louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03567070: Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.
Official title: Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems.

The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more brutally during delivery at the time of complications (neonatal or obstetric). In this context, health professionals are looking for levers that allow women to take appropriate care quickly.

This difficulty of access to care questions us and all the more because the time of the pregnancy is a moment of important psychic reorganization conducive to modify its habits, to change its glance on its consumptions and thus to start a care concerning addiction.

Invesigators hypothesize that this population has less access to medical care during pregnancy for fear of stigmatization by the health care provider.

Invesigators propose a multicenter qualitative study based on individual clinical interviews to collect the testimony of women who used psychoactive substance (s) during their pregnancy.

The purpose of this work is to identify ways to improve the multidisciplinary medical management of these women by focusing on the representations they can make care of.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Pregnant or having given birth since \<28 days
* Having used (whether declared or discovered incidentally) - regardless of the amount of psychoactive substance (s) during pregnancy: alcohol, and / or heroin or OST, and / or cannabis, and / or psychostimulants (cocaine, ecstasy, amphetamines)
* Followed or not in addictology during pregnancy

Exclusion Criteria:

* Minor patients
* Patients under legal protection (guardianship, guardianship)
* Linguistic obstacle
* Psychiatric pathology decompensated at the time of the meeting
* Women who only used tobacco regularly during pregnancy
* Women who have only regularly used psychoactive drugs and / or licit opiates (excluding prescription replacement products) during pregnancy

Primary outcomes:
measure: individual clinical interview
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT04038970: Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Official title: A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 145
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: The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of KN019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.

Detailed description: This study is designed to provide efficacy data in support of the proposed claims of reducing signs and symptoms, improvement in physical function, and 1 year safety data for KN019 dosed at 5 and 10 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate.

Eligibility criteria: Key Inclusion Criteria:

* The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA) by satisfying at least four of the seven criteria;
* Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 7.5-25 mg, and a stable dose for 28 days prior to treatment (Day 1)
* The patient must have active disease at both screening and baseline, as defined by having both:

  6 tender/painful joints on motion (out of 68 joints assessed); and; 6 swollen joints (out of 66 joints assessed); CRP ≥ 7 mg/L, or ESR ≥28 mm/h

Key Exclusion Criteria:

* Pregnant or lactating females.
* History of any other autoimmune rheumatic disease.
* Patients who have previously received CTLA4-Ig therapy for any reason.

Primary outcomes:
measure: Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169
timeFrame: At Day 169
Secondary outcomes:
Other outcomes:
Locations:
city: PingXiang
country: China
facility: Pingxiang people's hospital
state: Pingxiang
Study officials:
References:
Clinical trial NCT01834170: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
Official title: EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic cancer
Pancreatic adenocarcinoma
Endoscopic ultrasound
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.

About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.

The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor

Exclusion Criteria:

* Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
* Pancreatic cancer with distant metastasis
* Unwilling to sign informed consent

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of participants who remain alive one year after enrollment compared to the historical matched control group
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Digestive Disease Research Center, Shariati ospital
Study officials:
affiliation: Digestive Disease Research Center, University of Tehran/Medical sciences
name: Mehdi Mohamadnejad, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Center, University of Tehran/Medical Sciences
name: Reza Malekzadeh, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01838070: Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
Official title: Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis A
Keywords: Hepatitis A
Hepatitis A vaccine
AVAXIM 160U
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-04-23
Enrollment: 614
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received AVAXIM 160U (Hepatitis A Vaccine) according to Summary of Product Characteristics (SmPC)

Brief summary: This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".

Primary objective:

* To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Detailed description: The study will be conducted under the real clinical practices in accordance with Korea Food and Drug Administration "Basic standard for reexamination of new drug".

No vaccine will be provided and/or administered as part of this protocol, however only participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics will be part of the surveillance.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 16 years and older
* Informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years
* Informed consent sign by subject for subject aged of 20 year of age and older
* Receipt of AVAXIM 160U according to Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Contraindications to vaccination according to AVAXIM 160U Summary of Product Characteristics (SmPC)
* Subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)

Primary outcomes:
measure: Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine
timeFrame: Day 0 up to 30 Days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kim H, Oh Y, Thollot Y, Bravo C. Post-Marketing Surveillance of Hepatitis A Virus Vaccine (Avaxim(R) 160U) in South Korea from 2011 to 2015. Infect Dis Ther. 2019 Mar;8(1):105-112. doi: 10.1007/s40121-019-0230-9. Epub 2019 Jan 23.
Clinical trial NCT00168870: Study of Metastatic Ocular Melanoma
Official title: Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ocular Melanoma
Keywords: metastatic ocular melanoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 48
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: This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Detailed description: Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Metastatic ocular melanoma

Exclusion Criteria:

* Prior treatment with chemotherapy
* Active 2nd malignancy
* Cerebral metastasis

Primary outcomes:
measure: Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Secondary outcomes:
measure: Time to progression
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hematology & Oncology Charité CBF Berlin
Study officials:
affiliation: Charité Campus Benjamin Franklin Berlin
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622270: Energy Expenditure in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease

Brief summary: The objective of this study is to investigate the changes in crohn on resting energy expenditure.


Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease

Primary outcomes:
measure: changes in crohn on resting energy expenditure
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01255670: Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
Official title: Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonsillar Abscess
Keywords: Peritonsillar Abscess
Quinsy
Penicillin
Metronidazole
Recurrence
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 200
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: Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.


Eligibility criteria: Inclusion Criteria:

* referring doctor suspects peritonsillar abscess
* patient is voluntary
* patient has daily access to his/her e-mail
* patient speaks and understands Finnish of Swedish
* female patients have adequate birth-control method
* patient has peritonsillar abscess

Exclusion Criteria:

* allergy to penicillin
* allergy to metronidazole
* use of metronidazole in preceding one month
* pregnancy
* breast-feeding
* renal insufficiency
* liver insufficiency
* alcoholism (drunk at least once a week)
* participant in another clinical trial at the moment
* treatment of peritonsillar abscess requires in-patient care
* tonsillectomy during the next 30 days
* army recruit

Primary outcomes:
measure: Number of Participants With Recurrence of Peritonsillar Abscess
timeFrame: 56 days
Secondary outcomes:
measure: Number of Participants Recovering From Peritonsillar Abscess
timeFrame: 28 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: consultant
name: Karin V Blomgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiksten JE, Pitkaranta A, Blomgren K. Metronidazole in conjunction with penicillin neither prevents recurrence nor enhances recovery from peritonsillar abscess when compared with penicillin alone: a prospective, double-blind, randomized, placebo-controlled trial. J Antimicrob Chemother. 2016 Jun;71(6):1681-7. doi: 10.1093/jac/dkw038. Epub 2016 Mar 10.
Clinical trial NCT06698770: Leveraging Behavioral Science to Improve Medicine Optimization Conversations with Older Adults
Official title: Leveraging Behavioral Science to Improve Medicine Optimization Conversations with Older Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Deprescribing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2024-11-21
Enrollment: 2400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our online, survey-based experiment will include 2,400 adults who are 65-years and older (n=1,200 each from United States and Australia). Each participant will be asked to give their opinions on a hypothetical patient scenario that has been developed by our diverse team in partnership with our stakeholder organizations.This work is expected to significantly contribute to our understanding of how older adults make decisions about deprescribing medications.


Eligibility criteria: Inclusion Criteria:

* 65 years and older and resides in Australia or the United States

Primary outcomes:
measure: Preference regarding starting medication
timeFrame: 1 year
measure: Stopping medication
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT02030470: Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
Official title: Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: Periodontitis, treatment, photodynamic, mid-term, bacteria
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. The therapeutic additional value of photodynamic anti-infectious treatment remains controversial. The objective of this study is to evaluate the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.


Eligibility criteria: Inclusion Criteria:

* aged 40 years
* signed informed consent
* generalized severe chronic periodontitis
* patient with at least 24 teeth
* more than 30% of sites with clinical attachment loss \>5mm- at least 5 sites with pocket depth \>4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30%

Exclusion Criteria:

* aggressive periodontitis
* smoking more than 10cig/day
* patient with endocarditis risk or need of antibiotic prophylaxis
* pregnant women
* patient included in other trials
* patient under guardianship
* patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels...) influencing periodontal status within 6 months before examination
* patient suffering from diseases influencing periodontal status (diabetes...)
* patient periodontally treated with root planing or periodontal surgery within 1 year before examination
* patient with scheduled extensive prosthetic treatment
* patient with a high haemorrhagic risk (INR\>4)
* impossible patient cooperation

Primary outcomes:
measure: Change of periodontal pocket depth
timeFrame: 6 months
Secondary outcomes:
measure: Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora
timeFrame: 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de parodontologie
state: Alsace
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Jean-Luc Davideau, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courval A, Harmouche L, Mathieu A, Petit C, Huck O, Severac F, Davideau JL. Impact of Molar Furcations on Photodynamic Therapy Outcomes: A 6-Month Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Jun 11;17(11):4162. doi: 10.3390/ijerph17114162.
Clinical trial NCT02203370: Cerebral Oximetry for Carotid EEA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Thrombendarterectomy
Cerebral Oxygenation
NIRS
Regional Anesthesia
Lead sponsor: Salzburger Landeskliniken
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for CTEA at the University Hospital Salzburg

Brief summary: Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.

We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.


Eligibility criteria: Inclusion Criteria:

- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia

Exclusion Criteria:

* refusing participation
* age \<18 years
* pregnancy
* any contraindication to regional anesthesia or the use of NIRS
* participation in any other study affecting the study protocol

Primary outcomes:
measure: absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)
timeFrame: During the surgical procedure
Secondary outcomes:
measure: NSE
timeFrame: Before and after the surgery
measure: S100B
timeFrame: Before and after the surgery
Other outcomes:
measure: Hemodynamic parameters
timeFrame: During the surgical procedure
measure: Hemodynamic parameters
timeFrame: During the surgical procedure
measure: Hemodynamic parameters
timeFrame: During the surgical procedure
Locations:
city: Salzburg
country: Austria
facility: LKH University Clinic Salzburg
Study officials:
affiliation: UK für Anästhesiologie, LKH Salzburg
name: Andreas Koköfer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: