louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05473481: Dynamic EchoCardiographic Optimisation REsponse Study
Official title: Dynamic EchoCardiographic Optimisation REsponse Study (Studio Sulla Risposta All'Ottimizzazione Dinamica Ecocardiografica)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers, who did not respond to the implantation of the device in clinical and electrophysiological terms.

Brief summary: The aim of this study is to evaluate the effects of heart rate optimization and guided A-V and V-V delay from color Doppler echocardiography, in subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers who did not respond to device implantation in clinical, electrophysiological, and other terms.


Eligibility criteria: Inclusion Criteria:

1. Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form;
2. Heart failure with ventricular ejection fraction left \<45%;
3. Presence of CRT-D devices in a non-responder patient for cardiac resynchronization
4. NYHA \>II;
5. Resting heart rate \<65 beats per minute;
6. Biventricular pacing \>97%.

Exclusion Criteria:

1. Age \<18 and \>85 years;
2. Insufficient functional capacity to complete the tests required by the research protocol;
3. Permanent Atrial Fibrillation

Primary outcomes:
measure: Change in the number of acute heart failure episodes
timeFrame: Baseline to 12 months post discharge
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: Baseline to 12 months post discharge
measure: Echocardiofic changes of diastolic left ventricular function
timeFrame: Baseline to 12 months post discharge
Secondary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline to 12 months post discharge
measure: Change in NYHA class
timeFrame: Baseline to 12 months post discharge
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale Maggiore Policlinico di Milano
state: MI
Study officials:
References:
Clinical trial NCT00624481: Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD
Official title: A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteopenia
Osteoporosis
Keywords: osteoporosis
osteopenia
bone mineral density
teriparatide
Lead sponsor: Nastech Pharmaceutical Company, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 350
Sex: FEMALE
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal Female patients up to 89 years, inclusive;
* BMI ≤ 35 kg/m2, inclusive;
* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
* Have a minimum of two evaluable non-fractured lumbar vertebrae.
* Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip

Exclusion Criteria:

* Serious Medical Condition
* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
* Have a history of cancer within the past 5 years, except for basal cell carcinoma
* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.

Primary outcomes:
measure: Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in bone mineral density from baseline to 12 weeks post treatment
timeFrame: 12 weeks
measure: Safety, including hypercalcemia and nasal effects
timeFrame: 24 weeks
measure: Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment
timeFrame: 4, 12 and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nastech Pharmaceutical Company, Inc.
name: Gordon Brandt, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00545181: Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Official title: Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis
vaginal acidifying gel
recurrence
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

Detailed description: Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

Eligibility criteria: Inclusion Criteria:

1. All women of between 18-50 years of age.
2. Confirmed current diagnosis of BV using Amsel's criteria.
3. Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months

Exclusion Criteria:

1. Patient who received antibiotic therapy within the past two weeks.
2. Patients who had co-existing gonorrhea or Chlamydia infection
3. Any contraindications or sensitivity to taking the vaginal gel.
4. Allergy to metronidazole
5. Alcoholics or those unable to abstain from alcohol consumption.
6. Pregnancy

Primary outcomes:
measure: Recurrent Bacterial Vaginosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: David M Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06707181: Comparative Study for Medical Therapy for Lower Ureteral Stones
Official title: Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Ureteral Stones
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 180
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 goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are:

* Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil as a therapy for lower ureteral stones?
* What medical problems do participants have when taking these drugs?

Researchers will compare silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil to see which drug works better to treat lower ureteral stones Participants will:

* Take silodosin, tamsulosin, silodosin plus tadalafil or tamsulosin plus tadalafil every day for 28 days
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were adult patients aged 18 years and older with lower ureteral stones measuring 5-10 mm in diameter, diagnosed through imaging techniques such as kidney-ureter-bladder (KUB) x-rays or computed tomography (CT) scans.

Exclusion Criteria:

* Exclusion criteria included pregnant and lactating women, renal insufficiency, congenital urinary tract abnormalities, associated kidney stones or contralateral ureteric stones, solitary kidneys, associated infected stones, uncontrolled pain, severe hydronephrosis, history of allergy to the study medications and recent treatment for ureteral stones within the past 3 months (e.g., lithotripsy or surgery) .

Primary outcomes:
measure: Expulsion rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Medicine, Fayoum University
Study officials:
References:
Clinical trial NCT06366581: Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology
Official title: Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Extracellular Matrix Alteration
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group), and patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group).

Brief summary: This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix.


Eligibility criteria: Inclusion Criteria:

1.18 to 75 years 2.diagnosed with incisional hernia 3.normal tumour markers 4.elective surgery patients.

Exclusion Criteria:

1. patients with vital organ failure (heart liver, lung, kidney and others)
2. malignant tumors not been completely relieved by active treatment,
3. patients who have psychiatric diseases or comprehension disorders.
4. patients with metabolic disease involving connective tissue collagen.

Primary outcomes:
measure: the gene expression list
timeFrame: 2023.3-2023.9
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hua Dong Hospital Affiliated to Fu Dan University
Study officials:
References:
Clinical trial NCT00719381: Effect of Pioglitazone on Inflammation in Cystic Fibrosis
Official title: Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of pioglitazone on reducing airway inflammation in cystic fibrosis and characterize the amount and timecourse of pioglitazone elimination from the body.

Detailed description: Progressive loss of lung function due to chronic infection and inflammation is the primary cause of morbidity and mortality in patients with CF. Current therapies directed at treatment of chronic P. aeruginosa infection (e.g. aerosolized tobramycin, azithromycin) provide short-term improvement in pulmonary function; however, persistence of the infection/inflammation causes the inevitable loss of lung function. PPARgamma is a nuclear transcription factor which is known to reduce activation of NFKB, a central mediator of airway inflammation in CF. Recent studies demonstrate that PPARgamma expression is reduced in patients with CF and may offer a potential therapeutic target to combat airway inflammation in CF. Pioglitazone is a thiazolidinedione whose principal pharmacological target it PPARgamma. The purpose of this pilot study is to determine the pharmacokinetics/pharmacodynamics of pioglitazone and effect on reducing airway inflammation in cystic fibrosis.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Clinically stable (FEV1 within 10% of baseline)
* FEV1 \> 40% predicted

Exclusion Criteria:

* History of hypoglycemic events
* Hepatic disease (AST, ALT \> 2.5x ULN)
* Renal disease (GFR \< 60 ml/min - 1.73m2)
* Currently receiving beta-blocker, oral corticosteroids, statin, angiotensin receptor blocker, trimethoprim-sulfamethoxazole, gemfibrozil, or rifampin therapies.
* Allergy to thiazolidinediones
* Pregnancy or attempting to conceive, breast feeding
* Hematocrit \< 30
* Congestive heart failure
* Pulmonary hypertension

Primary outcomes:
measure: To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.
timeFrame: 83 days
Secondary outcomes:
measure: To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.
timeFrame: 83 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Paul M Beringer, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590381: Assessment of HBV Vaccine Immunity After 18 Years
Official title: Assessment of the Immune Status of New Health Care Workers in the Israel Defense Forces (IDF) Vaccinated in Infancy Against Hepatitis B Virus (HBV), Before and After a Booster Dose.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis b Vaccine
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of both males and females who were born after January 1st 1992, who are in medical training at the Medical Corps Training Base.

Brief summary: The purpose of this study is to assess HBV immunity and institute policy regarding the Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during infancy.

Detailed description: The study population will consist of both males and females who were born after January 1st 1992, who are in medical training at the Medical Corps Training Base. Demographic information will be obtained through a questionnaire given to the soldiers in the study , as well as the IDF computerized personnel information database.

This study is designed to determine HBV vaccination policy among new HCWs in the IDF, who were vaccinated during infancy. This population was recruited to the IDF since the second half of 2010. Therefore, it is necessary to conduct this study on new HCWs that will be receiving the routine HBV vaccination and that will be at risk for HBV infection in the future due to their occupation in the army (HCWs, etc).

Eligibility criteria: Inclusion Criteria:

1. Soldiers born on or after January 1st, 1992
2. Soldiers taking part in a medical training course
3. Soldiers that signed an informed consent form

Exclusion Criteria:

1. Born before January 1st, 1992
2. Soldiers with previous known infection with HBV
3. Soldiers with documented evidence of immunity against HBV
4. Soldiers that refuse to participate in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Israeli Defense Forces
Study officials:
affiliation: International Diabetes Federation
name: Michael Hartal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05077410: Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming
Official title: Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthrosis
Keywords: Arthrosis
Spondylolisthesis
Degenerative spondylolisthesis
Arthrodesis
Osteosynthesis-arthrodesis
Fluoroscopy.
Pedicle screws
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5

Brief summary: Surgery for degenerative spondylolisthesis requires decompression of the narrow lumbar canal and fixation by osteosynthesis-arthrodesis. Conventional surgery is done through the open route. For 10-15 years, minimally invasive techniques have been established, allowing faster postoperative recovery for the patient. The downside to these techniques is the use of intraoperative fluoroscopy. This is why surgical navigation systems have been developed, allowing safe positioning of implants (pedicle screws). A new process (augmented reality navigation) has been tested in vitro and applied in open surgery. The HUS were the first establishment to apply this new method in minimally invasive surgery in a hybrid room of surgery and interventional radiology.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject operated at the HUS between March and December 2019
* Subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective description of minimally invasive surgery using augmented reality navigation
timeFrame: Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
name: Yann Philippe YannPhilippe.CHARLES@chru-strasbourg.fr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04228510: Two- Dimensional Speckle Tracking Echocardiography After Primary Percutaneous Coronary Intervention
Official title: The Role of Two- Dimensional Speckle Tracking Echocardiography in Prediction of Remodeling and Major Adverse Cardiovascular Events in ST Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ST elevation myocardial infarction patients after primary percutaneous coronary intervention who will be followed up for a one year in Assiut University hospital.

Brief summary: ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and secondary prevention, mortality remains considerable. Reduced EF is a well-known predictor of increased short and long term major adverse cardiovascular events MACE :( heart failure, stroke and death)


Eligibility criteria: Inclusion Criteria:

* ST elevation myocardial infarction patients after primary percutaneous coronary intervention

Exclusion Criteria:

* Previous myocardial infarction.
* Sever or haemodynamically significant (associated with chamber dilation) valvular heart diseases.
* Previous heart failure.
* Previous cerebrovascular strokes.
* Atrial fibrillation.
* Severe comorbidities as severe renal impairment, hepatic or respiratory failure.
* Bad equality views which affects accurate speckle tracking imaging.

Primary outcomes:
measure: The Incidence of major adverse cardiovascular events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hatem Helmy, MD
role: STUDY_DIRECTOR
References: