louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00711269: Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Official title: Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.


Eligibility criteria: Main Inclusion Criteria:

* Patient meets DSM-IV criteria for schizophrenia.
* Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
* Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.

Main Exclusion Criteria:

* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.

Primary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)
timeFrame: Baseline and Week 6 [Last Observation Carried Forward (LOCF)]
Secondary outcomes:
measure: Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)
timeFrame: Baseline and Week 6 (LOCF)
measure: Change From Baseline in the PANSS Negative Subscales at Week 6
timeFrame: Baseline and Week 6 (LOCF)
measure: Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)
timeFrame: Baseline and Week 6 (LOCF)
measure: Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline to up to 8 weeks
measure: Proportion of Participants With TEAEs Leading to Discontinuation
timeFrame: From Baseline to up to 8 weeks
measure: Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: From Baseline to up to 8 weeks
Other outcomes:
Locations:
city: Tokyo, Etc.
country: Japan
facility: Japan: 67 sites
city: Seoul, Etc.
country: Korea, Republic of
facility: Korea: 14 sites
city: Taipei, Etc.
country: Taiwan
facility: Taiwan: 11 sites
Study officials:
affiliation: Sumitomo Pharma Co., Ltd.
name: Drug Development Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT01704469: A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Keywords: Opioid induced hyperalgesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but conflicting. Previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.


Eligibility criteria: Inclusion Criteria:

* age 20-80
* cancer patient
* patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen.

Exclusion Criteria:

* patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure
* an inability to understand English or adequately respond to the relevant questions

Primary outcomes:
measure: Post-injection pain intensity
timeFrame: 1 min after lidocaine anesthetic injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06509269: Intraoral Scanning v.s Desktop Scanning
Official title: Effect Of Intraoral Scanning Versus Desktop Scanning on The Retention Of Maxillary Denture Bases In Completely Edentulous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Keywords: Intraoral Scanning
CAD/CAM denture
Desktop Scanning
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.

Detailed description: The use of intra oral scanners (IOS) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. The stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. The main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.

Eligibility criteria: Inclusion Criteria:

* Patients with well-developed ridge
* Firm healthy mucosa
* Free from any signs of inflammation

Exclusion Criteria:

* Patients having flabby ridge
* Decreased flow of saliva
* Limited mouth opening

Primary outcomes:
measure: Retention of denture base
timeFrame: "through study completion, an average of 1 year"
measure: Adaptation of denture base
timeFrame: "through study completion, an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
state: Shorook
Study officials:
affiliation: British University In Egypt
name: Ramy K Elashmawy, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osman RB, Alharbi NM. Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: An in vitro study. J Prosthodont. 2023 Dec;32(9):821-828. doi: 10.1111/jopr.13633. Epub 2023 Jan 11.
citation: Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.
citation: Manicone PF, De Angelis P, Rella E, Damis G, D'addona A. Patient preference and clinical working time between digital scanning and conventional impression making for implant-supported prostheses: A systematic review and meta-analysis. J Prosthet Dent. 2022 Oct;128(4):589-596. doi: 10.1016/j.prosdent.2020.11.042. Epub 2021 Mar 5.
Clinical trial NCT06242769: Clinical Research Study to Evaluate the Stain Removal Efficacy
Official title: Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth Stain Removal
Keywords: Composite Lobene
extrinsic stain
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Good general health
* Male and female subjects, aged 21-70, inclusive
* Present 12 scoreable natural anterior teeth
* A minimum mean Composite Lobene Index score of 1 or greater
* Available for the duration of the study
* Clinical evidence of a tendency to form extrinsic stain on anterior teeth

Exclusion Criteria:

* Presence of orthodontic bands
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
* Five or more carious lesions requiring immediate restorative treatment
* Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study
* Participation in any other clinical study or test panel within the one month prior to entry into the study
* Self-reported pregnancy and/or women who are breast feeding
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
* On any prescription medicines that might interfere with the study outcome
* History of alcohol and/or drug abuse
* Exposed to a tooth whitening procedure during the last 3 months

Primary outcomes:
measure: Composite Lobene Stain Index
timeFrame: measurement at baseline, 3 week & 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Dental Research Associates, Inc.
Study officials:
affiliation: Dental Research Associates, Inc
name: Augusto R Elias-Boneta, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04945369: Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
Official title: Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Children
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 114
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.

It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.

It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.

Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.

Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.


Eligibility criteria: Inclusion Criteria:

* Children hospitalised at the Nantes University Hospital in the neonatal period
* With a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol
* Born prematurely (under 35 weeks of amenorrhea)
* Included in the Lift cohort with follow-up up to 7 years
* Aged between 8 and 14 years at inclusion

Exclusion Criteria:

* Children with an isolated metabolic disease: insulin-dependent diabetes; endocrine disease (Cushing's, hypothyroidism)
* Age of 15 years or more
* with a chromosomal anomaly
* with contraindicating measurement of the BOP-POD: ventilatory support, continuous parenteral feeding, elimination stoma
* Refusal of either parent or child

Primary outcomes:
measure: Insulin resistance as measured by the Triglyceride-Glucose Index
timeFrame: 1 day
Secondary outcomes:
measure: Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index
timeFrame: 1 day
measure: Body composition (percentage of fat versus fat free mass) by BOP-POD and by impedancemetry (biodyXpert) for assessment of body composition variations between peripubertal period and neonatal period
timeFrame: 1 day
measure: creatinine clearance
timeFrame: 1 day
measure: Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire
timeFrame: 1 day
measure: Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"
timeFrame: 1 day
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT05090969: Study of Febrile Syndromes After Tick Bite
Official title: Study of Febrile Syndromes After Tick Bite
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Syndrome
Keywords: Febrile syndrome
Tick bite
Anaplasma phagocytophilum
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 940
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020

Brief summary: Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica...), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020

Exclusion criteria:

* Subject having expressed his opposition to his medical data and biological resources not being reused for scientific research.
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective search for the presence of an emerging pathogen in the cohort of patients with febrile syndrome after tick bite
timeFrame: Files analysed retrospectively from January 01, 2009 to August 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg
name: Benoit JAULHAC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg
name: Pierre BOYER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06905769: Effects of Aquatic Therapy Versus Neuro-dynamic Technique for the Treatment of Carpal Tunnel Syndrome Patient
Official title: Effects of Aquatic Therapy Versus Neuro-dynamic Technique for the Treatment of Carpal Tunnel Syndrome Patient: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Carpal Tunnel Syndrome (CTS) is a common neurological disorder due to entrapment of median nerve which runs from the forearm into the hand through a tunnel, compressed or pinched due to anatomical factors, such as a narrow carpal tunnel. Widespread condition that affects 3-6% of the general population worldwide. Carpal Tunnel Syndrome (CTS) a prevalent and debilitating condition leading to disability despite optimal interventions to rehabilitation that aimed to reducing pain and improving neural function status in Carpal Tunnel Syndrome Patients .

Detailed description: This study investigates the additional benefits of Aquatic Therapy and Neuro-dynamic Technique in Carpal Tunnel Syndrome Patients .The researcher employs a randomized controlled trial methodology. Participants are divided into two groups: one receiving Aquatic Therapy, and the other receiving Neuro-dynamic Technique.

Outcomes are assessed over an 8-week period, focusing on pain levels and neural function restoration and grip strength. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, intervention to alleviate symptoms and improve the quality of life, neural restoration for those suffering Carpal Tunnel Syndrome (CTS).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with mild-to-moderate carpal tunnel syndrome by Neuromuscular Physician
* Participants who presented with unilateral CTS with symptoms reported up to 3 months
* Male and female
* Aged 18 years or older

Exclusion Criteria:

* Patients with non-specified stage of CTS,median nerve entrapment in TOS, Cervical Radiculpathy
* Participants presents with co-morbidities,Hx of CTS (e.g., pregnancy, diabetes, trauma, congenital disorders, obesity, post-surgical release, and hypothyroidism)
* Cardiovascular disease, thenar muscle atropy"

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE (NPRS)
timeFrame: 12 Months
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: 12 Months
measure: Grip Strength
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University CRC
state: Punjab
Study officials:
References:
Clinical trial NCT06749769: Simulation-Based Learning Experience in Strengthening Stoma Care Education
Official title: Investigation of the Effectiveness of Simulation-Based Learning Experience in Strengthening Stoma Care Education on Patients with Stoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stoma
Keywords: stoma care
patient education
simulation
patient&#39;s learning experience
Strengthening patients
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.

The main hypothesis it aims to test are:

H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.

H2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.

H3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.

Researchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.

Participants will be asked to;

* Answer the questions (demographic data form and anxiety scale)
* Receive education regarding stoma care (verbal and demonstration)
* Practice stoma care on their own


Eligibility criteria: Inclusion criteria

1. Age 18 and above
2. First time having a stoma and having an intestinal stoma,
3. Communicable, open to cooperation,
4. Able to speak and understand Turkish,
5. Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.

Exclusion Criteria

1. Patients who develop surgical complications in their stoma.
2. Patients who are unable to perform stoma care due to any complication
3. Having previously received stoma care training or participated in its implementation for any reason

Primary outcomes:
measure: Stoma Care Skills Rubric
timeFrame: Post-operative 3rd day
measure: Generalized Perceived Self-Efficacy Scale
timeFrame: at the time of enrollement, and Post-operative 3rd day
Secondary outcomes:
measure: State Anxiety Level
timeFrame: at the time of enrollement, and post-operative 3rd day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospital
state: Other
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hospital
state: Other
Study officials:
References:
Clinical trial NCT01955369: Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
Official title: Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: incidence
phenotype
mortality
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)

Brief summary: There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants.


Eligibility criteria: Inclusion Criteria:

* diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria
* minimum of 18 years
* minimum of 6 months of residency in Rhinelnad-Palatinate

Exclusion Criteria:

* patients below 18 years
* ALS patients outside Rhineland-Palatinate

Primary outcomes:
measure: Death
timeFrame: an average of 3 years
Secondary outcomes:
measure: Tracheostomy
timeFrame: an average of 3 years
Other outcomes:
measure: Gastrostomy
timeFrame: an average of 3 years
Locations:
city: Ludwigshafen
country: Germany
facility: Dept. of Neurology, Klinikum Ludwigshafen
Study officials:
affiliation: Dept. Neurology, Klinikum Ludwigshafen
name: Joachim Wolf, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors Predicting Survival in ALS Patients--Data from a Population-Based Registry in Rhineland-Palatinate, Germany. Neuroepidemiology. 2015;44(3):149-55. doi: 10.1159/000381625. Epub 2015 Apr 21.
citation: Wolf J, Wohrle JC, Palm F, Nix WA, Maschke M, Safer A, Becher H, Grau AJ. Incidence of amyotrophic lateral sclerosis in Rhineland-Palatinate, Germany. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):269-74. doi: 10.3109/21678421.2014.887733. Epub 2014 Feb 26.
citation: Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Variability and prognostic relevance of different phenotypes in amyotrophic lateral sclerosis - data from a population-based registry. J Neurol Sci. 2014 Oct 15;345(1-2):164-7. doi: 10.1016/j.jns.2014.07.033. Epub 2014 Jul 19.
citation: Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors predicting one-year mortality in amyotrophic lateral sclerosis patients--data from a population-based registry. BMC Neurol. 2014 Oct 4;14:197. doi: 10.1186/s12883-014-0197-9.