louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04777266: Music Therapy for People With Schizophrenia and Relates Psychosis.
Official title: The Music Therapy for People With Schizophrenia and Relates Psychosis: Effects on Symptoms, Self-esteem, Self-stigma, Social Cognition, Social Functioning and Quality of Live. Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia; Psychosis
Keywords: Music Therapy
Psychosis
Adjunct Therapy
Psychosocial Rehabilitation
Recovery
Lead sponsor: State reference center for psychosocial care
Sponsor class: OTHER_GOV
Collaborators: name: University of Valencia
First posted: 2021-03-02
Enrollment: 60
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: Treatment of symptoms, rehabilitation of cognitive deficits, improvement of social functioning and quality of life in schizophrenia and other psychoses are approached through a comprehensive strategy that combines psychopharmacology with psychosocial interventions. However, despite the efficacy of these interventions, this is not the same in all patients, and a large percentage do not achieve functional recovery.

Detailed description: The aim of this research is to carry out a randomized trial on the effects of a music therapy (MT) program, implemented in addition to the usual pharmacological and psychosocial rehabilitation (TAU), on symptoms, self-esteem, internalized stigma, social cognition, social functioning and the quality of life in these patients.

Eligibility criteria: Inclusion Criteria:

* The patients will be diagnosed with schizophrenia or schizoaffective disorder in accordance with DSM-IV-TR criteria using the Structured Clinical Interview for DSM-IV-TR (SCID-I).
* The patients will all clinically stable with a diagnosis of schizophrenia and regularly attended in the state approved centre for psychosocial attention CREAP (Centro de Referencia Estatal para la Atención Psicosocial) in Valencia (Spain).

Exclusion Criteria:

* Previous brain damage
* Substance abuse in the last year
* Display of mood disorders
* Organic or substance based mental disorders
* Disrupted symptomatology
* Serious symptoms with difficulty in understanding the implications of informed consent and not replying in the interviews and assessment questionnaires

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 10 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 10 weeks
measure: World Health Organization Quality of Life-Short version (WHOQOL-BREF)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Sergio Lacamara Cano
Study officials:
References:
Clinical trial NCT05714566: Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
Official title: Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Clostridium Difficile Infections
Microtia
Keywords: Inflammatory bowel disease
Clostridium difficile disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. IBD group: inpatients diagnosed with ulcerative colitis or Crohn's disease.
2. IBD+CDI group: IBD patients positive for C.difficile toxin and having diarrhea
3. Health control: people without diarrhea or any other intestinal diseases and negative for C.difficile toxin tests

Brief summary: The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.

type of study: observational study participant population/health conditions

1. population diagnosed with Ulcerative colitis or Crohn's disease
2. Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.


Eligibility criteria: Inclusion Criteria:

* inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
* age from 18 to 75 years old

Exclusion Criteria:

* other infection caused diarrhea
* other metabolic diseases or inflammatory diseases
* patients who are not able to send back samples 4-6 weeks after therapy

Primary outcomes:
measure: C.difficile positive
timeFrame: 1 day
measure: C.difficile negative
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai jiaotong university, school of medicine, affliated Renji hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Min Li, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03990766: Smell Changes & Efficacy of Nasal Theophylline
Official title: SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Olfactory Disorder
Anosmia
Viral Infection
Theophylline Causing Adverse Effects in Therapeutic Use
Smell Disorder
Keywords: Olfactory dysfunction
Anosmia
Hyposmia
Post-viral
Theophylline
Adverse effects
Smell
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized arms
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of nasal theophylline irrigation in treating smell loss related to a viral respiratory infection. Half the participants will undergo nasal theophylline irrigation treatment while the other half will undergo placebo nasal irrigation with saline alone. All participants will have their sense of smell tested before and after 6 weeks of treatment. All participants will also be regularly asked about any potential side effects related to treatment. In addition, the first 10 participants will have their blood drawn to measure their theophylline level after 1 week of starting treatment to ensure it is not abnormally elevated.


Eligibility criteria: Inclusion Criteria:

* Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months duration after a presumed viral upper respiratory infection
* Ability to read, write, and understand English

Exclusion Criteria:

* Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease
* History of an allergic reaction to theophylline or other methylxanthines
* Prior sinonasal or anterior skull base surgery
* Nasal polyposis
* History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
* Pregnant or breastfeeding mothers
* Current use of medications with significant (≥40%) interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin

Primary outcomes:
measure: Number of Patients With Improvement in Global Rating of Smell Change
timeFrame: 6 weeks
Secondary outcomes:
measure: University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change
timeFrame: 6 weeks
measure: Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change
timeFrame: 6 weeks
measure: Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT00649766: Tailored Messages to Increase Eye Examination Behavior
Official title: Tailored Messages to Increase Eye Examination Behavior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Disease
Eye Care
Keywords: tailored health messages
glaucoma
diabetic retinopathy
dilated fundus exams
health behavior
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 2008-04-01
Enrollment: 330
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.

Detailed description: Studies have shown that people are not getting their eyes examined on a regular basis, even though dilated eye exams can detect eye diseases like glaucoma and diabetic retinopathy early, before significant vision loss has developed. Early detection can lead to earlier treatment, which can save sight by preventing or slowing the progression of these eye diseases. In this project we designed, implemented, and are now evaluating tailored and targeted print health messages to increase eye examination behavior in an African-American population 65 years of age and older, a group at increased risk of glaucoma and diabetes.

Eligibility criteria: Inclusion Criteria:

* African-American
* 65 years of age or older
* no dilated fundus exam in past 2 years

Exclusion Criteria:

* appointment for dilated fundus exam scheduled
* no access to phone

Primary outcomes:
measure: doctor-confirmed dilated eye examination
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Nancy J. Ellish, DrPH, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellish NJ, Royak-Schaler R, Passmore SR, Higginbotham EJ. Knowledge, attitudes, and beliefs about dilated eye examinations among African-Americans. Invest Ophthalmol Vis Sci. 2007 May;48(5):1989-94. doi: 10.1167/iovs.06-0934.
citation: Ellish NJ, Royak-Schaler R, Higginbotham EJ. Tailored and targeted interventions to encourage dilated fundus examinations in older African Americans. Arch Ophthalmol. 2011 Dec;129(12):1592-8. doi: 10.1001/archophthalmol.2011.190.
Clinical trial NCT01373866: Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
Official title: Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallucinations
Schizophrenia
Perceptual Disorders
Keywords: Repetitive Transcranial Magnetic Stimulation
Neuronavigation
Functional Magnetic Resonance Imaging
Diffusion Tensor Imaging
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 76
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
* This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
* The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations


Eligibility criteria: Inclusion Criteria:

* Right-handed Female/Male, \[13-60 y.o.\],
* Schizophrenia (DSM-IV-TR diagnosis),
* Drug-resistant hallucinations (Kinon \& Kane criteria, 1993),
* Unmodified antipsychotic dosage during the 30 days preceding rMTS,
* No anticonvulsive medication,
* No neurological disorder, no addictive behavior,
* Matched for sex, age and PANSS scores,
* Consent to participate to the study,

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI scan
* Contraindication to rTMS treatment
* Claustrophobia
* No social insurance

Primary outcomes:
measure: Severity and Frequency of Hallucinations
timeFrame: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)
Secondary outcomes:
measure: Clinical State
timeFrame: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)
measure: MRI changes
timeFrame: Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital Centre
city: Paris
country: France
facility: Saint-Anne Psychiatric Hospital
Study officials:
affiliation: Lille University Medical Centre, France
name: Renaud Jardri, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.
Clinical trial NCT04704466: Impact of Covid-19 Pandemic on Management of Head and Neck Cancers
Official title: Observational Study Evaluating the Impact of the Covid-19 Pandemic on the Management of Patients With Head and Neck Cancer in the Maxillofacial Surgery Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Covid19
Patient Care
Keywords: Head and Neck Cancer
upper aero digestive tract cancer
Covid19
patient care
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing maxillofacial surgery at the Amiens-Picardie University Hospital between March the 1st 2020 and February the 28th 2021, and in particular from those who have benefited from a multidisciplinary consultation meeting in H\&N oncology for treatment decisions during this period.

Brief summary: Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths.

Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H\&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.


Eligibility criteria: Inclusion Criteria:

* patient diagnosed with cancer of the upper aero digestive tract
* patient benefiting from a medical consultation
* patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021.

Exclusion Criteria:

* patient diagnosed with cancer other than upper aero digestive tract cancer
* patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie).

Primary outcomes:
measure: Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02114866: Quality of Handover to a Post Anaesthesia Care Unit in a Children's Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Information Transfer During Postoperative Handovers
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 441
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients (\<18 years of age) at Children's Hospital Cologne, being admitted to the main postoperative care unit (PACU), after they underwent interventions within normal surgery hours

Brief summary: Postoperative handovers to the post anaesthesia care unit (PACU) in adult anaesthesia are described as incomplete and unstructured, although their relevance for the patient safety is well known. It must be assumed that for children, this handover is at least comparable important.

With a self-developed checklist information transfer during postoperative handovers will be documented and subsequently compared with patient information in anaesthesia records.


Eligibility criteria: Inclusion Criteria:

* All patients transferred to the PACU after surgery

Exclusion Criteria:

* Age \> 18 years

Primary outcomes:
measure: Quantity of Information Loss during Postoperative Handovers in the PACU
timeFrame: Three month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Piekarski F, Kaufmann J, Laschat M, Bohmer A, Engelhardt T, Wappler F. Quality of handover in a pediatric postanesthesia care unit. Paediatr Anaesth. 2015 Jul;25(7):746-52. doi: 10.1111/pan.12646. Epub 2015 Apr 2.
Clinical trial NCT00202566: Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
Official title: Evaluation of the Anti-anginal Efficacy and Safety of Oral Administration of Ivabradine Compared to Placebo on Top of Background Therapy With Atenolol in Patients With Stable Angina Pectoris. A Four-month Randomised Double-blind, Parallel Group International Multicentre Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina Pectoris
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris


Eligibility criteria: Inclusion Criteria:

* Chronic stable angina pectoris
* Documented coronary artery disease
* Previous treatment with atenolol or other beta-blocker agent
* Exercise tolerance test positivity and stability

Exclusion Criteria:

* Heart rate \< 60 bpm
* Congestive heart failure

Primary outcomes:
measure: Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Secondary outcomes:
measure: Rate pressure product
measure: Clinical evaluation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Jean-Claude Tardif, Pr
role: STUDY_CHAIR
References:
citation: Tardif JC, Ponikowski P, Kahan T; ASSOCIATE Study Investigators. Efficacy of the I(f) current inhibitor ivabradine in patients with chronic stable angina receiving beta-blocker therapy: a 4-month, randomized, placebo-controlled trial. Eur Heart J. 2009 Mar;30(5):540-8. doi: 10.1093/eurheartj/ehn571. Epub 2009 Jan 9.
Clinical trial NCT00904566: Validation of 70-gene MammaPrint Profile in Japanese Population
Official title: Validation 70-gene MammaPrint Profile in Japanese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: microarray
gene expression profiling
MammaPrint
breast cancer
Lead sponsor: Agendia
Sponsor class: INDUSTRY
Collaborators: name: Osaka General Medical Center
First posted: 2009-05-19
Enrollment: 102
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients, node-negative, treated with breast conserving therapy or mastectomy with axilary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases.

Brief summary: By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. The aim of this study is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with node-negative breast cancer.

Detailed description: Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as genomic high risk or genomic low risk.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients
* Node-negative
* Treated with breast conserving therapy or mastectomy with axillary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases

Primary outcomes:
measure: The probability of recurrence free survival (PRFS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cadiovascular Diseases
Study officials:
affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases
name: Kikuya Kato, MD, PhD, Prof
role: STUDY_CHAIR
References: