louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04964713: A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes
Official title: A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Prognosis
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Zhongshan Hospital
name: Henan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: Guangdong Provincial People's Hospital
First posted: 2021-07-16
Enrollment: 2300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with type 2 diabetes mellitus and prediabetes were diagnosed according to the WHO 2006 criteria, aged 35 -79 years, who are undergoing echocardiography examination in clinical needs.

Brief summary: The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

Detailed description: This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

Eligibility criteria: Inclusion Criteria:

people with T2DM according to the WHO 2006 criteria

Exclusion Criteria:

including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: through study completion, an average of 6 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Union Hospital, China
name: Jing Jing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040413: Database Maintenance for Bariatric Procedures
Official title: Institutional Bariatric Database Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-07-31
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All morbidly obese individuals seeking bariatric surgery and approved by multidisciplinary bariatric committee.

Brief summary: Bariatric surgery registry for quality control and investigational purposes.


Eligibility criteria: Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* unfit for surgery

Primary outcomes:
measure: Surgery type
timeFrame: 10 years
measure: Percent total weight loss (%TWL)
timeFrame: 1 year from surgery
measure: Percent total weight loss (%TWL)
timeFrame: 5 years from surgery
measure: Percent total weight loss (%TWL)
timeFrame: 10 years from surgery
measure: Percent BMI loss (%BMIL)
timeFrame: 1 year from surgery
measure: Percent BMI loss (%BMIL)
timeFrame: 5 years from surgery
measure: Percent BMI loss (%BMIL)
timeFrame: 10 years from surgery
Secondary outcomes:
measure: Co-morbidity resolution
timeFrame: 1 year from surgery
measure: Co-morbidity resolution
timeFrame: 5 years from surgery
measure: Co-morbidity resolution
timeFrame: 10 years from surgery
measure: 30 day morbidity/mortality
timeFrame: up to 30 days from intervention
measure: long-term morbidity/mortality
timeFrame: 31 days to 10 years from surgery
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02995213: Quantification of UE Use and Effects of Feedback in the Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Cleveland State University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs, and

iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.


Eligibility criteria: Inclusion Criteria:

* Subjects post-stroke
* chronic post ischemic or hemorrhagic cortical or subcortical stroke
* 25 - 100 years old
* upper extremity impairment
* Subjects will need to be able to flex their paretic shoulder and their elbow \> 40° without assist
* able to follow 2-step commands
* community dwelling with or without assistance
* intact superficial light touch sensation in both upper extremities
* must also have some movement in both arms

Exclusion Criteria:

* can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis
* no upper extremity injury within the last 3 months

Primary outcomes:
measure: Accelerometer based paretic arm amount of use
timeFrame: 3 week period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00985036: Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients
Official title: Is VEGF a Useful Serum Biomarker for Patients Diagnosed With Meningioma or Glioma?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glioma
Meningioma
Keywords: glioma
meningioma
VEGF
Lead sponsor: Marquette General Health System
Sponsor class: OTHER
Collaborators: name: Upper Michigan Brain Tumor Center
First posted: 2009-09-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to Marquette General Hospital with a probable or confirmed diagnosis of meningioma or glioma

Brief summary: Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. The questions that will be addressed include:

1. Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?
2. Is the VEGF level an indicator of the response to treatment?
3. Does the VEGF level correlate with tumor histology and behavior?
4. Is there a relationship between VEGF level and outcome?


Eligibility criteria: Inclusion Criteria:

* any patient presenting with glioma or meningioma

Exclusion Criteria:

* a different type of brain tumor

Primary outcomes:
measure: Determine if VEGF levels correlate with tumor progression or recurrence
timeFrame: every one to three months
Secondary outcomes:
measure: Determine if the VEGF level is an indicator of the response to treatment.
timeFrame: Every one to three months
measure: Determine if the VEGF level correlates with tumor histology and behavior.
timeFrame: Every one to three months
measure: Determine if there is a relationship between VEGF level and outcome.
timeFrame: Every one to three months
Other outcomes:
Locations:
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
Study officials:
affiliation: Upper Michigan Brain Tumor Center
name: Richard A Rovin, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Michigan University
name: Robert J Winn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marquette General Health Systems
name: Suresh Nukala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04101513: The Natural History of Parkinson's Disease-associated Spinal Disorders
Official title: The Natural History of Parkinson's Disease-associated Spinal Disorders
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
Idiopathic Parkinson Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients in their early to mid-disease state. (Hoehn and Yahr scale 1-3) Age 18-75 years

Brief summary: This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

Detailed description: This is a prospective single-institution longitudinal study to access quality of life with PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. This study will follow for five years post-consent.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75

Exclusion Criteria:

* Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (DISH), or other systemic condition that affects spinal function Inability to consent Current incarceration Presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing

Primary outcomes:
measure: Natural history of spine disorders in idiopathic Parkinson's disease
timeFrame: Consent to five years
Secondary outcomes:
measure: Clinical impact of Parkinson's related spinal disorders
timeFrame: Consent to five years
measure: Factors associated with the development and progression of Parkinson's related spinal disorders
timeFrame: consent to five years
measure: Parameters for optimal management
timeFrame: consent to five years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Andrew Grossbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558336: Schistosoma Haematobium Infections and Praziquantel
Official title: Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schistosomiasis
Keywords: Schistosoma haematobium
schoolchildren
Central Sudan
Praziquantel
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Hikma Pharmaceuticals LLC
First posted: 2012-03-20
Enrollment: 520
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.

Detailed description: A longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.

Eligibility criteria: Inclusion Criteria:

* School children

Exclusion Criteria:

* Taking praziquantel

Primary outcomes:
measure: cure rate
timeFrame: one year
Secondary outcomes:
measure: reduction in the intensity of infection by
timeFrame: one year
Other outcomes:
Locations:
city: Al Salamania
country: Sudan
facility: Al Salamania
state: Nile
Study officials:
References:
citation: Ahmed AM, El Tash LA, Mohamed EY, Adam I. High levels of Schistosoma mansoni infections among schoolchildren in central Sudan one year after treatment with praziquantel. J Helminthol. 2012 Jun;86(2):228-32. doi: 10.1017/S0022149X11000290. Epub 2011 Jun 8.
Clinical trial NCT02847936: Efficacy of Triclosan-coated Sutures in the Episiotomy
Official title: The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Episiotomy
Keywords: triclosan
sutures
infection
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.

Detailed description: Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).

Data were analyzed according to the intention to treat principle.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who had had an episiotomy at the delivery
* vaginal delivery
* no further perineal or vaginal lesions present

Exclusion Criteria:

* collagen disease
* known immunodeficiency
* Clinical signs of infection at the time of episiotomy
* History of keloids and a medical disorder that could affect wound healing
* Hypersensitivity to any of the suture materials used in the protocol
* Diabetes mellitus
* Disorders requiring chronic corticosteroid use or immunosuppression
* Instrumental extraction

Primary outcomes:
measure: number of sutures used
timeFrame: two hours
measure: number of patients with wound complications (infection, hematoma, disruption)
timeFrame: one week
Secondary outcomes:
measure: cost of the treatment with and without infection
timeFrame: two weeks
measure: number of patients with adverse outcomes
timeFrame: two weeks
Other outcomes:
Locations:
city: Bizerte
country: Tunisia
facility: University Hospital Bougatfa
Study officials:
References:
citation: Guo J, Pan LH, Li YX, Yang XD, Li LQ, Zhang CY, Zhong JH. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016 Mar;201(1):105-17. doi: 10.1016/j.jss.2015.10.015. Epub 2015 Oct 23.
Clinical trial NCT05327036: The Effect of Single Umbilical Artery Caused by Umbilical Artery Embolism on Pregnancy Outcome
Official title: The Effect of Single Umbilical Artery Caused by Umbilical Artery Embolism on Pregnancy Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy Outcome
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants include women with pregnancy meeting the inclusion criteria

Brief summary: To investigate the relationship between single umbilical artery caused by umbilical artery embolism and pregnancy outcome , and to provide evidence-based evidence for peripartum health care of pregnant women with umbilical artery embolism.


Eligibility criteria: Inclusion Criteria:

* Age 18 \~ 34years old
* B-ultrasound first showed double umbilical artery, then single umbilical artery or pregnant women with umbilical artery embolism supported by intrapartum and postpartum pathology.
* B-ultrasound of prenatal examination showed a single umbilical artery, and prenatal and postpartum pathology showed pregnant women with a single umbilical artery.

Exclusion Criteria:

* The fetus has extracardiac malformation and aneuploid deformity

Primary outcomes:
measure: Gestational week of delivery
timeFrame: 32 weeks to 40 weeks gestation
measure: mode of delivery
timeFrame: 32 weeks to 40 weeks gestation
measure: newborn birth weight
timeFrame: 32 weeks to 40 weeks gestation
measure: birth height
timeFrame: 32 weeks to 40 weeks gestation
measure: Apgar score
timeFrame: 32 weeks to 40 weeks gestation
Secondary outcomes:
measure: coagulation function
timeFrame: 32 weeks to 40 weeks gestation
measure: placental weight
timeFrame: 32 weeks to 40 weeks gestation
measure: umbilical cord placental insertion point
timeFrame: 32 weeks to 40 weeks gestation
measure: umbilical cord length
timeFrame: 32 weeks to 40 weeks gestation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ying Hua
role: STUDY_DIRECTOR
References:
Clinical trial NCT03513536: The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Official title: The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morning Sickness
Pregnancy Early
Keywords: Aromatherapy
Essential Oils
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. Participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.

Detailed description: The inhalation of certain essential oils has been found to reduce feelings of nausea and to improve quality of life during pregnancy.

The essential oils used in this study are applied topically to the temples and jaw line every 4-6 waking hours over a 6-day period. Each application will produce an exposure that lasts up to 30-45 minutes before fading. At the end of each day, nausea and vomiting levels will be assessed using a validated measurement instrument.

Quality of life is measured using a 30-question tool that measures both pregnancy-related quality of life and pregnancy-induced nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

* age: 18-45 years
* confirmed pregnancy
* healthy pregnancy

Exclusion Criteria:

* hyperemesis gravidarum
* tobacco use in the home
* high risk pregnancy

Primary outcomes:
measure: Change from Nausea and Vomiting 6-part Quantification of Emesis scale
timeFrame: daily for 6 days
Secondary outcomes:
measure: Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale
timeFrame: baseline and day 6
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Institute of Wellness
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: Jessie Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01438736: Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
Official title: A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bleeding
Keywords: Focus:
preceding
desogestrel predicts
pattern of following
etonogestrel implant
Lead sponsor: VL-Medi Oy
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-09-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.


Eligibility criteria: Inclusion Criteria:

* Healthy women, 18-40 years of age
* regular menstrual cycle (period 23-35 days)

Exclusion Criteria:

* -Immediate previous use of progestin only contraception within 2 months
* Known or suspected pregnancy
* Acute tromboembolic disorder
* Presence or history of hepatic disease, as long as the liver function values have not returned to normal
* Undiagnosed vaginal bleeding
* Known or suspected sex-steroid influenced malignancies (e.g. breast cancer)
* Hypersensitivity to the active substances or to any of the excipients of the medicines
* Pregnant or breast feeding within 6 weeks
* The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.

Primary outcomes:
measure: The total number of bleeding days per 90 days reference period in women using Cerazette before Nexplanon and in women starting Nexplanon without preceding POP
timeFrame: 9 months
Secondary outcomes:
measure: The number of bleeding episodes according to WHO definitions
timeFrame: 9 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: VL Medi Oy
Study officials:
affiliation: VL-Medi Oy
name: Dan Apter, Docent
role: PRINCIPAL_INVESTIGATOR
References: