louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05669742: Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
Official title: Evaluating the Safety and Efficacy of Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients.A Double-Blind, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Olanzapine is a thieno-benzodiazepine derivate that is effective managing the symptoms of schizophrenia and reducing the psychopathological symptoms of psychosis. It is also effective in controlling the acute manic episodes associated with bipolar disorder, and have provided some therapeutic advantages over other antipsychotic agents (Citrome et al., 2019).

However, Ola administration has been reported to induce profound BWG accompanied with higher incidence of metabolic deficits, such as hypertension, diabetes and hyperlipidemia, as compared to other antipsychotic agents (Mauri et al., 2014).

Adjunctive treatment with other agents that can minimize or normalize Ola-induced BWG can enhance the safety and tolerability profiles of an effective antipsychotic, thus highlighting the need to develop improved therapies or interventions to minimize these side effects. A meta-analysis of 12 published studies found that antidiabetic drugs such as metformin improved metabolic parameters in patients treated with antipsychotics (de Silva et al., 2016).

These studies encouraged the evaluation of other antidiabetic agents as adjunctive therapies to minimize Ola-induced BWG. Empagliflozin (EMPA)is the third-generation anti-diabetic drug acting as sodium-glucose transport protein two inhibitor (SGLT2), which provides a new mechanism of action to improve glycemic control with modest decreases in systolic blood pressure and body weight (Pradhan et al., 2019). The effects of EMPA on Ola-induced BWG have not been determined and require further investigation.


Eligibility criteria: Inclusion Criteria:

Schizophrenia Patients treated with Olanzapine with ages ranging from 18 to 60 years.

Exclusion Criteria:

patients who had any other inflammatory disease (cardiovascular, asthma, bone

Primary outcomes:
measure: Change in body weight and body mass index (BMI)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Adverse events (AE) as measures of safety and tolerability of Empagliflozin
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06388642: Pharmacokinetics of Afamelanotide in EPP Patients
Official title: A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Erythropoietic Protoporphyria
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.


Eligibility criteria: Inclusion Criteria:

* EPP patients aged between 12 and 70 years
* BMI between 15 and 30 kg/m2
* \>50 kg

Exclusion Criteria:

* Any personal or direct family history of melanoma
* Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used
* Any significant illness during the four weeks before the study screening period
* Any evidence of hepatic or renal impairment

Primary outcomes:
measure: Cmax (maximum Plasma Concentration)
timeFrame: Baseline to Day 7
measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t)
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: AUC(0-∞) (area under the curve extrapolated to infinite time)
timeFrame: Baseline to Day 7
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: CLINUVEL Site
city: Rotterdam
country: Netherlands
facility: CLINUVEL Site
Study officials:
References:
Clinical trial NCT05455242: Habit Formation for Diabetes Self-Management
Official title: The Effectiveness of an Occupation-Based Habit Formation Intervention in Promoting Healthy Behaviors Among Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Keywords: Habit Formation
Occupational Therapy
Self-Management
Diabetes Type 2
Lead sponsor: Des Moines University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine the feasibility of interventions which focus on building habits as a method of improving diabetes self-management behaviors for individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* 19 years old
* read and write in the English language
* have technology capability for virtual or telephone sessions
* are reachable by phone or text messaging
* have a diagnosis of T2DM
* were willing and able to participate in all study-related activities, and
* were not currently involved in other diabetes-related education and behavioral interventions.

Exclusion Criteria:

* younger than 19 years old
* unable to read and write in the English language
* did not have technology capability for virtual or telephone sessions
* were not reachable by phone or text messaging
* were unwilling or unable to participate in all study-related activities, and/or
* were currently receiving or involved in other diabetes-related education and behavioral interventions.

Primary outcomes:
measure: Change in Diabetes Self-Care
timeFrame: 13 weeks
measure: Change in Behavior Automaticity
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
References:
Clinical trial NCT00311142: Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section
Official title: Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Sleep pattern
newborn
actigraphy
delivery mode
Parents' approval
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-04-05
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected and measured with actigraphy, using a wrist-watch like device that continuously measures and records the subject's movements.The present study aims to compare vacuum delivery with regular, elective and not elective caesarean sections. We hypothesize that the sleep of vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.


Eligibility criteria: Inclusion Criteria:

* Healthy newborn, born either by regular delivery, vacuum extraction or cesarean section

Exclusion Criteria:

* Preterms, newborns that need special medical treatment and/or repeated blood sampling as glucose.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ayala Maayan-Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korte J, Hoehn T, Siegmund R. Actigraphic recordings of activity-rest rhythms of neonates born by different delivery modes. Chronobiol Int. 2004 Jan;21(1):95-106. doi: 10.1081/cbi-120027980.
Clinical trial NCT06636942: Effects of Intermittent Pneumatic Compression Following an Officiall Soccer Match
Official title: Effects of Intermittent Pneumatic Compression Following an Officiall Soccer Match on Elite Youth Soccer Players
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intermittent Pneumatic Compression
Placebo - Control
Keywords: sports
recovery
athletic performance
soccer
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to identify the effects of the use of intermittent pneumatic compression on the recovery kinetics following an official soccer match, in comparision with a placebo condition. Participants will perform neuromuscular tests (ie, cmj, broad jump) and respond to perception scales (RPE, hooper index). These assessments will be carried out before the match, 30 minutes post match, at the 24th and 48th hour.


Eligibility criteria: Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* absent from injuries
* playing less than 70 minutes

Primary outcomes:
measure: Countermovement jump height
timeFrame: 30 minute, 24 hour, 48 hour
measure: low-frequency fatigue
timeFrame: baseline, 30 minute, 24 hour, and 48 hour
measure: creatine-quinase
timeFrame: baseline, 24 hour, and 48 hour
measure: Hooper index
timeFrame: baseline, 30 minute, 24 hour, and 48 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00114842: Magnetic Resonance (MR) Colonography With Fecal Tagging
Official title: MR Colonography With Fecal Tagging: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Polyps
Keywords: colorectal polyps
colorectal cancer
Virtual colonoscopy
Fecal tagging
MR colonography
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2005-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses "invisible" on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.


Eligibility criteria: Inclusion Criteria:

* Suspicion of colorectal polyps or cancer
* Referred for colonoscopy

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Sensitivity/specificity for water versus air for distension of colon in MR colonography
Secondary outcomes:
measure: Feasibility of MR colonography with fecal tagging
measure: Sensitivity/specificity of MR colonography versus colonoscopy
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Radiology Copenhagen University Hospital Herlev
Study officials:
affiliation: Department of Radiology Copenhagen University Hospital Herlev
name: Michael P Achiam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297842: Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
Official title: An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Safety
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.

Detailed description: Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients aged \>18 years with documented ESBL +ve GNB infection
* Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy

Exclusion Criteria:

* Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
* Have active P. aeruginosa co-infection
* Pregnancy or breast feeding
* Allergy to carbapenems

Primary outcomes:
measure: Number of subjects with cure or improvement
timeFrame: 14 days
Secondary outcomes:
measure: Number of subjects with eradication of the causative bacteria
timeFrame: 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rattanaumpawan P, Werarak P, Jitmuang A, Kiratisin P, Thamlikitkul V. Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial. BMC Infect Dis. 2017 Mar 1;17(1):183. doi: 10.1186/s12879-017-2284-1.
Clinical trial NCT05651542: A Comprehensive Self-Management Intervention for Individuals with Inflammatory Bowel Disease
Official title: A Comprehensive Self-Management Intervention for Individuals with Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Keywords: IBD
UC
CD
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-12-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.


Eligibility criteria: Inclusion Criteria:

* Healthcare provider diagnosis of inflammatory bowel disease
* Report current symptoms
* Able to read and write in English

Exclusion Criteria:

* Live outside of Washington state
* Bowel-related surgery within the past month

Primary outcomes:
measure: Recruitment feasibility
timeFrame: From screening to enrollment
measure: Intervention feasibility
timeFrame: 3 months
measure: Acceptability
timeFrame: 6 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 3 months, 6 months
measure: Change in Symptoms
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Self-Efficacy for Managing Chronic Disease
timeFrame: Baseline, 3 months, 6 months
measure: Index of Self-Regulation
timeFrame: Baseline, 3 months, 6 months
measure: Patient Activation Measure
timeFrame: Baseline, 3 months, 6 months
measure: Fecal Calprotectin
timeFrame: Baseline, 3 months
measure: Gut Microbiome
timeFrame: Baseline, 3 months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kendra Kamp, PHD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426342: Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression
Official title: Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression and Suicide Ideation
Keywords: depression
Employee
Preventive Health Program
Digital Health
Suicide
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees.


Eligibility criteria: Inclusion Criteria:

* Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004

Exclusion Criteria:

* 1) being unemployed or having less than 1 year job experience,
* 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects.

Primary outcomes:
measure: Recruitment
timeFrame: baseline
measure: The retention rate
timeFrame: Baseline, at 5 weeks after intervention.
measure: Acceptability
timeFrame: at 5 weeks after intervention.
Secondary outcomes:
measure: Depression scale
timeFrame: Baseline, at 5 weeks after intervention.
measure: Positive and Negative Affect Schedule
timeFrame: Baseline, at 5 weeks after intervention.
measure: Satisfaction with Life Scale
timeFrame: Baseline, at 5 weeks after intervention.
measure: Sleep Quality scale
timeFrame: Baseline, at 5 weeks after intervention.
measure: Burnout assessment tool
timeFrame: Baseline, at 5 weeks after intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Ewha Womans Univeristy
name: Suk-Sun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174042: The Effect of Tang Ning Tongluo Formula in Type 2 Diabetics Clinical Analysis
Official title: The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: General Disorders and Administration Site Conditions
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 120
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: The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule.

Detailed description: The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.

Eligibility criteria: Inclusion criteria:

1. diagnosis of type 2 diabetes for more than one year.
2. the sustained follow-up time \>3 month.
3. TNTL single or combined treatment time \>3 month.
4. Chinese ethnicity.

Exclusion criteria:

1. the medical record information is not original and available.
2. lactating or pregnant.
3. diagnosis of heart failure, acute myocardial infarction, stroke, or serious injuries.
4. any other conditions not suitable for trial as evaluated by the physician in charge.

Primary outcomes:
measure: The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline
timeFrame: At least 3 months
Secondary outcomes:
measure: The Number of Participants with Adverse Events Using Tangning Tongluo Capsule
timeFrame: At least 3 months
Other outcomes:
measure: Number of adverse events in recruited patients.
timeFrame: At least 3 months
Locations:
city: Beijing Shi
country: China
facility: Nanmeng Tianyuan hospital; Dongfang Hospital; China-Japanese Friendship Hospital
state: Guizhou
Study officials:
affiliation: ICMJE
name: Wenshu Teng, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00576342: Patient Preference Study
Official title: A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent;
* Diagnosis of glaucoma or ocular hypertension;
* On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
* IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
* Pregnant, nursing, or not using highly effective birth control methods;
* Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
* History of bronchial asthma or severe chronic obstructive pulmonary disease;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of patients with a stated preference for either study medication
timeFrame: Day 2
Secondary outcomes:
measure: Mean ocular discomfort score
timeFrame: Day 1, 1 minute after drop instillation
Other outcomes:
Locations:
Study officials:
References: