louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05760287: Echocardiographic Characterization of Cardiac Amyloidosis
Official title: Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Keywords: echocardiography
left ventricle
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In the retrospective phase, patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Agostino Gemelli between January 2020 and November 2022 will be enrolled.

In the prospective phase, patients with the same features evaluated between December 2022 and December 2028.

Brief summary: This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) will be enrolled.

The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype.

Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.


Eligibility criteria: Inclusion Criteria:

* patients with cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit.

Exclusion Criteria:

* missing data
* decline to the study participation

Primary outcomes:
measure: changes in echocardiographic parameters (in patients receiving or not specific treatment)
timeFrame: 6 months
measure: cardiovascular outcomes
timeFrame: 24 months
Secondary outcomes:
measure: major cardiac arrhythmias
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT06377787: Effects of ELDOA in Patients With Cervicogenic Headache
Official title: Effects of ELDOA in Patients With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: ELDOA
Cervicogenic Headache
Cervical spine
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache.

Detailed description: Cervicogenic Headache (CEH) is mainly caused by neck or paravertebral soft tissue lesions. It is chronic headache that arises from the Atlanto-occipital and upper cervical joints and is perceived in one or more regions of the head or face. One of the known treatment options that create decompression at spinal segment level is called ELDOA it is described as a conditioning method involving a series of movements and body stretches to help correct body posture, rehabilitate people with injuries and prevent injuries

Eligibility criteria: Inclusion Criteria:

* Age: 30-45 years
* Both male and female.
* Onset of pain \> 4 weeks.
* Flexion rotation test positive with estimated rotation range reduced by more than 10 degrees from the anticipated normal range (44 degrees)
* Tenderness of upper three cervical joints.
* Presence of active trigger points in upper trapezius and sub occipital extensors.

Exclusion Criteria:

* Hypertension.
* Recent (\<6 months) whiplash injury and other cervical soft tissue injuries.
* History of cervical spinal vertebrae fracture.
* Positive sharp purser test
* Acute disc protrusion • History of cancer.
* Previous surgical intervention of head, neck and thoracic spine

Primary outcomes:
measure: (Numeric Pain Rating Scale).
timeFrame: four weeks
measure: NDI (U) (Neck Disability Index)
timeFrame: four weeks
measure: Inclinometer
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Alkhidmat Raazi Hospital CBR Town
state: Punjab
Study officials:
affiliation: Riphah International University
name: maria Khalid, MSOMPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Asghar Khan
role: STUDY_CHAIR
References:
Clinical trial NCT02105298: Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
Official title: Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Acute Respiratory Failure Requiring Reintubation
Pulmonary Edema
Pneumonia
Hypoxia
Acute Kidney Injury
Keywords: Fluids
Intraoperative
Respiratory
Outcomes
Surgery
Anesthesia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 104000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012

Brief summary: Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.

Hypotheses:

Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.


Eligibility criteria: Inclusion Criteria:

* Ages 18 upwards
* Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure

Exclusion Criteria:

* Cases where the subject had additional surgeries within the previous four weeks
* Ages under 18

Primary outcomes:
measure: Mortality
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 3 days after surgery
measure: Acute Kidney Injury
timeFrame: within 48 hours of surgery
measure: Post-extubation oxygen desaturation
timeFrame: within the first 10 minutes after extubation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthias J Eikermann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535698: Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.
Official title: A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Keywords: Hormonal Balance Support
Menstrual Cycle
Mood Swings
Lead sponsor: Perelel Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-08-02
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.


Eligibility criteria: Inclusion Criteria:

* Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid new hormonal balance treatments during the study
* Consistent use of current hormonal balance treatments for at least 3 months prior to the study

Exclusion Criteria:

* Chronic conditions preventing adherence to the protocol Diabetes
* Planned hormonal balance-related procedures during the study
* Started any new medications or supplements that target hormonal balance in the past 3 months
* Anyone with diabetes
* Severe allergies requiring EpiPen
* Pregnant, breastfeeding, or trying to conceive
* Recent surgeries or planned surgeries during the study
* Unwilling to follow the study protocol

Primary outcomes:
measure: Changes in Symptoms of Hormonal Imbalance
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Changes in Overall Menstrual Health
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT03749798: Comparing an Intraoperative vs. a Standard Wavefront Device
Official title: To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Cataract
Wavefront measurement
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Detailed description: Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age.

Intraoperative measured data could help to get a better information about wavefront aberrations.

Eligibility criteria: Inclusion Criteria:

* Cataract
* Age 21 and older
* Able to understand the patient information
* Willing to follow the instructions and attend all follow-up visits
* Willing to sign informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
* Previous ocular surgeries on the study eye
* Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
* Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Primary outcomes:
measure: Wavefront aberration measurements
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
References:
Clinical trial NCT01884298: Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity
Official title: Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and morbidity---a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: remifentanil
isolated systolic hypertension
morbidity
epidural combined general anesthesia
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.


Eligibility criteria: Inclusion Criteria:

- adults aged 50-70 with isolated systolic hypertension .

Exclusion Criteria:

* age \< 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 \< 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine \> 50% or liver enzymes \> 50% upper limit of normal values)

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: 5 weeks
measure: cardiovascular morbidity
timeFrame: 2 weeks
measure: respiratory morbidity
timeFrame: 2 weeks
measure: postoperative renal failure
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PKU 1st hospital
state: Beijing
Study officials:
affiliation: PKU 1st hospital
name: Dongxin Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01868698: Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Peripheral Arterial Disease
Keywords: Physical Therapy Modalities
Electric Stimulation Therapy
Hyperthermia, Induced
Diabetes Mellitus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.


Eligibility criteria: Inclusion Criteria:

* Women
* Diagnosis of diabetes
* Diagnosis of peripheral arterial disease

Exclusion Criteria:

* Regular physical activity
* Smokers
* Thrombosis active
* Severe peripheral arterial disease

Primary outcomes:
measure: Doppler ultrasound
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rinaldo Guirro, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993798: An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Official title: An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Post operative pain
Local anaesthesia
Postoperative pain after arthroscopic shoulder surgery
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2009-10-12
Enrollment: 107
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: The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.


Eligibility criteria: Inclusion Criteria:

* Subacromial impingement syndrome
* MRI with intact rotator cuff
* Patients suitable for general anaesthesia

Exclusion Criteria:

* Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
* Abnormal ECG
* Prolonged QT syndrome
* Current or regular use of analgesic medication for other indication(s)

Primary outcomes:
measure: Pain Intensity (PI)
timeFrame: 0-3 days after surgery
measure: Supplemental Opioid Use
timeFrame: 0-3 days after surgery
Secondary outcomes:
measure: Time to First Opioid Rescue Medication Usage
timeFrame: 0-14 days after surgery
measure: Opioid Related Side Effects
timeFrame: 0-7 days after surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Nycomed Investigational Site
city: Vienna
country: Austria
facility: Nycomed Investigational Site
city: Vienna
country: Austria
facility: Nycomed Investigational Site
city: Berlin
country: Germany
facility: Nycomed Investigational Site
city: Dresden
country: Germany
facility: Nycomed Investigational Site
city: Marburg
country: Germany
facility: Nycomed Investigational Site
city: Riga
country: Latvia
facility: Nycomed Investigational Site
city: Valmiera
country: Latvia
facility: Nycomed Investigational Site
city: Lodz
country: Poland
facility: Nycomed Investigational Site
city: Stockholm
country: Sweden
facility: Nycomed Investigational Site
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT02556398: Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control
Official title: Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project involve evaluation of a web-based nutrition education program and pilot-testing of a new smartphone app for real-time data logging to identify factors causing glycemic variability.

Detailed description: The intervention will be three (3) months in duration and will entail use of a smart phone app for real-time data logging to identify factors causing glycemic variability, as well as use of a web-based nutrition education program. The investigators postulate that the interactive nutrition education curriculum - which will provide feedback to patients about the inter-relationship between their food intake and postprandial glucose profiles, as well as practical guidance for improvements - will lead to a change in food choices and improved post-prandial glucose control.

Eligibility criteria: Inclusion Criteria

Individuals that satisfy all of the following conditions will be considered for participation:

1. Must be between the ages of 25 - 75 years of age (inclusive)
2. Type 1 diabetes diagnosis at least 1 year, treated with multiple daily injections or insulin pump.
3. A1c 7.5-9.0%

Exclusion Criteria

1. Current or past use of real-time CGM for more than 2 months.
2. Pregnancy (self-reported) or planning conception in next 6 months.
3. History of disordered eating, actively trying to lose weight or planning to do so, BMI \> 30 kg/m2 (to limit participation by individuals who are actively trying to lose weight),
4. Medical conditions or medications that would affect gastric emptying such as gastroparesis, bariatric surgery, medications such as pramlinitide, liraglutide or exenatide.

Primary outcomes:
measure: area under the curve (AUC) above target (> 180 mg/dL)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Elena Toschi, MD
role: PRINCIPAL_INVESTIGATOR
References: