louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00939068: Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Official title: A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B, Gestation
Keywords: Chronic hepatitis B, Telbivudine, Intrauterine transmission
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed description: In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.

Eligibility criteria: Inclusion Criteria:

* 20-40 years old pregnant woman with gestational age of 20-32 week;
* positive serum HBsAg;
* HBV DNA≥1.0x106 copies/ml;

Exclusion Criteria:

* with previous antiviral treatment;
* with clinical sign of threatened miscarriage or related treatment in early pregnancy;
* positive serum HAV, HCV, HDV and HEV tests;
* fetus deformity by 3-D ultrasound examination;
* on other dugs, such as immune modulators, cytotoxic drugs or steroids;
* husbands are infected with HBV.

Primary outcomes:
measure: the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
timeFrame: 1 month post partum
Secondary outcomes:
measure: liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
timeFrame: 1 month post partum
measure: drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
timeFrame: .1 year after childbirth
Other outcomes:
Locations:
Study officials:
affiliation: the Second Affiliated Hospital of Southeast University
name: Wei Zhao, P.H.D
role: STUDY_CHAIR
References:
citation: Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
Clinical trial NCT02266368: Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents
Official title: A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Keywords: Ureteral stents
Double J stent
Antimicoreal coated stent
USSQ
UTI
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents

Detailed description: The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo ureteral stent placement

Exclusion Criteria:

* Patients allergic to sulpha containing medications
* Ureteral stent insertion for infected hydronephrosis
* Patients who developed septic complications requiring antibiotic treatment after stent placement
* Patients who need bilateral stents
* Patients with chronic kidney disease grade IV and V (GFR \<30ml/min)
* Immunocompromised patients as those with malignancy or organ transplantation.

Primary outcomes:
measure: Incidence of urinary tract infection (UTI)
timeFrame: up to 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
affiliation: Assistant Professour, urology department, urology and nephrology center, mansoura university
name: Ahmed R EL-NAHAS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01819168: Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will perform a retrospective study to review the data of bladder diary, urodynamic studies and clinical data of patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital.

Brief summary: The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.


Eligibility criteria: Inclusion Criteria:

* patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital

Exclusion Criteria:

-

Primary outcomes:
measure: bladder diary
timeFrame: 3 months
Secondary outcomes:
measure: Frequency and Urgency
timeFrame: 3 months
Other outcomes:
Locations:
city: Pan-Chiao,
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01975272: The Use of Iron Therapy for Patients With Anemia After Caesarean Section
Official title: The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Anaemia
Keywords: postoperative
anemia
gynaecologic
surgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2013-11-03
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.

Detailed description: Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.

The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.

Eligibility criteria: Inclusion Criteria:

* Gynecological surgery
* Hb 5-7 mmol/L

Exclusion Criteria:

* Pregnancy
* Oncological operations
* Infections (PID)
* Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
* Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
* Small vulvar / vaginal operations such as (cysts, labia correction)
* Endometrial ablation
* Legal incapacity
* The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
* Hematologic disorders
* Erythropoiesis-stimulating agents \&lt; 3months ago
* Myelosuppressive therapy in history
* Hepatitis
* HIV
* Alcohol abuses
* Not understanding Dutch
* Allergic reaction to iron therapy in past

Primary outcomes:
measure: Hemoglobin
timeFrame: 3 weeks postoperative
Secondary outcomes:
measure: Serum Ferritin
timeFrame: 3 weeks postoperative
measure: Serum Hepcidin
timeFrame: 3 weeks postoperative
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
city: Sittard
country: Netherlands
facility: Orbis Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Roy Kruitwagen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496272: Atrial Fibrillation Cycle Length Measured on Transesophageal Echocardiography
Official title: Atrial Fibrillation (AF) Cycle Length Measured on Transesophageal Echocardiography : a Feasible Parameter for Predicting the Recurrence of AF in Patients With AF Converted to Sinus Rhythm After DC Cardioversion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-valvular atrial fibrillation

Brief summary: Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV.

Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.


Eligibility criteria: Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* moderate or severe mitral stenosis
* prosthetic heart valve

Primary outcomes:
measure: AF free survival rate at 6 months after DCCV
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References:
Clinical trial NCT01271972: Study of Nesvacumab (REGN910/ SAR307746)
Official title: A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-01-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of advanced solid malignancy.
2. ECOG performance status 0 - 1
3. Adequate hepatic, renal and bone marrow function
4. At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
5. At least 6 weeks since last dose of bevacizumab
6. At least 4 weeks since last surgery
7. At least 4 weeks since last dose of investigational treatment

Exclusion Criteria:

1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
2. Patients with serious non healing wound or acute ulcer
3. Either systolic blood pressure \>150 mm Hg or diastolic blood pressure \>95 mm Hg
4. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
5. Patients with deep vein thrombosis or pulmonary embolism within last 6 months

Primary outcomes:
measure: Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
timeFrame: 28 days
Secondary outcomes:
measure: PK/PD profile
timeFrame: 28 days
measure: Immunogenicity
timeFrame: 28 days
measure: Anti-tumor activity
timeFrame: 28 days
measure: Correlative biomarkers
timeFrame: 28 days
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: San Antonio
country: United States
state: Texas
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT02939872: Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
Official title: Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Percutaneous Transluminal Coronary Angioplasty
Coronary Disease
Keywords: DAPT
BVS
Bioresorbable Vascular Scaffold
Dual Antiplatelet Therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-10-20
Enrollment: 238
Sex: ALL
Minimum age (years): 19
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 evaluate optimal duration of antiplatelet therapy after Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic events.


Eligibility criteria: Inclusion Criteria:

1. Men or women at least 19 years of age
2. Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS
3. Among the participants underwent PCI with BVS, event-free patients who survived the first 12 months without death, serious MI, stroke, repeat revascularization or major bleeding (except non-significant peri-procedural MI)
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindication to antiplatelet therapy
2. If the physician believes that the patient need continuation of dual anti-platelet therapy because of comorbidities (ACS, peripheral vascular disease, significant carotid disease, etc.)
3. Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis)
4. Cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
5. Pregnancy test positive (hCG test is performed before randomization in all fertile women)

Primary outcomes:
measure: composite event of death, myocardial infarction, or stroke
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 5 years
measure: Myocardial Infarction
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
measure: Target Vessel Revascularization
timeFrame: 5 years
measure: Target Lesion Revascularization
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Bleeding
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
References:
Clinical trial NCT00941772: Confirmation of Nasogastric Tube Placement Via Ultrasonography
Official title: Confirmation of Nasogastric Tube Placement Via Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasogastric Tube Intubation
Keywords: Nasogastric tube verification with ultrasonography
ultrasonography
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if ultrasonography is an adequate means for confirmation of nasogastric tube placement and that ultrasonography is more time efficient than radiography confirming nasogastric tube placement.

Detailed description: Our current nasogastric tube placement protocol requires confirmation of nasogastric tube placement with plain radiography. Obtaining a plane radiograph in the emergency department can be time consuming and exposes the patient to radiation. Ultrasound is readily available to our physicians and does not expose patients to radiation.

Confirmation of nasogastric tube placement by ultrasonography may provide a faster means of confirmation and expose patients to less radiation.

Eligibility criteria: Inclusion Criteria:

* Male or Female Patients 18 years of age or older.
* Patients in the emergency department at Oklahoma State University Medical Center that require NG intubation with radiography confirmation.

Exclusion Criteria:

* Patients under the age of 18 years of age.
* Patients that are prisoners of the State or Government.
* Patient is pregnant.

Primary outcomes:
measure: Ultrasonography is as accurate as plain radiograph in confirming nasogastric tube placement
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Medical Center
state: Oklahoma
Study officials:
affiliation: Oklahoma State University of Health Sciences
name: Bryan J Menges, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685672: Safety of Epidural Fentanyl and Adrenalin During Childbirth
Official title: Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Pain
Keywords: labor analgesia
fentanyl
epinephrine
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2008-05-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Detailed description: Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at term in active labor

Exclusion Criteria:

* age below 18 years
* BMI \> 40
* drug hypersensitivity

Primary outcomes:
measure: Plasma concentration of fentanyl
timeFrame: hours
Secondary outcomes:
measure: length of active labor
timeFrame: hours
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital
Study officials:
affiliation: Dep of Anesethesiology, Akershus University Hospital
name: Vegard Dahl, PhD MD
role: STUDY_DIRECTOR
References:
citation: Haidl F, Rosseland LA, Spigset O, Dahl V. Effects of Adrenaline on maternal and fetal fentanyl absorption in epidural analgesia: A randomized trial. Acta Anaesthesiol Scand. 2018 Oct;62(9):1267-1273. doi: 10.1111/aas.13175. Epub 2018 Jun 25.