louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03209050: Evaluation of the Surfacer System Approach to Central Venous Access
Official title: Evaluation of the Surfacer System Approach to Central Venous Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Occlusion
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2017-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients requiring venous access
Primary purpose: TREATMENT

Brief summary: Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.

Detailed description: This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.

Eligibility criteria: Inclusion Criteria:

* referred for placement of central venous access catheter
* have limited or diminishing upper body venous access
* have pathology impeding standard access methods
* willing to give written informed consent

Exclusion Criteria:

* occlusion of the right femoral vein
* occlusion of the iliac vein
* occlusion of the inferior vena cava
* contraindicated by physician
* acute thrombosis within any vessel planned to be crossed by the Surfacer \*tortuous anatomy which precludes a straight line from femoral vein to subclavian
* diagnosed with active pericarditis
* diagnosed with active endocarditis
* suspected pericardial effusion
* known or suspected aneurysm or ectasia of ascending aorta
* innominate artery or subclavian artery
* pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study

Primary outcomes:
measure: Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted
timeFrame: 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: Meditrial Europe Ltd.
name: Monica Tocchi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03262350: The Effects of Yoga on Body Image in College Women
Official title: Can Yoga Reduce Body Image Concerns in Females, Thereby Reducing Risk of Obesity and Eating Disorders?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Eating Disorder
Obesity
Yoga
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: The Emily Program
name: Neuropsychiatric Research Institute
First posted: 2017-08-25
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of a regular yoga practice on body image in college women.

Detailed description: A randomized controlled design will be used to study the effects of a regular yoga practice on body image in young adult women. Fifty female freshman, sophomores, and juniors between the ages of 18 and 26 years will be recruited from the University of Delaware student population, specifically targeting those new to yoga. Age, academic standing, availability and prior yoga experience will be evaluated.

Consented individuals will be randomized to one of two conditions: (1) yoga (offered 3 times per week) for 10 weeks; or (2) a control group. Baseline assessments, midpoint assessments, and end-of-study assessments will be conducted on all participants. Participants will be compensated for their attendance at assessment visits.

Eligibility criteria: Inclusion Criteria:

* Freshman, sophomore, or junior at the University of Delaware
* Available Spring 2017 on Mondays, Wednesdays, and Fridays from 1:25-2:15pm
* Physically able to participate in yoga

Exclusion Criteria:

* Females who are seniors at the University of Delaware (This is because participants in the control condition will be given a pass to participate in group fitness at the end of the study, and would not be able to use this incentive if they are seniors)

Primary outcomes:
measure: Body Image
timeFrame: 10 weeks
measure: body image
timeFrame: 10 weeks
Secondary outcomes:
measure: change in Body Mass Index
timeFrame: 10 weeks
measure: disordered eating attitudes/behaviors
timeFrame: 10 weeks
measure: disordered eating attitudes/behaviors
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT04271150: Efficiency of Different Modes of Universal Adhesive
Official title: Clinical Evaluation of Universal Adhesive's Different Application Modes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Adhesion
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.

Detailed description: Class 2 composite restorations will be placed using a bulk-fill composite resin restorative on two posterior teeth with proximal caries, in a split mouth design. 25 patients will be included in the study. The teeth will be randomized into two groups according to the application mode of universal adhesive material.

Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.

The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.

Eligibility criteria: Inclusion Criteria:

* a need for at least two but not more than four posterior tooth-colored restorations
* the presence of teeth to be restored in occlusion
* teeth that were symptomless and vital
* a normal periodontal status
* a good likelihood of recall availability.

Exclusion Criteria:

* partly erupted teeth
* absence of adjacent and antagonist teeth
* poor periodontal status
* adverse medical history
* potential behavioral problems

Primary outcomes:
measure: Marginal adaptation
timeFrame: From baseline to 6 year the change of restorations will be evaluated
measure: Marginal discoloration
timeFrame: From baseline to 6 year the change of restorations will be evaluated
measure: Retention
timeFrame: From baseline to 6 year the change of restorations will be evaluated.
measure: Anatomic form
timeFrame: From baseline to 6 year the change of restorations will be evaluated.
measure: Color change
timeFrame: From baseline to 6 year the change of restorations will be evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University School of Dentistry
name: Ayse R Yazici, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06221150: Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy
Official title: Ultrasound-guided Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Congenital Heart Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The serratus anterior plane block (SAPB) is an anterolateral thoracic wall block that was described in 2013 by Blanco et al. who presented it as an alternative to other regional anesthetic techniques. It has been described in adults as an adjunct to general anesthesia or as a primary anesthetic technique for breast surgery, it has not been widely utilized as a primary anesthetic technique in the pediatric population. It was designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. It provides a viable alternative to paravertebral blockade and central neuraxial block in this patient population The investigators believe that the bilateral two-level injection technique may provide effective analgesia as its efficacy was not properly investigated in corrective heart surgeries with median sternotomy in the pediatric population.


Eligibility criteria: Inclusion Criteria:

* Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy

Exclusion Criteria:

* • Refusal of legal guardian.

  * Patient with congestive heart failure .
  * Patient weaned from cardiopulmonary bypass on high doses of inotropic support (Adrenaline or noradrenaline more than 200ng/kg/min).
  * Patient undergoing Redo cardiac surgery.
  * Known allergy to local anesthetics.
  * Infection at injection site.
  * Bleeding disorders (drug induced i.e., coumadin; or genetic i.e. hemophilia; or acquired i.e. DIC), coagulopathy: PTT \> 40 seconds, INR \> 1.4, platelet count \< 100x10⁹.
  * severe renal or hepatic insufficiency.
  * Neurological disorders because it will be difficult to assess their pain score (e.g. cerebral palsy).

Primary outcomes:
measure: Postoperative Fentanyl consumption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric University Hospitals
Study officials:
References:
Clinical trial NCT00168350: Memantine in Patients With Chronic Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double-masked clinical trial of memantine in patients with glaucoma


Eligibility criteria: Inclusion Criteria:

* glaucoma damage on examination of visual field and optic disc
* good visual acuity (with glasses if needed)

Primary outcomes:
measure: Progression of glaucoma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02109250: CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice
Official title: CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Medullary Thyroid Cancer
Keywords: Medullary Thyroid Cancer (MTC) vandetanib caprelsa
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: It is planned to include all Belgian sites which have patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC who have been prescribed vandetanib and fulfilling the criteria for reimbursement.

Brief summary: In this registry it is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).

The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore real life data regarding demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be included.


Eligibility criteria: Inclusion criteria

The subject population that will be observed in this registry, must fulfil all of the following criteria:

1. Provision of subject Informed Consent
2. Patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC
3. Patients who already received a prescription for vandetanib in accordance with the scientific leaflet and fulfilling the reimbursement criteria of vandetanib and who are currently treated or have been treated with vandetanib 100 mg or 300 mg tablets.

The prescription of the medicinal product is clearly separated from the decision to include the subject in the registry.

Exclusion criteria Not applicable since patients participating in another study can take part in this registry.

Primary outcomes:
measure: The primary objective of this registry is to describe the characteristics of patients who receive Caprelsa® and who are fulfilling the reimbursement criteria.
timeFrame: Up to 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arlon
country: Belgium
facility: Clinique du Sud Luxembourg
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: UCL St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Roeselare
country: Belgium
facility: AZ Delta
city: Tournai
country: Belgium
facility: CH de Wallonie
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05720650: B Vitamin Deficiency and Pregnancy Complications
Official title: B Vitamin Deficiency and Pregnancy Complications
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gestational Hypertension
Preeclampsia
Keywords: B vitamins
pregnancy complications
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
First posted: 2023-02-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women aged 18-45 years old

Brief summary: This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.

Detailed description: In clinical practice, women diagnosed with gestational hypertension or preeclampsia will be asked to participate this study to fill a questionnaire reporting their basic information. Meanwhile, women with matched age and gestation week and without any kinds of hypertensive disorders will also be invited for this study. Participants' blood samples will be analyzed for B vitamin levels at the end of the study.

Eligibility criteria: Inclusion Criteria:

* pregnant women aged 18-40 years old

Exclusion Criteria:

* women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
* women with severe physical or mental diseases

Primary outcomes:
measure: gestational hypertension
timeFrame: seven days after delivery
measure: preeclampsia
timeFrame: seven days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Hongjun SHI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04272450: Respiratory Muscle Strength in Different Age Groups
Official title: Respiratory Muscle Strength in Different Age Groups_Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Keywords: respiratory muscle
mouth pressure
normative data
predicted value
respiratory muscle strenght
Turkey
Istanbul
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical ventilation. But Turkey normative values, these values are not available. In the investigator's country, the respiratory muscle forces of the cases are evaluated by comparing them with the normal / expected values of the Scandinavian races that do not have similar anatomical features with the Turkish society, which causes errors in diagnosis.

The 250 healthy cases, whose age ranges are between 20-70, 20-29, 30-40, 40-49, 50-59 and 60-70, will be examined by a pulmonologist and asked if they have any disease that may affect respiratory muscle strength. Mouth pressure measurements will be made for healthy and inclusion criteria, and maximal inspiratory and expiratory pressure distributions will be examined.


Eligibility criteria: Inclusion Criteria:

* The age range is 20-70,
* Body mass index to be 18.0- 29.5 kg / m2
* No cardiac, neuromuscular or endocrine disease that may affect any respiratory muscle strength Respiratory function parameters to be normal,
* Not being a smoker

Exclusion Criteria:

* Not agreeing to participate in the study
* Not being able to adapt to the device

Primary outcomes:
measure: Respiratory muscle strenght measurement
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References:
Clinical trial NCT01499550: Nocturnal Transnasal Insufflation (nTNI)
Official title: Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Hypercapnia
Keywords: transnasal high flow therapy
COPD
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: TNI Medical AG
First posted: 2011-12-26
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.

Thirty hypercapnic COPD GOLD IV patients (PCO2 \> 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.


Eligibility criteria: Inclusion Criteria:

* Hypercapnia in Routine Blood Gas Analysis with \> 50 mmHg PCO2
* Clinically stable respiratory situation
* Treatment on normal ward possible

Exclusion Criteria:

* Before known obstructive sleep apnea syndrome (OSA)
* A found OSA during study means no exclusion
* Any other severe or acute physical illness which requires intensive medical care
* Acute hypercapnic decompensation with pH \< 7.30 in capillary Blood Gas Analysis

Primary outcomes:
measure: PCO2 decrease
timeFrame: within 2 days
Secondary outcomes:
measure: Changes of breathing pattern
timeFrame: within 2 days
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrock
state: NRW
Study officials:
affiliation: Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References: