louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06224439: Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery
Official title: Comparison of the Effectiveness of Lumbar Plexus Block and Unilateral Spinal Anaesthesia in Patients Undergoing Femoral Neck Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Regional Anesthesia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.

Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.

Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.


Eligibility criteria: Inclusion Criteria:

* \>18 years and \<90 years
* ASA (American Society of Anesthesiologists) score between I and IV
* Patients who will undergo femoral neck fracture surgery

Exclusion Criteria:

* Previous local anesthetic allergy
* Those with bleeding diathesis disorder
* Having a mental disorder
* Those who are allergic to the drugs used
* Patients who did not consent to participate in the study
* Presence of infection in the block area
* Body mass index \>30
* Preoperative or intraoperative general anesthesia
* Patients for whom consent cannot be obtained
* Pregnant patients

Primary outcomes:
measure: intraoperative haemodynamic parameters
timeFrame: intraoperative 2 hours
Secondary outcomes:
measure: Entropy
timeFrame: intraoperative 2 hours
measure: SPI
timeFrame: intraoperative 2 hours
measure: sedation and analgesic
timeFrame: intraoperative 2 hours
measure: Intraoperative bleeding
timeFrame: intraoperative 2 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
References:
Clinical trial NCT05687539: Mastiha or Mastiha Water in Functional Dyspepsia
Official title: The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.

Detailed description: Functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. Its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. Mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. In the present study, the investigators aim to determine whether Mastiha capsules or Mastiha water have a better effect on the improvement of functional dyspepsia symptoms. Therefore, the investigators designed a randomized, three-way cross-over clinical trial. Fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. The three treatments will be: Mastiha capsules, Mastiha water or Mastiha free treatment. The primary outcome, which will be assessed by intention to treat, will be the Leuven Postprandial Distress Scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the European Medicines Agency.

Eligibility criteria: Inclusion Criteria:

functional dyspepsia diagnosis according to

* Rome criteria
* negative urea breath test for Helicobacter pylori
* upper gastrointestinal tract endoscopy with biopsy

Exclusion Criteria:

* organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome
* pregnancy or lactation
* history of abdominal surgery or actinotherapy
* mental illness
* Severe impairment of heart, liver, or kidney function or respiratory function
* Alcohol overuse

Primary outcomes:
measure: Changes in Leuven Postprandial Distress Scale (LPDS)
timeFrame: 1 month
Secondary outcomes:
measure: Change in quality of life
timeFrame: 1 month
measure: Use of medicines
timeFrame: 1 month
measure: Change in anxiety
timeFrame: 1 month
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
affiliation: Harokopio University
name: Andriana C. Kaliora, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02183922: Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome
Official title: Hypocaloric Diet With or Without Microencapsulated Fish Oil or Conjugated Linoleic Acid on Oxidative Stress and Cardiovascular Risk Factors in Women With Metabolic Syndrome Genotyped for Polymorphisms in the Genes PPAR Gamma 2 (Pro12Ala) and Adiponectin (G276T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Oxidative Stress
Lipid Profile
Blood Pressure
Anthropometric Measure
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2014-07-08
Enrollment: 37
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene.


Eligibility criteria: Inclusion Criteria:

* adults women (30-45 years old);
* diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
* Pro12Pro genotype in gene PPARγ2.

Exclusion Criteria:

Participants were excluded if they:

* Were allergic to strawberries or fish
* Were pregnant or lactating
* Took fatty acid supplements
* Had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous three months

Primary outcomes:
measure: Oxidative stress biomarker
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Insulin resistance
timeFrame: Change from baseline at 12 weeks
measure: Lipid profile
timeFrame: Change from baseline at 12 weeks
measure: Anthropometric measures
timeFrame: Change from baseline at 12 weeks
measure: Body composition measures
timeFrame: Change from baseline at 12 weeks
measure: Blood pressure
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Sofia Uehara, Nutritionist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00408122: Evaluation of Preoperative Investigations in Patients With Liver Cancer
Official title: Evaluation of Positron Emission Tomography/ CT Scan, Endoscopic Ultrasono¬Graphy, and Laparoscopic Ultrasonography in the Preoperative Assess¬Ment of Resectability in Patients With Primary and Secondary Liver Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Liver Cancer
Liver Metastasis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-12-06
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PAtients with liver tumors

Brief summary: The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.


Eligibility criteria: Inclusion Criteria:

* all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer.

Exclusion Criteria:

* age less than 18 years
* patients who are not fit for liver surgery because of co-morbidity
* patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as

  * Patients with s-creatinin \> 150 micromol/l
  * Patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus
* patients who do not understand the patient information
* patients who do not want to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Dept of Surgery, Odense university Hospital
Study officials:
affiliation: dept. of Surgery, Odense University Hospital
name: Henning O Nielsen, MD, DMsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670722: Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin
Official title: Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 6500
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: Patients with Type 2 diabetes

Brief summary: This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Current treatment with human soluble insulin, insulin NPH or premixed human insulin
* The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
* Previous enrolment in this study
* Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

Primary outcomes:
measure: HbA1c after switch from human insulin to modern insulin treatment
timeFrame: After 24 weeks
Secondary outcomes:
measure: Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment
timeFrame: After 12 and 24 weeks
measure: Postprandial glycaemic control as measured by PPG
timeFrame: After 12 and 24 weeks
measure: Glucose variability as measured by FPG
timeFrame: After 12 and 24 weeks
measure: Insulin dose and number of injections
timeFrame: After 12 and 24 weeks
measure: Body weight
timeFrame: After 12 and 24 weeks
measure: Number of hypoglycaemic events
timeFrame: During treatment
measure: Number of adverse drug reactions (ADR)
timeFrame: After 12 and 24 weeks
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04609722: Effect of Solution-Focused Support Program on Anxiety Levels of Parents During the COVID-19 Pandemic
Official title: Effect of Solution-Focused Support Program on Anxiety Levels of Parents With Children Aged 3-6 Years During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Parents
Covid19
Keywords: anxiety
child
nursing practice
parents
Solution-Focused Support Program
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.

Detailed description: The study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. In collecting research data; an introductory information form prepared by researchers and the State-Trait Anxiety Inventory will be used.

Eligibility criteria: Inclusion Criteria:

* Parents with children aged 3-6,
* Having internet at home or mobile phone,
* Parents who volunteer to participate in the study

Exclusion Criteria:

* Having communication problems,
* Parents who have not attended at least one session

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Online- Data will be collected through the form created with the Google-Forms
Study officials:
affiliation: Adiyaman University
name: Ceyda Başoğul
role: PRINCIPAL_INVESTIGATOR
affiliation: İnönü University
name: Emriye Hilal Yayan
role: PRINCIPAL_INVESTIGATOR
affiliation: Adiyaman University
name: Mürşide Zengin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391039: Diagnostic Study of Early Breast Cancer Using Ultrasound
Official title: Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ductal Carcinoma In-situ
Keywords: Ductal Carcinoma In-situ
Contrast Ultrasound
Microinvasion
Elastography
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

Detailed description: Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.

Eligibility criteria: Inclusion Criteria:

* A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
* At least 18 years of age

Exclusion Criteria:

* Pregnant or possibly pregnant or breast feeding
* Unable to provide informed consent
* Drug or multiple allergies
* Known cardiac shunts
* Known cardiac or chronic pulmonary disease
* Hypersensitivity to perflutren

Primary outcomes:
measure: Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
timeFrame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Secondary outcomes:
measure: Measurement of transient shear wave elastography .
timeFrame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Roberta A Jong, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06884839: Tumor Deposits in Colorectal Cancer and Its Prognostic Value in Survival and Metastasis
Official title: Tumor Deposits in Colorectal Cancer and Its Prognostic Value in Survival and Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor Deposits
Colorectal Cancer
Prognosis
Survival
Metastasis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 30
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: This prospective and retrospective study will be conducted on 30 patients with colorectal cancer.

Brief summary: This study aims to evaluate the tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

Detailed description: Tumor deposits (TDs) are defined as isolated tumor foci found in the pericolonic or perirectal fat or the adjacent mesentery (mesocolonic fat) away from the invasive margin of the tumor without evidence of residual lymphatic tissue. TDs are significantly correlated with poor prognosis after colorectal cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years old.
* Both sexes.
* All Colorectal cancer patients From Stage I to III Colorectal cancer with pathologically positive Tumor deposits.

Exclusion Criteria:

* Patient took neoadjuvant therapy.
* No information available on tumor deposits.
* Colorectal cancer is not the only primary cancer.
* Patients with incomplete information about follow-up.

Primary outcomes:
measure: Patients' overall survival
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Distant metastasis
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT01365039: Safety and Efficacy of a Contact Lens for Daily Disposable Use
Official title: A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.


Eligibility criteria: Inclusion Criteria:

* Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
* Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
* Subjects must be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Exclusion Criteria:

* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.

Primary outcomes:
measure: Slit Lamp Findings > Grade 2
timeFrame: 4 visits over 3 months
measure: High Contrast, Distance logMAR Visual Acuity (VA)
timeFrame: 4 visits over 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Inc.
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly Barna, CCRA
role: PRINCIPAL_INVESTIGATOR
References: