louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03751553: Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)
Official title: Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC):a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Duration of Labor
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract in women undergoing a Vaginal Birth After Cesarean (VBAC).

Detailed description: Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.

Eligibility criteria: Inclusion Criteria:

* • Age between 18 and 40 years

  * Women who have had only one prior cesarean birth with no previous vaginal delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.
  * Singleton baby in vertex presentation
  * Low-risk pregnancy at term (37-41 weeks of gestation)
  * Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
  * Signed written informed consent

Exclusion Criteria:

* • Contraindications for vaginal delivery (placenta previa, active herpes infection, etc...)

  * Suspected amniotic infection (fever, foul-smelling discharge, fetal tachycardia, abdominal pain)
  * A non-reassuring fetal heart tracing
  * Prolonged rupture of the membranes (24 hours)
  * Suspected major fetal malformations
  * Suspected cephalopelvic disproportion

Primary outcomes:
measure: length of the second stage of labor
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Ashour
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405753: Potential Health Effects of Aronia Intake
Official title: Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Effects of Aronia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 109
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Intervention cross-over study during which participants receive standardized amounts of aronia berry tablets or placebo for three months, then wash out for three months, then aronia tablets or placebo for three months. The potential health effects are investigated. Following parameters are measured before and after each period of tablet intake: 1) Blood pressure, 2) Lipid fractions, 3) Testosterone, 4) Phase II markers, 5) HbA1c, 6) HSCRP, 7) F2-isoprostanes, and 8) semen quality.


Eligibility criteria: Inclusion Criteria:

* Healthy men with total cholesterol between 5 and 7 mmol/L, who do not take medication

Exclusion Criteria:

* Chronic diseases and intake of medication or antioxidants

Primary outcomes:
measure: Cholesterol
timeFrame: 9 months
Secondary outcomes:
measure: Phase II enzyme activity
timeFrame: 9 months
measure: Phase II enzyme activity
timeFrame: 9 months
measure: Phase II enzyme activity
timeFrame: 9 months
measure: Isoprostanes
timeFrame: 9 months
measure: Semen quality
timeFrame: 9 months
measure: Semen quality
timeFrame: 9 months
measure: Semen quality
timeFrame: 9 months
measure: Blood pressure
timeFrame: 9 months
measure: High Sensitivity C reactive protein
timeFrame: 9 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Study officials:
References:
citation: Sangild J, Faldborg A, Schousboe C, Fedder MDK, Christensen LP, Lausdahl AK, Arnspang EC, Gregersen S, Jakobsen HB, Knudsen UB, Fedder J. Effects of Chokeberries (Aronia spp.) on Cytoprotective and Cardiometabolic Markers and Semen Quality in 109 Mildly Hypercholesterolemic Danish Men: A Prospective, Double-Blinded, Randomized, Crossover Trial. J Clin Med. 2023 Jan 3;12(1):373. doi: 10.3390/jcm12010373.
Clinical trial NCT00354653: A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
Official title: AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CHRONIC HEPATITIS B
Keywords: HBeAg
HBV
CHRONIC HEPATITIS
lamivudine
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.


Eligibility criteria: Inclusion Criteria:

* Confirmed active liver disease due to Hepatitis B virus.
* Patients must have adequate blood \& liver functions.
* Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
* Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible.

Exclusion Criteria:

* Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.

Primary outcomes:
measure: Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit)
Secondary outcomes:
measure: Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00202553: S90652 in Paediatric Hypertension
Official title: Acceptability, Safety, Pharmacokinetics and Effects on Blood Pressure of a Daily Dose of 0.025 to 0.135 Milligram Per Kilogram of S90652, a Paediatric Formulation of Perindopril, in 2-16 Years Old Hypertensive Children - 3 Month Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril given in hypertensive children


Eligibility criteria: Inclusion Criteria:

* Hypertensive children

Exclusion Criteria:

* Renal failure
* Unstable renal function
* Hyperkaliemia

Primary outcomes:
measure: Safety assessed from the patient's (parents) complaints and the clinical follow-up
Secondary outcomes:
measure: Acceptability, efficacy, pharmacokinetics
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Hôpital Necker-Enfants Malades, Paris, France
name: Patrick Niaudet, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT03587753: Experiment 2: Understanding Liver Fat Metabolism
Official title: Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Nutrients on Liver Fat Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Acid Oxidation
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross-over
Primary purpose: BASIC_SCIENCE

Brief summary: There is a largely unsubstantiated thought in the literature that dietary unsaturated enter oxidation pathways preferentially compared to saturated fatty acids. This study is undertaking a direct comparison of the oxidation of dietary saturated and unsaturated fatty acids.

Detailed description: Provided subjects meet the inclusion criteria, then at least one week after the screening visit volunteers will then undertake the first two 'study days'. There will be two study days on separate occasions that will be up to 3 weeks apart. Each study day will be approximately 7 hours in duration. On each study day participants will be given a standardised 'test' meal that contains specially labelled fat molecules (stable-isotope tracer) and then repeated breath and blood samples will be taken over the course of the next 6 hours. The test meal consumed on each 'study day' will be identical in composition with only the specially labelled fat molecules being different (either unsaturated or saturated fat) and these will be given in a random order.

Eligibility criteria: Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.

Male or Female, aged \>18 and \<65 years BMI \>19 \<35kg/m2 No medical condition or relevant drug therapy known to affect liver metabolism

Exclusion Criteria:

* • Age \<18 or \>65 years

  * Body mass index \<19 or \>35kg/m2
  * A blood haemoglobin \<120mg/dL
  * Any metabolic condition or relevant drug therapy
  * Smoking
  * History of alcoholism or a greater than recommended alcohol intake
  * Pregnant or nursing mothers
  * Women prescribed hormone replacement therapy (HRT) or who have used this within the last 12 months
  * History of severe claustrophobia
  * Presence of metallic implants, pacemaker
  * Haemorrhagic disorders
  * Anticoagulant treatment

Primary outcomes:
measure: Dietary fatty acid partitioning
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Centre for Diabetes, Endocrinology and Metabolism
Study officials:
References:
citation: Parry SA, Rosqvist F, Cornfield T, Barrett A, Hodson L. Oxidation of dietary linoleate occurs to a greater extent than dietary palmitate in vivo in humans. Clin Nutr. 2021 Mar;40(3):1108-1114. doi: 10.1016/j.clnu.2020.07.013. Epub 2020 Jul 22.
Clinical trial NCT01415453: Evoked Retinal Response
Official title: Evoked Visual Response Using Pulsed Ultrasound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
acoustic radiation force ultrasound
RP
visual field loss
Photoreceptor
Vision loss
retina
progressive vision loss
ultrasound
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor cells (cells in the retina that detect light). Photoreceptor cells capture and process light helping us to see. As these cells breakdown and die, people experience progressive vision loss. There is no known cure for retinitis pigmentosa. The investigators have observed that short pulses of focused ultrasound can cause perception of light when directed to spots on the retinal surface. The investigators propose to conduct a study to determine if pulsed ultrasound will stimulate the perception of light in the absence of functional photoreceptors in people with RP

Detailed description: Patients affected by retinitis pigmentosa (RP) and related diseases suffer loss of vision due to death of photoreceptor cells. The investigators have observed that short pulses of focused ultrasound can cause perception of light (phosphenes) when directed to spots on the retinal surface. If this phenomenon is caused by direct stimulation of the retinal nerves, which seems probable, then it might be possible to use this phenomenon to produce a form of vision in such patients. The investigators propose to conduct a study of a small cohort of patients affected by RP to determine if pulsed ultrasound will evoke a perception of light in the absence of functional photoreceptors.

Eligibility criteria: Inclusion Criteria:

* retinitis pigmentosa
* legally blind in at least one eye

Exclusion Criteria:

* unable to lay down on an exam table

Primary outcomes:
measure: Phosphene Perception in Response to Ultrasound Pulse.
timeFrame: Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ronald H Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782353: Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
Official title: A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: HCV
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

Detailed description: The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.

Eligibility criteria: Inclusion Criteria:

* Male or female, ages 18 to 65 years
* Documented chronic HCV infection, genotype 1a or 1b
* Treatment-naïve
* BMI = 18 - 35 kg/m2

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Previous treatment for HCV infection
* HIV or HBV positive
* Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
* History of any other known cause of liver disease;

Primary outcomes:
measure: The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
timeFrame: 10 days
measure: The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: United States, Missouri
state: Missouri
city: New York
country: United States
facility: United States, New York
state: New York
city: San Antonio
country: United States
facility: United States, Texas
state: Texas
city: Santurce
country: Puerto Rico
facility: Puerto Rico, Santurce
Study officials:
References:
citation: Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.
Clinical trial NCT04008953: Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study
Official title: Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Failure
Keywords: volume assessment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sixteen consecutive pediatric patients having end stage renal disease scheduled for living related donor renal transplant surgery

Brief summary: This study is designed for volume assessment in pediatrics during major surgery using non-invasive tools as ultrasonography without the need of invasive techniques avoiding its complications and as a guide for fluid therapy needed for maintaining adequate hemodynamics

Detailed description: Intravascular volume assessment during surgery is important for maintaining adequate hemodynamics. Methods approved for volume assessment include the use of echocardiography to measure left ventricular end diastolic area (LVEDA), central venous pressure (CVP) and pulmonary artery diastolic pressure (PAD). LVEDA is considered the good predictor for volume status assessment. CVP and PAD are invasive can potentially subject the patient to complications. Recently study performed an ultrasound assessment of the internal jugular vein (IJV) as a useful means of volume status assessment intraoperative under general anesthesia. In the pediatric population, only few studies are carried out to assess the use of ultrasound for intravascular volume assessment. This study will evaluate use of Ultrasonography of IJV in volume assessment in pediatrics will undergo renal transplant surgery and correlate IJV diameter, cross sectional area to CVP and LVEDA.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with end stage renal disease
* Weight between: 12 to 30 kg

Exclusion Criteria:

* Infection at the site of CVP or generalized infection.
* IJV thrombosis

Primary outcomes:
measure: Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area
timeFrame: 3months
Secondary outcomes:
measure: Internal jugular vein diameter, cross sectional area and central venous pressure
timeFrame: 3months
Other outcomes:
Locations:
Study officials:
affiliation: Departement of Anesthesia Kasr Alainy Medical School Cairo University
name: Sherif Soaida
role: STUDY_DIRECTOR
References:
Clinical trial NCT00913653: Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure
Official title: An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart failure
LCZ696
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 30
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 study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients with documented heart failure (NYHA class II-IV)

Exclusion Criteria:

* Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening

Primary outcomes:
measure: Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696
timeFrame: 14 days
Secondary outcomes:
measure: Pharmacokinetics of LCZ696 and its metabolites
timeFrame: 14 days
measure: Pharmacodynamics of LCZ696
timeFrame: 14 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: GOUVPO Russian Peoples´ Friendship University, Center of Applied
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kobalava Z, Kotovskaya Y, Averkov O, Pavlikova E, Moiseev V, Albrecht D, Chandra P, Ayalasomayajula S, Prescott MF, Pal P, Langenickel TH, Jordaan P, Rajman I. Pharmacodynamic and Pharmacokinetic Profiles of Sacubitril/Valsartan (LCZ696) in Patients with Heart Failure and Reduced Ejection Fraction. Cardiovasc Ther. 2016 Aug;34(4):191-8. doi: 10.1111/1755-5922.12183.