louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01567449: Risk Factors for Aneurysm Rebleeding
Official title: Risk Factors in Predicting Spontaneous Intracranial Aneurysm Rebleeding During Hospitalization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 66 SAH patients were enrolled in this study

Brief summary: The purpose of this study is to examine the risk factors for aneurysm rebleeding.

Detailed description: To investigate risk factors for spontaneous aneurysm rebleeding during hospitalization and to reach conclusions if any,of clinical signs for predicting rebleeding.

Eligibility criteria: Inclusion Criteria:

* Individual whose clinical course was clear enough to be traced back and whose conservative treatment duration was shorter than 6 weeks was included

Exclusion Criteria:

* Rebleeding patients with certain inducing factors such as:

  * severe emotional episode,
  * severe coughing,
  * constipation,
  * excessive activities, or
  * with coagulation disorder,or
  * with other intracranial vascular malformations,such as:

    * moyamoya disease,
    * arteriovenous malformation were excluded.
* Also patients who rebled while angiography were excluded.

Primary outcomes:
measure: Aneurysm rebleeding
timeFrame: up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital,Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Dezhi kang, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03824249: Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation
Official title: Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency in Children
Noninvasive Ventilation
Nutrition Assessment
Keywords: Energy Expenditure
Ventilator Weaning
Calorimetry, indirect
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach.

Currently, IC is not validated during the use of non-invasive ventilation.

Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.


Eligibility criteria: Inclusion Criteria:

* children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation.
* age ≤ 6 years
* patients whose parents provided signed informed consent

Exclusion Criteria:

* age \> 6 years
* patients whose parents didn't provide signed informed consent

Primary outcomes:
measure: Resting energy expenditure (REE)
timeFrame: 1 day
Secondary outcomes:
measure: Carbon dioxide production (VCO2)
timeFrame: 1 day
measure: Oxygen consumption (VO2)
timeFrame: 1 day
measure: Respiratory quotient (RQ)
timeFrame: 1 day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Thomas Langer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Edoardo Calderini, MD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Carlo Agostoni, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04029649: Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis
Official title: The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: Beta-1,3/1,6-D-Glucan
Ganoderma lucidum
Ulcerative colitis
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 204
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 aim of this study is to determine the efficacy and safety of Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum on ulcerative colitis


Eligibility criteria: Inclusion Criteria:

* age ≥18 years old
* ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
* agreed to participate in this study

Exclusion Criteria:

* ulcerative colitis patients who are treated by corticosteroid, immunosuppressive agents and biologic agents
* allergic to Ganoderma lucidum
* could not be randomised and participate in this study by clinical judgement

Primary outcomes:
measure: Change in Quality of Life: SF-36 questionnaire
timeFrame: 0 and 90 days
Secondary outcomes:
measure: Change of C-Reactive Protein (CRP) level
timeFrame: 0 and 90 days
measure: Change of Erythrocyte Sedimentation Rate (ESR)
timeFrame: 0 and 90 days
measure: Change of Tumor Necrosis Factor Alpha (TNF-α) level
timeFrame: 0 and 90 days
measure: Change of Interleukin 6 (IL-6) level
timeFrame: 0 and 90 days
measure: Change of fecal calprotectin level
timeFrame: 0 and 90 days
measure: Change of Mayo score
timeFrame: 0 and 90 days
measure: Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
timeFrame: 0 and 90 days
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: 30, 60 and 90 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: 30, 60 and 90 days
Locations:
city: Jakarta
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
state: Jakarta Pusat
Study officials:
affiliation: Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
name: Marcellus Simadibrata
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04400149: Progesterone Levels and Pregnancy Results
Official title: The Effect of Maternal Serum and Amniotic Fluid Progesterone Levels on Pregnancy Results
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Complications
Pregnancy Preterm
Pregnancy Loss
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 100
Sex: FEMALE
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 consists of 18-45 years old pregnant women who had a high risk in the antenatal screening test and give consent to perform amniocentesis.

Brief summary: The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome

Detailed description: Studies have investigated the relationship between maternal serum progesterone level and low birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding. In some cases, patients are supported by oral or vaginal progesterone treatments during pregnancy. We also measure the relationship between maternal serum progesterone by measuring the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by observing preterm birth, premature rupture of membranes, low birth weight, baby gender, maternal problems that may occur during pregnancy, fetal problems.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Women who did not receive progesterone treatment during pregnancy

Exclusion Criteria:

* Women who receive progesterone treatment during pregnancy
* multiple pregnancies
* Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease

Primary outcomes:
measure: pregnancy outcome
timeFrame: starting from 16 weeks, ending at the delivery of the baby
measure: pregnancy outcome
timeFrame: starting from 16 weeks, ending at the delivery of the baby
measure: pregnancy outcome
timeFrame: starting from 16 weeks, ending at the delivery of the baby
measure: pregnancy outcome
timeFrame: starting from 16 weeks, ending at the delivery of the baby
Secondary outcomes:
measure: fetal outcomes
timeFrame: starting from 16 weeks, ending at the delivery of the baby
measure: fetal outcomes
timeFrame: starting from 16 weeks, ending at the delivery of the baby
measure: fetal outcomes
timeFrame: starting from 16 weeks, ending at the delivery of the baby
Other outcomes:
Locations:
Study officials:
References:
citation: Johansson ED, Jonasson LE. Progesterone levels in amniotic fluid and plasma from women. I. Levels during normal pregnancy. Acta Obstet Gynecol Scand. 1971;50(4):339-43. doi: 10.3109/00016347109157335. No abstract available.
citation: Lau IF, Saksena SK, Salmonsen R. The concentration of progesterone, 20 alpha-dihydroprogesterone, testosterone, oestrone and oestradiol-17 beta in serum, amniotic fluid and placental tissue of pregnant rabbits. Acta Endocrinol (Copenh). 1982 Apr;99(4):605-11. doi: 10.1530/acta.0.0990605.
Clinical trial NCT02221349: A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Official title: A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form
* Complete a confidentiality disclosure agreement
* Be in good general health as determined by the Investigator/designee
* Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.

Exclusion Criteria:

* Self-reported pregnancy or nursing
* Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* Active treatment of periodontitis
* Fixed facial orthodontic appliances
* A history of kidney stones
* Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
* Any diseases or conditions that might interfere with the safe completion of the study
* An inability to undergo any study procedures.

Primary outcomes:
measure: Change From Baseline Air Challenge
timeFrame: 60 days
Secondary outcomes:
measure: Change From Baseline Visual Analog Scale
timeFrame: 60 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Chad J Anderson DMD Inc
state: California
Study officials:
affiliation: Chad J Anderson DMD Inc
name: Chad J Anderson, MS, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03733249: Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
Official title: Follow-up of Phase 1/2 Study of CaspaCIDe T Cells (BPX-501) From an HLA-partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia
Leukemia, Acute Myeloid (AML), Child
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Primary Immunodeficiency
Anemia, Aplastic
Hemoglobinopathies
Cytopenia
Fanconi Anemia
Diamond Blackfan Anemia
Thalassemia
Anemia, Sickle Cell
Keywords: Long term follow up
Gene-modified cells
ALL
AML
hematologic neoplasms
hematologic malignancies
anemia
congenital cytopenia
primary immune deficiencies
hemoglobinopathy
Lead sponsor: Bellicum Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 187
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a long-term follow up study evaluating the safety of BPX-501 T cells (rivogenlecleucel) and infused in pediatric patients previously enrolled on the BP-004 study.

Detailed description: Subjects enrolled on the BP-004 study who have completed or discontinued from the study, and are beyond Day 180 will be requested to enroll on this long-term follow up protocol. Long term follow up for gene therapy clinical and safety endpoints will continue up to 15 years.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent by the patient or the patient's guardian for children who are minors
* Enrolled on BP-004 protocol, received BPX-501 infusion, completed or discontinued from the study, and are beyond Day +180.

Exclusion Criteria:

* Lack of parents'/guardian's informed consent for children who are minors
* Loss of allograft prior to 6 months

Primary outcomes:
measure: Overall Survival
timeFrame: 1 and 2 years after rivogenlecleucel infusion
measure: Incidence of Disease-free Survival
timeFrame: 1 and 2 years after rivogenlecleucel infusion
measure: Relapse-free Survival
timeFrame: 1 and 2 years after rivogenlecleucel infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù
Study officials:
affiliation: Bellicum Pharmaceuticals, Inc.
name: Bellicum Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00699049: A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Alpha blocker
Tamsulosin
Solifenacin
Overactive Bladder
Urgency incontinence
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2008-06-17
Enrollment: 94
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.


Eligibility criteria: Inclusion Criteria:

* Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:

  * symptoms of urinary urgency (defined as a level of \>=3 in a 5 point urgency scale) at least two episode per 24 hours and
  * symptoms of urinary frequency ( \>8 micturitions per 24 hours)
* On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

* Previous history of acute urinary retention
* Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
* Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
* Symptomatic acute urinary tract infection (UTI) during the screening period
* Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
* A 5-alpha reductase inhibitor if started less than 3 months prior to screening
* Patients with previous urethral, prostate or bladder neck surgery

Primary outcomes:
measure: Achievement level of patients' individual satisfaction
timeFrame: At weeks 4 and 12
Secondary outcomes:
measure: Changes in urgency episodes
timeFrame: At weeks 4 and 12
measure: Changes in OAB symptom scores
timeFrame: At weeks 4 and 12
measure: Changes in QoL score by OAB-q
timeFrame: At weeks 4 and 12
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00288249: Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer
Official title: Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Breast Cancer, Metastatic
Keywords: Breast Cancer
Breast Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 82
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: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer
* No previous treatment with taxanes, and vinca alkaloids
* Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

* More than 2 previous chemotherapies
* Previous participation in another trial within the last 4 weeks
* Breast feeding
* Active infections

Primary outcomes:
measure: Tumor response rate (complete or partial response according to RECIST)
timeFrame: Every 6 weeks
Secondary outcomes:
measure: Duration of complete or partial tumor response
timeFrame: Every 6 weeks
measure: Time to tumor progression
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Wien
country: Austria
city: Wien
country: Austria
city: Brasschaat
country: Belgium
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Angers
country: France
city: Bordeaux
country: France
city: Clermont Ferrand
country: France
city: Saint Herblain Cedex
country: France
city: Vandoeuvre les Nancy
country: France
city: Berlin
country: Germany
city: Forlì
country: Italy
state: FC
city: Milano
country: Italy
state: MI
city: Reggio Emilia
country: Italy
state: RE
city: Olsztyn
country: Poland
city: Warszawa
country: Poland
city: Ljubljana
country: Slovenia
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Manchester
country: United Kingdom
state: Greater Manchester
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00294749: Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy
Official title: Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
Keywords: Prostate,
Infection,
Biopsy,
Antibiotic,
Prophylaxis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy

Detailed description: Prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate.

The majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. However, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis.

The objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days

Eligibility criteria: Inclusion Criteria:

* abnormal digital rectal examination
* abnormal PSA values

To be excluded those patients with:

* ciprofloxacine contraindication
* indwelling urethral catheter,
* positive urine culture,
* presence of cardiac valve prosthesis,
* uncontrolled diabetes mellitus,
* use of antimicrobials in the 7 days prior to biopsy.
* Urinary endoscopic procedure in the 7 days prior to biopsy
* coagulation defect
* Renal insufficiency
* Hepatic insufficiency

Primary outcomes:
measure: Bacteriuria five days after prostate biopsy
Secondary outcomes:
measure: - Clinically diagnosed infectious complications
measure: - Other complications related to the procedure
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers Hospital University
Study officials:
name: Irani Jacques, professor
role: PRINCIPAL_INVESTIGATOR
References: