louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02691364: Different Regulation of Immune Cells in Patients With Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Pregnancy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with and without preeclampsia

Brief summary: Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory cells are not known. The main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.


Eligibility criteria: Inclusion Criteria:

* healthy
* written informed consent
* 18-40 years

Exclusion Criteria:

* smoking
* immune related disorders (other than preeclampsia)
* fever / illness within the last month
* infertility
* body mass index \<18 or \>30

Primary outcomes:
measure: Cell levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02128464: Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
Official title: Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Total Knee Arthroplasty
Customized Cutting Block
Conventional Intramedullary Cutting Guide
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 108
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Detailed description: Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Eligibility criteria: Inclusion Criteria:

* Age 60-90
* Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
* Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
* Correction of varus or valgus.
* Willing to participate and return for follow-up study visits.

Exclusion Criteria:

* Vascular insufficiency
* Previous deep vein thrombosis and pulmonary embolism
* Previous osteotomy
* Previous patella fracture or surgery
* Previous healed tibia or femur fractures
* Previous joint replacement surgery

Primary outcomes:
measure: Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
timeFrame: 3 Months Post-operative
Secondary outcomes:
measure: Intraoperative Bleeding
timeFrame: Intra-operative
measure: Operative time
timeFrame: During the procedure
measure: Blood volume in suction drain
timeFrame: Post-operative Day 2
measure: Hemoglobin level
timeFrame: Post-operative day1, 2, 3
measure: WOMAC score
timeFrame: 6 weeks
measure: WOMAC score
timeFrame: 3 Months
measure: WOMAC score
timeFrame: 6 Months
measure: WOMAC score
timeFrame: 1 year
Other outcomes:
measure: WOMAC Score
timeFrame: 2 years
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital.
Study officials:
affiliation: Thammasat University
name: Phonthakorn Panichkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02638064: Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
Official title: Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus Disorder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of surgiflo injection for treating pilonidal sinus disease

Detailed description: Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up

Eligibility criteria: Inclusion Criteria:

Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study

Exclusion Criteria:

We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.

Primary outcomes:
measure: Recurrence of the condition
timeFrame: 2 years
Secondary outcomes:
measure: Complications of the procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Hosam Elbanna
state: Dakahlia
Study officials:
affiliation: private basis
name: Hosam Elbanna, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04400864: Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease
Official title: Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2020-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation.

The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance.

The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.

Detailed description: Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.

Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.

blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.

Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups.

Eligibility criteria: Inclusion Criteria:

* NAFLD

Exclusion Criteria:

* pregnancy
* Chronic kidney disease
* post transplant

Primary outcomes:
measure: Changes in the severity of the fatty liver measured by ultrasound and elastography.
timeFrame: 3 months
Secondary outcomes:
measure: Changes in HbA1C
timeFrame: 3 months
measure: Changes in Triglycerides levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Amir Shlomai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03982264: Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
Official title: Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neuroendocrine Tumor
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 90
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: Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75 years;
* Definite diagnosis of rectal NET less than 10mm;
* Patients plan to receive either EMR-C or ESD treatment.

Exclusion Criteria:

* Serious comorbid diseases such as advanced malignant tumor and organ failure;
* Patients received conventional EMR, snare electrotomy and no treatment;
* Rectal NET with metastasis;
* Pregnant patient;
* Poor compliance

Primary outcomes:
measure: complete resection rate(R0 rate)
timeFrame: within 14 days after procedure
Secondary outcomes:
measure: operating time
timeFrame: intraoperative
measure: complications rate
timeFrame: within 14 days after procedure
measure: length of stay
timeFrame: within 14 days after procedure
measure: hospitalization cost
timeFrame: within 14 days after procedure
measure: recurrence rate
timeFrame: one year after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00404664: Improving Influenza Vaccination Rates Among Health Care Professionals
Official title: A Novel Approach To Improve Influenza Vaccination Rates Among Health Care Professionals: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza vaccine
influenza immunization
reminder letters
raffle prize
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The purpose of this study was to see if reminder letters and a large raffle prize would encourage health care workers to receive influenza vaccinations.

Detailed description: Eight hundred employees of an urban tertiary care hospital, 200 each from the following four categories: professional staff, resident physicians, registered nurses, and licensed practical nurses comprised the study group. Subjects were randomly assigned to receive: 1) no intervention, 2) a reminder letter for flu vaccine, 3) a raffle ticket to win a free Caribbean vacation with flu vaccine administration, or 4) both the reminder letter and raffle ticket. We compared the proportion of employees receiving vaccination and participating in the raffle across groups.

Eligibility criteria: Inclusion Criteria:

* Hospital employees, staff physicians, residents, rn's, lpn's

Exclusion Criteria:

* non patient care hospital employees

Primary outcomes:
measure: Proportion of employees receiving vaccination and participating in the raffle across groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael L Macknin, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06694064: Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effect on Pulpotomy
Official title: Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effectiveness in Pulpotomy of Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.


Eligibility criteria: Inclusion Criteria:

* healthy patients with carious primary molars

Exclusion Criteria:

* root resorption

Primary outcomes:
measure: evaluate pain of the teeth
timeFrame: 6 months
Secondary outcomes:
measure: absence of radiolucency
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
Study officials:
References:
Clinical trial NCT01279564: Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation
Official title: Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation During Regular and Difficult Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: Endotracheal intubation and its outcomes
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere.

To make intubation easier, several newly designed tubes and laryngoscopes are developed and tested every year. Their performance is evaluated subjectively by the acting anesthesiologist, and by using objective parameters such as speed of intubation, the force applied during laryngoscopy , or catecholamines secretion during intubation as a stress parameter . The studies set for testing these parameters lead to establish accepted indications for the treatment of the airway in cases of anticipated and unanticipated difficult airway.

In the present study we will compare the performance parameters of intubation using Etview Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer dimensions and material is exactly as the standard tube, the difference is only the inner fiber of the camera.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Age under 18 years
* ASA greater than 3
* Lip, oral or airway infection
* Coagulopathy
* Indication to perform Sellick's maneuver for increased risk of aspiration

Primary outcomes:
measure: In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube
timeFrame: 1 year
measure: Duration of Endotracheal Intubation
timeFrame: The induction of general anesthesia, on the operating day (first day)
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Michal Barak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420664: Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis
Official title: The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Stasis
Deep Venous Thrombosis
Keywords: cast
orthosis
immobilisation
venous stasis
circulation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Research subjects receive lower limb immobilisation with cast and with orthosis alternatively, randomised so as subsequent persons begin with different modality.
Primary purpose: BASIC_SCIENCE

Brief summary: In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two.

Detailed description: Background: Lower limb immobilisation, for example after an Achilles tendon rupture, is known to be a cause for DVT, partly due to blood stasis. VACOped is a weight-bearing orthosis with adjustable range of motion of the ankle which is used in our department in patients operated for Achilles tendon rupture.

Aim: To assess the effects of a) lower leg casting in equinus without loading and b) application of the aforementioned orthosis with full weight baring in blood flow and microcirculation in the lower limbs.

Study Plan: Ten healthy individuals are planned to be recruited for this study. Blood flow in the Right popliteal will be measured with vein before, 30 and 60 min after the application of the cast or orthosis (alternate order between consequent individuals) with Duplex Ultrasound. The orthosis will be set to allow for ankle plantarflexion restricted between 15 and 30 degrees. Tissue oxygen saturation in the lower limbs will also be measured using a somatic regional oxymetry modality, INVOS, with adhesive sensors applied on each leg above the soleus.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Severe cardiovascular or renal disease causing pitting oedema
* Previous operation in the lower limbs affecting the vascular or lymphatic system
* Pregnancy

Primary outcomes:
measure: The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
timeFrame: 2.5 hours
Secondary outcomes:
measure: Lower limb macrocirculation under cast immobilisation
timeFrame: 1 hour
measure: Lower limb microcirculation under cast immobilisation
timeFrame: 1 hour
measure: Lower limb macrocirculation under orthosis mobilisation
timeFrame: 1 hour
measure: Lower limb microcirculation under orthosis mobilisation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska university Hospital
Study officials:
References:
Clinical trial NCT03156764: Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
Official title: The Accuracy of Qp/Qs Calculated by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia, General
Congenital Heart Disease
Blood Gas Monitoring, Transcutaneous
Blood Gas Analysis
Keywords: Qp/Qs ratio
Pediatric congenital heart disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 29
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)

Brief summary: In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.

This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.

Detailed description: Blood sampling will be performed in both arterial and central venous lines.

Eligibility criteria: Inclusion Criteria:

1. pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
2. preoperative SpO2\<97%

Exclusion Criteria:

1. unable to measure pulse oximeter or cerebral oximeter signal
2. unable to measure SaO2 or SmvO2
3. unstable vital sign

Primary outcomes:
measure: the difference between Qp/Qs-monitor and Qp/Qs-blood
timeFrame: within 1 week after surgery
Secondary outcomes:
measure: the difference between SpO2 and SaO2
timeFrame: within 1 week after surgery
measure: the difference between cerebral oximeter score and and SmvO2
timeFrame: within 1 week after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01647464: Renal Retention of Microbubbles
Official title: Study of Whether There is Renal Retention of Lipid Microbubble Ultrasound Contrast Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: - Study Focus: Renal Retention of Lipid Microbubbles
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing contrast echocardoigraphy

Brief summary: Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice.

Detailed description: In this study patients undergoing clinically indicated contrast echocardiography will have renal ultrasound performed 10 minutes after completion of contrast infusion to determine the presence and location of renal retention of lipid microbubbles.

Eligibility criteria: Inclusion Criteria:

* Undergoing clinically indicated contrast echo
* adequate renal ultrasound images

Exclusion Criteria:

* chronic inflammatory disease
* known kidney disease
* immunomodulatory therapy

Primary outcomes:
measure: Renal Video Intensity Units
timeFrame: 10 min
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: