louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05248906: Giant Cell Arteritis - Optimization of Diagnostics
Official title: Giant Cell Arteritis - Examination of the Optimal Diagnostic Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Keywords: Temporal artery biopsy,
Giant cell arteritis
Ultrasound
18F-FDG PET/CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical suspicion of giant cell arteritis

Brief summary: Giant cell arteritis - Optimization of diagnostics

Detailed description: A prospective study. Investigating the use of ultrasound, temporal artery biopsy, biomarkers and 18F-fluorodeoxyglucose positron emission tomography-computed tomography for establishing a diagnosis of giant cell (temporal) arteritis.

Eligibility criteria: Inclusion Criteria:

Clinical suspicion of giant cell arteritis

Meets the American College of Rheumatology Criteria:

Age at disease onset =\> 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate \>=50 mm/hour Abnomal artery biopsy

Exclusion Criteria:

Active cancer Use of steroid for more than a week (the prior 6 months)

Primary outcomes:
measure: Giant cell arteritis
timeFrame: Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steffen Hamann, MD, PhD,FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956406: Motivational Interviewing for Adult Kidney Transplant Recipients
Official title: The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motivational Interviewing
Adult
Kidney Transplantation
Self-Management
Treatment Adherence
Medication Adherence
Patient Outcome Assessment
Keywords: Motivational Interviewing
Recipient
Kidney Transplantation
Self-Management
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study aimed to determine the effect of motivational interviewing on self-management of treatment regimen, medication adherence, and patient outcomes in adult kidney transplant recipients between 3 months and 6 months after kidney transplant in the transplant outpatient clinic.

Design: The research is a single-centered, single-blind, parallel and 1:1 randomized active comparative experimental study.

Method: A total of 80 individuals, of the 40 in the control group and 40 in the intervention group, will be included in the study. Motivational interview sessions for the intervention group will be held 3 times between 15-30 minutes with an interval of 10 days. The control group will be given routine care (approximately 1 hour of face-to-face standard training) by the nurse educator. Within the research pattern, intervention and control groups will be applied pre-test at the first interview and post test after one month. In addition, follow-up test will be performed 3th month. The data will be obtained using the Self-Management Scale in Kidney Transplant Recipients, Visual Analog Scale (VAS) for self-care and VAS for medication adherence. In the study, Standard Protocol Items: Recommendations for Interventional Trials- SPIRIT(2013) and CONSORT 2010 (Consolidated Standards of Reporting Trials) were used.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study,
* aged ≥18 years old
* 3-6 months after kidney transplant
* Speaking, reading and writing in Turkish
* Having a mobile phone

Exclusion Criteria:

* Request to leave work

Removing Criteria:

* Development of rejection

Primary outcomes:
measure: Self-management scale
timeFrame: Change from Baseline Self Management at 3 months
measure: VAS for medication adherence
timeFrame: Change from Baseline VAS for Medication Adherence at 3 months
measure: VAS for self care
timeFrame: Change from Baseline VAS for self care at 3 months
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: Change from Baseline GFR at 3 months
measure: Serum Creatinine
timeFrame: Change from Baseline Serum Creatinine at 3 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References:
Clinical trial NCT05382806: Reversal of Remimazolam by a Single Dose of Flumazenil
Official title: Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flumazenil Adverse Reaction
Ambulatory Surgery
Postoperative Nausea
Remimazolam
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 224
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
Primary purpose: TREATMENT

Brief summary: Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.

Detailed description: As ambulatory surgery has been increased last two decades, 'Enhanced Recovery After Surgery (ERAS)' also has become an important issue in clinical fields.

It is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.

Even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.

Common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.

In this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.

Eligibility criteria: Inclusion Criteria:

* participants aged over 20 years scheduled for ambulatory gynecologic surgery.

Exclusion Criteria:

* allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
* arrhythmia, myocardial infarction, coronary artery disease
* obstructive sleep apnea
* severe or acute respiratory distress
* tricyclic anti-depressant
* lactose intolerance
* BMI over 30kg/m2
* ASA classification 4 or 5

Primary outcomes:
measure: the incidence of postoperative nausea and vomiting (PONV)
timeFrame: up to 24 hours after participants discharge from day surgery center.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-T'ǔkpyǒlshi
Study officials:
affiliation: Konkuk University Medical Centre
name: Seong-Hyop Kim, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06741306: Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX-2
Official title: Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX-2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ChemSex Users for YMSM
Keywords: ChemSex Users
Lead sponsor: Institute of HIV Research and Innovation Foundation, Thailand
Sponsor class: OTHER
Collaborators: name: The US NIH through the International Epidemiology Databases to Evaluate AIDS (IeDEA) IeDEA Asia-Pacific
name: amfAR, The Foundation for AIDS Research
First posted: 2024-12-18
Enrollment: 150
Sex: MALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current chemsex users

Brief summary: CLYMAX is a two-phase observational study that assess multiple aspects of chemsex and young men who have sex with men (YMSM).

Phase I of the study (CLYMAX,IRB No. 0695/65) was a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) assessing multiple aspects of chemsex, including the patterns of chemsex use and the perspectives on factors influencing chemsex initiation/discontinuation, effects on physical health, mental health and social outcomes, and the necessary services for a comprehensive chemsex clinic among YMSM; and the acceptability and feasibility of developing a comprehensive chemsex clinic from the perspective of YMSM, their family members or peers, and clinic staff.

This phase II study (CLYMAX-2) will be a prospective cohort study using a quantitative data collection exploring the effectiveness of the implementation strategy of harm reduction models and consist of a larger number of YMSM, important baseline and follow-up information on multiple aspects of physical, psychological, and social harms.


Eligibility criteria: Inclusion Criteria:

1. Men who have sex with men
2. Aged 16-35 years
3. Current chemsex users (defined as last chemsex used within 3 months)
4. Able to read and communicate in Thai
5. Provide informed consent

Exclusion Criteria:

None

Primary outcomes:
measure: The study outcomes of phase II can be broadly categorized into implementation outcomes include the prevalence and incidence of physical, psychological, and social harms which will be evaluated by laboratory or self-reported assessments as follows:
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rainbow Sky Association of Thailand (RSAT)
state: Bangkapi
city: Bangkok
country: Thailand
facility: Foundation for Action on Inclusion Rights (FAIR)
state: Minburi
Study officials:
affiliation: Institute of HIV Research and Inovation
name: Siriporn Nonenoy, BNH,MPH
role: STUDY_CHAIR
References:
Clinical trial NCT06223906: A Registry Study of Biomarkers in Heart Valve Disease
Official title: A Registry Study of Biomarkers in Heart Valve Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart valve disease accorrding to Inclusion and exclusion criteria.

Brief summary: Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches


Eligibility criteria: Inclusion Criteria:

* Patients clinically diagnosed with heart valve disease in Beijing Anzhen Hospital

Exclusion Criteria:

* Age \< 18 years
* Failure to obtain medical records and ultrasound data
* Refuse follow-up

Primary outcomes:
measure: All-cause death
timeFrame: These data is collected during follow-up visit at 12 months after discharge
Secondary outcomes:
measure: HF rehospitalization
timeFrame: These data is collected during follow-up visit at 12 months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
name: Jie Du, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01333306: Enhancing Cognitive Training Using tDCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognition
Keywords: tDCS
cognitive training
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2011-04-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: BASIC_SCIENCE

Brief summary: Cognitive rehabilitation involves enhancing an individual's capacity to process information to improve their everyday functioning. One common form of intervention is computerised cognitive training (CT); however, efficacy results have been mixed. This research aims to investigate a novel method for enhancing outcomes from CT through combining CT with transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain stimulation. In this study we aim to determine the efficacy of this approach through comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in healthy participants. We hypothesise that tDCS combined with CT will have greater generalisability effects than the other conditions.


Eligibility criteria: Inclusion Criteria:

* Participants will be healthy right-handed subjects aged 18 to 40

Exclusion Criteria:

* Concurrent medication likely to affect mental performance
* History of drug or alcohol abuse or dependence current or in the last 3 months
* Any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute Building
state: New South Wales
Study officials:
References:
Clinical trial NCT02079506: Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin
Official title: An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers af aged between 20 years to 45 years
* Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
* Eligible subjects with acceptable medical history and physical examination

Exclusion Criteria:

- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Primary outcomes:
measure: AUCτ,ss of candesartan
timeFrame: 22 points
measure: Cmax,ss of candesartan
timeFrame: 22 points
measure: AUCτ,ss of rosuvastatin
timeFrame: 28 points
measure: Cmax,ss of rosuvastatin
timeFrame: 28 points
Secondary outcomes:
measure: tmax,ss of candesartan
timeFrame: 22 points
measure: CLss/F of candesartan
timeFrame: 22 points
measure: Cmin,ss of candesartan
timeFrame: 22 points
measure: tmax,ss of rosuvastatin
timeFrame: 28 points
measure: CLss/F of rosuvastatin
timeFrame: 28 points
measure: Cmin,ss of rosuvastatin
timeFrame: 28 points
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Daejeon
Study officials:
affiliation: Chungnam National University Hospital
name: JangHee Hong, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06994806: A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor Malignancies
Lead sponsor: Kumquat Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:

* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?

Participants will:

* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of solid tumor malignancy.
* Unresectable or metastatic disease that has progressed on immunotherapy.
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active primary central nervous system tumors
* Cardiac abnormalities
* History of lung diseases
* Any condition that may impair drug absorption or prevent oral dosing
* Known history of immune-mediated colitis and uncontrolled autoimmune diseases

Primary outcomes:
measure: Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
timeFrame: up to 36 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 36 months
measure: Duration of response (DOR)
timeFrame: up to 36 months
measure: Time to response (TTR)
timeFrame: up to 36 months
measure: Disease control rate (DCR)
timeFrame: up to 36 months
measure: Progression-free survival (PFS)
timeFrame: up to 36 months
measure: Overall survival (OS)
timeFrame: up to 36 months
measure: Concentration-time curve (AUC)
timeFrame: up to 36 months
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 36 months
measure: Time to maximum plasma concentration (tmax)
timeFrame: up to 36 months
measure: Pharmacologically Active Dose (PAD)
timeFrame: up to 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04596306: Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.
Official title: Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: More Complex But Equally Safe and Effective. A Retrospective Study on 879 Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic cholecystectomy for acute calculous cholecystitis

Brief summary: With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.


Eligibility criteria: Inclusion Criteria:

* acute calculous cholecystitis

Exclusion Criteria:

* tumors of the biliary tract

Primary outcomes:
measure: In-hospital morbidity
timeFrame: 30 day
measure: In-hospital mortality
timeFrame: 30 day
Secondary outcomes:
measure: conversion to open rate
timeFrame: 30-day
measure: length of stay
timeFrame: 30-day
measure: major complication rate
timeFrame: 30-day
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOUPisana
state: Tuscany
Study officials:
References: