louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03301818: Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
Official title: Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence, Female
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 23
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
Primary purpose: DIAGNOSTIC

Brief summary: Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.

Detailed description: Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O repair.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility criteria: Inclusion Criteria:

* Any woman undergoing USI repair.

Exclusion Criteria:

* Women with high grade pelvic floor prolapse.

Primary outcomes:
measure: Vaginal elasticity assessment
timeFrame: up to 3 months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860118: LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
Official title: LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-05-22
Enrollment: 601
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology clinic

Brief summary: This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target effects for future LRRK2 inhibitor clinical trials.


Eligibility criteria: Inclusion Criteria:

Parkinson's disease inclusion criteria:

Inclusion criteria will be based on UK Brain Bank criteria for the clinical diagnosis of PD. These require 1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years.

Control inclusion criteria: ages of between 21-99 years, a lack of PD in first-degree blood relatives, and a lack of positive responses on more than 3 items on the PD Screening Questionnaire.

Exclusion Criteria:

For all subjects:

include atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, History of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\< 5 years), dementia, known severe anemia (hematocrit \<30), history of kidney disease and/or current or past glomerular filtration rate (GFR) \<60 possibly indicative of kidney disease, or a serious comorbidity that may interfere with participation in the study.

Primary outcomes:
measure: Biomarkers
timeFrame: up to 3 years
Secondary outcomes:
measure: LRRK2 expression and/or phosphorylation
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Sparks Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594718: Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)
Official title: Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Zenker Diverticulum
Keywords: Zenker's diverticulum
Z-POEM
Diverticuloscope
Knife Septotomy
Clutch Cutter
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum

Brief summary: Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. This is a prospective, comparative, observational, multicenter study with the primary objective of comparing the symptomatic recurrence rate one year after endoscopic tunnelization therapy (Z-POEM) versus non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )
* Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.
* Patient aged 18 years or older
* Patient with ASA 1, ASA 2, ASA 3 status
* No participation in another concurrent clinical study

Exclusion Criteria:

* Patient under 18 years old
* Patient with ASA 4 or ASA 5 status
* Pregnant woman
* Patient with coagulation disorders preventing the performance a polypectomy: PT \< 50%, Platelets \< 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.
* Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum

Primary outcomes:
measure: Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
timeFrame: 12 months
Secondary outcomes:
measure: Clinical success rate after endoscopic treatment.
timeFrame: 3 months
measure: Variation in Augsburg score at different time points
timeFrame: 3 months, 6 months, 12 months, and 24 months
measure: Complication rate associated with the endoscopic procedure
timeFrame: 15 days
measure: Radiographic resolution rate of the diverticulum
timeFrame: 3 months
measure: Symptomatic Recurrence Rate Post-Treatment:
timeFrame: at 3, 6, 12, and 24 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01160913: Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section
Official title: Evaluation of Optimal Anatomical Layer for Continuous Wound Infusion of Local Anesthetics Combined With NSAIDs Through a Multiorifice Catheter for Postoperative Pain Intensity After Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section
Lead sponsor: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.


Eligibility criteria: Inclusion Criteria:

* elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria:

* allergy to NSAIDs
* ASA III or higher
* refusal to participate

Primary outcomes:
measure: Cumulative intravenous morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative pain intensity at rest and mobilization
timeFrame: admission, 3,6,12,24,36,48h
measure: adverse effects (nausea, vomiting, itching, sedation)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
References:
citation: Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.
Clinical trial NCT00340613: Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes
Official title: A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Poorly controlled glucose
adolescents
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2006-06-21
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled T1DM.

Detailed description: The Diabetes Control and Complications Trial (DCCT), for type 1Diabetes (T1DM), showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes. However, adolescents with T1DM continue to be a high-risk population due to the difficulties in coping with the physical, emotional, and social demands associated with managing diabetes themselves.

We propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and with a lunchtime insulin injection. We want to see if this will improve blood sugar control, improve school grades, and decrease absences from school in adolescents with poorly controlled diabetes. Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control. We hope to improve blood sugar control, school grades and decrease absences from school in teens with poorly controlled diabetes.

Eligibility criteria: Inclusion Criteria:

* Child with T1DM for at least 1 year
* Age 10-19 years
* Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months.
* School must have a school nurse

Exclusion Criteria:

* Child who has Type 2 diabetes
* Subject receiving home schooling

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: At the start of the study and again in 3 months
Secondary outcomes:
measure: Urine microalbumin
timeFrame: At the beginning and the end of the study
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Diabetes Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rubina A Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen TM, Mason KJ, Sanders CG, Yazdani P, Heptulla RA. Targeting blood glucose management in school improves glycemic control in children with poorly controlled type 1 diabetes mellitus. J Pediatr. 2008 Oct;153(4):575-8. doi: 10.1016/j.jpeds.2008.04.066.
Clinical trial NCT04280913: Clinical Outcomes of Patients With COVID19
Official title: Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronavirus Disease 2019
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Huizhou Municipal Central Hospital
First posted: 2020-02-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective study of hospitalized patients with COVID19.

Brief summary: As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with COVID19

Exclusion Criteria:

* Suspected patients with COVID19, not confirmed by the laboratory
* Patients who are refused to receive medical treatments

Primary outcomes:
measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2
timeFrame: 1 month
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 1 month
measure: Survival
timeFrame: 1 month
measure: Intubation
timeFrame: 1 month
Other outcomes:
Locations:
city: Huizhou
country: China
facility: HuiZhou Municipal Central Hospital
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Luqian Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174213: Validity and Reliability in Measuring Iliotibial Tract by Using Ultrasound
Official title: Validity and Reliability in Measuring Iliotibial Tract by Using Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Injuries
Keywords: iliotibial tract
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to estimate the validity and reliability in measuring the iliotibial tract by using ultrasound.


Eligibility criteria: Inclusion Criteria:

* Patients with knee injuries who need magnetic resonance imaging (MRI) evaluation

Exclusion Criteria:

* Patients who have an iliotibial tract lesion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, NTU, Taiwan
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Hsing-Kuo Wang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01703013: The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
Official title: The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Insufficiency
Inflammatory Lung Diseases
Keywords: Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)

Brief summary: The pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear. In a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with COPD and pneumonia).


Eligibility criteria: Inclusion Criteria:

* Patients 18-80 yo
* Patients diagnosed with pneumonia or exacerbated COPD
* Healthy controls 18-80yo
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating females
* Life threatening severe disease
* Known primary or secondary adrenal insufficiency
* Systemic steroid therapy in the last 8 weeks
* Systemic therapy with opioid
* Systemic therapy with Ketoconazol, Mitotane, Metopyron, Etomidat, Rifampicin
* In healthy controls: relevant respiratory disease or known adrenal insufficiency or indication of infection
* Allergic reaction to ACTH
* Missing informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02013713: French Observatory of Familial Hypercholesterolemia in Cardiology
Official title: French Observatory of Familial Hypercholesterolemia in Cardiology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Familial Hypercholesterolemia
Keywords: Cardiology
Family Hypercholesterolemia
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is proposed to cardiology services hospitals. Aged 18 or more, seen in cardiology (USIC, Hospitalization, Consultation), who agreed to participate in the observatory, and coronary patients who have LDL-c levels

Brief summary: The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.

The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.

Main objectives:

* Establish a monitoring patients with hypercholesterolemia Family cardiology in France
* Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* coronary patients
* who agreed to participate
* high LDL-c levels: \* LDL-c\> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL\> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family.

or

\* LDL-c\> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score.

Exclusion Criteria:

* Expressed refusal to participate in the observatory
* Age ≤ 18

Primary outcomes:
measure: Frequency of the Family Hypercholesterolemia in cardiology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: European Hospital Georges Pompidou
Study officials:
References:
citation: Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. doi: 10.1016/j.atherosclerosis.2003.11.010.
Clinical trial NCT04695613: Shivering Control After Percutaneous Nephrolithotomy
Official title: Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shivering Control
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.

Detailed description: A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.

Eligibility criteria: Inclusion Criteria:

* ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.

Exclusion Criteria:

* Hepatic inefficiency
* Renal inefficiency
* Spinal anesthesia because of a different mechanism of hypothermia

Primary outcomes:
measure: Postoperative shivering grade
timeFrame: 2 hours postoperative
Secondary outcomes:
measure: Shivering frequency
timeFrame: 2 hours postoperative
measure: Blood loss volume
timeFrame: 2 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: