timeFrame: Throughout the study
Secondary outcomes:
measure: Change in forearm blood flow after ischaemia reperfusion
timeFrame: throughout the study
measure: Change in platelet-monocyte-binding after ischaemia reperfusion
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh, 49 Little France Crescent
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD, FRCP
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Rajesh K Kharbanda, PhD, FRCP
role: STUDY_DIRECTOR
References:
citation: Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.
Clinical trial NCT06343051: USCOM in Newly Diagnosed FGR Cases
Official title: Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Growth Restriction
USCOM
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed fetal growth restriction at greater than 27 weeks 6 days' gestation will be eligible to enroll in this study.

Brief summary: The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnant patients with a new diagnosis of fetal growth restriction (estimated fetal weight \<10th percentile or abdominal circumference \<10th percentile) in the third trimester (gestational age \>27w6d)

Exclusion Criteria:

* Multiple gestation
* Fetal anomalies
* Gestational diabetes or pregestational diabetes.

Primary outcomes:
measure: Systemic vascular resistance obtained from USCOM
timeFrame: every 2-4 weeks at time of prenatal ultrasound, until the end of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nicola F Tavella, MPH
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Rachel J Meislin, MD
role: PRINCIPAL_INVESTIGATOR
References: