louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01111266: Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)
Official title: Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease
Keywords: in vivo KUF
ß2M
leptin
Lead sponsor: B.Braun Avitum AG
Sponsor class: INDUSTRY
Collaborators: name: Labor Limbach, Heidelberg, Germany
name: Clin-Sol, Würzburg, Germany
First posted: 2010-04-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from patient or parents/ guardian.
* Subject age \>= 18
* Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
* On hemodialysis for a minimum of 3 months
* Use of Cimino- or Gore-tex shunts
* Routine dialysis-treatment for 240 min
* Documented dialysis adequacy parameter that has been stable for past 3 months
* Plan to dialyze at participating hemodialysis centre for at least 3-months duration.
* Free from any currently known unusual clotting or access problems
* Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
* Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days
* Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days
* Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment

Exclusion Criteria:

* Patients who are unable to tolerate an effective blood flow of 350 ml/min
* Patients using catheter for dialysis
* Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
* Previous plan for extended absences from the participating hemodialysis centre
* Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study

Primary outcomes:
measure: in vivo KUF
timeFrame: 6 weeks
Secondary outcomes:
measure: Determination of removal rates
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Georg-Haas Dialysezentrum der PHV
state: Hessen
Study officials:
affiliation: B.Braun Avitum AG
name: Jürgen Wagner, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00222066: Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
Official title: Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cyst
Ultrasonography Prenatal
Keywords: Aspiration
Fetal ovarian cyst
Ovarian torsion
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

Detailed description: With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However

Eligibility criteria: Inclusion Criteria:

* Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)

Exclusion Criteria:

* Multiple pregnancy
* Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
* Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
* Unability to give informed consent

Primary outcomes:
measure: To avoid neonatal surgery
timeFrame: 3 months after birth
Secondary outcomes:
measure: Ultrasound pattern of neonatal ovarian cyst
timeFrame: 3 months after birth
measure: Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration
timeFrame: 3 months after birth
Other outcomes:
Locations:
city: Tours
country: France
facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital
state: Centre
city: Nantes
country: France
facility: CHU de Nantes
state: Loire Atl
city: Caen
country: France
facility: CHU de Caen
Study officials:
affiliation: Tours University Hospital
name: Franck Perrotin, MD--PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. doi: 10.1046/j.1469-0705.2000.00247.x.
citation: Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.
Clinical trial NCT01928966: Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
Official title: Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Disease
Blood Pressure
Keywords: dietary fat
fat intake
blood pressure
women
phytoestrogen
pumpkin seeds
cardiovascular disease
heart disease
secoisolariciresinol
monounsaturated fat
polyunsaturated fat
feeding study
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.

Detailed description: Cardiovascular disease is the number one cause of morbidity and mortality in United States. Diets high in polyunsaturated and monounsaturated fatty acids have been shown to decrease the risk of cardiovascular disease. Pumpkin seeds are a good source of monounsaturated and polyunsaturated fatty acids. Oil extracted from pumpkin seeds has been shown to lower blood pressure. One purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds per day will improve polyunsaturated and monounsaturated fatty acid intake in the diet in healthy adult women. Another purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds a day will lower blood pressure.

Eligibility criteria: Inclusion Criteria:

* Female
* Over the age of 18
* Able to read, write, and speak English
* Able to keep a three-day diet diary
* Willing and able to consume pumpkin seeds

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Allergic to pumpkin seeds
* High blood pressure
* Regularly consuming pumpkin seeds (more than 4 times per month)
* Taking blood pressure medication
* Liver disease
* Kidney disease
* Gastrointestinal disease
* History of bariatric surgery
* History of a major cardiovascular event
* Heart disease
* Currently undergoing cancer treatment (except nonmelanoma cancer)
* Following a weight control diet
* Following a disease specific diet
* Following a vegan diet
* Have a diagnosed eating disorder

Primary outcomes:
measure: Dietary fatty acid intake
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: John D Radcliffe, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01207466: Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.


Eligibility criteria: Inclusion Criteria:

* Currently wearing soft contact lenses with astigmatism correction
* Other protocol inclusion criteria may apply

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment
* Currently enrolled in an ophthalmic clinical trial
* Strabismus
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
* Other protocol exclusion criteria may apply

Primary outcomes:
measure: Quality of Vision (Crisp and Clear)
timeFrame: 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03321266: Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
Official title: A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Fistula
Keywords: Fistula plug
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.

Brief summary: The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-\[X\]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure

Exclusion Criteria:

* Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula

Primary outcomes:
measure: Rate of fistula closure
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Providence
country: United States
facility: University Surgical Associates
state: Rhode Island
city: Wiesbaden
country: Germany
facility: St Josef's Hospital
Study officials:
affiliation: St Josef's Hospital, Wiesbaden
name: Adal Saeed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318266: NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.
Official title: NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Detection of Bladder Cancer using NMP22 Urine Test Kit
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 73
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: Patient with a history og pTis, pT1, larger ( \>2 cm) pTa or multiple pTa bladder tumors.

Brief summary: It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.

Detailed description: Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.

Eligibility criteria: Inclusion Criteria:

* · History of pTis, pT1, large (\>2cm) pTa or multiple pTa bladder cancer tumours.

Written Informed Consent prior to any study-related procedures.

Exclusion Criteria:

* History of bladder cancer tumours other than those listed in inclusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Jonathan Izawa, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471166: The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
Official title: The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ectopic Pregnancy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University

Brief summary: Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve


Eligibility criteria: Inclusion Criteria:

* The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)
* Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery

Exclusion Criteria:

1. The use of hormonal contraceptives within two months of enrolment
2. If other surgery was conducted at the time of salpingectomy.
3. If a woman was pregnant at follow up visit for AMH measurement
4. History of previous surgeries of fallopian tubes and/or ovaries

Primary outcomes:
measure: Change in levels of AMH pre and post treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT05879666: Improving Health and Environmental Health Literacy of Professionals
Official title: Improving Health and Environmental Health Literacy of Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 213
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to understand the impact of an educational intervention on reproductive health care providers' environmental health literacy related to phthalates. The main questions to answer are:

1. Does a web-based educational intervention improve the environmental health literacy of personal care product chemicals based on pre/post/post intervention survey data?
2. Does a web-based educational intervention improve reproductive health professionals' confidence and awareness for communication to patients on environmental health literacy?
3. Do concentrations of personal care product chemicals in reproductive health professionals decrease after the web-based educational intervention?

Participants will be asked to complete three surveys: one before the educational intervention, and two after the intervention. The will be asked to complete the approximately 1-hour online educational intervention, which consists of a series of videos from the perspectives of patients, OBGYNs, and researchers, an interactive module, and a worksheet to facilitate conversation with patients.


Eligibility criteria: Inclusion Criteria:

* Employed in a patient-facing role relevant to reproductive health care (e.g., obstetricians, gynecologists, medical assistants, doulas, and nurses, etc.)

Exclusion Criteria:

* Practitioner does not interact with patients

Primary outcomes:
measure: Baseline phthalate environmental health literacy
timeFrame: Up to 2 weeks
measure: Change from baseline phthalate environmental health literacy
timeFrame: Up to 4 weeks
measure: Sustained change from baseline phthalate environmental health literacy
timeFrame: 2 months
measure: Baseline urinary biomarkers of phthalate exposure
timeFrame: Up to 2 weeks
measure: Change in urinary biomarkers of phthalate exposure
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H. Chan School of Public Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT00667966: Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Official title: Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Spinal Cord Injury
Keywords: Spinal cord injury
Urodynamic
Erectile dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assess efficacy of Vardenafil in patients with traumatic spinal cord injury


Eligibility criteria: Inclusion Criteria:

* Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy

Primary outcomes:
measure: Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests
timeFrame: 4 treatment days
Secondary outcomes:
measure: Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo
timeFrame: 4 treatment days
measure: Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo
timeFrame: 4 treatment days
measure: Number of participants with adverse events
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
state: Barcelona
city: Toledo
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00179166: Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
Official title: Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Renal Failure
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 3
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: We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age admitted to the intensive care unit
* New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
* ARF will be defined by a sustained (over 24 hours) increase in serum creatinine \> 0.5 mg/dl from baseline
* Patients will be recruited for the study within 3-5 days following establishment of ARF

Exclusion Criteria:

* Institutionalized patient
* Previous kidney transplant
* Pregnancy
* Unable to obtain consent from subject or legally recognized representative
* ARF from urinary tract obstruction or a volume responsive pre-renal state.
* Liver Failure
* Recent cerebrovascular accident (CVA)
* Coagulopathy defined as: Platelets \< 50, PT \> 20, INR \> 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.
* Life expectancy \< 48 hours

Primary outcomes:
measure: whole-body net protein balance
timeFrame: 10 hours
Secondary outcomes:
measure: Net skeletal muscle protein balance
timeFrame: 10 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References: