louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00660413: Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents
Official title: Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Acceleromyography
Mechanomyography
Neuromuscular block
Neuromuscular monitoring
Dose-response
Potency
Rocuronium
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Ideal weight +/-20%
* Both arms available for neuromuscular monitoring
* Surgery in supine position
* Participated surgery time more than 30 min

Exclusion Criteria:

* Pregnant and breast-feeding women
* Patients with known illness or use of medications known to influence the neuromuscular transmission
* Known significant renal or hepatic dysfunction
* Allergy to medications used in the study

Primary outcomes:
measure: Comparison of ED50 with the two methods
Secondary outcomes:
measure: Comparison of ED95 with the two methods
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Casper Claudius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05377736: Thyroid Nodule Gene Sequencing in a Danish Population
Official title: Thyroid Nodule Gene Sequencing in a Danish Population - a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thyroid Nodule (Diagnosis)
Thyroid Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Odense University Hospital
First posted: 2022-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population.

Patients with thyroid nodules suspected of malignancy is included prospectively.

Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.


Eligibility criteria: Inclusion Criteria:

* Thyroid nodule \>1.5 cm
* BSRTC: IV, V, og VI

Exclusion Criteria:

* No surgical specimen available
* Purely cystic nodules

Primary outcomes:
measure: DNA alterations
timeFrame: Two years
measure: RNA alterations
timeFrame: Two years
measure: DNA methylation
timeFrame: Two years
measure: Circulating tumor DNA
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus Universityhospital
Study officials:
affiliation: Aarhus University Hospital
name: Kristine Z Swan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889636: Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use
Official title: Assessment of the Impact of Pharmaceutical Care on the Quality of Life in Conditions Related to Psychotropic Drug Use and Evaluation of the Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Services
Keywords: Mental disorders
Quality of life
Drug-related problems
Lead sponsor: University of Rijeka
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to assess and describe the impact of pharmaceutical care on identified drug-related problems (DRPs) in subjects using psycholeptics and psychoanaleptics in primary care, improving subjects' self-assessed quality of life (QoL)

The hypothesis of the study are:

1. Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
2. Treatment effectiveness and safety affect the subjects´ QoL

Detailed description: The study objectives are to:

1. assess QoL in subjects using psycholeptics and psychoanaleptics,
2. analyze identified DRPs and their causes in subjects using psycholeptics and psychoanaleptics
3. evaluate the correlation between the type and total number of DRPs identified in a single subject with QoL,
4. describe the impact of pharmacists´ intervention in the identification and resolution of the DRPs and their causes on subjects´ QoL.

Eligibility criteria: Inclusion Criteria:

* Adult participants (years 18+)
* Usage of psycholeptic or psychoanaleptic medicines
* Residence in Istrian County (Croatia)

Exclusion Criteria:

* Minor participants
* Hospitalization during study participation
* Unable to live by themselves
* Unable to participate in study for 3 months

Primary outcomes:
measure: Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics
timeFrame: Prior and after the pharmacists' intervention during three months period.
Secondary outcomes:
measure: Analysis of identified drug-related problems
timeFrame: During period of three months.
Other outcomes:
Locations:
city: Pula
country: Croatia
facility: Pharmacy Bobanovic Vujnovic Pula
Study officials:
References:
Clinical trial NCT06530836: Chronic Diarrhea Owing to Underlying Microscopic Colitis
Official title: Chronic Diarrhea Owing to Underlying Microscopic Colitis: Diagnosis Challenges and Size of the Problem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Diarrhea
Microscopic Colitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-31
Enrollment: 116
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 presented with chronic diarrhea in the outpatient clinic or the inward in the Gastroenterology and Hepatology unit in the Internal Medicine Department, Zagazig University hospitals from January 2024 to January 2025

Brief summary: The goal of this observational study is to search for accurate diagnoses for patients with chronic diarrhea and assess the prevalence of microscopic colitis. The main question\[s\] it aims to answer \[is/are\]:

Does microscopic colitis account for a significant portion of patients with chronic diarrhea?

Participants will subjected to:

* Routine laboratory examination.
* Colonoscopy: A total colonoscopy will be done with visualization of the terminal ileum. Biopsies will be taken from each segment of the colon and any abnormal appearing areas, the right-sided colon (cecum, ascending colon, and transverse colon), the left-sided colon (descending colon and sigmoid colon), and the rectum.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic watery diarrhea

Exclusion Criteria:

* Infectious colitis.
* Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, and indeterminate colitis).
* Systemic disease associated with chronic diarrhea, e.g. Diabetes mellitus and Thyroid disease.
* Drugs causing chronic diarrhea, e.g. antibiotics, antidepressants, and angiotensin-converting enzyme inhibitors.
* Chronic diarrhea of decreased digestion as in pancreatic insufficiency and bile acid deficiency.

Primary outcomes:
measure: Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis
timeFrame: 6 weeks
Secondary outcomes:
measure: Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospital
state: Sharkia
Study officials:
affiliation: Associate Professor of Internal Medicine - Zagazig University
name: Ayman Sadek, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01056536: Brief Intervention and/or Distribution of Free Condoms for Travelers
Official title: Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Keywords: Travel
casual sexual relationships
condoms
Structured intervention
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 1681
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the impact of a structured intervention and/or free distribution of condoms during the pre-travel consultation on sexual risk behavior of young persons traveling alone.

Detailed description: All persons aged 18 - 44 years planning to travel alone and attending the travel clinic of the Medical Outpatient Clinic in Lausanne will be asked to participate. The subjects will be randomized into three groups: 1. no intervention, 2. free condoms without further explanations, 3. a structured intervention of 5 minutes on STI risk reduction plus free condoms. The structured interventions will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The subjects will complete a pre-travel questionnaire prior to the medical consultation. A post-travel questionnaire will be sent to them 10 days after their trip. The questionnaires will include questions on demographic characteristics, sexual habits, alcohol/tobacco/marijuana consumption and sexual relationships during the trip.

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 44 years
* Travelling without the regular partner

Exclusion Criteria:

* Refusal of patient to participate

Primary outcomes:
measure: Number of Subjects Who Had New Sexual Relationships
timeFrame: 10 days after returning from abroad
Secondary outcomes:
measure: Number of Subjects Who Used Condoms Inconsistently
timeFrame: 10 days after returning from abroad
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Travel Clinic, Medical Outpatient Department, University of Lausanne
state: Vaud
Study officials:
References:
citation: Senn N, de Valliere S, Berdoz D, Genton B. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial. BMC Infect Dis. 2011 Nov 1;11:300. doi: 10.1186/1471-2334-11-300.
Clinical trial NCT03193736: MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Official title: A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 26
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: The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled

Exclusion Criteria:

* Diagnosis of glaucoma other than open angle glaucoma
* Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
* Neovascular glaucoma in the study eye
* Prior glaucoma surgery in the study eye
* Clinically significant corneal disease
* Patients with poor vision

Primary outcomes:
measure: Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
timeFrame: 6 months after implantation surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Maxivision Eye Hospital
state: Telangana
city: Panama city
country: Panama
facility: Clinica de ojos Orillac-Calvo
Study officials:
affiliation: iSTAR Medical
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
citation: Denis P, Hirneiss C, Durr GM, Reddy KP, Kamarthy A, Calvo E, Hussain Z, Ahmed IK. Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. Br J Ophthalmol. 2022 Jan;106(1):65-70. doi: 10.1136/bjophthalmol-2020-316888. Epub 2020 Oct 3.
Clinical trial NCT04272736: PKU Low Calorie Drink Study
Official title: Evaluating the Compliance, Acceptability, Safety and Tolerance of a Lower Calorie Protein Substitute for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Phenylketonurias
Hyperphenylalaninaemia
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU) or hyperphenylalaninemia (HPA).


Eligibility criteria: Inclusion Criteria:

* Male or female
* 3 years of age or above
* Diagnosed with classical or variant type phenylketonuria (PKU), or hyperphenylalaninemia (HPA)
* Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalent daily, for at least 1 month prior to study commencement
* Have a prescribed daily Phe allowance
* Written informed consent from patient, or from parent / carer if applicable

Exclusion Criteria:

* Pregnant or lactating
* Requiring enteral tube or parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry to this study
* Allergy to any of the study product ingredients
* Investigator concern around the patient being underweight (e.g.: BMI lower than 18.5kg/m2 for adults) and/or having an eating disorder
* Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements

Primary outcomes:
measure: Compliance
timeFrame: Daily for 31 days
Secondary outcomes:
measure: Acceptability: Tick-box questionnaire
timeFrame: Recorded at baseline and end of intervetnion (day 31)
measure: Blood phenylalanine and other amino acid levels
timeFrame: Recorded at baselien and end of intervention (day 31)
measure: Gastro-intestinal tolerance
timeFrame: recorded at baseline, beginning of intervention and end of intervention(12 out of 31 days in total)
measure: Nutrient intake
timeFrame: Recorded at basleine and end of intervention (day 31)
measure: Anthropometry
timeFrame: Recorded at baseline and end of intervention (day 31)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00738036: Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects
Official title: Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: Analgesics
Opioid
Opioid maintenance therapy
Acute pain
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 151
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 under opioid maintenance therapy

Brief summary: To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy.

The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or more.
* Patients under opioid maintenance therapy (buprenorphine or methadone)
* Patients treated by the same drug (buprenorphine or methadone) since at least 3 months

Exclusion Criteria:

* Refusal of the patient to take part in the study
* Absence of possible follow-up

Primary outcomes:
measure: Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
measure: pain, anxiety, drugs, alcohol and other substances abuse and dependence, drug prescription (included for pain treatment and opioid maintenance)
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Maryse Lapeyre-Mestre, MD
role: STUDY_DIRECTOR
References:
citation: Bounes V, Palmaro A, Lapeyre-Mestre M, Roussin A. Long-term consequences of acute pain for patients under methadone or buprenorphine maintenance treatment. Pain Physician. 2013 Nov-Dec;16(6):E739-47.
Clinical trial NCT02728336: MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)
Official title: MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Magnetic Resonance Imaging (MRI)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goals of this project are to: 1) explore the potential use of magnetic resonance imaging (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use the MRI-derived data together with a computer model of the cardiovascular system to study the relative roles of different factors in the mechanical effects of dyssynchrony in failure, and in the response (or lack thereof) to CRT.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ages 18 and over scheduled by conventional criteria (symptomatic impairment of cardiac function with broadened QRS) for clinical CRT procedures at NYULMC.
* Normal kidney function as determined by GFR levels.

Inclusion Criteria for Controls

* Normal kidney function as determined by GFR levels
* No significant cardiovascular disease or risk factors.

Exclusion Criteria:

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing (which will be removed)
* pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.

Primary outcomes:
measure: Derivation of score of patient suitability for CRT
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Leon Axel, MD
role: PRINCIPAL_INVESTIGATOR
References: