louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02627014: Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Official title: Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Temporomandibular Disorders
Keywords: Chronic Migraine
Temporomandibular Disorders
Physical Therapy
Manual Therapy
Home physical Therapy
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital Miguel Servet
First posted: 2015-12-10
Enrollment: 45
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: The aim of this study is to determine whether treatment of temporomandibular joint is more effective than usual care in patients with chronic migraine and temporomandibular disorders to reduce pain.

Detailed description: The aim of this study is to determine whether treatment of temporomandibular joint added to the control group treatment and drug therapy patient base is more effective than just using the control group treatment and drug therapy in patients with chronic migraine and temporomandibular disorders to reduce pain and improve the quality of life related to health of patients.

Eligibility criteria: Inclusion Criteria:

* Chronic migraine (ICHD_III beta, 2013)
* Temporomandibular disorders (RDC/TMD)

Exclusion Criteria:

* other neurological disease
* psychiatric diseases
* Physical therapy treatment in the last 6 months
* dental treatment in the last 6 months
* surgery or trauma in the orofacial region

Primary outcomes:
measure: Headache Impact Test (HIT-6)
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
measure: Quality of life (SF-36)
timeFrame: 3 months
measure: Sleep Quality
timeFrame: 3 months
measure: Pain threshold pressure
timeFrame: 3 months
measure: Pain catastrophizing scale (PCS)
timeFrame: 3 months
measure: Craniofacial Pain and Disability Inventory (CF-PDI)
timeFrame: 3 months
measure: Tampa scale of Kinesiophobia (TSK)
timeFrame: 3 months
measure: Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
timeFrame: 3 months
measure: Maximal Mouth Opening pain free
timeFrame: 3 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad San Jorge
Study officials:
affiliation: Universidad San Jorge
name: Miriam Garrigós
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03070314: Echinaforce Junior Bioavailability Trial
Official title: Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Common Cold
Keywords: Echinacea
bioavailability
children
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
Collaborators: name: University Children's Hospital, Zurich
First posted: 2017-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study participants take 5 tablets Echinaforce junior at once one after another per os. registered in Switzerland for children from age of 4 -12 years Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and then analyzed on the amount of tetraen. Bioavailability parameters will thereafter be calculated.
Primary purpose: BASIC_SCIENCE

Brief summary: In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

Detailed description: In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and thereafter the bioavailability is measured and calculated.

Eligibility criteria: Inclusion Criteria:

* Children in the age group 4-12 years with an uncomplicated common cold (upper respiratory tract infection)
* First symptoms appeared within the last 72 hours
* Written consent given by the parents and verbal consent of children who are capable of judgement

Exclusion Criteria:

* Not able to fast 2 hours prior to the treatment
* intake of another preparation containing echinacea within the last 24 hours
* Participation in a clinical trial within the last 30 days
* any progressive systemic illness, including tuberculosis, leukemia, connective tissue diseases, multiple sclerosis, or other autoimmune diseases; or
* history of relevant allergy, including allergy to Compositae plants

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 270 minutes measurement
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 270 minutes measurement
measure: Timepoint when Cmax is reached (tmax)
timeFrame: 270 minutes measurement
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital (UZH-UCH), Infectiology, University of Zurich
Study officials:
References:
Clinical trial NCT00162214: Study of Dasatinib in Patients With Advanced Solid Tumors
Official title: Phase I Study to Evaluate the Effect of Ketoconazole on the Pharmacokinetics of Dasatinib and the Effect of Dasatinib on Pharmacodynamic Markers in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Keywords: Advanced Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 60
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: The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* ECOG status 0-2
* Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists)
* Biopsy pretreatment
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Serious cardiovascular disease
* Bleeding disorders
* Gastrointestinal (GI) tract disease
* Platelet inhibitors
* H2 blockers, proton pump inhibitors

Primary outcomes:
measure: Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors
measure: Segment 2: Assess the pharmacodynamic activity of dasatinib
Secondary outcomes:
measure: Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole
measure: Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Lee S. Rosen M.D.
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT05297214: A Study of Acute Kidney Injury in Children at Sohag University Hospital
Official title: A Study of Acute Kidney Injury in Children at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute kidney injury (AKI) will be defined by the presence of an Increase in serum creatinine by 0.3 mg/dL or more within 48 hours, or increase in serum creatinine to 1.5 times or more baseline within the prior seven days, or urine output less than 0.5 mL/kg/h for at least 6 hours . AKI will be classified according to serum creatinine level (SCr) and urine output as in table .

Brief summary: Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Acute kidney injury (AKI) is a very common condition, especially among hospitalized patients.

this work aims to study the demographics, etiology, clinical characteristics, and outcome of acute kidney injury in children in Sohag University Hospital - Pediatrics Department.


Eligibility criteria: Inclusion Criteria:

* All children with acute kidney injury with an age range from 1 month to 16 years old

Exclusion Criteria:

1. patients with chronic kidney disease (CKD)
2. Patients with irregular follow up
3. Patients with incomplete data
4. Patients whose medical guardians refuse participation in the study

Primary outcomes:
measure: Serum creatinine level
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag General Hospital
Study officials:
References:
citation: Tresa V, Yaseen A, Lanewala AA, Hashmi S, Khatri S, Ali I, Mubarak M. Etiology, clinical profile and short-term outcome of acute kidney injury in children at a tertiary care pediatric nephrology center in Pakistan. Ren Fail. 2017 Nov;39(1):26-31. doi: 10.1080/0886022X.2016.1244074. Epub 2016 Oct 21.
citation: Akcay A, Turkmen K, Lee D, Edelstein CL. Update on the diagnosis and management of acute kidney injury. Int J Nephrol Renovasc Dis. 2010;3:129-40. doi: 10.2147/IJNRD.S8641. Epub 2010 Sep 29.
citation: Lameire NH, De Vriese AS, Vanholder R. Prevention and nondialytic treatment of acute renal failure. Curr Opin Crit Care. 2003 Dec;9(6):481-90. doi: 10.1097/00075198-200312000-00004.
citation: Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18.
Clinical trial NCT05761314: Solid Tumors in RASopathies
Official title: Incidence and Molecular Pathogenesis of Solid Tumors in RASopathies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: RASopathy
Costello Syndrome
Cardio-Facio-Cutaneous Syndrome
Noonan Syndrome
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RASopathies are a group of syndromes, caused by variants of genes involved in the regulation of the Ras/MAP/ERK pathway. This intracellular transduction pathway profoundly affects embryogenic development, organogenesis, synaptic plasticity and neuronal growth.

RASopathies are characterized by multi-organ involvement, growth delay, premature aging and haemato-oncological manifestations.

Based on evidences provided by literature, cancer screening protocols are applied in some individuals affected by RASopathies, even though detailed information about prevalence and molecular pathogenesis of such tumors is still not clearly elucidate.

Detailed description: To define the prevalence of solid (non-haematological) neoplasms in a monocentric cohort of patients affected by RASopathies To perform Next Generation Sequencing (NGS) analysis on tissue samples to preliminarily characterize the molecular pathogenesis of solid tumors in these patients' categories.

Eligibility criteria: Inclusion Criteria:

* Clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Clinical diagnosis of RASopathy without molecular characterization

Primary outcomes:
measure: Prevalence of solid tumors in RASopathies
timeFrame: 5 years
Secondary outcomes:
measure: Molecular characterization of solid tumors in RASopathies
timeFrame: 5 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli, IRCCS
name: Chiara Leoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246414: Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients
Official title: Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Exhaled breath condensates
Cytokines
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2010-11-23
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatic patients in Allergy clinic, King Chulalongkorn Memorial Hospital (10 allergic and 10 non-allergic) and 10 non-asthmatic controls will be enrolled to this study to collect exhaled breathe condensates (EBC) and measure levels of inflammatory cytokines in EBC

Brief summary: This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.


Eligibility criteria: Inclusion Criteria:

1. Have been diagnosed as asthma at least 6 months before enrolled to the study
2. Known skin prick test results to aeroallergens ; either positive or negative
3. 15-65 years of age

Exclusion Criteria:

1. On oral or inhaled corticosteroids within 1 month before the study
2. Having asthma exacerbation
3. Being pregnant
4. Suffering from severe systemic disease/ in bad health

Primary outcomes:
measure: Levels of inflammatory cytokines in exhaled breathe condensates
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boonpiyathad S, Pornsuriyasak P, Buranapraditkun S, Klaewsongkram J. Interleukin-2 levels in exhaled breath condensates, asthma severity, and asthma control in nonallergic asthma. Allergy Asthma Proc. 2013 Sep-Oct;34(5):e35-41. doi: 10.2500/aap.2013.34.3680.
Clinical trial NCT05756114: Self Management and Recovery Training (SMART) Recovery Study
Official title: Self Management and Recovery Training (SMART) Recovery Involvement and Alcohol Use Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Society of Addiction Psychology
First posted: 2023-03-06
Enrollment: 0
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 identifies whether and how online support groups may work to confer therapeutic benefits onto its participants.

Detailed description: Online support groups (e.g., SMART Recovery) are an increasingly common non-professional intervention for people who engage in problematic alcohol use, but it is unclear how they help participants reduce their use.

The primary objective of this study is to determine whether alcohol use decreases more after attending online SMART Recovery psychoeducational support group meetings, as compared to receiving psychoeducational content alone.

The secondary objectives are to identify whether variables such as quality of life and recovery capital (i.e., resources to support recovery from addiction) relate to treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* Is fluent in English and have a 6th grade reading level or higher
* AUDIT score of ≥8
* Has some desire to cut down or quit their alcohol use
* Has access to a phone or computer with reliable internet connection, a functional microphone and camera
* Is willing to consent to being audio and video recorded during the meetings

Exclusion Criteria:

* Is not able to commit to the 6 weeks of intervention and the one- and three-month follow-up.
* Has vulnerable population status (e.g., pregnant people, prisoners)

Primary outcomes:
measure: Change in past-month alcohol use: drinking days
timeFrame: Baseline, 1 month and 3 months
measure: Change in past-month alcohol drug use: heavy drinking days
timeFrame: Baseline, 1 month and 3 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 1 month and 3 months
measure: Change in recovery capital
timeFrame: Baseline, 1 month and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience
name: Marc Potenza, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03676114: Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Official title: Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Ketamine
Breast Cancer Surgery
Postoperative Recovery
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer patients often have perioperative emotional disorders such as anxiety and depression, which can lead to poor quality of recovery.This study aims to determine whether ketamine could improve the quality of recovery in breast cancer patients. Meanwhile, it will show if ketamine could improve anxiety, depression, postoperative pain and fatigue.This trial also will bring great concerns on patients' mental health perioperatively and explore the measures to improve their quality of life.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists Grade I-II
2. Patients undergoing elective breast cancer surgery under general anesthesia

Exclusion Criteria:

1. Unstable hypertension, history of heart disease
2. Hepatic or renal dysfunction
3. Patients undergoing chemotherapy before surgery
4. Have a history of chronic pain or chronic use of analgesic
5. Have mental illness or can't cooperate with investigators
6. Have a history of ketamine allergy

Primary outcomes:
measure: QoR40 score
timeFrame: the first day after surgery
Secondary outcomes:
measure: ICFS scores
timeFrame: Postoperative 3 days, 7 days and 30 days
measure: HADS scores
timeFrame: Postoperative 2 days and 3months
measure: Chronic Pain
timeFrame: 3 months after surgery
measure: NRS pain scores
timeFrame: at 4 hours, 24 hours, and 48 hours after surgery
measure: Postoperative complications
timeFrame: Postoperative 1 day, 2 days and 3 days
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04369014: Effect of Etomidate and Propofol on Electroencephalography
Official title: Characteristic Changes During Anesthesia With Etomidate and Propofol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Keywords: electroencephalography
etomidate
propofol
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 68
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: Electroencephalography (EEG) monitoring reflect the brain electro-activity. Different anesthetics may show different changes in EEG during anesthesia. Etomidate and propofol are widely used for general anesthesia. The characteristic changes of these two anesthetics may be different.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery under general anesthesia
* Patients provided written informed consent

Exclusion Criteria:

* Patients with history of neurological or psychiatric diseases
* Patients younger than 18 years old
* Patients scheduled for surgery involved head
* Patients with pregnancy or planned for breeding

Primary outcomes:
measure: delta wave deficiency during anesthesia
timeFrame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
Secondary outcomes:
measure: spindle wave deficiency during anesthesia
timeFrame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
measure: burst suppression during anesthesia
timeFrame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT01238614: Universal Screening for Maternal Depression With the CHICA System
Official title: Universal Screening for Maternal Depression With the CHICA System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Keywords: maternal depression
clinical decision support
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2010-11-10
Enrollment: 3250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and referral of mothers with maternal depression.


Eligibility criteria: Inclusion Criteria:

* All families of patients age 0 to 15 months

Exclusion Criteria:

* None

Primary outcomes:
measure: Percent of mothers screening positive for maternal depression.
timeFrame: 1 year after child's birth
Secondary outcomes:
measure: Percent of mothers diagnosed with maternal depression
timeFrame: one year after child's birth
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: CHSR
state: Indiana
Study officials:
References: