louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04549298: Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage
Official title: Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Diastolic Dysfunction
Keywords: Diastolic dysfunction
White matter hyperintensities
Carotid atherosclerosis
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 88
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 88 subjects of both genders will be included in the study.

Brief summary: Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.


Eligibility criteria: Inclusion Criteria:

* age ≥ 35 and ≤ 65 years
* written informed consent

Exclusion Criteria:

* previous stroke or TIA
* arrhythmia or severe cardiac disease
* renal disease
* psychiatric disease
* neurological or neurodegenerative disease
* dementia
* previous carotid artery stenting or carotid surgery
* inability to be subjected MRI analysis

Primary outcomes:
measure: Measurement of white matter hyperintensities volume
timeFrame: At Enrollment
Secondary outcomes:
measure: Detection of plaques and carotid atherosclerosis
timeFrame: At Enrollment
measure: Characterization of cardiac overload with blood markers
timeFrame: At Enrollment
measure: Detection of cognitive decline by decrease of MoCA score
timeFrame: At Enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00563498: Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
Official title: A Randomized Control Studies on the Effects of Glutamine on the Clinical Outcome of Bone Marrow Transplant Recipients With Special Reference to Veno-occlusive Disease and Mucositis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Veno-Occlusive Disease
Hepatic Veno-Occlusive Disease
Mucositis
Keywords: Veno-occlusive disease
Mucositis
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
name: Fresienius Kabi HK Ltd
First posted: 2007-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.


Eligibility criteria: Inclusion Criteria:

* Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.

Primary outcomes:
measure: Veno-occlusive disease
timeFrame: 1 month
measure: Mucositis
timeFrame: 1 month
Secondary outcomes:
measure: Hospital stay
timeFrame: 2 months
measure: Use of antibiotics
timeFrame: 2 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong
name: Albert Lie, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304798: Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)
Official title: Pilot Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Transient Ischemic Attack (TIA)
Stroke
Keywords: Transient Ischemic Attack (TIA).
Stroke.
Hospital admission.
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-03-20
Enrollment: 0
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: Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.

Detailed description: 20 patients will be randomized within 24 hours of a TIA to be admitted to the hospital or discharged to home, and the investigator will compare outcomes, cost, and evaluate the feasibility of a larger study.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older.
* Clinical diagnosis of TIA within 24 hours of consent.

Exclusion Criteria:

* Crescendo TIAs, defined as multiple within 24 hours of presentation.
* Posterior circulation TIAs diagnosed clinically by a member of the Stroke Team.
* High grade carotid stenosis.
* Any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new EKG changes, pneumonia, sepsis). Patients will only be enrolled if the only consideration for admission is the TIA, and they otherwise meet appropriate standard of care criteria for discharge to home.
* Patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.

Primary outcomes:
measure: modified Rankin Scale at one year.
timeFrame: 1 year
Secondary outcomes:
measure: Stroke and TIA incidence at one year
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD Stroke Center
name: Matt B Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06006598: A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1584862 in Healthy Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple rising doses.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. Body mass indey (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Primary outcomes:
measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: Up to 27 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
timeFrame: Up to 15 days
measure: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References:
Clinical trial NCT05862298: Spinal-Induced Hypotension in Geriatric Patients
Official title: Pre-Anaesthetic Venous Excess Ultrasound -Score and Their Correlations With the Spinal-Induced Hypotension in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Induced Hypotension
Geriatric Population
Intravascular Volume
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: geriatric patients aged greater 65 years scheduled for Lower body surgeries under spinal anaesthesia with BMI less than 30 kg/m2 with ASA I-III. These populations are high susceptible for development of spinal induced hypotension with high incidence of morbidity and mortality

Brief summary: The study will be conducted to asses preoperative condition of venous system by VExUS score and it's relation with the incidence of spinal induced hypotension in geriatric patients undergoing surgery with spinal anaesthesia.

Detailed description: An assessment of the intravascular volume deficit prior to the spinal anaesthesia conduction may help to predict the occurrence of a critical decrease in blood pressure, so several indices have been proposed to assess it's status depending on either a fluid challenge or an assessment of heart-lung interaction. Heart rate variability, passive leg raise test, and peripheral perfusion index have revealed good abilities to predict spinal induced hypotension. The inferior vena cava (IVC) collapsibility index provides high diagnostic accuracy in predicting spinal induced hypotension The VeXUS score is a four-staged validated protocol which evaluates the presence and severity of systemic venous congestion in the inferior vena cava (IVC) and organs (liver, gut, and kidneys) by evaluating the (IVC) diameter, venous waveforms of the hepatic vein (HV), portal vein (PV), and interlobar renal veins using colour Doppler (CD) and pulsed wave Doppler (PWD)

Eligibility criteria: Inclusion Criteria:

* . Patients aging 65 or older
* Lower body surgeries to be done with spinal anaesthesia
* BMI less than 30 kg/m2.
* Patients with ASA I-III

Exclusion Criteria:

* Patient refusal
* Major bloody surgeries (class c surgeries)
* Patients with a history of cardiovascular disorders including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, AF
* Patients with a history of respiratory disorders
* Patients with cirrhotic liver
* Patients with pulmonary hypertension
* Patients with renal diseases

Primary outcomes:
measure: venous excess ultrasound score
timeFrame: immediate preoperative period before the induction of spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: tarek Abdelhay Mostafa
state: El Gharbyia
Study officials:
References:
Clinical trial NCT00283998: Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Official title: Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Odontoid Fractures Type II
Keywords: Odontoid
Type II fractures
Elderly patients
Surgical vs. conservative treatment
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AOSpine North America
First posted: 2006-01-31
Enrollment: 166
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \>/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.


Eligibility criteria: Inclusion Criteria:

* All new type II odontoid fractures including \< those in which the fracture line crosses into the body of C2 \< as long as it doesn't enter the superior articular process of C2
* Age 65+
* Stable and unstable fractures
* \< 3 months postinjury
* No previous treatment for an odontoid fracture

Exclusion Criteria:

* Pathologic fractures unrelated to osteoporosis
* Severe dementia or other severe mental health problem if there is no consentable surrogate available
* Participating in other trials or unlikely to attend follow-ups

Primary outcomes:
measure: Quality of life using the Neck disability Index
timeFrame: 12 months
measure: Quality of life using the SF-36
timeFrame: 12 months
measure: Proportion of bony fusion between the two treatments
timeFrame: 6 months
measure: Proportion rate of non-union between the two treatments
timeFrame: 6 months
Secondary outcomes:
measure: Rate of complications
timeFrame: 12 months
measure: Cervical range of motion
timeFrame: 12 months
measure: Identify the risk factors for a poor outcome independent of treatment intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University SOM: Orthopedics
state: Georgia
Study officials:
affiliation: Th. Jefferson University Philadelphia
name: Alexander R Vaccaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173498: Common Allergens in Skin Tests for Adult Atopic Dermatitis
Official title: Common Allergens in Skin Tests for Adult Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, skin test
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To analyze the common allergens revealed by skin tests in adult atopic dermatitis patients.

Detailed description: The allergens involved in atopic patients are widely existed in our environment. Traditionally, we use serum specific IgE, skin prick test or intradermal test to verify the possible causative allergens in patients with atopic dermatitis. This study will evaluate the correlation between serum specific IgE, skin prick test, intradermal test, and patch test for common allergens in adult patients with atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* patients with atopic dermatitis (according to Hanifin and Rajka criteria)
* age older than 16 years old

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dermatology, National Taiwan University Hospital
Study officials:
affiliation: Department of Dermatology, National Taiwan University Hospital
name: Chia-Yu Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darsow U, Laifaoui J, Kerschenlohr K, Wollenberg A, Przybilla B, Wuthrich B, Borelli S Jr, Giusti F, Seidenari S, Drzimalla K, Simon D, Disch R, Borelli S, Devillers AC, Oranje AP, De Raeve L, Hachem JP, Dangoisse C, Blondeel A, Song M, Breuer K, Wulf A, Werfel T, Roul S, Taieb A, Bolhaar S, Bruijnzeel-Koomen C, Bronnimann M, Braathen LR, Didierlaurent A, Andre C, Ring J. The prevalence of positive reactions in the atopy patch test with aeroallergens and food allergens in subjects with atopic eczema: a European multicenter study. Allergy. 2004 Dec;59(12):1318-25. doi: 10.1111/j.1398-9995.2004.00556.x.
citation: Ingordo V, Dalle Nogare R, Colecchia B, D'Andria C. Is the atopy patch test with house dust mites specific for atopic dermatitis? Dermatology. 2004;209(4):276-83. doi: 10.1159/000080848.
citation: Weissenbacher S, Bacon T, Targett D, Behrendt H, Ring J, Darsow U. Atopy patch test--reproducibility and elicitation of itch in different application sites. Acta Derm Venereol. 2005;85(2):147-51. doi: 10.1080/00015550410024418.
Clinical trial NCT01196598: Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse
Official title: Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic floor
pelvic organ prolapse
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-09-08
Enrollment: 84
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.

Detailed description: To verify if three months of an exercise program could improve stage II of pelvic organ prolapse, as a conservative treatment.

Eligibility criteria: Inclusion Criteria:

* women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study

Exclusion Criteria:

* Neuromuscular diseases and use of hormonal therapy

Primary outcomes:
measure: Pelvic floor muscle changes
timeFrame: 3 months after the begining of treatment
Secondary outcomes:
measure: Pelvic Organ Prolapse changes
timeFrame: 3 months after the begining of treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Post graduate student
name: Ana Paula M. Resende
role: PRINCIPAL_INVESTIGATOR
References:
citation: Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
citation: Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
Clinical trial NCT01665898: Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Official title: Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyps
Keywords: cold biopsy forceps
cold snare biopsy
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 138
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.

Detailed description: Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.

Eligibility criteria: Inclusion Criteria:

* patients older than 40 years old and
* patients who are receiving colonoscopies and
* patients who have colon polyps

Exclusion Criteria:

* patients who have not agreed to the study
* patients with bleeding tendencies

Primary outcomes:
measure: Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
timeFrame: up to 3 years
Secondary outcomes:
measure: Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
timeFrame: participants will be followed up for 1 month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Bo-In Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.