louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01510886: Assessment of MDD Management in Andalusia
Official title: Assessment of MDD Management Strategies in Andalusia: A Sub-analysis of the PismaEP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MDD Management Strategies
Keywords: MDD, management, Andalusia, Database, PismaEP
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 5309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MDD patients treated in Primary Care or Secondary Care in the Region of Granada and recruited for the PISMA-Ep Study

Brief summary: The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.

Detailed description: Assessment of MDD management strategies in Andalusia: A Sub-analysis of the PismaEP Study

Eligibility criteria: Inclusion Criteria:

* MDD Diagnosis Participants of the PismaEP study 18 yo. or older

Exclusion Criteria:

* No specific exclusion criteria

Primary outcomes:
measure: Number of Visits to Primary Care
timeFrame: From Jan 2010 to Jan 2011
measure: Number of Visits to Secondary Care
timeFrame: From Jan 2010 to Jan 2011
measure: Number of Referrals
timeFrame: From Jan 2010 to Jan 2011
Secondary outcomes:
measure: Demographics
timeFrame: From Jan 2010 to Jan 2011
measure: Type of site
timeFrame: From Jan 2010 to Jan 2011
measure: Type of therapeutic strategy
timeFrame: From Jan 2010 to Jan 2011
measure: Type of disease
timeFrame: From Jan 2010 to Jan 2011
measure: Severity of disease
timeFrame: From Jan 2010 to Jan 2011
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Research Site
Study officials:
affiliation: Hospital San Cecilio
name: Jorge Cervilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00431886: Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients
Official title: Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pains
Keywords: Chest pains
Computed tomography
Emergency
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients in emergency room

Detailed description: We prospectively enrolled the patients with acute chest pain who visited ED. Exclusion criteria were myocardial infarction (MI) with ST elevation, unstable vital sign, uncontrolled arrhythmia, renal dysfunction, hypersensitivity to contrast media and pregnancy. Patients were allocated into 3 categories based on history, physical exam, and electrocardiogram: 1) definite angina with uncertainty of regarding MI (high risk), 2) probable angina (intermediate risk), 3) low likelihood of angina (low risk), and then randomized to either receive MDCT immediately (MDCT group), or not (control). We compared diagnostic accuracy, length of stay in ER, admission rate, and major adverse cardiac events (MACE) and clinical diagnosis in 1 month after discharge from ED.

Eligibility criteria: Inclusion Criteria:

* Acute chest pain patient visiting emergency room

Exclusion Criteria:

* unstable vital sign
* renal failure
* ST elevation myocardial infarction
* uncontrolled arrhythmia
* hypersensitivity to contrast dye
* clinically no possibility of angina

Primary outcomes:
measure: Admission rate
measure: Unnecessary admission rate
Secondary outcomes:
measure: Stay time in emergency department
measure: Diagnostic accuracy
measure: MACE
Other outcomes:
Locations:
city: Sungnam-si
country: Korea, Republic of
facility: Seoul National University Bundang hospital
state: Kyungkido
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Huk-Jae Chang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01501786: Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions
Official title: The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Sedated for Cardiac Catheterization
Keywords: children
sedation
propofol
ketamine
Lead sponsor: Ibaraki Children's Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.


Eligibility criteria: Inclusion Criteria:

* 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization

Exclusion Criteria:

* patients who have neurological disease,
* endocrinological disease,
* airway anomaly, who require positive pressure ventilation

Primary outcomes:
measure: difference of end tidal partial pressure of carbon dioxide between the groups
timeFrame: 30 and 60 min after anesthetic induction
measure: difference of partial pressure of arterial carbon dioxide between the groups
timeFrame: 60 min after anesthetic induction on average
measure: heart rate change from baseline value
timeFrame: 30 and 60 min after anesthetic induction
measure: non-invasive blood pressure change from baseline value
timeFrame: 30 and 60 min after anesthetic induction
Secondary outcomes:
measure: movement at topical anesthetic injection
timeFrame: 20 min after anesthetic induction on average
measure: the number of times that secreted saliva is aspirated by an attending anesthesiologist
timeFrame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction
Other outcomes:
Locations:
city: Mito
country: Japan
facility: Ibaraki Children's Hospital
state: Ibaraki
Study officials:
affiliation: Ibaraki Children's Hospital
name: Kazuhiko Okuyama, MD
role: STUDY_CHAIR
affiliation: Ibaraki Children's Hospital
name: Yuki Takeda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912286: Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques
Official title: Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth,Non-vital
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 57
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Detailed description: Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery.

Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria.

The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant.

The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Eligibility criteria: Inclusion Criteria:

* Males or Females
* Age between 16-60 years old
* Permanent Mandibular molars with:

  * Non-vital response of pulp tissue
  * Absence of spontaneous pain

Exclusion Criteria:

* Pregnant females
* Patients having significant systemic disorder
* Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
* Teeth that have:

  * Vital pulp tissues
  * Association with swelling or fistulous tract
  * Acute periapical abscess
  * Greater than grade I mobility
  * Pocket depth greater than 5mm
  * Previous endodontic treatment

Primary outcomes:
measure: postoperative pain measured by numerical rate scale
timeFrame: 4 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00336986: Efficacy Study of IL-21 to Treat Metastatic Melanoma
Official title: An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Malignant Melanoma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-06-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed surgically incurable metastatic melanoma
* Patients must have measurable disease
* ECOG performance status of 0 or 1
* Expected life expectancy at least 4 months

Exclusion Criteria:

* History of and signs/symptoms of uncontrolled brain metastases or edema.
* Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
* Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
* Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

Primary outcomes:
measure: Tumor size assessed according to international criteria
timeFrame: After 8 weeks
Secondary outcomes:
measure: Serum levels of antibodies against recombinant human IL-21.
measure: Markers of immunomodulation in blood.
measure: Safety evaluation.
measure: Time to progression.
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: East Melbourne
country: Australia
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Australia
facility: Novo Nordisk Investigational Site
city: Malvern
country: Australia
facility: Novo Nordisk Investigational Site
city: Nedlands
country: Australia
facility: Novo Nordisk Investigational Site
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
city: Westmead
country: Australia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR; 1452)
role: STUDY_DIRECTOR
References:
citation: Coquet JM, Skak K, Davis ID, Smyth MJ, Godfrey DI. IL-21 Modulates Activation of NKT Cells in Patients with Stage IV Malignant Melanoma. Clin Transl Immunology. 2013 Oct 18;2(10):e6. doi: 10.1038/cti.2013.7. eCollection 2013 Oct.
Clinical trial NCT03168386: Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Official title: Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Motor Function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 196
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intenstive motor rehabilitation
Primary purpose: TREATMENT

Brief summary: Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of motor rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

Detailed description: Intensive cognitive rehabilitation group

- physical and occupational therapy for 3 hours on every working day for 2 weeks

Eligibility criteria: Inclusion Criteria:

* Acute first-ever stroke
* Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25\~84

Exclusion Criteria:

* Transient ischemic stroke
* Joint contracture of affected upper extremity

Primary outcomes:
measure: Upper limb score of Fugl-Meyer assessment
timeFrame: Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.
Clinical trial NCT04867486: Urdu Version of the Dynamic Gait Index: Reliability and Validity Study
Official title: Reliability and Validity of Urdu Version of the Dynamic Gait Index in Pakistani Geriatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balance
Keywords: Dynamic gait index
balance
reliability
validity
geriatric population
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people, especially those of the advanced ages, suffer from coexistent disorders, many of which are chronically degenerative, falls and gait disorders are common issues. About one-third of all elderly people aged 65 as well as above fall at least once a year. Injury, physical impairments, morbidity, cognitive side effects, and even disability are all linked to fall because equilibrium and postural control are essential for the everyday work.

Brief summary: In this study, Investigators will observe the reliability and validity of dynamic gait index in Urdu language in Pakistani geriatric population with balance impairments.

Detailed description: The aim of study is to translate and culturally adapt DGI into Urdu language and secondly to investigate the reliability and validity of DGI in geriatrics Pakistani population.This study will be cross sectional survey in which convenience sampling technique will be used to enroll participants as per pre-defined criteria.

The results of study will help to know the validity and reliability of DGI in Urdu version with balance impairments in geriatric population.The reliability of the scale will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value.Test-retest reliability will be assessed using an intraclass correlation coefficient with 60 patients

Eligibility criteria: Inclusion Criteria:

* Age at least 65 years
* Ability to walk a minimum of 6m with or without a walking Aid
* One or more falls in the last year or
* Observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Time Up and Go test, Morse Fall Scale)

Exclusion Criteria:

* Inability to understand or follow the instructions of the DGI
* Experience with the DGI in the last 6 months
* Acute illness or fracture in the lower extremities or knee/hip replacement within the last 3 months.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 1st day
measure: Dynamic Gait Index
timeFrame: 2nd day
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 1st day
measure: Time Up and Go Test
timeFrame: 1st day
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT01324986: A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraesophageal Symptoms
Gastroesophageal Reflux Disease (GERD)
Keywords: extraesophageal symptoms of gastroesophageal reflux disease
Lead sponsor: General Public Hospital Zell am See
Sponsor class: OTHER
First posted: 2011-03-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.


Eligibility criteria: Inclusion Criteria:

* persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes \>73.

Exclusion Criteria:

* previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zell am See
country: Austria
facility: General Public Hospital Zell am See
state: Salzburg
Study officials:
References:
Clinical trial NCT03801486: Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
Official title: The Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Dysfunction
Lead sponsor: Montclair State University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The investigators examined the effects on post-digestion brachial artery flow mediated dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with sprouted chickpea flour.

Detailed description: The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40% of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment of effects on post-digestion endothelial function. The investigators hypothesized that FMD would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs. 100% of semolina flour pasta.

Eligibility criteria: Inclusion Criteria:

* healthy adult

Exclusion Criteria:

* have diabetes mellitus, kidney disease, a history of cancer, cardiac issues, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions.
* food allergies relevant to wheat, gluten, chickpea, and pasta sauce.
* are currently being treated for infectious mononucleosis, hepatitis, pneumonia, or other infectious diseases.
* are unable or unwilling to refrain from recreational drug (marijuana, cocaine, etc.) or alcohol use during the 24 hours prior to your exercise session.
* use nicotine products, or non-contraceptive hormonal therapy (birth control is okay).
* are pregnant or trying to become pregnant.

Primary outcomes:
measure: Post-digestion flow mediated dilation
timeFrame: Two hours following meal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bruno JA, Feldman CH, Konas DW, Kerrihard AL, Matthews EL. Incorporating sprouted chickpea flour in pasta increases brachial artery flow-mediated dilation. Physiol Int. 2019 Sep 1;106(3):207-212. doi: 10.1556/2060.106.2019.21. Epub 2019 Sep 30.