louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00444067: Study to Evaluate Safety & Effectiveness of Spinal Sealant
Official title: A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrospinal Fluid Leakage, Subdural
Keywords: Prevention of CSF leak
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Medtronic - MITG
First posted: 2007-03-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Detailed description: Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for a spinal procedure that requires a dural incision

Primary outcomes:
measure: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
measure: Incidence of Post-Operative CSF Leaks
timeFrame: 90 Days
measure: Incidence of Post-Operative Surgical Site Infections (SSIs)
timeFrame: 90 Days
Locations:
city: Bedford
country: United States
facility: Confluent Surgical, Inc.
state: Massachusetts
Study officials:
affiliation: Conlfuent Surgical/Covidien
name: Jen Doyle
role: STUDY_DIRECTOR
References:
citation: Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810.
Clinical trial NCT04921267: Impacts of Training on Effortful Listening
Official title: Impacts of Training on Effortful Listening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Training Group
Lead sponsor: Kansas State University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.
Primary purpose: BASIC_SCIENCE

Brief summary: Human listeners will hear speech masked by single-talker speech before and after auditory training.

Detailed description: Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.

Eligibility criteria: Inclusion Criteria:

* normal hearing

Exclusion Criteria:

* hearing loss

Primary outcomes:
measure: pretest EEG alpha power
timeFrame: one day before training
measure: posttest EEG alpha power
timeFrame: one day after training
measure: pretest accuracy
timeFrame: one day before training
measure: posttest accuracy
timeFrame: one day after training
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Kansas State University
state: Kansas
Study officials:
affiliation: Kansas State University
name: Matthew Wisniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244567: Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
Official title: Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Polycystic Ovarian Syndrome
Keywords: PCOS
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2014-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.

Detailed description: Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).

Eligibility criteria: Inclusion Criteria:

* Lean women BMI 25 or less
* Hyperandrogenic clinically and/or biochemically.
* Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria

Exclusion Criteria:

* BMI more than 20
* Other causes of hyperandrogenism
* Other causes of metabolic disorders or diabetes.

Primary outcomes:
measure: High Serum under-carboxylated osteocalcin
timeFrame: 3 months
Secondary outcomes:
measure: Metformin therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nesreen Abdel Fattah Abdullah Shehata
Study officials:
References:
Clinical trial NCT04211467: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Depression
Clinical Depression
Depression, Anxiety
Depression, Postpartum
Depression, Endogenous
Depression in Remission
Depression Chronic
Depression Moderate
Depression Severe
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with depression

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to depression.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of depression based on DSM-V criteria

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968367: To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation
Official title: To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation Among Patients With High DNA Fragmentation Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Male
Keywords: magnetic activated sperm sorting
DNA fragmentation index
sperm up
density differential centrifugation
clinical outcome
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. The sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high DNA fragmentation index (DFI). Hence, this study aimed at determining the efficiency of MASS in improving the clinical outcome of patients with high DFI).

Detailed description: Patients will be recruited from our reproductive medicine center in Nanjing Drum towel Hospital, from July 2019 to July 2020. After semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (DGC) with swim up, and the observation group will be screened by MASS, followed by DGC. Then the procedure of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) will be performed. Embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. The clinical outcomes after transplantation will be followed up.

Eligibility criteria: Inclusion Criteria:

* Patients were diagnostic as infertile according to 2007 WHO guidelines;
* DFI\>25%.

Exclusion Criteria:

* With obvious female infertile factors;
* Sperm count \<10 million;
* Chromosomal abnormalities in either or both of the couple;
* Loss of follow up or incomplete information of patients.

Primary outcomes:
measure: Pregnancy rate
timeFrame: 2-3 months
measure: Implantation rate
timeFrame: 2-3 months
measure: Live-birth rate
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT06963567: Left Ventricular Thrombus Registry
Official title: Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Thrombus
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)) will be screened. Patients that do not have LV thrombus but are at risk for developing thrombus such as those with severe LV dysfunction, LV aneurysms, large territory infarcts will also be included.

Brief summary: Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber.

Having a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis.

A sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.


Eligibility criteria: Inclusion Criteria:

* Patients with LV thrombus or;
* Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.

Exclusion Criteria:

* Age \< 18 years
* Unable to consent

Primary outcomes:
measure: Composite Result
timeFrame: From baseline to final 12 month follow up (+/- 2 months)
Secondary outcomes:
measure: CMR prediction of thrombus
timeFrame: From baseline to 6 month follow up (+/- 3 months)
measure: Blood Test
timeFrame: From baseline to 6 month follow up (+/- 3 months)
measure: Quality of Life Questionnaire
timeFrame: From baseline to final 12 month follow up (+/- 2 months)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
References:
Clinical trial NCT02260167: Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
Official title: Effective Treatment of Alzheimer's and Dementia With the MIND Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Lead sponsor: Practitioners Alliance Network
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treating with measures that may improve metabolic functioning of neurons in an integrated protocol

Detailed description: Most organ failure results in modest drops in function until over 50% of function is lost. At a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. Though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. The hypothesis is that by using an integrated protocol to, essentially, "tune up" neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. This tune-up will include "MIND":

M- Metabolism-- optimizing hormonal function I- Infections-- looking for and eliminating N- Nutritional and herbal support D- Drugs- Weaning subjects off unneeded medications

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Alzheimer's and/or dementia with an MMSE score over 12 or being ambulatory and able to travel outside the home with assistance.
* Must have a caregiver living with them.

Exclusion Criteria:

* Overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.
* Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
Secondary outcomes:
measure: Mini Mental Status Exam (MMSE)
timeFrame: 6 months
measure: Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kailua
country: United States
facility: PAN
state: Hawaii
Study officials:
References:
Clinical trial NCT04468867: Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy
Official title: Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Some women who have been diagnosed with a breast cancer will require chemotherapy as part of their treatment. The chemotherapy can be given before breast surgery - neoadjuvant chemotherapy or after breast surgery - adjuvant chemotherapy. Whether chemotherapy is given before or after does not affect the clinical outcomes for the woman - ie there is no disadvantage to the woman. Due to the fact that giving chemotherapy before has no disadvantages, many of the oncologists like to give the chemotherapy before because they can see if the breast cancer is responding. They are able to do this by using imaging. The best imaging test is breast MRI. Ultrasound can be used but studies have shown that it is not as good. However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in being able to see if a tumour is responding to the chemotherapy. The breast MRI requires women to lie facing down and takes about 20mins. It involves an injection of contrast called gadolinium via a cannula. ABUS involves scanning the whole breast with the patient lying on their back and takes 10mins. There is no injection of contrast. MRI is an expensive test and often there is limited access to the scanner and so patients may have to wait for an appointment. ABUS because it is an automated process for obtaining the images can be performed in the breast unit in a timely manner without the issue of competing demands. All women who agree to take part in the study will have both the breast MRI - standard or care and the ABUS.


Eligibility criteria: Inclusion Criteria:

1. All female participants eligible for neoadjuvant chemotherapy and planning surgical treatment
2. Able to give informed consent

Exclusion Criteria:

1. All female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned
2. Unable to provide informed consent
3. Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum

Primary outcomes:
measure: Tumour size
timeFrame: 20 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
References:
Clinical trial NCT03621267: Interactive Stepping Exercise on Executive Function and Gait Variability
Official title: Effects of Interactive Stepping Exercise on Executive Function and Gait Variability in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Service for the Aged
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is to examine the effects of interactive stepping exercise on executive function and gait variability in community-dwelling older adults

Detailed description: This is a single blinded, randomized controlled trial. 40 community-dwelling older adults will be recruited and randomly assigned to either experimental group (n=20) or control group (n=20). The 12-week intervention comprises of 1-hour exercise per day and 3 days per week. The experimental group will receive interactive stepping exercise while the control group will be put under home exercise program. Primary outcome measures are executive function and gait variability. Secondary outcome measures include community walking test and other gait parameters (gait velocity, stride length and stride time). The participants will receive assessment at pre- and post-intervention

Eligibility criteria: Inclusion Criteria:

* community-dwelling older adults
* age ≥ 65 years old
* able to walk independently outdoor without an assistive device
* Mini-mental state examination ≥ 24
* use an exercise pre-participation health screening form by the American College of Sports Medicine to recruit those participants that are suitable to join the training session

Exclusion Criteria:

* diagnosed of any psychiatric and neurologic disorders such as schizophrenia, stroke, Parkinson, Alzheimer disease, etc.
* any comorbidity or disability that would preclude training

Primary outcomes:
measure: Trail Making Test
timeFrame: Change from Baseline at 12 weeks
measure: Stroop Test
timeFrame: Change from Baseline at 12 weeks
measure: Digit Span Test
timeFrame: Change from Baseline at 12 weeks
measure: Executive Interview 25 questions
timeFrame: Change from Baseline at 12 weeks
measure: Gait Variability
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
measure: Gait velocity
timeFrame: Change from Baseline at 12 weeks
measure: Stride length
timeFrame: Change from Baseline at 12 weeks
measure: Stride time
timeFrame: Change from Baseline at 12 weeks
measure: Functional Ambulation in community
timeFrame: Change from Baseline at 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
state: Beitou
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Yea-Ru Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: