louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01186549: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection
Official title: Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain Due to Propofol Injection
Hemodynamic Changes Due to Propofol Injection
Keywords: propofol
ephedrine
pain
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: Injection pain and hypotension are two main adverse effects of propofol which distresses patient. The aim of this prospective double blind study was to compare the effect of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and hemodynamic changes due to propofol induction.

Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30), ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation


Eligibility criteria: Inclusion Criteria:

* patients with American Society of Anesthesiologists(ASA)physical statusIandII

Exclusion Criteria:

* patients with difficulty in communication
* history of allergic, neurologic or cardiovascular disease
* patients who had received an analgesic medication within 24 hr before surgery

Primary outcomes:
measure: pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)
timeFrame: during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation
measure: heart rate
timeFrame: before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical science
Study officials:
References:
Clinical trial NCT05698849: Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids (2859)
Official title: Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rate of Water Appearance/Delivery in the Blood Water Balance
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Entrinsic Beverage Company LLC
First posted: 2023-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomised, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the effects of a moderate amount of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes. Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.


Eligibility criteria: Inclusion Criteria:

* Generally fit and healthy (determined by health screen questionnaire)
* Recreationally active (minimum 3 hours of physical activity per week including walking)

Exclusion Criteria:

* Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes
* Smoking (including vaping)
* BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5

Primary outcomes:
measure: Time at which drink absorption rate was maximum (tmax)
timeFrame: 60 minutes
measure: Maximum absorption of drink (Cmax)
timeFrame: 60 minutes
measure: Area under the curve for D2O
timeFrame: 60 minutes
Secondary outcomes:
measure: Plasma volume
timeFrame: 60 minutes
measure: Plasma osmolality
timeFrame: 60 minutes
measure: Urine specific gravity
timeFrame: 60 minutes
measure: Urine volume
timeFrame: Post-trial (at 60 minutes)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References:
Clinical trial NCT00455949: Effect of Premature Luteinization on the Oocyte Quality in Oocyte Donation Program.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Luteinization
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-04-04
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Analyze the possible effect of the progesterone levels of the hCG administration on the oocyte embryo quality. The primary endpoint of this study is the pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* Oocyte donors; age range: 18 - 34; BMI: 18 - 29; long protocol.

Exclusion Criteria:

* PCO syndrome;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de la Infertilidad
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Marco Melo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06391606: CoQ10 in Statin-associated Asthenia
Official title: Effect of Coenzyme Q10 on Physical Performance in Elderly Patients With Statin-associated Asthenia: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Physical Performance
Keywords: Statin
Asthenia
Coenzyme Q10
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effects of supplementation with CoQ10 phytosome on physical performance in older adults with self-reported statin-associated asthenia.


Eligibility criteria: Inclusion criteria:

* 65-80 years of age
* treatment for \>6 months with statin monotherapy (i.e. enrolled individuals were asked to be on the same statin at the same dosage for \>6 months)
* statin-associated asthenia for \>3 months

Exclusion criteria:

* serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
* orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia
* obesity (body mass index (BMI)\> 30 Kg/m2)
* known gastrointestinal disorders potentially affecting the absorption of CoQ10

Primary outcomes:
measure: Effect on handgrip strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect on handgrip strength
timeFrame: 4 weeks
measure: Effect on statin-associated asthenia
timeFrame: 4 weeks
measure: Effect on statin-associated asthenia
timeFrame: 8 weeks
measure: Effect on 1-min sit-to-stand repetitions
timeFrame: 4 weeks
measure: Effect on 1-min sit-to-stand repetitions
timeFrame: 8 weeks
measure: Effect on 2-minute step test
timeFrame: 4 weeks
measure: Effect on 2-minute step test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: BO
Study officials:
affiliation: University of Bologna
name: Claudio Borghi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03744806: Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular AMD
Official title: Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exudative Age-related Macular Degeneration
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* active AMD-associated choroidal neovascularization (CNV) confirmed with fluorescein angiography (FA) and optical coherence tomography (OCT)

Exclusion Criteria:

* history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (VEGF) injections

Primary outcomes:
measure: Anterior chamber (AC) inflammation evaluated with laser flare photometry.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06668506: To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
Official title: A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastritis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 2814
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The minimum number of study subjects required to estimate the two-sided 95% confidence interval of the change in the total score of subjective symptoms at 2 weeks compared to the baseline as -3.19 to 2.99, with the standard deviation assumed by referring to the AD-203P3 literature, is calculated to be 15,247 ( PASS 13. NCSS, LLC. (Kailsville, Utah, USA)

Brief summary: This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.


Eligibility criteria: Inclusion Criteria:

* Men or women aged ≥ 19 years
* Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab
* Subjects with subjective symptoms
* Subjects who voluntarily consent to participate in this observational study

Exclusion Criteria:

* Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab
* Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Primary outcomes:
measure: Change in total subjective symptom score compared to baseline
timeFrame: 2 weeks (up to 4 weeks)
Secondary outcomes:
measure: Change in individual subjective symptom score compared to baseline
timeFrame: 2 weeks (maximum 4 weeks)
measure: The effective rate of subjective symptoms compared to baseline
timeFrame: 2 weeks (maximum 4 weeks)
measure: Overall change assessed by study subjects after administration of the study drug
timeFrame: 2 weeks (maximum 4 weeks)
measure: Overall change assessed by the researcher after administration of the drug under study
timeFrame: 2 weeks (maximum 4 weeks)
measure: Adverse events that occurred after administration of Mucotra® extended-release tablets
timeFrame: 2 weeks (maximum 4 weeks)
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Song Kwang Seon Internal medicine clinic
Study officials:
References:
Clinical trial NCT04567706: A Storage Facility for Tissues Obtained From Patients With Malignant Melanoma
Official title: Analysis of the Tumor Microenvironment and Immune Response in Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being evaluated or treated for malignant melanoma by members of the departments of Surgical Oncology, Medical Oncology, and Radiation Oncology and normal controls

Brief summary: This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease.

Detailed description: PRIMARY OBJECTIVE:

I. Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma.

OUTLINE:

Patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). Patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. Healthy individuals undergo collection of blood samples up to 4 times over 1 year.

Eligibility criteria: Inclusion Criteria:

* Patient with malignant melanoma or personal history of melanoma
* Normal donors
* Informed consent can be obtained
* Patients with any stage of malignant melanoma

Exclusion Criteria:

* Incarcerated individuals will be excluded from this protocol

Primary outcomes:
measure: New prognostic markers in malignant melanoma
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: William E Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05618106: Low FODMAP Diet in Patients With IBS
Official title: Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Carbohydrates
low FODMAP diet
components in the low FODMAP diet
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period
Primary purpose: TREATMENT

Brief summary: The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.

Detailed description: Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.

Eligibility criteria: Inclusion Criteria:

* IBS diagnosed by the Rome III criteria and
* referred to the clinic for treatment by diet

Exclusion Criteria:

* Dementia
* lack of ability to speak Danish
* additional chronic diseases prevailing participation

Primary outcomes:
measure: Birmingham IBS questionnaire and adequate relief (IBS-AR).
timeFrame: 3 months
Secondary outcomes:
measure: IBS Quality of Life Scale questionnaire (IBS-QOL)
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Frederiksberg
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD, MPA
role: STUDY_CHAIR
References:
Clinical trial NCT06386406: This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain
Official title: A Mono-centric Clinical Investigation to Evaluate Performance of a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.

The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life.


Eligibility criteria: Inclusion Criteria:

Male and female adults

* Age ranging 18 to 70 years
* Patients with a history of at least 6 months of plantar fasciitis resistant to other conventional therapies
* Willingness and ability to participate in the trial
* Informed Consent signed by the subject

Exclusion Criteria:

* Diabetes mellitus not controlled pharmacologically
* Rheumatoid arthritis
* Previous foot surgery
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.

Primary outcomes:
measure: Change in pain severity according to visual analog scale
timeFrame: 3 months
Secondary outcomes:
measure: Change in pain severity according to visual analog scale
timeFrame: 2 weeks, 6 weeks, 6 and 12 months.
measure: Subjective functional recovery based on the Foot Function Index (FFI) score [
timeFrame: baseline, 2 and 6 weeks, and 3, 6, and 12 months
measure: Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ)
timeFrame: baseline, 2 and 6 weeks, and 3, 6, and 12 months follow-up
measure: Patient satisfaction on a 0-10 numeric rating scale (NRS)
timeFrame: 2 weeks, 6 weeks,3, 6, and 12 months
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: EOC
Study officials:
References:
Clinical trial NCT02400606: The Effect of Constructing Virtual Patient Cases
Official title: The Effect of Constructing Versus Solving Virtual Patient Cases on Transfer of Learning: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: constructing VPs
knowledge and skills transfer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Centre for Clinical Education
First posted: 2015-03-27
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study was to explore the effect of actively constructing Virtual patient (VP) cases compared with solving VP cases using 'Web-SP', Stockholm University, Stockholm, Sweden on knowledge gains and skills transfer in a group of pre-clerkship medical students.

Detailed description: Solving VP cases is associated with large improvements in learning but its effectiveness is dependent on active student involvement. Constructing VP cases rather than solving them may engage students more actively in encoding new information and integrating it with previous knowledge.

Fourth-year medical students were included and randomized to constructing (intervention) or solving (control) four cardiopulmonary VP cases. The participants were presented with a short case overview. The control group solved the cases, whereas the intervention group also received the final diagnosis and had to complete the history, physical findings, and lab results. After a week, participants completed a transfer test involving two standardized patients presenting a respiratory case and a cardiology case, respectively. Performances were video-recorded and subsequently assessed by two blinded raters using the Reporter-Interpreter- Manager-Educator (RIME) framework. Knowledge gains were assessed using a pre- and post-test of a 95-item Multiple-Response-Questionnaire (MRQ).

Eligibility criteria: Inclusion Criteria:

* fourth-year medical students, University of Copenhagen
* pre-study participation in the mandatory patient encounter skills course

Exclusion Criteria:

* medical students who had taken the three pre-clerkship years at other universities, because of curriculum discrepancies

Primary outcomes:
measure: Evaluation of the medical students' management of a simulated patient encounter using a RIME-structured scoring form
timeFrame: After working with the virtual patient cases for one week +/- 3 days
Secondary outcomes:
measure: Multiple Choice/Answers Questionnaire
timeFrame: When entering the study and after working with the virtual patient cases for one week +/- 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Clinical Education
name: Charlotte Ringsted, MD MHPE PHD
role: STUDY_DIRECTOR
References: