louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03809806: Four-arm Mesh for Vaginal Stump Prolapse
Official title: Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Sexual Function Abnormal
Keywords: vaginal stump prolapse
sexual function
quality of life
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Primary purpose: TREATMENT

Brief summary: To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification \[POP-Q\] system staging).

Detailed description: Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification \[POP-Q\] staging, preoperative and 1-year postoperative questionnaires were performed.

Eligibility criteria: Inclusion Criteria:

* Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy

Exclusion Criteria:

* malignant diseases
* unability to understand informed consent

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
timeFrame: 1 year
Secondary outcomes:
measure: Sexual function 1 year after procedure
timeFrame: 1 year
measure: Urinary incontinence 1 year after procedure
timeFrame: 1 year
measure: quality of life 1 year after procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: 2nd Gynecology Department
Study officials:
affiliation: 2nd Gynecology Department Medical University in Lublin
name: Tomasz Rechberger, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635306: 13C-Spirulina Nitrogen Content GEBT Study
Official title: Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test (GEBT) Results
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroenterology
Gastric emptying breath test
Lead sponsor: Cairn Diagnostics
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).

Detailed description: In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% Nitrogen content will be administered. Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling. The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling.

Eligibility criteria: Inclusion Criteria:

* Males and females, 18-85 years old at time of signing consent form
* Ability to eat test meal and provide breath samples

Exclusion Criteria:

* History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
* Symptoms consistent with delayed gastric emptying
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Receipt of an investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of Gastric Emptying Breath Test meal
* History of neurologic or psychiatric disorder

Primary outcomes:
measure: Difference in vivo 13C-Spirulina GEBT response
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Cairn Diagnostics
state: Tennessee
Study officials:
affiliation: Cairn Diagnostics
name: Alex Ryder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815606: Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
Official title: Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreas
cancer
EUS-FNA
19Gauge
25Gauge
35mm mass
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.

Detailed description: Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25, 22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and perform equally well. However, in a retrospective study, the diagnostic sensitivity of EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size masses. This is because larger size tumors have more necrosis and it is difficult to identify cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in larger size tumors to establish a diagnosis. In previous studies it has been shown that the larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be achieved with fewer passes.

Eligibility criteria: Inclusion Criteria:

All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (CT) that require FNA.

Exclusion Criteria:

* Age \< 19 years
* Unable to safely undergo EUS for any reason
* Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
* Unable to consent
* Non-English speaking patients
* Participation in any other clinical trial (excluding registries or databases)

Primary outcomes:
measure: Number of passes
timeFrame: Up to 12 months
Secondary outcomes:
measure: Rate of Complication
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317706: Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Induction of Labor
Keywords: Bishop score, Cervical length, Cervical ripening, Labor induction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.


Eligibility criteria: Inclusion Criteria:

* nulliparous patients
* singleton pregnancy
* live fetus with vertex presentation
* intact amniotic membranes
* \> 37 weeks gestation
* absence of labor
* no previous uterine surgical procedures

Exclusion Criteria:

* major congenital anomaly

Primary outcomes:
measure: Successful labor induction
timeFrame: Eleven hours of initiating oxytocin on the fist day of induction
Secondary outcomes:
measure: the need for oxytocin induction
timeFrame: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyo Hoon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594406: The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects
Official title: Therapeutic Effects of Oral Bifidobacterium on Depression by Promoting Exogenous Creatine Absorption
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to learn if Bifidobacterium has better antidepressant-like effects by enhancing creatine absorption in adults. The main questions to be answered are

Does Bifidobacterium combined with creatine have better antidepressant effects? Does Bifidobacterium enhance exogenous creatine uptake?

Researchers will compare bifidobacterium combined with creatine to creatine or bifidobacterium to see if bifidobacterium combined with creatine has better antidepressant effects.

Participants will:

Take bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.


Eligibility criteria: Inclusion Criteria for depression:

* Adults age 18-60 years inclusive.
* Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).
* Current Hamilton Depression Scale 17 score of \> 16.
* BMI (body Mass Index) between 18 and 28 kg/m²
* Right-handed

Exclusion Criteria:

* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5.
* History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
* History of seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome
* Antibiotic use in last 30 days
* Probiotics use in last 30 days
* Positive pregnancy test
* Breastfeeding

Primary outcomes:
measure: Change from Baseline in Hamilton Depression Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in creatine level in blood
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university
state: Guangdong
Study officials:
affiliation: Southern Medical University
name: Xiong Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04033406: Study of VIR-2482 in Healthy Volunteers
Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza A
Keywords: Influenza A
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.


Eligibility criteria: Inclusion Criteria:

* Healthy Male or Female age 18 to \< 65 years
* Body mass index (BMI) of 18.0 kg/m\^2 to 32.0kg/m\^2

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization.
* Fever-like illness within 5 days of randomization.
* History or clinical evidence of conditions considered high risk for developing influenza-related complications.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events.
timeFrame: Up to 12 months post-dose
measure: Number of participants with abnormalities in vital signs.
timeFrame: Up to 12 months post-dose
measure: Number of participants with abnormalities in electrocardiogram (ECG).
timeFrame: Up to 12 months post-dose
measure: Number of participants with abnormalities in clinically significant laboratory findings.
timeFrame: Up to 12 months post-dose
Secondary outcomes:
measure: Concentrations of VIR-2482 in serum
timeFrame: Up to 12 months post-dose
measure: Incidence of anti-drug antibody (ADA) to VIR-2482
timeFrame: Up to 12 months post-dose
measure: Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
timeFrame: Up to 12 months post-dose
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Investigative Site
state: Queensland
Study officials:
References:
Clinical trial NCT03504306: Validation of Ventriject Determined Maximal Oxygen Uptake
Official title: Validation of Ventriject Determined Maximal Oxygen Uptake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults

Brief summary: This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.

Detailed description: this study will be composed of the following tests:

* blood sample for measurement of blood values
* blood pressure measurement to rule out risks affiliated with maximal effort testing
* DXA body composition scanning
* Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires
* Measurements with phone (iPhone)
* VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment
* Hand-grip strength assessment

Eligibility criteria: Inclusion Criteria:

- healthy adults between 18 and 45 years of age

Exclusion Criteria:

* current or previous cardiovascular disease
* chronic use of medicine
* pregnancy
* illnesses which prohibits the testing of maximal oxygen uptake

Primary outcomes:
measure: Comparing how well the Ventriject software can estimate VO2 max
timeFrame: 4 months data collection, although cross sectional
Secondary outcomes:
measure: comparing how well the measurements from the mobile phone test compare to the same measurements with accelerometer and echosonography
timeFrame: 4 months data collection, although cross sectional
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Study officials:
affiliation: jhelge@sund.ku
name: Jørn W Helge, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01049906: Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery
Official title: A Study to Determine the Quality of Sensory and Motor Blockade of Popliteal Sciatic Nerve Block Catheters Placed Under Ultrasound Guidance With and Without Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Surgery
Ankle Surgery
Keywords: foot surgery
ankle surgery
Patients scheduled for foot and ankle surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.


Eligibility criteria: Inclusion criteria:

* patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville

Exclusion criteria:

* emergency surgery
* peripheral neuropathy in the distribution of the sciatic nerve on the operative side
* history of recent alcohol or drug abuse
* allergy to local anesthetics
* pregnancy
* coagulopathy
* subjects declined to participate

Primary outcomes:
measure: Complete motor and sensory anesthesia in the sciatic nerve distribution.
timeFrame: Upon block placement
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher Robards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02996006: New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Blood Loss
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 41
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patient sampling according to the eligibility criteria

Brief summary: This observational study introduced an new advanced bleeding control strategy during complex liver resection.This newly described "stepwise vascular control" technique was efficacious and feasible to control intra-operative bleeding in complex hepatectomy involving second hepatic hilum and retro-hepatic inferior vena cava.


Eligibility criteria: Inclusion Criteria:

* tumor size is more than 5cm in diameter;
* these tumor were close to or were compressing main hepatic veins and RIVC directly;
* Pugh-Child Grade is A or Indocyanine green retention rate at 15min (ICG15%) is less than 10% .

Primary outcomes:
measure: blood loss during liver resection
timeFrame: duration of operation time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dou L, Yu ZP, Yang HY, Ran J, Chen YF, Chen XP. Personalized stepwise vascular control during complex hepatectomy involving hepatocaval confluence. ANZ J Surg. 2018 Jul-Aug;88(7-8):E606-E609. doi: 10.1111/ans.14301. Epub 2017 Dec 10.
Clinical trial NCT02080806: Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke
Official title: Effects of Mechanical Insufflation-exsufflation in Stroke Patients With Dysphagia - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: stroke, dysphagia, cough, mechanical insufflation exsufflation
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response. This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE) therapy can help recover impaired cough function.

Detailed description: Mechanical Insufflation- Exsufflation (MI-E) is an assisted coughing machine that has been proven to be very effective in preventing the deterioration of pulmonary function in patients with degenerative neuromuscular disorders. Impaired airway clearance in stroke patients is associated with increased incidence of aspiration pneumonia.

In this pilot study the investigators attempt to assess the efficacy of MI-E as part of a protocol for patients with dysphagia with impaired cough response.

Eligibility criteria: Inclusion criteria Presence of neurogenic dysphagia Presence of impaired cough function

Exclusion criteria Episodes of acute pneumonia or diagnosis of pulmonary embolism at time of enrollment.

Previous history of chronic respiratory dysfunction or other systemic disorders that may impair respiratory function (ex,rheumatoid arthritis, chronic renal disorder, spinal cord injury) Episodes of diaphragm weakness due to peripheral polyneuropathy or phrenic nerve injury Concomitant diagnosis of myopathy, muscular dystrophy, or other neurodegenerative disorders.

Episodes of rib fracture within one year of enrollment. Chronic alcoholism Diagnosis of bullous emphysema Diagnosis of chronic renal failure

Primary outcomes:
measure: Coughing force as assessed by peak cough flow meter
timeFrame: baseline, 2 weeks
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressure
timeFrame: baseline- 2 weeks
measure: Cough force during reflexive cough test
timeFrame: baseline, 2 weeks
Other outcomes:
measure: Incidence of pneumonia
timeFrame: baseline 2 weeks
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Sun Im
role: PRINCIPAL_INVESTIGATOR
References: