louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03499496: Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk
Official title: Prevalence of Atherosclerotic Carotid and/or Femoral Plaques in Patients Without Known Cardiovascular Disease and at Low-risk for Major Cardiovascular Events (AGLA/GLSA Score) Visiting a Private Primary Healthcare Practice in Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis of Artery
Keywords: plaques detection by ultrasound
Lead sponsor: Cabinet de Medecine Interne Générale Demetrio Pitarch
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 22
Sex: ALL
Minimum age (years): 41
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The carotid and femoral arteries of 22 asymptomatic patients (9 females,13 males) aged between 41-72 having a low cardiovascular risk score based on blood pressure, nicotine abuse history, cardiac family history, blood analysis in fasting state for diabetes, lipid status including total cholesterol HDL-cholesterol, triglycerides and calculated LDL-cholesterol were screened by ultrasound.

Brief summary: Cardiovascular disease is a common diagnosed and treated condition in private practices of primary health care. There is growing evidence that atherosclerotic plaques as predictors for stroke and heart attack are more prevalent than expected based on the clinical score in people with low risk for stroke and heart attack .

Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be prescribed even if the clinical risk score is low or on the other hand if they can be observed even in high lipid levels.

Detailed description: Both common and proximal internal carotid arteries and both common femoral arteries (including bifurcations) were screened by ultrasound in patients who came for a check-up to a primary care practice with no known cardiovascular disease and low risk for stroke and heart attack according to the AGLA/GSLA risk score which is mostly used in Switzerland.

All patients agreed and gave written informed consent to be included in this study. Presence of plaques was defined as a focal carotid intima-media thickness \>0.5 cm on ultrasound. Screening was performed by a medical doctor (DP) certified for the procedure using the following ultrasound system: Toshiba Nemio XG, probe 7.5 MhZ.

Eligibility criteria: Inclusion Criteria:

* low cardiovascular risk assessed by the AGLA/GSLA-score

Exclusion Criteria:

* cardiovascular disease

Primary outcomes:
measure: Prevalence of plaques in cardiovascular low risk population
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cabinet de medecine generale
name: Demetrio A Pitarch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06216496: Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer
Official title: Evaluation of Amino Acid Metabolism Changes in Participants With Ovarian Cancer by Dynamic Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. It is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. To achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage III or IVa) managed at Grenoble Alpes University Hospital.
* Affiliation to the French social security system.
* Able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study.

Exclusion Criteria:

* Significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria).
* vegetarian or vegan diet
* difficult venous access
* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
* Subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study.
* Significant biological abnormalities (not explained by the underlying pathology for women with ovarian cancer)
* Liver metastases

Primary outcomes:
measure: metabolism of each amino acid, in women with non-immediately resectable ovarian cancer (with or without peritoneal metastases) of high-grade serous type.
timeFrame: 270 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble Alpes
Study officials:
References:
Clinical trial NCT06787196: Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery
Official title: Effect of Single Dose Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Extraction Status Nos
Cysts Dental
General Anesthesia
Keywords: Dexamethasone
postoperative pain
maxillofascial surgery
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effect of single-dose intravenous dexamethasone on postoperative pain and other complications in compacted tooth and cyst enucleation procedures performed under general anesthesia.

Detailed description: During surgery, patients were carefully monitored with standard equipment to track oxygen levels (SpO2), heart activity (ECG), blood pressure, and carbon dioxide levels. General anesthesia was started with medications like thiopental, rocuronium, and fentanyl, and maintained with a mix of oxygen, air, sevoflurane, and remifentanil. Patients were intubated with appropriate tubes, and the surgical team applied a local anesthetic (Articaine with Epinephrine) to the area before starting the procedure. After the surgery, patients were given dexamethasone (DXM) and pantoprazole intravenously, then safely extubated and sent to recovery. All patients were discharged on the same day.

Postoperative recovery was assessed using pain scores (VAS) and physical evaluations. Pain levels were categorized as mild, moderate, or severe, and an analgesic was provided if the score exceeded 3. Facial swelling was measured by comparing pre- and post-surgery facial landmarks, with swelling classified into grades based on the percentage of change. Mouth opening was evaluated with a caliper to check for trismus (jaw stiffness), with results grouped into normal, mild, moderate, or severe grades depending on the degree of restriction. Follow-ups were conducted by an independent clinician on postoperative days 1, 2, and 7.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* underwent split-mouth surgery

Exclusion Criteria:

* Patients undergoing corticosteroid therapy

Primary outcomes:
measure: IV dexamethasone (DXM) changes postoperative complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Funda Arun
state: Konya
Study officials:
affiliation: Selcuk University
name: Hasan Kucukkolbasi, prof.
role: STUDY_CHAIR
affiliation: Selcuk University
name: Emine Taskin, resid.
role: STUDY_CHAIR
References:
Clinical trial NCT00779896: Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Official title: Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cutaneous T-Cell Lymphoma
Keywords: To evaluate therapeutic potential of tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study
Stage I-IIA disease CTCL
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.


Eligibility criteria: Inclusion Criteria:

* Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides.

Exclusion Criteria:

* Patients with Stage \>IIA CTCL at the time of enrolment
* Women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception
* Patients who were treated with topical retinoid therapy in the past 3 months
* Patients who received any systemic CTCL therapy or systemic corticosteroid therapy within 30 days of the study start date
* Patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date

Primary outcomes:
measure: Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Montreal General Hospital
name: David Roberge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914896: Hyperosmolality and Acute Kidney Injury After Cardiac Surgery
Official title: Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Osmolality Disturbance
Cardiopulmonary Bypass
Keywords: Cardiopulmonary Bypass
Priming Solution
Plasma Osmolality
Acute Kidney Injury
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury.

Detailed description: Two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass. The high osmolality group (966 mOsm) received a prime solution containing Ringer-Acetate 1000 ml + Mannitol 400 ml (60 g) + Sodium-Chloride 40 ml (160 mmol) and Heparin 2 ml (10 000 IU), while the reference group with normal osmolality (388 mOsm) received a prime solution containing Ringer-Acetate 1400 ml and Heparin 2 ml (10 000 IU).

Eligibility criteria: Inclusion Criteria:

* Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.

Primary outcomes:
measure: Postoperative Acute Kidney Injury
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Public Health Clinical Medicine Umeå University
state: Vasterbotten
Study officials:
affiliation: Public Health & Clinical Medicine Umeå University, Sweden
name: Staffan Svenmarker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00983996: Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: MylanPharma
Sponsor class: UNKNOWN
First posted: 2009-09-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: Bioequivalence
timeFrame: urine collection up to 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Insitute Ltd.
state: North Dakota
Study officials:
References:
Clinical trial NCT00259896: In-patient Study in Patients With Type 2 Diabetes Mellitus
Official title: A Randomized, Open-label, Placebo-controlled, Repeat-dose Study to Assess the Pharmacokinetics and Pharmacodynamics of 5 Micrograms Exenatide Administered Subcutaneously Twice Daily for 7 Days in Healthy Normal Volunteers and in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: exenatide
pharmacokinetics
pharmacodynamics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.


Eligibility criteria: Inclusion Criteria:

* have type 2 diabetes mellitus that has been diagnosed for at least three months
* must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea
* must be willing to wash-out of these medications for 14 days prior to the start of the study
* must have bloodwork that meets certain criteria (for example, total cholesterol \< 240 mg/dL)

Exclusion Criteria:

* must not have any other major illness other than diabetes

Primary outcomes:
measure: Pharmacodynamic measurements during 7 days of dosing.
Secondary outcomes:
measure: Pharmacokinetic measurements during 7 days of dosing.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290896: Correlations Between Lens Star and Phacoemulsification.
Official title: Correlations Between Lens Star Parameters and Phacoemulsification in Clinical Practice.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lens Diseases
Lens Opacities
Keywords: Cataract
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Senile cataract patients
Primary purpose: TREATMENT

Brief summary: To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.

Detailed description: To analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.

Eligibility criteria: Inclusion Criteria:

* patients that will undergone phacoemulsification for their mild to moderate senile cataracts.

Exclusion Criteria:

* congenital and developmental cataract.
* cases with congenital lens anomalies as ectopia lentis and spheophakia.

Primary outcomes:
measure: Correlation between parameters measured by lens star.
timeFrame: Immediately before phacoemulsification surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Marwa A Abdelshafy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004796: Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Portal Hypertension
Hepatic Encephalopathy
Cirrhosis
Keywords: cardiovascular and respiratory diseases
cirrhosis
gastrointestinal disorders
hypertensive disorder
portal hypertension
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Northwestern University
First posted: 2000-02-25
Enrollment: 16
Sex: ALL
Minimum age (years): 0
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy.

II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests.

III. Assess which elements of the neuropsychological test battery show the response to lactulose.

Detailed description: PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks.

A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting

--Prior/Concurrent Therapy--

* No concurrent therapy for hepatic encephalopathy

--Patient Characteristics--

* Age: Under 65
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: See Disease Characteristics
* Renal: Not specified
* Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Andres Blei
role: STUDY_CHAIR
References:
Clinical trial NCT00878696: Influence of Tonic and Burst Transcranial Magnetic Stimulation (TMS) Characteristics on Acute Inhibition of Subjective Tinnitus
Official title: Influence of Tonic and Burst TMS Characteristics on Acute Inhibition of Subjective Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Brief summary: Transcranial magnetic stimulation (TMS) is already broadly used in different areas of neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.


Eligibility criteria: Inclusion Criteria:

* Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Exclusion Criteria:

* Patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.

Primary outcomes:
measure: VAS visual analogue scale
timeFrame: immediately before and immediately after single session TMS
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT00658996: Product Performance of a Toric Contact Lens
Official title: A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens


Eligibility criteria: Inclusion Criteria:

* Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
* Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
* Clear central cornea

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wears monovision or multifocal contact lenses
* Any grade 2 or greater slit lamp findings
* Adapted wearer of Ciba Focus Dailies Toric lens upon study entry

Primary outcomes:
measure: Symptoms and Complaints
timeFrame: Over-all follow-up visits for 2 week period
measure: Contact Lens High Contrast Visual Acuity
timeFrame: Over-all follow-up visits, 2 weeks
Secondary outcomes:
measure: Slit Lamp Findings
timeFrame: Over-all follow-up visits, 2 weeks
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Laser Focus Sdn Bhd, Vision Correction Centre
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, PhD,MCOptom
role: STUDY_DIRECTOR
affiliation: Laser Focus Sdn Bhd, Vision Correction Centre
name: Benny Chian, MCOptom,DO
role: PRINCIPAL_INVESTIGATOR
References: