louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02127476: A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease
Official title: A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2014-04-30
Enrollment: 57
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.


Eligibility criteria: Inclusion Criteria:

* Patients with prodromal AD or mild to moderate AD
* Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
* Have a cognitive impairment
* Low Aβ and high Tau in Cerebrospinal fluid (CSF)
* Mini Mental State Examination (MMSE) score \> 16 at Screening

Exclusion Criteria:

* Previous active treatment with an AD immunotherapy in an investigational study
* Use of another investigational drug within 30 days of screening
* History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
* Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent, De Pintelaan 185
city: Turku
country: Finland
facility: Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
city: Amsterdam
country: Netherlands
facility: Department of Neurology and Alzheimer Center, VU University Medical Center
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen (UMCG), Alzheimer Research Centre
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
city: Belgrade
country: Serbia
facility: Military Medical Academy, Crnotravska 17,
city: Malmö
country: Sweden
facility: Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
city: Mölndal
country: Sweden
facility: Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
city: Stockholm
country: Sweden
facility: Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit
Study officials:
References:
Clinical trial NCT05070676: Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients
Official title: Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients: A Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobile Application
Cephalometric Analysis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 17
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A newly developed mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the accuracy of a newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis of dental and skeletal deformities among pre-adolescent patients.

Detailed description: A mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations ,The mobile application will provide quick cephalometric analysis and therefore, offers rapid and accurate case diagnosis, reduces errors in tracing, measurement, and identification of the landmark.

Reference test: Cephalometric analysis by the conventional method

-Trial design: Diagnostic accuracy study

Eligibility criteria: Inclusion Criteria:

1. Digital Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old.
2. Cephalogram of good quality with all landmarks clearly visible
3. Presence of central incisors and first molars on cephalogram
4. Cephalogram with teeth in maximum intercuspation

Exclusion Criteria:

-

Primary outcomes:
measure: The Accuracy of the newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06349876: Cholecystectomy in Patients With Silent Common Bile Duct Stones
Official title: Cholecystectomy in Patients With Silent Common Bile Duct Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits
Keywords: CBD stones ,
cholecystectomy
silent stones
Lead sponsor: Suez University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients presented by chronic calcular cholecystitis and during investigation they discovers that they have silent common bile duct stones

Brief summary: Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones


Eligibility criteria: Inclusion Criteria:

* Patients with asymptomatic common bile duct stones.
* Patients with normal bilirubin levels.
* Patients with normal alkaline phosphates level.

Exclusion Criteria:

* Patients with history of jaundice.
* Patients with abnormal liver functions.

Primary outcomes:
measure: number of patients developed jaundice post cholecystectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qeft Teatching Hospital
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine
city: Suez
country: Egypt
facility: Suez Faculty of Medicine
Study officials:
References:
Clinical trial NCT05168176: Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State
Official title: Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
* The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily

Exclusion Criteria:

* Subjects with allergic constitution.
* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.
* Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
* Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 31 days
measure: Area under the plasma concentration versus time curve (AUC0-t)
timeFrame: 31days
measure: Area under the plasma concentration versus time curve (AUC0-∞)
timeFrame: 31days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 31days
measure: Incidence of abnormal blood pressure
timeFrame: 31 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References:
Clinical trial NCT00684476: Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venom Allergy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic patients failed to provide protection from systemic reactions after sting challenges. These patients should continue their immunotherapy at 1-3 month intervals.

Detailed description: Background: The intervals at which maintenance venom immunotherapy (MVIT) is administered have been progressively extended over the years.

Objective: To examine whether the administration of bee venom (BV) maintenance dose (MD) at 6-month interval is safe and efficacious.

Methods: The usual 3-month interval at which venom allergic patients were receiving their MVIT was gradually extended to 6 months. Systemic reactions (SRs) to immunotherapy injections or to field stings were regularly recorded. BV allergic patients were deliberately sting-challenged after reaching the 6-month interval.

Eligibility criteria: Inclusion Criteria:

* Venom allergy

Exclusion Criteria:

* none

Primary outcomes:
measure: whether the administration of bee venom (BV)
measure: maintenance dose (MD) at 6-month interval is safe and
measure: efficacious.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, affiliated with The Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
name: Arnon Goldberg, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06414876: Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy
Official title: Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Animal Assisted Therapy
Keywords: Children
Hospital
Oxytocin
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There has been growing interest in animal-assisted therapy (AAT) in recent decades due to increasing reports indicating its health benefits for adult patients. These benefits are partly attributed to changes, usually increased levels of the neuropeptide oxytocin.

Aim: To investigate changes in oxytocin levels in hospitalized children during animal-assisted therapy sessions with a certified hospital dog.

Method: Urine samples were collected from 35 hospitalized children (3-17 years) before and after each participant had a session with the hospital dog. Oxytocin levels were analysed with an acetylcholinesterase (AChE) competitive enzyme-linked immunosorbent assay (ELISA). Creatinine levels were measured to determine the subject's fluid intake and then divided by the hormonal concentration (uOT pg/mg).


Eligibility criteria: Inclusion Criteria:

* Hospitalized children

Exclusion Criteria:

* Multiresistent bacteria
* Immunosuppressed
* Large burns

Primary outcomes:
measure: Change in oxytocin levels
timeFrame: Day of enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00224276: Prevalence of Diabetes Mellitus Among Patients Treated With Atypical and Conventional Antipsychotics
Official title: Prevalence and Incidence of Diabetes Mellitus Among Patients Treated With Atypical and Conventional Antipsychotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Diabetes Mellitus
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica N.V., Belgium
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus may differ across antipsychotioc medications in a community mental health center. The study further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.

Detailed description: Study of longitudinal incidence proved impractical within the limitations of the project.

Eligibility criteria: Inclusion Criteria:

* Patients treated with antipsychotic medication at a community mental health center

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662376: Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
Official title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition Regimen Prior to Surgery
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Eligibility criteria: Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* bile duct stones
* ileus
* conditions affecting gastric emptying
* severe, organ-specific disorders
* HIV
* inherited metabolic disorders
* known intolerance against or allergy to any component of the investigational feeds

Primary outcomes:
measure: Safety parameters reflecting pathophysiological functions of the liver
timeFrame: day -1, 0, 1, and 7
measure: Gastrointestinal tolerance
timeFrame: day 0 before and 6-8h after surgery
measure: Metabolic parameters in serum, liver and muscle tissue
timeFrame: on day -1, 0, 1, and 7
Secondary outcomes:
measure: Clinical parameters (infectious and non-infectious complications)
timeFrame: until day 7
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
Study officials:
affiliation: Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
name: Dileep N. Lobo, MS, DM, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Awad S, Stephens F, Shannon C, Lobo DN. Perioperative perturbations in carnitine metabolism are attenuated by preoperative carbohydrate treatment: Another mechanism by which preoperative feeding may attenuate development of postoperative insulin resistance. Clin Nutr. 2012 Oct;31(5):717-20. doi: 10.1016/j.clnu.2012.02.015. Epub 2012 Mar 22.
citation: Awad S, Constantin-Teodosiu D, Constantin D, Rowlands BJ, Fearon KC, Macdonald IA, Lobo DN. Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Ann Surg. 2010 Aug;252(2):247-53. doi: 10.1097/SLA.0b013e3181e8fbe6.
Clinical trial NCT00329576: Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
Official title: Evaluate the Anti-HBs Antibody Persistence, in Subjects Who Received GSK Biologicals' Preservative-free or Thiomersal-free Engerix™-B or Engerix™-B Containing Thiomersal, Approximately 5 to 6 Yrs Earlier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

Detailed description: All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.

Eligibility criteria: Inclusion Criteria:

* Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
* Written informed consent obtained from the subject for the long-term follow-up.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Basel
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van Damme P, von Sonnenburg F, Hatz C, Hoet B, Lefevre I, Leyssen M. Long-term immunogenicity of preservative-free hepatitis B vaccine formulations in adults. J Med Virol. 2009 Oct;81(10):1710-5. doi: 10.1002/jmv.21568.
Clinical trial NCT04412876: Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study
Official title: Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Detailed description: To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Eligibility criteria: Inclusion Criteria:

- Stress urinary incontinence

Exclusion Criteria:

1. Take monoamine oxidase
2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
3. Allergy to duloxetine or imipramine
4. Uncontrolled angular glaucoma patients
5. Pregnant women

Primary outcomes:
measure: the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
timeFrame: 8 weeks
Secondary outcomes:
measure: the score of Urgency Severity Scale
timeFrame: 8 weeks
Other outcomes:
measure: the score of Overactive Bladder Symptom Score
timeFrame: 8 weeks
measure: the score of King's health questionnaires
timeFrame: 8 weeks
measure: the score of Brief symptom rating scale
timeFrame: 8 weeks
measure: the score of Female sexual function index
timeFrame: 8 weeks
measure: Blood flow index of the bladder
timeFrame: 8 weeks
measure: Bladder wall thickness
timeFrame: 8 weeks
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References: