louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04141514: Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
Official title: Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nausea Post Chemotherapy
Vomiting
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to estimate the effect of the practice of a short-term partial fasting compared to a usual alimentation on nausea and vomiting within 5 days after the start of a chemotherapy session on 2 successive chemotherapy courses (4 sessions of chemotherapy) in patients starting treatment with highly emetogenic chemotherapy (ABVD or AVD protocol).

Detailed description: Patients in fasting arm will practice partial fasting during 3 days (D-1, D1 (D day of chemotherapy) and D2) following a food guide during 4 chemotherapy sessions. Patients in usual alimentation arm will continue to take food as usual practice.

In each arm, patients will be interviewed at each chemotherapy sessions about nausea and vomiting (number and intensity of nausea and vomiting, treatments taken). Denutrition, quality of life improvement, compliance to partial fasting, treatment response will be evaluate too.

Eligibility criteria: Inclusion Criteria:

* patient starting a treatment by chemotherapy ABVD or AVD
* patient affiliated to a social security scheme
* patient who gives his informed consent before any procedure related to the study

Exclusion Criteria:

* patient with diabetes
* patient with recent gastric ulcer
* patient with low BMI (less than 18,5 for patients under 70 or less than 21 for patient over 70)
* albuminemia \<35
* patient wiht loss weight \> 10% in 6 months
* pregnant or lactating women
* chronic alcoholism
* unable to understand the objectives and risks of the study
* patient with psychiatric desorder, under guardianship or under judicial protection
* patient who cannot read

Primary outcomes:
measure: nausea and vomiting evaluation and quantification
timeFrame: Day 1 (first day of the chemotherapy cycle),
measure: nausea and vomiting evaluation and quantification
timeFrame: day 2 of the chemotherapy cycle
measure: nausea and vomiting evaluation and quantification
timeFrame: day 3 of the chemotherapy cycle
measure: nausea and vomiting evaluation and quantification
timeFrame: day 4 of the chemotherapy cycle
measure: nausea and vomiting evaluation and quantification
timeFrame: day 5 of the chemotherapy cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
affiliation: CHU de La Réunion
name: Marie-Elora MUSSARD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03574714: The Role of Extracellular pH on Spermatozoa's Directional Movement in Vitro
Official title: The Role of Extracellular pH on Spermatozoa's Directional Movement in Vitro
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Males who come in to have their semen quality assessed.

Brief summary: The purpose of this research project is to determine whether or not the directional movement of spermatozoa is influenced by a pH gradient by examining spermatozoa in vitro.


Eligibility criteria: Inclusion Criteria:

* Normal semen sample

Primary outcomes:
measure: Directional Movement
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
References:
Clinical trial NCT03235414: Normal Liver Stiffness by MR Elastography
Official title: Determination of Normal Liver Stiffness by MR Elastography in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Washington University School of Medicine
name: Children's Hospital of Philadelphia
First posted: 2017-08-01
Enrollment: 101
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

Detailed description: MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults \[Etchell, Xanthakos\]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (\<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.

Eligibility criteria: Inclusion Criteria:

* Age 7-17 years
* No documented history of liver diseases
* English speaking

Exclusion Criteria:

* NPO less than 4 hours
* Body mass index \<10th or \> 85th percentile for age
* Documented history of liver disease
* Pregnancy
* Inability to lie still for duration of the MRI
* Inability to breath hold for the duration of the 15-20 second MR elastography sequence
* Standard contraindication to MRI (implanted hardware, etc.)
* Requirement of sedation or general anesthesia for MRI
* Abnormality of any measured liver function test
* Liver fat fraction \>5% by MRI PDFF

Primary outcomes:
measure: Liver Stiffness
timeFrame: During investigation
Secondary outcomes:
measure: Cross-platform Variability
timeFrame: During Investigation
measure: Cross-field Strength
timeFrame: During investigation
measure: Sex-related Differences
timeFrame: During investigation
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrew Trout, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trout AT, Anupindi SA, Gee MS, Khanna G, Xanthakos SA, Serai SD, Baikpour M, Calle-Toro JS, Ozturk A, Zhang B, Dillman JR. Normal Liver Stiffness Measured with MR Elastography in Children. Radiology. 2020 Dec;297(3):663-669. doi: 10.1148/radiol.2020201513. Epub 2020 Sep 22.
Clinical trial NCT06350214: Physical Activity and Nutrition in Cancer Survivors
Official title: Joint Association of Physical Activity and Dietary Quality With Survival Among US Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Nutrition, Healthy
Physical Inactivity
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data of this observational cohort study were extracted from six consecutive cycles of the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey (NHANES): including waves of 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018. The NHANES database systematically gathered nationally representative health-related data on non-institutionalized general US civilians, utilizing a stratified, multistage probability sampling design.

Brief summary: This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Participants with history of cancers were included

Exclusion Criteria:

* Participants with missing cancer investigation, dietary recall, and incomplete follow-up information were excluded from this study.

Primary outcomes:
measure: All-cause mortality
timeFrame: Jan 1 2017 to Dec 31 2019
measure: Cause-specific mortality
timeFrame: Jan 1 2017 to Dec 31 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06263114: Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
Official title: Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Transplant; Complications
Liver Failure, Acute
Keywords: Pediatric
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Eurofins
First posted: 2024-02-16
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Liver Transplant

Brief summary: Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.

Detailed description: This study is an investigator-initiated, prospective, single-cohort trial to assess the ability of the TruGraf® Liver gene expression panel (GEP) to predict rejection in pediatric liver transplant recipients undergoing surveillance and for-cause liver biopsy.

Eligibility criteria: Inclusion Criteria:

• All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy

Exclusion Criteria:

• Non-English, non-Spanish Speaking

Primary outcomes:
measure: Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.
timeFrame: Week prior to or at time of biopsy
Secondary outcomes:
measure: Comparison of the GEP to non-rejection injury found on biopsy
timeFrame: Week prior to or at time of biopsy
measure: Utility of the GEP for monitoring liver injury
timeFrame: Week prior to or at time of biopsy
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Ryan Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708914: Study to Compare the Safety and Efficacy of UB-851 and Eprex®
Official title: A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Anemia
Lead sponsor: UBI Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 269
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.

Detailed description: This is a 52-week, phase III trial consisting of two parts:

Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks.

Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.

Eligibility criteria: Main Inclusion Criteria:

1. Subjects signed informed consent before undergoing any study procedures.
2. Subjects aged 20 to 85 years.
3. Hemodialysis subjects with chronic renal failure and renal anemia in outpatient clinic currently on stable Eprex® treatment administered by intravenous injection (1 to 3 times per week) for at least 3 months prior to randomization.

Main Exclusion Criteria:

1. Maintenance epoetin dose \> 300 IU/kg per week.
2. Treatment with long-acting epoetin analogues.
3. Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).

Primary outcomes:
measure: Mean change in hemoglobin (Hb) levels
timeFrame: Baseline and the evaluation period (evaluation period: Week21-Week24)
measure: Mean change in weekly epoetin dosage. between baseline and the evaluation period
timeFrame: Baseline and the evaluation period (evaluation period: Week21-Week24)
measure: Adverse events (AEs): incidence and severity of all drug-related AEs
timeFrame: up to 52 weeks
measure: Immunogenicity: occurrence of anti-erythropoietin antibody
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02010814: Characterization of a Prospective Cohort of Women With PCOS
Official title: Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Inflammation
Body Composition
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with PCOS, diagnosed by the Rotterdam criteria which include at least two of the following:

* irregular mestrual cycle
* polycystic ovaries
* biochemical/clinical hyperandrogenemia

Brief summary: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT.

As part of the project, a Biobank with fasting blood samples from participants is established.


Eligibility criteria: Inclusion Criteria:

* PCOS

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: bone mass density (BMD)
timeFrame: baseline
Secondary outcomes:
measure: Stress hormones
timeFrame: Baseline
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Department of Endocrinology, Odense University Hospital
name: Dorte Glintborg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566014: The Study Aims to Improve the Accuracy of Detecting Spina Bifida During Early Ultrasound Scans. to Achieve This, an AI Model Has Been Developed to Provide Feedback About the Presence of Spina Bifida. a RCT Has Been Designed to Compare the Effectiveness of AI Feedback with No AI Feedback.
Official title: Evaluation of XAI-assisted Spina Bifida Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A RCT has been designed to compare the effectiveness of AI feedback with no AI feedback.

Detailed description: The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A randomized controlled trial (RCT) has been designed to compare the effectiveness of AI feedback with no AI feedback. Forty fetal medicine specialists are randomly assigned to receive either the AI feedback or no feedback, and the two groups are compared to determine if the feedback improved the accuracy of detecting spina bifida.

Eligibility criteria: Inclusion Criteria:

* Obstetricians

Exclusion Criteria:

* Fetal medicine specialists

Primary outcomes:
measure: Evaluation of XAI-assisted spina bifida diagnosis
timeFrame: One month after the survey is distributed.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References:
Clinical trial NCT06761495: Can Cesarean Scar Defects be Prevented?
Official title: Is Isthmosel Becoming History? The Effect of Three Different Uterotomy Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Isthmocele
Keywords: niche
baseball suturing
uterotomy
caesarean section
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caesarean section patients were eligible for the study and randomized preoperatively into 3 different uterotomy closure techniques (baseball, single-locked and single-unlocked groups). In all 3 groups, No. 1 absorbable multiflament polyglactin 910(Vicryl, Ethicon Inc, Somerville, NJ, USA) suture thread was used to close the uterine incision. When necessary, haemostatic additional sutures were applied using the same material.
Primary purpose: PREVENTION

Brief summary: In this study, uterotomy after cesarean section was performed using 3 different suture techniques and aimed to demonstrate the potential of the baseball suture technique to prevent the isthmusel complication known as cesarean scar defect.

Detailed description: An isthmocoele or cesarean scar defect is a pit-like defect in the myometrium at the isthmic level, thought to be the result of inadequate healing of the uterine incision after cesarean section. It is important not to underestimate isthmocele and to take preventive measures as it can lead to serious gynecologic and obstetric complications. However, which suturing technique is best in preventing isthmocele formation has not yet been established. The aim of this study was to compare the effects of 3 different uterine closure techniques on isthmocele formation during cesarean section.

In this study, a total of 120 term (\>37 weeks) pregnant women with no previous cesarean section and scheduled for primary cesarean section will be randomized preoperatively to 3 different uterotomy closure techniques (baseball, single-lock and non-single-lock groups).

Eligibility criteria: Inclusion criteria:

* Pregnant women undergoing C/S for the first time
* 37 weeks \< gestation (term pregnancies)

Exclusion Criteria:

* Presence of regular contractions in the uterus
* Cervical dilatation of more than 4 cm, indicating the onset of the active phase of labour
* Placental abnormalities
* Previous uterine surgery
* Multiple pregnancy
* Premature rupture of membranes
* Chorioamnionitis
* Preoperative haemoglobin level below 10g/dl
* Body mass index (BMI) above 35kg/m2
* Any comorbidity (e.g. diabetes, hypertension, pre-eclampsia, eclampsia)
* Smoking and/or alcohol use
* The need for a blood transfusion.

Primary outcomes:
measure: Isthmocele was be evaluated
timeFrame: Three months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gazıosmanpasa Unıversity
Study officials:
affiliation: Gazıosmanpasa Unıversity
name: Neset Gumusburun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02054195: Training Model on Insertion Techniques for Postplacental Intra Uterine Device
Official title: Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intra-uterine Device Complication
Lead sponsor: Showa University
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 230
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion

Detailed description: The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion

Eligibility criteria: Inclusion Criteria:

* 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly

Exclusion Criteria:

* Any bleeding and infection complication

Primary outcomes:
measure: Number of Participants with IUD total or partial expulsion
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants with retained skill and knowledge
timeFrame: 12 Months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Central nationalHospital Cipto Mangunkusumo
Study officials:
affiliation: Indonesia University
name: Seno Adjie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: