louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03044496: NIRS Measurement After SCP Block
Official title: Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterio-venous Fistula
Keywords: NIR Spectroscopy
Nerve Blockade
Surgical Arteriovenous Shunt
Lead sponsor: Marienhospital Stuttgart
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 15
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: All patients undergoing shunt surgery under supraclavicular plexus block

Brief summary: Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .

Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .

The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing surgery under regional anaesthesia

Exclusion Criteria:

* patients refusal

Primary outcomes:
measure: NIRS after block
timeFrame: 5 minutes before block until 30 minutes after block
Secondary outcomes:
measure: Difference between both arms
timeFrame: 5 minutes before block until 30 minutes after block
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart, Dpt. of Anaesthesiology
state: Baden Württemberg
Study officials:
References:
citation: Keuler J, Weiss C, Klemm K, Pochhammer J, Schmidt R, Ilies C. Assessing changes in tissue oxygenation by near-infrared spectroscopy following brachial plexus block for arteriovenous fistula surgery: A prospective observational pilot study. Eur J Anaesthesiol. 2018 Oct;35(10):759-765. doi: 10.1097/EJA.0000000000000871.
Clinical trial NCT00318396: Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
Official title: Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coxarthrosis
Keywords: THA
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.

Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.


Eligibility criteria: Inclusion Criteria:

* Patients with primary arthritis in the hip
* Patients with sufficient bone density to allow uncemented implantation of a femoral component
* Informed patient consent in writing

Exclusion Criteria:

* Patients with neuromuscular or vascular disease in the affected leg
* Patients found upon operation to be unsuited for uncemented acetabulum component
* Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
* Patients with fracture sequelae
* Female patients of childbearing capacity
* Hip joint dysplasia
* Sequelae to previous hip joint disorder in childhood

Primary outcomes:
measure: To examine a possible difference in density of bones around implantation of femoral component.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Soeren Kold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Kjeld Soeballe, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03028896: 90° Rotation Technique for LMA FlexibleTM Insertion
Official title: Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Keywords: LMA Flexible
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.

Detailed description: One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class I - II
* Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM

Exclusion Criteria:

* known difficult airway
* mouth opening less than 2.5 cm
* limited extension of neck
* recent sore throat
* gastroesophageal reflux disease

Primary outcomes:
measure: First Attempt Success Rate
timeFrame: at induction
Secondary outcomes:
measure: Insertion Time
timeFrame: at induction
measure: Oropharyngeal Leak Pressure
timeFrame: at induction
measure: Number of Participants With Blood Staining on the Laryngeal Mask Airway
timeFrame: post op 1min
Other outcomes:
Locations:
Study officials:
References:
citation: Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.
Clinical trial NCT02939196: Pain in Different Office Hysteroscopy Diameter
Official title: Comparison of Pain Accompanying the Use of 3.7 mm and 4 mm Office Hysteroscopy in Nullipara: A Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Associated Office Hysteroscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patent between 20 to 45 years old who under go office hysteroscopy

Brief summary: The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy in vaginoscopic approach regarding pain during and after the procedure.

And to evaluate patient acceptability and tolerability in order to determine the best way to perform hysteroscopy in an outpatient setting.

Detailed description: Office hysteroscopy is used as diagnostic tool to investigate abnormal uterine bleeding and other diseases involving the uterine cavity one of The main limitation to its widespread use is feared from pain and low patient tolerability Narrower diameter hysteroscopy and endometrial biopsy devices are being developed to improve the acceptability of office hysteroscopy. Miniature optical systems allow performance of most diagnostic and operative hysteroscopy (after proper patient selection) in an outpatient or office setting .Flexible hysteroscopy seem to be less painful at the beginning and during the procedure ,but the optical qualities are poor Hysteroscopy is safe, feasible and accurate procedure for diagnosing intrauterine pathology.

Provision of outpatient based diagnostic and operative services are gaining prominence as a standard of cure but the experience of pain can be off-putting for patients having outpatient diagnostic hysteroscopy.

saline solution is an excellent alternative to carbon dioxide in women undergoing outpatient hysteroscopy, and there are fewer complications

Eligibility criteria: Inclusion Criteria:

* Woman with nulliparous cervix

Exclusion Criteria:

* Pregnancy.
* female genital cancer
* Active pelvic infection
* Multipara
* patient not receiving misoprostol

Primary outcomes:
measure: Pain more than 4 (according visual analogue scale
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut, Cairo, Egypt
country: Egypt
facility: Essam Othman
Study officials:
affiliation: Assiut
name: Essam Othman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113696: Intake of Omega 3 in Morbidly Obese Patients
Official title: The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: morbid obesity
BMI at or above 4O kg/m2
ingestion of omega 3
inflammatory cytokines
biochemical factors
anthropometric factors
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?

Detailed description: Intake of EPA and DHA for the management of morbid obesity in capsules

- Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.

Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18-65 years,
* BMI \> 40 kg/m2 (or \> 35 kg/m2 with comorbidities),
* ambulatory, receiving an oral diet,
* with a diagnosis of metabolic syndrome,
* and who signed a Term of Free and Informed Consent.

Exclusion Criteria:

* Systemic inflammatory response syndrome,
* coma or compromised organ,
* fever or infection foci,
* cancer with or without chemotherapy and radiotherapy,
* radiotherapy, inflammatory diseases of the gastrointestinal tract,
* transplant, trauma, surgery or hospital stay in the past 30 days
* use of steroids or non-steroid anti-inflammatory or immunomodulators agents or antibiotics,
* or those refusing to take part in the study.

Primary outcomes:
measure: Decrease of inflammatory levels on blood
timeFrame: 08 weeks
Secondary outcomes:
measure: Decrease of weight
timeFrame: 08 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS
name: Claudio C Motin, orientador
role: STUDY_DIRECTOR
References:
Clinical trial NCT06486896: Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus
Official title: Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaginismus
Keywords: Interferential, pelvic floor training, vaginismus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.

Detailed description: Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.

There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training

Eligibility criteria: Inclusion Criteria:

1. Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
2. Their pain level is ≥ 4 on the visual analogue scale.
3. They have a sedentary lifestyle.

Exclusion Criteria:

1. Vaginismus requiring surgical treatment.
2. Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
3. Lower urinary tract infection.
4. Husband with sexual dysfunction that prevents penetration.
5. Diseases involving nerves and muscles, such as myasthenia gravis.
6. Severe psychiatric disorder or cognitive relegation.

Primary outcomes:
measure: Assessment of pain intensity.
timeFrame: Eight weeks
measure: Quantification of pressure pain threshold in the perineum.
timeFrame: Eight weeks
measure: Assessment of pelvic floor muscle tone.
timeFrame: Eight weeks
Secondary outcomes:
measure: Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Women's Health, Faculty of Physical Therapy, Cairo University
name: Doaa A. Osman, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05598216: Assessment of Different Equations to Accurately Calculate LDL Cholesterol
Official title: LDL Cholesterol: Friedewald, Always the Best Option to Evaluate LDL cholesteRol Concentration in norMal and Dyslipidemic sUbjects, in Fasting and Pot-prandiaL State?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyslipidemias
Lipid Disorder
Keywords: LDL cholesterol
equation
postprandial
Dyslipidemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 160000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lipid profile performed in the lab during the recruitment period

Brief summary: Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.

New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .

Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis

To evaluate the most accurate equation in different conditions:

* Fasting and non-fasting state
* In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.


Eligibility criteria: Inclusion Criteria:

* lipid profile performed in the location 1 during the recruitment period

Exclusion Criteria:

* Results outside the first and 99th percentile for TG parameters
* Samples slightly opalescent

Primary outcomes:
measure: Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)
timeFrame: The outcome measure will be assessed through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est
Study officials:
References:
Clinical trial NCT02214316: IVF in Pediatric Concussion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pediatric Mild Traumatic Brain Injury
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with concussion may improve with intravenous fluids.


Eligibility criteria: Inclusion Criteria:

* History of acute concussion

Exclusion Criteria:

* Other significant medical illness

Primary outcomes:
measure: Postconcussive symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT02050516: Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish
Official title: Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Blastocyst, micro-well group culture dish
Lead sponsor: Eurofertil IVF Health Center
Sponsor class: OTHER
Collaborators: name: Vitrolife
First posted: 2014-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?


Eligibility criteria: Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check

Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage

-

Primary outcomes:
measure: Blastocyst development
timeFrame: 6 days
Secondary outcomes:
measure: Implantation rate
timeFrame: 1 month
Other outcomes:
measure: Clinical pregnancy rate
timeFrame: 1 month
Locations:
city: Istanbul
country: Turkey
facility: Eurofertil IVF Health Center
Study officials:
affiliation: Eurofertil IVF Health Center
name: Elif Güler Ergin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05027516: Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea
Official title: An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neisseria Gonorrhoeae
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this Randomized Controlled Trial, the investigators will recruit 42 men attending the STI and HIV clinic at the Institute of Tropical Medicine, with a diagnosis of N. gonorrhoeae and randomize them 1:1 to receive either ceftriaxone or ceftriaxone/azithromycin. They will be followed-up for a test of cure visit at day 14 post-treatment where urine, oropharyngeal and anorectal samples will be taken to test for cure and monitor treatment effects on the microbiome and resistome. The primary outcome will be evaluating the difference in the abundance of resistance conferring genes in the rectal microbiome in the two arms, 14 days after the receipt of therapy.


Eligibility criteria: Inclusion criteria:

1. Able and willing to provide written informed consent
2. Male sex at birth
3. At least 18 years old
4. Confirmed diagnosis of urethritis, proctitis or pharyngitis N. gonnorrhea - symptomatic or asymptomatic (Diagnosis of N. gonnorrhea will be by a positive NAAT performed according to the ITMs current laboratory protocols or for patients with urethritis a positive gram/methylene blue stain)

Exclusion criteria:

1. Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
2. Known contra-indications or allergy to ceftriaxone, azithromycin or lidocaine
3. Presence of any other condition, including other Sexually Transmitted Infections that will (likely) require the administration of another antibiotic at the time of enrollment, as assessed by the treating physician

Primary outcomes:
measure: Macrolide Resistance Determinants
timeFrame: Day 14
Secondary outcomes:
measure: Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class
timeFrame: Day 14
measure: Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea
timeFrame: Day 0 and Day 14
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Institute of Tropical Medicine
Study officials:
References: