louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06699966: Stony Brook Medicine Anti-Inflammatory Trial
Official title: Stony Brook Medicine Anti-Inflammatory Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 42
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: This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.


Eligibility criteria: Inclusion Criteria:

* Current consent form signed
* Capacity to give informed consent
* Age range 18-65 (inclusive)
* Diagnosis of MDD or bipolar depression and currently in a major depressive episode
* Score of at least 29 on the MADRS (at least moderate depression)

Exclusion Criteria:

* Hypersensitivity to celecoxib, minocycline, tetracyclines, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
* History of myocardial infarction or current cardiac condition
* Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib or minocycline
* Poor CYP2C9 metabolizer
* Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin), or minocycline (isotretinoin, ergot alkaloids) without providing physicians approval
* Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib or minocycline treatment)
* Unlikely to tolerate medication washout or the medication-free period following washout.
* Participant considered at significant risk for suicide.
* Electroconvulsive therapy (ECT) within 1 month
* High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
* Significant active physical illness or neurological deficit that may affect brain functioning.
* If participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation.
* Need for medications that control mania.

Primary outcomes:
measure: Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks
timeFrame: Baseline and 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stony Brook University
name: Ramin Parsey, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01915966: Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients
Official title: Randomized Clinical Trial of a Ginger and Cardamom Gelatin Compared to a Camomile and Lemon Juice Infusion in Control of Xerostomy in Terminally Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Salivary Gland Diseases
Mouth Diseases
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
Collaborators: name: Mutuam
First posted: 2013-08-05
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.

The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Receiving palliative care for terminall illness at MUTUAM PADES
* Complaining of dry mouth and should not have been treated for this problem
* Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so

Exclusion Criteria:

* Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
* Oropharinx neoplasm treated with surgery or radiotherapy.
* Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
* Motor dysphagia causing coordination problems in swallowing.
* Life expectancy less than seven days (Last Days Situation).

Primary outcomes:
measure: Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
timeFrame: At end of treatment (1 week )
Secondary outcomes:
measure: Objective signs of xerostomia
timeFrame: At end of treatment (1 week )
measure: Scale of subjective assessment of salival disfunction (Pai 2001).
timeFrame: At end of treatment (1 week )
measure: Treatment acceptability
timeFrame: At end of treatment (1 week )
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: MUTUAM
Study officials:
affiliation: Mutuam
name: Teresa Peris, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06497166: Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents with Internet Gaming Disorder
Official title: Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents Diagnosed with Internet Gaming Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internet Addiction Disorder
Keywords: Addiction
Executive functions
Internet gaming disorder
Occupational balance
Quality of life
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents diagnosed with internet gaming disorder

Brief summary: Internet gaming disorder leads to social problems and isolation, neglect of daily responsibilities, behavioral disorders, and cognitive and physical impairments. It is thought that assessing the occupational profiles and cognitive functions of adolescents with internet gaming disorder will bring a new perspective to the occupational therapy literature. The aim of the present study is to examine the occupational balance, executive functions, and quality of life of adolescents with internet gaming disorder.

Detailed description: The study, planned to be conducted with individuals aged 12-18 who are followed up in the Child and Adolescent Mental Health and Diseases outpatient clinic of Bezmialem Vakif University and diagnosed with internet gaming disorder according to DSM-V diagnostic criteria, will include a total of 62 participants, with 31 in the study group and 31 in the healthy control group. All individuals who provide written consent will be administered the Sociodemographic Data Form, Internet Gaming Disorder Scale, Teenage Executive Function Inventory, Pediatric Quality of Life Inventory-Adolescent Form, and Adolescent Occupational Balance Scale, and the results will be recorded. The obtained results will be statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Internet Gaming Disorder
* Aged between 12 and 18
* Proficiency in Turkish
* Open to communication and cooperation
* Willing to participate in the study
* No reported cognitive impairment

Exclusion Criteria:

* Additional psychiatric diagnosis
* Having a neurological problem that would impair communication and collaboration

Primary outcomes:
measure: Adolescent Occupational Balance Scale
timeFrame: Baseline
measure: Teenage Executive Functioning Inventory
timeFrame: Baseline
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline
measure: Internet Gaming Disorder Scale
timeFrame: Baseline
measure: Sociodemographic Information Form
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Beyzanur Demirci, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00769366: Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
Official title: Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.

The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI.
* Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain.
* Only patients in whom complete revascularization is achieved are being enrolled in the study.

Exclusion Criteria:

* Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.

Primary outcomes:
measure: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of re-hospitalisations
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San filippo Neri Hospital
Study officials:
References:
citation: Pristipino C, Roncella A, Pasceri V, Speciale G. Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results. Am J Med. 2019 May;132(5):639-646.e5. doi: 10.1016/j.amjmed.2018.12.025. Epub 2019 Jan 17.
citation: Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.
Clinical trial NCT01046266: A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
Official title: An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria:

* carcinoma of nasal cavity, paranasal sinus and nasopharynx
* recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
* known positivity for HIV, hepatitis B and/or hepatitis C infection

Primary outcomes:
measure: immune cell infiltration head and neck squamous cell cancer (HNSCC)
timeFrame: through study completion or early study discontinuation
Secondary outcomes:
measure: pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
timeFrame: through study completion or early study discontinuation
measure: safety and efficacy: AEs, laboratory parameters, tumour assessments
timeFrame: through study completion or early study discontinuation
Other outcomes:
Locations:
city: Toulouse
country: France
city: Villejuif
country: France
city: Milano
country: Italy
state: Lombardia
city: Nijmegen
country: Netherlands
city: Barcelona
country: Spain
city: Sevilla
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489.
Clinical trial NCT06101966: A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy
Official title: A Novel Predictive Model and Risk Stratification for Early Metastasis in Cervical Cancer Patients After Radiotherapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Radiotherapy
Distant Metastasis
Prognostic Model
Risk Factor
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cervical cancer patients recevied definitive radiotherapy.

Brief summary: This study aims to help to screen out appropriate cases for consolidation therapy and more intensive follow up.

Detailed description: Some cervical cancer patients experienced distant metastasis quickly after receiving complete radiotherapy and have a worse prognosis. However, there were few studies focused on these patients and with early distant metastasis. It is significant to predictive and screen out cervial cancer patients with a high risk of early metastasis for more comprehensive treatments and follow-up plans

Eligibility criteria: Inclusion Criteria:

* patients confirmed as cervical cancer by biopsies and treated with radiotherapy were initially enrolled

Exclusion Criteria:

* (1) patients treated with surgery. (2) patient received incomplete treatment somewhere else. (3) patients with cancer history. (4) patients with pelvic surgery history. (5) patients without complete pre-treatment medical information. (6) patients with unfinished radical radiotherapy. (7) patients suffered from metastasis within 3 months after radiotherapy. (8) patients without complete 1-year follow-up materials

Primary outcomes:
measure: Early distant metastases
timeFrame: 3-12months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References:
citation: Okazawa-Sakai M, Mabuchi S, Isohashi F, Kawashima A, Yokoi E, Ogawa K, Kimura T. Predictors of distant relapse in patients with FIGO stage IIB-IVA cervical cancer treated with definitive radiotherapy. J Obstet Gynaecol Res. 2017 Nov;43(11):1743-1750. doi: 10.1111/jog.13446. Epub 2017 Aug 17.
citation: Liu X, Meng Q, Wang W, Zhou Z, Zhang F, Hu K. Predictors of Distant Metastasis in Patients with Cervical Cancer Treated with Definitive Radiotherapy. J Cancer. 2019 Jul 5;10(17):3967-3974. doi: 10.7150/jca.31538. eCollection 2019.
citation: Li H, Wu X, Cheng X. Advances in diagnosis and treatment of metastatic cervical cancer. J Gynecol Oncol. 2016 Jul;27(4):e43. doi: 10.3802/jgo.2016.27.e43.
citation: Zeng W, Huang L, Lin H, Pan R, Liu H, Wen J, Liang Y, Yang H. Development and Validation of a Nomogram for Predicting Postoperative Distant Metastasis in Patients with Cervical Cancer. Med Sci Monit. 2022 Apr 12;28:e933379. doi: 10.12659/MSM.933379.
Clinical trial NCT00127166: Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Official title: A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Exercise Induced Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 154
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Eligibility criteria: Inclusion Criteria:

* 6-14 year old children with a history of asthma for at least 12 months
* must demonstrate airway constriction brought on by exercise

Exclusion Criteria:

* is taking any medications that are not allowed in the study

Primary outcomes:
measure: Maximum Post-exercise Percent (%) Fall in FEV1
timeFrame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary outcomes:
measure: Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
timeFrame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
measure: Maximum FEV1 % Predicted Following First Beta-agonist Use
timeFrame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
measure: Time to Recovery to Within 5% of Baseline FEV1
timeFrame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
measure: Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
timeFrame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.
Clinical trial NCT04523766: Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
Official title: Enhancing Pain Management and Preventing Opioid Misuse by Optimizing Mindfulness Based Interventions for Opioid-Treated Chronic Pain Patients: A Comparison of Mindful Interoceptive Mapping and Mindful Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Opioid Use
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 149
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: This is a single site, two-arm, parallel group randomized clinical trial comparing the effect of two mindfulness-based interventions (Mindful Interoceptive Mapping vs. Mindfulness of the Breath) on opioid-treated chronic pain patients' pleasant/unpleasant sensation reports and opioid use.


Eligibility criteria: Inclusion Criteria:

* (1) men/women ≥18 years of age,
* (2) current chronic low back pain condition determined by physician assessment (e.g., ICD-10 codes M54.5, M54.4, M54.3),
* (3) reporting pain ≥3 on 0-10 scale with opioid medication, and
* (4) long-term opioid pharmacotherapy (\>3 months of use).

Exclusion Criteria:

* (1) formal mindfulness training (e.g., MBSR/MBRP),
* (2) current cancer diagnosis,
* (3) psychosis, suicidality, and moderate/severe substance use disorder in the past year as assessed with the MINI, and
* (4) unstable illness, as judged by a physician, that may interfere with treatment.

Primary outcomes:
measure: Immediate Change in Pleasant Sensation Ratios
timeFrame: Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
measure: Longer-Term Change in Pleasant Sensation Ratios
timeFrame: At baseline and posttreatment, approximately 1.5 months
Secondary outcomes:
measure: Change in Opioid Medication Desire
timeFrame: Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
measure: Change in Pain Intensity
timeFrame: Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
measure: Change in Opioid Use
timeFrame: At baseline and 1-month follow-up, approximately 3 months
measure: Change in Pain Functional Interference
timeFrame: At pretreatment and 1-month follow-up, approximately 3 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: