louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03082547: A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points
Official title: A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myofascial Trigger Points
Keywords: Headache
Neuropsychological tests
Myofascial trigger points
electrophysiology
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To enroll headache patients with pericranial myofascial trigger points into the groups in our hospital outpatients and inpatients.

Brief summary: To study the clinical characteristics of headache patients with pericranial myofascial trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve the effect of headache treatment.

Detailed description: A series of neuropsychological test scale including Mini-mental State Examination(MMSE),Hamilton Anxiety Rating Scale(HAMA) and Hamilton Depression Rating Scale (HMAD) were evaluated among all patients.The needle pole electromyography (EMG) inspection were practiced on subjects with myofascial trigger points ,for analysing those electrophysiological characteristics.

Eligibility criteria: Inclusion Criteria:

* Primary headache patients with pericranial myofascial trigger points.

Exclusion Criteria:

* Cranial weeks muscle infection or trauma, medical history, physical examination, laboratory and imaging studies suggest secondary headache patients except cervicalheadache.

Primary outcomes:
measure: Electromyography
timeFrame: 30 minutes
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale(HAMA)
timeFrame: 20 minutes
measure: Mini-mental State Examination(MMSE)
timeFrame: 20 minutes
measure: Hamilton Depression Rating Scale (HMAD)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The needle pole electromyography
state: Jiangsu
Study officials:
References:
Clinical trial NCT00950547: ICU Cell Saver to Reduce Blood Transfusions in Cardiac
Official title: Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Transfusion
Cardiac Surgery
Keywords: Blood Transfusion
Cell Saver
Cardiac Surgery
Evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery in reducing blood transfusions.
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery.

METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device. The incidence of allogenic blood transfusion and clinical outcome in both groups are evaluated.


Eligibility criteria: Inclusion Criteria:

* All patients presenting for cardiac Surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Transfusions per patient
timeFrame: 10 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Cardiochirurgia European Hospital
Study officials:
References:
Clinical trial NCT01699347: Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Official title: Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: CYSTIC MALFORMATION
Keywords: OK432, CYSTIC MALFORMATION
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.

Detailed description: A cohort study, before the injection all the patients in the study will go through:

1. CT/MRI
2. US to estimate the cyst size
3. CBC, PT, PTT, INR, ASLO
4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral.

The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in.

After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia.

Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo.

Long term follow-up: 6 months, 1 year, 2 years

Eligibility criteria: Inclusion Criteria:

* LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
* ONLY IN THE HEAD AND NECK AREA
* TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria:

* penicillin allergy
* pregnancy
* familial history of RF
* Post streptococcal glomerulonephritis
* Background illness-heart, kidney, lungs
* fever \> 38.5c in the op day
* URT Infection
* Family history of PANDAS

Primary outcomes:
measure: evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
timeFrame: 4 years
Secondary outcomes:
measure: TREATMENT SAFETY BY no. of participants with adverse events
timeFrame: 4 YEARS
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Otolaryngology, Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel
name: Raanan Cohen-Kerem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01048047: Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: aliskiren
amlodipine
hypertension
ankle-foot volume
mild and moderate hypertension
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 88
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: Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.


Eligibility criteria: Inclusion Criteria:

* diastolic blood pressure \> 95 mmHg and \< 110 mmHg
* systolic blood pressure \> 140 mmHg and \< 180 mmHg
* no amlodipine therapy for the previous 6 months

Exclusion Criteria:

* diastolic blood pressure \> 110 mmHg and or
* systolic blood pressure \> 180 mmHg
* secondary hypertension
* heart failure
* diabetes mellitus
* liver or kidney diseases

Primary outcomes:
measure: Blood pressure, heart rate, ankle-foot volume
timeFrame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Secondary outcomes:
measure: Blood pressure and heart rate in sitting and standing position
timeFrame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
affiliation: University of Pavia
name: Roberto Fogari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704247: CARDIOSPACE Evaluation in Healthy Volunteers
Official title: Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: National Center for Spatial Study, Toulouse
name: Astronaut Center of China
First posted: 2016-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:

* ECG
* Brachial blood pressure
* Continuous finger blood pressure
* Ultrasound
* Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.


Eligibility criteria: Inclusion Criteria:

* Age : 18 to 40 years
* Size : 160 à 180
* Weight : BMI between 18 and 24
* Medical history :

  * No history of cardiovascular disease
  * No chronic treatment
  * No syncopal events (\>2 by year)
* Physical examination

  * Normal cardio-pulmonary ausculation
  * Normal (DBP \[60 - 90\] SBP \[100 - 140\]
  * Normal heart rate (between 50 and 80 at rest)
* Complementary examination

  * Normal Electrocardiogram
  * Presence of temporal acoustic window
* Capable to understand the objectives and constraints of this study
* Covered by health social insurance
* Have signed the informed consent

Exclusion Criteria:

* Pregnant woman (beta HCG by urinary test) or breastfeeding

  * Refusing to sign the informed consent
  * Don't understand the objectives of this study
  * Minors or majors protect by the law
  * Don't Benefit of social insurance
  * Participation at the time of study enrolment during the present trial period in another clinical trial investigating.
  * Having reached or surpassed the annual amount of compensation allowed by clinical trials
  * Receipt of any chronic and regular treatment
  * Presence of sign cardiovascular diseases during the questioning
  * Presence of sign cardiovascular diseases during the examination
  * Presence of sign syncopals events ATCD diseases during the questioning (\>2 by year)
  * Absence of temporal acoustic window with the Transcranial Doppler
  * Respiratory disorder, asthma
  * Any troubles preventing the realization of physical activity

Primary outcomes:
measure: Heart rate measure on ECG
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre de Recherche Clinique, CHU d'Angers
Study officials:
affiliation: University Hospital, Angers
name: Marc-Antoine CUSTAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03525847: The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
Official title: The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Ultrasonography
Keywords: Contrast endosonograpy
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy

Detailed description: A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors

Eligibility criteria: Inclusion Criteria:

* solid pancreatic tumor lesions

Exclusion Criteria:

* severe coagulopathy of trombocytopenia \<50.000
* patients refuse for biopsy prelevation or pacient's refuse to participate in the study

Primary outcomes:
measure: Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods
timeFrame: an average of 2 years
Secondary outcomes:
measure: Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)
timeFrame: 5 days
measure: Dysfunction in the two types of biopsies
timeFrame: day one
measure: Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core
timeFrame: day one
Other outcomes:
Locations:
city: Cluj-napoca
country: Romania
facility: Seicean Andrada
state: Cluj
Study officials:
affiliation: Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca
name: Seicean Andrada
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015.
citation: Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x.
citation: Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917.
Clinical trial NCT02437747: Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus
Official title: Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Chronic Periodontitis
Keywords: clinical trial
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.

Detailed description: Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.

The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.

HbA1c evaluated at baseline and 3 months.

Eligibility criteria: Inclusion Criteria:

1. Patients age 30 - 55 years from both genders.
2. Patients with controlled Type II Diabetes Mellitus (HbA1c \< 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
3. Patients on oral hypoglycaemic agents.
4. Subjects who have not received periodontal therapy within preceding 6 months.
5. Patients willing to comply with all study related procedures.

Exclusion Criteria:

1. Subjects who have received antibiotic treatment in the preceding 3 months.
2. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
3. Pregnant or lactating women.
4. Smokers.
5. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
6. Unwilling patients

Primary outcomes:
measure: Clinical parameter of probing pocket depth
timeFrame: 3 months
Secondary outcomes:
measure: Glycosylated haemoglobin
timeFrame: 3 months
measure: Clinical parameter of plaque index
timeFrame: 3 months
measure: Clinical parameter of gingival index
timeFrame: 3 months
measure: Clinical parameter of relative attachment level
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Dr.D.Y.Patil Vidyapeeth
name: Archana Singh, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02207647: Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Meningoencephalitis
Other Syndromes Requiring Lumbar Puncture in Emergency Department
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2014-08-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted by the Emergency ID Net Study group (P.I. David Talan), which consists of a network of 10 emergency departments in university-affiliated hospitals throughout the United States.

Brief summary: Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Progress in diagnostic technologies, especially molecular techniques based on genetic characteristics of potential pathogens, has greatly expanded the investigators capacity to evaluate specimens from patients for a much wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative agents for the approximately 50% of all such presentations which go un-diagnosed. The investigators propose a study involving a collaboration between the EMERGEncy ID NET, a network of 10 geographically diverse university-affiliated urban emergency departments (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and Prevention (CDC), to use these new technologies to address this issue.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 3 months old
* Receiving a Lumbar Puncture in the emergency department as part of their standard care.

Exclusion Criteria:

* No CSF available

Primary outcomes:
measure: prevalence of pathogens
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT02965547: Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
Official title: Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Preconditioning
Keywords: Ischemic Preconditioning
dynamic cerebral autoregulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

Detailed description: Remote ischemic preconditioning(RIPC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIPC provides neuro-protection by means of improving dCA.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 70,both genders
* Willing to participate in follow-up visits

Exclusion Criteria:

* current or having a history of chronic physical diseases or mental diseases
* suffering from infectious diseases in late one month
* pregnant and lactating women；
* smoking or drinking；
* inability to cooperate sufficiently to complete the dCA examination

Primary outcomes:
measure: phase difference(PD) in degree
timeFrame: 2 days
measure: the rate of recovery of cerebral blood flow velocity
timeFrame: 2 days
measure: gain in cm/s/mmHg
timeFrame: 2 days
Secondary outcomes:
measure: resistance index (RI) changes from supine to upright position
timeFrame: 2 days
measure: pulsatility index (PI) changes from supine to upright position
timeFrame: 2 days
measure: mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position
timeFrame: 2 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
citation: Qu Y, Liu J, Guo ZN, Zhang PD, Yan XL, Zhang P, Qi S, Yang Y. The Impact of Remote Ischaemic Conditioning on Beat-to-Beat Heart Rate Variability Circadian Rhythm in Healthy Adults. Heart Lung Circ. 2021 Apr;30(4):531-539. doi: 10.1016/j.hlc.2020.08.017. Epub 2020 Oct 5.
citation: Guo ZN, Guo WT, Liu J, Chang J, Ma H, Zhang P, Zhang FL, Han K, Hu HH, Jin H, Sun X, Simpson DM, Yang Y. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning. Neurology. 2019 Jul 2;93(1):e8-e19. doi: 10.1212/WNL.0000000000007732. Epub 2019 May 29.