louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04357015: Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy
Official title: Comparative Safety and Efficacy of Intravenous Tranexamic Acid Versus IV Carbetocin in Reducing Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 153
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial


Eligibility criteria: Inclusion Criteria:

* women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging

Exclusion Criteria:

* women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid

Primary outcomes:
measure: intraoperative blood loss
timeFrame: one hour
Secondary outcomes:
measure: need for blood transfusion
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01616615: Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Official title: Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Placental Insufficiency
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
* Single gestation
* Mean pulsatility index of the uterine arteries above the 95th percentile for our population

Exclusion Criteria:

* Pre-existing hypertension, renal or cardiovascular disease
* previous history of pre-eclampsia
* Pregestational diabetes
* Systemic lupus Erythematosus
* Gastric ulcer
* Acetylsalicylic acid or lactose hypersensitivity
* Bleeding disorders
* Fetal disorders (including chromosomal abnormalities)
* Administration of low molecular weight heparin
* Concomitant treatment with aspirin

Primary outcomes:
measure: Uterine artery mean pulsatility
timeFrame: at 28 weeks of gestation
Secondary outcomes:
measure: Pre-eclampsia
timeFrame: delivery
measure: Severe preeclampsia
timeFrame: at delivery
measure: Intrauterine Growth Retardation
timeFrame: at delivery
measure: Significant neonatal morbidity
timeFrame: at delivery
measure: number of cesarean
timeFrame: at delivery
measure: Neonatal acidosis
timeFrame: at delivery
measure: Perinatal mortality
timeFrame: 28 days post partum
measure: Days in the Neonatal Intensive Care Unit
timeFrame: 28 days post partum
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: Institut Dexeus
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Hospital Clinic of Barcelona
name: FRANCESC FIGUERAS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702415: Zoledronic Acid in Cystic Fibrosis
Official title: Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Bone density
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Novartis Pharmaceuticals
First posted: 2012-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.

Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF); they have an increased rate of bone fractures in comparison to the general population. CF patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. Predicted survival for patients with CF has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous bisphophosphonates are known to increase bone density in CF; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. Zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. The current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain its efficacy in cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Aged at least 18 years
* Bone mineral density score of -1.5 or less at lumbar spine or total hip
* Able to give informed consent

Exclusion Criteria:

* Previous solid organ transplant
* on solid organ transplant waiting list
* Long trem oral glucocorticosteroids
* CRP \>20mg on day of randomisation
* Hypocalcaemia
* Poor dental hygiene

Primary outcomes:
measure: Bone density
timeFrame: 12 months
Secondary outcomes:
measure: Effect of zoledronic acid on the number of bone fractures
timeFrame: 12 months
Other outcomes:
measure: Bone pain
timeFrame: 12 months
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Charles Dr Haworth, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05796115: PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
Official title: PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early-Onset Neonatal Sepsis
Keywords: Early-Onset Sepsis
Procalcitonin
Presepsin
Preterm infant
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 266
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS).

The main question it aims to answer is:

• Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH \>3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.

Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight \<1500 g will be eligible for enrollment in the study.

Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).


Eligibility criteria: Inclusion Criteria:

* infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.

Exclusion Criteria:

* Risk factors for EOS:

  * maternal GBS colonization without adequate prophylaxis;
  * clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°C or a temperature of 38.0-38.9°C that persists for \>30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia;
  * pre-labor rupture of membranes (ROM) \>1 h before delivery.
* Surgery within the first week of life,
* major congenital malformations,
* chromosomal syndromes,
* inherited metabolic disorders,
* fetal hydrops

Primary outcomes:
measure: Survival without major morbidities.
timeFrame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Secondary outcomes:
measure: Individual components of the composite primary outcome will be regarded as secondary outcomes.
timeFrame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05762315: Transformative Audio Storytelling
Official title: Un Protocollo di Studio Per l'Assessment Dell'Efficacia Dello Storytelling Audio Trasformativo Per Caregiver Informale (A Protocol for Assessing the Feasibility of Transformative Audio Storytelling for Informal Caregivers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Keywords: audio storytelling
informal caregivers
digital narratives
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-post
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pilot testing the feasibility of the Transformative Audio Storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.


Eligibility criteria: Inclusion Criteria:

* Informal caregiver (family members or significant other person who provides primary care for the patients visiting or being hospitalized in the Rehabilitation Ward)
* Age ≥18 years
* Native speaker of the Italian language
* Having voluntarily agreed to participate in the study and having signed the informed consent in all its points.

Exclusion Criteria:

* Informal caregiver for children
* Informal caregiver who does not personally play this role (primary caregiver)
* Informal caregiver of adults with a tumor pathological condition

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: pre-post (15 minutes) intervention
measure: Sense of Coherence Scale revised (SOC-R)
timeFrame: pre-post (15 minutes) intervention
measure: Meaning in Life (MLQ)
timeFrame: pre-post (15 minutes) intervention
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: pre-post (15 minutes) intervention
measure: Facial expressions responses (Noldus FaceReader)
timeFrame: during 15 minutes intervention session
measure: Burden Scale for Family Caregivers - Short Form (BSFC-s)
timeFrame: pre-post (15 minutes) intervention
Secondary outcomes:
measure: Feedback on the perceived value of audio storytelling
timeFrame: after 15 minutes intervention sessions
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
state: Lombardia
Study officials:
References:
Clinical trial NCT02310815: ReSure Sealant Post Approval Study
Official title: ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Events
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-08
Enrollment: 626
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with ReSure Sealant following cataract surgery

Brief summary: This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.


Eligibility criteria: Inclusion Criteria:

* Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement

Exclusion Criteria:

* ReSure Sealant is not applied to the operative eye

Primary outcomes:
measure: Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
timeFrame: Post operative days 20 to 40
measure: Hypotony (≤ 5 mmHg)
timeFrame: Post operative days 20 to 40
measure: Ocular discomfort
timeFrame: Post operative days 20 to 40
measure: Surgical reintervention
timeFrame: Post operative days 20 to 40
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03977415: Interstitial Lung Disease in Early Rheumatoid Arthritis
Official title: Interstitial Lung Disease in Early Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Interstitial Lung Disease
Keywords: Interstitial Lung Disease
ILD
Pulmonary Fibrosis
Rheumatoid Arthritis
RA
Rheumatology
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2019-06-06
Enrollment: 76
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: NON_PROBABILITY_SAMPLE
Study population: Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk fro the development of lung disease.

Brief summary: The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.

Detailed description: Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 90 years
2. Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
3. Able to read, speak, and understand English
4. Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time

Exclusion Criteria:

1. Subjects who do not meet all inclusion criteria
2. Pregnant women

Primary outcomes:
measure: Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD
timeFrame: 18 months
measure: Change in lung antigen targets in RA-ILD using induced sputum
timeFrame: 18 months
measure: Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute)
timeFrame: 18 months
measure: Change from baseline for Short Form (SF_36) questionnaire
timeFrame: 18 months
measure: Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire
timeFrame: 18 months
measure: Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Joshua Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03402815: Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.
Official title: Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection With Other Conditions
Cardiovascular Risk Factor
Atherosclerosis
Inflammation
Keywords: HIV
Maraviroc
Atherosclerosis
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in HIV infected patients with optimal viro-immunologic control and at high cardiovascular risk.

Detailed description: Experimental CCR5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary data in humans suggest an anti-atherosclerotic effect of the drug. The investigators assessed the impact of maraviroc treatment in HIV-infected patients on several subclinical indicators of atherosclerosis and putative mechanisms for such an effect.

HIV-treated patients under effective antiretroviral (ART) therapy, with a Framingham risk score \>20% and a brachial flow-mediated dilation (bFMD) \<4%, as indices of high cardiovascular risk, were recruited. Maraviroc (300 mg per os for 24 weeks) was administered on top of ART to all participants using a cross-over design. Brachial FMD, carotid-femoral pulse wave velocity (cfPWV) and carotid intima-media thickness (cIMT) were measured as non-invasive markers of atherosclerosis. Vascular competence, as expressed by the ratio of circulating endothelial micro-particles (EMPs) to endothelial progenitor cells (EPCs), as well as markers of systemic inflammation, monocyte activation and platelet activation were assessed.

Eligibility criteria: Inclusion Criteria:

* Eligible patients were consecutive ≥50-year-old individuals, treated for over 1 year with an effective protease inhibitor ART regimen (HIV RNA \<50 copies/mL), with CD4 T cell counts \> 300/ mm3 for at least 6 months and a Framingham risk score \>20% and bFMD \<4%.

Exclusion Criteria:

* Patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.

Primary outcomes:
measure: Change Flow Mediated Dilation
timeFrame: 24 weeks
measure: Change in Intima-Media Thickness
timeFrame: 24 weeks
measure: Change in carotid-femoral Pulse Wave Velocity
timeFrame: 24 weeks
Secondary outcomes:
measure: change in inflammatory markers
timeFrame: 24 weeks
measure: Endothelial microparticles/endothelial progenitor cells ratio
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Elisabetta Schiaroli
Study officials:
References:
Clinical trial NCT01742585: A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Official title: ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Renal Insufficiency
Hyperphosphatemia
Keywords: CKD
Not on dialysis
ASP1585
Bixalomer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 163
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients (eGFR \< 60 mL/min/1.73 m2)
* Serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention within 6 months

Primary outcomes:
measure: Change from baseline in serum phosphorus level at the end of treatment
timeFrame: Baseline and Week 12 or treatment discontinuation
Secondary outcomes:
measure: Achievement rate of the target range of serum phosphorus level
timeFrame: During 12 week treatment
measure: Time to achieve the target range of serum phosphorus level
timeFrame: During 12 week treatment
measure: Time-course changes in serum phosphorus levels
timeFrame: During 12 week treatment
measure: Time-course changes in serum calcium levels
timeFrame: During 12 week treatment
measure: Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
timeFrame: During 12 week treatment
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: