louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06436053: Acute Response to Left Bundle Branch Area Pacing With SyncAV
Official title: Acute Response to Left Bundle Branch Area Pacing With SyncAV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 50
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 approved indication for dual-chamber pacing or cardiac resynchronization therapy, with documented left bundle branch block or intraventricular conduction delay, long QRS duration, and intact AV conduction will be enrolled.

Brief summary: This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years of age and willing to comply with the study requirements
2. Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
3. Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
4. Patient has an intrinsic QRS duration ≥ 130 ms
5. Patient has intact AV conduction with PR interval ≤ 250 ms

Exclusion Criteria:

1. Patient has a resting ventricular rate \> 100 bpm
2. Patient has AV Block (2nd or 3rd degree)
3. Patient has documented persistent atrial tachycardia or atrial fibrillation
4. Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator
5. Patient is currently participating in another clinical investigation
6. Patient is pregnant or nursing
7. Patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
8. Patient does not have legal authority
9. Patient is unable to read or write

Primary outcomes:
measure: QRS duration
timeFrame: During the intervention/procedure/surgery
Secondary outcomes:
measure: LV hemodynamics
timeFrame: During the intervention/procedure/surgery
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: MI
Study officials:
References:
Clinical trial NCT05516953: Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery
Official title: Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Nausea and Vomiting
Laparoscopic Sleeve Gastrectomy
Morbid Obesity
Keywords: Postoperative Nausea and Vomiting
Laparoscopic Sleeve Gastrectomy
baclofen
Morbid Obesity
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Detailed description: . A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
* Patients fit for anesthesia and surgery.

Exclusion Criteria:

* Patients with BMI \>55 kg/m2.
* Patients with previous procedures for the treatment of obesity.
* Pregnant females and lactating women.
* Patients with psychological or psychiatric disease
* Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
* Patients who experienced vomiting within 24 hours before surgery.
* Patients with history of alcohol or drug abuse.
* Patients with hypersensitivity or contraindications to any of the drugs used in this study.

Primary outcomes:
measure: The primary outcome of this study will be the complete response
timeFrame: The first 48 hours after surgery.
Secondary outcomes:
measure: Change in serum level of vasopressin
timeFrame: The first 48 hours after surgery.
measure: Change in serum level of substance P
timeFrame: The first 48 hours after surgery.
measure: Change in serum level of dopamine
timeFrame: The first 48 hours after surgery.
measure: Change in serum level of serotonin
timeFrame: The first 48 hours after surgery.
measure: Change in serum level of tachykinin 1
timeFrame: The first 48 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital.
Study officials:
affiliation: Tanta University
name: Aya Moussa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06837753: Hamstring Stretching Effective on Nonspecific Low Back Pain
Official title: Does Hamstring Stretching Effective on Nonspecific Low Back Pain?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity. Low back pain is a multifactorial disease with multiple etiologies. Risk factors are difficult to identify. It is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical. Mechanical low back pain (MBA) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine. In order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded. The most common diseases that cause low back pain are; They are caused by mechanical factors and degenerative diseases. Mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain. Non-Specific many factors affect low back pain. Kim and Shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.


Eligibility criteria: Inclusion Criteria:

* Patients with complaints of low back pain,
* NLBP for at least 12 weeks,
* finger-to-ground distance greater than 0 cm; a passive straight-leg raising -(SLR) angle of less than 80°, measured with a hand-held goniometer;
* normal mobility of the hip;
* passive knee extension ≥25°,
* VAS score between 3 and 7 will be included.

Exclusion Criteria:

* People with a history of hamstring injury in the last two years,
* fractures in the spine or lower extremities,
* pregnancy,
* leg length difference of more than 2 cm,
* and obesity will be excluded from the study.

Primary outcomes:
measure: Pain status
timeFrame: 0-8 week
measure: Flexibility assessment
timeFrame: 0-8 week
Secondary outcomes:
measure: Functionality index
timeFrame: 0-8 week
measure: FUNCTIONAL STATUS
timeFrame: 0-8 week
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Eylül Pınar Kısa
state: İstanbul
Study officials:
References:
Clinical trial NCT05905653: Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
Official title: Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Males Volunteers
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol

Exclusion Criteria:

* Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
* Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 1 week, Day 1 and Day 7
Secondary outcomes:
measure: Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]
timeFrame: 1 week, Day 1 and Day 7
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
References:
Clinical trial NCT00631553: Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound
Official title: Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using microbubbles, is useful in assessing changes in kidney blood flow.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Males and females
* Ages 18-65 years old

Exclusion Criteria:

* Pregnancy or lactation
* H/o kidney disease
* H/o congestive heart failure, ischemic heart disease, severe pulmonary disease or allergy to the drug
* H/o any cardiovascular disease
* Abnormal liver function (liver function tests out of specified ranges)
* Screening urinalysis which indicates infection or inflammation
* Taking regular medications (except for over-the-counter vitamins or hormonal contraceptives.)
* Taking supplements, like protein shakes
* Unwilling or unable to eat chicken (used as protein meal)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kambiz Kalantarinia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009853: Steady State Study of Codeine Sulfate
Official title: A Single Dose, 1-Period, 1-Treatment Study of Codeine Sulfate 15 mg Tablets Under Steady State Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick Bieberdorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04778553: Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study
Official title: Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Tests
Keywords: CBC, WBC, Hemoglobin
Lead sponsor: Essenlix Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the hospital outpatient clinic who had voluntarily consented to blood donation for venous and capillary blood collection

Brief summary: This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

Detailed description: These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the "Instructions for Use".

Eligibility criteria: Inclusion Criteria:

* all clinic attendees

Exclusion Criteria:

* unable to provide a venous and fingerstick blood specimen

Primary outcomes:
measure: Method Comparison of CBC Results
timeFrame: October- December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
Study officials:
affiliation: Hunterdon Medical Center
name: Megha Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02532751: Effects of Body Contouring Surgery in Obese Patients
Official title: Effects of Body Contouring Surgery in Obese Patients: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validation Study
Quality of Life
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-08-26
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: 100 patients who underwent body contour surgery

Brief summary: The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

Detailed description: The BODY-Q is translated into Finnish through forward and backward translation and a committee review. The preliminary version is pilot tested with 20 participants undergoing body contouring surgery.

The study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. Data collection takes place in the Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland. The participants fill in three patient-reported outcome measures.

The outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. Test-retest reliability is assessed after two weeks from the first completion of the questionnaires. With validated questionnaires the effects of body contouring surgery is assessed.

Eligibility criteria: Inclusion Criteria:

* Body contouring surgery due to:

A) massive weight loss B) Postbariatric weight loss

* Patient age over 18 years

Exclusion Criteria:

* Patient age under 18 years
* No body contouring surgery
* Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District
* No obesity

Primary outcomes:
measure: Validity of the Finnish version of the BODY-Q questionnaire
timeFrame: 6 months
measure: Health-related quality of life after body contouring surgery in obese patients
timeFrame: 0.5 to 3 years
measure: Depression after body contouring surgery in obese patients
timeFrame: 0.5 to 3 years
measure: Body image after body contouring surgery in obese patients
timeFrame: 0.5 to 3 years
Secondary outcomes:
measure: The 15-Dimensions health-related quality of life instrument
timeFrame: 0.5 to 3 years
measure: The BODY-Q questionnaire
timeFrame: 0.5 to 3 years
measure: The Raitasalo Beck Depression Index questionnaire
timeFrame: 0.5 to 3 years
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Jorvi Central Hospital
state: Uusimaa
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
References:
Clinical trial NCT03806751: A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning
Official title: A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim of this project is to implement a non-invasive method of measuring quantitative regional cerebral blood flow (rCBF) on the UAB hybrid PET/MRI scanner to allow conducting such \[O-15\]water based scans with relative ease and safety in a large variety of important clinical and research applications. Participants will undergo imaging at baseline and after administration of a drug to increase cerebral blood flow to evaluate perfusion estimates during low and high flow states. The goal of this study is to generate data that will justify eliminating invasive arterial sampling in most \[O-15\]water-based PET protocols.


Eligibility criteria: Inclusion Criteria:

* Six participants aged 19-60 years of age, male and female, with no evidence of neurological disease, will be recruited from UAB and the surrounding community.

Exclusion Criteria:

* Participants will be excluded if there is any evidence or history of claustrophobia or the subject has metallic implants or devices that are normally exclusion factors for MRI.

Primary outcomes:
measure: Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Advanced Imaging Facility
state: Alabama
Study officials:
References:
Clinical trial NCT05609851: Relationship Occupation and Physical Performance in Elderly
Official title: The Relationship of Physical Performance With Perceived Occupational Competence and Value in Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Old Age; Atrophy
Elderly
Occupational Balance
Postural Balance
Physical Performance
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers aged 65 and over older adults.

Brief summary: Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Balance and falling losses can also affect occupation. Our study was conducted to examine the relationship between physical performance and occupational balance in elderly individuals. According to the power analysis, it is planned to include the individual in the study. Individuals will only be evaluated and the relationship between scale results will be analyzed statistically.


Eligibility criteria: Inclusion Criteria:

* Volunteers aged 65 and over will be included.

Exclusion Criteria:

* Having visual-hearing loss that prevents them from making evaluations,
* Individuals with poor co-operation will be excluded from the study.

Primary outcomes:
measure: OSA
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Tuba Maden
Study officials:
affiliation: University of Gaziantep
name: tuba maden, PhD
role: PRINCIPAL_INVESTIGATOR
References: