louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06107166: Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
Official title: Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Cardiovascular Diseases
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include stable females of reproductive age (18-51 years of age) with chronic kidney disease. Subjects will require permission of their primary nephrologist or primary care provider to participate

Brief summary: Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* female sex
* a diagnosis of chronic kidney disease or end stage kidney disease
* age 18-51

Exclusion Criteria:

Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.

Primary outcomes:
measure: Pulse wave velocity
timeFrame: Measured at baseline
measure: Aortic augmentation index
timeFrame: Measured at baseline
measure: Flow mediated dilation
timeFrame: Measured at baseline
measure: Velocity time integral
timeFrame: Measured at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT01217866: A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH
Official title: A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Uterine Disease
Keywords: laparoscopic
vaginal
hysterectomy
Lead sponsor: Womens Care
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2010-10-08
Enrollment: 79
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)

Brief summary: Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN\~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.

Detailed description: 79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever \>100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.

Eligibility criteria: Inclusion Criteria:

* none, observational study

Exclusion Criteria:

* none, observational study

Primary outcomes:
measure: Surgical time
timeFrame: Operating room time in minutes
measure: Estimated blood loss
timeFrame: Blood loss during surgery in cc per minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Glens Falls Hospital
name: Katie O'Keeffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031366: A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Official title: A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TIPS creation using real-time 3D roadmap
Primary purpose: TREATMENT

Brief summary: TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.


Eligibility criteria: Inclusion Criteria:

cirrhosis complications of portal hypertension requiring TIPS

Exclusion Criteria:

non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS

Primary outcomes:
measure: Technical success rate
timeFrame: 1 month
measure: number of punctures
timeFrame: 1 month
Secondary outcomes:
measure: radiographic fluoroscopy time for portal vein entry
timeFrame: 1 month
measure: radiographic fluoroscopy time for the whole procedure
timeFrame: 1 month
measure: procedural time
timeFrame: 1 month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT00887666: Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure
Official title: Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Hypovitaminosis D
Hyperparathyroidism
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with congestive heart failure

Brief summary: People with heart failure may have low magnesium and low vitamin D levels. They may also have abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests. We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.

Detailed description: This is a single-encounter crossectional prevalence study in which demographic information, health opinion surveys and labwork are all obtained at one visit. There are no follow up visits, however, if abnormal lab results are discovered, participants will be notified via US mail.

Eligibility criteria: Inclusion Criteria:

* congestive heart failure

Exclusion Criteria:

* pregnant
* hospitalized within one month
* taking calcium, vitamin D or magnesium supplements
* proteinuria \> 1g/24h
* creatinine clearance \<35 (MDRD)

Primary outcomes:
measure: Prevalence of hypovitaminosis D, Hyperparathyroidism, Hypomagnesemia in our cohort of CHF patients
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Mariana Markell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214266: A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Official title: A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* renal transplant recipients

Exclusion Criteria:

* Recipients of HLA-identical living-donor renal transplants;
* multi-organ transplant;
* known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;

Primary outcomes:
measure: renal allograft function
timeFrame: 2 years
Secondary outcomes:
measure: incidence of hypertension
timeFrame: 2 years
measure: incidence of diabetes
timeFrame: 2 years
measure: drug related side effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Hans Sollinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154866: Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
Official title: Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Caesarean Section;Stillbirth
Microbial Colonization
Keywords: Lactobacillus kefiri LKF01 DSM32079
Microbial Colonization
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.

Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.


Eligibility criteria: Inclusion Criteria:

* Term newborn
* Adeguate for gestational age
* Born by elective cesarean section
* Otherwise healthy newborn

Exclusion Criteria:

* major acute or chronic disease
* use of probiotics/antibiotics
* gastrointestinal malformation, cystic fibrosis, other genetic diseases
* concurrent participation in other clinical trials

Primary outcomes:
measure: Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
timeFrame: 21 days after supplementation start
measure: Number of participants with treatment-related adverse event
timeFrame: During 21 days after supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Study officials:
References:
Clinical trial NCT00848666: Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinea Pedis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and mycological examinations will be performed.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy patients with laboratory proven tinea pedis

Exclusion Criteria:

* Age lower than 18 and higher than 80

Primary outcomes:
measure: Cure of tinea pedis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT06893666: Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
Official title: Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Play Therapy
Down Syndrome
Attention
Randomized Control Trial
Child Development
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the attention level of children with down syndrome receiving play based therapy as compared to children receiving child centered play therapy.


Eligibility criteria: Inclusion Criteria:

* Age: 3-5 years
* Gender: Both male and female
* Children who are currently taking speech therapy sessions with parental involvement.
* Medically stable children with no severe ongoing health issues that could interfere with their participation in the study.

Exclusion Criteria:

* Children with severe sensory impairments
* Co-morbid neurological conditions that may confound the results
* Children who received intervention from any other institute

Primary outcomes:
measure: NHS Attention and Listening Screener
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University
name: Aleena Irum, Ms-SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu WP, Tsai WH, Lin LY, Hong RB, Hwang YS. The Beneficial Effects of Massage on Motor Development and Sensory Processing in Young Children with Developmental Delay: A Randomized Control Trial Study. Dev Neurorehabil. 2019 Oct;22(7):487-495. doi: 10.1080/17518423.2018.1537317. Epub 2018 Oct 30.
citation: Manshi, Dimple Choudhry, Anshu Kumari, & Priyanka Gulati. (2023). To Compare the Attention Span of Down Syndrome Children with Healthy Children of Same Age Group. International Journal of Medical Science and Diagnosis Research, 7(2). https://doi.org/10.32553/ijmsdr.v7i2.976
Clinical trial NCT00241566: Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Official title: Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain Rebel
Keywords: Neuropathic pain
Electric cortical stimulation
Economic Medical evaluation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2005-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.


Eligibility criteria: Inclusion Criteria:

* Presence of pain caused by lesion of central or peripheral nervous system
* Pain persistent since one year at least
* Pain untreated with 3 different antalgic treatments

Exclusion Criteria

* Pain linked t a malignant affection
* patient \< 18 years-old

Primary outcomes:
measure: Cost of treatment of this pathology
Secondary outcomes:
measure: Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand UH
state: Auvergne
city: Créteil
country: France
facility: Neurosurgery - Henri Mondor Hospital
state: Ile de France
Study officials:
affiliation: Clermont-Ferrand UH
name: Jean-Jacques Lemaire
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03312166: Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]
Official title: First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keloid
Keywords: ear lobe
compression
medical device
recurrence
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 yo;
* Patient with aer lobe keloid;
* Patient with an indication of reconstructive surgery;
* Signature of informed consent from the patient;
* Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study;
* Patient with French social insurance.

Exclusion Criteria:

* Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality);
* Patient with know nickel allergy;
* Patient with know silicon allergy;
* Pregnant women;
* Legal incapacity or limited legal capacity;
* Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator;
* Patient without health insurance;
* The patient is in the period of exclusion of another study.

Primary outcomes:
measure: Recurrence of keloid scar
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Brice Chatelain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764266: Glycocalyx During Normothermic Machine Perfusion
Official title: Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycocalyx
Liver Transplantation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 30
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: An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.


Eligibility criteria: Inclusion Criteria:

* First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
* Recipient age \>18 years
* Written informed consent

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Syndecan 1 level during normothermic machine perfusion
timeFrame: 24 hours
measure: Heparansulfate level during normothermic machine perfusion
timeFrame: 24 hours
Secondary outcomes:
measure: Syndecan 1 after transplantation
timeFrame: 72 hours
measure: Heparansulfate level after transplantation
timeFrame: 72 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Simon Mathis, MD
role: PRINCIPAL_INVESTIGATOR
References: