louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05072860: Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
Official title: The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a double-blinded randomized controlled trial
Primary purpose: PREVENTION

Brief summary: In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

Detailed description: patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Eligibility criteria: Inclusion Criteria:

* hypertensive women undergoing elective cesarean section

Exclusion Criteria:

* Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
* patients with the high possibility of the morbid adherent placenta,
* known coagulopathy and
* those presented with severe antepartum hemorrhage
* refuse to participate

Primary outcomes:
measure: intraoperative blood loss
timeFrame: 30 minutes
Secondary outcomes:
measure: need of blood transfusion
timeFrame: 12 hours
measure: need of uterotonic
timeFrame: 24 hours
measure: change in hemoglobin
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01751360: SYR-472 Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-12-18
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

-1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.

2. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

-1. The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease

. 2. The participant is assessed to be ineligible for the study by the investigator or subinvestigator.

Primary outcomes:
measure: Blood Glucose
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Suita-shi
country: Japan
state: Osaka
Study officials:
affiliation: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
name: General Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT05536960: Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
Official title: Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atheroscleroses, Coronary
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.


Eligibility criteria: Inclusion Criteria:

* Aged 50 years and older
* Underwent CCTA imaging within 78 weeks from the screening visit
* Either CAD-RADS 4 or higher or 0/1 on CCTA.
* Able to provide written informed consent

Exclusion Criteria:

* History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \< 45 ml/min/1,73m2.
* CVD events/revascularization in history
* Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
* Chronic or recent (\< 1 month) infections and/or clinical signs of acute infection.
* History of auto-immune diseases.
* Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
* Elevated liver enzymes (\> 2 ULN of liver transaminases), acute liver failure or known liver disease.

Primary outcomes:
measure: Difference in TBRmax
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between TBRmax and FAI.
timeFrame: 1 day
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
Clinical trial NCT05783960: External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.
Official title: Multicenter External Validation of Clinical Prediction Tools for Estimating Salt and Potassium . Study UniverSel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: salt diet
potassium diet
prediction tools
Bayesian network
kidney disease
epidemiology
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 629
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: The study population will be composed of patients consulting or hospitalized in day hospital in the nephrology department of one of the three centers participating in the study: Hôpital Lyon Sud (Hospices Civils Lyon), AURAL (Association pour l'Utilisation du Rein Artificiel dans la région Lyonnaise) Lyon and Hôpitaux Universitaires de Bordeaux. It is therefore composed of patients suffering from different types of nephropathy (lithiasis, diabetes, hypertension, tubulo interstitial, glomerular, autosomal dominant polycystic or other) whatever the stage of their disease and of healthy volunteers (living donors).

Brief summary: There is no validated self-questionnaire to assess salt and potassium intake in nephrology patients.

Using Bayesian models, researchers developed clinical prediction tools to estimate salt and potassium intake in nephrology patients. These prediction tools performed well, with an accuracy of 89% for salt and 74% for potassium, and have undergone internal validation.

Currently, the investigators wish to conduct an external validation study of these clinical prediction tools using data from patients followed at 3 nephrologic centers to generalize the performance results of the tools.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or older
* Consultant or inpatient in the nephrology department
* Having performed a 24-hour urinary assessment as part of his usual management with analysis of natriuresis and/or kaliuresis.

Exclusion Criteria:

* Patient having lost salt by vomiting, diarrhea and intense sweating (sport) in the week preceding the 24-hour urine collection.
* Person protected by the french law

Primary outcomes:
measure: External multicenter validation questionary
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de néphrologie Hôpitaux Universitaires de Strasbourg
state: Alsace
city: Lyon
country: France
facility: AURAL
city: Lyon
country: France
facility: Hopital Lyon SUD
city: Paris
country: France
facility: HÖPITAL bichat
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
affiliation: Service Nephrologie, Hôpital Edouard Herriot
name: Jean Pierre Fauvel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591760: Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Official title: Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Growth Hormone Deficiency
Ischemic Heart Disease
Keywords: Heart Failure
Growth Hormone
Anabolism
Anabolic Deficiency
Hormone replacement
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

Detailed description: To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Eligibility criteria: Inclusion Criteria:

* Heart Failure in ew York Heart Association functional class II to IV
* Left ventricular end diastolic diameter \> 60 mm
* Left ventricular ejection fraction \< 40%
* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \< 9 ng/dl)
* Age 18-80 years
* Clinical stability, guideline-oriented maximal pharmacological therapy
* Informed consent

Exclusion Criteria:

* Active Myocarditis
* Hypertrophic Cardiomyopathy
* Active endocarditis
* Active malignancy
* End stage renal disease
* Severe liver disease (Child B-C)

Primary outcomes:
measure: Peak VO2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federico II University - Naples
name: Antonio Cittadini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: Luigi Saccà, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00988676: The Effect of Bowel Preparation Status on the Polyp Missing Rate
Official title: The Effect of Bowel Preparation Status on the Polyp Missing Rate During Colonoscopy: Prospective Study Using Tandem Colonoscopic Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Colonoscopy
Bowel Preparation
Polyp Missing Rate
Lead sponsor: Konkuk University Hospital
Sponsor class: OTHER
Collaborators: name: Konkuk University Medical Center
name: Konkuk University
First posted: 2009-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center

Brief summary: High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Until now, several studies evaluated the impact of bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate in patients with adequate bowel preparation status to that in patients with inadequate bowel preparation status during colonoscopy. However, there was no direct measurement the effect bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem colonoscopic evaluation in prospective setting.

Detailed description: 1. Study flow

1. All patients perform Colonoscopy

   * record the polyp size, shape, location and number
   * record the factors affecting polyp missing rate

     * Patients' age / gender
     * Indication of colonoscopy
     * colonoscopist career
     * colonoscopy withdrawal time
     * bowel preparation status according to scale of U.S. Multi-Society Task Force on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality scale
2. the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage polypectomy was performed within 6 month)

   * record additionally detected polyp - size, shape, location and number

Eligibility criteria: Inclusion Criteria:

* The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center

Exclusion Criteria:

* Colonoscopy was not reached the caecum
* The patients with 10 or more polyps (who suspected polyposis syndrome)
* Bowel preparation was inadequate when 2nd stage colonoscopic polypectomy
* The patients with inflammatory bowel disease or suspected inflammatory bowel disease
* The patients had a history of bowel resection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center; Konkuk University School of Medicine
name: Sung Noh Hong, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01269476: Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers
Official title: Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Lead sponsor: SeneXta Therapeutics SA
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.

Objectives:

1. to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo
2. to establish SNX-001 pharmacokinetic profile.

Detailed description: This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy males or females
* Physically and mentally healthy subjects
* Body weight \>60 kg and body weight ≤ 100 kg

Exclusion Criteria:

* Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities
* History of general malignant diseases
* Evidence of myasthenic weakness
* Acute infection or any other febrile illness

Primary outcomes:
measure: Relationship of clinical safety measurements to dose
timeFrame: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)
Secondary outcomes:
measure: Effect of dose on pharmacokinetic (PK) parameters
timeFrame: After single (Day 1) and multiple (Day 12) doses
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Scope Life Sciences GmbH
Study officials:
affiliation: Scope Life Sciences GmbH
name: Jorg Sahlmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05502276: Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
Official title: Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 90
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: Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm


Eligibility criteria: Inclusion criteria:

* patients of age \>18 years
* Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
* "no-lift" colic injuries ≤ 3cm in diameter
* residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter

Exclusion criteria:

* pregnant women
* failure to accept or understand the consent to participate in the study
* patients with severe coagulopathies
* patients with short life expectancy (Charlson comorbidity index ≥8)
* patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)

Primary outcomes:
measure: En-bloc resection rate
timeFrame: 1 year
measure: R0 resection rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ariccia
country: Italy
facility: Ospedale Dei Castelli
state: Rome
Study officials:
References:
Clinical trial NCT05222776: Predictive Values for the Outcome of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain
Official title: Predictive Values for the Outcome of Ultrasound Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent US guided radiofrequency procedures of the genicular nerves for chronic knee pain

Brief summary: Researchers are trying to assess a predictive value or correlation between patient and procedural characteristics and outcome measures results after genicular nerve radiofrequency ablation.

Detailed description: Genicular nerve radiofrequency stimulation procedure is an effective treatment for patients with chronic pain due to knee osteoarthritis; however, little is known about factors that predict procedure success. This study evaluated correlation between patient characteristics and procedural characteristics and pain improvement after ultrasound guided genicular nerve radiofrequency stimulation procedure.

Eligibility criteria: Inclusion Criteria:

* Patient's 18 years or older
* Patients who recently underwent ultrasound guided genicular nerve radiofrequency (RF) procedure

Exclusion Criteria:

* lack of documentation of predictive factors to assess outcome
* Patients in whom adequate follow-up data was not available
* Patients who were prescribed a new analgesic drug or received concurrent treatments for different pain sources during the follow-up period, that could affect interpretation of genicular RF treatment results.

Primary outcomes:
measure: Pain assessed by NRS
timeFrame: Change from baseline pain score at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: selin guven kose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02339376: Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Official title: Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy, Temporal Lobe
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to open up the promising treatment of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective against seizures in patients with surface neocortical foci, to a much larger population of patients with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are not currently considered good rTMS candidates.

The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients with deep seizure foci by targeting its usage to accessible cortical partner regions. In this study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic stimulation protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mesial temporal lobe epilepsy based on the combination of clinical semiology, neuroimaging findings, and electroencephalogram results.
* At least 1 seizure with loss of awareness per 4-week period, on average, despite the use of antiepileptic drugs

Exclusion Criteria:

* Prior brain surgery or exposure to transcranial magnetic stimulation
* Rapidly progressive brain lesions
* Inability to tolerate MRI or TMS
* Specific MRI or TMS contraindication as set forth in standard protocols of our institution

Primary outcomes:
measure: Self-reported Seizure Frequency
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Bernard S Chang, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: